Review of the Pharmaceuticals area and Preparation of a

Mid-term Pharmaceuticals Policy and Implementation Plan

for the

Ministry of Health & Social Welfare,

Liberia

Draft Final Report

Consultancy on behalf of the European Commission Bernard Osmond MRPharms - Pharmaceuticals Management Expert (Team Leader) Andy O’Connell MSc - Financing and Planning Expert Roger Bunting LLB - Health Sector Legislation Expert

April 2007

i

Table of Contents List of Acronyms and Abbreviations iii Acknowledgements v Executive Summary vi 1.0 Background 1 2.0 Introduction 1 3.0 Approach and Methodology 2 4.0 Pharmaceutical Management Issues 34.1 Management Structure of the profession of pharmacy 34.2 Education and Training 84.3 Public Sector 84.3.1 Pharmacy division, MOHSW 84.3.2 National Drug Service 94.4 Private Sector 104.4.1 Premises and Supervision 104.4.2 Importation and Registration 114.5 Production of Up-dated lists etc. 114.5.1 The Essential Medicines List for Liberia 114.5.2 Guidelines on Medicines and Medical Supply

Donations 12

4.5.3 Standard Therapeutic Guidelines and Liberian National Formulary

14

5.0 Legislative Issues 155.1 Legislation 155.2 Other Legislative Issues 185.2.1 Enforcement and Sanctions 195.2.2 Complementary and Traditional Medicines 205.2.3 National Drug Policy 215.3 Regulations 225.3.1 Pharmacy Board Regulations 225.3.2 Ministry of Health & Social Welfare, Pharmacy

Division – regulations / guidelines 23

5.4 National Drug Service 24 6.0 Financing Pharmaceuticals in Liberia 266.1 Current policy relating to health care financing for

pharmaceuticals and medical supplies 26

6.2 Strategies for financing pharmaceuticals and medical supplies

26

6.3 Policy on Cost-Sharing 276.4 Current level of funding for pharmaceuticals and medical

supplies 28

6.5 Donation of Medicines and financial implications for Liberia 296.6 The Private Pharmaceutical Sector 29

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6.7 Private-out-of-pocket Expenditure 316.8 Issues relating to future funding of pharmaceuticals and

medical supplies 31

6.9 Other financing needs relating to Pharmaceuticals and Medical Supplies in Liberia

35

6.10 Procurement and Supply Chain Management 376.11 Supply Chain Management for Pharmaceuticals and Medical

Supplies 40

6.12 Future Role of the National Drug Service 426.13 Private Sector Importation Process for Pharmaceuticals 43 7.0 Next Steps 45 8.0 Annexes i. Abbreviated Terms of Reference 50ii. List of principle persons met 54iii. Organisations represented at the consensus building workshops 55iv. Mid-term Pharmaceuticals Management Policy 56v. Implementation Plan for the Pharmaceuticals Section of the

National Health Plan 60

vi. Complementary and Traditional Medicines 79vii Legal and regulatory enforcement, Liberian National Police and

Drug Enforcement Agency 83

viii Proposed (? 2006) amendment to Chapter 30, Executive Law. 1972 87ix Legal comment to the National Health Policy and Plan Draft April

9th 2007 93

x Briefing Paper on Medicine Registration 95xi Briefing Paper on the Establishment of a Liberian Medicines

Regulatory Authority 97

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List of Acronyms and Abbreviations AHA African Health Assistance AIDS Acquired Immuno-deficiency Syndrome ARV Anti-retroviral BPHS Basic Package of Health Services CAM Christian Aid Movement CHAL Christian Health Association of Liberia CHO County Health Officer CHSWB County Health & Social Welfare Board CHT County Health Team CMO Chief Medical Officer CPD Continuing Professional Development CPOP Community Pharmacy Outreach Programme DEA Drug Enforcement Agency DFID Department for International Development - UK DPC Disease Prevention and Control DRA Drug Regulatory Authority EC European Commission EDL Essential Drugs List EPI Expanded Programme on Immunisation FBO Faith Based Organisation FFS Fee for service GAVI Global Alliance for Vaccines and Immunisations GFATM The Global Fund for HIV/AIDS, Tuberculosis and Malaria GMP Good Manufacturing Practice GOL Government of Liberia HC Health Centre HR Human Resources HRIS Human Resources Information System ICB International Competitive Bidding ICRC International Committee of the Red Cross IDA International Dispensary Association IDP Import Declaration Permit INGO International Non Governmental Organisation IPD In-Patient department JFK The JFK Memorial Medical Centre LDHS Liberia Demographic Health Survey LMDA Liberian Medical and Dental Association LMIS Logistics Management Information System LNP Liberian National Police M & E Monitoring and Evaluation MCH Maternal and Child Health MD Medical Doctor MOHSW Ministry of Heath and Social Welfare MOIA Ministry of Internal Affairs MOU Memorandum of Understanding MOV Means of Verification MTPP Medium Term Procurement Plan NARDA New African Research & Development Agency

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NDP National Drug Policy NDS National Drug Service NF National Formulary NHA National Health Accounts NGO Non Governmental Organisation NHP National Health Plan OPD Out Patient Department OTC Over the Counter OVI Objectively Verifiable Indicator PBL Pharmacy Board of Liberia PD Pharmacy Division PER Public Expenditure Review PPCC Public Procurement and Concessions Commission PRSP Poverty Reduction Strategy Paper QA Quality Assurance QC Quality Control RDU Rational Drug Use SCF Save the Children (UK) SOP Standard Operating Procedure SOP-PSM Standard Operating Procedure-Procurement Supply Chain

Management STG Standard Therapeutic Guidelines STI Sexually Transmitted Infection SWAp Sector Wide Approach TB Tuberculosis TOR Terms of Reference TRIPS Trade Related Intellectual Property Rights UNDP United Nations Development Programme UNFPA United Nations Population Fund UNICEF United Nations Children’s Fund UNMIL United Nations Mission in Liberia USAID United States Agency for International Development WB World Bank WHO The World Health Organisation

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Acknowledgements The consultancy team wishes to acknowledge the help and support given throughout this assignment by the Ministry of Health and Social Welfare, the Pharmacy Board of Liberia, the National Drug Service, the World Health Organisation, and numerous International NGOs and FBOs. In particular the Hon. Minister of Health Dr. W. Gweningale, Chief Medical Officer Dr. B. Dahn, Deputy Minister for planning Mr. S. Varpilah, Dr. S. M. sheriff, Deputy Minister for Administration, Chief Pharmacist Rev. T.T. Tyee, Special advisor Amb Mrs. C. Bright-Parker, Chairman of the Pharmacy Board of Liberia Mr. B. Johnson and DPC advisor, WHO, Dr. F. Bolay.

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Executive Summary The Ministry of Health and Social Welfare of Liberia is currently in the process of finalising a National Health Policy and National Health Plan in order to revitalise the public health sector. Issues relating to the provision of pharmaceutical services and supplies are addressed within this policy and plan. The Ministry of Health recognises the many challenges posed by the pharmaceutical sector and has requested assistance from the European Union in planning the way forward. One such challenge is the severe shortage of pharmacists in the country with all of those having some civic responsibility, working in government departments, tending to hold multiple responsibilities; in addition, and due to the low level of government salaries, they also hold posts in the private sector which may at times lead to conflicts of interest. Within the MOHSW the Division of Pharmacy has had a very low status and has frequently not been involved in decisions on drug supply and policy. The division is understaffed and has no separate budget line for its operations, because of this low level of exposure of the division and due to the Chief Pharmacist also being secretary to the Pharmacy Board there has been a blurring of the lines of responsibility between the Pharmacy Division (MOHSW) and the Pharmacy Board of Liberia, which does have its own funds and can undertake certain operations which might better be carried out by the Pharmacy Division. This has also led to a number of misunderstandings on the roles of the two bodies by the INGO community and even by the UNDP in their draft Standard Operating Procedures for supply chain management, where they attribute roles to the Pharmacy Board which should rightly be those of MOHSW Pharmacy Division. The roles of all bodies involved in the management of pharmacists, pharmacies and pharmaceuticals need to be clearly spelled out and separated. The Pharmacy Division needs to be strengthened at central level in terms both of man-power and logistical capabilities, steps have already been taken to strengthen pharmaceutical management at decentralised level with the appointment of the first three of (eventually) 15 county pharmacists. The basic publications which should define the types of drugs to be available in the public sector and their mode of use (i.e.: The Essential Drugs List, The National Formulary and the Standard Therapeutic Guidelines) are all many years out of date, and / or have never been properly published and distributed. This may have contributed to the presence of inappropriate drugs in some health units and to the poor prescribing habits noted during visits. One major achievement of this consultancy has been to update the Essential Medicines List in line with current practice, to gain acceptance of its contents by all of the main users and to fund the printing of sufficient copies for an initial distribution to health facilities throughout Liberia. Along with this the consultancy has produced, and gained acceptance of, a new national “Guidelines on the Donation of Medicines and Medical Supplies” which, it is hoped, will go a long way towards reducing the number of inappropriate donations, and also ensuring that their true value to Liberia is reflected, rather than the frequently over stated value assigned by the donor, causing potential distortion to the budget allocation for drugs. The Public Health Law of 1975 is the far reaching statute governing pharmaceuticals and the Liberian Pharmacy Board is established under that Statute as the body to control all aspects of the profession and practice of pharmacy in the country. The statute and its various provisions give the board wide powers, especially in directing the private sector. However many of the statutory responsibilities of the Board have never been implemented and others

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are widely ignored or have fallen into disuse due to recent circumstances, even membership of the Board itself is no longer as the statute stipulates and no regulation or order has been found which makes that alteration. Registration of drugs for use in the country, in both the public and private sectors, is haphazard and un-coordinated. Legally it is the responsibility of the Pharmacy Board to produce both the “Liberian Drugs Register” and “Catalogues” of drugs and medicines. In practice such registration as has been undertaken has been done by the Pharmacy Division, MOHSW and neither Register nor Catalogue have been produced, although the pharmacy division has taken a first step towards this by calling for the “enlistment” of medicines being imported by the private sector importers. The National Drug Policy, 2001, calls for devolvement of certain of the Boards’ powers to a newly (to be) formed Drug Regulatory Authority (DRA), this is in keeping with the views expressed at the consensus building workshop held by this consultancy and should be implemented as a matter of priority. This DRA should be independent of the Ministry of Health and should have the sole responsibility for the registration of pharmaceuticals for use in the country and for authorisation of their importation, quality assurance and post-marketing surveillance. The Pharmacy Board as such then retains responsibility for pharmacists and pharmacy / medicines stores premises (registration, licensing, regulatory and professional / ethical control) but not of the pharmaceuticals themselves. In Liberia, as with most poor countries recovering from protracted civil conflict, the largest portion of health expenditures is covered by humanitarian aid in the initial phase. The National Drug Service, NDS, appears to be fairly well structured and capable of handling its current work load, much of which has to do with the handling of supplies procured by the various programmes under the umbrella of the Global Fund. However overtime the progressive improvement of public finances should allow the Treasury to shoulder an increasing share of health expenditures and as the availability of government or donor funding increases, NDS capability to undertake full scale procurement under International Competitive Bidding (ICB) or other conditions imposed by current procurement law or donor requirements needs to be strengthened. Funding and Technical Assistance for this have been promised under the next round of the GFATM. In the short-term there is need to estimate the funding gaps being created by the withdrawal of NGOs from the sector so that there is not a collapse of health services, and secondly, in the medium to long-term there is need to estimate the overall cost of drugs and medical supplies needed to provide essential health services to all the people of Liberia. It is however possible in the interim to do some estimations of the level of funding that may be required to fund pharmaceutical and medical supplies to deliver the BPHS. This can be done by collating data from a number of existing plans which have quantified pharmaceutical and medical supplies for the major national vertical programmes and by using some per capita expenditure data on usage of general curative drugs reported by an INGO working in the health sector in Liberia. This consultancy has worked with the NDS management to produce a draft development plan and estimated financial requirements for a fully functional and financially independent NDS. However, currently- NDS does not know the value of all the stocks which it holds on its premises, this

is due to medicines procured through outside agencies being delivered without copies of invoices just quantities specified on delivery notes , so NDS not aware

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of the value of stock for which they have a responsibility for and currently there are no arrangements made to cover loss of this stock;

NDS operates mainly, from its central warehouse in Monrovia and does not fully utilise its depots to re-position its drugs and medical supplies based on demand knowledge;

There is poor coordination and information exchange with the other procuring agents of the health sector especially those receiving donor support;

The status of stock keeping in health facilities is not known, nor is the current use of SOP manuals, BIN cards, etc, and if they exist there is need to ensure that the quality of the information they contain is correct and useable.

Structurally and legally NDS should be repositioned as an autonomous and professional “not for profit” entity or partnership with MOHSW / GOL as the legal partner, but contract-based client, with the current board reconstituted, shortened and repositioned to reflect the new autonomous status. The school of pharmacy at the university is in a seriously run down condition. The premises themselves are structurally sound and plenty large enough for their purpose, the library is large and well fitted but with few relevant or recent reference or text books. Laboratory rooms are also adequate in size but in need of refitting and are without equipment or reagents. A plan to turn a previous student dormitory block into laboratories for the college of medicine and school of pharmacy has stalled, leaving students short of accommodation and still with no laboratories. There are no full time staff at the school; the dean is both part time and engaged in an acting capacity, other pharmacists from both public and private service act as lecturers. Lectures etc. are held at times to fit with the lecturers’ schedules in their other duties, which can cause short notice cancellation of classes etc. The team is working with the dean to establish the human resource, physical and financial needs to bring the school of pharmacy up to a more acceptable standard and also to identify the requirements for re-establishing a dispenser’s training school. The private sector is poorly controlled; this appears to have come about through a combination of years of lack of proper knowledge or publication of the Public Health Law, 1975, possibly due to constant changing of responsible officers; and a lack of commitment and political will to enforce those laws. Most pharmacies are not owned by pharmacists but employ a pharmacist to “supervise” the professional aspects of the business and to satisfy the legal requirements. Due to the overall shortage of pharmacists each one is now “supervising” more than the legally allowed number of pharmacies. Regulations also stipulate that there shall be a minimum of 500 ft. (150 m.) between pharmacy premises. In practice pharmacies have been allowed to proliferate in Monrovia and the 500 ft rule has been completely ignored. Much of the blame for this has been put (by the Pharmacy Board) on past interference by political “godfathers” when they have tried to refuse licences to applicants who have not complied with this regulation. However the number of pharmacies in greater Monrovia has now been frozen and steps will be taken to tighten and up-grade the regulations on suitability of premises which may lead to closure of some of the less compliant and more poorly run pharmacies. A similar situation exists with medicine stores. By law no medicine store should be established within 10 miles of a pharmacy (an unfair and illogical rule in the first place) in

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practice (2006) over 200 medicine stores were licensed by the board in Montserrado County, the majority in greater Monrovia, and many more are operating with no licence. Here again the picture is one of regulations, whether by the Pharmacy Board or Pharmacy Division being largely unknown, unpublished and not clearly drawn. Likewise the law limiting medicine stores to the sale of class “C” medicines is completely ignored and not enforced and there is a proliferation of illegal hawkers of medicines on the streets of Monrovia. Enforcement of these laws is another area where there has been confusion and uncertainty. The consultancy team has supported the Pharmacy Division in hosting a joint meeting with the Narcotics Bureau of the Liberian National Police (LNP) and the Drug Enforcement Agency (DEA). This has helped to define each agencies responsibility and to establish a close and on-going working relationship between the three which should result in better efforts to clean up the illegal sellers and reduce the quantities of substandard and fake medicines on the market. Again from the overarching statute, the Public Health Law, clear and effective provisions of inspection, search, confiscation and criminal handover are laid out for MOHSW, Pharmacy Board and Pharmacy Division to execute together with LNP and the DEA. However these provisions have not been implemented largely due to lack of knowledge and understanding of both the law and existing regulations. In the area of complementary and traditional medicines, while the 2001 National Drug Policy calls for a clearly regulated sector, with active policy guidelines and regulatory input, this is absent; with the MOHSW Board of Complementary Medicine effectively moribund. The Chief Medical Officer has initiated moves to revitalise the areas of traditional and complementary as a contributor to the National Health Policy and Plan. Traditional medicine has been under the Ministry of Internal Affairs since time immemorial, the consultancy team and pharmacy division have established contact with the sector under an assistant Minister for Cultural Affairs and discussions on positive MOHSW input and linkage are now in hand.

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Liberian Pharmaceutical Sector Implementation Plan 2007/’08-2009/’10 - Overall Objectives (Nested logical framework of the National Health Plan 2007-2011) Objectively Verified Indicators Means of

Verification Assumptions

Health Policy Vision Improved health and social welfare status and equity in health [Expand access to basic health care of acceptable quality through an equitable, effective, efficient, responsive, and sustainable health care delivery system]

Infant Mortality Rate to be reduced from 157/1,000 live births

in 2006 (UNICEF 2006) to XX by 2011 Under-5 Mortality Rate to be reduced from 235/ 1,000 live

births 2006 (UNICEF 2006) to XX by 2011 Maternal Mortality Ratio 580/100,000 live births in 2005

(UNFPA 2005) to XX by 2011

LDHS LDHS LDHS

The overall policy goal can be attained through the improved management of expanded resources, provided by the state, donors, international agencies, non-profit health care providers, economic actors and communities.

Strong, structured partnerships around shared objectives and approaches, within and outside the health sector, will lead to improve health status.

Overall Objective (Goal) Increased access to efficacious, high-quality, safe and affordable medicine for the people of Liberia

100 % Availability of tracer essential drugs (specify which

drugs, check) by 2011 Stock out rates on essential medicines reduced by 75% by

2011 Fully Immunization Children Coverage reaches 85% and

being maintained by 2011 Contraceptive prevalence rate increased from 5% in 2006

(NHPlan) to 15% by 2011

LMIS LMIS EPI LDHS

The MOHSW capacity is strengthened to provide leadership and coordination of the health sector in Liberia All health partners align with MOHSW policy and strategies and harmonize their support to implement MOHSW policy

Immediate Objective (Purpose) To use available resources to develop pharmaceutical services to meet Liberia’s requirements in the prevention, diagnosis and treatment of diseases by using efficacious, high quality, safe and cost-effective pharmaceutical products

MOHSW budget allocation for Pharmaceuticals and medical

supplies increasing from 13% in 2006/7 to 20% by 2010/11 NDS maintaining its capital through revolving fund by

recovering cost of sales and services by 2011 Number of registered Pharmacists, currently 31 in 2007

increases by 5 per year until 2009 and by 20 per year thereafter

100% of pharmaceutical donations comply with national guidelines by 2011

Number of pharmaceutical samples tested reach the required quality standards increasing annually

PER Annual Audit. PBL Registrar. PD Annual Report. DRA Annual Report

GOL allocation to the health sector increases annually Resources are secured to capitalise NDS GOL/MOHSW retain and deploy health workers through appropriate conditions of service All donors supporting drugs and medical supplies in the health sector will adhere to the principles of an essential drugs programme Effective collaboration is established and maintained between MOHSW and Ministry of Justice on regulation

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Specific Objectives

Objectively Verifiable Indicators (OVIs)

Means of Verification (MOVs)

Assumptions

Specific Objective 1: To coordinate policy and regulation for the pharmaceutical sector and for the control of substances of abuse in Liberia, in collaboration with relevant GOL agencies

Essential Drug List revised and disseminated periodically,

2007, 2009 & 2011 National Formulary revised and disseminated periodically,

2007, 2009 & 2011 Sources of funding for pharmaceuticals diversified by 2009 Legislation and regulation on pharmaceuticals and controlled

substances published and widely distributed by 2008 Pharmacy Division representing Liberia internationally at

appropriate forums on pharmaceutical issues relevant to Liberia

Number of Complementary Medicine Practitioners registered increasing annually

Annual Report Annual Report NHA PD/PBL Annual Report PD Annual Report PD Annual Report

All pharmaceutical institutions recognize the regulatory function of the MOHSW, PBL and DRA and adhere to their regulations Other GOL agencies with responsibility for the control of pharmaceuticals, substances of abuse and complementary medicines will work in collaboration with the MOHSW Laws and conventions governing patents on drugs shall be reviewed, in order to ensure that the Liberian public is not disadvantaged from accessing essential drugs and medical supplies Donor support for pharmaceuticals is aligned and harmonized to support MOHSW annual needs for delivery of the BPHS

Specific Objective 2: To ensure constant availability of safe and effective drugs to all segments of the population

Cost of pharmaceutical, medical supplies and diagnostics

required to support the BPHS established by end of 2007 and updated annually to inform annual budgeting and planning process

Pharmaceutical storage sufficient and suitable throughout the supply chain

NDS and all Drug Depots reporting timely according to SOP guidelines by end of 2007 and maintained thereafter

Annual Procurement Plan developed for 2007/2008, moving towards a Medium Term Procurement Plan by 2008/2009 for all Pharmaceuticals and Medical Supplies

Logistics Management Information System established for GFATM products in operation by 2007 and expanded to include all products by 2009

Procurement Unit established in NDS by end of 2007 and doing increasing number of International Competitive Bids from 2008 onwards

Annual Operational Plan PSM Supervision Reports PSM-SOP Progress report MTPP, Annual Report PSM-SOP Progress report & Annual Report NDS Annual Report

GOL will continue to increase allocations to health in general and for procurement of drugs in particular MOHSW policies on supply of pharmaceuticals and medical supplies will not de-capitalise NDS NDS is sufficiently capitalised to allow it to function as an autonomous not-for-profit sustainable central medical stores to supply pharmaceuticals and medical supplies for public health services Health infrastructure is strengthened to facilitate supply chain management for pharmaceuticals and medical supplies Capacity in MOHSW and NDS will be sufficient for MOHSW to become Principle Recipient for Global Funds in 2009

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Specific Objectives

Objectively Verifiable Indicators (OVIs)

Means of Verification (MOVs)

Assumptions

MOHSW contracting NDS for supply of Pharmaceuticals and Medical Supplies for delivery of the BPHS through annual contract

Procurement Unit Report

Specific Objective 3: To facilitate rational use of drugs through correct diagnosis, sound prescribing, good dispensing practices, and appropriate usage

Standard Treatment Guidelines revised and health workers

trained through in-service training in their use periodically, 2007, 2009 & 2011

Pharmaceutical and Therapeutic Committees established by 2008 and functioning at central level and in all counties by 2009

Curriculum for Pharmacists and Dispensers training revised by 2007 and periodically thereafter, 2009 & 2011

Pharmaceutical component of all health workers curriculum revised periodically, 2007, 2009 & 2011

Number of Pharmacists graduating from School of Pharmacy increasing to at least 20 by 2009

At least one Pharmacist deployed and working as part of the County Health Team in every county by 2011

Plan for Continuing Professional Development for Pharmacists developed and incorporated into annual human resource development plan by 2008

Annual health promotion campaign on rational use of pharmaceuticals carried out at national and county levels

Annual Report Annual Report Annual Report SoP Annual Report HR Division Annual Report SoP HRIS Annual HR Development Plan Annual Report

GOL addresses conditions of services and incentives to ensure retention and deployment of health workers in rural areas Pharmacy as a profession will continue to attract sufficient numbers of entrants Sufficient resources will be made available to support pre-service training and continuing professional development of health workers MOHSW public health campaigns are sufficient to promote ration drug use amongst the general public in Liberia

Specific Objective 4: To strengthen the regulation of pharmaceutical professionals and pharmaceutical institutions

Code of ethical practice developed for Pharmacists and

adherence monitored for annual retention of licences and being implemented by Pharmacy Board of Liberia by 2008

Continuing Professional Development scheme for Pharmacists established for retention of licence and being implemented by Pharmacy Board of Liberia by 2010

All Pharmaceutical institutions registered/licensed by the Pharmacy Board of Liberia

All Pharmacies and Medicine Stores inspected at least annually by 2009, percentage of inspections meeting

PBL Annual Report PBL Annual Report PBL Inspectors Reports PBL Inspectors Reports/ CHTs annual reports

All agencies in Liberia employing practicing pharmacists comply with national regulation on registration Capacity is built and resources provided to the Pharmacy Board of Liberia to fully implement its mandate Capacity of County Health Team is strengthened to allow them to carryout their regulatory roles relating to Pharmaceuticals and controlled substances

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Specific Objectives

Objectively Verifiable Indicators (OVIs)

Means of Verification (MOVs)

Assumptions

minimum standards increasing by 2009 and progressing Annual awareness campaigns on obligations and rights of

Pharmacists and Pharmacy Institutions on pharmaceutical legislation and regulations carried out

PBL Annual Report

Specific Objective 5: To ensure that all pharmaceuticals available in Liberia are registered, meet approved quality standards and are approved for their intended use

National Drug Regulatory Authority Established by 2008 National Drug Quality Assurance Laboratory established and

functioning by 2008 Current Enlistment of Pharmaceutical Products becomes

National Register of Pharmaceuticals in Liberia by 2008 Manufacturers of Pharmaceuticals to be imported into Liberia

doing annual registration by 2009 All Pharmaceuticals imported into Liberia conform to GMP

and are authorized for import through the issue of an Importation Permit Declaration by the Drug Regulatory Authority by 2008

Number of pharmaceutical import samples being tested in Liberia increased annually from 2007

Number of pharmaceutical samples being tested as part of post marketing surveillance increasing annually from 2007

Number of arrests and confiscation of sub-standard and counterfeit pharmaceuticals and controlled substances increasing annually

DRA Annual Report

PD/DEA Annual Report

Sufficient resources are allocated to establish the Drug Regulatory Authority of Liberia Market size will not restrict manufacturers from the registering their pharmaceutical products in Liberia Other GOL agencies will collaborate with the MOHSW and DRA in the control of sub-standard pharmaceuticals and the control of substances of abuse

NB: The full implementation plan may be found in annex v.

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1.0 Background Pharmaceutical management (supply and demand; procurement, storage and distribution practices; use, regulation and quality control…) in Liberia has been very weak. Among other consequences, the access (including affordability) to quality drugs in a sufficient quantity and adapted to the country morbidity remains an acute problem; There is no effective regulation of the importation of pharmaceutical drugs in the country through porous borders, which with a lack of drugs testing capacity at national level, contributes to a significant spread of fake and sub-standard drugs on the market.

Among the constraints which have been standing out in relation with pharmaceuticals are: Lack of an adequate and consistent drug policy. Although most elements of the National

Drug Policy, 2001, are highly relevant some must be more fully developed and complemented by additional components. The policy must then be properly implemented.

Shortage of relevant information. Inadequacy of existing information and coordination systems, particularly on the supply side with too many separate agencies bringing un-coordinated imports of medicines and medical supplies.

Lack of effective regulation and control. Drugs have been freely imported and sold by private entrepreneurs, in the absence of quality checks.

Lack of a management structure specific to the pharmaceutical area within the Ministry of Health and Social Welfare, both centrally and at a de-centralised, county, level.

Fragmentation of all core functions, which are carried out by multiple, loosely-connected bodies in both the public and private sectors, frequently with conflicts of professional and financial interests.

Lack of an up to date essential drugs list, as well as of official guidelines for stock management, quality control or rational use of drugs. Aid agencies and NGOs had developed multiple lists and guidelines, which needed to be merged into a common list, to be adopted by all partners.

Shortage of skilled personnel. Little formal training of pharmacy staff is carried out, either of pharmacists once they have undergone their one year pre-registration training, or of dispensing staff at facility level.

Limited availability of essential drugs due to low priority in the budget and a reliance on donations and INGO support, which is now reducing.

Inadequate use of available drugs, with out of date and user non-friendly standard therapeutic guidelines, which in any case have not been properly distributed.

