adriana mitsue ivama medicines, vaccines and health technologies sub regional advisor

Pan AmericanHealthOrganization 1

Adriana Mitsue IvamaMedicines, Vaccines and Health Technologies Sub Regional Advisor

PAHO/WHO – Office of Caribbean Programme Coordination

The Pharmaceutical Situation in the Caribbean Countries


(1) Medicines and Biologicals in the Global and Regional Health Agenda

Global and Regional Mandates

1. Millennium Development Goals

2. XI WHO Medium Term Strategic Plan (2008-2015);

3. Health Agenda for the Americas (2008 – 2017)

4. PAHO Strategic Plan (2008-2012);

5. WHO Core Functions

6. PAHO 5 Organizational Change Objectives

WHO / PAHO Resolutions (selected)

• WHO Medicines Strategy (WHA54.11)• Ensuring accessibility of essential

medicines (WHA55.14)• Global strategy and plan of action on

public health, innovation and intellectual property (WHA 61.21)

• Access to Medicines (CD45.R7)• Public Health, Health Research,

Production, and Access to Essential Medicines (CD47.R7)

• Public Health, Innovation and Intellectual Property (WHA61.21): a regional perspective (CD48.R15)


Goals and Objectives: PAHO Project in Medicines and Biologicals 2008 - 2012• Goal:

– Equitable Access to essential medical products and technologies of assured quality, safety and efficacy, and cost effectiveness, and on their sound and cost-effective use.

• Objectives:– RER12.1 Comprehensive national policies on access, quality and

rational use– RER12.2 Implementation of international norms, standards and

guidelines for safety, quality, efficacy and cost effectiveness– RER12.3 Evidence base for cost effective use

Through the 5 Strategic Objectives of Organizational Change

Implementation Monitoring/Evaluation


A Comprehensive Approach

Equitable Access to

Medicines and Biologicals

(SO12)

Responding toCountry Needs

Innovative Modalities of Cooperation

StrengtheningRegional Fora

Using Knowledgeand Evidence

StrategicManagement


Priorities in the Caribbean

Port of Spain Declaration (2007):• “Our Ministries of Health, in collaboration with other

sectors, will establish by mid-2008 comprehensive plans for the screening and management of chronic diseases and risk factors so that by 2012, 80% of people with NCDs would receive quality care and have access to preventive education based on regional guidelines. It means it is necessary to consider an inter-programatic approach for guarantee access to quality and safety medicines and to promote their rational use”.


Caricom • Single Market and Economy (CSME);

• Caribbean Cooperation in Health Phase III (CCH III) “Investing in Health for Sustainable Development” purpose is “Access to safe, affordable and efficacious medicines improved”. The expected results are: – Caribbean Pharmaceutical Policy designed and implemented– Strengthened regulation of medicines including legislation and drug

registration– Harmonized medicines supply systems and sub-regional negotiation

mechanism – Caribbean Strategy for rational use of medicines approved and

implemented.


EU/ACP/WHO Partnership on “Pharmaceutical Policies”

• The agreement for the EU/ACP/WHO Partnership on Pharmaceutical Policies was signed on 7 March 2004 - Africa, the Caribbean and the Pacific.

• The overall objective is “to close the huge gap between the potential that essential medicines have to offer and the reality that for millions of people, particularly the poor and disadvantaged, medicines are unavailable, unaffordable, unsafe or improperly used”.


EU/ACP/WHO Partnership on “Pharmaceutical Policies”Strategic Objectives

1. Pharmaceutical Policy: To provide evidence basis and to support the development and the monitoring of pharmaceutical policies

2. Access and Innovation: To support the strengthening of integrated supply systems

3. Quality and Regulation: To support the strengthening of core functions of NRAs and sub-regional regulatory framework

4. Rational Use of Medicines: to support the strengthening of core-function


1) Pharmaceutical Policy: To provide evidence basis and to support the development and the monitoring of pharmaceutical policies

Outcomes:• Pharmaceutical Situation Assessment: to provide evidence for decision makers -

Level I (structure and process): 13 countries - publication and Level II (Outcomes): training.

Priorities:• To support the Level II surveys (outcomes): SAL, JAM, SUR (in progress), DOM,

SVG, TRT, BAR (proposals) and price survey;• To prepare the pharmaceutical situation in the Caribbean – Level II; • To support the development of a Caribbean Pharmaceutical Policy (TAG/Caricom)

with an interprogrammatic/intersectoral approach, in the CCH III framework;• To support development/updating and implementation of National Medicines

Policies

Medicines Strategy in the Caribbean


2) Access and Innovation: To support the strengthening of integrated supply systems

Drug Supply Management

Outcomes:• Establishment of CARIPROSUM (Caribbean Network for

Procurement and Supply Management); • Members of the PAHO/WHO Strategic Fund: BAR, BLZ, JAM,

SUR, TRT;

Priorities:• To continue supporting the CARIPROSUM: indicators; Good

Practices of Supply System (including pre-qualification); • To continue promoting PAHO/WHO Strategic Fund • To support development of cost-containment and pool

negotiation mechanisms;



