Submission on the policy address by the Hong Kong Association of the

Pharmaceutical Industry

Introduction

Found in 1968, the Hong Kong Association of the Pharmaceutical Industry (HKAPI)

represents 39 research and development (R&D) multi-national pharmaceutical

companies that supply 70% of prescription drugs in Hong Kong. Our mission is to

drive the expedient access to innovative healthcare solutions for the people of Hong

Kong and Macao with high ethical standards.

Like many other developed economies, the healthcare system in Hong Kong is facing

challenges, such as a rapidly aging population and the increasing cost of treatment.

Recently, the Hong Kong Government increased spending on healthcare. We are glad

to see that the Government is placing more emphasis on improving the healthcare

system for Hong Kong people. Nevertheless, resources are not unlimited and

therefore, we need to ensure there will be better resource allocation and a more

efficient system that will help to achieve improved outcomes.

It is the belief of the HKAPI that Hong Kong should adopt the framework announced

by WHO at the Sixty-Ninth World Health Assembly for integrated people-centred

health services. This includes:

• Equity in access: For everyone, everywhere to access the quality health services

they need, when and where they need them. In other words, achieving and

sustaining universal health coverage including utilization of primary health care

as part of strengthening the health system.

• Efficiency: Reducing duplication of services including hospitalizations and

lengths of stays.

• Engagement: Increased ability for individuals to self-manage and control

long-term health conditions as well as greater participation and shared decision

making about the use of health resources.

The HKAPI proposes that the above-mentioned principles be consolidated into two

clear directions:

1. Implementing structural changes in the healthcare service delivery system to

improve the system’s efficiency and effectiveness through developing an

integrated process thus providing better support to the patient journey.

2. Transforming healthcare provision into a model for sustainable economic

development by leveraging stakeholders and talent to build a holistic R&D

ecosystem.

Content

A. Building a Visionary and Efficient Healthcare Service Delivery System

1. Preventative and Primary Healthcare

2. Timely and Equitable Access to Innovative Medicines

2.1. Proposal of a New Review Process for NCE with Unmet Need

2.2. Timely and Equitable Access of Innovative Medicines to the Hospital

Authority Drug Formulary (HADF)

3. Develop a Comprehensive Rare Disease Policy in Hong Kong

B. Holistic Approach to Enhancing the R&D Eco-system in Hong Kong

4. Structural Support to Champion the Vision

5. Develop Hong Kong into Centre of Excellence for Clinical Trials in Asia

6. Unveil the Big Data in Public Hospital system

Conclusion

A. Building a Visionary and Efficient Healthcare Service Delivery System

Developing a structured primary healthcare system with reference to the patient

pathway with Community Health Centres (CHCs) providing integrated healthcare

services such as health education, disease prevention and screening, detection and

palliative services, private and GOPC PPP network doctors.

Creating a systematic framework for disease prevention (e.g. vaccination) and

screening (e.g. chronic diseases such as stroke and dementia) with relevant

resources.

Ensuring healthcare vouchers are used for their designated purpose according to

the care protocol developed for various chronic diseases and advised by family

doctors, to ensure money follows patients and encourages patients actively

participating in the management of their disease.

Establish a visionary pledge for the drug enlistment process to be completed in 12

months in the public sector to bring more new and innovative medicines to needy

patients in Hong Kong.

Set up a comprehensive rare disease policy in Hong Kong

1. Preventive and Primary Healthcare

Primary Healthcare became WHO’s core policy in 1978, with the adoption of the

Declaration of Alma-Ata. It identified Primary Healthcare as the key to the attainment

of health for all with guidance on:

• universal access to care and coverage on the basis of need;

• commitment to health equity as part of social justice;

• community participation in defining and implementing health agendas;

• intersectoral and multi-disciplinary approaches to healthcare provision.

Based on the philosophy of people-centred care, the patient pathway is core when

considering the delivery of healthcare services. The patient pathway should

encompass prevention, screening, diagnosis, treatment and palliative care as a basis

for building a model of Primary Healthcare.

