WHO Technical Briefing Seminar Geneva 01- 05 November 2010.

WHO Collaboration with Countries on Pharmaceutical Policies

Dr Gilles Forte Essential Medicines and Pharmaceutical Policies

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Gilles Forte

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03 November 2010

WHO: 193 Member States 6 Regional Offices

Regional Office AFRO Regional Office EMRO Regional Office EURO Regional Office WPRO

WHO HQ Geneva

Regional Office SEARO Regional Office AMRO

(Source: http://www.who.int/about/regions/en/index.html) 2 | WHO-Technical Briefing Seminar

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Coordination mechanisms for a sustainable collaboration with countries

WHO HSS EMP AFRO AMRO EMRO EURO SEARO WPRO

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WHO Country Medicines Advisers and Collaborating Centres

Medicines Adviser Collaborating Centre

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The WHO Country Medicines Advisers Network for Africa

Burundi Cameroon Central African Rep.

UEMOA Chad Congo Democratic Rep. of the Congo Ethiopia Ghana Kenya Mali Nigeria Rwanda Senegal Uganda United Rep. of Tanzania CEMAC SADC EAC 5 | WHO-Technical Briefing Seminar

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Medicines Advisers in 15 countries in Africa for:

• • • •

Assessing national medicines needs & priorities; Planning, implementing, monitoring WHO interventions; Facilitating coordination of partners; Contributing to WHO Regional work on medicines and health systems;

Key principles for collaboration with countries

 Country ownership - planning & implementation is country led - based on country needs and priorities;  Technical collaboration with countries: -for building evidence base and quality information; -for sound policies, good practices and advocacy; -for strengthening pharmaceutical systems & capacity;    Sustainability and continuity; Promoting regional and subregional collaboration and integration; Promoting efficient coordination of partners, synergies and aid effectiveness.

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Collaboration framework

       Millennium Development Goals 2000-2015 – Goal 4, 5, 6 & 8; Resolutions of the World Health Assembly – Endorsed by WHA; WHO Medium Term Strategic Plan 2008 - 2013 - Endorsed by WHA; Regional Declarations endorsed by Member States e.g. Abuja, Ougadougou, Talinn etc.

Priorities set by the Director General WHO Medicines Strategy 2008 -13 : – – – Information and Policy Access Quality and Safety Rational Use Multi Country Programmes e.g. EC/ACP/WHO; MeTA; etc.

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Partnership with ACP countries on Pharmaceutical Policies

60 50 40 30 20 10 0 Policies Patents

Number of countries supported by result areas

Prices Supply Quality Regulation Rational use by prescribers Rational use by consumers

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03 November 2010 n. of countries supported

National Medicines Policy

NMP and implementation plan

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90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Countries with NMP Countries with NMP updated within 5 years

WHO-Technical Briefing Seminar

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03 November 2010 Countries with implementation plan 2003 2007

Medicines regulation and quality assurance

System in place to report ADR

60% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Web-site of MRA

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03 November 2010 50% 40% 30% 20% 10% Computerized registration system 0% 2003 2007 2003 2007

Monitoring availability and pricing of medicines (Uganda)

100%

Median availability basket of key medicines, public & private sectors 2004-8

75% 50% 25% Private median Public median Linear (Private median) Linear (Public median) 0% Apr-04 Oct-04 Apr-05 Oct-05 Apr-06 Oct-06 Apr-07 Oct-07 Apr-08 Oct-08

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Selection and rational use of medicines

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% EML updated with 5 years

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03 November 2010 National STGs 2003 2007

The EC/ACP/WHO Partnership: collaboration with Sudan

         The National Medicines Policy was updated in 2005.

An assessment of the Pharmaceutical Sector was carried out in 2007 and a Pharmaceutical Country Profile was developed in 2010.

A survey on medicines prices was carried out and, as a result, advocacy work was conducted to reduce taxes on medicines and increase public funding. The effectiveness of the drug revolving fund as a mechanism for financing medicines was assessed. The supply system was evaluated and strengthened through the establishment of a national forecasting and surveillance unit, the purchase of IT material and training of personnel.

The situation of human resources for the pharmaceutical sector has been assessed.

