MeTA 25 05 09 1

Medicines Transparency Alliance: Under New Management

Dr Tim ReedDirector, Health Action International (Global)International MeTA Secretariat

Dr Gilles ForteCoordinator, Programmes Coordination, Policy and Information, WHO International MeTA Secretariat

MeTA Hypotheses

H1: Transparency of the pharmaceutical sector will bring about efficiencies in medicines supply chain and increase access to medicines

H2: All stakeholders with an interest in the outcome of the medicines market must be brought together and engage in a policy dialogue that should foster transparency and accountability

MeTA Core Principles Governments are ‘responsible’ for providing access to

health care, including access to essential medicines Stronger and more transparent systems and improved

supply chain management will increase access Increasing equitable access to medicines improves health

and enables other human development objectives to be achieved

Improved information about medicines can inform public debate, and provide a basis for better policy

A multi-stakeholder approach that involves all sectors – private, public and civil society - will lead to greater accountability

MeTA Scope

MeTA aims at improving access to quality medicines by

increasing transparency of the pharmaceutical sector through collection of reliable data, valid analysis, and then disclosure for advocacy and policy dialogue among stakeholders e.g. private sector/public sector/civil society.

7 pilot countries: Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda and Zambia.

Pilot Phase 2008-2010. MeTA Councils established in every country and work plans were developed, implemented and monitored.

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MeTA multi-stakeholder approach

Government

Civil society

Private sector

Internationalinstitutions DPs

Pharmaceutical companies (generic and innovator)Access to more information on medicines needsActive role in national policy agendaVisibility & concerned by public health issuesAddress quality matters

Ministers, Regulators & civil servantsImprove health systems efficiency & access to medicines Commitment to good governance & transparency agendaPromote multi stakeholders inclusive approach

Development PartnersGood governance agendaTackle corruptionIncrease access to medicinesSupport responsible business

International InstitutionsPromote transparency & good governance agendaImprove health systems efficiency & access to medicines

Wholesales, distributors, retail pharmaciesAccess to more information Opportunity for building capacity & improve business practicesActive role in policy agenda

Civil SocietyActive role in policy agendaSupportive environment for advocacyFinancial and other supportImproved dialogue with public and private sectors

Government at country level

Ministries of Health Medicines Regulators Government Insurance Funds Government Procurement Chief Pharmacists/Medical Officers et al …

Private sector at country level Multinationals and Innovators Generic importers Local Manufacturers Wholesalers, distributors Retail pharmacies Drug shops Private health care providers Mission Sector Insurance companies et al …

Civil Society at country level

Health NGOs/CSOs (domestic & international) Medicines NGOs/CSOs Transparency NGOs Patient Groups Consumer Groups et al …

What could be disclosed?

Medicines Registration and Quality Assurance Data Market registration procedures Registration status of all medicines Good Manufacturing Practice (GMP) outcomes for domestic

and foreign manufacturers Quality assurance processes in public and non-profit tenders Quality assurance data during registration or procurement Routine quality testing and adverse event monitoring

What could be disclosed?

Medicines Availability Volume and value of medicines procured in the

public and non-profit sectors Volume and value of medicines supplied in the

private sector Availability of medicines to consumers Routine audits for public, private, and non-profit

medicines outlets

What could be disclosed?Medicines Prices Consumer and ex-manufacture prices of medicines in the public, private,

and non-profit sectors Public sector medicines procurement prices Medicines price components in the public, non-profit, and private sectors Pharmaceutical patents held in-country

Medicines use and Promotion Standard treatment guidelines Essential medicines list Medicines promotion regulations, policies, and industry practices

New WHO Pharmaceutical Sector Monitoring Tools

Level III Indicators for specific components of the pharmaceutical sector: Pricing Rational useHuman Resources Assessing regulatory capacity

Procurement and Supply

Level II Core outcome/impact indicators

& household survey

CPHigh-level informationMostly structures and

policies

High-level policy information (Country Profiles)

• Questionnaire to Ministry of Health• Mostly Pharmaceutical sector indicators on structures & policies• Data on outcomes from Level II and III.• Regularly carried out

Household and health facilities surveys (Level II)

•Surveys based on samples• Monitoring of pharmaceutical policy outcome & impact. •Upon request

Topic-specific studies (Level III)

•More detailed indicators for monitoring and evaluating specific areas/components•Upon request

Pilot Outcomes

Robust & relevant information(Transparency)

Better policies and implementation(Efficiency)

Multi-sector data sharing and analysis (with MeTA TA)(Accountability)

Improved access to medicines

Routine Data Collection

Good on the first two, but in MeTA 2 we need to convert transparent data into initiatives that bring about better policies and improved access.

Pilot Successes The National Medicines Regulatory Authorities of Kyrgyzstan, Uganda and

Zambia have created web-sites on which they make available key information: registered medicines list, list of authorized wholesalers, etc.

Peru developed a database of medicines prices in public and private pharmacies. The system allows consumers to compare the prices and choose where to buy. This increased competition is meant to reduce prices of medicines.

Jordan conducted studies on access to medicines in health facilities and households. The studies indicated issues with rational use of medicines and therefore MeTA has supported the country to develop Standard Treatment Guidelines for key diseases.

In the Philippines MeTA contributed to the enactment of the "Cheaper Medicines Act" 2008 and to the establishment of an e-procurement system for medicines.

Pilot Lessons

• Multi-stakeholder working is a new concept – not easy – it takes patience, understanding, diplomacy and tact

• Identifying champions in each sector can greatly expedite the process of multi-stakeholder engagement and transparency

• Each sector needs to “give & take” to build consensus

• Conflict of Interest identification - transparency

• The MeTA process needs to be country-led but with guidance

• Gaining consensus and understanding requires a constant and frank exchange of views

• Tools for gathering baseline data on access do already exist; a new tool to measure multi-stakeholder collaboration has been developed; new innovative ‘useable’ tools required

MeTA 2: What’s changed

Pilot Model: Non-technical International MeTA Secretariat (IMS) based in UK, external

consultant driven technical support International Consultants appointed in UK to facilitate in-country work Short timeline – Two years Financing and Sustainability

MeTA2: IMS joint ownership WHO and HAI In-country technical support by WHO In-country Civil Society support by HAI Longer timeline - Four years Sustainability model Expansion into new countries? Year three ….