ASSESSMENT OF STRUCTURES FOR ACCREDITATION OF VETERINARY DRUGS IN THE ECOWAS MEMBER

STATES (CAPE VERDE, THE GAMBIA, GHANA, GUINEA, NIGERIA, LIBERIA, SIERRA LEONE).

Dr AssiongbonTEKO-AGBO,Dr Junaidu MAINA

Dr Serge DIAGBOUGA

Workshop of the ECOWAS Animal Health Networks (RESEP-AO, RESOLAB-AO and CVOs) and the Establishment of Animal Production Networks

21 to 25 September 2015, Abuja, Nigeria

Plan INTRODUCTION

I. REGIONAL CONTEXT

II. OBJECTIVES

III. METHODOLOGY

IV. PRINCIPAL FINDINGS

V. PRINCIPAL RECOMMENDATIONS

Agricultural policy of ECOWASChallenges in veterinary drugs associated with manufacturing, importation, distribution in regional markets, unethical handling/administration, quality control and pharmaco-vigilance are of great concern in the context of the implementation of ECOWAS agricultural policy.

National and regional studies in Africa have highlighted:

Circulation of poor quality veterinary drugs/biologicals in national markets.

Lack of laws, regulations, inefficient registration procedures and poor quality control of veterinary drugs/biologicals.

INTRODUCTION

To address these challenges, the ECOWAS Commission with the political support of the member states:

is intervening to meet international standards in these areas in order to enhance food security and safety, protect the health of the people, animals as well as promote environmentally friendly veterinary practices.

Introduction-cont’d

The recommendations of the OIE Conference on Veterinary Medicinal Products in Africa held in Dakar from 25 to 27 March 2008, has further affirmed that:

the harmonization of veterinary pharmaceutical legislations is the most appropriate and feasible way forward .

Introduction-cont’d

Monetary and Economic Union of West Africa (WAEMU): Benin, Burkina Faso, Cote d’Ivoire, Guinee Bissau, Mali,

Niger, Senegal, TogoHarmonized veterinary pharmaceutical legislation:

A Permanent Secretariat for Veterinary drugs

A Regional Committee for Veterinary Medicinal Products

A Regional Veterinary Committee.

REGIONAL CONTEXT

ECOWAS

Harmonized veterinary pharmaceutical legislation:

In eight ECOWAS member states, both Committees are

already operational in the following member states: Benin,

Burkina Faso, Côte d'Ivoire, Guinea Bissau, Mali, Niger,

Senegal and Togo.

What is the situation in the following countries: Cape Verde,

Gambia, Ghana, Guinea, Nigeria, Liberia and Sierra Leone.?

This is the role of this consultancy

REGIONAL CONTEXT

ECOWAS

ECOWAS, the 65th regular session of the Council of

Ministers of the Member States held in Abuja Nigeria

25 - 26 November 2010 adopted the following 3

regulations and a directive as follows

1.The Regulation C/REG.21/11/10 on the harmonization of the

structural framework and operational rules of safety of

plants, animals and food in the ECOWAS region

REGIONAL CONTEXT

ECOWAS

2.The Regulation C/REG.22/11/10 establishing community

procedures for management of veterinary drugs or biologics

3.The Regulation C/REG.23/11/10 / establishing and operating

procedures for a Regional Veterinary Committee (RVC) within

the ECOWAS

The Directive C/DIR.1/11/10 on veterinary pharmacy within

the ECOWAS

REGIONAL CONTEXT

OBJECTIVES

General ObjectiveEvaluate the structure and management system for

registration of veterinary medicinal products in these Member States:• Cape Verde, • The Gambia, • Ghana, • Guinea, • Nigeria, • Liberia and • Sierra Leone

OBJECTIVES

Specific ObjectivesReview the current structure of application procedures, management and registration of veterinary medicinal products in each country;

Identify gaps (technical and organizational) and make proposals to simplify and / or improve the implementation of rules and procedures for the management and registration of veterinary medicinal products;

Analyze the needs of technical and institutional support, capacity building;

Propose a plan to upgrade the systems in these countries.

I.3. Etude des contaminants des alimentsThe methodology used for the mission included:

Literature & Documentary search and exchange of electronic

messages (E-mail)

Visits to 7 countries (Cape Verde, The Gambia, Ghana,

Guinea, Nigeria, Liberia and Sierra Leone):

• Visits to Departments of Veterinary Services,

• Food and Drugs Regulatory Authorities,

• Laboratories,

• Private veterinary pharmacies (wholesalers and retailers)

• Veterinary clinics and

• Livestock farmers.

METHODOLOGY

Les bactériesCollection of data and administration of Questionnaire on:

• System of quality assurance of veterinary drugs,

• Local production of veterinary drugs

• Imports of drugs and veterinary raw materials

• Distribution of veterinary medicines

• Pharmacovigilance system

• Awareness of ECOWAS regulations on veterinary drugs.