2) Access and Innovation: To support the strengthening of integrated supply systems

Intellectual Property Rights

Outcomes:• Active participation of Caribbean countries in the Inter-Governmental

Working Group on Public Health and Intellectual Property Rights (IGWI);

• Assessment of Intellectual Property Rights and access – as part of Technical Advisory Group of Medicines of Caricom (in progress)

Priority:• To support the development of a sub-regional strategy for Intellectual

Property Rights and Public Health and a work plan with Caricom based on the results of the Survey conducted and in the WHO Global Strategy – advocacy and training;



3) Quality and Regulation: To support the strengthening of core functions of NRAs and sub-regional regulatory framework

Outcomes:• Assessment of Drug Regulation in the Caribbean with

Caricom;• Support to the Caribbean Regional Drug Test Laboratory

(CRDTL); • Establishment of Pharmacovigilance Network – VIGICARIB: 2

full members of WHO Network (BAR, SUR) 1 associated member (OECS/PPS) - focus on HIV/Aids related medicines – Suriname is the focal coordinator

• Prevention and Combat of Counterfeit Medicines in the Caribbean: diagnosis; multisectoral workshops (OECS);



3) Quality and Regulation: To support the strengthening of core functions of NRAs and sub-regional regulatory framework

Priorities• To support the strengthening of National Regulatory Authorities;• To support implementation of the recommendations of the Pan

American Network of Drug Regulatory Harmonization (PANDRH) • To support the development of a sub-regional regulatory framework

based on the results of the Survey conducted within the TAG/Caricom;• To continue supporting CRDTL and the national laboratories of quality

control; • To continue supporting Vigicarib integrated into Public Health

Programmes and NRA; • To support an inter-sectoral response for prevention and combat of

counterfeit medicines (Caribbean, OECS, DOR);



4) Rational Use of Medicines: to support the strengthening of core-function

Outcomes:• Training for selection of medicines/therapeutics committees• Distance Learning course on ARV – in progress; • Information Bulletins;

Priorities• To support the development of a Caribbean Strategy of Promotion of

Rational Use of Medicines• To support the strengthening of Pharmacy Education and the

introduction of core elements of RUM into the health courses;• Distance Learning courses on ARV – 2nd edition and Rational Use of

Antibiotics;• To continue with Information Bulletins;



The Pharmaceutical Situation in the Caribbean13 participants: Antigua and Barbuda, Bahamas,

Barbados, Belize, Dominican Republic, Grenada, Guyana, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago

It was possible due to the collaboration of the National Authorities who provided the data answering the Level I Questionnaire of the Pharmaceutical Situation.


National Medicines Policies in 2007

Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

CARIBBEAN AMERICAS

Number of%

Number of%

NMP statuscountries countries

NMP document 7 53.8% 22 71.0%

NMP Official 4 57.1% 16 72.7%

Official document updated < 5 years 2 50.0% 9 60.0%

Official document updated < 10years 3 75.0% 13 86.7%

NMP implementation plan 5 55.6% 13 56.5%

updated within 5 years 4 80.0% 10 83.3%

NMP integrated in NHP 4 44.4% 16 66.7%


Medicines Regulatory Authority (MRA), 2007


CARIBBEAN AMERICAS

Policy area covered

Number of % Number of %

countries countries

Legal provision for establishment of MRA 11 84.6% 28 90.3%

Existing formal MRA 9 69.2% 27 87.1%

Legal provision requiring transparency 5 45.5% 20 71.4%

MRA involved in harmonization initiative 10 83.3% 28 93.3%

Publicly accessible MRA website 3 25.0% 19 63.3%

Sources of funding for MRA

Government budget 11 91.7% 29 96.7%

Medicines registration fees 1 14.3% 14 66.7%

Other 1 20.0% 7 53.8%


Medicines Registration, 2007

CARIBBEAN AMERICAS


Policy areas covered countries countries

Provision for marketing authorization 6 46.2% 24 77.4%

Marketing authorization list publicly available 4 30.8% 18 58.1%

Computerized system for registered products 2 18.2% 20 69.0%

WHO Certification Scheme part of MA 4 30.8% 16 51.6%

INN used in registration of medicines* 6 46.2% 24 77.4%

Official registration committee 4 30.8% 16 55.2%

Median Median

[25th, 75th percentile] [25th, 75th percentile]