2.0 Introduction This consultancy has been part of a wider programme to support the re-establishment and functioning of key public Ministries of the government of Liberia, and has had the following specific objectives as set out in the ToR:

2

To support the Ministry of Health in assessing the pharmaceutical system in Liberia (elaboration of an information base and a situation analysis regarding the area of pharmaceuticals in Liberia).

To support the Ministry of Health in elaborating a pharmaceuticals policy and plan relevant to the mid-term Health and Social Welfare National Policy and Implementation plan currently being completed.

To support the adoption and start of implementation of immediate recommendations and improvement of practices in pharmaceutical management.

The assignment is seen as covering all elements of the pharmaceutical sector in Liberia, public and private, government, NGO, FBO etc. In fact all bodies involved in the procurement, sale, distribution, prescribing, dispensing, and control of pharmaceuticals and the profession of pharmacy. Whilst there have been a number of past consultancies and reports focussing on the National Drug Service (NDS) there has not, to our knowledge, been a “sector-wide” approach of this nature attempting to pull all of the elements together. The assignment has taken place at a time when the country as a whole is in a stage of transition between emergency and development, and the health sector in particular is trying to re-build on the basis of a new National Health Policy and Mid-Term Implementation Plan. Including a “Basic Package of Heath Services” A secure supply of basic, affordable and good quality medicines is fundamental to this re-building if public sector health care is to have the confidence of the public. At the same time the private sector has a significant role to play, frequently being the “first stop” in an episode of illness the services and products which it offers must be of high quality. Note: This report should be read in conjunction with the previous, mid-term, report which goes into greater detail in some areas. Since production of the mid-term report the team have found little significant new material, exceptions being in the areas of traditional and complementary medicine and of law enforcement which are presented as annexes to this report. In this latter stage of the assignment the team has concentrated more on assisting with the planning for implementation of the pharmaceutical component of the National Health Policy, and in practical support to implementation of previous recommendations. 3.0 Approach and Methodology The team has carried out a review of background materials including reports on NDS, the National Health Policy and Plan, the National Drugs Policy, the impending “Transition Gap”, and Decentralisation. The Public Health Law and its various sections and regulations relating to Pharmacy have been studied as have the most recently available regulations and guidelines relating to the Liberian Pharmacy Board and NDS. However it should be noted that following many years of war and civil unrest, with the associated looting of public institutions, some background documents may well be missing. In an attempt to gain broad acceptance of the recommendations which are expected from the team wide ranging meetings have been held and consensus has been sought at all levels and between all stakeholders.

3

The team members have held meetings with officials of the MOHSW, NDS, CHAL, UNMIL, the Liberian National Police forensic laboratory, Drug Enforcement Agency (DEA) numerous INGOs’ and FBOs’ and other key stakeholders. This has included meeting with various other consultants on related topics such as the BPHS, Human Resources and resource development, re-vitalisation of the health professions training schools, family and reproductive health etc. Regular contact has been maintained with the Chief Pharmacists and members of the Pharmacy Division MOHSW and weekly or fortnightly meetings have been held with members of the Pharmacy Board of Liberia. Visits have been made to Public and FBO health facilities in Grand Cape Mount, Bomi, Margibi and Grand Bassa counties and to a number of retail and wholesale pharmacies in Monrovia and Kakata and to medicine stores in Monrovia and Robertsport. Two workshops have been held, one to present the base line findings of the team with the aim of reaching a wide consensus on the priorities for improvement in the areas of pharmaceutical legislation, importation and control of drugs, quality assurance, availability and use in the public sector and better control of the private sector. The second workshop to present the draft of a new, up to date, Essential Medicines List for Liberia, and the draft of a new Guidelines on the Donation of Medicines and Medical Supplies. 4.0 Pharmaceutical Management Issues 4.1 Management Structure of the profession of pharmacy The status of Pharmacy in Liberia is at a very low level. There are currently only 31 active pharmacists on the register although five more have recently completed their post-graduate training and are waiting to be registered. Under the Public Health Law of 1975 the Pharmacy Board of Liberia is responsible for all professional aspects of Pharmacy including: Setting examinations Registering Pharmacists Licensing Wholesale and Retail Pharmacies Licensing Medicines Stores Inspection of all Pharmaceutical Premises Under the law the PBL is at least theoretically autonomous but reports directly to the Hon. Minister of Health and Social Welfare. It receives no grant or financial support from government and derives its income from the fees charged for registration of Pharmacists and Pharmaceutical premises. Whilst this financial autonomy is welcome there is a temptation to increase the number of pharmacies and medicine stores licensed simply in order to raise revenue with no social or other need. Membership of the Pharmacy Board: The statute establishing the Board specifies its membership as: The Chief Pharmacist, MOHSW

4

A representative of the Liberian Medical Association A representative of the Liberian Pharmacists Association and Two pharmacists in private practice, appointed by the Minister The chairman being appointed from within the above membership by the Minister for a period of two years at a time, in current practice the membership of the Board is different from that specified in the statute and comprises:

- Chairman, A private pharmacist, (currently also Operations Manager of NDS), appointed by the Minister

- Vice Chairman, A Private Sector Pharmacists / Industrial Chemist (currently chairman of the Liberian Pharmacists Association)

- Secretary to the Board The Chief Pharmacist MOHSW - Legal Counsel A representative of the Ministry of Justice - Two other Pharmacist members – At the moment one of these is the acting dean of the

school of pharmacy. In addition there are currently two ex-officio members including the country’s “Ambassador at Large” who is a pharmacist and advisor to the President. There does not appear to be any legal basis for this change in membership. The Pharmacy Board has offices in Monrovia and meets on a regular basis, every month. It is responsible for setting policy and drafting regulations for control of the private Pharmaceutical Sector. Such regulations come under the Public Health Act 1975 and its amendment of 1983 and must be approved by the Hon. Minister of Health. Various regulations and policies have been written; unfortunately many of these are confused and contradictory, as are the responsibilities for their implementation and enforcement. The Board employs various staff, the Registrar and deputy registrar and is building up an Inspectorate Department. The inspectors are initially being drawn from recently qualified pharmacists. A room within the Pharmacy division in MOHSW is designated for their use and has been rehabilitated by this consultancy, for which strengthening of the inspectorate function is a priority. The Pharmacy Board is the de facto Drug Regulatory Authority of Liberia with the Pharmacy Division of the MOHSW as its implementing arm. This is an unsatisfactory arrangement and one which most countries have now abandoned as being un-workable and confusing. The National Drug Policy calls for the formation of a new independent body (A Drug Regulatory Authority), separate from the Pharmacy Board, to take over some of its duties and the general view of the Board members is that this policy should now be implemented. The diagram and table on the following pages illustrate the current and proposed situations.

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Diagram 4.1: Current Relationships and Cross Memberships of the Controlling Bodies of Pharmacy

Relationships between the MOHSW, National Drug Service (NDS), Pharmacy Board and Pharmacists Association etc.

MINISTRY of HEALTH

CURATIVE

PHARMACISTS

NDS PHARMACY DIVISION PHARMACY BOARD ASSOCIATION

Chairman

Operations Chief Pharmacist Registrar Employed by Board

Manager Registration of Pharmacists Registered Pharmacists

Deputy Deputy Licensing of Pharmacies

Licensing of Medicine Stores Private Pharmacies

INSPECTORATE Registration of Drugs & Medicine Stores

Q.C. LAB MOH HOSPITALS etc. INSPECTORS - Employed by Board

NGOs, FBOs

U.N. AGENCIES

DRUG IMPORTERS

Secretary to the Board

Chairman of Phcy. Board

Reports to the Hon. Minister

Authorises Imports

All imports to be registered

Q.C of Imported Drugs

Vice ChairmanPhcy. Board

Hon. Minister is Chair of NDS Board

Some by-pass official route

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Diagram 4.2: Possible membership of the controlling bodies and their relationships Reporting Advisory

Chairmen of Pharmacy Board, Drug Regulatory Authority and NDS are all appointed by the Hon. Minister but are not employees of the MOHSW

Hon Minister of Health

Deputy Minister Chief Medical Officer

Pharmacy Division

Chief Pharmacist Deputy (Clinical /RDU) Deputy (Financial/Supply)

Drug Regulatory Authority

Chairman (Not MOHSW) Chief Pharmacist Rep. of NDS One Retail Pharmacist Rep. of Pharm. Importers Rep. of Min. of Commerce Rep. of Med. & Dent.Assn Rep. of Trad Meds

Pharmacy Board of Liberia

Chairman (Not MOHSW) Chief Pharmacist Rep. of Pharmacists Assn. Dean of Pharmacy School Other Academic Rep. of Pharmacy Owners

National Drug Service

Chairman (Not MOHSW) Rep. of MOHSW Rep of MoFinance Rep of MoPlanning Rep of FBOs Rep of INGOs Rep of Med. & Dental Asn

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Table 4.1: The revised responsibilities of the Pharmacy Division, Pharmacy Board, Drug Regulatory Authority and National Drug Service should be as follows: Pharmacy Division MOHSW Pharmacy Board of Liberia Drug Regulatory Authority National Drug Service Headed by the Chief Pharmacist. Responsible for: - Setting drugs / medicines policy for the public sector. - Advising the Ministry on budgeting and resource allocation for pharmaceuticals - Establishing and ensuring operation of a National Drug and Therapeutics Committee. - Production and regular updating of the National Essential Medicines List, National Formulary and Standard Therapeutic Guidelines - Supporting the quantification of drug requirements for all MOHSW health facilities - Coordinating required inputs of pharmaceuticals and medical supplies from the various vertical programmes - Liaison and coordination with NDS on supply chain management - Advising on deployment of pharmacists and dispensers and their professional development - Coordinating and providing support supervision to county pharmacists

Chairman appointed by the Minister of Health on advice of the Board Responsible for: - Setting qualifying examinations for students of pharmacy - Examining post graduate pharmacists for membership of the Liberian Pharmacists Association - Registering and maintaining the register of Liberian Pharmacists - Supervision and control of the professional and ethical behaviour of Pharmacists in Liberia - Ensuring the continuing professional development of pharmacists - Licensing Retail and Wholesale Pharmacies and Medicine Stores - Licensing of pharmaceutical importers - Inspection of Pharmacy and Medicine Stores premises to ensure their suitability for purpose.

Chairman appointed by the Minister of Health on advice of the Authority Responsible for: - Registration of pharmaceuticals authorised for use in Liberia - Compilation and maintenance of the catalogue of registered drugs as required by the public health law - Authorising importation of duly registered drugs by licensed pharmaceutical wholesalers and importers - Inspection of imported pharmaceuticals for compliance with authorised products - Quality assessment and assurance of imported pharmaceuticals - Establishment, operation and control of a national pharmaceutical quality control laboratory - Submission of samples to regional or other laboratories for analysis when necessary - Post-marketing inspection of pharmaceuticals in wholesale and retail pharmacies and medicine stores

Chairman appointed by the Minister of Health on advice of the Board Responsible for: - Coordinating procurement, storage and distribution of all pharmaceuticals and medical supplies purchased under the national budget including supplies purchased under all vertical disease control programmes - Storage and distribution of all supplies purchased under vertical disease control programmes on payment of agreed fees - Ensuring that all pharmaceuticals procured are in compliance with the National Essential Medicines List - Liaison and coordination with the Pharmacy division on supply Chain management

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4.2 Education and Training Pharmacists are educated at the School of Pharmacy, Dolgotti University, which also has a Medical College. The degree course is 4 years followed by one year internship which may be served in the public or private sector. The school is in a very poor situation. It has no full time staff, including the acting Dean. All of the lecturers are part time and are generally pharmacists employed by the MOHSW (eg the Chief Pharmacist and deputy) or in retail pharmacy business. Many of the lecturers are themselves only recently qualified (and therefore inexperienced) and none has anything but a first degree. Since all of the staff hold other positions lectures etc. are held at times to fit with the lecturers’ schedules in their other duties, which can cause short notice cancellation of classes etc. The faculty has almost no equipment and no functioning laboratory. The Chief Pharmacist made a report on the situation with recommendations for improvement, to the previous Minister of Health, but received no response. The premises themselves are structurally sound and plenty large enough for their purpose, the library is large and well fitted but with the few reference and text books are old and out of date. Laboratory rooms are also adequate in size but in need of refitting and are without equipment or reagents. A plan to turn a previous student dormitory block into laboratories for the college of medicine and school of pharmacy has stalled, leaving students short of accommodation and still with no laboratories. Despite this the number of students registering to study for a degree in pharmacy has increased considerably this year and from an average annual output of only 5 – 7 per year 33 new students have registered this year. The team is working with the dean to establish the human resource, physical and financial needs to bring the school of pharmacy up to a more acceptable standard. This will involve not only hardware inputs – equipment, reagents, books etc. but also the up-grading of skills and qualifications of the lecturers, probably requiring the employment of additional staff while present staff members are under training. In addition to the basic qualification and post graduate training a process of regular continuing professional development (CPD) should be put in place to ensure that pharmacists are kept up to date with developments in their profession and the field of pharmaceuticals generally. Proof of having undertaken some form of CPD should eventually be made a condition for the annual retention of pharmacists on the pharmaceutical register. In the past there was also a formal education and training system for dispensers, albeit on a part-time, evening, basis. This ceased some years ago and should be revived, ideally as a full time course in line with other allied health professionals. The Liberian Pharmacists Association has produced an outline document of the requirements but this needs a great deal more attention, hopefully from the recent / on-going USAID consultancy on training schools. 4.3 Public Sector 4.3.1 Pharmacy Division, MOHSW The Division of Pharmacy is a sub-division of the curative department of the MOHSW, the Chief Pharmacist reports to the Chief Medical Officer. The division has had a very low status and level of recognition within the Ministry and has frequently not been involved in decisions

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on drug supply and policy. It is understaffed, under resourced and has no separate budget line for its operations. The Chief Pharmacist is also secretary to the Pharmacy Board and tends to carry out many of his Pharmacy Board functions from his office within the Ministry of Health due to the Pharmacy Division being seen as the implementing arm of the Pharmacy Board. Along with the fact that the Pharmacy Board does have its own funds and so can undertake certain operations which might better be carried out by the Pharmacy Division there has been a blurring of responsibilities between the two bodies. This has led to a number of misunderstandings by the INGO community and even by the UNDP. In their draft Standard Operating Procedures for supply chain management they attribute roles to the Pharmacy Board which should rightly be those of MOHSW Pharmacy Division. The severe shortage of pharmacists in Liberia has led to many of those with some civic responsibility, working in government departments, holding multiple responsibilities further confusion the “who does what” situation. See Diagram 4.1 above. The roles of all bodies involved in the management of pharmacists, pharmacies and pharmaceuticals need to be clearly spelled out and separated as illustrated in table 4.1 and diagram 4.2 above. Until such time as the new Drug Regulatory Authority is properly constituted and functional the pharmacy division should continue in its role of acting as the implementing body for the registration of drugs and inspectorate functions. During its remaining time the team will assist the pharmacy division in setting up simple data bases for the recording of registration applications and premises licensing. 4.3.2 National Drug Service The other body which is normally considered as “Public Sector”, although constitutionally it is a non-governmental organisation, is the National Drug Service. Currently NDS acts mainly as a conduit for drugs and medical supplies procured by other agencies, vertical programmes and INGOs. It is seriously underfunded and therefore under stocked. Government funding this year was budgeted at U.S. $ 1 million but in practice only $ 350,000 has been released. This has lead to widespread use of the private sector by the INGOs’ and FBOs’ although they say that they would prefer to use NDS if it was capable of providing their requirements. NDS appears to be fairly well structured institutionally and capable of handling its current relatively small work load. If the NDS is to strengthen its current position in the pharmaceutical sector in Liberia it will need to grow in terms of its turn-over and market share through a business model that ensures it’s sustainability and maintains it’s not-for-profit status; and as the availability of government or donor funding increases, NDS capability to undertake full scale procurement under ICB or other conditions imposed by current procurement law or donor requirements needs to be strengthened. Funding and Technical Assistance for this have been promised under the next round of the GFATM. This consultancy team has worked with the NDS management to produce a business development plan in order to estimate the financial requirements for a fully functional and financially independent NDS based on a study of the potential market size and target customers’ base. This will allow planning the size of investment to be done to constitute an initial revolving fund and the need in cash flow, to define the procurement procedures and plan the size of the capitalisation required. In addition the need for initial investment in infrastructure and the related costs of establishing and maintaining a supply chain have been estimated.

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NDS has a potential problem with the occupancy of its present site at the JFK Medical Centre compound, although this is supposed to be provided free of charge JFK are now insisting on payment of rent which NDS cannot afford. This issue with JFK could be resolved by NDS moving to new premises for which they already have a 5 acre site in Paynesville, an estimate for the construction and fitting of new warehouse premises on this site have been prepared by the team.

4.4 Private Sector Unfortunately the private sector is poorly controlled; this appears to have come about through a combination of lack of commitment and political will to enforce the laws; together with a considerable number of conflicts of interest and vested interests over a period of years. However the private pharmacy and medicine store owners have expressed a need for training in business management. If rational drug use (RDU) is to be practiced then there is a need to also train dispensers and pharmacy and medicine store workers on customer relations and RDU. 4.4.1 Premises and Supervision The 1975 law recognises the shortage of pharmacists and allows for a pharmacist to supervise up to three pharmacy premises “until such time as there are sufficient pharmacists to comply with the ‘one pharmacy / one pharmacist’ requirement”. Due to the shortage of pharmacists and failure to restrict the number of new pharmacies opening some pharmacists are “supervising” up to 8 pharmacies according to the 2006 register. Regulations also stipulate that there shall be a minimum of 500 ft. (150 m.) between pharmacy premises. In practice pharmacies have been allowed to proliferate in Monrovia, the 500 ft rule was apparently rescinded by a previous Minister of Health but no written regulation etc. has been found to this effect. The Pharmacy Board has now placed an embargo on the opening of new pharmacies within Monrovia A similar situation obtains with medicine stores. By law no medicine store should be established within 10 miles of a pharmacy (an unfair and illogical rule in the first place) in practice (2006) over 200 medicine stores were licensed by the board in Montserrado County, the majority in greater Monrovia. Similarly the regulation limiting medicine stores to the sale of class “C” medicines is completely ignored and not enforced. The Pharmacy Board is considering ways in which the numbers of pharmacies and medicine stores may be reduced to a more manageable level. In particular an up-grading of the suitability of premises requirements, and their more strict enforcement. Also in the case of medicine stores a reinforcement of the requirement to employ a registered dispenser. Whatever regulations are put in place and however much requirements are tightened little real progress will be possible without a stronger inspectorate function and if pharmacists are used as inspectors this further increases their range of duties and reduces the time available for supervisory activities. There is also a financial aspect in that when the number of premises is reduced the income of the Pharmacy Board from licence fees will fall accordingly, thus reducing their ability to employ (pay) inspectors; unless of course there is a substantial increase in the license fee.

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4.4.2 Importation and Registration A further feature of the private sector is that it is the major importer of medicines into Liberia, and there are currently around 17 active importers. At the moment there is no viable control over which medicines may be imported and from where. Recent attempts by the Chief Pharmacist, in his capacity as secretary to the Pharmacy Board, to bring some order and control by requiring all pharmaceutical importers to submit lists of those medicines which they may wish to import (an “enlistment” exercise) has largely been frustrated by the importers themselves flooding the “list” with every conceivable product. The consultancy team is now working with the Chief Pharmacist to turn the “enlistment” into the first step in a process of “Registration” and has held a joint meeting with the major importers to introduce ands discuss future requirements for the registration of medicines by the manufacturers and appointment of local importers / wholesalers as official distributors / agents on behalf of the manufacturers. (see Briefing Paper annex x) 4.5 Production of Up-dated Essential Medicines List and Guidelines on Medicine and Medical Supply Donations 4.5.1 The Essential Medicines List for Liberia 2007 One of the elements of the teams Terms of Reference was to review the current Essential Drugs List and propose a list acceptable to most partners. The need for such an up-dated and universally accepted Essential Medicines List to replace the previous (1998) list was also highlighted at the initial consensus building workshop in February. A new and acceptable list has now been produced by the team and awaits final clearance by the Ministry of Health before printing, the initial print run being paid for from the consultancy budget. In order to ensure wide acceptance of the new list the procedure adopted for its production was as follows:

As many as possible of existing lists in use were identified, being the following:

The Liberian National Essential Drugs List 1998 The list of basic medicines from the Merlin / UNICEF workshop 2006 Current lists in use by the various (vertical) disease control programmes ie: Leprosy and TB Control AIDS Control and STI Programme Malaria Control Programme Reproductive Health Programme Expanded Programme of Immunisation Current list in use by CHAL Current list in use by ICRC (Liberia) Current stock list of NDS

All drugs contained in the above lists were consolidated into one list and then

allocated to their appropriate therapeutic classifications in line with the WHO Model List of Essential Medicines, many of them being placed in more than one category as necessary.

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The previously existing two-tier “level of use” designation (MD and HC) was revised and brought into line with the current referral system as a five tier designation.

A “Level of Use” designation was allocated to each of the drugs within their therapeutic classifications.

This preliminary draft list was widely distributed to stakeholders in the MOHSW, County Health Teams, INGOs, FBOs, WHO and NDS with a request that it be reviewed and feed-back / comments / additions / deletions etc. made to the team within 3 weeks.

The feed back received was incorporated into a second draft list which was discussed at a well attended (over 50 participants from the above stakeholders including the WHO country representative) workshop.

Further comments, additions, alterations, deletions etc. received at the workshop were incorporated into a third draft list.

This third draft was sent for further review to a smaller number of participants, namely a number of CHOs, representatives of JFK, Redemption, Phebe and St. Josephs Hospitals, and a number of selected INGOs.

This draft was also reviewed by the USAID consultant on the Basic Package of Health Services to ensure consistency between the Essential List and the BPHS.

Feed back received on this third draft has been incorporated into the (hopefully) final version which awaits review by the WHO (Afro) regional office and MOHSW approval before printing.

4.5.2 National Guidelines on Donation of Medicine and Medical Supplies for Liberia 2007 The Liberian National Drug Policy of 2001 states that: “Drugs donated to and within Liberia shall comply with the ‘Liberian National Guidelines for Donation of Drugs and Medical Supplies’. In addition the Public Health Law of 1975 states that “Until such time as Liberia has established its National Guidelines donations shall follow the WHO Model Guidelines on Drug Donations” Liberia receives many donations of Medicines and Medical Supplies and the establishment of and adherence to a national standard is essential for the fulfilment of a National Drug Policy and by extension a National Health Policy. The team has found that no National Guidelines have existed up to now, and that the WHO guidelines were largely unknown and donations frequently fall outside the recommendations. Among the non-compliant donations which came to the teams notice two were particularly significant as examples of the need for easy to understand Guidelines.

A donation sent jointly for NDS and UNMIL was the subject of a very well publicised hand over at the Ministry of Health when its value was stated at US $ 12 million. The Deputy Minister for Administration queried this valuation, obviously being aware of the frequent over statement of value.

When the team carried out a valuation using international average prices for generic drugs the true value to Liberia was found to be only US$ 73,000. Although this is a significant and welcome contribution the overstatement of value, especially by such a large factor, could have the effect of the Ministry of Finance making a corresponding reduction in the budgetary allocation for MOHSW.

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A donation received by a Faith Based Organisation (FBO) which is operational in more than 30 health units throughout the country was found to contain: Significant quantities of drugs inappropriate for the level of facility to which they were sent Large numbers of different medicines which were “Class C”, over-the- counter medicines, inappropriate for use in hospitals or health centres Of a sample of eleven items picked at random only one was included in the Essential Medicines List

From this the urgency of setting a standard for Liberia was obvious. The team has therefore produced a ‘Liberian National Guidelines for Donation of Medicine and Medical Supplies’. Illustration Box 4.1

Model Application Form for the Receipt of Donation of Medicines or Medical Supplies Application to be made to the Chief Pharmacist, Ministry of Health and Social Welfare, P.O. Box 10-9009, Monrovia

Name of Applicant ....................................................................... (organisation or health facility) Address ........................................................................................ Telephone ..................................................................................... Fax or e-mail ................................................................................ County (s) where donation will be distributed ............................. ......................................................................................................

Level of Health Facility(s) where donation will be used: Referral Hospital County / District Hospital Health Centre Rural Dispensary Name of the Donor ...................................................................... Address ........................................................................................ Telephone ..................................................................................... Fax or e-mail ................................................................................ Contact Person & Designation .....................................................

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Description of Items to be Requested / Donated (Use generic / INN names) Name & Strength

Dosage Form

Unit or Pack size

Total Quantity

Estimate of value

Means of transport ................................................................ Port of entry / delivery ........................................................... Name of pharmacist authorising on behalf of the applicant ............................................................................................... Signature of pharmacist ........................................................ Stamp of applicants organisation

This is based on the WHO / Inter Agency Guidelines, adapted to Liberian needs and incorporates some additional material taken from the Kenyan National Guidelines on Drug Donations. It also incorporates a model application form for receipt of donations (see illustration Box 4.1 above) The draft of this work was presented to the same stakeholder workshop as had considered the Essential Medicines List and was adopted after some discussion. It now awaits review by WHO (Afro) regional office and confirmation by the Ministry of Health before printing. 4.5.3 Standard Therapeutic Guidelines and National Formulary Having now produced an agreed and up to date Essential Medicines List the way is now clear for the production of an updated Standard Treatment / Therapeutic Guidelines based on the contents of that list. World Health Organisation have been approached and agreed to assist in this exercise which should produce a user-friendly guideline suitable for use at all levels of the public health services and should be widely distributed and put to use in an attempt to improve prescribing practice and rational medicine use in the country. That publication should also become a standard basic work for the training of doctors and nurse prescribers. The final basic standard publication of any pharmaceutical system is the National Formulary (NF), although an NF may be produced on the basis of the Essential Medicines List a full NF would normally also include an additional range of medicines available to the private sector. As such production of a comprehensive NF may be better left until the process of Drug Registration is fully under way.

