World Health Organization 26 April 2017 WHO Technical Briefing Seminar Geneva 31 October- 04 November 2011 WHO Collaboration with Countries on Pharmaceutical Policies Mrs Helen Tata Essential Medicines and Pharmaceutical Policies

WHO Medicines Strategy as part of WHO Medium-term Strategic Plan 2008-2013 : Strategic Objective (SO-11) : To ensure improved access, quality and use of medical products and technologies Organization-wide expected results : (OWERs) 11.1 Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies advocated and supported; 11.2 International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies developed and their national and/or regional implementation advocated and supported; 11.3 Evidence-based policy guidance on promoting scientifically sound and cost-effective use of medical products and technologies by health workers and consumers developed and supported within the Secretariat and regional and national programmes.

New challenges in the global pharmaceutical landscape More players and partnerships in pharmaceutical sector with specific niches and/or unaware of countries priorities, overstretch experts and decision making capacity in countries Diseases specific programs and new global funding initiatives with specific delivery mechanisms and substantial funding could undermine health systems strengthening efforts in countries Less WHO core budget < 30%; more specified project Funding >70%

Added-value of WHO Development of norms and standards; access to information and expertise in the health sector (e.g. collaborating centres). Experience and operational capacity in countries; capacity of staff is being strengthened to better respond to countries' needs and to ensure effective coordination and policy dialogue. Promote partnership and put people together: WHO is a neutral partner with long-term experience and this facilitates dialogue among players. Monitoring and evaluation of policies: development of tools and strengthening of countries' capacities.

WHO: 193 Member States 6 Regional Offices Regional Office AFRO Regional Office EMRO Regional Office EURO Regional Office WPRO Regional Office SEARO Regional Office AMRO WHO HQ Geneva (Source: http://www.who.int/about/regions/en/index.html)

Coordination mechanisms for a sustainable collaboration with countries AFRO WHO AMRO HSS EMRO EMP EURO SEARO WPRO

WHO Country Medicines Advisers and Collaborating Centres

The WHO Country Medicines Advisers Network for Africa 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; UEMOA Burundi Cameroon Central African Rep. Chad Congo Democratic Rep. of the Congo Ethiopia Ghana Kenya Mali Nigeria Rwanda Senegal Uganda United Rep. of Tanzania CEMAC EAC SADC

Principles for collaboration with countries EC/ACP/WHO Partnership 2004-2010 Focus on countries and regions' needs rather than on development of tools. Build on work done, innovate and ensure sustainability. Technical assistance and country ownership: data collection and analysis Formulation of plans, policies and good practices Advocacy and capacity-building Promote collaboration and ensure synergies with other partners. Promote Regional and Sub-Regional Collaboration

Assessment of pharmaceutical situation and development of national policies and implementation plans Data on pharmaceutical situation (Level 1) collected in 68 ACP countries in 2007 and Regional Reports have been published. In-depth assessment of pharmaceutical policy at health-centre and household levels of 20 ACP countries; Large quantity of data collected and analyzed by local experts to increase capacity; advocacy on the importance of monitoring for policy implementation. 40 countries supported to develop national medicine policies and implementation plans. 15 of them have officially approved their policies. Common policies have been developed in CEMAC and SADC.

Regulation and Quality Assurance Between 2004 and 2010: More than 30 countries have received support to evaluate their Medicines Regulatory Authorities. 10 countries have installed the software SIAMED for registering medicines. 15 countries have been supported to produce laws aimed at better regulating their pharmaceutical sector (e.g. Mali, Nigeria, Senegal, Sudan, etc.). 23 countries have received support to strengthen monitoring of adverse reactions to medicines. 15 countries have received technical assistance to test quality of medicines in the market and to fight counterfeit medicines.

Selection and rational use of medicines Between 2004 and 2010: 40 countries supported to create or update their Essential Medicines Lists and Standard Treatment Guidelines. More than 1,000 national personnel trained in rational use of medicines. Technical and financial support to establish Drugs and Therapeutics Committees in seven countries (Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Senegal and Uganda. Rational use campaigns in 9 countries (Mali, Sudan, Zambia, Uganda, Kiribati, Solomon Islands, Tonga, Tuvalu and Vanuatu). Between the interventions there is the approval of laws to regulate medicines promotion (Mali and Zambia) and information campaigns using mass-media like radio and journals (Sudan, Uganda and Zambia). Pacific Islands have used theatre to better involved the public in rational use issues.

"Success stories" After a survey on medicines prices, the goverment of Mali decided to regulate the prices of around 100 widely-sold generic medicines. A study from M. Maiga and B William-Jones published in 2010 showed that the regulation was successuful and that between 2006 and 2009 medicines prices in Mali fell by about 23%. D Maiga and B Williams-Jones (2010), Assessment of the impact of market regulation in Mali on the price of essential medicines provided through the private sector, Health Policy 97 (2010): 130–135. In Ghana, WHO contributed to assess the situation of human resources for the pharmaceutical sector and to develop a national strategy for the production, recruitment and retainment of personnel based on the findings of the assessment. As part of the strategy, the programme of the degree in pharmacy has been modified to align it with the skills nowadays required by practising pharmacists. Availability of medicines has increased in Uganda. Monitoring of medicines prices and availability was established with WHO support. The information collected showed that between 2004 and 2008, availability of medicines in the public sector of Uganda grew from less than 40% to over 60%.

Results of sub-regional collaboration CEMAC, SADC and Caribbean: assessment and common pharmaceutical policy. EAC, SADC, Caribbean: work on pooled procurement and on harmonization of registration of medicines. UEMOA: work on pharmaceutical policies and harmonization of registration and inspection procedures. PIC: work on pooled procurement of medicines and harmonization of essential medicines lists. Caribbean: establishment of mechanism for joint monitoring of adverse reactions to medicines (VigiCarib).

Renewed Partnership between EU, ACP countries and WHO Principles: - The Renewed Partnership will focus on the implementation. - Pharmaceutical Policies should be given higer profile in the health sector of target countries. - Key partners and donors should be involved and coordination should be improved. - Promote intercountry collaboration to strengthen capacity and reinforce integration. - Collect quality information to increase transparency in the pharmaceutical sector. - Give more intense support to a limited number of countries. Expected results: 1) Average availability of key essential medicines in the public sector increased by 10%. 2) Final prices of key essential medicines in the public and private sector is reduced by 10%. 3) Number of essential medicines that comply with national quality standards increased by 5%. 4) Number of prescriptions that comply with national Standard Treatment Guidelines increased by 10%. 5) Good-quality data on the pharmaceutical sector of 20 countries is collected, analyzed and mada publicly available.

WHO partners at global and country levels WHO Department of EMP IPC WHO: HSS, EIP HIV, MAL, TB, RH, Collaborat.Centres UN: UNICEF, UNAIDS, UNFPA, WBank, GFATM, UNITAID NGOs: MSF, HAI, MSH, JSI FIP, IGPA, IFPMA, etc Regional Offices Country Offices MOH Outside MOH: Drug regulatory agencies, insurance, universities, missions, NGOs, consumers National programmes for health professionals, patients and consumers