CARIBBEAN PHARMACEUTICAL POLICY.indd

Caribbean

Pharmaceutical Policy

Caribbean Pharmaceutical Policy

Washington, D.C., 2013

PAHO HQ Library Cataloguing-in-PublicaƟ on Data

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Pan American Health OrganizaƟ on. Caribbean Community.

Caribbean PharmaceuƟ cal Policy. Washington, DC : PAHO, 2013.

1. Drug and NarcoƟ c Control. 2. Health Policy, Planning and Management. 3. NaƟ onal Drug Policy.

4. Caribbean. I. Title. II. CARICOM.

ISBN 978-92-75-11807-8 (NLM classiﬁ caƟ on: QV55)

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iii

CARIBBEAN PHARMACEUTICAL POLICY

Table of Contents

ACKNOWLEDGMENTS ............................................................................................................... v

ABBREVIATIONS AND ACRONYMS ......................................................................................... vii

EXECUTIVE SUMMARY ............................................................................................................. ix

1. INTRODUCTION ......................................................................................................................1

1.1 Background and context ...................................................................................................1

1.2 Health and the pharmaceutical situation in the Caribbean ...............................................3

1.3 Proposal for a model national medicines policy and technical advisory group .................4

1.4 Overview of the pharmaceutical situation .........................................................................6

2. GOAL, PRINCIPLES AND VALUES OF THE POLICY...........................................................11

2.1. Goal of the policy ........................................................................................................... 11

2.2. Principles and values of the policy ................................................................................ 11

3. OBJECTIVES AND STRATEGIES .........................................................................................13

3.1. Objectives ......................................................................................................................13

3.1.1. Pharmaceutical policy scope ................................................................................13

3.1.2. Regulatory framework ...........................................................................................13

3.1.3. Access ..................................................................................................................13

3.1.4. Rational use of medicines .....................................................................................14

3.2. Strategies ......................................................................................................................14

3.2.1. Pharmaceutical policy scope ................................................................................14

3.2.2. Regulatory framework ...........................................................................................15

3.2.3. Access ..................................................................................................................16

3.2.4. Rational use of medicines .....................................................................................17

4. MECHANISMS FOR IMPLEMENTATION, MONITORING AND EVALUATION .....................19

4.1. Responsibility and oversight structure ...........................................................................19

4.2. Strategies for implementation ........................................................................................20

4.3. Reporting mechanism ....................................................................................................20

4.4. Financing .......................................................................................................................20

5. FINAL CONSIDERATIONS ....................................................................................................21

REFERENCES ...........................................................................................................................23

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX I. Former Technical Advisory Group on Trade-Related Intellectual Property Rights .....23

ANNEX II. Executive Summary - CARICOM Regional Assessment of Drug Registration and

Regulatory Systems ...................................................................................................................25

ANNEX III. Executive Summary - Assessment of Patent and Related Issues and

Access to Medicines in CARICOM and the Dominican Republic - HERA Final Report –

31 December 2009 .....................................................................................................................35

ANNEX IV. Glossary of Terms ....................................................................................................43

ANNEX V. Development of the Caribbean Pharmaceutical Policy .............................................49

ANNEX VI. Outline of the Implementation Plan for the Caribbean Pharmaceutical Policy ........51

ANNEX VII. Terms of Reference - CARICOM Expanded Technical Advisory Committee on

Pharmaceutical Policiy (TECHPHARM) .....................................................................................53

ANNEX VIII. Roadmap for Development of the Pharmaceutical Policy .....................................59

CARIBBEAN PHARMACEUTICAL POLICY

ACKNOWLEDGMENTS

The development of this document was made possible through the invaluable contributions of a

number of individuals and organisations.

The process was coordinated by the Caribbean Community (CARICOM) Technical Advisory

Group (TAG) on Trade-Related Intellectual Property Rights. The draft Caribbean Pharmaceutical

Policy (CPP) was presented in July 2010 at a workshop on Caribbean Pharmaceutical Policies

held at the Pan American Health Organization/World Health Organization (PAHO/WHO) Ofﬁ ce of

Caribbean Program Coordination OCPC) in Barbados. The following TAG members contributed

to the draft policy:

Adriana Mitsue Ivama Brummell, Sub-Regional Advisor, Medicines and Health

Technologies, PAHO/WHO);

Francis Burnett, Managing Director, Organisation of Eastern Caribbean States

Pharmaceutical Procurement Service;

Lucette C. M. Cargill, Head of Unit, Caribbean Public Health Agency Drug Testing

Laboratory (formerly the Caribbean Regional Drug Testing Laboratory);

Rudolph Cummings, Programme Manager, Health Sector Development, CARICOM Secretariat;

Maryam J. Hinds, Director, Barbados Drug Service;

Miriam A. Naarendorp, Pharmacy Policy Coordinator, Ministry of Health, Suriname; and

Princess Thomas Osbourne, Director of Standards and Regulation; Ministry of Health

(MOH), Jamaica.

The following persons also participated:

Anthony K. Cyrus, Pharmacy Inspector, Ministry of Health, Grenada;

Damian Cohall, Lecturer in Pharmacology, Faculty of Medical Sciences, University of the

West Indies (UWI);

David L. Crawford, Drug Inspector, Barbados Drug Service;

Elizabeth M-R Ferdinand, Chief Medical Ofﬁ cer (acting), Ministry of Health, Barbados;

Eugenie Brown-Myrie, Dean, College of Health Sciences, University of Technology,

Jamaica;

Evelyn B. Davis, Pharmacy Educator, T.A. Marryshow Community College, Grenada;

Gracia A. Wheatley, Chief of Drugs and Pharmaceutical Services, Ministry of Health and

Social Development, British Virgin Islands;

Lesia Proverbs, Pharmacy Educator, Division of Health Science, Barbados Community

College;

Louisa Stuwe, Intern, PAHO/WHO;

Marthelise G. Eersel, Director of Health, Ministry of Health, Suriname;

Pamela E. Payne-Wilson, Assistant Director, Barbados Drug Service;

Patrick Martin, Chief Medical Ofﬁ cer, Ministry of Health, Saint Kitts and Nevis;

Rian M Extavour, Chair, Education Committee, Caribbean Association of Pharmacists;

St Clair A. Thomas, Chief Medical Ofﬁ cer, Ministry of Health, Saint Vincent and the

Grenadines; and

Robert C. Verhage, Consultant, Evaluation, Health Research for Action European

Community/African Caribbean and Paciﬁ c States/World Health Organization Partnership

on Pharmaceutical Policies.

Based on the workshop’s recommendations, the CPP was reviewed and edited by A. Ivama

Brummell, Nelly Marin (former PAHO/WHO advisor on pharmaceutical policies) and Rian M.

Extavour, with the collaboration of Maryam J. Hinds, Patrick Martin, Damian Cohall, M. Valdes

(PAHO/WHO), Murilo Freitas (PAHO/WHO), Irad Potter and Gracia A. Wheatley.

This document has been produced with the ﬁ nancial assistance of the European Union and the technical support of the Pan

American Health Organization/World Health Organization (PAHO/WHO). The views expressed herein are those of the authors

and can therefore in no way be taken to reﬂ ect the ofﬁ cial opinion of the European Union or the PAHO/WHO.

vii

CARIBBEAN PHARMACEUTICAL POLICY

ABBREVIATIONS AND ACRONYMS

ACP African, Caribbean and Paciﬁ c Group of States

ASEAN Association of Southeast Asian Nations

CARICOM Caribbean Community

CARIFORUM Caribbean Forum of African, Caribbean and Paciﬁ c States

CARIPROSUM Caribbean Regional Network of Pharmaceutical

Procurement and Supply Management Authorities

CARPHA Caribbean Public Health Agency

CCH III Caribbean Cooperation in Health Initiative, Phase III

CMOs Chief Medical Ofﬁ cers

COHSOD Council for Human and Social Development

CPP Caribbean Pharmaceutical Policy

CRDTL Caribbean Regional Drug Testing Laboratory

CSME CARICOM Single Market and Economy

DR-CAFTA Dominican Republic–Central America Free Trade Agreement

DTL Drug Testing Laboratory

EMA European Medicines Agency

EML Essential medicines list

EPA Economic Partnership Agreement

EU European Union

GMP Good manufacturing practices

HERA Health Research for Action

HIV/AIDS Human immunodeﬁ ciency virus/acquired immunodeﬁ ciency

syndrome

IPRs Intellectual property rights

MOH Ministry of Health

MRA Medicines regulatory authority

NCDs Non-communicable diseases

NMP National medicines policy

NRA National Regulatory Authority

OCPC Ofﬁ ce of Caribbean Program Coordination

OECS Organisation of Eastern Caribbean States

PAHO Pan American Health Organization

PANCAP Pan Caribbean Partnership against HIV and AIDS

PANDRH Pan American Network for Drug Regulatory Harmonization

PPS Pharmaceutical Procurement Service

SADC Southern African Development Community

STGs Standard treatment guidelines

TAG Technical Advisory Group

TECHPHARM CARICOM Expanded Technical Advisory Committee on

Pharmaceutical Policy

viii

CARIBBEAN PHARMACEUTICAL POLICY

TRIPS Trade-Related Aspects of Intellectual Property Rights

WHO World Health Organization

WTO World Trade Organization

CARIBBEAN PHARMACEUTICAL POLICY

EXECUTIVE SUMMARY

Every human being is entitled to the enjoyment of the highest attainable standard of health

conducive to living in dignity. Access to health care, which includes access to essential medicines,

is a prerequisite for realising that right. National medicines expenditures, as a proportion of total

health expenditures, currently range from 7% to 66% worldwide.

In the Caribbean, the implementation of the Revised Treaty of Chaguaramas and the

establishment of the CARICOM Single Market and Economy (CSME) provide a favourable

environment for regional integration. However, there are challenges in the area of health, given the

health situation, geography, limited human resources and continued migration. At the same time,

the tourism sector is being challenged by poor sanitation, untreated sewage that may damage

beaches, food-borne disease outbreaks in public places, the threat of natural disasters and the

need to mount an effective, rapid response to manage and control epidemics. There is a need to

focus on achieving a strong, comprehensive and integrated public health response through health

environment strategies that address these priority areas.

Recognising the challenge of ensuring sustained access to adequate quality medicines at

affordable prices, the CARICOM Ministers of Health, at the Tenth Meeting of the Council for

Human and Social Development (COHSOD) (April 2003), mandated the establishment of a

Technical Advisory Group (TAG) on Trade-Related Intellectual Property Rights (TRIPS). TAG,

by means of a regional assessment of drug regulatory and registration systems and a regional

assessment of patent and related issues and access to medicines in CARICOM countries and the

Dominican Republic, sought to assess the current situation and to propose solutions for improving

the situation with respect to medicines. Complementary to these studies, PAHO/WHO published

a report on the pharmaceutical situation in the Caribbean in 2007, with the participation of 13

Caribbean countries.

At the Eighteenth Meeting of the Caucus of CARICOM Health Ministers, held in 2009 in

Washington, D.C., the ministers supported an accelerated approach to a series of projects related

to improving quality of life, establishing partnerships in pharmaceutical policies, addressing

intellectual property rights, and strengthening the functions of the health sector, among others.

The Caucus also urged that there be coordinated collaboration among the Chief Medical Ofﬁ cers

(CMOs), the CARICOM Health Desk and PAHO on the issue.

CARIBBEAN PHARMACEUTICAL POLICY

Based on the ﬁ ndings of the above-mentioned studies and within the framework of the

Caribbean Cooperation in Health Initiative, Phase III (CCH III), the development of a Caribbean

Pharmaceutical Policy (CPP) was proposed. Earlier, in 1999, a draft Model National Medicines

Policy had been developed after a series of steps in that direction. Although the document was

updated in 2001, it was never ofﬁ cially adopted. This draft served as the main starting point for

developing the current CPP proposal. At a workshop convened in Barbados on 5–6 July 2010, a

proposal prepared by TAG was discussed with participation from the main regional and national

stakeholders, including representatives of the Organisation of Eastern Caribbean States (OECS),

the former Caribbean Regional Drug Testing Laboratory (CRDTL; now the Caribbean Public

Health Agency Drug Testing Laboratory [CARPHA/DTL]) and Caribbean Ministries of Health and

universities.

The proposal for the Caribbean Pharmaceutical Policy was presented at the Eighteenth

Meeting of Chief Medical Ofﬁ cers (CMOs) on 19 May 2010 and at the Nineteenth Meeting of the

Caucus of CARICOM Health Ministers in September 2010. The ministers agreed that a decision

should be taken on this matter at the next COHSOD meeting, to be held in April 2011, when the

policy was ﬁ nally approved.

The goal of the Caribbean Pharmaceutical Policy is to guide Caribbean countries in ensuring:

• Access: equitable access to, availability of and affordability of essential medicines;

• Quality: quality, safety and efﬁ cacy of all medicines; and

• Rational use: therapeutically sound and cost-effective use of medicines by health

professionals and consumers.

The regional pharmaceutical policy is guided by the main principle of access to medicines

as a human right. Additionally, it is guided by the values and principles of public health, with an

emphasis on the renewed Primary Health Care strategy.

The policy has four main areas, namely:

• Pharmacy policy scope;

• Regulatory framework;

• Access; and

• Rational use of medicines.

The CPP encompasses pharmaceutical products and services and related issues, with

objectives as follows.

Pharmaceutical policy scope

• Support collaboration mechanisms and develop regional guidelines in key areas of

implementation of the Caribbean Pharmaceutical Policy.

• Promote the development and management of human resources in the areas of

the pharmaceutical policy.

CARIBBEAN PHARMACEUTICAL POLICY

• Promote the use of evidence in decision-making for the development, implementation

and assessment of pharmaceutical policies, both at the sub-regional and national

levels.

Regulatory framework

• Develop a sub-regional regulatory framework for medicines and strengthen

the collaboration among Caribbean countries to ensure the performance of the

essential components of medicines regulation.

Access

• Strengthen the collaboration among the national pharmaceutical systems and

promote and support the development and implementation mechanisms for joint

negotiation of medicines procurement.

• Develop a sub-regional mechanism to strengthen patent examination systems with

a “pro–public health” approach and support the countries’ efforts to promote and

protect public health and access to medicines, in order to take advantage of Trade-

Related Aspects of Intellectual Property Rights (TRIPS) ﬂ exibilities in conformity

with the Doha Declaration on Public Health.

Rational use of medicines

• Develop a sub-regional strategy and work plan for strengthening the rational use

of medicines in the Caribbean as part of the pharmaceutical policy.

Mechanisms for implementation, monitoring and evaluation

An implementation plan with indicators for monitoring and evaluation will be

developed. The proposed mechanism, with responsibility for overseeing policy

implementation, includes the establishment of the Expanded Technical Advisory Group

on Pharmaceutical Policy (TECHPHARM). The policy establishes TECHPHARM and

its responsibilities for overseeing the implementation, monitoring and evaluation of

the CPP. These responsibilities are shared with the national health authorities and

stakeholders from the Caribbean, with technical and ﬁ nancial support from the

CARICOM Secretariat and PAHO/WHO.

TECHPHARM will assess the progress of the implementation of the policy in an

annual report to the Ministers of Health, embedded in the reporting mechanisms of

the CMOs regarding CCH III implementation. It is necessary to establish a sustainable

ﬁ nancing mechanism for the proposed policy, which provides guidelines for regional

donors’ support in a synergistic way.

The CPP will be an integral part of policies developed by Caribbean states and,

to the extent possible, will be incorporated into other policies related to public health.