METHODOLOGY

Country Period Responsible Consultant

NIGERIA 19-22 August 2013 Dr Teko-AgboDr Maina

Dr Diagbouga

SIERRA LEONE 12-14 February 2014 Dr Maina

GUINEA 27 February-1 March 2014

Dr Teko-Agbo

METHODOLOGY

Work Programme

Visit the Sierra Leone Animal Welfare Society (veterinary clinic)

Visit to Lagos: Office of the TURNER WRIGHT LIMITED (Private veterinary)

Meeting at the National Agency for Food and Drug Administration and Control at Lagos

Presentation of the objectives of the mission at Department of Livestock Services at Conakry

Visit of the Public Veterinary Clinic at Abuko (Gambia)

Visit of Ghana FDA laboratory of control drugsPresentation of the objectives of the mission at Department of Livestock Services at Praia

Country Period Responsible Consultant

THE GAMBIA 26 - 28 March 2014

Dr Teko-Agbo

CAPE VERDE 12-14 March 2014 Dr Diagbouga

GHANA 14-16 April 2014 Dr Teko-AgboDr Maina

Dr Diagbouga

LIBERIA 16-18 April 2014 Dr Maina

METHODOLOGY

Work Programme

PRINCIPAL FINDINGS

Guarantee system on quality of veterinary drugs

All countries have legislations on veterinary

drugs or draft under review in the case of Cape

Verde.

The drafting of these legislations was by the

Ministry of Agriculture in partnership with the

Ministry of Health (Guinea, Ghana, Sierra

Leone) or solely drafted by the Ministry of

Health (Nigeria, Liberia).

PRINCIPAL FINDINGS

Local production of veterinary drugs

Ghana and Nigeria have the structures for local production of veterinary drugs and vaccines, while other countries (Gambia, Sierra Leone, Liberia, Cape Verde, Guinea) do not.

PRINCIPAL FINDINGS

Importations of veterinary drugs and raw materials

The structures, for regulation of veterinary products in most countries are managed by pharmacists (Nigeria, Ghana, Gambia, Liberia) or through a joint committee composed of pharmacists and veterinarians (Guinea). Note recent creation of Directorate for Veterinary Drugs.

Generally, to obtain an authorization for marketing of a veterinary medicinal product, the applicant must provide a full registration dossier. In Ghana, Guinea and Nigeria the dossier takes into account the quality, safety and efficacy of the drug.

Ghana, Nigeria and Guinea have a list of veterinary products imported. In Ghana the management of importation of the veterinary products is under the responsibility of the veterinary service that issue permits.

PRINCIPAL FINDINGS

Veterinary drug distribution

On distribution, despite the existence of laws governing the possession and administration of drugs, there seems to be confusion in the powers and roles of different operators (importers, wholesalers / distributors, veterinary offices, professional associations of farmers, etc.). For example, there are no specific veterinary pharmacy inspection units in all states visited. Except in Cape Verde, many veterinary products are sold in parallel markets.

There was almost total absence of an organized quality control of veterinary drugs in visited countries except in Ghana and Nigeria that have quality control laboratories of international standards.

PRINCIPAL FINDINGS

Pharmacovigilance system for veterinary

products

There were no pharmacovigilance and risk

assessment of the effects of or abuse of

veterinary medicinal products in all the

Countries visited.

PRINCIPAL FINDINGS

Awareness and knowledge of ECOWAS legislation on the

management of veterinary drugs

The ECOWAS Community regulation on the

management of veterinary drugs were found to be poorly

distributed and poorly understood in the countries

visited.

PRINCIPAL RECOMMENDATIONS

• All Countries visited have in principle accepted the harmonization of pharmaceutical legislations within the ECOWAS Community. To this effect, the following recommendations are made:

1. ECOWAS Commission should establish a plan to allow the appropriation of Community texts by member states of ECOWAS. These member states of ECOWAS must undertake to accept the principle of subsidiary should it apply in such situations.

2. ECOWAS Commission should review all existing legislations of these 7 Member States with a view to harmonizing them.

PRINCIPAL RECOMMENDATIONS

3. ECOWAS Commission should assist Member States with no parliamentary act establishing the Veterinary Medicines and Products Regulatory Framework and Regulatory Authority to immediately pass one.

 4. ECOWAS Commission should encourage the strengthening of

veterinary competencies within the Regulatory Authorities in the following Member States, Ghana, The Gambia, Sierra Leone, Liberia, Cape Verde and Guinea. This should be through employment of veterinarians and capacity building of those within.

 5. Implement urgently within the ECOWAS Commission a

Permanent Secretariat in accordance with Article 4 of Regulation C/REG.22/11/10 with a view to pursuing the harmonization process.

PRINCIPAL RECOMMENDATIONS

6. Establish the Regional Committee for Veterinary Medicinal Products in accordance with Article 3 of Regulation C/REG.22/11/10 taking into account the existence of a Regional Committee in the WAEMU Commission.

 7. Collaborate with the WAEMU Commission with a view to

gradually pooling of regulations and the establishment of a regional office for veterinary medicinal products and SPS risk assessment.

CONCLUSION

• Sales of veterinary drugs in the regional market must be strictly controlled because of their impacts on:

– human public health, – animal health and – the environment.

• Structure for registration and management of veterinary medicinal products must be put in place without further delay in all member states.

• Similar structures already exist in eight member states of ECOWAS under the auspices of the West African Economic and Monetary Union (WAEMU).

• We need to go together for the development of the Whole ECOWAS region.

ACKNOWLEDGMENTS

• The three consultants express their deep and heartfelt gratitude to the ECOWAS Commission; specifically :– it’s President and the – Commissioner for Agriculture, Environment and his team

for the trust placed on us and for their cooperation during the mission.

• The consultants are also grateful to all the officials of the countries visited, particularly the authorities responsible for supervising veterinary services for their availability, and cooperation.

THANKS YOU FOR YOUR KIND ATTENTION