Graphic 1: A primary healthcare model based on the patient pathway

We are pleased that the Hong Kong Government unveiled its plan in the policy

address last October to develop a comprehensive Primary Healthcare model by

setting up District Healthcare Centres (DHCs) throughout the city. People visiting

these DHCs will receive a comprehensive supportive service including healthcare

promotion, patient empowerment programs, disease screening and detection and

palliative programs organized by multi-disciplinary allied healthcare professionals

including specialist nurses, pharmacists, nutritionists, physiotherapists and

optometrists. The HKAPI welcomes this plan.

These care centers could further be enhanced through the integration of clinical care

and services provided by front line general practitioners (GPs) and providers of other

ancillary and supportive services.

HKAPI recommends:

1.1 Prevention and Screening

According to numerous research studies, disease prevention and screening are

the most effective ways to reduce downstream healthcare costs. As preventive

measures and earlier treatments generally cost less than the treatments for most

advanced diseases, the HKAPI proposes that the Government put more

resources into these two areas and extends screening programs to diseases that

have a profound social as well as cost impact on society and families, such as

hepatitis, flu and dementia.

1.2 Diagnosis and Treatment

Early diagnosis allows reductions in hospital stays, disabilities, faster recovery and

less strain on healthcare manpower. Diagnosis and treatment can be supported

by GPs via Public-Private-Partnership (PPP) programs that aim to reduce patient

wait times and help existing public hospitals to refocus their resources on

secondary and tertiary care.

1.3 Integration with Doctors Network

The General Outpatient Clinic Public-Private Partnership Programme (GOPC PPP)

was launched by the Hospital Authority (HA) in mid-2014 with the aim of

providing choice to patients. People may receive Primary Healthcare services

from the private sector. The scheme seeks to enhance access to Primary

Healthcare services, promote the family doctor concept, help the HA manage

demand for general outpatient services and foster the development of the

territory-wide Electronic Health Record Sharing System. As of 20 August 2018,

there were 369 service providers from 18 districts participating in the

programme.

The HKAPI recommends integration of this program and the DHC Doctors

Network in order to avoid duplication of effort since the two networks have

similar objectives and job responsibilities are also highly likely to overlap.

Graphic 2: Reference patient’s journey in healthcare system

1.4 Building Capacity with Performance-based Incentive Models

To familiarize GPs with new care protocols, training and educational support for

managing chronic diseases should be provided in collaboration with academic

and medical societies through accredited courses endorsed by the industry.

Accredited courses leading to certification can help GPs prepare for the

expansion of PPP to cover more chronic diseases.

As it is important to monitor and improve treatment outcomes of people joining

the PPP program, performance-based incentive models can be introduced in the

Primary Healthcare setting. Quality measurements should be developed to

support assessment of care services at the provider level. Quality metrics have

proved to be valuable in helping healthcare professionals enhance patient

outcomes along the care pathways in the United Kingdom.

1.5 Designated Use of Healthcare Vouchers

The HKAPI supports the important principle that people should have a choice in

terms of choosing their services, services providers and also treatment options. In

addition, people should also be encouraged to take responsibility for their own

healthcare by actively participating in disease management. A healthcare voucher

with a designated purpose could be an effective vehicle for achieving this goal.

We propose that family doctors could be empowered to determine the usage of

the vouchers in accordance with the care protocols developed for chronic

diseases. The vouchers should be provided on an annual basis with no rollover to

subsequent years and used as co-payment for procuring healthcare solutions.

Under this scheme, the concept of “family doctors” could be promoted and the

scheme would allow people to make their own choices and play a more

prominent part in managing their own health.

Graphic 3: DHC Concept and Utilization of Healthcare Vouchers

2. Timely and Equitable Access to Innovative Medicines

2.1 Proposal of a New Review Process for NCE with Unmet Need

It is now universally accepted practice for health authorities to expedite the

availability of innovative drugs that treat serious or life-threatening diseases

particular those which are first in class or have advantages over existing

treatments. Food and drug administrations have developed approaches to

making such drugs available as rapidly as possible through priority or fast track

review and accelerated approval.

Hong Kong has adopted a “secondary review” for the registration of a

pharmaceutical product containing new chemical entities (NCEs)1 with two

Certificates of Pharmaceutical Products (CPPs) required before NCE application.

There is, on average, a time lag of six to nine months between the first and

second CPP of a new product. To catch up with the world trend as well as to

better support critically ill patients, the HKAPI recommends introducing a special

review process for drugs in areas of unmet need as is the case in Singapore.