CARIBBEAN PHARMACEUTICAL POLICY

1. INTRODUCTION

Health is a fundamental human right indispensable for the exercise of other human rights. Every

human being is entitled to the enjoyment of the highest attainable standard of health conducive

to living a life in dignity. The realisation of the right to health may be pursued through numerous,

complementary approaches, such as the formulation of health policies, the implementation of

health programmes, or the adoption of speciﬁ c legal instruments. Moreover, the right to health

includes certain components which are legally enforceable (1).

Access to health care, which includes access to essential medicines, is a prerequisite for

realising that right. It is part of the governance and steering role of the state to ensure the fulﬁ lment

the right to health. National medicines expenditures, as a proportion of total health expenditures,

currently range from 7% to 66% worldwide, and proportions are higher in developing countries

(24%–66%) than in developed countries (7%–30%) (2).

In accord with the mandates of the Tenth Meeting of COHSOD and the Eighteenth Meeting of

the Caucus of CARICOM Health Ministers, a Caribbean Pharmaceutical Policy (CPP) has been

proposed and approved in order to promote a sub-regional policy framework and to support and

facilitate the development of individual pharmaceutical policies in the Caribbean countries. It aims

to support the sustainability of the progress achieved, to date, and to address remaining gaps as

well as new challenges.

1.1 Background and context

The Caribbean includes countries and territories with different political structures and status,

as follows:

• Republics: Cuba, the Dominican Republic, Haiti, Suriname;

• Republics within the Commonwealth of Nations: Dominica, Guyana, Trinidad and

Tobago;

• Independent countries that are part of the Commonwealth: Antigua and Barbuda,

the Commonwealth of The Bahamas, Barbados, Belize, Grenada, Jamaica, Saint

Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines;

• UK Overseas Territories: Anguilla, Bermuda, the British Virgin Islands, the Cayman

Islands, Montserrat, Turks and Caicos Islands;

• Entities of the Kingdom of the Netherlands: Aruba, Bonaire, Curaçao, Sint Maarten,

Special Municipalities of the Netherlands;

• French Overseas Territories of the Americas: Guadeloupe, Guyana, Martinique,

Saint Martin; and

CARIBBEAN PHARMACEUTICAL POLICY

• United States (US) Overseas Territories: Commonwealth of Puerto Rico, US Virgin

Islands.

Not only is there diversity in political status and language, Caribbean countries also have

different legal systems: most English-speaking territories operate under a common law legal

system, while the other territories tend to operate under a civil law system. Most territories are

considered small developing states, due to their geographic size and population size as well as

the scale of their respective economies.

Caribbean countries have been aligned to a number of regional integration mechanisms and

associations. In this context, sub-regional collaboration is crucial to respond to a set of persistent

challenges, including the need for state reforms as well as increased pressure due to globalisation

and the economic recession. These challenges are reﬂ ected in the establishment of the Caribbean

Community (CARICOM)

and the steps taken towards the implementation of the Revised Treaty

of Chaguaramas, establishing the CARICOM Single Market and Economy (CSME) (2001). Article

6 of CSME outlines a set of objectives that include improved standards of living and work, more

efﬁ cient operation of common services and activities, full employment of labour and other factors of

production, and accelerated, coordinated and sustained economic development and convergence.

Article 17 addresses the promotion of human and social development and the development of

coordinated policies and programmes to improve the living and working conditions of workers. In

the Revised Treaty of Chaguaramas, allowances also have been made for new issues such as

e-commerce, government procurement, trade in goods from free zones, free circulation of goods

and the right of free movement of persons (3).

The 15 CARICOM countries and the Dominican Republic make up the Caribbean Forum of

African, Caribbean and Paciﬁ c States (CARIFORUM). These countries, together with countries

of Africa and the Paciﬁ c, constitute the ACP (African, Caribbean and Paciﬁ c Group of States)

countries that negotiated an Economic Partnership Agreement (EPA) with the European Union

(EU) in April 2004.

The framework for ACP-EU relations is centred on economic development,

reductions in and eventual eradication of poverty and the smooth and gradual integration of ACP

states into the global economy (4).

In addition to CARIFORUM, Caribbean countries participate in several other sub-regional

integration or strategic development groups, including the Association of Caribbean States, the

Organisation of Eastern Caribbean States (OECS), the Rio Group, the Union of South American

Nations, the Central American Integration System and the Association of Small Island States.

These collaborations lead to opportunities for cooperation among the countries in areas related

to health and development.

a) CARICOM Member States: Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica,

Montserrat, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname and Trinidad and Tobago; and

b) CARICOM associate members: Anguilla, Bermuda, British Virgin Islands, Cayman Islands and Turks and Caicos Islands.

The countries are as follows: Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, Dominican Republic, Grenada, Guyana,

Haiti, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname and Trinidad and Tobago. The

EPA was signed on 15 October 2008 by each of these countries with the exception of Guyana (which signed on 20 October

2008) and Haiti (which signed on 11 December 2009).

CARIBBEAN PHARMACEUTICAL POLICY

1.2 Health and the pharmaceutical situation in the Caribbean

According to PAHO/WHO (5):

“given the health situation, the geography, the lack of human resources and continued

migration, health challenges in the Caribbean require reviews of the incomplete agendas

with regard to malaria, TB, leprosy, as well as the epidemic of non-communicable diseases.

At the same time, the tourism sector is being challenged by poor sanitation, untreated

sewage that may damage beaches, food borne disease outbreaks in public places, the

threat of natural disasters, and inadequate capacity to mount an effective, rapid response

to manage and control epidemics. As such, there is the need for the Caribbean to focus on

achieving a strong, comprehensive and integrated public health response through Health

Promotion Strategies that address these priority needs”.

Figure 1. Leading causes of mortality in the Caribbean (2006)

Source: PAHO/WHO (6)

Over the past few decades, death rates in the Caribbean sub-region have been gradually

decreasing. Figure 1 shows that the French Departments of the Americas have the lowest mortality

rates, whereas Haiti has the highest. The other countries are similar in their mortality proﬁ les.

Between 1980 and 2000, the leading cause of mortality across all ages in the English-speaking

Caribbean was ischemic heart disease, followed by cerebrovascular disease, diabetes mellitus,

other heart diseases and hypertension. These conditions accounted for 47% of deaths in 1980

and 51% in 2000. Approximately 15%–20% of adults have diabetes, and about 20%–30% have

hypertension. Problems related to these major non-communicable diseases (NCDs) represent

the largest expenditures in national medicines budgets. The situation is similar in the non-English-

speaking countries.

200

400

600

800

1000

1200

1400

The Caribbean

French Departments

Larger Islands

Barbados and OECS

Mainland

HaiƟ

Rates per 100,000 pop.

CommDisease

Neoplasms

Circulatory

Ext. Causes

Other

CARIBBEAN PHARMACEUTICAL POLICY

Overall, NCDs are the leading cause of death. They share common underlying risk factors,

namely unhealthy eating habits, physical inactivity, obesity, tobacco and alcohol use and inadequate

utilisation of preventive health services. This situation suggests that providing medicines alone is

not enough; a different and more comprehensive approach is required.

During the period 2004–2010, the WHO/EU/ACP Partnership on Pharmaceutical Policies was

an important source of ﬁ nancing for the technical cooperation of CARICOM countries and the

Dominican Republic

through PAHO/WHO.

1.3 Proposal Model National Medicines Policy and Technical Advisory

Group

In 1999, a draft Model National Medicines Policy was developed following a series of steps in

that direction. First, a consultative workshop took place in May 1999 in Jamaica under the auspices

of the CARICOM Secretariat. As stated in the Introduction, the model policy resulted from the

pooling of opinions of key role players, primarily chief pharmacists of the CARICOM countries as

well as representatives of the Eastern Caribbean Drug Service (ECDS) (since renamed the OECS

Pharmaceutical Procurement Service [OECS/PPS]), the CARICOM Secretariat and PAHO/WHO.

Although the document was updated in 2001, it was never ofﬁ cially adopted. The draft model

served as the main starting point for developing the proposal for the Caribbean Pharmaceutical

Policy. Recognising the challenge of ensuring sustained access to adequate quality medicines

at affordable prices, the CARICOM Ministers of Health, at the Tenth Meeting of COHSOD in

April 2003, mandated the establishment of a Technical Advisory Group (TAG) on Trade-Related

Intellectual Property Rights (see Annex I). TAG, by means of a CARICOM regional assessment of

drug regulatory and registration systems (7) and an assessment of patent and related issues and

access to medicines in CARICOM and the Dominican Republic (8), sought to assess the current

situation with respect to medicines and to propose improvements for the situation.

The two above-mentioned assessments were part of the TAG mandate. Annexes II and III,

respectively, present executive summaries of these two studies, which were commissioned by the

CARICOM Secretariat, conducted by Health Research for Action (HERA), technically supported

by PAHO/WHO and ﬁ nanced by the Pan Caribbean Partnership against HIV and AIDS (PANCAP)

and the World Bank.

Complementary to these studies, PAHO/WHO published a report in 2010 on the pharmaceutical

situation in the Caribbean, with the participation of 13 Caribbean countries (9).

The agreement for this project was signed on 7 March 2004. In the Caribbean, technical cooperation is provided by PAHO/WHO

through its Ofﬁ ce of Caribbean Program Coordination (OCPC). The original duration of the project was ﬁ ve years (until

September 2009), but a “non-cost extension” was received and the project continued until September 2010. In addition to the

mandates from PAHO/WHO, project activities were guided by sub-regional mandates and country priorities.

The CARICOM Draft Model National Medicines Policy (2001 version) is an unpublished document.

CARIBBEAN PHARMACEUTICAL POLICY

At the Eighteenth Meeting of the Caucus of CARICOM Health Ministers, held in September

2009 in Washington, D.C., the ministers, with respect to PAHO’s Regional Strategic Framework,

supported an accelerated approach to a series of projects related to improving quality of life,

establishing partnerships in pharmaceutical policies, developing a pro–public health approach to

intellectual property rights, and strengthening the functions of the health sector, among others.

The Caucus also urged that there be coordinated collaboration among the CMOs, the CARICOM

Health Desk and PAHO on the issue. The proposal for the Caribbean Pharmaceutical Policy was

presented on 19 May 2010, at the Eighteenth Meeting of Chief Medical Ofﬁ cers, and in September

2010 at the Nineteenth Meeting of the Caucus of CARICOM Health Ministers in Washington, D.C.

The ministers agreed that a decision would be taken at the Twenty-First Meeting of COHSOD in

April 2011; at that meeting, the policy was approved.

There have also been efforts to contribute to and achieve the goals established by the

Declaration of Port of Spain (2007), one of which is that, by 2012, 80% of people with NCDs would

receive quality care and have access to preventive education based on regional guidelines (10).

Therefore, it is necessary to guarantee access to high-quality and safe medicines and to promote

their rational use.

In 2009, the Caribbean Cooperation in Health Initiative, Phase III (CCH III), Investing in Health

for Sustainable Development, was adopted by the Ministers of Health. According to the CCH

III, one of the expected results related to the strategic objective of ensuring that health services

respond effectively to the needs of the Caribbean people is improvements in access to safe,

affordable and efﬁ cacious medicines (11).

One of the areas for joint collaborative action is to support the design and implementation of

a Caribbean Pharmaceutical Policy and mechanisms to enhance access, quality and rational use

of medicines in the Region. In the same way, one expected result at the national level would be

improving access to safe, affordable and effective medicines and their rational use. This document

represents the mandate for developing the pharmaceutical policy and its components at both the

sub-regional and national levels (11).

The Caribbean Public Health Agency (CARPHA) was established by a CARICOM

intergovernmental agreement in June 2011, with the following objectives:

a) to promote the physical and mental health and wellness of people within the Caribbean;

b) to provide strategic direction in analysing, deﬁ ning and responding to public health priorities

of the Caribbean Community;

c) to promote and develop measures for the prevention of disease in the Caribbean;

d) to support the Caribbean Community in preparing for, and responding to public health

emergencies;

e) to support solidarity in health, as one of the principal pillars of functional cooperation in the

Caribbean Community; and

CARIBBEAN PHARMACEUTICAL POLICY

f) to support the relevant objectives of the CCH as approved by the Council. The Caribbean

Regional Drug Testing Laboratory (CRDTL)

will become part of CARPHA.

1.4 Overview of the pharmaceutical situation

A variety of sources have been used to present the information in this section, including a

PAHO/WHO assessment of the pharmaceutical situation in Caribbean countries (9), based on the

responses of 13 countries to a WHO questionnaire; a regional assessment of drug registration

and regulatory systems in CARICOM Member States and the Dominican Republic (7); and a

regional assessment of patent and related issues and access to medicines in CARICOM Member

States and the Dominican Republic (8).

The results show that progress has been made in six

areas:

• National Medicines Policy;

• Regulatory System;

• Medicines Supply System,

• Medicines Financing;

• Production and Trade; and

• Essential Medicines and Rational Use.

The main results in each of these areas related to CARICOM members and the Dominican

Republic are highlighted in this document.

According to PAHO/WHO, the number of countries with a national medicines policy (NMP)

increased from three in 2003—with only two of them ofﬁ cially adopted—to seven in 2007, with

four ofﬁ cially adopted. In the 2009 assessments commissioned by CARICOM, seven of the 16

countries included had an NMP, but only three of them had been ofﬁ cially adopted. In addition,

only two countries declared that intellectual property and access to medicines were covered in

their respective NMPs. Of the two countries reporting that they had a written policy on intellectual

property rights (IPRs), neither reported having a policy on pharmaceutical innovation. The data

suggest that special attention has to be given to:

1) the implementation, monitoring and evaluation of the existing policies; and

2) the development of a sub-regional pharmaceutical policy.

At the same time, these policies need to address aspects related to access to medicines,

IPRs and innovation and adopt a clear position on access to pharmaceuticals.

The Caribbean Regional Drug Testing Laboratory was established through an intergovernmental agreement among members of the

Caribbean Community; since the establishment of CARPHA, the laboratory has been renamed the Drug Testing Laboratory

(DTL).

The two regional surveys commissioned by the CARICOM Secretariat and conducted by Health Research for Action (HERA) were

part of the mandate of the Technical Advisory Group for Trade-Related Intellectual Property Rights (TAG/TRIPS), which included

the 15 CARICOM Member States and the Dominican Republic. The executive summaries of the two CARICOM/HERA studies

are presented in Annexes II and III of this document.

CARIBBEAN PHARMACEUTICAL POLICY

According to PAHO/WHO (9), in 2003, only four countries reported that they had legal

provisions for the establishment of a medicines regulatory authority (MRA). By 2007, this number

had increased to 11. According to the CARICOM report (7), none of the existing legislation is

fully comprehensive. Even though progress can be observed with regard to several individual

components of the regulatory structure, it is a priority to strengthen the institutional capacity of

MRAs and, in particular, their technical capacity. This is important to ensure the performance

of several essential functions of medicines regulation, such as registration or marketing

authorisation, inspection and licensing of facilities and personnel, and marketing surveillance

and pharmacovigilance. In this regard, there is a need for a sub-regional regulatory framework

and a network among the MRAs to improve harmonisation and integration efforts as well as

collaboration.

According to the CARICOM report (7), seven of the countries studied have privately owned

pharmaceutical manufacturing plants that produce multi-source (generic) products only; four of

these countries have export capacity. Private sector pharmaceutical importers and/or wholesalers

are operating in 14 of the 16 countries, while all of the countries have private retail pharmacies

(ranging from one pharmacy in Montserrat to 2,812 in the Dominican Republic). In view of this

multitude of stakeholders and actors, it is necessary to establish a comprehensive regulatory

framework.