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5.0 Legislative and Regulatory Issues 5.1 Legislation: The Executive Law 1972 – Chapter 30 is the enabling law in respect of the Ministry of Health, and this:

a) Established the Ministry b) Set out the duties of the Minister c) Set out the post and duties of the Deputy Minister d) Set out the posts and duties of Assistant Ministers e) Set out the organization of the Ministry f) Set out the advisory councils

The governing statute over all matters of health, and thus all matters relating to drugs, pharmaceuticals, medicines, therapeutic devices is the Public Health Law 1975 (Title 33 of the Liberian Code of Laws Revised) approved by the President and published on July 16 1976. An Executive Law amendment of October 15 2003 added a chapter 18 to the statute covering HIV/AIDS/STD’s. No other amendments or additions to the Public Health Law 1975 have been made, (although incomplete amendment papers have been discovered seeking to extend and rationalize the ministry its functions and responsibilities – see annex viii ). In particular relation to drugs, pharmaceuticals, medicines and therapeutic devices the following sections of the Public Health Law 1975 are relevant: PART V – REGULATION OF DRUGS - Chapters 41,42,43,44 These cover Narcotic drugs, Halucinogenic drugs, Poisons, and control of other drugs. Subchapter D - Chapter 41.41 – Establishes a Narcotics Control Unit within MOH&SW, and this is handled by the Deputy Chief Pharmacist who deals with registrations and licensing and liaison with the International Narcotics Board. However the same chapter requires the publishing of regulations covering Narcotics, education and training in prevention, diagnosis, treatment, together with broader education on the nature and consequences of narcotic addiction to garner support from the public. None of these duties have been carried out. Chapter 43 – Control of Drugs other than Narcotic and Halucinogenic Drugs: This chapter establishes – through the Pharmacy Board – the Liberian Drug Register together with published regulations consisting of schedules of drugs and medical preparations including proprietary medicines which may be sold and dispensed in Liberia: Category A – Prescriptive drugs and medical preparations Category B – Non prescriptive drugs and medical preparations dispensable by licensed pharmacists

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Category C – Non prescriptive drugs and medical preparations dispensable by registered medicine stores Category D – Unrestricted drugs and medical preparations which may be sold in any outlet Chapter 43 also calls for “Quality Control of imported drugs, medical preparations and therapeutic devices” through the promulgation of a catalogue – again through the Pharmacy Board - of approved products classified under their generic names plus brand names, the names and addresses of manufacturers in each category manufacturing the same items approved for import. All drugs to be imported were to be in this catalogue, failing which quality approval for inclusion in this catalogue was to be made prior to importation. However non of the provisions and directives in chapter 43 have been implemented at all (apart from imported drugs, medicines requiring an permit/license to import issued by the Pharmacy Division MOH&SW and against details laid out in Pharmacy Division import guidelines issued in late 2006, and formal directive memorandum to importers of mandatory detail for importation in November 2006 covered under regulations later in this section). Chapter 44 – Poisons – requires the Pharmacy Board to promulgate and publish a detailed Poisons Schedule. The pharmacy Board does not produce such a schedule. PART VI – REGULATION AND SUPERVISION OF MEDICAL AND ALLIED HEALTH PROFESSIONS – Chapter 67 Pharmacy This chapter covers issues relating to Pharmacists, Licensed Retail Drug Dispensing establishments, Licensing of wholesalers and manufacturers, Regulation of hospital dispensaries, oversight of licensed establishments. Chapter 67 – Subchapter A – Introductory Matters – chapter 67.6 calls for the establishment of a national board for pharmacy to be known as the Liberian Pharmacy Board to assist the minister on matters relating to the practice of pharmacy, and to license pharmacists, dispensers, pharmacies, registered medicine stores, manufacturers and wholesalers. The Pharmacy Board is also to regulate and control the sale, distribution, character and standard of drugs, medicines, poisons, and therapeutic devices. 67.24 – Pharmacy Board to promulgate and publish catalogues of Drug Sundries to be dispensed, sold, in licensed pharmacies and registered medicine stores The Pharmacy Board does register and license pharmacists and dispensers, and pharmacies, medicine stores, wholesalers and manufacturers(there are no manufacturers in Liberia). However registration and licensing of drugs, medicines is carried out by the Pharmacy Division MOH&SW. Quality control of the standard of drugs, medicines, to a very limited extent, has been carried out by the Pharmacy Division MOH&SW in the past using the very limited and now effectively absent MOH&SW laboratory. The current position is that samples brought to the

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Pharmacy Division MOH&SW, or gathered during inspections are sent to regional test laboratory facilities – usually Ghana. The Pharmacy Board does not publish a list of “Drug sundries”, detailed in the Public Health Law as: “…….those products which are related and supplementary to medicine such as health aids, therapeutic devices and appliances, medical equipment, baby products, toiletries and cosmetics”. In practice, if chapter 67.24 and 67.25 were to be read and interpreted together and positively, and then advocated and published, the potential effect would be to encourage Liberias’ private sector pharmacy and medicine stores to offer a greater range of healthcare product, with the potential of increased turnover and profitability. Another potential positive outcome of these chapters being promoted would be encouragement of existing outlets to improve their layout, appearance and general appeal to the public, and reduce the possible threat of closure for outlets found by inspectors of the Pharmacy Board not to be operating as directed in their licensing of pharmacy or medicine store. It would further have the potential to encourage much greater health product range stock and display among medicine stores currently in violation of the limitation to the sale of schedule C medicines (see schedules above as per chapter 43). This in turn would lead to greater commitment to regulation, through common sense encouragement as well as firmness in the application of existing legislation. NB: Overall point on legislation: Recommendations in this report call for the re-structure and simplification of the current relationships and cross memberships of the controlling bodies of pharmacy, replacing these complicated and fraught with core conflicts of interest, and unclear lines of responsibility and accountability. (See Section 4.1: Management structure of the profession of Pharmacy – for detailed recommendations) The recommended new structure creates 3 autonomous advisory bodies:

A new Pharmacy Board, with changed responsibilities, composition, and functions focused on the profession and professional outlets

A new Drug Regulatory Authority with responsibilities, composition and functions focused on drug registration and quality laboratory assurance

A new NDS (National Drug Service) retaining its not for profit status with revised Responsibilities, composition, and functions focused on GOL / MOHSW procurement on contract, storage and distribution on contract, commercial procurements on contract, compliance with Essential Medicines List, supply chain management

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In the case of restructuring and changes to the existing Pharmacy Board, and the establishment of the new Drugs Regulatory Authority , these will require promulgation via short acts to amend chapter 30 of the executive law of 1972. In the case of restructuring and changes to NDS (National Drug Service), this will require changes and additions to the existing articles to adopt the new structure which will require official board approval. There will also be a need for either a limited PPP partnership agreement with MOH&SW (the preferred route) or a new memorandum of understanding between NDS and MOH&SW (less attractive because of similar MOU / NDS history). The recommended new structure establishes for the first time a formal structure for:

A new MOH&SW Pharmacy Division with responsibilities, composition, functions focused on the public sector, publications, and the vital coordination roles

In the case of this re-structure and establishment, it is recommended that promulgation of a short act to amend chapter 30 of the executive law of 1972 be put in place to reflect the important structural changes, responsibilities and reporting envisaged in the overall revised structure. This will also have the effect of adding further credibility to MOH&SW Pharmacy Division in legislation. (see Section 4.1: Management structure of the profession of Pharmacy – for detailed recommendations) NB: These structures and changes could easily be incorporated within the overall draft organization and plan seen with MOH&SW, and reflected within the also seen draft Appendix – An Act to amend chapter 30 of the executive law of 1972 – apparently circulated during 2006 at the time the new National Health Policy and the new National Health Plan drafts were being prepared. NB: Implementation of circulation, advocacy, publication of the existing Public Health Law to build awareness and knowledge and capacity for positive interpretation among stakeholders should NOT be held back while decisions are made and preparations for the launch of the overall recommendations are in hand. This approach should also be followed in respect of the urgent need to revise and re-publish existing Pharmacy Board, and Pharmacy Division MOH&SW regulations as quickly as possible. 5.2 Other Legislative issues. Having stated above, particular sections and chapters of the Public Health Law 1975 and its provisions specific to pharmaceuticals, and medicines, the far-reaching extent of the Public Health Law in relation to pharmaceuticals, medicines, and their overall relation to healthcare in Liberia is by no means limited to the sections quoted above. As will be emphasized later in this section, awareness, knowledge and understanding of the Public Health Law 1975 in MOH&SW, Pharmacy Board, Pharmacy Division, then out to County Health Officers and their teams is virtually no-existent.

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While this worrying and quite unacceptable situation persists, there can be little hope of strong and positive interpretation and firm even-handed application of this comprehensive statute. 5.2.1 Enforcement and sanctions In relation to the alarming issue and question of fake, counterfeit, and substandard pharmaceuticals and medicines in Liberia, and in respect of efforts to put a stop to these damaging and illegal practices, the Public Health Law 1975 offers very clear and concise remedies. PART I – GENERAL PROVISIONS – CHAPTERS 1,2,3,4,5 Detail sweeping and flexible powers of MOH&SW officials, County Health Officers, local health authorities, local authorities of entry, search, seizure, confiscation of suspected fake, counterfeit and/or substandard pharmaceuticals and medicines, or other substances potentially harmful or unfit for consumption. These powers when put together with those of arresting agencies LNP Liberia National Police, and DEA Drug Enforcement Authority make a powerful and highly workable combination in what it must be realized is set to be a constant fight against fakes, counterfeits, and substandard medicines. PART V – REGULATION OF DRUGS Chapter 41 subchapter E provides powers of identification, search, seizure, confiscation and legal criminal hand over powers, again made powerful when viewed together with the powers of the arresting agencies LNP and DEA. PART VI – REGULATION AND SUPERVISION OF MEDICAL AND ALLIED HEALTH PROFESSIONS – Chapters 61, 67 Provide for a wide range of enforcements, regulation, and sanctions which again when put together with powers of arrest and criminal charge vested in the arresting agencies LNP and DEA provide other powerful sources of regulation and potential control of the damaging fake, counterfeit, sub-standard medicines activity which is so rife in Liberia. It can not be stressed too strongly that awareness, knowledge of, understanding and comprehension, and most important the application of the long-established and available positive provisions of the Public Health Law 1975 is very low in MOH&SW, Pharmacy Board, Pharmacy Division MOH&SW. The wider pharmaceuticals and medicines stakeholder awareness, knowledge, understanding and applicability of the Public Health Law 1975, is similarly dismal. This overall situation of ignorance of the law must be addressed as a priority in MOH&SW, and because of the position and responsibilities of the ministry, it must ensure radical improvements of the position in all other stakeholders in the pharmaceuticals and medicines sector in Liberia, in respect to the Public Health Law 1975.

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It is the responsibility of those with obligations and responsibilities clearly stated and expressed in the Public Health Law 1975 to advocate, publish, make known, and make work its provisions. A close and operationally simple working relationship between MOH&SW Pharmacy Division, the Liberia National Police Special Unit, the Drug Enforcement Agency, is essential to an effective long term enforcement strategy. Regular, working collaboration meetings with LNP and DEA have now been established, with the first meeting demonstrating extremely clearly that MOH&SW needs to be the driver of the enforcement strategy, providing LNP and DEA with targeted information from the provisions of the Public Health Law 1975, in respect of the powers and responsibilities of MOH&SW, Pharmacy Board, Pharmacy Division, and their respective regulations. Also needed, and to be kept up-dated is a listing of approved pharmaceuticals and medicines, licensed pharmacists and dispensers, and licensed pharmacies, medicine stores, and wholesalers. This to be added to by the inclusion of simplified presentation of all issued licenses, permits, and import permits. This activity has been established as a key implementation need, and must be actioned swiftly. (See annex vii for detailed document) 5.2.2. Complementary and Traditional medicines An area not covered or mentioned in the Public Health Law 1975, but clearly and specifically marked out in the 2001 National Drug Policy, itself an important milestone existing document, and the to-all-intents-and-purposes authoritative Liberian Drug Policy. Reference is made in the 2001 NDP to a functioning complementary medicines board operating under the MOH&SW, coding of species of plants, indications, labeling, duration of use, together with regulations to be set governing the practice of Traditional medicine particularly in plant use. The complementary medicines board is composed of just one person, and is effectively inoperative. None of the activities or involvement quoted in the 2001 NDP have been put into effect or even started upon. The capacity and knowledge of MOH&SW in complementary and traditional medicines it must be recognized is extremely low, with no staff, no structure and one medical doctor nominally operative on what appear to be ad hoc issues. MOH&SW is in the process of revitalizing complementary and traditional medicines, and is actively recruiting senior personnel to head a re-structured complementary medicines board who have strong knowledge and capacity in the complementary medicines sector.

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However, it must be said that it will be some considerable time until a competent complementary and traditional medicines unit with a strong board is functioning at MOH&SW. Traditional medicines are in fact handled by an Assistant Minister Culture Affairs in the Ministry of Internal Affairs. This ministry has handled traditional medicines for many many years. Contact has been established with the Ministry of Internal Affairs in relation to traditional medicines and an information-based dialogue is in place to establish the beginnings of a working bilateral relationship with MOH&SW. Detailed recommendations on suggested working arrangements have been put forward to MOH&SW and approved for action.(See annex detailed document) The first stage of this bilateral arrangement is in hand with the production of a database modeling questionnaire for all certificated/registered traditional medicines practitioners with MOIA. Distribution of questionnaires is to be done by regional representatives of the Traditional Healers Council. The Ministry of Internal Affairs Culture Affairs is most keen to work alongside MOH&SW in re-establishing a credible role for traditional medicines within the new National Health Policy and the new National Health Plan. 5.2.3. The National Drug Policy The existing 2001 National Drug Policy issued by MOH&SW, is a key part of policy with regard to legislation and intended legislation. This policy document contains reference to the intention to split the current functions of the Pharmacy Board, making the Pharmacy Board responsible for the registration, and licensing of pharmacists and retail, wholesale pharmacies, and medicine stores. The 2001 document calls for the creation of a new body – the Drug Regulatory Authority – to be responsible for registration and licensing of all pharmaceuticals authorized for use in Liberia. This new Drug Regulatory Authority to also be responsible for post-marketing surveillance, pharmaceutical inspections, regulation and control of drug promotion and advertising. This DRA would also be responsible for the setting up of a national drug laboratory for quality testing assurance. These provisions in the 2001 National Drug Policy, have not been carried out, and the Pharmacy Board remains in control of both the profession and its outlets, and registration of drugs and medicines. However registration of drugs and medicines and the issue of import licences, is handled by MOH&SW Pharmacy Division.

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This 2001 provision separating Pharmacy Board from Drug Regulatory Authority and making each an autonomous advisory body to the MOH&SW feed from government and politics and with accountable responsibility for their sectors should be implemented. (see Section 4.1 Management structure of the profession of Pharmacy for detailed recommendation). Responsibility for medicine samples testing also nominally done by the Pharmacy Division, but in practice samples are either taken to or sent to Ghana for laboratory testing. But effectively this means virtually no testing of samples, and with the number and incidence of fakes, counterfeits and substandard medicines blatantly available in the country this situation is not acceptable. For example, a group of randomly collected samples from medicine stores in Monrovia were tested in early April at laboratory facilities in Ghana – all failed.(see again Section 4.1 Management structure of the profession of Pharmacy for detailed recommendation for national pharmaceutical quality control laboratory – under the new Drug Regulatory Authority). It is understood that UNIDO have expressed interest in providing funding and other assistance for the proposed national pharmaceutical quality control laboratory – and this interest is being actively pursued by MOH&SW Pharmacy Division. The 2001 National Drug Policy also contains specific provisions for complementary and in particular traditional medicines (these have been covered and commented upon in a previous section above) which have not been implemented, and traditional medicine is actually the responsibility of the Ministry of Internal Affairs (Culture Affairs section). In short, numbers of the provisions published in the 2001 National Drug Policy are contradictory while others have simply not been implemented. However this 2001 document is the “published” National Drug Policy from MOH&SW, and needs to be revised in line with the overall recommendations and proposals in this report. Undoubtedly the poor awareness and knowledge of contents or understanding of the 2001 National Drug Policy stems again from low publishing, circulation and distribution of the document originally and events of the following years of civil war. Once revised and agreed, this new National Drug Policy document must together with other legislative, regulatory and policy documents, be widely circulated, advocated and promoted to ensure credibility particularly for MOH&SW. (See annex vii for detailed baseline legislation and regulation document) 5.3 Regulations: 5.3.1 Pharmacy Board Regulations: Existing Pharmacy board “Revised Regulations” were approved by the then minister of Health Dr Coleman on October 9 2003, although copies discovered are unsigned. They were presumably published on or soon after this date.

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There appear to have been no other communications or guidelines issued by the Pharmacy Board since October 2003, except an April 10 2007 memorandum from the Pharmacy Board announcing a temporary freeze on the establishment of Pharmacies, and Medicine Stores operating in Monrovia until further notice. The existing Pharmacy Board Regulations are entitled – “The Liberian Pharmacy Board Pharmacies/Drugstores & Wholesales and Medicine Stores – Revised Regulations”. It should be noted that there are no Drugstores as an outlet type in Liberia. In the preamble paragraph the unfortunate statement “The Pharmacy profession, like other paramedical professions…………”probably represents the current low status of pharmacy and pharmaceuticals/medicines in Liberia. These regulations are stated as having been drawn from the new Public Health Law of Liberia, and contain 30 provisions covering a wide number of issues. These range from pharmaceutical imported shall be subject to analysis through the Quality Control Laboratory of MOH&SW – currently effectively inoperative – to drug peddling not to be permitted in any form or manner – to all pharmacies shall have basic current and reference books (Martindales, pharmacology, toxicology, BP or USP-NF and Pharmacy Laws of Liberia. The point needs to be made that it is not that Pharmacy Board Regulations do not exist – they do – however they need to be urgently revised and re-structured in content, language and presentation to be able to be used effectively. In particular, newly drawn Pharmacy Board Regulations need to be clear and concise on logical application and the relationship between the Pharmacy Board, and MOH&SW Pharmacy Division. On the issue of publication, advocacy, and circulation, there is no doubt that the existing Pharmacy Board Regulations have never been widely published, and this a major reason why pharmaceuticals and medicines stakeholders across the sector have a poor knowledge and understanding of their content and provisions. This state of affairs is exactly the same as the position in relation to knowledge, content and understanding seen in legislation and policy, and must be promptly remedied. (See annex vii for detailed document Baseline legislation and regulations) 5.3.2 MOHSW Pharmacy Division regulations / guidelines: Two documents have been published by MOH&SW Pharmacy Division: The first is entitled “Guidelines for the Importation and Exportation of Drugs and Medicines 2006”, and is believed to have been published in the second half of 2006, and circulated to the 17 drug and medicines importers in Liberia.

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This covers 20 clauses of guiding information and process required by MOH&SW Pharmacy Division, however the guidelines are unsigned and undated. This was followed on November 17 2006 with the publication of a memorandum signed by the Chief Pharmacist MOH&SW, again circulated to drug and medicines importers. It was entitled “Enlistment of Pharmaceutical Products on the Liberian market”. This second document informed importers of:

the need to streamline and identify all fake drugs on the Liberian market a requirement that all importers prepare a list of drugs intended for import the Pharmacy Division intention to establish a database of products of all importing

pharmaceutical institutions with respective addresses of manufactures (these three database points to be operative until December 31 2006) As of January 1 2007 importation to be based on these product lists as submitted to

Pharmacy Division After the January 1 2007 deadline any product intended for import will require the

approval of the Pharmacy Board. Product enlistment done in the following order: – Generic Name- Brand Name- Strength/Concentration- Dosage Form- Name of Supplier- Name of Manufacturer- country of Origin

The Pharmacy Division stated as the objectives in this exercise:

keeping track of all potent pharmaceutical products in circulation protect legitimate pharmaceutical businesses and partners who handle drugs fulfilling the global demand of certificating pharmaceutical products moving into

international commerce ensure that the drug products imported into Liberia will be in compliance to the

National Drug Policy of Liberia Pharmacy Division regulations and guidelines need to be redrawn and published as user friendly documentation to stakeholders importers and partners, and to clarify the relationship between the Pharmacy Board and the Pharmacy Division MOH&SW. The question of relationships between legislation, or policy documents needs to be addressed by setting these out clearly, and again wide publication, advocacy and promotion of regulations, guidelines and directives needs to be effective to produce greater awareness, knowledge and understanding of these documents. (see Annex vii for detailed document Baseline legislation and regulations) 5.4 NDS – National Drug Service: NDS as currently constituted is a separate legal entity from GOL/MOH&SW formed under articles of association filed with the Ministry of Foreign Affairs, and established as a Not-For Profit Corporation pursuant to the provisions of Part II Not-For-Profit Corporation Act of the Associations Law of Liberia.

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It operates under published Bye Laws stemming from its amended articles of association December 22 1999. A Memorandums of Understanding between MOH&SW and NDS – : grants the right to NDS to import, procure, manufacture, manage, administer, evaluate and distribute drugs and related products within the Republic of Liberia, and to perform any and all acts consistent with and necessary for the implementation of this right. A further Memorandum of Understanding exists between MOH&SW and NDS confers NGO status on NDS facilitating operations between NDS and Donor organizations A memorandum of Understanding between MOH&SW, NDS and JFK Hospital confers the right for NDS to occupy and use premises at JFK Hospital grounds rent free. The complex history of NDS since its change in 1986 from the National Medical Supply Depot through grant funds provided by USAID, to the National Drug Service NDS, through civil wars and national unrest, up to the present day has lead to blurring of position for NDS. It is believed that the optimum positioning for NDS to play a major contributive role in the Liberian pharmaceuticals and medicines sector is as laid out in “Other Legislative issues” above (5.2). These recommendations are further detailed in Section 4.1 Management Structure of the Profession of Pharmacy. From a further legislative perspective in relation to NDS, the Public Health Law obviously still makes reference to the National Medical Supply Depot, and Central Medical Stores and the opportunity should be taken to remove these references, replacing them with NDS as applicable.

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6.0 Financing Pharmaceuticals in Liberia 6.1 Current policy relating to health care financing and financing of pharmaceuticals and medical supplies The Government of Liberia (GOL) is committed to finance health care to the highest level compatible with its revenues, and its competing priorities. The Government is a signatory to the Abuja declaration which sets a target of 15% of public expenditure for health. Currently Liberia has one of the lowest levels of public expenditure on health in Africa. Of the government’s proposed USD$122 million budget for financial year 2006/07, just over USD$10.2 million (8.4%) was allocated to health (USD$7.2 million for Ministry of Health and Social Welfare (MOHSW), USD$2.5 million for JFK Medical Centre and USD$500,000 for Phebe Hospital), of which MOHSW allocated USD$1million for pharmaceuticals and medical supplies. This means that the health sector will continue to be dependent on external funding for many years to come. Current total annual health care expenditure is estimated at about US$12 per head, but could be higher if private spending is included. Most facilities supported by NGOs are providing services free of charge. Faith-based organizations (FBOs) usually raise revenue through charging user-fees. Other facilities charge for services, often on an informal basis. No global estimate of private health expenditure is available. UN agencies, coordinated through UNMIL, play a vital role in supporting the health sector namely, UNDP, UNFPA, UNHCR, UNICEF and WHO. While there is extensive INGO and FBO activity in Liberia, there are very few bilateral donors engaged in supporting the health sector other than the EC and USAID. In the last two years the Global Fund for AIDS, TB and Malaria (GFATM) has been a major contributor to the sector through the UNDP as the principal recipient. Support has also been received from GAVI to support EPI. Overall value of the support from non-government sources is estimated to be between USD$15 to USD$20 million per annum. The private for-profit sector is poorly developed in Liberia and its input is not known (exception: Firestone Hospital). The goal of the National Drug Policy (NDP), June 2001, is to use available resources to develop pharmaceutical services to meet Liberia’s requirements in the prevention, diagnosis and treatment of diseases by using efficacious, high quality, safe and cost-effective pharmaceutical products. It is a specific objective of the NDP to provide drugs through the government, private and non-governmental sector at affordable prices. The policy proposes strategies for drug financing such as community health financing through revolving drug funds, fee-for-service (FFS) and engagement in international agreements to control the cost of drugs through trade agreements such as the Trade Related Intellectual Property Rights Agreement (TRIPS). The NDP also states that the Government will promote a competitive environment in the pharmaceutical sub-sector, in order to ensure that products are readily available at affordable prices and to investigate the role of health insurance schemes as a strategy for public financing for essential drugs and medical supplies. 6.2 Strategies for financing of pharmaceutical and medical supplies In Liberia, as with most poor countries recovering from protracted civil conflict, the largest portion of health expenditures is covered by humanitarian aid in the initial phase. Overtime the progressive improvement of public finances should allow the Treasury to shoulder an increasing share of health expenditures in a second phase. This pattern is starting to emerge in Liberia and will hopefully continue. The cost of reconstruction is certainly huge, greatly

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surpassing internal revenues; therefore external assistance will be required for sometime to come. Donor support will be sought to support the recovery process by channelling their contributions in more predictable, effective and efficient ways through longer term development assistance programmes rather than through the current short-term humanitarian assistance mode. Currently the Government coordination of external assistance is fragmented and this will need to be strengthened in the future so as to ensure that all future support will be more aligned with the long term policies and strategies of the government and its ministries. In the past the MOHSW had pursed a number of cost-sharing schemes including charging for drugs, however following the most recent civil war and the resulting poverty levels the MOHSW decided to suspend the administration of user fees at the primary level. Currently cost-sharing is only being done in secondary and tertiary hospitals and in FBO, national NGO run and private-for-profit health facilities. The suspension of user-fees in public health facilities is to remain in place until the socio-economic situation improves, and financial management systems perform to a level that ensures the proper collection, accounting and utilization of revenues. Meanwhile, private health spending is to be studied in order to gain useful insights for the formulation of a pro-poor comprehensive health financing policy. There is currently a Health Financing Coalition working group set up to promote sharing of experiences amongst member on health financing, to coordinate studies on different cost-sharing schemes in operation, the group will also advocate for the creation of a sustainable pro-poor health financing system in Liberia. This group is currently chaired by Save the Children and includes MOHSW representation, it will be a rotating chair. The Government is committed to progressively increase the share of its budget apportioned to the health sector. In addition, the MOHSW wish to purse a mix of other financing strategies (user fees, health insurance, and other forms of pre-payment) in the future when the environment is conducive. Presently, multiple vertical programs account for an important proportion of the health services provided in Liberia, many of these programmes have their own programme funding arrangements through a number of bilateral and multilateral funding agencies. The MOHSW is making efforts to ensure that resources and capacities of such programmes are better integrated so as to ensure best outcomes for the total investment in health. The envisioned integration process is to be incremental, and be guided by the concern of attaining systemic efficiencies without disrupting the delivery of the health services supported by vertical programs. A large part of the budget for these vertical programmes goes to drugs, commodities and medical supplies. There is also a growing private pharmaceutical sector in Liberia. Currently 17 companies are registered as importers and provide wholesale services, five of which are considered to be medium to large in terms of operation, private pharmaceutical financing is discussed below. 6.3 Policy on Cost-Sharing For the moment the policy of the MOHSW is the suspension of cost-sharing at primary health care level. This suspension is to remain until such time as there is an improved economic climate and improved capacity in the health sector to manage finances and resources. Currently there is a working group established under the INGO health working group on health financing. It is hoped that this group will be advisory to the MOHSW and will provide some evidence based research from the Liberia context and lessons learnt from other country

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experiences to inform the MOHSW on its cost sharing policy and to support the monitoring of the current policy in Liberia. However, there are a number of schools of thought amongst the current stakeholders in the health sector relating to cost-sharing, ranging from support for universal free health services to insurance and pre-payment based cost-sharing schemes for those that can afford. 6.4 Current level of funding for pharmaceutical and medical supplies The main funding for pharmaceutical and medical supplies in Liberia is through humanitarian aid through the public and the private-not-for-profit health providers. Although comprehensive data on the total value of pharmaceuticals and medical supplies is not available from anyone source in Liberia for the purposes of this assessment an estimate of the value of support through different sources has been made and is presented in Table 6.1 below. As can be seen from the table the funding of drugs and medical supplies is still highly dependent on external assistance, at least 80%, while the value of out-of-pocket expenditure by individuals for drugs and medical supplies through private sources is not known. Table 6.1: Estimated current resource envelope for drugs and medical supplies in Liberia 2007 & 2008

Year Source

2007 USD$

2008 USD$

Government of Liberia* 1,000,000.00 1,000,000.00 EC 0 0 USAID 0 0 GFATM 1,292,000.00 2,000,000.00 GAVI 850,000.00 2,427,881.00 UNICEF** 2,465,142.00 1,318,276.00 WHO** 986,336.00 290,227.00 UNFPA n/a n/a NGOs*** 2,840,010.00 2,840,010.00 FBOs n/a n/a Revenue (cash sales NDS)****

450,000.00 450,000.00

Private-out-of-pocket n/a n/a UNMIL n/a n/a Commercial (Firestone) n/a n/a Total 9,883,488.00 10,326,394.00 *based on MOHSW maintaining same level of funding for next year, ** figures for vaccines and immunisation only, *** based on interviews and questionnaire returned by the major NGOs in health and on the same level of funding remaining for 2008, **** based on NDS cash sales available for procurement remaining the same. n/a: no available data As already mentioned in the current financial year the MOHSW has made a USD$1million allocation for the procurement of drugs and medical supplies. This is being split into two sub-allocations, USD$350,000 to NDS to carryout an emergency restricted procurement and the MOHSW will coordinate an international competitive bidding (ICB) procurement with the balance of the funds. The funding of the budget line for drugs through the Treasury is a positive move and demonstrates a commitment from the government and the MOHSW to start to co-finance drugs and medical supplies from their meagre budget and given the considerable other demands on their resources.