HKAPI recommends

2.1.1 Scope

The proposed scheme would apply to the registration of products for oncology,

rare diseases2 and life-threatening diseases that currently lack safe and effective

treatments.

2.1.2 Criteria for Special Review

The applicant would be required to provide scientific evidence to substantiate

the claim that there is a local unmet medical need. The proof should include a

review of current available treatments and standard therapies and the

1 “Primary review” means a full review on the safety, efficacy and quality of the drug by scrutinizing

all the preclinical (i.e. animal) studies, clinical studies and manufacturing and quality control

documentation. “Secondary review” means approval of drugs based on the reviews conducted by one

or more of the reference drug regulatory authorities (e.g. US or EU).

2 Rare diseases as per the classification used in a reputable reference country or by China's Food and

Drug Administration.

limitations of these therapies. The applicant should provide epidemiological data

to support the application.

The Department of Health may examine the evidence in association with one or

more independent reviewers3

The Department of Health could hold a pre-submission meeting to let the

applicant respond to certain preliminary questions before allowing a special

Review for the application. If the request for review is not granted, the applicant

would have to follow the normal NCE submission requirements.

2.1.3. Evaluation on Efficacy, Safety and Quality

The Department of Health can evaluate the efficacy, safety and quality of a

product based on the Clinical Technical Dossiers and one CPP issued by a

reference country. The independent reviewer can evaluate the efficacy and

safety of the product based on the clinical data provided. The introduction of an

independent reviewer would provide the scientific justification for the use of a

product without the requirement for two CPPs.

2.1.4. Pharmacy Poisons Board (PPB) Approval

PPB may invite independent reviewers to address questions in the review

meeting. During the session, the PPB may, if deemed appropriate, impose

additional licensing conditions e.g. annual product license review and additional

risk minimization measures. It may also have the right to revoke a registration

license if the product in question is withdrawn or suspended in the reference

country owing to any safety issues.

3 An independent reviewer is a local clinical expert teaching at a university. He or she would be invited by the Department of Health to join the review panel.

2.2 Timely and Equitable Access of Innovative Medicines to the Hospital Authority

Drug Formulary (HADF)

The Hospital Authority (HA) has operated the HADF since 2005 with a view to

ensuring equitable access by patients to cost-effective drugs with proven safety

and efficacy by standardizing the drug policy and utilization in all public

hospitals.

Recently (June 2018), the HKAPI conducted a survey on oncology treatment

access as there is a narrow treatment window to enhance survival for cancer

patients. The result showed that it takes around 34 months for a registered drug

to be enlisted in all the HA hospitals. From DAC approval, it takes 19 months

before drugs are listed in Safety Net (Samaritan Fund and Community Care Fund).

It is critical that Hong Kong people have speedier access to medical

advancements.

HKAPI calls for the HA to develop a visionary pledge to ensure timely patient

access to innovative and effective new treatments within 12 months from drug

registration. All patients in the HA should have equitable access to innovative

medicines at the same time and stage of their disease.

Figure 1: Current Safety Net Enlistment Process and Timeline (HKAPI oncology

enlistment survey June 2018)

It takes almost 34 months to introduce new treatments to the HADF

Step 1: Drug and Therapeutics Committee (DTC)

Applications for inclusion of new drugs into the HADF must be initiated by

clinicians, endorsed by the heads of the clinical departments and reviewed and

recommended by at least one DTC of the relevant hospital cluster or hospital.

Step 2: Drug Advisory Committee (DAC)

Drugs are evaluated and approved by the DAC. New drug will be approved under

General Drug or Special Drug or Self-Financed Item (SFI) without Safety Net.

Step 3: Drug and Therapeutics Committee (DTCs)

After DAC approval, many patients still have to wait for the review and decision

of the remaining relevant DTCs in different clusters/hospitals before they can

access the drugs.

On average, it takes almost 34 months to complete the whole process.

Additional 19 months to access Safety Net

Step 1: Central Committee (CC) and Coordinating Committee (COC)

If a clinician wants to prescribe a SFI treatment to a patient who cannot pay out

of pocket, he/she has to initiate an application to the respective CC and COC for

the relevant disease area. To fulfill the application requirements, the clinician

needs to collate drug information including pricing as well as information on

clinical criteria.