In the PAHO/WHO assessment (9), all participating Caribbean countries reported having

public sector procurement pooled at the national level. In 2003, in all seven responding countries,

one of the functions of the Ministry of Health was procurement of medicines. In 2007, this was the

case in 12 of the 13 responding countries (92%). The distribution function was performed by the

Ministry of Health in ﬁ ve countries in 2003 and in seven countries in 2007. Three countries used

more than one procurement mechanism in both 2003 and 2007; one of them was through OECS/

PPS. The median total expenditure on medicines in the public sector in the Americas region (US$

34,087,493) was considerably higher than the expenditure in participating Caribbean countries

(US$ 4,000,000), but the median per capita/per year public expenditure was nearly twice as high

in the participating Caribbean countries (US$ 20.90) as in the Region of the Americas as a whole

(US$ 11.50). Factors to consider in conducting a comparative analysis include a country’s size

and, consequently, its scope of pharmaceutical marketing, the complexity of its health systems

and the effectiveness of its procurement mechanisms and negotiating capacity, including the use

of brand or generic medicines and levels of government subsidies for medicines.

The CARICOM report (7) stated that establishing an effective regional negotiation platform

for medicines requires that needs and beneﬁ ts are clearly deﬁ ned, political will is present and

a regional body can be established. With respect to these areas, it is necessary to strengthen

medicines procurement and supply systems, thereby ensuring sustainability and cost containment.

It is also important to strengthen collaborative mechanisms, such as the Caribbean Regional

Network of Pharmaceutical Procurement and Supply Management Authorities (CARIPROSUM),

and to work towards a sub-regional mechanism for pooled negotiations. Additional studies should

be conducted with regard to price and expenditure of medicines for supporting these proposed

activities.

Although the issue of implementation of TRIPS ﬂ exibilities had been under discussion for

several years, only one country had included TRIPS ﬂ exibility provisions in its legislation as of

2007. “Compulsory licensing” was under debate in four countries (57%) in 2003 and in 2007, but

CARIBBEAN PHARMACEUTICAL POLICY

only two countries (50%) had adopted this legal provision. In 2003, three countries reported that

they had discussed incorporating Bolar exceptions; none of the countries, however, reported

having such legal provisions in 2007. In 2007, the number of countries that had changed their

national legislation to implement the TRIPS Agreement and its ﬂ exibilities was still minimal (9).

In 2009, according to the CARICOM assessment (8), all 16 countries under study had patent

acts. In seven of these countries, however, the acts were considered outdated, and in nine of

them the legislation was being reformed so that it would be TRIPS compliant. Hence, the study

considered that TRIPS ﬂ exibilities were not well implemented in the region. Only three countries

permitted international exhaustion of IP rights and thus allowed parallel import” from the world

market. The other 13 countries permitted regional or national exhaustion, reducing their options

to purchase more affordable brands elsewhere in the world. No country, at that time, had enacted

the “30 August decision” or the “Article 31bis amendment”. Both could become relevant with

respect to the import and regional distribution of multi-source products in the future.

According to the study, the Dominican Republic was the only country that prohibited new use

or second use patents, whereas three countries explicitly allowed this so-called evergreening of

patents. Nine countries allowed experimental use, but only the Dominican Republic had an early

working or Bolar clause (allowing manufacturers of multi-source products to apply for medicine

registration before patent expiry). Seven countries permitted de minimis exceptions, which allow

travellers to import small amounts of patented medicines. The situation was better regarding

compulsory licensing, which is allowed in 12 countries and authorised in draft laws in two other

countries. However, seemingly these clauses have never been used for medicines. Additionally,

although all 16 Caribbean countries under study reported that they had a patent ofﬁ ce, only 10

reported that they processed patent applications and only two indicated that they carried out

substantive examinations of patent applications. Special attention should be given to this area, in

particular, to implement the Global Strategy on Intellectual Property Rights in the Caribbean and

to support Member States in implementing TRIPS ﬂ exibilities (8).

The availability and utilisation of essential medicines lists (EMLs) and standard treatment

guidelines (STGs) increased in the Caribbean between 2003 and 2007. It would be useful to

obtain additional information regarding the utilisation of these tools and their impact on rational

use of medicines and, in this regard, to conduct more speciﬁ c studies such as household surveys.

However, not enough progress has been achieved regarding the introduction of concepts related

to rational use of medicines in the curricula of health professions programmes in the Caribbean.

It is proposed that support be provided for the development of a sub-regional strategy for the

rational use of medicines (9).

The progress observed in 2007 was compared with the 2003 baseline data in the different

components of the Caribbean pharmaceutical sector (9). There is still a signiﬁ cant amount of work

to be done to improve performance in these areas. The CARICOM report posits that a Regional

Medicines Policy needs to be developed, taking into account the ‘Model’ National Medicines

Policy developed by CARICOM in 1999 (8). The formulation of a regional quality assurance policy

(regulatory framework) is considered a critical part of the regional pharmaceutical policy to be

adopted by Member States. A secretariat should be established, as well as a strategic work plan

with funds secured for its implementation.

CARIBBEAN PHARMACEUTICAL POLICY

The second CARICOM study sheds light on the need to implement TRIPS intellectual property

ﬂ exibilities related to public health and to study the possibility of establishing a model wherein

patent rights are granted and enforced for each designated country. This would allow each country

to retain ﬂ exibilities and exceptions in order to protect public health and consumer interests.

Special attention is given to aspects of human resources, mainly due to current shortages and

high levels of rotation, the need to strengthen regulation of medicines and, possibly, the need to

establish a pool negotiation mechanism for procurement. All of these areas should be within the

framework of a regional pharmaceutical policy (8).

Based on the ﬁ ndings of the above-mentioned studies and within the framework of CCH III,

the Caribbean Pharmaceutical Policy (CPP) has been developed with participation from the

main regional and national stakeholders, including representatives of OECS, CRDTL (now the

CARPHA Drug Testing Laboratory [CARPHA/DTL]) (12), and Caribbean Ministries of Health and

universities.

Considering the context of the work that has been conducted by TAG, in cooperation with the

PAHO/WHO Ofﬁ ce of Caribbean Program Coordination (OCPC) and funded by the WHO/EU/ACP

Partnership on Pharmaceutical Policies project, this document cannot cover the varied integration

mechanisms of all Caribbean countries. Hence, the document covers CARICOM Member States

and the Dominican Republic.

Annex IV of this document presents a glossary of terms related to the CPP, and Annex V describes

the development of the policy.

CARIBBEAN PHARMACEUTICAL POLICY

2. GOAL, PRINCIPLES AND VALUES OF THE

POLICY

2.1. Goal of the policy

The goal of the Caribbean Pharmaceutical Policy (CPP) is to guide Caribbean countries in

ensuring:

2.2. Principles and values of the policy

The sub-regional pharmaceutical policy is guided by the main principle that access to medicines

is a human right (1). Additionally, it is guided by the values and principles of public health, with an

emphasis on the renewed Primary Health Care strategy (13).

The pharmaceutical policy has to be integrated into national (health) policies or plans.

Pharmaceutical policies are part of the governance and steering role of the state and are among

the essential public health functions, including the six building blocks of well-functioning health

care systems identiﬁ ed by WHO: a service delivery health workforce; information; medical

products, vaccines and technology; ﬁ nancing; and leadership and governance (12). The

Caribbean Pharmaceutical Policy will also be guided by sub-regional mandates, with particular

attention to the CCH III (11), the Declaration of Port of Spain (10) and the PAHO/WHO Sub-

regional Cooperation Strategy for the Caribbean (5).

To guide Caribbean countries to ensure:

• Access: equitable access, availability and affordability of essential medicines

• Quality: quality, safety and efﬁ cacy of all medicines

• Rational use: therapeutically sound and cost-effective use of medicines by health

professionals and consumers

CARIBBEAN PHARMACEUTICAL POLICY

3. OBJECTIVES AND STRATEGIES

The priority areas, objectives and strategies related to the Caribbean Pharmaceutical Policy

have been identiﬁ ed based on the ﬁ ndings of the existing surveys, the recommendations of the

Eighteenth Meeting of the Caucus of CARICOM Health Ministers (held in Washington, D.C., in

September 2009) and the Eighteenth Meeting of Chief Medical Ofﬁ cers (held in Trinidad and

Tobago in March 2010), and discussions held during the sub-regional technical workshops.

3.1. Objectives

The CPP comprises four main areas, namely:

• Pharmaceutical policy scope;

• Regulatory framework;

• Access; and

• Rational use of medicines.

The policy encompasses pharmaceutical products and services and related issues, with

objectives as follows.

3.1.1. Pharmaceutical policy scope

• Support the strengthening of collaboration mechanisms and develop regional guidelines

in key areas of implementation of the Caribbean Pharmaceutical Policy.

• Promote the development and management of human resources in the areas related to

the pharmaceutical policy.

• Promote the use of evidence in decision-making for the development, implementation and

assessment of pharmaceutical policies both at the sub-regional and national levels.

3.1.2. Regulatory framework

• Develop a sub-regional regulatory framework for medicines and strengthen the collaboration

among Caribbean countries to ensure the performance of the essential components of

medicines regulation.

3.1.3. Access

• Strengthen the collaboration among the national pharmaceutical systems and promote

and support the development and implementation mechanisms for joint negotiation of

medicines procurement.

• Develop sub-regional mechanisms for strengthening patent examination systems with a

“pro–public health” approach and support the countries’ efforts to promote public health

and access to medicines in order to take advantage of TRIPS ﬂ exibilities in conformity with

the Doha Declaration on Public Health.

CARIBBEAN PHARMACEUTICAL POLICY

3.1.4. Rational use of medicines:

• Develop a sub-regional strategy and work plan for strengthening the rational use of

medicines in the Caribbean as part of the pharmaceutical policy.

3.2. Strategies

The strategies are presented according to the same approach as the CCH III, as national-

level strategies and as areas for joint collaboration.

3.2.1. Pharmaceutical policy scope

Objective: Support the strengthening of collaboration mechanisms and develop regional

guidelines in key areas of implementation of the Caribbean Pharmaceutical Policy.

Areas for joint collaborative action

• Develop an implementation plan for the Caribbean Pharmaceutical Policy, including

collaboration and communication mechanisms among the national health authorities and

establishment of regional structures for policy oversight;

• Strengthen pharmaceutical services within the network of health services, emphasising

the renewed Primary Health Care concept;

• Develop a sub-regional legal framework and model legislation related to medicines and

pharmaceutical services (with provisions for language and cultural idiosyncrasies);

• Develop sub-regional policies related to medicines pricing and generic medicines;

• Develop strategies for promoting the appropriate use of traditional and complementary

medicines in the Caribbean; and

• Support countries in the planning and negotiation of international and inter-governmental

agreements related to pharmaceutical policies.

At the national level

• Strengthen policy and regulation of pharmaceutical products and services as part of the

steering role of the state to ensure essential public health functions;

• Update, monitor and evaluate the existing policies and the development of new national

pharmaceutical policies; and

• Support the updating of the national legal framework related to medicines and

pharmaceutical services.

Objective: Promote the development and management of human resources in the areas

related to the pharmaceutical policy.

Areas for joint collaborative action

• Provide support for the Caribbean Network on Pharmacy Education and the rationalisation

and harmonisation of pharmacy education programmes;

CARIBBEAN PHARMACEUTICAL POLICY

• Support capacity-building in all related areas, in collaboration with Caribbean tertiary-level

educational institutions;

• Develop a strategic plan for human resource development, identifying needs and

opportunities for training institutions;

• Support the development of a mechanism for accreditation of pharmacy programmes and

the licensing of all categories of pharmacy professionals within the CSME;

• Collaborate with the Caribbean Accreditation Authority for Education in Medicine and other

Health Professions to facilitate the accreditation of pharmacy programmes in the Region.

Objective: Promote the use of evidence in decision-making for the development, implementation

and assessment of pharmaceutical policies both at the sub-regional and national levels.

Areas for joint collaborative action

• Develop the Pharmaceutical Observatory as a resource for evidence-based decision-

making;

• Support the strengthening of the information systems; and

• Support the development of operational research in strategic areas of pharmaceutical

policy.

3.2.2. Regulatory framework

Objective: Develop a sub-regional regulatory framework for medicines and strengthen the

collaboration among Caribbean countries to ensure the performance of the essential components

of medicines regulation.

Areas for joint collaborative action

• Develop a sub-regional platform for regulation of medicines, integrated with the regulation

of other health technologies;

• Develop draft legislation for the Caribbean and the participating countries for the

development of essential regulatory functions;

• Strengthen collaboration among the national authorities and establish a Caribbean

Network of Medicines Regulation, including the existing Pharmacovigilance Network of

the Caribbean, working in close collaboration with the Pan American Network for Drug

Regulatory Harmonization (PANDRH);

• Strengthen the Caribbean Regional Drug Testing Laboratory (CRDTL)

and support its

incorporation into CARPHA; and

• Develop guidelines for a code of ethics for pharmacists, model codes of conduct for

health professionals involved with issues related to the pharmaceutical policy and ethics

guidelines for committees and advisory bodies to avoid conﬂ icts of interest.

Currently, Caribbean Public Health Agency/Drug Testing Laboratory (CARPHA/DTL).

CARIBBEAN PHARMACEUTICAL POLICY

At the national level

• Strengthen the existing national regulatory authorities to perform essential regulatory

functions with the updating of national institutional arrangements and national legislation;

• Strengthen regulatory enforcement mechanisms and enhance the quality assurance of

pharmaceutical products and services, in both public and the private sectors;

• Strengthen existing national laboratories for quality control of medicines and support the

development of laboratories, when pertinent, integrated into the Pan-American Network

of NLQCM.

3.2.3. Access

Objective: Strengthen the collaboration among the national pharmaceutical systems and

promote and support the development and implementation mechanisms for joint negotiation of

medicines procurement.

Areas for joint collaborative action

• Strengthen the Caribbean Regional Network of Pharmaceutical Procurement and Supply

Management Authorities (CARIPROSUM) and the harmonisation of medicines supply

systems in the Caribbean;

• Promote the development of a sub-regional platform for pooled negotiations; and

• Develop a sub-regional policy framework for cost-containment strategies, including use

of generic medicines, sustainability of ﬁ nancing mechanisms and price regulation and

monitoring.

At the national level

• Strengthen national medicines supply systems, including public procurement and supply

management agencies, by ensuring sustainability and cost containment; and

• Develop and implement cost-containment strategies, including use of generic medicines,

sustainable ﬁ nancing mechanisms and price regulation and monitoring.

Objective: Develop sub-regional mechanisms for strengthening patent examination systems

with a “pro–public health” approach and support the countries’ efforts to promote and protect public

health and access to medicines in order to take advantage of TRIPS ﬂ exibilities in conformity with

the Doha Declaration on Public Health.

Areas for joint collaborative action

• Develop a work plan for implementing the Global Strategy on Intellectual Property Rights in

the Caribbean as part of the pharmaceutical policy, including the development of strategic

alliances;

• Develop and harmonise procedures for patent analysis with a pro–public health approach

and support national patent ofﬁ ces in improving their procedures for analysis within this

approach; and

• Support CARICOM Member States in adopting TRIPS ﬂ exibilities.