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Other sources of pharmaceuticals and medical supplies 6.5 Donation of Medicines and financial implications for Liberia The newly developed Liberia guideline on donations of medicines (2007) is based on the WHO “Guidelines for Drug Donations”, revised 1999, states that the declared value of a drug donation should be based upon the wholesale price of its generic equivalent in the recipient country, or, if such information is not available, on the wholesale world-market price of its generic equivalent. This provision is solely to prevent drug donations being valued in the recipient country according to the retail price of the product in the donor country, this may lead to elevated overhead costs for import tax, port clearance and handling in the recipient country, it may also result in a corresponding decrease in the public sector drug budget in the recipient country. Possible exception, in the case of patented drugs, (for which there is no generic equivalent), the wholesale price of the nearest therapeutic equivalent could be taken as a reference. There are anecdotal reports of over valuing of drug donations to Liberia, especially donations of drugs-in-kind through INGOs. The Guidelines also states that costs of international and local transport, warehousing, port clearance and appropriate storage and handling should be paid by the donor agency, unless specifically agreed otherwise with the recipient in advance, this is rarely the practice. It should be recognized that drugs do not arrive in an administrative vacuum. Drug donations should not create an abnormal situation which may obstruct or delay national capacity building in selection, procurement, storage, distribution and rational use of drugs. Special care should therefore be taken that the donated drugs respond to an expressed need, comply with the national drug policy, and are in accordance with national treatment guidelines in the recipient country. Administratively, the drugs should be treated as if they were procured. This means that they should be registered or authorized for use in the country through the same procedure that is used for government tenders. They should be entered into the inventory, distributed through the existing channels and be subject to the same quality assurance procedures. If cost-sharing procedures are operational in the recipient country, the donated drugs should not automatically be distributed free of charge. There are several examples in Liberia of unsuitable drug donations which have had to be disposed of at the country’s expense, plus examples of INGOs insisting that their ‘donated’ drugs must be dispensed free of charge even through health facilities which are currently practicing cost-sharing. 6.6 Private Pharmaceutical Sector Although the private drug market in Liberia is small and the possibility for growth is limited in absolute terms, it is however growing relative to other parts of the health sector. Due to poor regulation it is reported that drugs are imported illegally across the boarders from neighbouring countries and not declared upon importation at Liberia ports. In 2006 the Pharmacy Board of Liberia registered 121 pharmacies and 208 medicine stores. Of the 121 pharmacies registered 17 operate as wholesalers carrying out importation of drugs and medical supplies, of which five are considered to be large in size in terms of volume of trade. The pharmacy board registration fees are as follows; wholesale initial registration is L$26,500 and annual re-registration is L$5,750, pharmacy initial registration is L$21,500 and annual re-registration is L$4,000, Medicine Store initial registration is L$2,850 and annual re-registration is L$2,450. Each pharmacy is to be supervised by a registered pharmacist, the

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regulations state that a pharmacist can supervise up to three pharmacies, however as there are currently only 31 registered pharmacists in the country this regulation is not adhered to. Pharmacies pay their supervising pharmacist a retainer, current rate is approximately USD$200 per month. Drug wholesalers and retailers also have to register with the Ministry of Commerce, the annual fee for registration is USD$900 for a wholesaler and USD$450 for a retailer. Private Sector Procurement and Importation The majority of private wholesalers import directly from India and China, with one wholesaler specialising in importing from Europe and using this as a marketing strategy, there are some limited imports from other countries, namely USA and Lebanon. Import duty on pharmaceuticals and medical supplies is 12.5% and storage charges are applied normally after eight days of goods in demurrage. Importers report that they use a number of measures to assure quality, all reported that copies of drug certificate of analysis reports are part of standard documentation, and some reported that they only procure from companies which are ISO9001 and GMP certified. The process for importation is long, taking approximately six months from initiation of order to receipt of goods. The process is lengthy as there are many steps, as shown in Box 1 below: Currently, there is no drug register in Liberia, although the legal framework makes provision for one. A number of the drug importers expressed concern that many manufacturers may not consider it viable to incur the cost and administrative burden of registering their products in Liberia as the return on sales may not justify such an outlay given the size of the market. Therefore if drug registration is to be introduced in Liberia the cost and process for doing so will need to take into consideration the size of the market and will need to facilitate the registration of low volume and low value essential drugs. The main customer base for wholesalers are the private pharmacies and medicine stores, followed by the NGOs, FBOs and others, e.g. hospitals, company clinics. Private Sector Financing Issues Access to credit is a major constraint for the expansion of many Liberian private pharmacy and medicine stores. The wholesalers give credit to the medicine stores, but this is limited to two to four weeks at most. Commercial banks or micro-finance bodies will only lend against guarantees. Private pharmacy and medicine store owners report that they can only raise finances through personal loans at non-commercial rates. Access to foreign exchange is also a problem, most importers reported that if they have to access foreign exchange through the non-banking sector, e.g. bureau de changes, and their own USD$ cash sales. In the past price standardisation was practiced, but this no-longer happens, some private pharmacies and medicine store owners reported that currently there is competition and reductions in prices but complained that this may be at the expensive of quality of products. Without a proper quality control system in place it is difficult to verify this claim. Capacity building for Private pharmacies and medicine stores There was an expressed need for training in business management by the private pharmacy and medicine store owners. If rational drug use (RDU) is to be practiced then there is a need to also train dispensers and pharmacy and medicine store workers on customer relations and RDU. Some dispensers explained how difficult it was to deal with customers who come

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without a prescription and are requesting prescription drugs. In most private pharmacy premises there are no pharmaceutical reference materials available, e.g. NF, even though they are required by law to have them available on the premises. Estimate of size of market for private pharmacies and medicine stores As stated above all bodies importing drugs and medical supplies into Liberia should be registered to do so with both the Pharmacy Board of Liberia and the Ministry of Commerce. In addition all imports must have an Importation Permit Declaration (IPD), these IPD are issued by the Chief Pharmacist in the MOHSW, at a fee of LD$1,000 per IPD. A review of the IPDs for the calendar years 2005 and 2006 was done; results are shown in the table 6.2 below: Table 6.2: Analysis of Import Permit Declarations for 2005 & 2006 2005 2006 No. of IPDs issued to all importers (private and INGOs)

108 152

No. of IPD letters of authorisation on file for Private Importers

43

67

No. of IPDs for Private Importers with supporting documentation

30 (69%)

50 (75%)

Reported value of drugs imported as per supporting documentation

USD$1,118,342.50

USD$1,537,183.42

Source: IPD files Pharmacy Division, MOHSW Findings presented in the above table shows that supporting documentation was not available for some of the IPDs, however the available figures does show an increase in total value of drugs being imported. Given the lack of supporting documentation and the unsubstantiated reports of importation of undeclared drugs though ports the actual value of drugs and medical supplies through the private for profit sector in Liberia is much higher than the figures shown in the table above. 6.7 Private-out-of-pocket Expenditure

Although there are no studies in Liberia to provide current levels of private-out-of-pocket expenditure on health in general and on pharmaceuticals in particular the figures from the analysis above of private importers suggests that it may be significant. This would support future policy on re-introducing cost-sharing for pharmaceuticals at least amongst those that could afford. 6.8 Issues relating to future funding of medicines and medical supplies Currently predictability of funding is weak. As generally humanitarian aid is done on a year to year basis, at most two years, resource availability beyond two years has not been possible. However, now with a move towards more longer term aid and funding modalities and a revitalisation of public expenditure there are a number of funding modalities that are starting

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to offer more long term and predictable funding, e.g. GFATM new five-year grant proposal, bilateral/multilateral funding programmes being negotiated with WB, Irish Aid and DFID, and possibility of USAID and EC future funding. However, as mentioned above, such long-term investment in pharmaceuticals and medical supplies will need to be coordinated and planned for through a comprehensive annual procurement planning process and eventually through a medium term procurement plan (MTPP). There are two main concerns in estimating the future funding needs for drugs and medical supplies in Liberia. Firstly, in the short-term there is need to estimate the funding gaps being created by the withdrawal of NGOs from the sector so that there is not a collapse of health services, and secondly, in the medium to long-term there is need to estimate the overall cost of drugs and medical supplies needed to provide essential health services to all the people of Liberia. Firstly, the funding gap to be created by the withdrawal of these NGOs is not known, nor any breakdown in terms of what current NGO support covers, i.e. pharmaceuticals and medical supplies, staff incentives, other running costs, etc. Of the 389 functioning health facilities, 304 (78%) are currently supported by NGOs (including local private and Faith-Based not-for-profit organizations). An additional 20 health facilities are being reconstructed with NGO assistance, but are currently considered non-functioning. Most NGO assistance is humanitarian and scheduled to be phased out as development assistance begins scheduled for the end of 2008 for most. Potential gaps in assistance and health care will result if development assistance does not begin promptly and provides some planning and implementation overlap with humanitarian aide. Secondly, longer-term development in Liberia is being planned through the framework of a poverty reduction strategy paper (PRSP). The country currently has an interim PRSP and is in the process of development a full PRSP to guide future development in the short to medium term which is to be launched in the second half of 2007. The MOHSW is in the process of finalising a new National Health Policy and National Health Plan as its sector response in support of the PRSP. The central MOHSW policy for address the health in Liberia is the delivery of a basic package of health services (BPHS), accessible to all people in Liberia. A lot of work has been done to date to define the content of the basic package, and work is in progress through engagement with the national health programmes to elaborate the content of the package by level of care. Work is also being done to identify what inputs will be needed to deliver the basic package, i.e. human resources, pharmaceutical and medical supplies, diagnostic support, equipment, etc. Eventually a costing of the delivery of the basic package will be done to inform future budgeting and planning. The main challenge will be both internally and externally to align and harmonise the support to the health sector and the current national health programmes towards the delivery of the basic package. This will require greater alignment by development partners and donors to national policy and guidelines, i.e. NHP, BPHS, EDL, and Guidelines for the Donation of Medicines and Medical Supplies for Liberia and greater integration by national vertical programmes in their planning, implementation, monitoring and reporting on the sector performance. It is however possible in the interim to do some estimations of the level of funding that may be required to fund pharmaceutical and medical supplies to deliver the BPHS. This can be done by collating data from a number of existing plans which have quantified pharmaceutical and medical supplies for the major national vertical programmes and by using some per capita expenditure data on usage of general curative drugs reported by an INGO working in

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the health sector in Liberia. Table 6.3 below shows the estimated cost per capita by type of programme and overall estimate of requirements. Table 6.3: Estimation of Pharmaceutical and Medical Supplies requirements for delivery of the national health programmes for 2007 and patient usage data for 2006

Based on population of 3.4m Main health programme area

Per capita cost USD$

General Curative pharmaceuticals and medical supplies*

1.42

Reproductive Health Programme .15 National TB Programme*** .10 National Malaria Control Programme*** .93 Nation AIDS Control Programme*** .38 Expanded Programme on Immunisation**** .25

Total average per capita cost 3.23 Estimated total value of pharmaceutical and medical supplies required

USD$10,982,000

Source: * ICRC patient drug usage from Lofa and Grand Kru for 2006 **MOHSW/Deliver Forecast for 2007 ***Round 6 Global Fund Application estimates for 2007 ****GAVI Application estimates for 2007

The per capita cost of USD$3.23 corresponds with a recent costing done in Tanzania for the pharmaceutical and medical supplies for a basic package in Zanzibar which also came out at just over USD$3 per capita1. The figures from the potential resource envelope for pharmaceuticals of USD$9.88million is favourable with the estimated need of USD$10.98, showing a gap of USD$1.1million. However, experience has shown that potential resource envelopes rarely materialises in practice mainly due to poor capacity to absorb the funds, lack of coordination and phasing of inputs, thus the actual funding gap and actual shortage of pharmaceuticals will be greater. This gap will be greatest in the area of funding for general curative pharmaceuticals and medical supplies, i.e. non vertical programme items. Another challenge in Liberia is that currently support for pharmaceutical and medical supplies through the INGOs is conditional either to donations in-kind or has to be sourced through their own head office channels, plus as it is mainly funded through humanitarian aid modalities it does not mean that longer-term development aid modalities will automatically be allocated for the same purpose. But these figures do however show that potentially there are significant resources to finance the pharmaceutical requirements of the country if the capacity to absorb them effectively can be strengthened. Therefore a phased approach needs to be taken, as follows: Policy and Guidelines

1. Approve and disseminate the national Essential Drug List to all potential development partners and donors and in-country health managers, both public (national programme managers, CHOs, etc) and private (INGO health officers, NGO health officers, FBOs, CHAL, etc)

1 Personal correspondence with Sally Lake, Health Economist, Zanzibar and research associate London School of Hygiene and Tropical Medicine, UK

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2. Approve and disseminate the “Guidelines for the Donation of Medicines and Medical Supplies for Liberia, 2007” to all potential development partners and donors and in-country health managers, both public (national programme managers, CHOs, etc) and private (INGO health officers, NGO health officers, FBOs, CHAL, etc)

3. Finalize and disseminate the Basic Package for Health Services to all potential development partners and donors and in-country health managers, both public (national programme managers, CHOs etc) and private (INGO health officers, NGO health officers, FBOs, CHAL, etc)

Coordination and common management arrangements 4. Establish a national pharmaceutical logistics coordinating committee to coordinate the

planning and budgeting of the pharmaceutical and medical supply needs for the BPHS and to identify the resource envelope for pharmaceuticals and medical supplies from all sources

5. Establish a procurement unit in NDS which will work with the logistics committee to develop an annual procurement plan for pharmaceuticals and medical supplies

6. The national pharmaceutical logistics coordinating committee will work in close collaboration with the Supply Chain Management Technical Working Group to monitor the flow of pharmaceuticals and medical supplies (initially for GFATM funded products but eventually to be expanded for all)

7. Initially there is need to ensure better coordination of the multiple funds flow for pharmaceuticals and medicals supplies, which are represented under Option A in figure 6.1 below.

8. However, it may be also possible to establish a ‘joint’ fund for the procurement of pharmaceuticals and medical supplies. Potentially some Development Partners could combine their funds in a common account dedicated to pharmaceuticals and medical supplies, this would need to be coordinated through an annual procurement plan and monitored by the proposed logistics committee. This ‘joint’ fund is shown under option B in figure 6.1 below. This funding could augment MOHSW funds.

9. Option C below shows a more pooled or sector wide approach (SWAp) to supporting the implementation of the National Health Plan 2007-2011, this would mean the pooling of Development Partner and MOHSW funding through Ministry of Finance. The reality is more likely to be that all three options will need to be managed to facilitate the needs of the individual development partners.

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Development Partners GOL

Option C (budget support with/without earmarking):‘Common Trust Fund’ in MOHSW Development Account

HSCC (MOHSW-DP) Fund Management Committee (PMU)

County Health

Services

HRH Systems Support

Development

Option A:Direct Project

Funding< HSCC, Clusters >

Option B: Pooled Funding

for specific areas (com. bank acc. with fund agent or DP/MOHSW)

-On-going projects addressing MOHSW priorities (aligned with NHP and Implementation Plan)-Tech Assistance (under an aligned and harmonised planning mechanism (NHP and Implementation Plan)

-BHSP-National Programmes-Capacity Building-Tech Assist

-HRH (PE)-Implement nation HR strategy-HRH Development

- infrastructure development plan, essential medical equipment, preventive maintenance programme, etc

Policy, Planning, M&E, Financial Management, Procurement, Drug Supply, etc

Shift towards more ‘Common Fund’ arrangements over time, (Aid alignment and harmonisation)

Figure 6.1: Funding Mechanisms for the Ministry of Health & Social Welfare

Ministry of Finance (Treasury)

Infrastructure Devleopment

Systems strengthening

Emergency Hiring Program

Drug Procurement Funding

Infrastrcture Devleopment, Non-public Sector

Funding- contracting,Etc.

County Health Services Funding

6.9 Other financing needs relating to Pharmaceutical and Medical Supplies in Liberia Besides ensuring that adequate funds are available for funding the procurement and supply chain management of pharmaceuticals and medical supplies there is also the need to ensure that adequate funding is available for the institutional arrangements to support the pharmaceutical sector in Liberia. The main organisational structures with responsibility for pharmaceuticals in Liberia are;

1. Pharmacy Division, MOHSW 2. National Drug Service 3. Pharmacy Board of Liberia 4. School of Pharmacy (School of Dispensing) 5. Drug Regulatory Authority (not yet established, currently most functions undertaken

by the Pharmacy Division of the MOHSW) All five of these stakeholders have a major role to play in the supporting the implementing of the proposed pharmaceutical implementation and financing plan which is attached in Annex v. The overall goal for the pharmaceutical sector in Liberia is “increased access to efficacious, high-quality, safe and affordable medicine for the people of Liberia”, with the immediate purpose of the support required being “to use available resources to develop pharmaceutical services to meet Liberia’s requirements in the prevention, diagnosis and treatment of diseases by using efficacious, high quality, safe and cost-effective pharmaceutical products”. There are five specific objectives of the plan for the pharmaceutical sector, with each of the five main stakeholders having a primary responsibility, as follows:

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Specific Objectives and Main Responsibility

1. To coordinate policy and regulation for the pharmaceutical sector and for the control of substances of abuse in Liberia, in collaboration with relevant GOL agencies – Pharmacy Division

2. To ensure constant availability of safe and effective drugs to all segments of the population - National Drug Service

3. To facilitate rational use of drugs through correct diagnosis, sound prescribing, good dispensing practices, and appropriate usage – School of Pharmacy

4. To strengthen the regulation of pharmaceutical professionals and pharmaceutical institutions – Pharmacy Board of Liberia

5. To ensure that all pharmaceuticals available in Liberia are registered, meet approved quality standards and are approved for their intended use - Drug Regulatory Authority

All require predictable and increased funding to finance their recurrent budgets, as well as capacity building for their staff and systems. Capital investment is also required. Table 6.4 below gives a budget summary of the investment needed to implement the proposed plan. Details of activities and estimated costs under each output are presented the Annex v. Table 6.4: Pharmaceutical Implementation Plan Budget Summary

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

Year 1-3 USD$ USD$ USD$ USD$ Output 1: Pharmaceutical Policy & Regulation (Pharmacy Division)

113,700.00

450,000.00

8,500.00

572,200.00

Output 2: Adequate supply of Pharmaceuticals (NDS)

39,770,075.00

336,000.00

6,121,525.00

46,227,600.00

Output 3: Rational Drug Use through training and capacity building (School of Pharmacy)

576,100.00

787,500.00

701,655.00

2,065,255.00

Output 4: Regulation of Pharmacists and Pharmacy Institutions (Pharmacy Board)

169,200.00

-

8,000.00

177,200.00

Output 5: Quality Control of Pharmaceuticals (Drug Regulatory Authority)

179,300.00

160,000.00

200,000.00

539,300.00

Totals

40,808,375.00

1,733,500.00

7,039,680.00

49,581,555.00

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6.10 Procurement and Supply Chain Management

The transitional Government of Liberia passed an Act creating the Public Procurement Concessions’ Commission (PPCC) in September 2005, i.e. The Public Procurement and Concessions Act 2005 (Liberia). This Act mandates the PPCC to ensure that bidders, suppliers, contractors, and consultants observe the highest standard of ethics during the procurement and execution of contracts using public funds. In essence the PPCC is a government body set up to provide oversight for all public procurement and to support public procurement entities. The Act applies to the procurement of goods, works and services, financed in whole or in part from public funds including the disposal of government stores, plant and equipment and all concessions as defined under the Act. The Act applies to all executive agencies including Government ministries, commissions, bureaus, departments and agencies; subsidized – agencies; Independent bodies and commissions set up by the State; All public enterprises which are wholly owned by the State or in which the State has majority interest; Counties, districts and local authorities. Therefore the MOHSW, the National Drug Service (NDS) and potentially the County Health Teams and Hospital Management Boards can be designated procurement or concession entities under the Act. The Act provides for the establishment of a Procurement Committee in every entity. The Procurement Committee shall consist of at least five (5) persons constituted by the head of the entity as follows: (a) The head of the Procuring Entity, as Chairperson

(b) Two other senior officials of the entity, one of whom shall be the head of finance of the entity, (c) A representative of the concerned end-user department who shall be a rotating member (d) Any member co-opted for the purpose

The main functions of the Procurement Committee will be to: review procurement plans in order to ensure that they support the objectives and operations of the entity and comply with the national budget process; engage the services of such consultants and advisors, or co-opt persons with specialised expertise as may be required for the proper and efficient discharge of its functions. The Procurement Committee shall meet as and when required to review a bid or perform related functions but shall in any event meet at least once every quarter. A Procurement Unit will be established in each Procuring Entity under the Act. The Procurement Unit should be staffed with persons trained and knowledgeable in procurement and charged with carrying out, on an ongoing basis, functions related to procurement. The head of the Procuring Entity shall determine the composition of the Procurement Unit but every Procurement Unit shall consist of not-less than two (2) officials charged with the responsibility of budgeting, expenditure, and the administration of public procurement for the entity. The functions of a Procurement Unit shall include:-

(a) Planning of procurement (b) Preparation of invitations to bid and of bidding documents (c) Publication and distribution of invitations to bid (d) Receiving and safeguarding of bids

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(e) Conducting bid opening procedures in accordance with sub-section 5 of Section 61 of the Act

(f) Performance of secretarial services for the respective procurement committees (g) Administering the implementation and monitoring of contracts (h) Assessment of the quality of the procured goods, works and services (i) Sourcing and profiling of all suppliers, contracts and consultants, and the

maintenance of a database for that purpose (j) Such other functions as may be conferred by any other enactment

Appointment of staff to the Procurement Unit bay may be made subject to certification and qualification requirements that shall be instituted by the PPCC with advice from the Civil Service Agency. The Procurement Unit shall operate under the supervision of the Procurement Committee. Each Procurement Committee shall constitute a Bid Evaluation Panel with the required expertise as and when required. The Bid Evaluation Panel shall be responsible for the evaluation of bids in accordance with the predetermined and published evaluation criteria as outlined to bidders in the bid documents in accordance with the Act and shall prepare and submit an evaluation report for the consideration of the Procurement Committee. The PPCC may make rules to regulate the composition and activities of the Bid Evaluation Panel. Under the general provisions of the Act provision is made for health sector specific bidding documents for the procurement of goods. The Act requires all Procuring Entities to undertake procurement planning, with a view to achieving maximum value for public expenditure. The Procuring Entity shall employ international competitive bidding procedures when the estimated contract amount is higher than the value threshold specified in the Schedule, see illustration box 6.1 below for outline of current schedule: Illustration Box 6.1: Schedule to the Public Procurement and Concessions Act 2005 (Liberia).

Thresholds

1. Contract awards shall be published when the estimated value of the contract is above: a. Goods >US$25,000 b. Services >US$10,000 c. Works > US$50,000 2, 3 & 4 Procurement Thresholds

Goods Services Works Shopping Procedures

<US$2,000

<US$2,000

<US$10,000

National Competitive Bidding

<US$100,000

<US$50,000

<US$200,000

International

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Competitive Bidding

>US$100,000 >US$50,000 >US$200,000

5. Approval of Contract Awards (Value in US$) The Solicitation of Expressions of Interest is required when the estimated value of the consultants’ services is US$100,000 Type of Contract

Contract Value (Threshold

Authority Approving Proposed Contract Award

Less than US$10,000

Head of Procuring Entity Goods

Over US$10,000 Procurement Committee Less than US$50,000

Head of Procuring Entity

Works/ Technical Services

Over US$50,000 Procurement Committee

Less than US$10,000 Head of Procuring Entity Consulting Services

Over US$10,000 Procurement Committee

6. The Commission shall be notified of proposed contract awards over US$150,000 and the contract shall not be signed until at least fourteen (14) days after the date of the notice. 7. The Ministry of Finance shall take part in negotiations of contracts over US$250,000 for information purposes only. Training to procurement entities through the PPCC is ongoing through support from the World Bank. Training for the MOHSW and NDS is scheduled by the PPCC for the end of April 2007. This training will initially focus on the dissemination of obligations of procurement entities under the Act. Within the MOHSW there is currently a procurement unit which needs strengthening. Under the 1992 Memorandum of Understanding establishing the NDS provision is made recognising NDS as a procurement entity for the purposes of its mandate. For the purposes of procurement of pharmaceutical and medical supplies the MOHSW currently creates an institutional arrangement for the purpose of each large specific international tender, this includes establishing of a tender committee with broad representation, a set of guidelines for the tender process. The MOHSW use a set of standard GOL procurement guidelines. Restricted tenders for pharmaceutical and medical supplies are done by NDS. Although NDS is recognised as a procurement entity it does not have a full time procurement unit, rather for the purposes of procurement it has a procurement focal group which is made up of senior NDS management. NDS has standard procurement bidding documents that it uses. Planning for procurement is largely based on estimates derived from previous year stock utilisation and a calculation of requirements based on population and ratio of essential drugs, but very often is more dictated by the availability of funds. Fully responsive demand informed procurement relies on the real consumption of supplies throughout the country and

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needs forecasting for the next month or quarter. Such a system necessitates obtaining information from the facilities, an aggregation mechanism and a capacity to procure within a short period of time or to keep large stocks. At this stage, such a system does not exist and it will take time and investment to develop one. To ensure adherence to the Public Procurement Act and to satisfy conditions under the current Global Fund financing agreement both the MOHSW and NDS will need support to establish procurement units, establish annual procurement plans and strengthen the supply chain management to the beneficiary level. Initial support for NDS is expected to be provided by the UNDP through Global Funds support as part of Procurement and Supply Chain Management strengthening programme. Specific support for the establishment of a procurement unit in the MOHSW is still to be identified. The issue of procurement is critical to support the delivery of health services and procurement and supply chain performance is essential to ensuring that the fiduciary risk for both national and development partners funding to the sector is reduced, thus ensuring that maximum benefit of investment is achieved and evidenced through improved delivery of health services and improved health outcomes in the longer term. 6.11 Supply Chain Management for Pharmaceuticals and Medical Supplies Although NDS is defined as a procuring entity it also manages stores, and uses them to store the government stocks of medical supplies procured through other sources, other agencies and in-kind donations. Stocks of medical supplies belong to the MOHSW and not NDS that is a separate legal entity. NDS does not always receive invoices so they are not always aware of the value of the stocks they are holding, these items are not insured and in event of theft NDS would not know the value of the goods for which they would have responsibility to ‘self-insure’. For some pharmaceutical and medical supplies, received from both donor and INGO sources (e.g. GFATM drugs and supplies through UNDP, drugs and medical supplies on behalf of Africare and Merlin, etc), NDS acts as a store and issuing facility for some supplies, while it acts as distributors for others. Control of Delivery (down to beneficiaries) The control of delivery for NDS is now ending at the depot level with the receipt of the drugs and medical supplies by the health facility in-charge for primary and secondary level for those drugs distributed. For pharmaceuticals purchased for cash the receiving officer at the point of issue from NDS signs for the pharmaceuticals and control finishes there. At the health facility level the stocks are managed by the facility manager, with regular releases to the facilities’ pharmacies. A number of health facilities have functioning health facility committees. The role of these committees could be strengthened to monitor the receipt of pharmaceuticals against order and entry to stock records, also monitor value of pharmaceuticals received or pharmaceutical budget if facility funds are being used to procure the pharmaceuticals at that level. Storage and Distribution Infrastructure Under the existing arrangements; NDS is responsible for storage and distribution of the pharmaceutical and medical supplies purchased on behalf of the MOHSW. The following issues have been highlighted in previous assessments and still need addressing:

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NDS does not know the value of all the stocks which it holds on its premises, this is due to medicines procured through outside agencies being delivered without copies of invoices just quantities specified on delivery notes, so NDS not aware of the value of stock for which they have a responsibility for and currently there are no arrangements made to cover loss of this stock;

NDS operates mainly, from its central warehouse in Monrovia and does not fully utilise its depots to re-position its drugs and medical supplies based on demand knowledge;

There is poor coordination and information exchange with the other procuring agents of the health sector especially those receiving donor support;

The status of stock keeping in health facilities is not known, nor is the current use of SOP manuals, BIN cards, etc, and if they exist there is need to ensure that the quality of the information they contain is correct and useable.