Total no. of products with MA 7,175 11,571

4,763 9,588 6,499 16,849

N=2 N=19



Licensing of Facilities and Professionals, 2007


CARIBBEAN AMERICAS

Legal provision for licensing


Countries Countries

Manufacturers 12 92.3% 29 93.5%

Distributors/wholesalers 12 92.3% 29 93.5%

Importers or exporters of medicines 11 91.7% 27 93.1%

Prescribers 12 92.3% 30 96.8%

Pharmacy 13 100.0% 31 100.0%


Regulatory Inspections, 2007


CARIBBEAN AMERICAS


Legal provision to inspect premises Countries Countries

ManufacturersFacilities inspected 6 50.0% 24 80.0%

Written national guidelines 4 57.1% 19 86.4%

Wholesalers/ distributorsFacilities inspected 8 61.5% 24 77.4%


Importers/ exportersFacilities inspected 8 61.5% 22 75.9%


Retail distributors/ pharmaciesFacilities inspected 8 66.7% 24 82.8%



Quality Control, 2007


CARIBBEAN AMERICAS


countries Countries

Quality management system in place 7 53.8% 21 72.4%

Samples tested for

Medicines registration 5 41.7% 18 62.1%

Post-marketing surveillance 6 54.5% 20 74.1%

Samples tested in

Government quality control laboratory 5 55.6% 19 79.2%

Local academic institutions 1 16.7% 8 42.1%

Private laboratory 3 50.0% 7 41.2%

Mini laboratories (district, regional) 2 33.3% 3 18.8%

Quality control laboratory in another country 7 87.5% 9 47.4%

Quality control procedures for imported medicines 10 76.9% 26 86.7%

Legal procedures to recall/ dispose defective products 8 61.5% 23 76.7%


Pharmacovigilance, 2007


CARIBBEAN AMERICAS


Countries countries

Monitoring of ADRs5 38.5% 18 58.1%

Local level2 40.0% 11 64.7%

Regional level1 20.0% 8 50.0%

Central level4 66.7% 16 88.9%

International reporting of ADRs3 23.1% 14 48.3%


Prevention and Combat of Counterfeit Medicines, 2007


CARIBBEAN AMERICAS


countries Countries

Laws or regulations on counterfeit medicines 7 53.8%

20 64.5%

Sources used to detect counterfeit medicines

national authorities 10 83.3%

22 84.6%

specific / ad hoc studies 9 81.8%

21 87.5%

pharmaceutical sector 12 100.0%

27 96.4%

Civil society/NGOs 9 100.0%

19 86.4%


Legislation on Generics Medicines, 2007


CARIBBEAN AMERICAS


Policies on generic medicines countries countries

Prescribing generics mandatory in

Public sector 7 53.8% 23 76.7%

Private sector 2 16.7% 10 37.0%

Permitting generic substitution in

Public pharmacies 13 100.0% 27 90.0%

Private pharmacies 9 75.0% 21 77.8%

Incentives to promote generics dispensing

Public pharmacies 5 38.5% 8 26.7%

Private pharmacies 2 18.2% 6 22.2%


Policies on Medicines Prices, 2007


CARIBBEAN AMERICAS


countries countries

Policy covering medicine prices


Private Sector 4 33.3% 12 42.9%

NGO 1 11.1% 4 18.2%

If yes, which areas are covered?

Maximum wholesale mark-up



NGO 2 100.0% 4 50.0%

Maximum retail mark-up



NGO 2 66.7% 5 50.0%

Duty on raw pharmaceutical materials



NGO 3 75.5% 4 44.4%

Duty on finished pharmaceutical materials



NGO 3 75.0% 5 45.5%


Public sector procurement and distribution in 2007


CARIBBEAN AMERICAS


countries countries

Entire public sector procurement pooled at national level 13 100.0% 25 80.6%

Responsible agency for public procurement

Ministry of Health

Procurement 12 92.3% 26 89.7%

Distribution 7 87.5% 18 85.7%

NGOsProcurement 2 28.6% 4 25.0%

Distribution 0 0% 2 20.0%

Private institutionProcurement 2 28.6% 2 12.5%

Distribution 2 100% 3 27.3%

Individual health institution Procurement 0 0.0% 11 52.4%


Availability and status of Essential Medicines List (EML)


CARIBBEAN AMERICAS


countries countries

Existence of EML* 10 76.9% 25 80.6%

Last Update of EML < 5 years 9 100% 24 100.0%

No separate paediatric EML 9 100% 21 100.0%

Use of EML in different sectors

Public sector procurement 10 90.9% 24 88.9%

Public insurance reimbursement 5 50.0% 9 40.9%

Private insurance reimbursement 2 22.2% 3 14.3%

Committee for EML medicines selection 10 90.9% 24 88.9%

Median Median


Number of medicines in EML

464 512

350 526 386 598

N=8 N=22

Paediatric formulations in National EML

40 58.5

30 50 29.5 263.5

N=2 N=10


Total and per capita public expenditure for medicines (TPE) in $US, 2007


CARIBBEAN AMERICAS

Median Median


Median Total public expenditure for medicines (TPE) in $US

$ 4,000,000 $ 34,087,493

815,000 13,000,000 $ 3,750,000 $ 53,081,172

N=9 N=24

Median Public medicines per capita in $US

$ 20.90 $ 11.50


Were we want to be/what goals we want to achieve in…• 2 years…

• 4 years…

• 10 years…


What are the priorities?

• At Caribbean level• Country level


How can PAHO/WHO support Caribbean countries to achieve those goals?


Thanks!

Contact: [email protected]

adriana mitsue ivama medicines, vaccines and health technologies sub regional advisor

Documents

safety medicines

medicines cd45

efficacious medicines

caribbean countries1

rational use of medicines

essential medicines

r7public health

regional health agendaglobal