CARIBBEAN PHARMACEUTICAL POLICY

At the national level

• Promote legislative changes to adopt TRIPS ﬂ exibilities; and

• Strengthen collaboration between health and trade agencies and improve procedures for

analysis of pharmaceutical patents with a pro–public health approach.

3.2.4. Rational use of medicines

Objective: Develop a sub-regional strategy and work plan for strengthening the rational use of

medicines in the Caribbean as part of the pharmaceutical policy.

Areas for joint collaborative action

• Develop a model sub-regional EML and formulary;

• Develop and promote harmonised regional STGs; and

• Develop a regional medicines information centre in close collaboration with poisoning

information centres, working as a network with national medicines information centres

and in partnership with the Latin American and Caribbean Medicines Information Network.

At the national level

• Support countries in strengthening selection and use of medicines;

• Promote advocacy for strengthening access and rational use of medicines in the

community; and

• Support the integration of the existing national medicines information centres into a

regional scheme.

CARIBBEAN PHARMACEUTICAL POLICY

4. MECHANISMS FOR IMPLEMENTATION,

MONITORING AND EVALUATION

4.1. Responsibility and oversight structure

The implementation of the Caribbean Pharmaceutical Policy is a shared responsibility of the

national health authorities and stakeholders from the Caribbean institutions, with technical and

ﬁ nancial support provided by the CARICOM Secretariat and PAHO/WHO. Establishment of the

Expanded Technical Advisory Committee on Pharmaceutical Policy (TECHPHARM) will be part of

the oversight mechanism. This committee will be responsible for facilitating the implementation,

follow-up and assessment of the policy (see Annex VI). The secretariat for policy implementation

will work under CARPHA. In the transition period for the establishment of CARPHA, PAHO/WHO,

through OCPC, will provide support to the secretariat in close collaboration with the CARICOM

Member States and associate members, as well as the CARICOM Secretariat and the CARPHA

implementation team.

It is proposed that TECHPHARM be an advisory body. With respect to its operational

procedures, a simple majority has been proposed for its quorum and for voting purposes.

TECHPHARM should meet twice a year and, if necessary, schedule additional meetings and

solicit the support of small working groups. In the meantime, members should make use of virtual

collaborative mechanisms.

TECHPHARM will assess the progress of the implementation of the policy in an annual report

to the CARICOM Ministers of Health, convening as COHSOD, that will be embedded in the

reporting mechanisms of the CMOs regarding CCH III implementation. A set of core members

and rotating country representatives will be present, as well as sub-groups and observers. The

rotating portion of TECHPHARM should not exceed one third of its membership, to ensure the

continuity of its work. Furthermore, in order to take informed decisions based on expertise, it is

important to have senior representation in TECHPHARM.

A declaration of conﬂ ict of interest and impartiality should be signed by its members, and a

code of conduct should be established and adhered to. The tenure for TECHPHARM members

is set at three years.

TECHPHARM will support and oversee the proposed collaborative activities and mechanisms

and integrate different related initiatives of, for example, the Caribbean network of pharmacy

schools. TECHPHARM will also be responsible for identifying sources of ﬁ nancial support and

submitting proposals for ﬁ nancing sub-regional structures.

Annex VII of this document outlines the proposed terms of reference for TECHPHARM at its

inception.

CARIBBEAN PHARMACEUTICAL POLICY

4.2. Strategies for implementation

An implementation plan with performance indicators will be developed as part of the

implementation, monitoring and evaluation of the Caribbean Pharmaceutical Policy. An outline of

the implementation plan is presented in Annex VI of this document, and a roadmap for the plan is

provided in Annex VIII. The plan will be developed once the policy has been approved.

The strategic implementation plan will be created as part of a

participative process. A proposal

has been made to organise the implementation plan within a matrix based on the six building

blocks of well-functioning health care systems:

• governance and stewardship;

• management;

• service delivery, ﬁ nancing and accountability;

• human resources;

• knowledge management and information systems; and

• monitoring and evaluation.

All of these elements ﬁ t within the four above-mentioned areas of policy scope, regulatory

framework, access and rational use of medicines.

4.3. Reporting mechanism

TECHPHARM will assess the progress of the implementation of the policy and will submit an

annual report to the CARICOM Ministers of Health, embedded in the reporting mechanisms of the

CMOs relating to CCH III implementation.

4.4. Financing

It is necessary to establish a sustainable ﬁ nancing mechanism for the policy, including

TECHPHARM with respect to policy oversight. The policy document provides guidelines for

regional donors’ support to the community in a synergistic way, setting the priorities for the Region.

Furthermore, it is necessary to cooperate with an increased set of donors in order to speed up the

process and to establish mechanisms through which governments can participate in ﬁ nancing the

strengthening of the public pharmaceutical sector.

CARIBBEAN PHARMACEUTICAL POLICY

5. FINAL CONSIDERATIONS

The establishment of the Caribbean Pharmaceutical Policy and the creation of national

pharmaceutical policies are urgent priorities. For this purpose, the countries are urged to gradually

incorporate the provisions of the policy into their respective national legal systems and to take

the necessary steps to establish and participate in the proposed collaborative network approach.

CARIBBEAN PHARMACEUTICAL POLICY

REFERENCES

1. United Nations, Social and Development Council. The Right to the Highest Attainable Standard

of Health: 08/11/2000. E/C.12/2000/4 (General Comments). Available at: http://www.unhchr.

ch/tbs/doc.nsf/(symbol)/E.C.12.2000.4.En#1

2. World Health Organization. Global Comparative Pharmaceutical Expenditures: With Related

Reference Information (Health Economics and Drugs EDM Series No. 3, Document EDM/

PAR/2000.2). Geneva: WHO, 2000.

3. Caribbean Community Secretariat. The Revised Treaty. Available at: http://www.caricom.org/

jsp/community/community_index.jsp?menu=community

4. Caribbean Community Secretariat, Ofﬁ ce on Trade Negotiations. CARIFORUM Economic

Partnership Agreement (EPA) Negotiations. Available at: http://www.crnm.org/index.

php?option=com_content&view=article&id=276&Itemid=76

5. Pan American Health Organization/World Health Organization. PAHO/WHO Sub-regional

Cooperation Strategy—Caribbean 2010–2015 [approved by the Caucus of CARICOM Health

Ministers, 2010]. Bridgetown Barbados: PAHO/WHO, 2010.

6. Pan American Health Organization/World Health Organization. Health Situation in the

Americas: Basic Indicators, 2006. Available at: http://www2.paho.org/hq/dmdocuments/2009/

BI_2006_ENG.pdf

7. Health Research for Action/Caribbean Community. Regional Assessment of Drug Registration

and Regulatory Systems in CARICOM Member States and the Dominican Republic.

Georgetown, Guyana: CARICOM, 2009.

8. Health Research for Action/Caribbean Community. Regional Assessment of Patent and

Related Issues and Access to Medicines in CARICOM Member States and the Dominican

Republic. Georgetown, Guyana: CARICOM, 2009.

9. Pan American Health Organization/World Health Organization. Pharmaceutical Situation in

the Caribbean: Factbook on Level I Monitoring Indicators—2007. Available at: http://www.

paho.org/hq/index.php?option=com_docman&task=doc_download&gid=20839&Itemid=&lan

g=en

10. Caribbean Community. Declaration of Port of Spain (2007): Uniting to Stop the Epidemic

of Chronic NCDs. Available at: http://www.caricom.org/jsp/communications/meetings_

statements/declaration_port_of_spain_chronic_ncds.jsp

11. Caribbean Community. Caribbean Cooperation in Health Phase III (CCH III): Investing in

Health for Sustainable Development 2010–2015. Georgetown, Guyana: CARICOM, 2010.

12. World Health Organization. Everybody’s Business: Strengthening Health Systems to Improve

Health Outcomes. WHO’s Framework for Action. Geneva: WHO, 2007.

13. Pan American Health Organization/World Health Organization. Renewing Primary Health

Care in the Americas: A Position Paper of the Pan American Health Organization/World Health

Organization (PAHO/WHO). Washington, D.C.: PAHO/WHO, 2007.

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX I. Former Technical Advisory Group on Trade-Related Intellectual Property

Rights (TAG)

Princess Thomas-Osbourne Head of the Standards and Regulation Division,

Ministry of Health, Jamaica

Maryam Hinds Director, Barbados Drug Service

Ministry of Health, Barbados

Miriam Naarendorp Pharmacy Policy Coordinator

Ministry of Health, Suriname

Richard Aching Intellectual Property Ofﬁ ce, Ministry of Legal Affairs,

Trinidad and Tobago

Lucette C.M Cargill Director, Caribbean Regional Drug Testing

Laboratory

Francis Burnett Managing Director, Pharmaceutical Procurement

Services, Organisation of Eastern Caribbean States

Adriana Mitsue Ivama Brummell Sub-Regional Advisor on Medicines and

Health Technologies, Pan American Health

Organization/World Health Organization

Ofﬁ ce of Caribbean Program Coordination

Malcolm Spence Technical Advisor, Ofﬁ ce of Trade Negotiations,

CARICOM Secretariat

Rudolph Cummings Programme Manager, Health Sector Development,

CARICOM Secretariat

Rhonda Wilson Deputy Programme Manager, External

Economic and Trade Relations, CARICOM

Secretariat

TAG was responsible for the development of the CPP as well as for the consultation process leading to its approval.

CARIBBEAN PHARMACEUTICAL POLICY

Annex II. Executive Summary - CARICOM Regional Assessment of Drug Registration and

Regulatory Systems

CARICOM countries are faced with an increasing burden of chronic non-communicable

diseases for which treatment and care need to be ensured. This, in addition to scaling up treatment

of HIV/AIDS, requires sustained access to adequate quality medicines at affordable prices.

In this context the Technical Advisory Group, established at the 10th CARICOM Council

of Human and Social Development, recommended that a study be conducted on regulatory

systems for existing medicines in CARICOM countries with a view to establishing their adequacy

for ensuring the timely supply of safe, effective and quality medicines. Realising that market,

human and ﬁ nancial constraints might pose a potential barrier to effective and efﬁ cient medicines

regulation in individual Member Countries, the study was also tasked with establishing strategies

and an action plan for the development of a harmonised medicines regulation system for the

Region.

Study Implementation

The 15 CARICOM Member States (Antigua and Barbuda, the Bahamas, Barbados, Belize,

Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saint Kitts and Nevis, Saint Lucia, Saint

Vincent and the Grenadines, Suriname and Trinidad and Tobago) were included in the study.

The Dominican Republic had been identiﬁ ed as an additional beneﬁ ciary of the study in the Pan

Caribbean Partnership against HIV/AIDS (PANCAP)/World Bank agreement.

The study was conducted in two main phases, i.e., a data collection phase and a consolidation

phase. Data collection for the regulatory systems assessment in countries was based on the Guide

for Data Collection to Assess Drug Regulatory Performance, developed by WHO and amended to

suit the speciﬁ c purposes of this study. Both the data collection instruments and implementation

work plan were approved by the CARICOM Secretariat and the Technical Advisory Group.

Based on the WHO assessment instrument, stakeholder interviews were conducted in

Barbados, the Dominican Republic, Guyana, Jamaica, Saint Lucia, Suriname and Trinidad and

Tobago during the period 18 January to 15 February 2009. During the same period, questionnaires

for self-completion were sent out to the remaining study countries. These countries were supported

in person by HERA team members of the CARICOM Study on Intellectual Property Rights, TRIPS

and Access to Medicines that was conducted in parallel and through telephonic follow-up by the

study team leader.

During the consolidation phase, responses collected in countries were analysed and

documented in speciﬁ c reports for each study country (Volume 2), and summarised for the main

report. In addition, study countries’ medicines legislation was assessed.

Study ﬁ ndings and resulting recommendations for medicines regulatory harmonisation

strategies presented in the draft report were discussed with the Technical Advisory Group. This

Final Report includes the results of these discussions.

For further information, please see the complete report: Regional Assessment of Drug Registration and Regulatory Systems in

CARICOM Member States and the Dominican Republic (July 2009).

CARIBBEAN PHARMACEUTICAL POLICY

Medicines Regulation

Medicines are a crucial input to improving and maintaining the health of the population, and

considerable funds are dedicated by governments and individuals to the purchase of medicines.

In order to be beneﬁ cial, medicines need to be safe, effective and of adequate quality—otherwise

funds will be wasted, and the populations’ health will be put at risk. However, neither the consumer

nor the prescriber has the information and expertise needed to establish whether a particular

product complies with these requirements. It is thus in the interest of public health that government

intervenes in the medicines market through regulation.

According to international consensus, medicines regulation encompasses the following critical

functions that need to be provided for in the national medicines legislation:

• Licensing (registration) of pharmaceutical products;

• Licensing of pharmaceutical premises (manufacturers, importers, distributors);

• Inspection of distribution channels and goods manufacturing facilities;

• Quality control laboratory testing;

• Adverse drug reaction monitoring;

• Control of advertising and promotion; and

• Control of clinical trials.

The National Regulatory Authority (NRA) is the authority empowered by law to carry out

regulatory functions pertaining to medicines and to ensure compliance with the legal requirements.

Study Findings

Pharmaceutical sector characteristics deﬁ ne to a great extent the context within which medicines

regulatory systems operate. National Medicines Policies provide guidance on governments’ goals

related to the public and private pharmaceutical sectors, including the commitment to ensure

quality, safety and efﬁ cacy of the medicines marketed. Of the 16 study countries, seven have a

National Medicines Policy, and of these three have been ofﬁ cially adopted by the government.

Seven of the study countries have privately owned pharmaceutical manufacturing plants

producing multi-source (generic) products only, with production also for export in four countries.

Private sector pharmaceutical importers and/or wholesalers are operating in 14 of the 16 countries,

while all of the study countries have private retail pharmacies (ranging from 1 in Montserrat to

2,812 in the Dominican Republic).

Legislative provisions

All study countries have some type of medicines legislation, including speciﬁ c acts providing

for the control of narcotics and psychotropic substances. However, none of the existing legislation

is fully comprehensive. Provisions frequently missing include:

• control of clinical trials;

• adverse drug reaction monitoring;

CARIBBEAN PHARMACEUTICAL POLICY

• control of product promotion and advertisement; and

• speciﬁ c prohibition of counterfeit medicines.

Registration of pharmaceutical products is a requirement by law in seven of the 16 study

countries.

Challenges identiﬁ ed include:

• legislation that is not being updated;

• provisions in “old” laws that have not been harmonised with newer legislation; and

• multiple amendments not consolidated into one revised law.

In some countries enforcement of laws is constrained by the lack of regulations. The passing

of medicines-related bills and draft regulations has been found to be a very lengthy process.

Regulatory framework and institutional capacity

In those study countries with more comprehensive medicines legislation, the NRA is set up by

law as a public sector entity operating under and/or reporting to the Ministry of Health. Of the six

countries that have operational medicines registration systems, two have an NRA responsible for

all regulatory activities. In the remaining four countries, responsibilities are spread over different

Ministry of Health departments, with no dedicated overall responsible body. It was reported that

this leads to coordination and communication challenges and is affecting the efﬁ ciency and

effectiveness of regulatory performance.

All study countries reported a shortage of human resources assigned to medicines regulatory

activities, which was attributed most frequently to low salaries, lack of funds and bureaucratic

delays in approving restructuring proposals. Except for the Pharmacy Council in Jamaica, none

of the regulatory authorities have the power to recruit or retrench their staff. Human resource

capacity is further constrained by the general lack of adequate training activities to build the

speciﬁ c technical expertise required for medicines regulatory functions.