In addition the quality of infrastructure for the safe storage of drugs and medical supplies needs improving. The MOHSW is in the process of carrying out an infrastructure survey to determine the current physical status of all health facilities in the country, this assessment will eventually lead to the development of an infrastructure development plan. The MOHSW currently does not have a transport policy and with the phased withdrawal of many NGOs from the sector the potential for inadequate arrangements for the provision of transport for the sector exists, especially during the transition period. As many County Health Teams may have vehicles but insufficient running costs to maintain and run these vehicles. Management of Disposals The management of disposal of drugs and medical supplies is unsatisfactory; there are incinerators at JFK and the Catholic Hospitals which are used. These are of low capacity and probably do not reach sufficiently high temperatures nor have sufficiently high chimneys for the proper and safe dispersal of smoke and fumes. A procedure for reporting drugs damaged during distribution and spoiled during use exists. This is an important element of control for health safety. Currently there is no country wide information on the level and value of out of date stocks. At health facility level there are wood fired generators and in some facilities waste is burned in open pits. Future support to strengthen the supply chain management should lead to decreases in expired medicines and should reduce the need for disposal. Addressing Procurement and Supply Chain Management Strengthening The programme to support ‘Standard Operating Procedure for Procurement and Supply Chain Management’ (SOP-PSM) through UNDP support by the Global Funds proposes to address most of the issues relating to procurement and supply chain management. Initially the support will focus on ensuring that SOPs for PSM are following in relation to goods supported through the Global Fund, but with the potential and intention of future expansion to serve all pharmaceutical and medical supply needs of the sector. However, this support on its own will may not be sufficient and once the final funding for the programme is agreed and approved there is need to look at how other sources of funding could augment the programme. 6.12 Future Role of the National Drug Service

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If the NDS is to strengthen its current position in the pharmaceutical sector in Liberia it will need to grow in terms of its turn-over and market share through a business model that ensures its’ sustainability and maintains its’ not-for-profit status. Currently the NDS main functions are:

1. Procurement of Essential Drugs for public and private-not-for-profit 2. Procurement and logistics services 3. Management of EPI supply 4. Monitoring (RDU, CSS, etc) 5. Cost Sharing Scheme 6. Community Outreach Project

What is important for the NDS is that any activity it carries out must be paid for, otherwise NDS will have to finance its overheads through de-capitalisation of its stocks of pharmaceuticals and medical supplies, as is currently happening. The function of monitoring rational drug use and cost-sharing schemes are not the responsibility of NDS and need to be re-institutionalised back into the MOHSW. NDS needs to concentrate on its core business of supplying the public sector and private-not-for-profit health providers with essential quality affordable pharmaceuticals and medical supplies. To fully implement its mandate there is need for the NDS to establish a development business plan based on the study of the potential market size and target customers’ base. The need of drugs within the public health system (which represents the first customer base) and its possible growth (with revitalization of the primary health facility network) can be identified to serve as a base to determine the volume of activity of the NDS and its possible development guided by the delivery of the BPHS. As already reported above the costing of supplies to deliver the BPHS is still to be done but some initial estimates have been done which can inform the potential level of capitalisation needed for NDS, if it is to operate as an autonomous sustainable wholesaler for the public health sector. Estimation of capitalisation can be done based on a number of assumptions, but it will be important to ensure that these assumptions are validated especially in relation to future resource envelope for pharmaceuticals and future funding mechanisms, i.e. will funds be at disposal of MOHSW or managed externally. In addition the need for initial investment in infrastructure is estimated at approximately USD$1.5million if NDS is to move from its current location to a green-field site in Paynesville. NDS sustainability means enabling the company to recover the procurement costs and to manage a revolving fund. NDS should perform as a private company, a wholesaler providing a service at a cost. It is not sustainable for the NDS that the MOHSW retains the authority to request distribution of drugs without charges. Therefore, MOHSW and NDS should agree an annual contract of what NDS is to provide on behalf of the MOHSWW and at what cost. NDS in return must agree to be bound by certain performance criteria which will monitor its effectiveness and efficiency, e.g. value for money, timely deliveries, minimised stock-outs, etc. The ideal situation would be that NDS is paid for the pharmaceuticals it delivers to the health facilities by the health facilities or on behalf of the health facilities by a third party, i.e. MOHSW or ‘joint drug fund’, etc. 6.13 Private Sector Importation Process for Pharmaceuticals

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Private wholesalers procure internationally and import. Currently there are 17 registered drug importers of which five are considered to be large in size in terms of volume of importation. These are based in Monrovia and their customer base is mainly private pharmacies and medicine stores and NGOs/FBOs (the latter mainly when stocks are not available at NDS or when there are large price differentials). The current regulations require all importers of drugs and medical supplies to be registered and to employ the services of a qualified pharmacist to oversee the procurement process. The steps for private importers to procure pharmaceuticals into Liberia are presented in illustration box 6.2 below: Illustration Box 6.2: Steps for the Private Sector to Import Pharmaceuticals into Liberia Step 1: Importer specifies and quantifies drugs to be ordered, subject to rules and regulations for drug importation into Liberia, and requests pro-forma from manufacturer/ overseas wholesaler. All drugs or medicines on the pro-forma invoice shall carry the following information:

Generic Name

Branded Name

Quantity Strength/ Concentration

DosageForm

Manufacturing Company

Country of Origin

Step 2: On receipt of the pro-forma, a proposed drug or medicine requisition is typed by importer and copy with pro-forma invoice is submitted to Pharmacy Division for review. The Importers’ Pharmacist (i.e. Applicant Importer) completes an “Application For Authorization to import Drug Products and/or Drug Substances, and/or Chemicals” for approval by the Chief Pharmacist. If requested, all medicine(s) importers shall surrender all samples of intended imports for analysis prior to the arrival of the said consignment, if samples intended for importation fail the importer shall be notified that said medicines cannot be imported. Step 3: Chief Pharmacist, MOHSW authorises medicines to be imported. Step 4: Importer places order for drugs, and initiates terms of contract for supply and payment of consignment. Step 5: Importer receives confirmation of order with support documentation of validity and quality of drugs, with Dispatch Note and applies to Ministry of Commerce for entry permit. Step 6: Importer gets bank guarantee of 1.5% of CIF value of goods and requests Bureau of Veritas to carryout pre-inspection and to issue inspection No. for consignment. Step 7: Importer receives Consignment Delivery Documentation which contains the following information: Quantity Branded

Name Generic Name

Batch Number

ManufacturingDate

ExpirationDate

ManufacturingCompany

Country of Origin

The support documentation shall include certificate of analysis per batch, pre-inspection certificate. Step 8: Upon arrival of consignment in Liberia importer applies for Letter of Authorisation to Import Pharmaceuticals and Related Products from Chief Pharmacist, Pharmacy Department;

44

application for Letter of Authorisation to be accompanied by Entry Permit and Pre-inspection certificate. Step 9: Importer receives notification of shipping of drugs and advises customs broker to initiate documentation for clearance of consignment Step 10: Importer receives notification of arrival of consignment and notifies customs broker to carry out clearance procedures. Step 11: Importer pays importation duties to Ministry of Finance and customs clearance charges and expedites consignment from customs Once the consignment is in Liberia, the national drug quality control technicians shall be authorized to collect samples per batch number for further analysis before the good is authorised for sale or use

45

7.0 Next Steps to implement the Liberian Pharmaceutical Sector Implementation Plan 2007/’08-2009/’10 Activity No.

Activity Description Expected Output Timeline Estimated Cost Responsibility/ Source of Funds

Specific Objective 1: To coordinate policy and regulation for the pharmaceutical sector and for the control of substances of abuse in Liberia, in collaboration with relevant GOL agencies 1.1 Disseminate sections of the Public Health Law of

1975 relevant to pharmaceuticals, National Drug Policy to all pharmacists, health managers, county health teams, Pharmacy Board of Liberia, Liberian Medical Board, School of Pharmacy

Copy of legislation and national policy available to all major stakeholders

May-June $750 Pharmacy Division Needs financing

1.2 Essential Medicine List officially approved by the MOHSW Revised Essential Medicine List disseminated

Copy of Essential Medicines List available to all major stakeholder

April-August none Pharmacy Division, Distribute to Counties and facilities through NDS (printing of EML done under EC pharmacy consultancy)

1.3 Liberian Guideline on donation of medicines approved by MOHSW Liberian Guideline on donation of medicines disseminated

Copy of guidelines available to interested parties

April May-June

none Pharmacy Division, NDS (Distribute through INGO Coordinator, Development Partner meetings, etc) (printing of guideline done under EC pharmacy consultancy)

1.4 Continue monthly meetings with Ministry of Justice- Liberia National Policy & Drug Enforcement Agency, Pharmacy Board of Liberia on coordinating the control of substances of abuse, sub-standard and counterfeit medicines

Plans for coordination developed Monthly none Pharmacy Division No budget for meetings initially, but funding required to carryout inspections once planned

1.5 Develop terms of reference for National Pharmaceutical and Therapeutics Committee, and identify committee participation, hold first meeting and develop schedule for meetings

Terms of Reference approved and committee meeting

ToRs by June and meeting at least quarterly

None Pharmacy Division, Chief Medical Officer, National Vertical Programme Managers No budget required unless inclusion of representatives from the County Health Teams

1.6 Initiate meetings with Ministry of Internal Affairs on complementary medicines

Roles and responsibilities relating to complementary medicines clarified and coordination mechanism established

May and periodically thereafter

None Pharmacy Division, Chief Medical Officer

46

Activity No.

Activity Description Expected Output Timeline Estimated Cost Responsibility/ Source of Funds

Plan for routine follow-up meetings on coordination

Initially no budget required, future budget required if non-Monrovia participants involved

1.7 Pharmacy Division action plan for 2007/2008 included in the MOHSW annual operational plan for 2007/2008

Pharmacy Division plan included in main sector plan

April-June None Pharmacy Division, Planning Department

1.8 Ensure that support for Pharmacy Division is included in future proposals for external assistance, especially areas under new World Bank Proposal, i.e. computers, office equipment, IT and Communications needs, human resource development needs, etc.

Areas of future support for Pharmacy Division included in World Bank proposal

April-May None Pharmacy Division, Planning Department -potential funding from World Bank through new proposal

Specific Objective 2: To ensure constant availability of safe and effective drugs to all segments of the population 2.1 Set up procurement-unit in NDS

Procurement Unit Established April –

ongoing To be finalised UNDP (GFATM), additional support

on public procurement through PPCC

2.2 Annual budget and resource envelope for financing pharmaceuticals and medical supplies identified

Resource envelope known April - June None NDS, Pharmacy Division, Planning Department

2.3 An Annual Procurement Plan for all pharmaceuticals from all sources and through all channels needs to the public sector needs to be developed, to be coordinated by NDS & Pharmacy Division

Annual Procurement Plan, at least initially for goods for the public sector being handled by NDS

April-June Updating to be continued as information available

None NDS, Pharmacy Division, Chief Medical Officer, Planning Department, National Health Programmes, INGOs (role of procurement unit once established in NDS)

2.4 Develop annual contracts and Memorandum of Understanding’s with all customers/clients including MOHSW

Contracts and MOU developed and updated

April - June None for meetings TA support

NDS, Finance Department -TA support through EC NHP implementation support on contracting

2.5 Carryout Training needs assessment and develop HR development plan for NDS staffing, start implementing some local training based on current available funding

Training Needs Assessment Done, HR development plan available, advocate for funding

May- July None for TNA Local Training budget to be decided based on NDS operational budget

NDS

2.6 Finalise and being implementation programme for Programme approved and implementation April- ongoing To be finalised NDS, SCM-Technical Working

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Activity No.

Activity Description Expected Output Timeline Estimated Cost Responsibility/ Source of Funds

Standard Operational Procedures for Procurement and Supply Chain Management strengthening

plan started Group, Clinton Foundation, UNDP -financed by GFATM through UNDP

2.7 Procurement of Pharmaceuticals with current available resources, both in NDS and outstanding balances in MOHSW annual allocation

Pharmaceuticals procured April - ongoing

Annual allocation was USD$1m

NDS, MOHSW-Procurement Committee

Specific Objective 3: To facilitate rational use of drugs through correct diagnosis, sound prescribing, good dispensing practices, and appropriate usage 3.1 Basic Package of Health Services is finalised,

pharmaceutical inputs finalised and costed as part of the overall package

Basic Package finalised April- August To be finalised Chief Medical Officer, Pharmacy Division, National Health Programmes

3.2 Curriculum for Dispensers training revised

Revised Curriculum April- August None for initial meetings (Future TA and workshop needed to finalise- $23,000)

School of Pharmacy, Pharmacy Board of Liberia, Pharmacy Division -future finance needed

3.3 Official Request to WHO for further support for revision National Formulary requested. Timetable planned for activity

Confirmation from WHO of support and dates fixed for activity Work on NF Scheduled

April To be advised

none Pharmacy Division/ Chief Medical Officer -WHO support

3.4 Official Request to WHO for further support for revision Standard Therapeutic Guidelines requested. Timetable planned for activity

Confirmation from WHO of support and dates fixed for activity Word on STGs scheduled

April To be advised

none Pharmacy Division/ Chief Medical Officer -WHO support

3.5 Training needs assessment done for all pharmacists in the public sector and input into MOHSW human resource development plan section of national health annual operational plan, and future proposals for external financing (e.g. World Bank proposal)

Types of training identified and initial plan to address needs developed, included in World Bank proposal

April- June None Pharmacy Division, Planning Department -Possibility of funding through new World Bank Proposal

3.6 Ensure that support for School of Pharmacy is included in future proposals for external assistance, especially areas under new World Bank Proposal, i.e. teach aids, text books, laboratory equipment and supplies, rehabilitation of offices, class rooms and teaching labs.

Areas of future support for School of Pharmacy included in World Bank proposal

April-May None Pharmacy Division, School of Pharmacy, College of Medicine, Planning Division -potential funding from World Bank through new proposal

Specific Objective 4: To strengthen the regulation of pharmaceutical professionals and pharmaceutical institutions

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Activity No.

Activity Description Expected Output Timeline Estimated Cost Responsibility/ Source of Funds

4.1 Registrar of all practicing licensed pharmacists in Liberia maintained

Practicing Pharmacists Licensed April - Ongoing

None Pharmacy Board of Liberia

4.2 Code of ethical conduct developed and adopted, dissemination to all members started;

Code of Ethics approved by Board June None Pharmacy Board of Liberia

4.3 Registrar of all pharmaceutical institutions

Register of Pharmacy Importers, Pharmacies, Medicine stores up to date

April - ongoing

None Pharmacy Board of Liberia

4.4 Accreditation of training institutions for pharmaceutical science/discipline and overview of pharmacy education

Institutions accredited April - ongoing

Part of routine budget Pharmacy Board of Liberia

4.5 Hold regular meetings with the Private sector on obligations and rights under legislation and regulation

Private sector meetings held April on-going none Pharmacy Board of Liberia, coordinate with Pharmacy Division

4.6 Carryout routine inspections of all pharmacies and medicine stores to ensure compliance with regulations

Schedule of inspections prepared and being implemented

April ongoing Part of routine budget Pharmacy Board of Liberia, coordinate with Pharmacy Division

4.7 Pharmacy Board Meetings

Meetings held monthly April and every month

$375 per month Pharmacy Board of Liberia, operational budget

Specific Objective 5: To ensure that all pharmaceuticals available in Liberia are registered, meet approved quality standards and are approved for their intended use 5.1 Strengthen Drug quality control laboratory Quality Control laboratory doing basic

tests April ongoing Future funding required

to strengthen laboratory from basic tests

Pharmacy Division initially, responsibility moving to Drug Regulatory Authority once established. Initial capital costs required, potentially DRA can self finance based on drug registration

5.2 Ensure that support for strengthen quality control laboratory is included in future proposals for external assistance, especially areas under new World Bank Proposal, i.e. laboratory equipment and supplies, future training needs of staff

Areas of future support for Quality Control Laboratory included in World Bank proposal

April-May None Pharmacy Division, Pharmacy Board of Liberia, Planning Department -potential funding from World Bank

5.3 Continue current enlistment of medicines to be imported as basis of future drug register

All importers aware and have listed future medicine to be imported

April - September

None Pharmacy Board of Liberia, responsibility moving to DRA once established

5.4 Issue authorisation to import pharmaceuticals and control substances

Import authorisations issued April - ongoing

None Currently Pharmacy Division, responsibility moving to DRA once established

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Activity No.

Activity Description Expected Output Timeline Estimated Cost Responsibility/ Source of Funds

5.5 Carryout non-routine inspections in collaboration with Ministry of Justice, Liberia National Policy, Drug Enforcement Agency to remove sub-standards, counterfeit and controlled substances and arrest illegal drug vendors

Inspections carried out June- ongoing Fuel and allowances, dependant on number of operations

Pharmacy Division initially, responsibility moving to DRA once established in collaboration with MOJ-LNP & DEA

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8.0 Annexes Annex i: Abbreviated terms of Reference for the Consultancy

Brief Terms of Reference

for a Review of the pharmaceuticals area and preparation of a mid-term Pharmaceuticals

Policy and Implementation plan for the Ministry of Health, Liberia

Global objectives

The overall objectives of the programme of which this contract will be a part are as follows:

To encourage and accelerate the process of social and economic rehabilitation of the affected populations, and to contribute to the rehabilitation of public basic services and infrastructures, including the availability of Health services;

To support the re-establishment and functioning of key public Ministries.

Specific objectives

The specific objectives of this contract are as follows:

- To support the Ministry of Health in assessing the pharmaceutical system in Liberia (elaboration of a synthetic base of information and a situation analysis regarding the area of pharmaceuticals in Liberia).

- To support the Ministry of Health in elaborating a pharmaceuticals policy and plan relevant to the mid-term Health and Social Welfare National Policy and Implementation plan currently being completed.

- To support the adoption and start of implementation of immediate recommendations and improvement of practices in pharmaceutical management.

Requested services

The experts employed under this contract will carry out this assignment by:

1/ Under objective 1: To support the Ministry of Health and social Welfare (MoHSW) in assessing the pharmaceutical system in Liberia:

Reviewing available information on pharmaceuticals area and policy and analysing the present situation (namely but non exclusively: institutional framework, human resources and training needs, management and administration, facilities situation and their potential, present financing and funding sources, potential for fund raising opportunities);

The review and analysis should namely encompass the following areas:

Component Themes

Supply and demand

Review the National Essential Drugs List and of the presently procured drugs in particular from the point of view of their appropriateness with regard to the current Health sector situation and the envisaged (mid term strategy) Health System in Liberia;

Assess the current availability of these drugs at health facilities at community, district, county and national levels and propose improvements of the facilities

Assess the volume of drugs sold through the public and private supply chains, and

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analyse the role of the public and private sectors in the availability and affordability of drugs

Procurement, storage and distribution

Review the current practices for international procurement, storage and distribution of essential drugs, e.g:

- Procurement: Comparative efficiency of existing arrangements for procurement. Not-for-profit and for-profit procurement schemes

- Storage: Adequateness of the warehousing network to handle present and projected drug supplies

- Distribution and availability of drugs. Strengths and weaknesses of the existing supply mechanisms

Management, regulation and quality control

Review existing quality control mechanisms, namely : quality standard in the private for-profit and not-for-profit components of the health sector; the regulations and testing mechanisms at the MoHSW to register and test imported drugs, to control the efficacy and quality of drugs and to ensure proper disposal of expired drugs.

Present patters of use of drugs. Dispensing practice. Patient compliance. The informal market.

Financing Review and assessment of existing internal and external financing (including donor funding of drug purchases) and of funding mechanisms. Assessment of the financial sustainability of the current pharmaceutical management systems.

Regulation Overview of existing laws and regulations, their strengths and weaknesses

The Assessment will produce a comprehensive mapping of the players involved in the pharmaceutical area, complete with functions fulfilled, interests, capacity and comparative strengths and weaknesses.

Supporting / facilitating a consultation process at central (Monrovia) and if required decentralised (counties) levels between pharmaceutical sector stakeholders (workshops), as well as donors coordination in this area.

Elaborating recommendations, having ensured the involvement and consensus of the relevant stakeholders of the pharmaceutical area;

The recommendations should namely encompass the following areas

Component Themes

Supply and demand

Improvements of the system to improve planning and adequacy between supply and demand, including accessibility (availability, affordability)

Essential drugs lists satisfying the demands of most partners

Procurement, storage and distribution

Increasing the appropriateness of the procurement process, and the efficiency of the distribution process.

Ways to streamline the present procurement storage and distribution situation

Investment needed to raise storage capacity to the required standards.

Ways to improve the distribution and availability of drugs situation, and namely supplies to areas of difficult access.

Management, Development/procurement of an adequate Drugs storage and Inventory Management

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regulation and quality control

System and provision of corresponding training program

Ways to improve and expand quality control mechanisms

Rational use of drugs. Ways to improve the use of drugs across the health sector.

Human resources

Human resource development in the pharmaceutical area.

Steps needed to start the training of mid-level pharmacy personnel.

Financing Adequate financing options. Ways to rationalise and improve sustainability of funding mechanisms

Regulation Approaches to regulation appropriate to the context.

Measures needed to implant regulatory functions in the pharmaceutical area.

2/ Under objective 2: To support the Ministry of Health in elaborating a drugs policy and

plan relevant to the mid-term Health and Social Welfare National Policy and Implementation plan

Defining a mid-term strategy for the pharmaceutical area relevant to the National Policy, by: Identifying and proposing possible alternatives concerning priority strategy and

objectives for the mid-term in the pharmaceutical sector, with their related operational frameworks and required resources / sources of funding and financing;

Ensuring the legitimacy of the options proposed and their ownership by all the major stakeholders (including the MoH, key UN agencies, NGO representatives and potential donors) by bringing them together in a strategic planning process. For this purpose, executive summaries of the proposed alternatives and an overall comparison will be provided to stakeholders with due antecedence.

Based on these consultations, selecting with the responsible officials of the Ministry of Health, and formulating in details the resulting mid-term strategy for the development of pharmaceuticals management.

Elaborating an Implementation Plan: Formulating a detailed organisational, operational and financial proposal for the pharmaceuticals area mid-term strategy implementation, including a financing programme and a diagram identifying precursor and successor responsibilities for all stakeholders of the programme (both for funding and implementation).

Providing contributions concerning the Health sector and Health strategy for the programming of the 10th EDF in Liberia (information, program concept note or programming document, etc.)

Identifying further needs for longer term Technical Assistance and studies/surveys in this sector and drafting Terms of Reference for these;

3/ Under Objective 3: To support the adoption and start of implementation of immediate recommendations and improvement of practices in pharmaceutical management.

Along the whole exercise, work alongside MoHSW pharmaceutical and NDS staff, exposing them to most adequate practices and lessons learned from pharmaceutical management systems developed in similar contexts, particularly in post-conflict recovery processes.

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4/ Cross-cutting activities: In the framework of its contribution to the revision of the National Health Policy and elaboration a National Health Development Plan, WHO and USAID are seconding short term consultancies. The EC has provided a mid-term technical assistance tot the process. UNICEF also support this exercise.

It is anticipated that the experts employed under this contract will:

Closely liaise and ensure complementarity and consistency with the contributions of experts seconded by other organisations;

Integrate these contributions in achieving the specific objectives of the contract;

Ensure consistency in carrying out he tasks involved under objectives 1 and 2 with the EC Programming guidelines in Health, AIDS and population;

Facilitate the link between Health and other sectors dealing with issues of poverty, governance and decentralisation;

Support donor co-ordination by the Ministry of Health, and the dissemination of information.

Expected results A situation analysis of the pharmaceuticals area in Liberia as well as preliminary

recommendations based on this analysis have been elaborated and discussed with relevant stakeholders.

A mid-term Pharmaceuticals Management Policy, and a related mid-term Implementation and Financing Plan will have been approved by the Liberian Ministry of Health.

Immediate improvement and best practices have been recommended and initial support provided to start their implementation.

Possible further mid-term and consistent support (in the framework of the 10th EDF) in the pharmaceuticals area will have been identified and base documents for such support drafted, upon request.

The draft Pharmaceuticals Management Policy, will comprise in annex a summary/review of the present situation (pharmaceutical sector assessment), and a synthetic table linking the key issues resulting from the assessment to the orientations of the Pharmaceutical and National Health and Social Welfare policies.

The draft implementation Plan, submitted after the discussion on the alternatives, will include namely: An executive summary of the strategy, a synthetic description of the sector context, development partners co-ordination, objectives, expected results and activities, risks and assumptions, crosscutting issues, monitoring and indicators; a logical framework. A linkage to the PRSP should be clearly identified.

The Implementation Plan will include namely: a description of pre-requisites for financing and sources of funding; a detailed budget; a detailed description of the operational plan, Diagrams and timetables for the studies, implementation and funding.

