Pharmaceutical Sector Country Profiles WHO Experience

1. Pharmaceutical Sector Country Profiles WHO Experience Dr Gilles Forte Dr Richard Laing Essential Medicines and Health Products Department WHO HQ

2. 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. WHA-54.11/2001 Improve indicators and tools for measuring results and impact of pharmaceutical policies; harmonize them with those of other agencies; support countries to develop national pharmaceutical profiles to be used as an official and reliable source of information of the national pharmaceutical sector;

3. Department for Essential Medicines and Health Products (EMP) - areas of work Medicines Policy, Information and Country Support Indicators and tools for pharmaceutical sector monitoring & assessment Transparency & Good governance in medicines Medicines Policy; country collaboration and support Publications & website Quality Assurance and Safety: Medicines Norms/standards (nomenclature) Quality assurance (incl. blood products) Safety / pharmacovigilance Prequalification of medicines; Regulation Medicines Access and Rational Use Rational use and ant-microbial resistance Selection of essential medicines Supply systems; Psychotropics & narcotics, including substance evaluation Access controlled meds Medical Devices and Diagnostics Policies, norms/standards Prequalification, quality and safety Management; Access & use; Regulation

4. Issues to address • A vast amount of information exists on the pharmaceutical sector of countries; • BUT this information is often not available to the public or even to decision makers in the countries involved; • Duplication of efforts with multiple data collection initiatives in the same country; not always endorsed; • This information is not always reliable.

5. WHO Pharmaceutical Sector Monitoring Tools • High-level policy information (Country Profiles), through a global survey • Questionnaire to Ministry of Health • Indicators on structures, policies and outcomes; • Carried out every four years • Health facility and household surveys (Level II) • Surveys based on interviews • Indicators on policy outcome • Upon country request • Topic-specific studies (Level III) • More detailed indicators for monitoring and evaluating specific areas/components • Upon country request CP High-level information Mostly structures and policies Level II Core outcome/impact indicators & household survey Level III Indicators for specific components of the pharmaceutical sector: Pricing Rational use Human Resources Assessing regulatory capacity Procurement and Supply

6. Content of the Country Profile questionnaire The questionnaire is divided into 9 chapters: Health and Demographic data. Health Services. Policy Issues. Medicines Trade and Production. Medicines Regulation. Medicines Financing. Pharmaceutical Procurement and Distribution. Selection and Rational Use. Household data/access.

7. Rationale for Country Profiles • Assist countries produce reliable indicators and information on structures, processes and outcomes; using existing data e.g. pricing & availability; • Support countries to establish a unique and reliable source of information for identifying gaps, carrying out policy dialogue and policy formulation; • Information available for coordination of international partners in countries; • Global survey in 193 Member States every four years; comparisons among large number of countries (156 in 2007; 130 in 2011), regions and income groups; • Systematic data collection allows comparison over time (2003,2007,2011);

8. 2011 Survey: ensure quality of information Year and source of each piece of information is recorded and key documents are provided and stored in the WHO Medicines Library. Fields for comments are provided to allow respondents to provide more nuanced information; A manualwith instructions to fill in the questionnaire has been developed to guide data collection; English, French and Spanish; A glossarywith definitions of key items has been produced to make sure questions are interpreted consistently across countries and regions; Names and contacts of respondents are collected and interactions with WHO are taking place for data quality checking; Data is endorsedby a senior Official at the Ministry of Health as official country information and authorisation for disclosure granted; Quality checking of information is supported by WHO at HQ and Regional Offices. This is done through: Checking with previous information available for the country; Checking for consistency within the questionnaire; Cross checking with other sources and profiles (for example, National Health Accounts);

9. 2011 Survey: reduce burden of data collection in countries Core and supplementary indicators defined; Mostly Yes/No questions; limited financial and human resources needed; Questionnaires have been prefilled for 193 Member States with all information available at WHO HQ. About 50% of each questionnaire has been prefilled. Countries are asked to verify the information provided and fill in gaps; WHO support provided for quality checking; The Country Profile is meant to be an official and unique source on pharmaceutical sector information in the country for national and international experts; It is expected that the availability of reliable information will reduce data collection initiatives in countries; The questionnaire has been endorsed by The Global Fund to replace GF Health Products Management (PHPM) Profile. In 2011, It has been an important source of information and step for GF grant signing; Joint data collection between WHO and GF has been carried out in countries; Discussions are ongoing to align the questionnaire with other International agencies e.g. Unicef, World Bank;

10. Countries involvement and WHO support • The survey is coordinated by the Ministry of Health in countries and involves relevant national institutions e.g. MRA, NHA etc.; • EMP and 6 Regional Advisers are involved in the coordination of WHO support for country profiles completion and for collaboration with GF;; • At country level, WHO Medicines and Health systems experts collaborate and support the Ministry of Heath for collection of quality information, coordination with national institutions and GF representatives and for use of data for policy dialogue and formulation; • Country profiles are meant to be updated and published every four years;

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

12. RESULTS

13. Health exp as % of govt budget in Africa Abuja Declaration, 15%

14. Taxes on medicines

15. Human Resources, Africa

16. Dissemination and use of information collected A Senior Official from the Ministry of Health will be asked to provide formal authorization to disseminate the data; Country profiles information aims to contribute to health policy dialogue/process in countries (e.g. CHIP; MeTA; etc.) And to the: Development of narrative Pharmaceutical Sector Country Profiles; Display of information collected into key databases such as WHO Global Health Observatory, Regional Health Observatories (e.g. PAHO); Development of global and regional reports on the pharmaceutical situation (geographical and technical scope).

17. Global and Regional Reports • Web Publications of Country Profiles and Data available at: http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index1.html • Regional Reports for AFRO, EURO, WPRO produced by Regional Offices and Utrecht University CC • Global Report produced by HQ Team, University of Utrecht CC, Jonny Meldrum, Catherine Shih • Technical Reports on • Financing and pricing • Selection • Rational Use

18. Country Profiles:alignment between WHO and TGF During 2010, WHO-EMP and GF worked together to harmonize their tools: June-September 2010: series of technical meetings between WHO and GF staff to agree on a common instrument. PART 1- Context and System Description (country-specific) Fully Harmonized with WHO. PART 2- Operational Systems in Place (specific to the Principal Recipient). • An MOU has been signed between WHO and GF to collaborate on data collection in 75 priority countries. In these countries WHO takes the lead for the common tool (PART I) and will support GF Principal Recipients to fill in PART II

19. Objectives of the Country Profile approach Move away from the existing project-based approach. With PSM Plans, the same information has to be submitted separately for each grant, and even if the Principal Recipient is the same, Reduce the number of iterations associated with the Standard PSM Plan approval process, Avoid the duplication of information collected by countries and provided to the Global Fund, Minimize the Grant signing requirements of Principal Recipients, Contribute to standardizing the conditions included in Grant Agreements.

20. Example:Thailand SSF 2011 with Country Profile Update Procurement Plan to reflect HIV SSF (Round 10) Mal SSF R10 Procurement Plan Update Procurement Plan to reflect TB SSF (Round 10)