Step 2: Drug Management Committee (DMC)

After deliberation, the proposing COC or CC will present clinical evidence and

pricing information to the DMC.

Step 3: Medical Services Development Committee (MSDC)

The DMC will then evaluate and prioritize all recommendations to the Samaritan

Fund Management Committee (SFMC). After that, the SFMC will pass the

application to the MSDC for endorsement, where a final verdict will be passed. If

the application fails, the clinician has to begin the process again by launching

another application to the COC and CC.

HKAPI Recommends

2.2.1 Streamline the DTC process and shorten the lead time for patients to gain

access to needed new treatmentsEliminate the requirement for

hospital/cluster DTC scientific evaluation after DAC approval. This will

avoid duplicating administrative efforts and ensure equitable and timely

access to treatments between clusters.

• Expedite the post-DAC administrative procedure, reducing the drug code

creation, from three months to a more reasonable timeline.

• Recognize that for oncology patients where weeks matter, early access to

new treatments is even more critical to survival time and quality of life by

fast-tracking the review for all cancer treatments at the initial DTC stage.

Figure 2: Suggested Improvements (From 1st DTC to post DAC)

2.2.2 HADF Value-based Decision Making

HKAPI recommends that DAC refers to the following when considering whether a

treatment should be included in the HADF:

• Benchmark decisions of other key health authorities e.g. United Kingdom,

Australia and Taiwan.

• Take into account priority review or breakthrough status by international

regulatory authorities or treatment guidelines.

• Reference the International Society of Pharmcoeconomics and Outcomes

Research (ISPOR) recommendations by considering the costs of other

condition-related healthcare services provided by the HA e.g. physicians

and emergency visits, hospitalization, diagnostic and surgical procedures

and laboratory testing in addition to the cost of new drugs, when assessing

the cost effectiveness of introducing a new treatment.

Figure 3: “Drug Value” in DAC Enlistment Decisions

2.2.3 Delineating the process of Safety Net Evaluation

• Currently, the decision to include a drug in Safety Net has to go through 6

committees: DAC, CC, COC, DMC, SMFC and MSDC with duplicated criteria

and a lengthy process. The HKAPI calls for clearly delineating the

decision-making criteria of these committees.

• In additions, many countries have consulted patient groups in their drug

reimbursement decisions and we recommend that the HA follows suit and

collects individual patient and patient groups’ opinions on their treatment

needs. This would also fit with the people-centered care approach which

WHO advocates.

2.2.4 Conclusion: Improvement Outcomes and Benefits to Stakeholders

With the adoption of the proposed changes: -

From drug registration, a new treatment could be made available in 7

months (compared to 34 months in the current process).

New treatments, especially in Oncology, where time is critical to patient

survival and which can be relatively more expensive than other disease

areas, would have Safety Net enlistment 14 months after new drug

registration.

Figure 4: Improved Enlistment

Process

3. Develop a Comprehensive Rare Disease Policy in Hong Kong

To remove the considerable barriers that exist in terms of access to appropriate care,

delayed diagnosis and limited or non-existing treatment options, HKAPI recommends

the Government considers establishing an integrated and comprehensive Rare

Disease Policy in Hong Kong. HKAPI recommends:

3.1 Defining Rare Disease

To optimize people-centred care, a clear definition of rare diseases is of critical

importance. People affected by rare diseases should be provided with timely

access to relevant medical and social support. HKAPI recommends Hong Kong

follow the European Union’s example and define rare diseases as those with a

prevalence rate of less than 5 in 10,000 persons. Hong Kong should adopt the

first list of rare diseases released by the China Government. It would also be

prudent to establish a rare diseases registry to monitor the prevalence of rare

diseases in Hong Kong and support better evidence-based strategic planning and

decision making in future.

3.2. Detection and Awareness

HKAPI recommends that the current neonatal screening protocol and genetic

clinic services be reviewed to enable early diagnosis and access to innovative

treatments. There is potential for the Hong Kong Children’s Hospital to establish

a Centre for Rare Diseases providing medical and social support to people and

families affected by a rare disease. More education on screening and diagnosing

rare diseases should be provided to obstetric and neonatal healthcare

professionals, as well as parents-to-be.