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Annex ii List of Principle Persons Met

Dr. W. Gweningale Hon. Minister of Health MOHSW Dr. B. Dahn Chief Medical Officer MOHSW Dr. M. G. Perwu Assistant Minister (Curative) MOHSW Mr. S. Varpilah Deputy Minister (Planning) MOHSW Dr. M. Sheriff Deputy Minister (Administration) MOHSW Mr. N. Bropleh Assistant Minister (Planning) MOHSW Rev. T T Tyee Chief Pharmacist MOHSW Mr. Joseph Jimmy Deputy Chief Pharmacist MOHSW Mr. W. Martin Snr. Advisor to MOHSW MOHSW Mr. Tommy Gully Managing Director NDS Mr. Beyan Johnson Operations Manager NDS and Chairman PBL Mrs. C. Bright-Parker Ambassador at large and special Advisor to PBL Mr. Joseph. Weah Registrar Pharmacy Board of Liberia Mr. Neikata Jackson President Pharmacists Association Dr. Koka Hara Rao Chief Medical Officer UNMIL Dr. Iain Aitken Consultant - BPHS USAID / MSH Dr. Claudine Dauby Medical Coordinator ICRC (L) Dr. Moses Aikins Health Economist WHO Consultant Mr. W G Kokulo Exec. Director Research/ Special Project Min. of Internal Affairs Mr. Brent L. Fox Managing Director Christian Aid Ministries Ms. Sonja van Osch Country Director Merlin Dr. Julius Wekesa Country Health Director Merlin Ms. Susan Grant Field Director - Liberia Save the Children (UK) Ms. Nichola Cadge Health Advisor Save the Children (UK) Mr. Franklin Baer PHC Systems Consultant Basics USA Mrs. Ellen Williams Coordinator CHAL Mae Podesta Country Director HIV/AIDS Clinton Foundation Mr. Björn Forssen Head of Health & Nutrition Unicef Dr. Raymond Kromah County Health Officer Grand Cape Mount Theresa Kalpha County Health Team Grand Cape Mount Dr. Linda Birch County Health Officer Bomi County Netus Nowine County Health Officer Grand Gedeh County C. Paul Nyanzee County Health Officer Nimba County Dr. Kabor Jaudh County Health Officer Lofa County Mr. R. Cassell Hospital Administrator C H Rennie Hospital Dr. M Kamara Medical Director Redemption Hospital Sr. Barbara St. Theresa Convent Dr. S. Duale Consultant–medical training schools USAID Mr. Demissie Tadesse Medical Coordinator AHA Liberia Dr. M. S. Fatouma Medical Coordinator MSF (France) Dr. J. Reed Founder and Head of Liberian Tradnl Medical Services Ass Dr. S.H. Sajow Coordinator Reproductive Health UNFPA Ch. Insp. Embra JC Harmon Chief Inspector LNP / CID Insp. Oscar N Porte. Deputy Chief Anti Narcotics unit LNP Dr. Giles Raguin MD Head of Medical Dept. ESTHER Col. S A Gibson Opps DDO Drug Enforcement Unit MoJ Mr. Alphen Lumeh Chief Pharmacist LNP Crime Lab. Dr. J Reed Complementary Medicine Expert Private Practice

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Annex iii Organisations represented at the consensus building workshops Thinkers Village February 20th 2007 Corina Hotel April 4th 2007 Ministry of Health and Social Welfare Curative Dept Pharmacy Division Family Health Division All 15 County Health Officers National Leprosy and TB Programme National EPI Programme National AIDS Control and STI Programme Malaria Control Programme INGO Coordinator World Health Organisation International Committee of the Red Cross ECHO Special and Tertiary Level Institutions JFK Medical Centre Phebe Regional Referral Hospital Redemption Hospital St. Josephs Catholic Hospital National Drug Service Pharmacy Board of Liberia Liberian Pharmacists Association Liberian National Police – Forensic Laboratory Private Sector Pharmacists School of Pharmacy – University of Liberia School of Nursing and Lab. Technicians – St. Theresas International NGOs and FBOs Christian Health Association of Liberia Christian Aid Ministries Africare AHA Cap Anamur Medcins du Monde Medcins sans Frontiere Mentor Initiative Mercy Ships Merlin North West Medical Teams Paracom Save the Children (UK)

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Annex (iv) Mid-Term Pharmaceuticals Management Policy Introduction The Terms of Reference for this Review require that a Draft Pharmaceuticals Management Policy be produced at the Mid-Term of the assignment and that this is developed into an agreed Financing and Implementation Plan to be included in the final report. Scope The required management policy should cover public, parastatal and private sectors. In the public sector this should include:

The Pharmacy Division, MOHSW National and Referral Hospitals, including those falling under FBO administration County Health Services, the CHTs’, Health Centres and Clinics Pharmaceutical education National Disease Control Programmes (Vertical Programmes)

For the purpose of this document, and due to their sometimes ambiguous position, the following institutions will be considered as Parastatal:

The National Drug Service, NDS The Pharmacy Board of Liberia including a Drug regulatory Authority (to be formed)

The Private Sector pharmaceutical supplies and services are also included since they play an important role in the supply of medicines directly to patients at retail level, supplies made to government and NGO / FBO health units and the drug supply to private (for profit) clinics. The following are therefore included:

Drug / Medicine Importers Pharmaceutical Wholesalers Retail Pharmacies and Medicine Stores

Pharmaceuticals Management Policy 1.0 Public Sector 1.1 Ministry of Health and Social Welfare The Ministry of Health, through the Pharmacy Division, shall be responsible for: Posting of Pharmacists to the Counties as members of the CHT Issuing Job Descriptions for the County Pharmacists and Monitoring and

Supervising their performance Compilation, up-dating, printing, publishing and distribution of the necessary

literature to enable implementation of this policy, including but not limited to: - The Essential Medicines List of Liberia - The Liberian National Formulary - The Liberian National Standard Therapeutic Guidelines

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- The Guidelines on Donations of Drug and Medical Supply to Liberia

Coordination of the various vertical disease control programmes to ensure the supply of adequate quantities of the correctly selected and quantified drugs and medical supplies to satisfy the demands placed on those programmes

The Ministry of Health shall also be responsible for: Budgeting and ensuring the release of adequate funds for the procurement of drugs

and medical supplies by NDS

1.2 National and Referral Hospitals, including those falling under FBO administration shall:

Respect and implement the National Drug Policy of using only Generic (INN) names Respect and implement the National Drug Policy of prescribing and using only those

drugs which are included in the National List of Essential Medicines Respect and implement the provisions of the Guidelines on Donation of Medicines

and Medical Supplies for Liberia

1.3 County Health Services shall: Employ the services of a County Pharmacist Establish County and / or Hospital Drug and Therapeutics Committees With the county pharmacist develop morbidity-based procurement plans to satisfy the supply needs to implement the BPHS Ensure suitable and sufficient storage facilities for drugs and medical supplies Ensure the availability of suitable and sufficient stationery for the proper recording and control of drugs and medical supplies in all health units,including but not limited to:

- Bin cards or similar stock recording forms - Ledgers to record supplies inward and outward from the store - Medication charts for inpatients - Prescription forms for the prescribing of outpatient medication - Ledgers to record outpatient prescriptions - Financial ledgers to record the value of drugs and medical supplies received and issued

1.4 The Ministry of Education, through the University of Liberia, shall provide premises,

facilities and staff for the education of pharmacists to first degree level and of dispensers to diploma level

1.5 National Disease Control Programmes (vertical programmes) shall maintain close

liaison with the Pharmacy Division (MOHSW), NDS, and the county pharmacists to ensure that adequate supplies of the correctly identified medicines and medical supplies are available in all designated health facilities, based on requests from the facilities / CHO, and that excess stocks are not “pushed” to facilities or allowed to build up.

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2.0 Parastatal Bodies 2.1 National Drug Service (NDS) NDS shall prioritise procurement of drugs and medical supplies necessary for

delivery of the BPHS NDS shall develop a medium term procurement plan based on morbidity-related data

supplied by the Pharmacy Division / County Pharmacists NDS management shall develop a closer coordination, through the division of

pharmacy, with the various vertical programmes in order to ensure procurement of the correct type of drugs and medical supplies, and for NDS to have full knowledge of the value of such drugs and medical supplies

NDS shall seek means of increasing their capital base in order to better meet the demands of their core customers

NDS shall continue to develop and expand their number of community outreach pharmacies, run on a “not for profit” basis, as a means of demonstrating good pharmaceutical practice and promoting rational medicine use in the community

2.2 The Pharmacy Board of Liberia and Drug Regulatory Authority The Pharmacy Board, together with the Ministry of Health, shall promote the

formation of a new, independent, Drug Regulatory Authority (DRA) which shall have sole responsibility for the registration of drugs for use in Liberia and for the production and publication of a drugs register

The newly formed DRA shall have responsibility for issuing import permits for drugs and medical supplies in the private sector and for the inspection of imported drugs and for post-marketing surveillance of their distribution

The Pharmacy Board shall remain responsible for the registration of pharmacists and dispensers, and for overseeing their professional and ethical conduct

The Pharmacy Board shall remain responsible for the licensing of pharmacies and medicine stores, for their inspection and for ensuring their compliance with all relevant legislation concerning premises and conduct

3.0 Private Sector 3.1 Drug Importers All importers of drugs and medical supplies for the private sector shall obtain an

importation permit from the DRA for each consignment All importation for the private sector shall be restricted to those drugs registered for

use in the country (as the register is populated) Importers shall sell only to wholesale or retail pharmacies, medicine stores or

ministry of health facilities Sale to medicine stores shall be restricted to class “C” medicines All importation for the public sector shall be restricted to those drugs included in the

Essential Medicines List for Liberia and registered for use in the country (as the register is populated)

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All importations of drugs shall be inspected on arrival by inspectors of the DRA and shall be accompanied by a certificate of analysis per batch and a certificate of free sale per item

A sample of each batch of imported drug / medicine shall be submitted for analysis as analytical capacity becomes available

3.2 Wholesale Pharmacies All pharmaceutical wholesalers shall purchase from importers who follow the above

procedures, or shall follow the above procedures if importing directly themselves Wholesale pharmacies may sell to retail pharmacies, medicine stores, Ministry of

Health facilities and private “for profit” health facilities Sale to medicine stores shall be restricted to class “C” medicines and sales to

Ministry of Health facilities shall be restricted to drugs included in the Essential Medicines List of Liberia and shall respect the designated “Level of Use” of those facilities

Wholesale pharmacies shall be situated in separate premises from retail pharmacies or any other business

3.3 Retail Pharmacies and Medicine Stores Retail pharmacies shall procure their drugs / medicines only from authorised

importers or licensed wholesale pharmacies Retail pharmacies may sell without prescription medicines and medical preparations

included in categories “B”; “C” and “D” of the drugs schedules Retail pharmacies may dispense medicines included in category “A” of the drugs

schedules only on receipt of a duly written prescription as specified in chapters 41 and 43 of the Public Health Law 1975

Medicine stores shall procure their medicines only from licensed wholesale or retail pharmacies and shall sell only medicines and medical preparations included in categories “C” and “D” of the drug schedules

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Annex v: Liberian Pharmaceutical Sector Implementation Plan 2007/’08-2009/’10 (nested logical framework of the National Health Plan 2007-2011)

Objectively Verified Indicators Means of Verification

Assumptions

Health Policy Vision Improved health and social welfare status and equity in health [Expand access to basic health care of acceptable quality through an equitable, effective, efficient, responsive, and sustainable health care delivery system]

Infant Mortality Rate to be reduced from 157/1,000 live births

in 2006 (UNICEF 2006) to XX by 2011 Under-5 Mortality Rate to be reduced from 235/ 1,000 live

births 2006 (UNICEF 2006) to XX by 2011 Maternal Mortality Ratio 580/100,000 live births in 2005

(UNFPA 2005) to XX by 2011

LDHS LDHS LDHS

The overall policy goal can be attained through the improved management of expanded resources, provided by the state, donors, international agencies, non-profit health care providers, economic actors and communities.

Strong, structured partnerships around shared objectives and approaches, within and outside the health sector, will lead to improve health status.

Overall Objective (Goal) Increased access to efficacious, high-quality, safe and affordable medicine for the people of Liberia

100 % Availability of tracer essential drugs (specify which

drugs, check) by 2011 Stock out rates on essential medicines reduced by 75% by

2011 Fully Immunization Children Coverage reaches 85% and

being maintained by 2011 Contraceptive prevalence rate increased from 5% in 2006

(NHPlan) to 15% by 2011

LMIS LMIS EPI LDHS

The MOHSW capacity is strengthened to provide leadership and coordination of the health sector in Liberia All health partners align with MOHSW policy and strategies and harmonize their support to implement MOHSW policy

Immediate Objective (Purpose) To use available resources to develop pharmaceutical services to meet Liberia’s requirements in the prevention, diagnosis and treatment of diseases by using efficacious, high quality, safe and cost-effective pharmaceutical products

MOHSW budget allocation for Pharmaceuticals and medical

supplies increasing from 13% in 2006/7 to 20% by 2010/11 NDS maintaining its capital through revolving fund by

recovering cost of sales and services by 2011 Number of registered Pharmacists, currently 31 in 2007

increases by 5 per year until 2009 and by 20 per year thereafter

100% of pharmaceutical donations comply with national guidelines by 2011

Number of pharmaceutical samples tested reach the required quality standards increasing annually

PER Annual Audit. PBL Registrar. PD Annual Report. DRA Annual Report

GOL allocation to the health sector increases annually Resources are secured to capitalise NDS GOL/MOHSW retain and deploy health workers through appropriate conditions of service All donors supporting drugs and medical supplies in the health sector will adhere to the principles of an essential drugs programme Effective collaboration is established and maintained between MOHSW and Ministry of Justice on regulation

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Specific Objectives

Objectively Verifiable Indicators (OVIs)

Means of Verification (MOVs)

Assumptions

Specific Objective 1: To coordinate policy and regulation for the pharmaceutical sector and for the control of substances of abuse in Liberia, in collaboration with relevant GOL agencies

Essential Drug List revised and disseminated periodically,

2007, 2009 & 2011 National Formulary revised and disseminated periodically,

2007, 2009 & 2011 Sources of funding for pharmaceuticals diversified by 2009 Legislation and regulation on pharmaceuticals and controlled

substances published and widely distributed by 2008 Pharmacy Division representing Liberia internationally at

appropriate forums on pharmaceutical issues relevant to Liberia

Number of Complementary Medicine Practitioners registered increasing annually

Annual Report Annual Report NHA PD/PBL Annual Report PD Annual Report PD Annual Report

All pharmaceutical institutions recognize the regulatory function of the MOHSW, PBL and DRA and adhere to their regulations Other GOL agencies with responsibility for the control of pharmaceuticals, substances of abuse and complementary medicines will work in collaboration with the MOHSW Laws and conventions governing patents on drugs shall be reviewed, in order to ensure that the Liberian public is not disadvantaged from accessing essential drugs and medical supplies Donor support for pharmaceuticals is aligned and harmonized to support MOHSW annual needs for delivery of the BPHS

Specific Objective 2: To ensure constant availability of safe and effective drugs to all segments of the population

Cost of pharmaceutical, medical supplies and diagnostics

required to support the BPHS established by end of 2007 and updated annually to inform annual budgeting and planning process

Pharmaceutical storage sufficient and suitable throughout the supply chain

NDS and all Drug Depots reporting timely according to SOP guidelines by end of 2007 and maintained thereafter

Annual Procurement Plan developed for 2007/2008, moving towards a Medium Term Procurement Plan by 2008/2009 for all Pharmaceuticals and Medical Supplies

Logistics Management Information System established for GFATM products in operation by 2007 and expanded to include all products by 2009

Procurement Unit established in NDS by end of 2007 and doing increasing number of International Competitive Bids from 2008 onwards

Annual Operational Plan PSM Supervision Reports PSM-SOP Progress report MTPP, Annual Report PSM-SOP Progress report & Annual Report NDS Annual Report

GOL will continue to increase allocations to health in general and for procurement of drugs in particular MOHSW policies on supply of pharmaceuticals and medical supplies will not de-capitalise NDS NDS is sufficiently capitalised to allow it to function as an autonomous not-for-profit sustainable central medical stores to supply pharmaceuticals and medical supplies for public health services Health infrastructure is strengthened to facilitate supply chain management for pharmaceuticals and medical supplies Capacity in MOHSW and NDS will be sufficient for MOHSW to become Principle Recipient for Global Funds in 2009

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Specific Objectives

Objectively Verifiable Indicators (OVIs)

Means of Verification (MOVs)

Assumptions

MOHSW contracting NDS for supply of Pharmaceuticals and Medical Supplies for delivery of the BPHS through annual contract

Procurement Unit Report

Specific Objective 3: To facilitate rational use of drugs through correct diagnosis, sound prescribing, good dispensing practices, and appropriate usage

Standard Treatment Guidelines revised and health workers

trained through in-service training in their use periodically, 2007, 2009 & 2011

Pharmaceutical and Therapeutic Committees established by 2008 and functioning at central level and in all counties by 2009

Curriculum for Pharmacists and Dispensers training revised by 2007 and periodically thereafter, 2009 & 2011

Pharmaceutical component of all health workers curriculum revised periodically, 2007, 2009 & 2011

Number of Pharmacists graduating from School of Pharmacy increasing to at least 20 by 2009

At least one Pharmacist deployed and working as part of the County Health Team in every county by 2011

Plan for Continuing Professional Development for Pharmacists developed and incorporated into annual human resource development plan by 2008

Annual health promotion campaign on rational use of pharmaceuticals carried out at national and county levels

Annual Report Annual Report Annual Report SoP Annual Report HR Division Annual Report SoP HRIS Annual HR Development Plan Annual Report

GOL addresses conditions of services and incentives to ensure retention and deployment of health workers in rural areas Pharmacy as a profession will continue to attract sufficient numbers of entrants Sufficient resources will be made available to support pre-service training and continuing professional development of health workers MOHSW public health campaigns are sufficient to promote ration drug use amongst the general public in Liberia

Specific Objective 4: To strengthen the regulation of pharmaceutical professionals and pharmaceutical institutions

Code of ethical practice developed for Pharmacists and

adherence monitored for annual retention of licences and being implemented by Pharmacy Board of Liberia by 2008

Continuing Professional Development scheme for Pharmacists established for retention of licence and being implemented by Pharmacy Board of Liberia by 2010

All Pharmaceutical institutions registered/licensed by the Pharmacy Board of Liberia

All Pharmacies and Medicine Stores inspected at least annually by 2009, percentage of inspections meeting

PBL Annual Report PBL Annual Report PBL Inspectors Reports PBL Inspectors Reports/ CHTs annual reports

All agencies in Liberia employing practicing pharmacists comply with national regulation on registration Capacity is built and resources provided to the Pharmacy Board of Liberia to fully implement its mandate Capacity of County Health Team is strengthened to allow them to carryout their regulatory roles relating to Pharmaceuticals and controlled substances

63

Specific Objectives

Objectively Verifiable Indicators (OVIs)

Means of Verification (MOVs)

Assumptions

minimum standards increasing by 2009 and progressing Annual awareness campaigns on obligations and rights of

Pharmacists and Pharmacy Institutions on pharmaceutical legislation and regulations carried out

PBL Annual Report

Specific Objective 5: To ensure that all pharmaceuticals available in Liberia are registered, meet approved quality standards and are approved for their intended use

National Drug Regulatory Authority Established by 2008 National Drug Quality Assurance Laboratory established and

functioning by 2008 Current Enlistment of Pharmaceutical Products becomes

National Register of Pharmaceuticals in Liberia by 2008 Manufacturers of Pharmaceuticals to be imported into Liberia

doing annual registration by 2009 All Pharmaceuticals imported into Liberia conform to GMP

and are authorized for import through the issue of an Importation Permit Declaration by the Drug Regulatory Authority by 2008

Number of pharmaceutical import samples being tested in Liberia increased annually from 2007

Number of pharmaceutical samples being tested as part of post marketing surveillance increasing annually from 2007

Number of arrests and confiscation of sub-standard and counterfeit pharmaceuticals and controlled substances increasing annually

DRA Annual Report

PD/DEA Annual Report

Sufficient resources are allocated to establish the Drug Regulatory Authority of Liberia Market size will not restrict manufacturers from the registering their pharmaceutical products in Liberia Other GOL agencies will collaborate with the MOHSW and DRA in the control of sub-standard pharmaceuticals and the control of substances of abuse

64

Output 1: Policy and regulation for the pharmaceutical sector and for the control of substances of abuse in Liberia, in collaboration with relevant GOL agencies coordinated

Cost Timeframe Responsibility/ Activities Inputs/ Costs USD$ ‘07/08 ‘08/09 ‘09/10 Source of funds

1.1 Revise, Publish and disseminate legislation, policies, regulation and guidelines relating to pharmaceuticals in Liberia

1.1.1 Disseminate role and responsibilities according to the public health law 1975 Legislation and regulation on pharmaceuticals and controlled substances published and widely distributed by 2008

Publishing of 500 copies @ $1.50 2,250.00

750 750 750 -Pharmacy Division -MOHSW

1.1.2 National drug policy and related strategies published and disseminated

Publishing of 500 copies @ $1.50 2,250.00

750 750 750 -Pharmacy Division -MOHSW

1.1.3 Essential Drug List revised and disseminated periodically, 2007, 2009 & 201

One day workshop for 50 people @ $3000, publishing of 500 copies @ $1.50

11,250.00

3750 3750 3750 -Pharmacy Division -MOHSW

1.1.4 National Formulary revised and disseminated periodically, 2007, 2009 & 2011

One day workshop for 50 people @ $3000, publishing of 500 copies @ $1.50

7,500.00

3750 3750 -Pharmacy Division -WHO and Development Partners

1.1.5 Liberian National Standard Treatment Guidelines used for training

STG revised and health workers trained as part of integrated training for BPHS

-CMO, Pharmacy Division -WHO and Development Partners

1.1.6 Liberian Guidelines on drug donations and medical supply adherence

Publishing of 500 copies @ $1.50 2,250.00

750 750 750 -Pharmacy Division -MOHSW

25,500.00

9750 6000 9750

1.2 Coordinate all stakeholders with responsibility for the safe use and access to pharmaceuticals

1.2.1 Coordination of partners on control of substances of abuse, sub-standard and counterfeits: Monthly collaborative meetings with MOJ, LNP, DEA, inspectorate division of PBL and DRA (when established)

Monthly meetings, stationery and other expenses @ $100 per meeting

3,600.00

1200 1200 1200 -Co-ordinated by Pharmacy Division -MOHSW

65

1.2.2 National Pharmaceutical and Therapeutics committee meetings, involvement of vertical programmes on BPHS, NDS link to logistics committee, Procurement Evaluation Panel

Monthly meetings, stationery and other expenses @ $100 per meeting

3,600.00

1200 1200 1200 -Pharmacy Division -MOHSW

1.2.3 Coordination meetings with Ministry of Internal Affairs on complementary medicines

Monthly meetings, stationery and other expenses @ $100 per meeting

3,600.00

1200 1200 1200 -Pharmacy Division -MOHSW

1.2.4 Procurement of drugs, MOH Procurement Unit and NDS Procurement Unit, through national logistics committee in NDS

Expenses covered by Procurement Unit budgets -Pharmacy Division, Procurement Unit, NDS -MOHSW, GFATM & Development Partners

10,800.00

3600 3600 3600

1.3 Advocate for greater resources for the pharmaceutical area

1.3.1 MOHSW planning and budgeting process, Drug Financing: Sources of funding for pharmaceuticals diversified by 2009, health financing forums

Pharmacy Division involvement in annual planning and budgeting process, further technical support to be provided on short-term basis

-Pharmacy Division, Planning Department -MOHSW & Development Partners

1.3.2 HRH: Ensure adequate human resources for the pharmaceutical sector in Liberia, Continuing Professional Development for pharmacists, Pharmacists posting to counties, monitoring and support supervision of pharmacists

Pharmacy Division involvement in annual human resource development planning process, training needs assessment, further technical support to be provided on short-term basis @ $20,000 per annum and long-term TA for two years @ $180,000

420,000.00

200,000 200,000 20000 -Pharmacy Division, Human Resources Division -MOHSW & Development Partners (World Bank proposal)

1.3.3 Support County Health Teams during their annual planning process

Support visits to CHTs twice a year, 5x2 visits @ $150 and 10x2 @ $200

16,500.00

5500 5500 5500 -Pharmacy Division & Planning Dept. -MOHSW

436,500.00

205500 205500 25500

1.4 Pharmacy Division representing Liberia internationally at appropriate forums on pharmaceutical issues relevant to Liberia

1.4.1 Attend annual West-Africa Pharmacists association meetings, regional

Attendance of two people at international meetings @ $3500

21,000.00

7000 7000 7000 -Pharmacy Division -Development Partners

1.4.2 Other international forums Attendance of two people at regional meetings @ $1500

9,000.00

3,000 3000 3000 -Pharmacy Division -Development Partners

30,000.00

10000 10000 10000

66

1.5 General Office administration of the Pharmacy Division MOHSW

1.5.1 Office equipment Computer sets 4 @ $2000, additional office equipment small @ $500

8,500.00

8500 -Pharmacy Division, Procurement Unit -Development Partners (World Bank Proposal)

1.5.2 Office Stationery and miscellaneous running expenses

Stationery, printer refills, etc @ $8000 per annum 24,000.00

8000 8000 8000 -Pharmacy Division, Procurement Unit -MOHSW

1.5.3 Pharmacy Division Communications Transport @ 11,100 per annum, telephone expenses @ $100 per month

36,900.00

12300 12300 12300 -Pharmacy Division, Procurement Unit -MOHSW

69,400.00 28800 20300 20300 Total per annum USD$ 257650 245400 69150

67

Output 2. Sufficient supply of pharmaceuticals and medical supplies

Cost Timeframe Responsibility/ Activities Inputs/ Costs USD$ ‘07/08 ‘08/09 ‘09/10 Source of funds

2.1 Procurement of Pharmaceuticals and Medical Supplies for use in public and private-not-for-profit health services 2.1.1 Annual budget and resource envelope for financing pharmaceuticals and medical supplies identified

Meetings and workshop to finalise annual budget and resource envelope annually @ $3,000

9,000 3000 3000 3000 NDS Logistics Committee, Procurement Unit, Pharmacy Division NDS Operational Budget

2.1.2 Annual Procurement Plan and Medium Term Procurement Plan developed for all Pharmaceuticals and Medical Supplies

Meetings and workshop to finalise annual procurement plan and up-date MTPP annually @ $3,000

9,000 3000 3000 3000 NDS Logistics Committee, Procurement Unit, Pharmacy Division NDS Operational Budget

2.1.3 Annual release of funds to finance procurement of pharmaceuticals and medical supplies from all sources

General Curative Drugs, Reproductive Health commodities, HIV/AIDS & STI, Malaria, TB, & EPI

38,379,275 11,000,000 12,705,000 14,674,275 MOHSW, GFATM, GAVI, UNICEF, UNFPA, INGOs, NDS & Development Partners

38,397,275.00

11006000 12711000 14680275

2.2 Strengthen Procurement and Supply Chain Management 2.2.1 Set up procurement-unit in NDS Training for NDS staff in procurement in-

service@ $1000, Technical assistance support @ $20,000, initially and annually

63,000.00

21000 21000 21000 -NDS -NDS Operational Budget, PPCC, GFATM & Development Partners

2.2.2 Procurement Unit functioning Procurement Committee meetings held monthly to review implementation of annual procurement plan and review recommendations of Procurement review panel, monthly meetings x2 @ $100

7,200.00

2400 2400 2400 -NDS, MOHSW, Clinton Foundation -GFATM & Development Partners

68

2.2.3 Strengthen Supply Chain Management Storage sufficient and suitable throughout the supply chain, SOPs finalised and staff trained, reports done timely, support supervision visits on done according to schedule, Logistics Management Information System established for GFATM products and expanded to include all products by 2009

- 0 0 0 -NDS, MOHSW, Clinton Foundation -GFATM & Development Partners

70,200.00

23400 23400 23400

2.3 Routine Operational Costs of NDS 2.3.1 Personnel Costs Management and support staff

481,000.00 145,000 160000 176000 -NDS

-NDS Operational Budget

2.3.2 Routine Office operational, administration and stationery costs

Stationery, form printing, minor building maintenance and security, staff welfare, etc

315,500.00

95,000 105,000 115,500 -NDS -NDS Operational Budget

2.3.3 Generator, Fuel and Transport Fuel, repairs, servicing, other running costs 481,000.00

145,000 160000 176000 -NDS -NDS Operational Budget

2.3.3 Port Charges Expedite goods from port 66,200.00

20,000 22000 24200 -NDS -NDS Operational Budget & Development Partners

2.3.4 Audit and consultancy expenses Annual Audit fee 9,900.00

3000 3300 3600 -NDS -NDS Operational Budget & Development Partners

2.3.5 Develop annual contracts and Memorandum of Understanding’s with all customers/clients

Annual contracts and renewal of MOUs with Clients, part of routine business activities

-

0 0 0 -NDS Procurement Unit -NDS Operational Budget

2.3.6 Annual minor capital investment for NDS

Replacement of computers, printers and other equipment @ $10,000 per annum

30,000.00

10000 10000 10000 -NDS Procurement Plan -NDS Operational Budget

1,383,600.00

418,000 460300 505300

2.4 Strengthen Organisation capacity of the National Drug Service

69

2.4.1 Develop and fund human resource development plan to strengthen NDS capacity to respond to its organisational needs

Carryout Training needs assessment and develop HR development plan @ $3000, post-graduate training one per annum @ $60,000, local part-time training support for staff 5 per annum @ $1,000

198,000.00

68000 65000 65000 -NDS -NDS operational budget, GFATM, GAVI & Development Partners (World Bank proposal)

2.4.2 Strengthen financial management and costing to ensure cost recovery for all services and to inform pricing policy to ensure sustainability

Provide support for financial staff to pursue further training in financial management and cost accounting 4 per annum @ $1,500

18,000.00

6000 6000 6000 -NDS -NDS operational budget, GFATM, GAVI & Development Partners

2.4.3 Develop a financial plan so that after initial investment NDS fully recovers its costs through the payment of services rendered at cost price and NDS does not need subsidies anymore