All but one study country reported that ﬁ nancial resources to carry out medicines regulatory

functions were inadequate. Regulatory authorities are generally not aware of their operational

budgets. While in eight countries fees are being collected for, e.g., product registration or licensing

of premises and persons, only in one country can these fees be used to support NRA activities.

Some deﬁ ciencies regarding adequate infrastructure for NRAs were reported. These were

mainly related to access to transportation to carry out inspections and, in a few cases, to availability

of reliable communication tools (Internet and e-mail facilities).

Licensing and inspection

The following pharmaceutical licensing activities were reported to be conducted:

• licensing of manufacturers: seven countries (all countries with pharmaceutical

manufacturing);

CARIBBEAN PHARMACEUTICAL POLICY

• licensing of importers and/or wholesalers/distributors: nine of 14 countries where these

businesses are present;

• licensing of retail pharmacies: 11 of 16 countries; and

• licensing of other retail premises allowed to sell a restricted number of non-prescription

medicines: seven of 16 countries.

Six countries that issue licenses for all types of pharmaceutical premises were questioned

about the existence of unlicensed establishments: four countries were aware of or thought it very

likely that unlicensed activities took place in their countries. The extent was not known.

None of the study countries license or otherwise control the operation of Internet pharmacies.

Import permits are required by all countries for controlled medicines falling under the respective

UN conventions. Import permits for other pharmaceutical products need to be obtained from the

NRA in ﬁ ve countries, while three require import permits for antibiotics only.

Distribution channel inspections are conducted in 11 of the 16 study countries. However, these

are mainly pre-licensing inspections as compared to preventive planned inspections (surveillance).

Nevertheless, violations of medicines legislation during the past three years were detected by

inspectors in nine countries. These included the sale of medicines in street markets, operation of

businesses without a licence, sale of unregistered and expired products, and improper storage

conditions.

The seven countries with pharmaceutical manufacturing conduct good manufacturing practices

(GMP) inspections, mainly in connection with licensing. However, GMP certiﬁ cates for export are

only issued by three countries.

Product assessment and registration

Pharmaceutical product registration is a legal requirement in seven of the 16 study countries,

but is only being implemented in ﬁ ve countries. One additional country requires registration of

medicines without having an explicit legal provision for this.

All six countries with an operational registration system require registration of new medicines

and known multi-source (generic) medicines for human use. Some countries also register

veterinary medicines, biologicals, herbal products, or medical devices. The number of products

registered varied between 2,635 and 12,124. Information on how many of the registered products

were actually available on countries’ markets was not available from the NRAs.

One country makes the list of registered products publicly available on the department’s web

site, and four countries produce updated lists from time to time, which can be obtained on request

by interested parties. In one country, the newly registered products are published in the ofﬁ cial

gazette, but a complete list is not available.

All countries collect registration fees for processing an application for registration. These fees

varied between US$ 10 and US$ 128 for new medicines.

CARIBBEAN PHARMACEUTICAL POLICY

Four of the six countries have access to external expert committees for the assessment of

application dossiers. Reported time needed to process registration applications was acceptable

(between three and six months for new medicines).

While provisions are made for requiring proof of registration with other established NRAs, this

was reported not to impact the regulatory assessment process. Likewise, different information

requirements for the application for registration of new and known products are not always clearly

speciﬁ ed in the legislation. In practice, clinical safety and efﬁ cacy studies are usually not required

for registration of known (multi-source/generic) products. Only one country has different processes

for assessment of applications for registration of new and known products.

Linkages between intellectual property laws and medicines registration were reported by three

countries, where provisions for data exclusivity exist. Only one country reported implementing this

provision.

Regulatory quality control laboratories

Thirteen of the 16 study countries are signatory to the agreement establishing the Caribbean

Regional Drug Testing Laboratory (CRDTL), and 12 countries are using this facility (OECS Member

States usually submit samples through the OECS Pharmaceutical Procurement Services [OECS/

PPS]). CRDTL also conducts planned quality surveillance of priority pharmaceutical products

where samples are to be submitted by individual countries as per established schedules. Out of 640

samples analysed by CRDTL during 2006-2008, 89 or 13.9% were found to be of unsatisfactory

quality. Because there is inadequate random sample collection and testing, the general level of

substandard pharmaceutical products in the CARICOM region is not known.

Four of the 16 study countries have in-country regulatory quality control laboratories that are

all operating under the respective Ministries of Health. Sterility and microbial limit tests cannot be

performed and are done by the CRDTL. Pyrogen and toxicity testing cannot be done by any of the

regulatory quality control laboratories in the Region.

Challenges identiﬁ ed by the existing laboratories include inadequate human and ﬁ nancial

resources to operate satisfactorily.

Speciﬁ c quality assurance measures in countries without pharmaceutical product registration

Ten of the study countries do not have an operational registration system for pharmaceutical

products that would require pre-marketing assessment of product quality, safety and efﬁ cacy.

All of these countries do implement quality assurance measures during the processes of

pharmaceutical procurement for the public sector, e.g., requiring proof of registration with other

speciﬁ ed regulatory authorities, pre-registration of suppliers, or random quality control testing.

For OECS Member States, quality assurance measures instituted by OECS/PPS apply. These

include use of pre-qualiﬁ ed suppliers, speciﬁ c tender conditions and quality control testing of

samples in-house (qualitative) and at CRDTL.

CARIBBEAN PHARMACEUTICAL POLICY

Two of the 10 countries require import permits for the importation of antibiotics by the private

sector. All import documents are screened in one country, and no speciﬁ c quality assurance

measures are taken in seven countries. Quality assurance of pharmaceutical products in the

private sector is clearly inadequate in the 10 countries.

Discussion of Study Findings

The assessment indicated that effectiveness and efﬁ ciency of medicines regulation in the

study countries is affected by delay in updating and passing legislation, human resources

constraints, institutional constraints and inadequate access to fully functional regulatory quality

control laboratories. While ﬁ nancial constraints were noted by 15 of the 16 countries, there was

no detailed information available to establish the extent of the problem.

The risk of unsafe, ineffective or substandard medicines being sold or dispensed to patients

clearly increases when the regulatory functions are being performed only partially or not at all.

Only two countries provided concrete examples for counterfeit medicines. However, without

effective registration and surveillance systems the chances for detecting counterfeit products

are low. All study countries reported cases of substandard pharmaceutical products in the public

sector, where quality assurance measures are more widely applied. Again, the low level of post-

marketing surveillance (including random sample collection and testing) makes it difﬁ cult to detect

substandard medicines in the private sector.

The recommendations should consider the different country contexts; For the smaller

CARICOM Member States it will not be feasible to establish comprehensive medicines regulatory

systems, taking into account market factors, speciﬁ c technical expertise requirements, and

associated costs. For the larger countries with established medicines registration systems, the

required extension of regulatory activities to ensure adequate performance of inspection and

surveillance systems will be a challenge. It is suggested that CARICOM countries establish a

network for cooperation among NRAs to discuss viable approaches to address the identiﬁ ed

common challenges.

Except for two countries, policy guidance on the envisaged development of the pharmaceutical

sectors, including medicines regulatory systems, is either not available, not updated, or not being

implemented. We would therefore recommend that National Medicines Policies be developed/

updated and implemented. In addition, the development of an overall CARICOM Regional

Medicines Policy would be useful to comprehensively deﬁ ne regional goals, strategies and

commitments.

Harmonisation of medicines regulation

Existing harmonisation initiatives usually focus on harmonisation of medicines registration,

with the overall aim of reducing registration processing times due to different country requirements.

Harmonisation should translate into signiﬁ cant cost savings to the pharmaceutical industry and

quicker access to new and improved therapies at more affordable prices. Medicines regulatory

harmonisation activities have often been triggered by wider regional integration activities aiming

at the creation of single or common markets, and there has been an increasing trend towards

harmonisation globally.

CARIBBEAN PHARMACEUTICAL POLICY

However, the focus on speedy approval of new products may impact appropriate

pre-marketing evaluation. It is thus important to keep the primary objective of medicines

regulation in mind—i.e., the protection of public health—when considering the

harmonisation option. Harmonisation initiatives are ongoing in several regions worldwide. For

example:

European Union

Harmonisation activities started in 1965, and in 1995, the European Medicines Agency was

established. To date, three different routes exist through which applications for registration can

be submitted:

• the traditional route (application to individual Member States’ NRA);

• the decentralised procedure (mutual recognition); and

• the centralised procedure (simultaneous registration in all EU Member States through the

EMA).

Association of Southeast Asian Nations (ASEAN)

The concept of pharmaceutical harmonisation was endorsed in 1999 and facilitated by the

Pharmaceutical Product Working Group established under the ASEAN Consultative Committee

for Standards and Quality. The focus is on the development of common technical dossiers and

technical requirements for medicines registration. In April 2009, a mutual recognition arrangement

for good manufacturing practices inspections was signed.

Southern African Development Community (SADC)

Harmonisation activities in the region started in 1995 with the development of technical

guidelines. Currently the SADC Directorate of Social and Human Development/Health and

Pharmaceuticals in Botswana coordinate activities. To date, 14 guideline documents have been

approved by Member States. Challenges experienced included varying capacity of pharmaceutical

sectors and level of economic development in Member Countries, language differences and a

rather weak secretariat.

Pan American Region through the Pan American Network for Drug Regulatory Harmonization

(PANDRH)

PANDRH was formally endorsed at the 42nd Meeting of the PAHO Directing Council in 2002.

It comprises NRAs of all 35 PAHO Member States and representatives of the pharmaceutical

industry. The secretariat is provided by PAHO and 12 working groups have been established

to address speciﬁ c regulatory sub-areas. To date, ﬁ ve conferences have been held, where

decisions on adoption of harmonised guidelines were taken. Approved guidelines include those

on bioequivalence testing and on the prevention and combat of counterfeit medicines.

CARICOM Member States’ NRAs are members of PANDRH. Challenges regarding active

participation, and communicating and implementing PANDRH decisions at the national level have

been identiﬁ ed.

CARIBBEAN PHARMACEUTICAL POLICY

In addition, there are global harmonisation initiatives (e.g., the International Conference on

Harmonisation), and initiatives supporting national NRAs’ capacity (e.g., the United States Food and

Drug Administration’s tentative approval mechanism, the EMA’s scientiﬁ c opinion mechanism, the

WHO pre-qualiﬁ cation project, and the International Conference of Drug Regulatory Authorities).

Harmonisation in the CARICOM context

In 2001, CARICOM Member States signed the Revised Treaty of Chaguaramas Establishing

the Caribbean Community including the CARICOM Single Market and Economy (CSME). Part 2

of the treaty addresses consumer protection and provides-among others-for Member States to

enact harmonised legislation.

Respondents in study countries were asked about their general perception regarding

harmonisation of medicines regulation and any priority areas for harmonisation. Those countries

that do not yet have registration systems were in favour of a central body for assessing applications

for registration. The main reason provided was lack of expertise and human and ﬁ nancial capacity

at the country level. Respondents that do register medicines were more in favour of enhanced

cooperation between NRAs. In addition to assessment of applications for registration, priority

areas for harmonisation included:

• technical support and information sharing;

• regional quality control; and

• harmonized norms for inspections.

It was also remarked that countries’ sovereignty would need to be respected, and that any

regional regulatory body should be built on existing structures.

Strategic options for medicines regulatory harmonisation in CARICOM

CARICOM countries can be divided into three groups, based on their medicines regulatory

features:

• Group 1 comprises the ﬁ ve countries with more comprehensive medicines regulatory

systems, including medicines registration. These countries account for approximately

91% of the total population of CARICOM Member States.

• Group 2 comprises the two countries where there are plans to implement the registration

of medicines in the near future.

• Group 3 comprises the eight countries with limited regulatory systems and where there

exist no plans to register medicines in the near future. Seven of these countries belong to

the OECS. Due to limited market size and human and ﬁ nancial constraints, implementation

of stand-alone medicines registration systems in each of these countries does not appear

to be feasible.

However, public health in all countries needs to be protected by ensuring that only safe, effective

and quality medicines are circulating and made available to patients. We therefore suggest, as

the overall mission of a CARICOM medicines quality assurance policy and harmonised structure,

ensuring that there is a provision in all CARICOM Member States that adequate pharmaceutical

CARIBBEAN PHARMACEUTICAL POLICY

products to address prevalent health conditions are marketed in a timely manner, and that these

products are of proven safety, efﬁ cacy and quality.

Harmonisation Strategies

It is suggested that the policy principles guiding harmonisation efforts and strategy selection

include the following:

• Member States’ governments commit to support all areas of medicines regulation,

considering this a critical step in protecting public health;

• Only medicines that have been assessed for safety, efﬁ cacy and quality will be allowed to

be marketed;

• The assessment process will, as far as possible, be based on harmonised requirements

and guidelines appropriate for the Region;

• Existing guidelines developed by PANDRH will be considered;

• There will be distinct requirements for the assessment of products containing new chemical

entities and well-known multi-source (generic) products;

• There will be procedures to ensure priority assessment of dossiers for applications for

registration of priority medicines;

• Joint support will be provided for Member States without a registration system to implement

licensing requirements using a phased approach; and

• Existing resources will be shared among Member States.

The following strategies are recommended for consideration:

• Development of harmonised guidelines for application and assessment;

• Capacity-building of National Regulatory Authorities:

• Capacity-building of the local pharmaceutical industry;

• Promoting formal cooperation/exchange of information;

• Resource sharing;

• Supporting the licensing of medicines in countries without a registration system; and

• Strengthening quality control capacity.

The body of this Report provides detailed descriptions for each of the strategies, and

summarises requirements, challenges and opportunities related to their implementation.

Institutional framework

For a sustainable harmonisation effort, it is imperative to have a formal structure that enables

effective coordination of issues agreed by Member States, where the guiding principle should be

to create efﬁ cient and effective systems without expensive structures.

CARIBBEAN PHARMACEUTICAL POLICY

Identifying as priority strategies those related to development/adoption of harmonised

guidelines and general capacity-building, it is recommended that a small but permanent secretariat

be established, charged with, e.g., establishment of relevant databases of guidelines, legislation,

experts, etc.; communication with countries, relevant regional and international organisations, the

pharmaceutical industry and the public; and coordination, and organisation of meetings (physical

or virtual) per the established business and work plan.

Because of its regional public health responsibility, it is recommended that consideration

be given to establishing the Secretariat under the planned Caribbean Public Health Agency

(CARPHA). In the event that the establishment of CARPHA is delayed, possible options for

provisional housing of the Secretariat include PAHO/OCPC in Barbados or CRDTL in Jamaica.

This would ensure that none of the Member States feels disadvantaged (which is a possibility,

should the Secretariat be established under one of the existing NRAs).

Due to the amount of work that will arise from listing products, and the time needed for establishing

the legal requirement for registration for Group 2 and Group 3 countries, a recommendation has

been made to handle this as a special project. Within the framework of this project the options for

establishing a sub-regional regulatory authority for OECS could be explored. One option could

include linking this authority to the Secretariat in charge of regional harmonisation activities. In

that case, this sub-regional authority can serve as a ‘pilot’ for a CARICOM Medicines Regulatory

Agency that may be envisaged.

Critical steps towards harmonisation

The report identiﬁ es ﬁ ve critical steps for commencing regional medicines regulatory

harmonisation efforts:

1) Formulation of a regional quality assurance policy (to be integrated in a CARICOM

Regional Medicines Policy);

2) Adoption of the regional policy by Member States;

3) Establishment of a harmonisation Secretariat;

4) Development of a strategic and annual work plan for policy implementation; and

5) Securing funding for work plan implementation;

Concluding Remarks

The report concludes by reiterating the key issues and lessons learnt for harmonisation of

medicines regulation, i.e.:

• Medicines regulation serves the protection and promotion of public health;

• Harmonistion takes time;

• Commitment is essential;

• Legal backing, while important, is not absolutely necessary for all activities; and

• Building trust among Member States is key.