3.3. Fast tracking Regulatory Approval for Rare Disease Treatments

To shorten the time from product licensure in the country of origin to access for

people in Hong Kong, HKAPI recommends relaxing the registration requirements

to one CPP for treatments falling into the rare disease definition. The CPP can be

issued by any overseas authorities including US FDA, EU EMA, Taiwan FDA and

China CFDA.

A treatment for a disease of extreme rarity (e.g. only one person affected in

Hong Kong) should be considered for a special named patient program thus

removing any further delays if the treatment has been approved by an overseas

authority.

3.4 Accelerating Enlistment and Reimbursement in the Hospital Authority

HKAPI recommends that treatments suitable for managing rare diseases

(including medications for peripheral symptom relief) should be eligible for

fast-track enlistment and reimbursement evaluation to enhance the timeliness of

treatment accessibility. This includes setting up an expert panel for rare diseases,

with members composing of a geneticist, pharmacist, paediatrician and internal

medicine for the HA. A support network of experts in nearby Asian countries

could also be included to facilitate exchange in knowledge and best practices in

rare diseases management and support decision making for enlistment and

reimbursement.

3.5. Enhancing the Sustainability of Treatment Funding

HKAPI recommends operational improvements to ensure treatments and

funding are accessible to people affected by rare diseases at optimum speed.

This includes:

• Building a sustainable budget pool separated from the recurrent HA drug budget

for rare disease treatments. An annual review should be put in place to assess

the need for additional budget injections according to new treatments approved.

• Consideration of risk sharing schemes between pharmaceutical companies

manufacturing rare disease treatments and the HA or co-payment schemes for

people affected by rare diseases.

B. Holistic Approach to Enhancing the R&D Eco-system in Hong Kong

The Government has identified biomedical technology as one of the potential new

drivers of Hong Kong’s economy. In 2017, the total research and development (R&D)

investment by the bio-pharmaceutical industry was estimated to be US$ 158 billion.

On a regional basis, Asia’s pharmaceutical industry has the largest share of both

global GDP and the sector’s workforce.4 Many countries have grown their share of

this investment through the provision of infrastructure, streamlined processes,

enhanced tax and other economic benefits.

Other advantages of participating in R&D

• Participation in clinical research is crucial to the training of healthcare

4 Ostwald, D. A. / Zubrzycki, K. / Knippel, J. (2015): The Economic Footprint of the Pharmaceutical Industry – Regional Breakdown and Differentiation between Originators and Generics. Berlin.

Enhancing Clinical Research and Development will transform Hong Kong

healthcare into a profitable bio-medical industry, as well as a service to improve

outcomes for our people. Setting a clear vision is crucial e.g. to include 10% of

patients within 10 years into clinical trials.

Appoint a Government Chief Scientific Officer (CSO) reporting to the Chief

Executive and Secretary for Food and Health to coordinate this transformation

with a cohesive strategy.

Establish a Dedicated Clinical Trials organization. This should be separated from

the “Risk and Quality department” and set up as a central part of good clinical

care; staffed by nurses, to implement the acceleration of the start-up of studies

(single ethics committee and removal of delays).

Leveraging big data will be a unique opportunity to assess patient population size

estimates and better prioritize Hong Kong to be a chosen location for research.

The Big Data strategy should be led by the CSO.

Extend research conducted in Hong Kong to include people across the Greater

Bay Area taking the research population from 7.4 million to over 60 million

people and developing a centre of excellence for clinical trials in Asia

professionals and can enable Hong Kong to keep pace with new scientific

advances.

• Scientists participating in clinical drug development will gain access to privileged

scientific information, which may stimulate their own research.

• Enhancing clinical trial opportunities will reduce academic/clinician “Brain Drain”

4. Structural Support to Champion the Vision

In the 2017 policy address, to encourage research and development (R&D)

investment by enterprises, the Government proposed to introduce a 300% tax

deduction for the first $2 million eligible R&D expenditure, with the remainder at

200%.

HKAPI Recommends

4.1 Set a Vision and Define Success for R&D in Hong Kong

Visionary key performance indicators can outline the future state of Hong Kong

R&D development. Currently, less than 0.1% of patients in Hong Kong are

recruited to take part in clinical trials. However, in the UK, 10 % of patients have

already been involved in clinical trials. Therefore Hong Kong should set a goal

and work toward having 10% of local patients participating in clinical trial in 10

years.