Technical assistance @ $20,000 annually, and workshop to develop plan and annually to review progress @ $3,000

69,000.00

23000 23000 23000 -NDS -NDS operational budget & Development Partners

285,000.00 97000 94000 94000

2.5 Future Capital Investment in NDS 2.5.1 Capitalisation of pharmaceuticals and Medical Supplies

Initial Capitalisation based on certain assumptions, see costing details annexed

4,604,025.00

4604025 - -NDS, MOHSW -Development Partners

2.5.2 Establishment of NDS in new green-field site

Construction of new warehouses and offices and security fence at Paynesville site, see costing details annexed

1,487,500.00

1487500 - -NDS, MOHSW -Development Partners

6,091,525.00

4604025 1487500 -

Total per annum USD$

16,148,425 14,776,200

15,302,975

70

Output 3. Rational use of pharmaceuticals and medical supplies through capacity building

Cost Timeframe Responsibility/ Activities Inputs/ Costs USD$ ‘07/08 ‘08/09 ‘09/10 Source of funds

Output 3: Rational use of drugs strengthened through correct diagnosis, sound prescribing, good dispensing practices, and appropriate usage

3.1 Pre-service training – Pharmacists

3.1.1 Curriculum and accreditation: External accreditation and verification, internship for graduates; Curriculum for Pharmacists training revised by 2007 and periodically thereafter, 2009 & 2011; Faculty employment and retention; support from West Africa Postgraduate College of Pharmacists

Technical support, 1 full-time TA for 2 years, international and regional short-term TA, total costs @ $202,500 Yr1&2 and @22500 Yr3, curriculum development @ $12,000 per annum

463,500.00

214500 214500 34500 -School of Pharmacy, Pharmacy Division -MOE, MOHSW scholarships, Other scholarships

3.1.2 General administration and management of Schools; Management (coordination with College of Medicine) Administration; Maintenance; Transportation

Routine recurrent costs, staff costs @ $70,800 per annum, Other admin costs @ $70, 900 Yr1 and $85,900 thereafter, Lab supplies @ $10,000 and Maintenance @ $10,000 from Yr2

505,100.00

151700 176700 176700 -School of Pharmacy -MOE, MOHSW and Development Partners

3.1.3 Ensure teaching and learning environment is of best standards and suitable for delivery of the curriculum, Student well-being; Study resources, Accommodation, Food, Recreational, Text books, Lab facilities

Rehabilitation of classroom and offices @ $120,000 Yr 1, Construct Hostel @ $400,000 Yr2 and further Rehab @ $4,000 Yr3, Equipment @ $43,700 Yr1, Library/Resource Centre @ $30,500 Yr1 & $10,000 Yr2&3, Lab set up @ $63,455 Yr1 & $10,000 Yrs 2&3

701,655.00

257655 420000 24000 -School of Pharmacy -Development Partners, Capital Investment programme for the School (potential part funding through World Bank)

1,670,255.00

623855 811200 235200

3.2 Pre-service training – Dispensers 3.2.1 Curriculum for Dispensers training revised by 2007 and periodically thereafter, 2009 & 2011

Workshop for one week to revise curriculum and do lesson plans, @ $9,000

9,000.00

9000 - - -School of Pharmacy, Pharmacy Division -MOHSW HRH development training budget

71

3.2.2 General administration and management of School; Management, Administration; Maintenance; Transportation

To be provided by SOP administration support initially until fully established

- - -School of Pharmacy -MOHSW HRH development training budget

9,000.00 9000 - - 3.3 Pre-service Pharmacy training – all health workers 3.3.1 Pharmaceutical component of all health workers curriculum revised periodically, 2007, 2009 & 2011

Workshop to review curricula, @ $3000 12,000.00

6000 6000 -Pharmacy Division, School of Pharmacy -MOHSW

12,000.00 6000 6000

3.4 In-service training for all health workers – EDL, NF and STG 3.4.1 National Formulary revised and health workers trained through in-service training in their use periodically, 2007, 2009 & 2011

Training as part of integrated training for all health workers as part of implementation of the BPHS

-

- - -Pharmacy Division, School of Pharmacy -WHO, MOHSW

3.4.2 Standard Treatment Guidelines revised and health workers trained through in-service training in their use periodically, 2007, 2009 & 2011

Training as part of integrated training for all health workers as part of implementation of the BPHS

-

- - -CMO, Pharmacy Division -WHO, MOHSW and other Development Partners

3.4.3 Upgrading of dispensers through in-service training

To be funded through Human Resources for Health Development Plan

-

- - - -Pharmacy Division, HRH Development Division -MOHSW HRH development training budget

-

- - -

3.5 Ensuring rational use of pharmaceuticals 3.5.1 Pharmaceutical and Therapeutic Committees established by 2008 and functioning in all counties by 2009

Central support to CHTs to established, Pharmaceutical and Therapeutic Committee 10 visits @ $200

2,000.00

2000 -Pharmacy Division -MOHSW

3.5.2 Annual health promotion campaign on rational use of pharmaceuticals for the general public carried out at national and county levels

National Radio Campaign 6 @ $500, Leaflet and posters @ $1000 per annum

12,000.00

4000 4000 4000 -Pharmacy Division, Health Promotion Unit -MOHSW

14,000.00 6000 4000 4000

72

3.6 Continuing professional development for all pharmacists in Liberia, priority SOP

3.6.1 Plan for Continuing Professional Development for Pharmacists developed and incorporated into annual human resource development plan by 2008

External post-graduate training of 2 pharmacists per year @ $60,000, 1 School of Pharmacy & 1 MOHSW

360,000.00

120000 120000 120000 -Pharmacy Division, HRH Development Division -MOHSW HRH development training budget (World Bank proposal)

3.6.2 School of Pharmacy Faculty members involved in relevant research activities

Support to faculty members mainly through routine operational costs and support

-

0 0 0 -School of Pharmacy -MOE, INGOs, Development Partners

360,000.00

120000 120000 120000

Total per annum USD$ 764,855.00

935,200.00

365,200.00

73

Output 4. Supervision of Pharmacists and Pharmacy Institutions

Cost Timeframe Responsibility/ Activities Inputs/ Costs USD$ ‘07/08 ‘08/09 ‘09/10 Source of funds

Output 4: Regulation of pharmaceutical professionals and pharmaceutical institutions strengthened

4.1 Registration and licensing of all pharmacists and dispensers 4.1.1 Registrar of all practicing licensed pharmacists in Liberia maintained

Routine activity, need to be computerized 4 computers @ $2,000

8,000.00

8,000 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

4.1.2 All pharmacists and dispensers registered

Routine activity, need to be computerized

-Pharmacy Board of Liberia

4.1.3 Code of ethical conduct developed and adopted, disseminated to all members; disciplinary committee established and meeting when required

Workshop to develop code of ethics $3000, Hold annual meeting on professional ethics @ $3000 per annum, Publish code and disseminate, mail shot @ $200

12,000.00

6000 3000 3000 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

4.1.4 Continuing Professional Development scheme for Pharmacists established for retention of licence

Workshop to develop CPD scheme @ $3000, disseminate scheme details annually, @ $300

3,900.00

3300 300 300 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

23,900.00 17,300 3300 3300

4.2. Issue of licences to pharmaceutical institutions 4.2.1 Registrar of all pharmaceutical institutions with appropriate addresses, numbers of retail pharmacies, number of wholesale pharmacies, number of medicine stores maintained

Registrar, Assistant Registrar, stationery and printed licences, part of routine operations costs

-Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

4.2.2 Accreditation of training institutions for pharmaceutical science/discipline

Fuel and Allowances for inspections, 6 annually @ $200

3,600.00

1200 1200 1200 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

3,600.00 1200 1200 1200

4.3. Pharmacies and medicines stores complying with relevant legislation concerning premises and conduct of staff

74

4.3.1 Hold regular meetings with the Private sector on obligations and rights under legislation and regulation

Hold semi-annual open meetings for private sector on legislations and regulations, publish regulations and disseminate @ $300

900.00

300 300 300 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

4.3.2 Carryout routine inspections of all pharmacies and medicine stores to ensure compliance with regulations

Inspectors, transport, allowances : Non-routine inspections, fuel and allowances 6 times a year @$300

5,400.00

1800 1800 1800 -Pharmacy Board of Liberia, Pharmacy Division, DRA -Partly funded through License Fees / Development Partners

6,300.00 2100 2100 2100

4.4 Promulgation and dissemination of pharmaceutical regulations relating to The Public Health Law 1975

4.4.1 Annual review of regulations Workshop to review regulations @ $3000

9,000.00

3000 3000 3000 -Pharmacy Board of Liberia, Pharmacy Division -Partly funded through License Fees / Development Partners

4.4.2 Annual dissemination of regulations to all licensed practitioners and institutions

Hold annual meeting with all Licence holders @ $3000 per annum, Publish regulations and disseminate, @ $300

9,900.00

3300 3300 3300 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

18,900.00 6300 6300 6300

4.5. Pharmacy Board Expenses and General Administration 4.5.1 Pharmacy Board Meetings Quarterly Meetings, board expenses @

$4,500 per annum

13,500.00 4500 4500 4500 -Pharmacy Board of Liberia

-Partly funded through License Fees / Development Partners

4.5.2 General office and administration expenses

Staffing, office running costs, stationery, utilities, etc

111,000.00

37000 37000 37000 -Pharmacy Board of Liberia -Partly funded through License Fees / Development Partners

124,500.00

41500 41500 41500

Total per annum USD$ 68,400 54,400 54,400

75

Output 5. Pharmaceutical and Medical Supplies Quality Control

Cost Timeframe Responsibility/ Activities Inputs/ Costs USD$ ‘07/08 ‘08/09 ‘09/10 Source of funds

Output 5: All pharmaceuticals available in Liberia are registered, meet approved quality standards and are approved for their intended use 5.1 National Drug Regulatory Authority Established 5.1.1 Initial set-up costs of DRA office Office Equipment & Furniture, Computers,

Transport, etc

100,000.00 100000 -Pharmacy Division

-Development Partners 5.1.2 Establish Drug quality control laboratory

Essential Laboratory Equipment and Supplies 100,000.00

100000 -Pharmacy Division -GFATM/ Development Partners (World Bank Proposal)

200,000.00 200000

5.2. National pharmaceutical registrar 5.2.1 Advocating for registration of all produced to be imported

Printing of guideline for registration $500, Annual awareness campaign amongst importers $500 per annum

2,000.00

1000 500 500 -Drug Regulatory Authority -DRA Registration Fees

5.2.2 Register pharmaceuticals and publish catalogue of registered products annually and disseminate

Registration part of routine activities, publication of catalogue done annually 100 copies @ $2

600.00

200 200 200 -Drug Regulatory Authority -DRA Registration Fees

5.2.3 Issue authorisation to import pharmaceuticals and control substances against national register in accordance to set standards

Import Permit Declaration Stationery, part of routine expenses

-Drug Regulatory Authority

2,600.00 1200 700 700

5.3 Ensure Drug Quality 5.3.1 Quality Control Laboratory functioning

Reagents, consumables $15,000 per annum 45,000.00

15000 15000 15000 -Drug Regulatory Authority -DRA Registration Fees

5.3.2 CPD for laboratory staff 2 Staff MSc International @ $60,000, 2 Staff regional @ $20,000

160,000.00

80000 80000 Development Partners

205,000.00 95000 95000 15000

5.4 Inspectorate function

76

5.4.1 Inspection of goods being imported Inspectors, transport, allowances : part of routine costs

-

-Drug Regulatory Authority -DRA Registration Fees

5.4.2 Post surveillance inspection Inspectors, transport, allowances : Non-routine costs monthly @ $200

7,200.00

2400 2400 2400 -Drug Regulatory Authority -DRA Registration Fees

5.4.3 Carryout non-routine inspections in collaboration with Ministry of Justice, Liberia National Policy, Drug Enforcement Agency to remove sub-standards, counterfeit and controlled substances from illegal channels and to arrest illegal drug vendors

Inspectors, transport, allowances : Non-routine inspections, fuel and allowances 6 times a year @$300

5,400.00

1800 1800 1800 -Drug Regulatory Authority -DRA Registration Fees

12,600.00 4200 4200 4200

5.5 General office and administration expenses 5.5.1 Board meetings Quarterly Board Meetings $4,500 per annum

13,500.00 4500 4500 4500 -Drug Regulatory Authority

-DRA Registration Fees 5.5.2 Office costs, administration, communications

Staff costs, transport, office rent, stationery, etc $35,200 per annum

96,600.00

35200 35200 35200 -Drug Regulatory Authority -DRA Registration Fees

5.5.3 Coordination with MOHSW-PD & PBL

Attendance at regular meetings, part of routine costs

110,100.00

39700 39700 39700

Total per annum USD$ 340,600.00 139,600.00 59,600.00

77

Analysis of budget costs: Summary of Budget

Pharmaceutical Implementation Plan Budget Summary

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

Year 1-3 USD$ USD$ USD$ USD$ Output 1: Pharmaceutical Policy & Regulation (Pharmacy Division)

113,700.00

450,000.00

8,500.00

572,200.00

Output 2: Adequate supply of Pharmaceuticals (NDS)

39,770,075.00

336,000.00

6,121,525.00

46,227,600.00

Output 3: Rational Drug Use through training and capacity building (School of Pharmacy)

576,100.00

787,500.00

701,655.00

2,065,255.00

Output 4: Regulation of Pharmacists and Pharmacy Institutions (Pharmacy Board)

169,200.00

-

8,000.00

177,200.00

Output 5: Quality Control of Pharmaceuticals (Drug Regulatory Authority)

179,300.00

160,000.00

200,000.00

539,300.00

Totals

40,808,375.00

1,733,500.00

7,039,680.00

49,581,555.00 Summary of Budget by Outputs:

Output 1: Pharmaceutical Policy & Regulation (Pharmacy Division)

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

USD$ USD$ USD$ USD$

Year 1

39,150.00

210,000.00

8,500.00

257,650.00

Year 2

35,400.00

210,000.00 -

245,400.00

Year 3

39,150.00

30,000.00 -

69,150.00

Total

113,700.00

450,000.00

8,500.00

572,200.00

Output 2: Adequate supply of Pharmaceuticals (NDS)

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

USD$ USD$ USD$ USD$

Year 1

11,422,400.00

112,000.00

4,614,025.00

16,148,425.00

Year 2

13,166,700.00

112,000.00

1,497,500.00

14,776,200.00

Year 3

15,180,975.00

112,000.00

10,000.00

15,302,975.00

Totals

39,770,075.00

336,000.00

6,121,525.00

46,227,600.00

78

Output 3: Rational Drug Use through training and capacity building (School of Pharmacy)

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

USD$ USD$ USD$ USD$

Year 1

184,700.00

322,500.00

257,655.00

764,855.00

Year 2

192,700.00

322,500.00

420,000.00

935,200.00

Year 3

198,700.00

142,500.00

24,000.00

365,200.00

Total

576,100.00

787,500.00

701,655.00

2,065,255.00

Output 4: Regulation of Pharmacists and Pharmacy Institutions (Pharmacy Board)

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

USD$ USD$ USD$ USD$

Year 1

60,400.00

-

8,000.00

68,400.00

Year 2

54,400.00

- -

54,400.00

Year 3

54,400.00

- -

54,400.00 Total

169,200.00

-

8,000.00

177,200.00

Output 5: Quality Control of Pharmaceuticals (Drug Regulatory Authority)

Recurrent Costs

Technical Assistance & Capacity Building

Capital Investment Total

USD$ USD$ USD$ USD$

Year 1

60,100.00

80,000.00

200,000.00

340,100.00

Year 2

59,600.00

80,000.00 -

139,600.00

Year 3

59,600.00

- -

59,600.00

Total

179,300.00

160,000.00

200,000.00

539,300.00

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Annex vi Complementary and Traditional Medicine Complementary and Traditional medicines – current status April 11 2007 In the course of analysis and evaluation of the Liberian drugs, pharmaceuticals, medicines sector, the important issue of complementary and traditional medicines needs to be addressed. It is known that a substantial proportion of the Liberian population consults or uses the services of complementary and particularly traditional medicine healers, and there can be little doubt that considerable benefits and relief is obtained. Traditional medicines are deeply embedded in the Liberian culture and access to this medicine grows stronger inland in rural areas sparsely served by conventional western clinics and health centres. The MOHSW is nominally responsible for the complementary and traditional medicine sector, with a complementary medicines unit and board supposed to be operationally based in MOHSW. However this unit and board with only one identifiable member, no staff or offices is inoperative. The Public Health Law 1975 has no reference to complementary or traditional medicine but the 2001 National Drug Policy from MOHSW talks of strengthening the complementary medicines unit within the ministry, improving all aspects of traditional medicine, coding of plant species, and improving indications, labeling and duration of use. The 2001 NDP also talks of the board of complementary medicine setting regulations governing the practice of traditional medicine relating to the use of plant products. Current situation and status quo in complementary and traditional medicine In practice, Liberian traditional medicine and its practitioners have been handled by the Ministry of Internal Affairs for many years. In an exploratory meeting with officials in the research and planning division of Internal Affairs, much useful background and operational information was positively put forward by the Ministry of Internal Affairs: 1. Traditional medicine, registration of licensed practitioners, collection of annual

registration fees, coordination through the Traditional leaders council, and other matters is headed by an Assistant Minister for Culture Affairs – Joseph B. Jangar.

2. The Traditional Leaders Council is comprised of 14 members. 11 nationally and

regionally elected members and 3 officials. This council meets regularly at the Ministry of Internal Affairs in Mamba Point Monrovia to discuss current issues and direction in traditional medicine.

3. Registered and certificated traditional practitioners are in two categories: a: Zoes (Poro

for male society and Sande for female society) b: Herbalists. 4. Registration and licensing is renewed every year at a fee of +\- 300 Liberian $.

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5. Qualification for certification by the Assistant Minister is in three parts:

a) Completion of a registration form b) Interview of the applicant c) Amplitude evaluation team in the county of application check and assess accuracy and truth of all information submitted with report back to the Assistant Minister

Exact numbers of certificated practitioners are difficult to assess due to the periods of civil war and records destroyed, however the following rough estimates are a guide:

Southeast region: Maryland, River Gee, Grand Kru, Grand Gedeh, Sinoe. Approx certificated/registered practitioners - 500+ Most notable medical problems seen by practitioners in addition to general Liberia diseases– Elephantitis, sores Central/East region: Lofa, Bong, Nimba, Margibi Approx certificated/registered practitioners - 800+ Most notable medical problems seen by practitioners in addition to general Liberian diseases – Goitre Central/West region: Bomi, Gbarpolu, Grand Cape Mount, Montserrado Approx certificated/registered practitioners - 1300+ Medical problems seen by practitioners - general Liberian diseases Southern region: Grand Bassa, River Cess Approx certificated/registered practitioners - 300+ Most notable medical problems seen by practitioners in addition to general Liberian diseases – Measles, Diarrohea, Typhoid Thus approximate national total of certificated/registered practitioners – 2900+ 6. The Traditional Council, in addition to its supervisory role in regular meetings together with the Ministry of Internal Affairs Culture section, also deals with social

disputes 7. Officials involved in the culture affairs section on traditional medicine at the

Ministry of Internal Affairs are keen to see linkages developed to bring traditional medicine in line with modern pharmaceutical and medical treatment, and in particular:

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a) To develop policy and treatment guidelines b) To address ingredient content and standard dosage issues c) To address side effect problems d) Develop an accurate and useable database and data collection system e) To address the urgent need for update research and development

8. The only contact with MOHSW in the past was an approach to assist MOHSW in

Midwifery, particularly in rural and up country areas; Apparently this is still happening 9. While currently supervision by the Ministry of Internal Affairs is centralized in

Monrovia, there is an urgent need to decentralize delivery to better match the traditional medicine county and societal needs.

10. Ministry of Internal affairs officials are keenly aware of the issue of witchcraft in respect of traditional medicine, and are anxious to distance this and other negative influences from the strong current and future potential benefits offered in traditional medicine. NB: No discussion was held surrounding the issue of MOHSW having responsibility and authority for traditional medicine as the purpose of the meeting was to gather information on structure and activities and views from the Ministry of Internal Affairs.

MOHSW and complementary and traditional medicine As stated earlier MOHSW does not have a unit or any staff or any structure dealing with complementary and traditional medicine, and the complementary medicines board has apparently only one member and no presence in the ministry. There are current plans to revitalize and restructure the complementary medicines board and to focus MOHSW regulation and input to the important complementary and traditional medicines sector in line with the overhaul and streamlining of the health sector put forward in the new National Health Policy and the National Health Plan. MOHSW has identified a highly qualified candidate to head the revitalized complementary and traditional medicines unit and board, and discussions are on-going as to proposed structure and operations. It is however put forward that in the shorter term MOHSW would be ill-advised to exercise its “pure prerogative”, and simply take traditional medicine into the ministry. Quite apart from the political protocol ramifications and inter-ministry potential conflict which such a move would undoubtedly cause, there are other vital issues to consider.

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Continuity, lack of familiarity with current structure and operation in traditional medicine, lines of communication, information gathering, retention of the registered / certificated practitioners, national and regional healthcare outreach, social and cultural positioning, and of course the potential risk of cultural insult and isolation. MOHSW has much to do in assembling a holistic strategy for effective and positive input and delivery to the entire complementary medicine field as well as the traditional medicines arena. Incorporation of these inputs and delivery within the overall National Health Policy and particularly the National Health Plan will need to be approached with both sensitivity and objectivity. A considerable learning curve lies ahead with much information to be gathered before positive input in the areas set out above can be established through regulation and directional strategic influence into traditional medicines. The best course of action – it is put forward – will be for MOHSW to work together with MOIA to devise best practice input and thus regulation for Liberia’s long established but largely unstudied and misunderstood traditional medicine area. Directional and regulatory input and influence should be MOHSW’s responsibility, while structure, operation, access, registration and certification remains with MOIA Culture Affairs with its well established and staffed operating model. In this way the resources of MOHSW in respect of medicines regulation development and those of MOIA Culture Affairs can be best focused on achieving the objectives for traditional medicine(page 12.clause 9.7 Traditional Medicine.) laid out in the existing National Drug Policy(2001). This process should start as soon as possible with a sensitive but formal approach from MOHSW to MOIA setting up protocol for bilateral cooperation between MOHSW and MOIA in respect of traditional medicines optimal delivery as a constituent of the National Health Plan and its attendant specific operational plans. Operational management decisions in respect of including traditional medicines more literally under the umbrella of MOHSW can be made at a later more appropriate point in time.

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Annex vii Pharmaceuticals and medicines – Legal and Regulatory enforcement – LNP & DEA April 12 2007 In order to review the area of legal and regulatory enforcement, particularly in relation to principle areas of concern such as:

a) Illegal importation/smuggling of medicines into Liberia b) Illegal sale of medicines in pharmacies, medicine stores, wholesalers c) Illegal sale of medicines on the street/by peddlers d) Possession and sale of fake/counterfeit, or substandard medicines

A coordination meeting was set via ministerial office protocol with MOH Pharmacy Division, Liberian National Police special units (LNP), and Drug Enforcement Agency (DEA), to share information on functions, responsibilities and structures. Two representatives from LNP were present: Chief Inspector Embra JC Harmon LNP/CID Inspector Oscar N Porte. Deputy Chief Anti Narcotics unit Two representatives from DEA were present: Sebastian A Gibson ops/DDO/DEA/MOJ Kriba Lousat DEA/MOJ MOH Pharmacy Division present: Rev T.T. Tyee Chief Pharmacist MOH Joseph N.B. Jimmy Deputy Chief Pharmacist MOH Also present were the three EC Liberia Pharmaceuticals Assessment consultants. MOH Pharmacy Division: Detailed its functions, responsibilities and structure, and highlighted the particular problems in relation to illegal medicines, licensing, fake and counterfeit, out of date and substandard medicines, improper medicines sales, and street peddlers. LNP: Detailed its specialist functions, responsibilities and structure focused on both Narcotics, and the fast growth in fake, counterfeit, out of date and substandard medicines, smuggling. Emphasis was placed on the “porous” nature of Liberian borders with Sierra Leone, Cote d’Ivoire, and in particular Guinea, the lack of naval coast guard, and problems surrounding ports and the main airport. Emphasized was the extent to which Drug Laws in particular reference to narcotics criminals, dealers etc were not enforced strongly, and it was all too easy for a lawyer to get a

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charged individual/group bailed quickly, whereas some years ago this was much more difficult. Emphasized the extent to which LNP are constrained by law, and the time and paperwork needed to get warrants, have Sheriff representatives with them prior to making a raid and making arrests. Pointed out the nature of many street peddlers/traders as being ex-combatants and the presence and back-up required to make raids effective. They were well aware of flagrant selling of out of date drugs in a variety of outlets, and the street peddling of highly specialized prescription only medicines apparently supplied by known pharmacy and medicine store outlets. They need listings of medicines approved to be in the country, and a clear understanding of the registration process for medicines and thus the import license certificate, and similarly a clear understanding of the licenses pharmacies, pharmacists, medicine stores, wholesalers must have in order to sell medicines legally. They pointed out the alarming mushroom growth of pharmacy stores particularly across Monrovia, a growing number of which had “clinics” attached which offered a range of treatments, injections and medicines apparently without registration, certification, licenses or qualified staff. They need clear information again on the procedures and the licenses outlets must have to operate legally. They similarly need information and listings of legally registered pharmacists, outlets, importers and outlets in the private sector. They also highlighted the need for fast medicine and drugs testing facilities. In the past, there was close cooperation between LNP and MOH witness the example of the current Pharmacy Board Registrar, who used to be in the LNP. LNP has a police force of over 4000 officers at its disposal, and has an active information and surveillance team acting on informants, tips and observation DEA: Detailed its specialized functions, responsibilities and structure as the recently formed sister organization to the LNP. DEA only came into being in early 2006, set up by the Ministry of Justice as a special anti drugs unit. They principally operate in Monrovia and only through the City Police, and cite considerable funding and logistics problems. Their early focus was on marijuana but now cite as per LNP that the full range of narcotics and banned drugs circulate in Liberia. Like the LNP the DEA has informants and an information and surveillance team

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Their total manpower on payroll is 75, with hopes of growing in numbers and logistics if funds allow. They like the LNP report huge growth and occurrence in particularly fake, counterfeit, substandard medicines coupled with large smuggling rackets, quoting current information on the imminent arrival of a large truckload of fake smuggled medicines/drugs from Guinea to be delivered to a Paynesville pharmacy. Similar to the LNP they need clear detail of laws, regulations, license categories, medicine listings etc to assist their work. They like LNP are also constrained by law in their targets, warrants, Sheriffs participation and charging of suspects. They quoted together with LNP the recent example of the Chinese medicines being peddled on the streets – with MOJ approaching the Chinese Embassy to have this stopped and explanations given. The Embassy answer was that a Chinese project workforce who had brought Chinese medications/drugs with them for their own use during their project stay, had “given” the remaining medicines to certain people on their departure. However the sheer quantities of Chinese medicines in the hands of street peddlers during this recent incident makes this explanation highly questionable. This in common with other incidents and the growing evidence of ignoring known medicines regulations, laws etc is an alarming trend which will only be stopped once publication, advocacy of the laws and regulations surrounding medicines is achieved and then followed by strict “visible” enforcement. Overall summary It is very clear that regular and active coordination and communication between MOH Pharmacy Division, Liberian National Police Force special forces, and Drug Enforcement Agency must be established and rigorously maintained. A suggested monthly meeting to update all parties was agreed to with the next meeting to take place on May 11, MOH Pharmacy Division to circulate agenda prior to this meeting. MOH needs to urgently inform LNP and DEA as to: Public Health Law 1975 – provisions relevant to medicines, drugs Pharmacy Board regulations, licensing/certification listings MOH Pharmacy Division registrations, regulations/guidelines Listings of medicines registered/and approved for Liberia Copies of the new Essential Medicines List While LNP and DEA are constrained by the laws governing the process of warrant, search, Sheriff officers, MOH officials, Pharmacy Board Inspectors, County Health Officers, Local Health Officers are not subject to such constraints.