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX III. Executive Summary: Assessment of Patent and Related Issues and Access to

Medicines in CARICOM and the Dominican Republic (HERA Final Report, 31 December

2009)

CARICOM countries are faced with an increasing burden of communicable and non-

communicable, chronic diseases for which they need to ensure appropriate treatment and

care. Both require sustained access to good quality, essential medicines at affordable prices.

Unfortunately, many of these medicines are patented and expensive. Since 2000, the Agreement

on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade

Organization (WTO) has required that CARICOM countries implement stronger patent protection

for pharmaceuticals in their national legislation on intellectual property rights (IPRs).

In 2004, the 10th CARICOM Council for Human and Social Development (COHSOD), concerned

about the increasing cost of antiretrovirals (ARVs) due to the TRIPS Agreement, mandated the

establishment of a Technical Advisory Group (TAG) that would commission studies to address

inter alia trade related health issues impacting access to medicines and make recommendations

to policymakers in this regard.

Study Objectives

The objectives of this study were: (a) to explore the possibilities of developing a harmonised,

pro-public health regional (Caribbean) IP (intellectual property) regulation and medicine policy (to

include generic medicines) framework; (b) to make recommendations on the promulgation/updating

of IP legislation and regulation that will maximise TRIPS ﬂ exibilities while being TRIPS compliant;

for medicines; (d) to identify mechanisms for building/strengthening coalitions and negotiating

positions at WTO and in bilateral and regional forums for ensuring access to medicines; and (e)

to make recommendations on the adequacy of the systems in Member States for regulation of

the pharmaceutical market to ensure the timely supply of safe, effective and quality medicines.

Study Implementation

The 15 CARICOM Member States (Antigua and Barbuda, the Bahamas, Barbados, Belize,

Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saint Kitts and Nevis, Saint Lucia, Saint

Vincent and the Grenadines, Suriname and Trinidad and Tobago) were included in the study.

The Dominican Republic had been identiﬁ ed as an additional beneﬁ ciary of the study in the Pan

Caribbean Partnership against HIV/AIDS (PANCAP)/World Bank agreement.

Except for Haiti (which, as a less developed country, has an exemption until 2016) and the Bahamas (not yet a WTO member).

The Dominican Republic (DR) is not a CARICOM member, although high-level discussions have taken place regarding the possibility

of it joining CARICOM. The Dominican Republic is a member of CARIFORUM and is party to the Dominican Republic–

Central America Free Trade Agreement (DR-CAFTA) with the United States. The DR-CAFTA includes a substantial number

of obligations with respect to IPR standards and enforcement that have resulted in signiﬁ cant changes in IPRs and related

regulatory legislation in the Dominican Republic. These changes will affect the country’s pharmaceutical market, and they

potentially will affect public access to medicines. Implementation of the DR-CAFTA is at a relatively early stage, and it is

difﬁ cult to draw conclusions about its actual impact. Nonetheless, in addition to providing a basis for suggestions regarding

the Dominican Republic’s legislation and policy on IPRs, its inclusion in this study may be useful to CARICOM members

as they consider potential future free trade agreement commitments. The Dominican Republic has a robust local generic

pharmaceutical manufacturing industry that distinguishes it from CARICOM members, so some caution must be exercised in

making comparisons.

CARIBBEAN PHARMACEUTICAL POLICY

The study was conducted in two main phases, a data collection phase and a consolidation

phase. All 16 study countries were visited between 24 January and 21 February 2009.

In the data collection phase, a speciﬁ c data collection instrument was developed. The

CARICOM Secretariat and TAG approved this instrument and the study work plan. The data

collection instrument was pilot tested in Guyana and Trinidad and Tobago. Study consultants also

developed a database of all relevant intellectual property and pharmaceutical and public health

professionals in the 16 study countries, searched for the IP and patent laws in these countries,

and collected relevant literature regarding the impact of the TRIPS Agreement on access to

medicines in the Caribbean region. More than 30 speciﬁ c articles and papers were summarised

in a literature review.

During the consolidation phase, IP and patent legislation and the data collected from all

16 visited study countries were analysed (chapter 3) and documented in speciﬁ c country reports

(Volume II of the report). Interviews in Jamaica and Suriname were redone as original data were

lost. Study ﬁ ndings and resulting recommendations presented in the draft report were shared with

TAG. The present Final Draft Report takes note of the comments received.

Study Findings

Country-based ﬁ ndings

The Pan American Health Organization (PAHO) recommends that all countries develop a

National Medicines Policy. The CARICOM Secretariat developed a Model National Medicines

Policy in 1999 and updated it in 2001. At the time of the study, only seven of the 16 study countries

had a written National Medicines Policy, and only three of these policies had been formally adopted

by the respective government. Only two countries mentioned the issue of IPRs and access to

medicines in their National Medicines Policy.

PAHO also recommends that each country have a medicines regulatory authority or at least a

unit that regulates market access (registration) for medicines. This helps ensure that all products

circulating in the country are effective, safe and of good quality. Only six of the 16 countries had

a functional system of medicines regulation. In the 10 “non-regulation” countries, the burden was

on the national (or regional) procurement agency to ensure quality in the public sector. In seven

countries, there was no control at all on products imported by the private sector. This poses a

signiﬁ cant health risk to the population.

Two of the 16 countries reported having a written policy on intellectual property rights. No

country had a declared policy on pharmaceutical innovation or technical development. Only three

countries reported carrying out pharmaceutical research and development. No country reported

receiving any transfer of technology in the pharmaceutical sector, but several expressed an

interest in receiving it.

All countries reported having an IP ofﬁ ce, but only 10 countries are processing patent

applications. Six countries were not administering patents due to absent or incomplete legislation

or inadequate capacity, including lack of staff. Stafﬁ ng levels were poor: three IP ofﬁ ces reported

having patent examiners, but only two ofﬁ ces reported carrying out a substantive examination of

patent applications.

CARIBBEAN PHARMACEUTICAL POLICY

To assess potential IP barriers, a basket of medicines was identiﬁ ed that could potentially be

subject to patent protection (based on USA data). In most countries it was difﬁ cult or impossible

to establish, during the two- to three-day mission, whether a speciﬁ c product was covered by a

valid patent. Only one IP ofﬁ ce (Trinidad and Tobago) reported valid patents for two ARVs in the

basket. Multi-source

(generic) products seemed to enter the study countries without infringement

problems; only Jamaica reported that a patent holder had stopped a multi-source product entering

the country.

Study countries adhere to several international agreements relevant in terms of access to

medicines, including the TRIPS Agreement, the Patent Cooperation Treaty, and the CARIFORUM-

EC Economic Partnership Agreement (EPA). The last two have some aspects that go beyond

the minimum required by the TRIPS Agreement and were thus considered “TRIPS plus”, even

though the EPA speciﬁ cally states that [n]othing in this Agreement shall be construed as to

impair the capacity of the Parties and the Signatory CARIFORUM States to promote access to

medicines.

The Dominican Republic has signed the Dominican Republic–Central America Free

Trade Agreement (DR-CAFTA), which is signiﬁ cantly “TRIPS plus”. This agreement may have an

adverse impact on access to medicines.

All 16 countries were found to have patent acts, but the study results revealed that seven of

them were “obsolete” and were therefore candidates for replacement or complete revision. Over

the preceding 10 years, nine countries had developed patent legislation that could be considered

TRIPS “compliant”. Haiti, the only Least Developed Country in CARICOM, is permitted to delay

becoming TRIPS compliant with respect to pharmaceuticals until 2016. The 15 other study

countries were all required to have become TRIPS compliant as of 2000.

In order to maximise access to medicines, it is crucial to have all “TRIPS ﬂ exibilities” enabled in

national legislation. Unfortunately, this is not well implemented in the region. Only three countries

permitted “‘international exhaustion” of IP rights and thus allowed “parallel import” from the world

market. The other 13 countries permitted “regional” or “national” exhaustion. This reduces their

options to source more affordable brands elsewhere in the world.

No country had yet enabled the “30 August decision” or the “Article 31bis amendment”,

which could become relevant for import and regional distribution of multi-source products in the

future. According to the study, only the Dominican Republic prohibited “new use “or “second use”

patents, whereas three countries explicitly allowed them (allowing “evergreening” of patents). Nine

countries allowed “experimental use”, but only the Dominican Republic had an “early working” or

“Bolar” clause (allowing multi-source products to apply for medicine registration before patent

expiry). Seven countries permitted de minimis exceptions, which allow travellers to import small

amounts of patented medicines. The situation was better regarding “compulsory licensing”: this

was enabled in 12 countries and authorised in draft laws in two other countries. However, these

clauses appeared to have never been used for medicines. In summary, the study showed that

many countries deprive themselves of the possibilities to make use of the full set of “ﬂ exibilities”

permitted under TRIPS and conﬁ rmed by the 2001 Doha Declaration.

WHO prefers the term “multisource” rather than “generic” which can be multi-interpretable. From this point forward this report refers

to generic medicines as multisource medicines.

EPA article 139.2

CARIBBEAN PHARMACEUTICAL POLICY

TRIPS-plus provisions go beyond the minimum protections required by TRIPS and therefore

might unnecessarily hinder access to medicines. Several of the TRIPS-plus features are the

result of the “Free Trade Agreements” such as DR-CAFTA, which bind countries to allow higher

protection of IPRs than the minimum required under TRIPS. Next to IP or patent legislation

as a potential barrier to access, several non-IP barriers to access exist. These include: bias

against multi-source products, unmotivated preference for more expensive branded versions,

slow registration processes, logistics, management and human resource issues. High margins,

duties, taxes and VAT (value added tax) increased costs and made medicines less affordable for

the uninsured. Also, treatment guidelines could be more evidence-based or better adhered to by

prescribers.

Regarding regional collaboration, 14 study countries are part of the CARICOM Single Market

and Economy (CSME); this should in the future allow inter alia the free ﬂ ow of medicines among

these countries. However, because medicines are subject to national regulation, the study

suggested that the CARICOM countries harmonise their medicine regulation systems in order to

make the single market a reality. The new Caribbean Public Health Agency (CARPHA) might be

able to assist in this process.

Interestingly, the OECS (Organization of Eastern Caribbean States) countries have developed

a successful regional “group contracting” system (the OECS Pharmaceutical Procurement

Service, or PPS, is active in seven of the study countries), but it might not be easy to scale

this model up to include other CARICOM countries. Seven other countries had joined the

PAHO Regional Revolving Fund for Strategic Public Health Supplies. PAHO is also promoting

regional cooperation in procurement through CARIPROSUM (Caribbean Regional Network of

Pharmaceutical Procurement and Supply Management Authorities). While political will is present,

many obstacles are still in the way of optimal regional collaboration.

Regional IP issues

As CARICOM countries are not obliged to go beyond the minimum required by TRIPS, it

is recommended that TRIPS-plus legislation should be actively avoided as a balance between

innovation and public health.

A CARICOM Regional Patent Policy and patent ofﬁ ce may be desirable from a public health

perspective. Therefore, the lessons learned from the long and slow development of the European

patent system and the experiences from other regional patent ofﬁ ces have been noted. The

analysis included a comparison of the “unitary” patent model with the “non-unitary” patent model

and a “mixed” approach, as well as the public health perspectives of a possible regional patent

system, including the need to enable regional “ﬂ exibilities”.

Furthermore, the Patent Cooperation Treaty (which has become an obligation for all EPA

signatories) may have potential negative consequences by increasing the number of patent

applications.

In order to strengthen initiatives and lobbying techniques regarding the regional position at

WTO, one important strategy is to form coalitions of developing countries with similar interests

(bearing in mind the risk that the richer countries would seek to target individual countries by

offering them special incentives). Another suggested strategy is to collaborate with highly

CARIBBEAN PHARMACEUTICAL POLICY

specialised NGOs and to use the media. The risk that health and industry ministries are played

against each other can be minimised by arranging regular meetings in the home countries.

Strengthening the bargaining position in bilateral negotiations with the USA or EC is more

difﬁ cult. The role of sympathetic NGOs and individual congressmen or parliamentarians could

be important, as large coalitions do not work so well. CARICOM would probably beneﬁ t from

strengthening a “pro-public health” NGO in the region.

Regional pharmaceutical issues

Establishing an efﬁ cient regional negotiation platform for medicines requires that needs

and beneﬁ ts are clearly deﬁ ned and political will present. A regional body needs to be set up

(or the task allocated to an existing body). Technical solutions need to be considered, options

analysed and a model chosen. There must be a Regional Medicine Policy, accurate information

on what quantities of product are needed and where, a joint ﬁ nancing system, standardised and

evidence-based treatment guidelines and essential medicines collection, harmonised medicine

regulation, a joint policy on patents, reduced border procedures and free movement of goods

in the region, agreement obtained on a price differentiation system, and legislation adopted for

regional negotiation.

With a view to deal with existing problems in the CARICOM pharmaceutical market, a Regional

Medicines Policy needs to be developed, taking into account the “Model” National Medicines

Policy developed by CARICOM in 1999. The TAG has been mandated to strengthen regional

collaboration on pharmaceutical issues and seems well placed to take the lead in developing this

new policy.

Conclusions and Recommendations

The CARICOM countries and the Dominican Republic (CARICOM/DR) face many challenges

common to developing and smaller economy countries around the world. These challenges

include promoting economic growth and employment opportunities in a highly competitive global

economic environment and promoting and protecting the public health of citizens and residents

with budgets that are strained more than normal due to the extraordinary global ﬁ nancial and

economic crisis. The Caribbean region also faces a high incidence of HIV infection, necessitating

the development and maintenance of expensive prevention and treatment programmes, and an

increasing burden of non-communicable diseases also requiring access to patented medicines.

In this environment, it is essential that the ﬁ nancial resources available to CARICOM/DR

for the acquisition of public health–related supplies, most notably pharmaceutical products,

are used in efﬁ cient and effective ways. As a general proposition, this implies that public health

procurement authorities and private sector pharmaceutical procurement enterprises should

emphasise the acquisition of safe and effective products at the lowest possible price. In some

cases, procurement of new therapies requires negotiation with single-source originator or patent

holder suppliers. In many cases, multi-source versions of pharmaceutical products, which are on

patent in some countries, are available from sources where no patents are in force.

Multi-source products may be available because patents were never applied for, have expired,

are invalid or because government-use or compulsory licenses have been issued.

CARIBBEAN PHARMACEUTICAL POLICY

The subject matter of IPRs is complex. It is made more so when a relatively large basket of

international, regional and bilateral agreements and rules are brought into the picture. At the present

time, patents and other forms of IPRs do not constitute a signiﬁ cant obstacle to the procurement

of essential medicines by CARICOM/DR public health and private sector enterprises. The main

reason is that the administrative systems for granting patents within the region are largely non-

operational, and a relatively low volume of pharmaceutical related patents appears to have been

granted up to this point. Perhaps largely as a consequence of this, there have been few efforts by

pharmaceutical patent holders to block importation of multi-source versions of products into the

region. If patents have not been granted in the country, there is no legal right to block importation

and distribution. Although some countries in the region are beginning to implement data protection

rules that may ultimately inhibit the registration of multi-source products, so far such rules do not

appear to have been implemented and/or enforced in any signiﬁ cant way.

