World Health Organization 8 April 2017 Good governance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco Cécile Macé Department of Essential Medicines and Health Products Side event at the 66th WHA

Ten leading causes of inefficiency World Health Report 2010, Chapter 4 1. Medicines: underuse of generics and higher than necessary prices for medicines 6. Health-care services: inappropriate hospital admissions and length of stay 2. Medicines: use of substandard and counterfeit medicines 7. Health-care services: inappropriate hospital size (low use of infrastructure) 3. Medicines: inappropriate and ineffective use 8. Health-care services: medical errors and suboptimal quality of care 4. Health-care products and services: overuse or supply of equipment, investigations and procedures 9. Health system leakages: waste, corruption and fraud 5. Health workers: inappropriate or costly staff mix, unmotivated workers 10. Health interventions: inefficient mix/ inappropriate level of strategies From the 2010 WHR, out of the 10 leading causes of health system inefficiency, 4 are related to medicines: prices, quality, use and waste. Waste could be attributed to medicines supply chain inefficiencies, unethical practices and corruption. In the WHR 2010, it is estimated that «Reducing unnecessary expenditure on medicines and using them more appropriately, and improving quality assurance, could save countries up to 5% of their health expenditure.»

Falsification safety/ R&D and clinical trials Inefficiencies and unethical practices can occur throughout the medicines supply chain Conflict of interest Pressure Falsification safety/ efficacy data State Capture Bribery Patent R&D and clinical trials Manufacturing Inspection Distribution Registration Selection Procurement & import Pricing Prescription Dispensing Pharmacovigilance R&D priorities Cartels Thefts Over- invoicing Tax evasion Counterfeit/ substandard Collusion Unethical donations High prices Waste Losses Promotion Throughout the various steps of the medicine supply chain, from Research and production and up to prescription and dispensing, inefficiencies, unethical practices and corruption can lead to weaker pharmaceutical systems and waste of financial resources that could have been reallocated to cover more services, more medicines and more people. Inappropriate use Unethical promotion

Why improve good governance in the pharmaceutical sector To improve health, health service delivery and access to quality and affordable medicines To contribute to Universal Health Coverage, through reduced inefficiencies, unethical behavior and corruption To establish relevant structures and processes for efficient implementation of medicines policies and the enforcement of laws and regulations in countries To increase transparency, accountability and ethical management of pharmaceutical systems To improve public trust and confidence on the health system and prevent misuse of public, patients and donors funds

Common elements of governance relevant to the pharmaceutical sector World Health Organization 8 April 2017 Common elements of governance relevant to the pharmaceutical sector Transparency Accountability Participation Consensus Ethics Efficiency Information Rule of law Regulation Leadership Equity Efficacy Policy formulation & planning There is no ideal/universal definition of Good Governance Selection of Good Governance elements is based on established hypothesis (e.g. MeTA); country contexts and priorities; and on principles and values

WHO contribution to good governance in the pharmaceutical sector World Health Organization 8 April 2017 GGM MeTA Leadership Ethics Anti-corruption Rule of law Regulation Transparency Participation Accountability Efficiency Policy Information Currently WHO is implementing two programmes to improve transparency and good governance in the pharmaceutical sector The Good Governance for Medicines Programme (GGM) The Medicine Transparency Alliance (MeTA) in collaboration with HAI. These two programmes have in common 5 core elements, meanwhile other elements are programme specific e.g. Ethics, Rule of law etc. WHO integrates transparency and good governance into the work done on pharmaceutical policies in countries e.g. EC partnership Better access to medicines

WHO Good Governance for Medicines programme (GGM) Goal To contribute to health systems strengthening and to prevent corruption by promoting good governance in the pharmaceutical sector Specific objectives To raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agenda To increase transparency and accountability in medicine regulatory and supply management systems To promote individual and institutional integrity in the pharmaceutical sector To institutionalize good governance in pharmaceutical systems by building national capacity and leadership Today we will focus on the Good Governance for Medicines programme, called GGM

Good Governance for Medicines programme: a model process PHASE II Development national GGM framework PHASE III Implementation programme PHASE I National transparency assessment Clearance MOH GGM integrated in MoH plan GGM is a 3 phase model: Phase I for carrying out a National Transparency Assessment and assess vulnerability to corruption; Phase II for the development of a national GGM Framework/programme and Phase III for implementation of the GGM programme in the country. Assessment report GGM framework officially adopted

World Health Organization 8 April 2017 Today 36 countries are implementing GGM: 13 countries/territory in Phase I, 11 countries in Phase II and 12 countries in Phase III. Both, Malawi and Thailand are in Phase III.

National Transparency Assessment PHASE II PHASE I PHASE III National Transparency Assessment Assesses transparency and vulnerability to corruption of pharmaceutical systems Looks at key functions such as: Regulation: registration, licensing, inspection, promotion, clinical trials Supply: selection, procurement, distribution Elements evaluated: Regulations and official documents Written procedures and decision-making processes Committees, criteria for membership and conflict of interest policy Appeals mechanisms and other monitoring systems Assessment report National transparency assessments available (33 countries) and published (17 countries)

Development of a GGM Framework PHASE II PHASE I PHASE III Development of a GGM Framework "Discipline-based approach" Aims to put into place laws, policies and procedures for the pharmaceutical sector and against corruption Attempts to prevent unethical and corrupt practices through fear of sanctions on reprehensible acts "Values-based approach" Attempts to motivate ethical conduct of public servants Promotes institutional and individual integrity through promotion of ethical principles GGM Phase 2 is about the development of a national GGM framework or policy which is carried out through a national consultative process involving key stakeholders. Task forces and steering committees including other stakeholders (MoH, other ministries, anti-corruption commission, NGOs, private sector) are put in place to develop national frameworks. National framework identifies interventions necessary to address gaps identified in the Transparency Assessment. GGM framework officially adopted

Implementation of National GGM Programme PHASE II PHASE I PHASE III Increase of information publicly available (regulations, laws, procedures, inspection reports, procurement contracts and tenders, web-based platforms with procurement prices…) Revision of policies and procedures; Operational guidelines developed; Appeal mechanisms put in place Adoption of codes of conduct for people working in the pharmaceutical sector; Development and adoption of policies on conflicts of interest Clarification of TORs and selection criteria for various committees GGM fully institutionalized, funded by government budget and part of the anti-corruption national plan Regular training sessions on ethical leadership and Good Governance at national and regional level GGM included in the curricula of pharmacy students GGM integrated in MoH plan Translation of the GGM national frameworks into action. Institutionalization and fully integrated within the MoH. 13 countries in Phase III, implementation of GGM, including Malawi and Thailand. Examples of countries by activity 1- Mongolia and Thailand 2- Lebanon and Philipinnes 3- Malaysia, Jordan, Thailand 4- Mongolia, Malawi 5- Thailand, Philipinnes 6- Malaysia, Mongolia 7- Mongolia, Thailand

Next steps/Final words Develop methodologies for assessing good governance interventions and their impact on reducing inefficiencies and on improving access to quality and affordable medicines. Strengthen WHO support to countries for good governance in pharmaceutical and health systems as a contribution to the achievement of universal health coverage. Facilitate sharing of experiences among countries and explore synergies with other partners and sectors.