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This greater freedom of inspection, search, confiscation brings a flexibility of approach to tackling the problems discussed, and planning should be put in hand to mount joint MOH, LNP and DEA operations along the lines of an outline plan shown put forward in March this year. More immediate raid and search plans need to be made ready to be used in cases such as the Guinea fake drugs intended delivery to a Paynesville Pharmacy.

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Annex viii Proposed (? 2006) amendment to Chapter 30, Executive Law. 1972

AN ACT TO AMEND CHAPTER 30 OF THE EXECUTIVE LAW OF 1972

WHEREAS, the Government of the Republic of Liberia has adopted a new National Health Policy as the framework for health reform in Liberia, in the new

millennium;

WHEREAS, the thrust of the new policy is to redouble national efforts to ensure equity of access to quality and primary health care and social welfare services for all the people of Liberia, utilizing all available national and other available resources; and

WHEREAS, the Government has decided that this national goal can best be achieved through a process of devolution of authority in all health matters, and by the decentralization of managerial responsibility so that the population to whom health services are to be delivered will participate in the implementation of such policies and health laws; NOW, THEREFORE,

It is enacted by the Senate and House of Representatives of the Republic

of Liberia, in Legislature Assembled:

Section 1. Chapter 30 of the Executive Law of 1972 is hereby amended as follows:

Chapter 30. Ministry of Health and Social Welfare

SUB HEADINGS Section 30.1

Establishment of Ministry

There is hereby established in the Executive Branch of Government a Ministry to be known as the Ministry of Health and Social Welfare There shall be at the head of the Ministry a Minister of Health and Social Welfare who shall be appointed by the President, by and with the advice and consent of the Senate.

Section 30.2 Duties of the Minister of Health and Social Welfare.

The Minister of Health and Social Welfare shall be charged with the responsibility of .administering governmental activities pertaining to the protection, promotion and improvement of public health and social welfare.

More specifically, the duties of the Minister shall include:

(a) Prevention of the introduction and spread of communicable infectious, and preventable diseases within the Republic.

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(b) Provision of medical care and treatment through public and private hospitals, clinics, mental institutions and rehabilitation centers for alcoholic and narcotic addicts;

(c) Licensing and supervision of medical/health practitioners and facilities;

(d) Promotion and conduct of research in the prevention and treatment of human diseases and the collection and compilation of pertinent statistical data;

(e) Prevention and abatement of conditions hazardous to the public health;

(f) Supervision of the collection of data relating to births, deaths, and burials; (g) Supervision and regulation of the sanitary aspects of hotels, boarding houses, public eating and

drinking establishments, bathing establishments, and other businesses and activities affecting public health;

(h) Overseeing of the just, human and economic administration of all Government-operated welfare institutions, exclusive of those expressly within the purview of other agencies of Government;

(i) Supervision of the distribution of all relief and welfare funds granted by the Government to the needy and underprivileged;

(j) Cooperation with the judicial system in its administration of the law relating to juvenile delinquency; and with any other Agencies of the Government authorized to administer institutions or activities concerned with social welfare;

(k) Under authority of Statute or Executive Order, lending of assistance to persons in need because of public disaster;

(I) Originating and participating in programs for promotion of child welfare and for prevention of juvenile delinquency;

(m) To the extent provided by law, overseeing the care of juvenile delinquents and homeless children in foster homes, hostels, and vocational institutions;

(n) Improving rehabilitation knowledge and its application to increase the Nations service supply of

trained rehabilitation manpower and to promote public understanding about the needs and ability of handicapped people;

(o) Promotion of research, experiments, investigations and studies in the development of scientific methods for the diagnosis and prevention of social problems;

(p) Offering assistance in the management of charitable organizations established within the Republic so as to provide maximum benefit to the public and ensure that their funds are utilized for the purposes for which they were established; and

(q) Performing such other functions as may from time to time be assigned by the President.

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30.3 Deputy Minister of Health and Social Welfare for Administration

The President, by and with the advice and consent of the Senate, shall appoint a Deputy Minister of Health and Social Welfare for Administration The Deputy Minister shall assist the Minister of Health and Social Welfare in the discharge of his duties; shall also assist and advise the Minister of Health and Social Welfare in providing administrative services for the Ministry and perform such other duties as may be assigned to him by the Minister; and in the event of the absence, death, resignation or removal from office of the Minister of Health and Social Welfare, he/she shall perform the duties of the Minister as Acting Minister of Health and Social Welfare until a successor is duly appointed or the Minister resumes his , duty. The Deputy Minister of Health and Social Welfare for Administration shall also be responsible to oversee the operations of a departmental division of administration of the Ministry which shall be comprised of the Bureau of Central Administration and the Bureau of Fiscal Affairs.

Section 30.4 Chief of Health Services

The President, by and with the advice and consent of the Senate, shall appoint a Chief of Health Services, who shall have the rank of a Deputy Minister of Health and Social Welfare. The Chief of Health Services shall assist the Minister of Health and Social Welfare in the discharge of his duties; he/she shall be responsible to oversee the operations of a departmental division of health services of the Ministry which shall be comprised of the Bureau of Curative Services, the Bureau of Preventive Services, the Bureau of Pharmaceutical Services; and the Bureau of Nursing Affairs; and he/she shall also perform such other duties as may be assigned to him by the Minister of Health and Social Welfare Section 30.5 Deputy Minister of Health & Social Welfare for Social Welfare

The President, by and with the advice and consent of the Senate, shall appoint a Deputy Minister of Health and Social Welfare for Social Welfare This Deputy Minister shall assist the Minister of Health and Social in the discharge of his/her duties; he/she shall oversee the operations of a departmental division of social welfare which shall be comprised of the Bureau of Family & Community Welfare, and the Bureau of Youth Development and Rehabilitation; and he/she shall perform such other duties as may be assigned to him/her by the Minister of Health and Social Welfare. Section 30.6 Deputy Minister of Health and Social Welfare for Planning, Research and Development

The President, by and with the advice and consent of the Senate, shall appoint a Deputy Minister of Health and Social Welfare for Planning Research, £nd Development. This Deputy Minister shall assist the Minister of Health and Social Welfare in the discharge of his/her duties; he/she shall be responsible to oversee the operations of a departmental division of planning, research, and development which shall be comprised of the Bureau of Planning and Development, and the Bureau of Research and Statistics; and he/she shall perform such other duties as may be assigned to him/her by the Minister of Health and Social Welfare.

Section 30.7 Department of Administration

The Department of Administration of the Ministry of Health and Social Welfare shall manage the personnel, financial, and logistical support system of the Ministry and its functions shall be as follows:

(a) Personnel services administration (headquarters/national level staff) (b) Logistics (procurement and stores, transport, power and water , housing, and other related services). (c) Maintenance services (buildings, vehicles, equipment, other properties);

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(d) Public relation and liaison; (e) Budgeting and financial management; (f) Accounting; (g) Internal audits; (h) Financial reporting; and

(i) Other administrative matters that may be assigned by the Minister of Health & Social Welfare.

Section 30. 8 Department of Health Services

The Department of Health Services of the Ministry of Health and Social Welfare shall be responsible for the delivery of promotive, preventive curative and rehabilitative health care services; to determine the appropriate mix of curative and preventive services to be provided; and to determine how primary health care shall be promoted in Liberia, and its functions shall be to:

(a) Collaborate with other interested parties in setting policies and standards to guide and regulate health care provision and health program management in the country;

(b) Monitor the health care delivery system to ensure that cost-effective quality care is provided and accessible to all;

(c) Provide supportive supervision and up-to-date technical support and guidance for capacity building at various levels of health care delivery and health program implementation; (d) Coordinate and consolidate county program development in support of county/district

initiatives;

(e) Compile county basic health programs and synchronize them to reflect a national health programming strategy.

(f) Develop and manage a basic health program monitoring and evaluation system;

(g) Develop and promote culturally sensitive health learning methods, systems and materials as demanded by county health programs;

(h) Evolve mechanisms fo r d r ug management, control, information system, regulation and regjstratjon: and

(i) Other related matters that may be assigned by the Minister of Health & Social Welfare.

Section 30.9 Department of Social Welfare.

The Department of Social Welfare of the Ministry of Health and Social Welfare shall be responsible for the management of the Social Welfare System of the Ministry, and its functions shall be to:

(a) Ensure through the provision and/or regulation of services, proper care for children in need of special protection;

(b) Protect tho elderly, pensioners and rehabilitation of the disabled

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(c) Collaborate in the administration of juvenile justice system and the prevention of juvenile delinquency;

(d) Ensure care for those suffering from psycho-social trauma;

(e) Supervise the operations of orphanages and foster care programs

(f) Promote child welfare;

(g) Provide assistance for victims of public disasters:

(h) Create an enabling environment to prevent juvenile delinquency and oversee the care of delinquent children;

(i) Provide special education; and

(j) Other related matters that may be assigned by the Minister of Health & Social Welfare.

Section 30.10 Department of Planning, Research and Development.

The Department of Planning, Research, and Development, of the Ministry of Health and Social Welfare shall be responsible for planning, research and development, and the health and management information systems of the Ministry of Health and Social Welfare, and its functions shall be as follows:

(a) Health system research and development;

(b) Strategic planning, broad programming and formulation of sector development plan and budget;

(c) Monitoring and evaluating priority health projects and programs

(d) Managing the mobilization of local and external resource for health. and coordinating relations with partners;

(e) Preparation of annual National Health Plan of Action and trie Ministry's budget including budgets from the operational levels of the Ministry;

(f) Health policy development, revision and monitoring;

(g) Provision of technical support and advice to strengthen planning at the county level;

(h) Coordination of human resource development for health (i) Commission and/or conduct periodic sector performance appraisals or analyses, as well as special studies relative to national program areas;

(j) Developing, managing and coordinating management and health information systems at county and national levels, including systems for registration and certification of vital events;

(k) Managing the collection, analysis and dissemination of health and management information;

(l) Serving as the national depository for all records of health and vital statistics; and

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(m) Other related matters that may be assigned by the Minister of Health & Social Welfare.

Section 30.11 Bureaux.

There shall be established in the Ministry of Health and Social Welfare a Bureau of Fiscal Affairs, a Bureau of Administration, a Bureau of Curative Services, a Bureau of Preventive Services, a Bureau of pharmaceutical Services, a Bureau of Nursing Affairs, a Bureau of Family and Community Welfare, a Bureau of Youth Development and Rehabilitation, a Bureau of Planning and Development, and a Bureau of Research and Statistics Each Bureau shall be headed by an officer bearing the title of Assistant Minister, who shall be recommended by the Minister of Health and Social Welfare, subject to approval of the President, with the exception of Bureau of Nursing Affairs which shall be headed by an officer bearing the title of Chief Nursing Officer, who shall have the rank of Assistant Minister The head of each Bureau shall be responsible directly to the respective heads of the departmental division under which the Bureau falls, and to supervise and direct the operations and functions of the respective Bureau

Section 30.12 County Health and Social Welfare Services.

The Minister of Health and Social Welfare shall establish within each county a County Health and Social Welfare Board and a County Health Services Administration.

(a) County Health and Social Welfare Board (CHSWB) Structure and Functions.

1. Each CHSWB shall be comprised of representatives of groups of citizens and residents of the County, e.g., health care providers, representatives of district health services representatives of Superintendent's Council, a representative each of the Ministries of Education Agriculture, Public Works, and Rural development; and representatives of local health professionals and traditional

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Annex ix Legal comment to the National Health Policy and Plan Draft April 9th 2007 In the course of making recommendations for input into the current draft National Health Policy and National Health Plan, (see Pharmacy inputs 9 April 2007, it was noted that various references to legislation and regulation made elsewhere in these documents require comment and suggested revision.

1. National Health Policy:

(page 9) – heading – Drugs – second sentence should read: Implementation and adherence to existing competent legislation and regulation in the sector is deficient. This deficiency has lead to high levels of counterfeit, fake, substandard, expired drugs circulating in the country. (page 10) – last * point ………In the long term: should read: Implement existing competent legislation and regulations…………..to ensure… (page 16 )– 4.1.1 re Central : first role and function – should read: Implementation, monitoring and evaluation of Health Legislation and Regulations laid out in the Public Health Law 1975 and its provisions. (page 21) - …Pharmaceuticals/Health – second last point should read: Implementation of existing competent legislation and regulation framework as laid out in Public Health Law 1975, (page 23 ) – Law Enforcement – the last sentence should read: The Ministry will advise Health Officers……………… Experience gained…………………in order to improve impact of current competent legislation and regulations. (page 27) – Enabling Environment – 6.1 Legislation: (It is the view of consultants working on Pharmaceuticals sector assessment that the Public Health Law 1975 is adequate for the Pharmaceuticals sector, although some changes may need to be made if overall recommendations are to be accepted and implemented correctly(see final de-brief report and recommendations Pharmaceuticals sector. While it is not known if other constituent parts of the Ministry of Health have been evaluated, and work-shopped with stakeholders, as no specific sections of the Public Health Act 1975, nor individual constituents of the Ministry of Health are spelled out by name in

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this “Legislation” passage, care should be taken not to discount what is by legislative standards a relatively recent and comprehensive Public Health Law.)

2. National Health Plan: (page 2) – Long term challenges include………: The challenge……….”Introduce effective regulatory provisions” to be changed to: “Implement fully the existing comprehensive Public Health Law 1975 and its regulatory provisions’ (page 4) – VI – Guiding Principles and Strategic Orientation – A – Health as a human right: (the reference to ………”is enshrined in the constitution”……….should be removed, as the constitution of Liberia does not contain this right provision) (page 11) – Objective 2: “strengthen professional organisations and update definitions of scope of practise……………Associations will be guided by government legislation as contained in the Public Health Law 1975,………………….. Ministry of Health will ensure proper and regular consultations and recommendations to routinely orient professional bodies on……………………policies plans and guidelines. Overall comment: There is sparse reference to the Public Health Law 1975 in both the draft National Health Policy and the National Health Plan. However this Public Health Law 1975 is wide-reaching and comprehensive in the 62 chapters it contains. In stakeholder discussions and detailed workshops surrounding the Pharmaceuticals, Drugs, Medicines, Therapeutic devices, sector, it was clearly evident that stakeholders across the board had little or no awareness or understanding of the provisions of the Public Health Law. Implementation of the provisions of the Public Health Law in the Drugs, Medicines sector has been at best sketchy, with some important provisions having not been implemented at all. It is not known at the time of writing to what extent the Public Health Law has been implemented in other major Health sectors covered by the Law. It is suggested that careful consideration to needs and applications be urgently made in these other major Health sectors before committing to change in milestone documents, other than natural incremental development or specific and well-founded change cases.

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Annex x Briefing Paper on Medicine Registration Presented to and discussed by Pharmaceutical Importers 26.04.2007 Liberian Drug Register and Catalogue The Public Health Law of Liberia 1975 (Chap. 43.1) states: .... “With all convenient speed after the effective date of this title, subject to the exemptions set forth in section 43.2 the Liberian Pharmacy Board, with the approval of the Minister, shall promulgate a Liberian Drug Register by regulations to be officially published, consisting of schedules of drugs and medical preparations including proprietary medicines, which may be sold and dispensed in the Republic” “The schedules shall be classified as follows: Category A - Prescriptive drugs and medical preparations Category B - Non-prescriptive drugs and medical preparations dispensible by licensed pharmacists; exception Category C - Non-prescriptive drugs and medical preparations - dispensing by Registered Medicine Stores Category D - Unrestricted drugs and medical preparations... and (Chap.43.4)... “With all convenient speed after the effective date of this title the Liberian Pharmacy Board , with the approval of the minister, shall by regulation to be officially published , promulgate a catalogue based on quality, of drugs, medical preparations and therapeutic devices, other than non-exempted narcotic drugs covered by the provisions of chapter 41 which may be imported into the republic, classified under their generic names , with the brand names, if any, and the name and addresses of the manufacturers in each category manufacturing the same item approved for import into the Republic. Thereafter, no person may import into the republic any drug medical preparation or therapeutic device other than non-exempted narcotic drugs which are covered by the provisions of chapter 41, unless it is contained in the catalogue.” The National Drug Policy , 2001, also states (Chap. 9.3) that: “Procurement of Drugs, including donations, will be limited to items registered for use in Liberia and also registered in the country of origin and sold on that market, except for certain drugs used for the treatment of specified tropical or other diseases.” “All products imported in the country shall be covered by ‘Product Certificate’ in WHO Format” Production and maintenance of the catalogue and register referred to above will become the responsibility of a newly formed, independent, Drug Regulatory Authority in accordance with the National Drug Policy. Until that Authority is established the process of registration and compilation of the catalogue will be undertaken by the Pharmacy Board of Liberia. A first step in fulfilling these requirements has been taken by the secretary to the Pharmacy Board by way of the “Enlistment” exercise carried out in November and December 2006. However this enlistment was on the basis of submissions by the pharmaceutical importers whereas the usual process of REGISTRATION requires that pharmaceuticals are registered

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by the manufacturer, and only those pharmaceuticals so registered will be allowed for importation into the country. This process of registration involves the MANUFACTURER in submitting a comprehensive product folder. For well documented pharmaceuticals which have been in general use for a number of years this may consist of the following basic, minimum requirements:

A Free Sale Certificate for the product issued by the responsible body in the country of manufacture

A GMP certificate for the company manufacturing the product and relating to the specific site at which the product is manufactured

A Product Formulation report A Sample of the product with corresponding documentation – a Batch Certificate

(WHO Format) and Certificate of Analysis A Sample and description of the packaging A Sample of the package insert

For more recently introduced products additional information may be required detailing the manufacturing process, safety tests and clinical trials carried out, stability data, and much more. It is usual for a registration fee to be levied on the first registration of a product, and the term “Product” refers to each strength, presentation and pack size of the item so that an item which is presented as for example a tablet in two strengths, one of which comes in two pack sizes, and a syrup would be classed as four “Products”. A retention or re-registration fee may be levied after a set period (usually 3 – 5 years) Given the relatively small market in Liberia it is recognised that the scale of registration fees charged in many other countries would discourage manufacturers from registering their products. The following scale of fees is therefore proposed for registration and retention on the register for a period of three years, after which the scale of fees will be reviewed and manufacturers who’s products are registered will have the opportunity to extend the registration period under the new fee structure (which may be unaltered at the discretion of the DRA) For medicines contained in the LEML and marketed as Generic Product – US $ 25 For medicines contained in the LEML and marketed under Brand Name - US $ 30 For any medicine product not contained in the LEML - US $ 50 The above fees are per product as defined above. For the purpose of registration each “product” shall comply with the following definition of a medicine: “Any substance or preparation used or intended to be used for internal or external application to the human body either in the treatment or prevention of disease or for improving physiological functions; or advertised for any of these purposes”

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Annex xi Briefing Paper on the Establishment of a Liberian Medicines Regulatory Authority

Briefing Note on the Establishment of a Liberian Medicines Regulatory Authority (LMRA)

Introduction This paper presents some proposals and ideas for the formation, functions and carrying out the duties of the newly formed Medicines Regulatory Authority, it is intended as a discussion paper on which the Authority may wish to base its own procedures and guidelines. It is based on the concept that the “Authority” will be a supervisory and advisory body consisting of senior representatives of a range of relevant professions concerned with assuring the quality of medicinal and pharmaceutical products in use in Liberia. It should be chaired by a person of high reputation and with very good contacts within both the medical and political fields as it will undoubtedly come under some pressure as it implements what may prove to be unpopular measures. It is envisaged that the Authority will have an implementing arm, referred to here as the “Inspectorate” of the Authority, which will be responsible for the day to day activities of implementing the responsibilities and duties of the Authority. The Inspectorate will be headed by a “Chief Inspector”, who will be the senior implementing officer of the Authority and who will report to the Authority on a regular basis. In addition to the Chief Inspector the Authority should expect to employ other inspectors and officers responsible for the various processes of registration, pre and post- marketing inspection and quality assurance and other activities necessary for implementation of the regulatory aspects of the Liberian National Drugs Policy, 2001, and any subsequent amendments. Such officers may be directly employed by the Authority or may be seconded by the Ministry of Health & Social Welfare, but under control of the Chief Inspector. The Authority will derive income from (among others) fees charged to Pharmaceutical manufacturing companies for registration of their products in Liberia

Establishment of the Liberian Medicines Regulatory Authority In accordance with the Liberian National Drugs Policy, 2001, there shall be established a Liberian Medicines Regulatory Authority (The Authority) which shall be a body corporate with perpetual succession and a common seal and may sue or be sued in its corporate name. The Authority shall consist of A Chairman (Appointed by the Hon. Minister of Health, on advice of the Authority, who shall not be an employee of that Ministry) The Chief Pharmacist, MOHSW, as secretary to the Authority A Representative of the National Drug System One Retail Pharmacist A Representative of the Pharmaceutical Importers A Representative of the Ministry of Commerce A Representative of the Medical & Dental Association of Liberia A Representative of the Traditional Medicines Association A Representative of the Ministry of Justice

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The above is a minimum suggestion others may be added at the discretion of the Minister on advice of the Authority. Some similar authorities have a “Member of the public”, usually a lay person of high standing in the community.

Functions of the Authority

The Authority shall be charged with implementation of the regulatory aspects the of the Liberian National Drugs Policy, 2001, in relation to drugs, medicines and pharmaceutical products, and in particular shall —

Deal with the development and regulation of the drugs in the country; Coordinate with the Pharmacy Division, MOHSW, on approval and revision of the

National List of Essential Medicines. Provide advice and guidance to the Minister and bodies concerned with drugs on the

implementation of the Liberian Medicines Regulatory Policy; Undertake the registration of pharmaceuticals authorised for use in Liberia Undertake compilation and maintenance of the catalogue of registered drugs as

required by the public health law Control the importation, exportation, and sale of pharmaceuticals by authorising

importation of duly registered drugs by licensed pharmaceutical wholesalers and importers

Ensure Inspection of imported pharmaceuticals for compliance with authorised products

Control quality assessment and assurance of imported pharmaceuticals Establish, operate and control a national pharmaceutical quality control laboratory Arrange submission of samples to regional or other laboratories for analysis when

necessary Undertake Post-marketing inspection of pharmaceuticals in wholesale and retail

pharmacies and medicine stores Instigate prosecution or other legal measures against any person or body found to

be in breach of the laws of Liberia with respect to importation, sale, dispensing or otherwise trading in any medicinal or pharmaceutical product

and Perform any other function that is connected with the above or that may be

accorded to it by law. Meetings of the Authority The Authority shall meet for the discharge of its functions at least six times a year. In addition the Authority will need to meet on an ad hoc basis to consider (for example) matters concerning closure and possible prosecution of offenders.

Funds of the Authority The funds of the Authority shall consist of—

Grants from Government; Grants and loans from any body, organisation or person; Money collected by way of legitimate fees levied by the Authority Interests on savings made by the Authority; Money that may accrue to the Authority in the discharge of its functions; and Money from any other source as may be approved by the Minister.

The Authority shall possess a bank account in a bank approved by it.

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Inspectorate The Authority shall have an Inspectorate which shall be responsible for the day-to-day operations of the Authority. The Inspectorate shall be headed by the Chief Inspector of the Authority who shall be appointed by the Authority on terms and conditions that the Authority may determine. In addition to any other functions that may be conferred upon him by the Authority, the Chief Inspector shall—

Be responsible for the day to day operations of the Authority and keeping of the records of the transactions of the Authority.

Supervise compilation and maintenance of the catalogue of registered medicines Issue authorisations for the importation of registered medicines and pharmaceuticals Arrange and ensure inspection and, when necessary, analysis of all imported

medicines and pharmaceuticals Arrange and ensure post-marketing surveillance, including random sampling and

testing, of all medicines and pharmaceuticals being traded on the Liberian market. Power of entry and inspection is given in Chapter 67, sub chapter F of the Public Health Law

Instigate, with the appropriate law enforcement bodies, closure of any business or premises found to be in breach of the laws concerning sale or dispensing of medicines or pharmaceuticals

Report any such closure immediately to the chairman of the Authority An employee of the Authority shall not, in his personal capacity, be liable to any civil or criminal proceedings in respect of any act done or omission made in good faith in the performance of his duties.

Loss of class A or B Drugs Any person entitled to supply or dispense class A or B drug shall, upon the loss of that drug in his possession or control or of any records kept in relation to that drug, report that loss to the Chief Inspector of the Authority, within seven days of the loss, giving particulars of the ingredients and quantities of the drugs or the particulars of the records lost.

Impure drugs not to be supplied Any person who—

Sells any drug, medicine, pharmaceutical substance, medical appliance or similar article which is not of the nature, substance and quality demanded or which, unless otherwise agreed at the time of demand, does not conform to the standards laid down in the authorised pharmacopoeia; or Supplies any drug which is unwholesome or adulterated or which does not conform to the prescription under which it is supplied - commits an offence and is liable to a fine not exceeding …………….. or to imprisonment for a term not exceeding ……… years or both.

Power to prohibit retail sale of proprietary drugs The Authority may prohibit the sale by retail of a proprietary drug, medicine or pharmaceutical product if, in the opinion of the Authority— Claims are made for the product which are unjustified; or The use of the product may endanger the health of the user or there may be other undesirable effects in the use of the product; or Details of the composition of the product differ substantially from those disclosed on an analysis of samples of the product obtained from retail suppliers; or

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Descriptive matter published in relation to the product differs substantially from that, whether or not in the same language, contained in copies furnished to the Authority in relation to the product. Drug quality The Authority shall advise the Minister on measures to be taken to ensure the quality of medicines and pharmaceutical products, imported into or held in stock in the country. The inspection of drugs and measures prescribed may be delegated to the Chief Pharmacist (MOHSW) or a Pharmacist attached to a County Health Team, who shall be considered an inspector under the Authority for that purpose. Accounts

The Authority shall keep proper books of accounts of all its income and expenditure and proper records in relation to those accounts.

Subject to any direction given by the Minister of Finance, the Authority shall cause to be prepared in respect of each financial year, a statement of accounts which shall include—

A balance sheet, a statement of income and expenditure and a statement of surplus and deficit: and

Any other information in respect of the financial affairs to the Authority as the Minister responsible for finance may require.

Audits

The accounts of the Authority shall, in respect of each financial year, be audited by the Auditor-General or an auditor appointed by him.

The Authority shall ensure that within four months after the end of the financial year a statement of accounts is submitted to the Auditor-General for auditing.

The Auditor-General and any auditor appointed by him shall have access to all books of accounts, vouchers and other financial records of the Authority and be entitled to have any information and explanation required by him in relation to those records.

The Auditor-General shall, within two months after receipt of statements of accounts under this section audit the accounts and deliver to the Drug Auhority and the Minister a copy of the audited accounts and his report on those accounts.

Drugs Register

In accordance with Chapter 43.1 of the Public Health Law of Liberia there shall be established a Drugs register under the office of the Chief Inspector of the Authority

The Chief Inspector or other officer of the Authority appointed by him - Shall keep and maintain a register in which shall be entered details of composition of

all drugs registered for use in the Republic of Liberia Shall keep and maintain a list of all toxic substances, their composition, toxicity and

antidotes; Supply such information to medical practitioners, dentists or veterinary surgeons in

respect of drugs, as may be in its possession in emergency cases of poisoning. In order to discharge its functions under this section, the Authority may require

any person to give any information in his possession or control regarding any drug, and such person shall furnish such information within such period as may be specified by the Authority.