The Adverse Drug Reaction Centre has been supported. Software Vigiflow has been purchased.

The National Quality Control Laboratory (NDQCL) was assessed and personnel was trained on use of equipment. The Medicines Regulatory System was assessed in 2008. Software SIAMED for registration installed. Guidelines for quality assurance developed in July 2006 and personnel trained. Guidelines and SOPs for key regulatory activities developed. Equipment and training provided to inspectors.

A number of training sessions and workshops held to promote rational use of medicines.

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The EC/ACP/WHO Partnership: collaboration with the Caribbean

      Support provided to carry out pharmaceutical sector surveys (Level 1 2007,Facility and Household surveys in Barbados, Jamaica, Saint Lucia and Suriname), regional meta analysis (report published in 2009) and development of regional medicines policy (June 2010 draft available); Support provided to the Caribbean Regional Network of Pharmaceutical Procurement and Supply Management Authorities (CARIPROSUM). The network includes the Organization of Eastern Caribbean Countries Pool Procurement Service (OECS/ PPS) which received support through training sessions, participation to workshops and assessment of its procurement system. Support was provided for the assessment of Medicines Regulatory Authorities and establishment of regulators network as part of PANDRH; Information on counterfeit medicines was collected and a position paper with options for actions was developed. A campaign was conducted in 2008-9 to sensitize the public; The Caribbean Regional Drug Testing Laboratory (Jamaica) was supported and used to conduct training courses. The laboratory is currently working to achieve WHO pre-qualification status.

A regional network for Pharmacovigilance (VIGICARIB) was established in 2008 for monitoring of adverse drug reactions.

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Synergies for increased efficiency and aid effectiveness in countries

Opportunities for synergies in countries:

– With programmes aimed at supporting countries to deliver on MDGs 4, 5 and 6 e.g. GFATM etc. – With other initiatives for improving access to medicines (e.g. Medicines Transparency Alliance (MeTA), Southern Africa Regional Programme on Access to Medicines (SARPAM) etc.; – With other activities aimed at strengthening health systems and improve coordination of development partners e.g. EC/WHO on HRH; NHPSP; IHP+;

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03 November 2010

DFID/ WHO/HAI-A Regional Collaboration

MoH Pharm Dept Ghana, Kenya, Uganda Collaboration to improve policies and practices for access to medicines WHO Country Medicines Adviser

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03 November 2010 HAI Africa

MeTA multi stakeholders approach

Pharmaceutical companies

(generic and patent) •Access to more information on medicines needs •Active role in national policy agenda •Visibility & concerned by public health issues •Address quality matters

Ministries & Gov. agencies

•Improve health systems efficiency & access to medicines •Commitment to good governance & transparency agenda •Promote multi stakeholders inclusive approach

Wholesales, distributors, retailers

•Access to more information Opportunity for building capacity & improve business practices •Active role in policy agenda Private sector Int. institutions DPs Civil society • Active role in national policy agenda •Supportive environment for advocacy •Financial and other support •Improved dialogue with public and private sectors •Promote transparency & good governance agenda •Improve health systems efficiency & access to medicines Good governance agenda Tackle corruption Increase access to medicines Support responsible business

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Some readings

 WHO Medicines Programme Coordination (MPC) web page http://www.who.int/medicines/areas/coordination/en/index.html

 Evaluation of WHO/DFID/HAI Regional collaboration for Action on Essential Medicines in Africa http://apps.who.int/medicinedocs/documents/s16564e/s16564e.pdf

 Evaluation of the Government, civil society and WHO Partnership http://apps.who.int/medicinedocs/documents/s16564e/s16564e.pdf

 Medicines Transparency Alliance (MeTA) web pages http://www.who.int/medicines/areas/coordination/meta/en/index.html

 MeTA assessment report (summary): http://www.medicinestransparency.org/fileadmin/uploads/Documents/Evaluation/MeTA_Evaluation_Summary_Report.pdf

 EC-ACP-WHO Partnership web pages http://www.who.int/medicines/areas/coordination/ecacpwho_partnership/en/index.html

 Web page on Medicines Adviser in the African Region (key products available): http://www.who.int/medicines/areas/coordination/medicinesadvisers/en/index.html

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03 November 2010