This does not mean that procurement enterprises within the region have been securing

pharmaceutical products at, or near, the lowest possible prices. To the contrary, for reasons other

than protection of IPRs, it appears that often procurement authorities have not sought to obtain

multi-source versions of originator products that are available on the international market. These

reasons include underdeveloped procurement systems, small markets (and thus limited interest

of suppliers), an apparent preference for originator brand name products, slow efforts to register

multisource products for import and sale and an element of non-transparency in international

procurement. Moreover, procurement authorities in the region have, in general, not yet sought to

coordinate or pool their pharmaceutical purchases, which might yield signiﬁ cantly lower prices (as

has been the experience of the OECS PPS).

However, it is a “backward-looking” assessment that patents and other IPRs have not played

a signiﬁ cant role to date in the procurement of medicines in the CARICOM/DR region. The

CARICOM/DR countries have recently entered into new international agreements that promise

to focus new attention on their intellectual property systems. These include for the CARIFORUM

countries the EPA with the European Community (EC), and for the Dominican Republic a free trade

agreement with Central America and the United States (DR-CAFTA). Each of these agreements

includes new IP-related commitments, and in the case of the EPA, “aspirational” commitments on

the part of CARIFORUM countries to move toward a regional system for administering IPRs.

this end, a study has already been undertaken under the auspices of WIPO (World Intellectual

Property Organization) to consider the potential establishment of a regional patent system.

The consequence of these developments on IPRs is that patents and other forms of right holder

protection will almost certainly play a larger role in the CARICOM/DR public health procurement

process over the coming years. This fact must be taken into account in the larger context of an

international patent system that has recently extended its scope such that developing countries

(in particular, India, which for many years served as supplier of low-cost multi-source versions of

new pharmaceutical products) will no longer be able to act freely in this way.

see Article 141, CARIFORUM-European Community EPA

CARIBBEAN PHARMACEUTICAL POLICY

The forward-looking assessment and analysis in this report therefore urges CARICOM/DR

countries to closely examine their existing patent and data protection legislation with a view

towards implementing IP-related ﬂ exibilities that are permitted under international rules, but which

have not yet been adopted or implemented. These ﬂ exibilities may well be critical to maintaining

adequate supplies of new pharmaceutical products in the future.

The study examined the possibility of establishing a regional patent ofﬁ ce and system, and

this report makes recommendations about how that system might be structured in a way more

likely to promote public health and consumer interests. It suggests that CARICOM countries

avoid adoption of a “unitary” patent model and adopt instead a model in which patent rights are

granted and enforced for each designated country, allowing each country to retain ﬂ exibilities

and exceptions. It observes the potential advantages in establishing a regional patent ofﬁ ce with

consolidated technical capacity to examine pharmaceutical-related patent applications (consistent

with whatever policies and rules CARICOM countries adopt). The report recommends the

establishment of a working group or groups to consider the potential structure of a regional patent

system, recognising that there are a number of difﬁ cult legal and technical issues to assess.

The report notes that one problem confronting the region is the continuing movement

of government staff between ministries and agencies. The laws and regulations affecting the

pharmaceutical sector, including public health, trade and IPRs, are complex and require several

years to master. The constant movement of staff means that ofﬁ cials who have mastered these

laws and regulations will ultimately be moved into new positions; institutional memory is therefore

limited. This report recommends that annual or biennial workshops be conducted on IP, patents

and public health. These workshops should be attended by a cross-section of agency ofﬁ cials,

representing public health, trade and intellectual property, to facilitate discussion and coordination

among these various areas of regulation.

The report also recommends the initiation of work towards the development of a regional

procurement negotiating platform. Such a platform would become increasingly important as multi-

source supplies of new medicine therapies diminish over time and the region becomes increasingly

dependent on more expensive, patented, single-source products. The region will have to be well-

organised to negotiate better prices during procurement from the medicine companies. As the

establishment of the platform is a medium- to long-term enterprise, the report advises CARICOM/

DR countries to initiate work soon.

Among the foundations for the regional platform would be the development of a Regional

Medicines Policy, including promotion of more harmonised regulatory standards, to facilitate

common procurement efforts. This report provides a concept note with suggestions for this

development, and for a possible way forward. Once CARICOM and the TAG have decided how

they want to move forward, they need to commission development of a road map for action at

different levels.

The IP legislation of the country studies was analysed, and speciﬁ c recommendations

regarding how access to medicines can be maximised while remaining TRIPS compliant are

made in the 16 country reports in Volume II of the report.

Consultants requested but did not obtain access to the WIPO regional patent ofﬁ ce study. They were thus unable to provide speciﬁ c

comments on the WIPO study proposals.

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX IV. Glossary of Terms

CODE OF CONDUCT (CODE OF BEHAVIOUR)

A code of conduct is a set of conventional principles and expectations that are considered binding

on any person who is a member of a particular group.

[Source: http://wordnet.princeton.edu/]

CONFLICT OF INTEREST

A ‘conﬂ ict of interest’ is a situation in which a public ofﬁ cial’s decisions are inﬂ uenced by the

ofﬁ cial’s personal interests.

[Source: http://wordnet.princeton.edu/]

The common meaning of conﬂ ict of interest is a conﬂ ict between an individual’s private or personal

interest and his or her duty. However, conﬂ ict of interest may also refer to a situation in which

an individual has several duties that conﬂ ict without the involvement of any private or personal

interest. Mitigating conﬂ ict of interest means eliminating a conclusive or a reasonable presumption

of bias in decision-making processes.

[Source: PAHO Governance Manual]

DRUG

See Pharmaceutical

DRUGS AND THERAPEUTICS COMMITTEE

A drugs and therapeutics committee is a group of people established and ofﬁ cially approved by

the Ministry of Health and/or health facility management that promotes the safe and effective use

of medicines in the area or facility under its jurisdiction.

[Source: http://apps.who.int/medicinedocs/en/d/Js4882e/3.html]

ESSENTIAL MEDICINES

Essential medicines are deﬁ ned by WHO as medicines that “satisfy the priority health care needs

of the population. They are selected with due regard to public health relevance, evidence on

efﬁ cacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be

available within the context of functioning health systems at all times in adequate amounts, in

the appropriate dosage forms, with assured quality and adequate information, and at a price

the individual and the community can afford. The implementation of the concept of essential

medicines is intended to be ﬂ exible and adaptable to many different situations; exactly which

medicines are regarded as essential remains a national responsibility.”

[Source: http://www.who.int/topics/essential_medicines/en/]

LEGISLATION

The ﬁ rst stage of the legislative process, in which laws are passed by the legislative body of

government with regard to a subject matter such as the control of pharmaceuticals. Laws deﬁ ne

the roles, rights and obligations of all parties involved in the subject matter in general terms (see

also Regulations, below).

[Source: http://apps.who.int/medicinedocs/documents/s14866e/s14866e.pdf]

CARIBBEAN PHARMACEUTICAL POLICY

MEDICINE

See Pharmaceutical

MEDICINES REGULATORY AUTHORITY

A national body that has the legal mandate to set objectives and administer the full spectrum of

medicines regulatory activities, including the following functions, in conformity with national drug

legislation:

• Marketing authorisation of new products and variation of existing products;

• Quality control laboratory testing;

• Adverse drug reaction monitoring;

• Provision of medicine information and promotion of rational use of medicines;

• Good manufacturing practices (GMP) inspections and licensing of manufacturers,

wholesalers and distribution channels;

• Enforcement operations; and

• Monitoring of medicines utilisation.

[Source: http://infocollections.org/medregpack/ interface/ﬁ les/glossary.pdf]

NATIONAL DRUG POLICY

See National Pharmaceutical Policy

NATIONAL MEDICINES POLICY

See National Pharmaceutical Policy

NATIONAL MEDICINES POLICY IMPLEMENTATION PLAN

A national medicines policy implementation plan is a written expression of the government’s plans

to put into action the national medicines policy, setting out activities, responsibilities, budgets and

timelines.

[Source: http://www.who.int/medicines/publications/WHO_TCM_2007.2/en/]

NATIONAL PHARMACEUTICAL POLICY (NMP)

A national pharmaceutical policy (also referred to as a national medicines policy or national drug

policy) is a commitment to a goal and a guide for action. It expresses and prioritises the medium- to

long-term goals set by the government for the pharmaceutical sector and identiﬁ es the main strategies

for attaining them. It provides a framework within which the activities of the pharmaceutical sector can

be coordinated. It covers both the public and the private sectors and involves all of the main actors

in the pharmaceutical ﬁ eld. A national drug policy, presented and printed as an ofﬁ cial government

statement, is important because it acts as a formal record of aspirations, aims, decisions and

commitments. Without such a formal policy document there may be no general overview of what is

needed; as a result, some government measures may conﬂ ict with others, because the various goals

and responsibilities are not clearly deﬁ ned and understood. The policy document should be developed

through a systematic process of consultation with all interested parties. In this process the objectives

must be deﬁ ned, priorities must be set, strategies must be developed and commitment must be built.

[Source: http://apps.who.int/medicinedocs/en/d/Js2283e/#Js2283e]

CARIBBEAN PHARMACEUTICAL POLICY

NATIONAL REGULATORY AUTHORITY (NRA)

See Medicines Regulatory Authority

PHARMACEUTICAL (MEDICINE, DRUG)

A pharmaceutical is any substance or pharmaceutical product for human or veterinary use that is

intended to modify or explore physiological systems or pathological states for the beneﬁ t of the

recipient.

[Source: http://apps.who.int/medicinedocs/documents/s14866e/s14866e.pdf]

QUALITY ASSURANCE

Quality assurance is a wide-ranging concept covering all matters that individually or collectively

inﬂ uence the quality of pharmaceuticals. It is the totality of the arrangements made with the object

of ensuring that pharmaceuticals are of the quality required for their intended use.

[Source: http://apps.who.int/medicinedocs/documents/s14866e/s14866e.pdf ]

RATIONAL USE OF MEDICINES

Rational use of medicines requires that patients receive medications appropriate to their clinical

needs, in doses that meet their own individual requirements, for an adequate period of time, and

at the lowest cost to them and their community.

[Source: http://apps.who.int/medicinedocs/pdf/h3011e/h3011e.pdf]

REGULATIONS

The second stage of the legislative process (the ﬁ rst stage being legislation; see above).

Regulations are speciﬁ cally designed to provide the legal machinery to achieve the administrative

and technical goals of legislation.

[Source: http://apps.who.int/medicinedocs/documents/s14866e/s14866e.pdf ]

STANDARD TREATMENT GUIDELINES (STGs)

STGs summarise recommended treatments for commonly occurring conditions. They should

represent a consensus on what is regarded as the most appropriate treatment for each condition.

The aim of providing such information is that treatments become standardised throughout a health

system and that prescribing for the conditions covered is rationalised. Widespread adoption and

application of standardised treatments also make it possible to use these, together with morbidity

and patient attendance data, as a basis for quantiﬁ cation of drug requirements. STGs are useful

to prescribers as ready reference texts for consultation during the course of daily clinical work and

also as resource materials for basic and in-service prescriber training.

[Source: http://apps.who.int/medicine- docs/pdf/whozip24e/whozip24e.pdf]

TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS)

The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) attempts

to strike a balance between the long-term social objective of providing incentives for future

inventions and creations and the short-term objective of allowing people to use existing inventions

and creations. The agreement covers a wide range of subjects, from copyright and trademarks to

integrated circuit designs and trade secrets. Patents for pharmaceuticals and other products are

only part of the agreement. The balance works in three ways:

CARIBBEAN PHARMACEUTICAL POLICY

• Invention and creativity in themselves should provide social and technological beneﬁ ts.

Intellectual property protection encourages inventors and creators because they can

expect to earn some future beneﬁ ts from their creativity. This encourages new inventions,

such as new drugs, whose development costs can sometimes be extremely high, so

private rights also bring social beneﬁ ts.

• The way intellectual property is protected can also serve social goals. For example,

patented inventions have to be disclosed, allowing others to study the invention even

while its patent is being protected. This helps technological progress and technology

dissemination and transfer. After a period, the protection expires, which means that the

invention becomes available for others to use. All of this avoids “reinventing the wheel”.

• The TRIPS Agreement provides ﬂ exibility for governments to ﬁ ne tune the protection

granted in order to meet social goals. For patents, it allows governments to make exceptions

to patent holders’ rights such as in national emergencies, anti-competitive practices, or if

the right-holder does not supply the invention, provided certain conditions are fulﬁ lled.

For pharmaceutical patents, the ﬂ exibility has been clariﬁ ed and enhanced by the 2001

Doha Declaration on TRIPS and Public Health. The enhancement was put into practice in

2003 with a decision enabling countries that cannot make medicines themselves to import

pharmaceuticals made under compulsory license. In 2005, members agreed to make this

decision a permanent amendment to the TRIPS Agreement, which will take effect when

two thirds of members accept it.

[Source: http:// www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf]

TRADITIONAL MEDICINE (TM)

Traditional medicine is the sum total of knowledge, skills and practices based on the theories,

beliefs and experiences indigenous to different cultures, whether explicable or not, used in the

maintenance of health as well as in prevention, diagnosis, improvement or treatment of physical

and mental illnesses.

Herbal medicines: plant-derived material or preparations with therapeutic or other human health

beneﬁ ts that contain either raw or processed ingredients from one or more plants. In some

traditions, material of inorganic or animal origin may also be present.

Complementary/alternative medicine (CAM): often refers to a broad set of health care practices

that are not part of a country’s own tradition and are not integrated into the dominant health care

system. Other terms sometimes used to describe these health care practices include “natural

medicine”, “nonconventional medicine” and “holistic medicine”.

[Source: http://apps.who.int/medicinedocs/en/d/Js7916e/3.html]

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX V. Development of the Caribbean Pharmaceutical Policy

In April 2004, the Technical Advisory Group (TAG) on Trade-Related Intellectual Property

Rights was established. A regional assessment of drug regulatory and registration systems and

a regional assessment of patent and related issues and access to medicines in the CARICOM

countries and the Dominican Republic by Health Research for Action (HERA) were commissioned

by the CARICOM Secretariat as part of the mandate of TAG. The assessments were ﬁ nanced by the

Pan Caribbean Partnership against HIV and AIDS (PANCAP) and the World Bank, with technical

support from PAHO/WHO. In addition to these studies, PAHO/WHO published Pharmaceutical

Situation in the Caribbean Countries, a summary of the results of the 2007 WHO Level I Survey

among the 13 participating Caribbean countries.

The Caribbean Pharmaceutical Policy (CPP) was developed based on the ﬁ ndings of the just-

mentioned studies and framed by international and regional mandates such as the Caribbean

Cooperation in Health Initiative, Phase III (CCH III); the Declaration of Port of Spain; and the

PAHO/WHO Sub-regional Cooperation Strategy for the Caribbean: 2010–2015. The CCH III is

a mechanism designed to improve the health and well-being of the people of the Caribbean

and to develop their productive potential. It comprises eight priorities, among which is health

systems strengthening, which aims at responding effectively to the needs of the Caribbean

people and includes access to safe, affordable and effective medicines. Supporting the design

and implementation of a Caribbean Pharmaceutical Policy is one of the areas of joint collaborative

action in the CCH III to achieve this goal.

The Development of the CPP

The development process and the content of the policy are described below. The CPP is based

on the problems identiﬁ ed and the priorities proposed in the three above-mentioned surveys.