4.2 Create a dedicated role to champion the mission

Appoint a Chief Scientific Officer, reporting to the Chief Executive and Secretary

for Food and Health5, to lead the implementation of the Hong Kong SAR vision to

develop the R&D bio-medical hub and related core projects including initiatives

to develop a prioritized clinical trial centre and create a Healthcare Data

Analytics platform. The officer, as a coordinator, should advise relevant

5 The UK Government Chief Scientific Adviser (GCSA) is the personal adviser on science and technology-related activities and

policies to the Prime Minister and the Cabinet; and head of the Government Office for Science.

In Canada, the Chief Scientific Adviser has a significant public role as the government's most visible scientific expert. They are also head

of the Science and Engineering Profession in government.

• provide advice on the development and implementation of guidelines to ensure that government science is fully available to the

public and that federal scientists are able to speak freely about their work;

• provide advice on creating and implementing processes to ensure that scientific analyses are considered when the Government

makes decisions;

• assess and recommend ways to improve the existing science advisory function within the federal government; and

• Assess and recommend ways for the Government to better support quality scientific research within the federal system.

Government departments and stakeholders such as the Science Park and

academics on matters relating to funding or manpower development.

5 Develop Hong Kong into Centre of Excellence for Clinical Trials in Asia

As the pharmaceutical industry is engaged in many types of research and

development, this paper focuses on the clinical development of medicines in human

subjects. Such clinical research is the prerequisite for growth of pre-clinical and other

research.

The HKAPI carried out a survey among its member companies in 2017. The results

demonstrated that the top 5 drivers attracting research to Hong Kong were:

• High data quality

• Experienced and credible investigators

• Mutual recognition of trial data between Hong Kong and Mainland China

• Well-equipped hospitals and

• Simple and transparent approval procedures for the regulatory authority

There were also some deterring factors such as the time for setting up clinical trials,

lack of supporting incentives and the cost of clinical trials. Among all of these factors,

the most impactful one is the time spent on setting up clinical trials. Hong Kong

ranked behind South Korea, Singapore and Taiwan for regulatory and ethics

committee approval time. In total, the time taken by healthcare institutions in Hong

Kong to process trial contracts is 4 times longer than in Singapore.

Figure 6: Setting Up Clinical Trials in Hong Kong vs. Singapore

Therefore, to develop Hong Kong as the centre of excellence for clinical trials,

expediting the time to set up clinical trials is an important area to address.

HKAPI recommends

5.1 Creating a Clinical Trials Unit (CTU), to accelerate procedures to set up clinical

trials with the following responsibilities:

• Acting as a single point of contact to lead on trial feasibility and set-up

• Establishing a single Hong Kong ethics committee

• Accelerating legal review for contracts and indemnity

• Setting and measuring targets and standards for hospital clusters to deliver

clinical trials

• Training and providing dedicated staff in the hospitals to recruit and manage

patients

• Reviewing the existing facilities, such as hospital diagnostics equipment and

ensure that they are fit for the purpose

5.2 Providing Incentives for Companies to Initiate R&D

5.2.1 Provide a direct Government monetary incentive such as tax breaks or grants to

companies placing clinical trials in Hong Kong.

5.2.2 Introduce Adaptive Pathways (AP) and Managed Entry Agreements (MEA) to

enhance access as incentives

The rationale behind APs is the same which led to the development of coverage with

evidence development MEAs; enabling patients early to access new drugs while

collecting real-life data in order to update the final decision.

Definitions:

MEAs - it is the final reimbursement decision and the related restrictions or

recommendations on how a medicine should be used within the health system.

AP - it is about whether the drug should be made accessible to all patients or a

sub-population.

APs

The EMA launched a pilot in 2014 on AP. The aim of AP is to foster and facilitate the

pathway of product development to potentially achieve earlier access to medicines

through an early dialogue involving all stakeholders. Essentially APs are an

instrument to balance early access to new medicines to patients with the need of

collecting information on the drug benefits and harms. The concept is to initially focus

on a population of good responders followed by adaptation of the licensing

conditions as more evidence becomes available. There are two models for APs:

In the first model, the manufacturer secures approval in a well-defined

subpopulation with a high level of unmet clinical need, before expanding the

indication to a larger population.