1) Policy Paper:

A policy paper was developed that included:

b) A situation analysis that included a review of existing international recommendations,

mandates, and health contexts and identiﬁ cation of primary issues in the pharmaceutical

sector based on the above-mentioned exploratory studies;

c) A policy outline with the proposed structure and content; and

d) Governance mechanisms, including responsibilities and technical and ﬁ nancial viability.

The policy paper was presented to and approved by the CARICOM Chief Medical

Ofﬁ cers (CMOs) during their Eighteenth Meeting, held in Port of Spain, Trinidad and

Tobago, on 19–20 April 2010.

2) Consultation with stakeholders:

A draft Caribbean Pharmaceutical Policy (ﬁ rst version) was developed and submitted

for stakeholders’ consideration during a workshop held in Barbados on 6–7 July 2010.

After consolidation of their contributions, it was circulated to CARICOM countries and

the Dominican Republic for another review, systematisation of contributions and revision,

CARIBBEAN PHARMACEUTICAL POLICY

resulting in the issuing of a second version (August/September 2010). The document was

again circulated to CARICOM countries, the Dominican Republic and the sub-regional

institutions for ﬁ nal review and systematisation of contributions (November 2010 to

January 2011), and a third version was issued.

3) Submission to Ministers of Health for approval

The second draft policy document was presented to the Nineteenth Meeting of the

Caucus of CARICOM Health Ministers, who referred it to the Twenty-First Meeting of

COHSOD for a decision. The third version of the policy and the governing mechanisms

were approved, in principle, at the Nineteenth Meeting of CMOs, who recommended it to

COHSOD. It was approved at the Twenty-First Meeting of COHSOD in April 2011.

Conclusions

The CPP was developed using the existing evidence. It represents the necessary framework

for collaborative action and includes several networks and regional platforms of work that are

already under development.

Considering that most of the Caribbean countries are Small Island Developing States and

that there are several constraints for development of activities on their own, a willingness to

collaborate has been expressed at both the technical and political levels, which can facilitate the

implementation of the CPP.

References

1. Health Research for Action (HERA). Report on Regional Assessment of Drug Registration and

Regulatory Systems of CARICOM Member States and the Dominican Republic. Georgetown:

CARICOM, 2009.

2. Health Research for Action (HERA). Regional Assessment on Patent and Related Issues and

Access to Medicines in CARICOM Member States and the Dominican Republic. Georgetown:

CARICOM, 2009. After consolidation of their contributions, it was circulated to CARICOM countries

and the Dominican Republic for another review, systematisation of contributions and revision,

resulting in the issue of a second version (August/September 2010). The document was again

circulated to CARICOM countries and the Dominican Republic and the sub-regional institutions

for ﬁ nal review, systematisation of contributions and the issuing of a third version (November 2010

to January 2011).

3. PAHO/WHO. Pharmaceutical Situation in the Caribbean Countries. Bridgetown, Barbados:

PAHO/WHO, 2010.

4. PAHO. Informe del Grupo de Trabajo 2005. Los aspectos de los derechos de propiedad

intelectual relacionados con el comercio (ADPIC) y el acceso a medicamentos. Santo Domingo,

República Dominicana, 4-6 de abril, 2005. Available at: http://www. paho.org/Spanish/AD/FCH/

AI/Derechos_de_propiedad_intelectual_(ADPIC).pdf

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX VI. Outline of the Implementation Plan for the Caribbean Pharmaceutical Policy

Some of the priority areas identiﬁ ed for the Caribbean Pharmaceutical Policy are outlined in the

following table. The content should be expanded and completed to represent the implementation

plan for the CPP.

WHAT WHEN WHO REMARKS

Sub-regional platform for medicines

regulation

After

establishment of

policy

TECHPHARM Regional policy

functions include:

▪ registration of medicines

▪ importation of medicines

▪ procurement

a) If product is not

registered, under which

conditions would you

procure it?

b) How will government

procure?

Essential medicines list for the Caribbean,

including medicines for paediatric use

2011 TECHPHARM Includes creation of a

subcommittee

Development of the framework for the

establishment and integration of the

existing collaborative networks in the

pharmaceutical sector

2011 TECHPHARM Includes establishment of a

steering committee and legal

mechanisms

Harmonisation of procurement

and importation requirements and

establishment of a pool negotiation

mechanism for medicines in the

Caribbean

2012 TECHPHARM Includes strengthening

of CARIPROSUM and

collaboration among countries

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX VII. Terms of Reference - CARICOM Expanded Technical Advisory Committee on

Pharmaceutical Policy (TECHPHARM)

BACKGROUND

Every human being is entitled to the enjoyment of the highest attainable standard of health

conducive to living life in dignity. Access to health care, which includes access to essential

medicines, is a prerequisite for realising that right. However, the growing incidence and prevalence

of chronic diseases is a threat to the Region’s health and a considerable strain on health budgets.

Public health costs for care, treatment and support are rising faster than general inﬂ ation.

The Region’s geography and its small and open economies compound the ﬁ scal situation.

Both of these realities spell increased vulnerability to the negative impacts of natural disasters

and crises in international markets. Meeting health care guarantees and sustaining health gains

are serious challenges.

In response, the Region continues to forge areas for collective action. Under the mantra

“Investing in Health for Sustainable Development”, the Member States of the Caribbean Community

(CARICOM) have developed a framework called the Caribbean Cooperation in Health Initiative

(CCH). Now in its third phase, this initiative’s mission is to improve the health and well-being of the

people of the Caribbean and, by extension, develop their productive potential and the competitive

advantage of the Region.

A prominent priority area is the strengthening of health systems whose activities include

the development and implementation of a Caribbean Pharmaceutical Policy. This platform will

guide the actions of governments in the quest to ensure that essential medicines are available,

affordable and accessible to all people who have a legitimate need.

DEVELOPMENTS

In 2004, the Tenth Meeting of the Council for Human and Social Development (COHSOD)

mandated the establishment of a Technical Advisory Group (TAG) to address major health

challenges related to intellectual property rights (IPRs), particularly access to medicines, and to

provide advice to CARICOM governing bodies. TAG members include representatives of regional

health and related institutions such as the Caribbean Regional Negotiating Machinery, CRDTL,

OECS/PPS and PAHO/WHO, as well as technical ofﬁ cials from the governments of Barbados,

Jamaica, Suriname and Trinidad and Tobago. The group has been meeting periodically for the

last four years under the coordination of the CARICOM Secretariat and with administrative and

technical support from PAHO/WHO.

As TAG set about the task of formulating a pharmaceutical policy for the Caribbean, certain

developments in the interface between public health and global trade rules necessitated a

rethinking of its original scope.

A pharmaceutical policy should not focus solely on access to and rational use of safe, cost-

effective and quality essential medicines. The inherent tension between public health imperatives

CARIBBEAN PHARMACEUTICAL POLICY

and intellectual property rights related to product innovation can impede the Region’s access to

affordable medicines of assured quality. Therefore, policy provisions must be included to account

for trade rules and their impact on public health.

Innovation needs and access imperatives have made it necessary to reformulate the TAG

mandate and to review its functioning and interaction with CARICOM institutions and Member

States.

Accordingly, in September 2009, at the Eighteenth Meeting of the Caucus of CARICOM

Health Ministers in Washington, D.C., the ministers considered the Regional Strategic Framework

of PAHO/WHO in supporting an accelerated approach to a series of projects related to improving

quality of life, partnership in pharmaceutical policies, intellectual property rights, strengthening the

functions of the Health sector, among others.

The Caucus also urged that there be coordinated collaboration between the CMOs, the

CARICOM Health Desk and PAHO on the issue. Consequently, a draft proposal for the Caribbean

Pharmaceutical Policy was presented at the Eighteenth Meeting of Chief Medical Ofﬁ cers (CMOs)

on 19 May 2010.

Based on lessons learned in the Caribbean, the successful experiences in other sub-regions,

and the direction of the Caucus of CARICOM Health Ministers, it is proposed that the scope of

the current functioning of TAG be extended to the Expanded Technical Advisory Committee on

Pharmaceutical Policy (TECHPHARM). This technical advisory body will continue the process of

holistic policy development, implementation, monitoring and evaluation.

On 5–7 July 2010, the TECHPHARM proposal was reviewed and accepted by a joint meeting

of TAG and a representative group of CMOs, with the participation of a consultant from the EU, the

principal founder of the policy development process. The proposal will be submitted to COHSOD.

OBJECTIVES

General Objective

To improve access to assured quality, safe and cost-effective medicines, and promote their

rational use in the Caribbean.

Speciﬁ c Objectives

To guide the development, implementation and assessment of the Caribbean Pharmaceutical

Policy; and

To advise CARICOM governing bodies and support Member States in policy-related activities.

SPECIFIC RESPONSIBILITIES

TECHPHARM will formulate, implement and evaluate a work plan including, but not limited to,

the following functions:

CARIBBEAN PHARMACEUTICAL POLICY

• Act as an advisory body to the CARICOM Secretariat and Member States in matters

related to pharmaceutical policies;

• Present a proposal for the Caribbean Pharmaceutical Policy, along with an implementation

plan and mechanisms to monitor its implementation;

• Develop a sub-regional framework for the regulation of medicines and health technologies

based on the Pan American Network for Drug Regulatory Harmonization (PANDRH), WHO

frameworks and other relevant recommendations and contribute to national capacity-

building;

• Develop and implement mechanisms for pooled negotiation and price monitoring of

medicines integrated with other sub-regional and regional initiatives;

• Support CARICOM Member States in implementing TRIPS, ensuring that the full extent of

TRIPS ﬂ exibilities (including the successful management of intellectual property rights) is

acknowledged and implemented;

• Develop and implement a Caribbean Working Plan based on the regional perspective

regarding the Global Strategy on Public Health, Innovation and Intellectual Property and

the negotiation of international trade agreements, regulations and dispositions that might

affect access to affordable and adequate pharmaceutical products to address public

health needs; and

• Develop and implement a Caribbean Pharmaceutical Observatory (an information

clearinghouse).

PROCEDURES

TECHPHARM will have a coordinator who will be responsible for monitoring policy outcomes

and informing the CARICOM Secretariat and related governing bodies, including COHSOD, on the

committee’s scope of work. The coordinator will also ensure that a constant link with PAHO/WHO

and other possible technical partners is maintained, in order to assess progress and challenges in

executing the work plan. The coordinator will be selected by the members every three years and

supported by the respective Ministry of Health (MOH).

Decisions taken at each meeting should be based on consensus. The report of each meeting

must be agreed upon and signed by all present members in acknowledgment of adherence to the

meeting’s decisions. Documents will be sent to absent members, who will be asked to provide

comments.

TECHPHARM will assess the progress of the implementation of the policy in an annual

report to the Ministers of Health, embedded in reporting mechanisms of the CMOs regarding

CCH III implementation. COHSOD will provide the necessary political support and guidance for

implementing the agreements and recommendations of technical documents.

TECHPHARM can establish ad hoc working sub-groups for technical issues when required.

TECHPHARM will hold face-to-face meetings twice a year and use other mechanisms for

additional meetings as required (e.g., Elluminate).

CARIBBEAN PHARMACEUTICAL POLICY

TECHPHARM is responsible for articulating the different collaborative networks and sub-

groups and for integrating their work into the scope of the Caribbean Pharmaceutical Policy.

MEMBERS

TECHPHARM is composed of 10 members and respective alternates, namely:

• Three representatives of the Ministry of Health chosen from the following Member

Countries: Bahamas, Barbados, Belize, Jamaica, Haiti, Guyana, Suriname and Trinidad

and Tobago;

• Two representatives of the OECS countries;

• One representative of the UK Overseas Territories;

• One representative of CRDTL or CARPHA;

• One representative of PAHO/WHO;

• One representative of the academic institutions in the region; and

• One representative of the CARICOM Secretariat.

The alternate representative for each Member Country should ideally be from a different

country than the incumbent member. The country and academic institutions’ representatives and

alternates should rotate every three years.

Institutions with pharmacy programmes and relevant health professions will choose a

representative. Once the network of institutions with pharmacy programmes is established, that

agency will nominate the representative.

All of the CARICOM Member States will be invited to nominate a focal point to act as interlocutor

between TECHPHARM and the MOH.

Other sub-regional organisations or experts may participate, upon request. Cuba, the

Dominican Republic and overseas territories of France, the Netherlands, the United Kingdom and

the United States of America, as well as Caribbean academic institutions, are invited to nominate

focal points as observers who will collaborate with TECHPHARM.

After the CARPHA implementation transition period, CRDTL will be replaced by a CARPHA

representative with expertise related to medicines regulatory functions.

Proﬁ le of the Members

The representatives of Member Countries and academia who will be selected are required

to have professional expertise and work experience in the area of medicines. They should not

have any linkage with the pharmaceutical industry or any conﬂ ict of interest. In respect of that,

a statement declaring no conﬂ ict of interest should be signed by each member. The member

selected must be committed to the principles of public health, as deﬁ ned by TECHPHARM.

CARIBBEAN PHARMACEUTICAL POLICY

Nomination occurs through COHSOD, based on proposals from Member States, and rotation

takes place on a two-thirds basis.

TECHPHARM should establish a code of conduct that is agreed upon and signed by its

members and alternates.

Coordinator

One of the country members will be nominated to serve the coordinator on a rotation basis,

with another country acting as an alternate.

Secretariat

PAHO/WHO will support the secretariat until an ofﬁ cial mechanism can be established (e.g.,

CARPHA). It will work in close collaboration with the CARICOM Secretariat and the coordinating

country. It is recommended that a full-time staff be dedicated to the work of the secretariat.

FUNDING

It is proposed that PAHO/WHO continue to provide technical and ﬁ nancial support, in addition to

other funds that will be identiﬁ ed by TECHPHARM and the CARICOM Secretariat. TECHPHARM

should seek additional funding resources as well, supported by PAHO/WHO and the CARICOM

Secretariat.

Countries are encouraged to provide budgetary support to TECHPHARM.

WAY FORWARD

A request has been made for the CARICOM Secretariat to present the proposal to the CARICOM

Ministers of Health (at the COHSOD meeting or the meeting of the Caucus of CARICOM Health

Ministers) for TECHPHARM to be approved as a sub-committee of COHSOD.

CARIBBEAN PHARMACEUTICAL POLICY

ANNEX VIII. Roadmap for Development of the Pharmaceutical Policy

WHAT WHEN WHO REMARKS

Appointment of small working group (SWG) In process PAHO and CARICOM

staff

CPP documentation:

1) Review existing policy documents and determine policy

framework

2) Develop a glossary of terms

3) Identify gaps in the CPP document and address these gaps

4) Reformat the document so that it is reader-friendly

5) Create a draft document

6) Send the document to CARICOM

Draft by

August 15,

2010

Small working group Documentation completed

Circulation for comments among stakeholders 15–30

August

2010

CARICOM and

PAHO/WHO

In collaboration with the

Caribbean Association

of Pharmacists; process

completed

Submission of the policy and the TECHPHARM proposal to

the Caucus of CARICOM Health Ministers for approval

25–26

September

2010

CARICOM The technical staff

involved with the

development of the CPP

will be responsible for

brieﬁ ng their respective

CMOs and ministers and

advocating for its approval

Development of the implementation plan September

2010

TECHPHARM

Support for collaborative activities among schools in

providing technical assistance/collaboration

December

2010

TECHPHARM

Identiﬁ cation of ﬁ nancial support, submission of proposals for

ﬁ nancing of sub-regional structures

TECHPHARM

Caribbean

Pharmaceutical Policy

Caribbean Pharmaceutical Policy