In the second model, the manufacturer secures an early marketing authorization,

possibly on the basis of surrogate endpoints, subject to a commitment to reduce

uncertainty by gathering more evidence.

MEAs

Stretched health care budgets, increasing availability of potentially life-saving

high-cost drugs mean that manufacturers seeking reimbursement need to

demonstrate that their drugs can provide additional benefit in relation to current

therapies and value-for-money in order to obtain coverage. Data and the overall

evidence base available at registration are often insufficient to accurately estimate

the clinical and cost-effectiveness of a drug in clinical practice or its budget impact in

real life (e.g. oncology drugs). Uncertainty, due to lack of information on

effectiveness, may delay reimbursement decisions and patient access. There are two

main ways to address uncertainty relating to clinical and/or cost effectiveness:

The first is to grant reimbursement for a limited time period during which

additional evidence on the drug effectiveness will be collected and to update the

reimbursement decision afterwards based on the new cost-effectiveness results

(used in the Netherlands, Sweden and Portugal).

The second way is to decrease the price or to limit utilization so that the

cost-effective ratio is improved because of lower costs (UK, Czech Republic).

One of the most important instruments for MEAs is drug-monitoring registries. These

registries aim to asses and track patient eligibility, evaluate utilization in clinical

practice, collect epidemiological data including data on the safety profile and collect

additional information which was missing at the first evaluation stage. This should

guarantee appropriate use of medicines according to the therapeutic indications

while providing important information on the tolerability of a new drug and

prescribing appropriateness and can be especially useful in rare diseases.

5.3 Leveraging the China factor

Hong Kong should leverage its proximity to China as well as its advanced medical

infrastructure, high-quality and experienced research investigators to position

itself as the principal clinical trials site for conducting clinical research and

facilitate industry collaboration with research institutions in China.

The Government should facilitate the accreditation of additional clinical trial sites

and ensure clinical data transferability for trials conducted in Hong Kong. At the

same time, clinical trial in approved sites in Hong Kong could be recognized by

China’s authority automatically if they use the same clinical trial protocol. If Hong

Kong trial data was recognised by China FDA for registration of medicines in China,

this would be significantly attractive to global pharmaceutical companies.

Furthermore, to solve the problem of the limited number of subject matters

because of the limited population size, access to people in the Greater Bay Area

through R&D launched in Hong Kong would significantly increase the chances of

attracting clinical trials.

6.6. Unveil the Big Data in Public Hospital system

This clinical database empowers the HA to become the sole public health service

provider, serving a local population of 7.4 million and managing 87% of all hospital

beds in Hong Kong. Since its birth, database in HA has been collecting patient data for

more than 25 years and it contains essential real-world clinical information including

patient demographics, hospitalizations, visits to outpatient clinics and emergency

departments, diagnoses, laboratory results, procedures, prescriptions, dispensing of

medications and deaths. It can be anonymized for collective analyses and patients

are assigned a unique patient identifier in the system.

The Chief Executive announced that the HA will develop a Big Data Analytics Centre

to achieve the set goal of leveraging the database for R&D.

HKAPI Recommends

6.1 To ensure the data is user-friendly and future focused, invite relevant

stakeholders including academics, medical scientists and the pharmaceutical

industry to support the set up of the HA Big Data Analytics Centre.

6.2 To drive the formation of a consortium by relevant stakeholders to develop and

govern a transparent and structured system for open access to CDARS ensuring

access to data under a structured system with clear approval procedures, criteria

and timelines, similar to the databases operated in other countries such as the US

FDA and UK CPRD.

6.3 Establish a dedicated body to handle the administrative work for the

applications for accessing data. Ensure the database will be a publicly available

resource with access strictly controlled by an independent department and

granted by the consortium. The criteria and timeline for granting access to

specific clinical parameters will be clearly listed for applicants.

Conclusion

We believe that the Government is dedicated to enhancing healthcare services for

Hong Kong people and developing Hong Kong as biomedical hub. The HKAPI

recommendations outlined in this document are intended to provide clear direction

and to support the Government in developing a visionary and efficient

people-centred healthcare system in Hong Kong.