Presentation on theme: "World Health Organization"— Presentation transcript:
1World Health Organization 8 April 2017Good governance in the pharmaceutical sectorGilles ForteDeirdre DimancescoCécile MacéDepartment of Essential Medicines and Health ProductsSide event at the 66th WHA
2Ten leading causes of inefficiency World Health Report 2010, Chapter 4 1. Medicines: underuse of generics and higher than necessary prices formedicines6. Health-care services: inappropriate hospital admissions and length of stay2. Medicines: use of substandard andcounterfeit medicines7. Health-care services: inappropriate hospital size (low use of infrastructure)3. Medicines: inappropriateand ineffective use8. Health-care services: medical errors andsuboptimal quality of care4. Health-care products and services:overuse or supply of equipment,investigations and procedures9. Health system leakages: waste, corruption and fraud5. Health workers: inappropriate or costlystaff mix, unmotivated workers10. Health interventions: inefficient mix/inappropriate level of strategiesFrom 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.»
3Falsification safety/ R&D and clinical trials Inefficiencies and unethical practices can occur throughout the medicines supply chainConflict of interestPressureFalsification safety/efficacy dataState CaptureBriberyPatentR&D and clinical trialsManufacturingInspectionDistributionRegistrationSelectionProcurement & importPricingPrescriptionDispensingPharmacovigilanceR&DprioritiesCartelsTheftsOver-invoicingTax evasionCounterfeit/substandardCollusionUnethicaldonationsHigh pricesWasteLossesPromotionThroughout 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.InappropriateuseUnethicalpromotion
4Why improve good governance in the pharmaceutical sector To improve health, health service delivery and access to quality and affordable medicinesTo contribute to Universal Health Coverage, through reduced inefficiencies, unethical behavior and corruptionTo establish relevant structures and processes for efficient implementation of medicines policies and the enforcement of laws and regulations in countriesTo increase transparency, accountability and ethical management of pharmaceutical systemsTo improve public trust and confidence on the health system and prevent misuse of public, patients and donors funds
5Common elements of governance relevant to the pharmaceutical sector World Health Organization8 April 2017Common elements of governance relevant to the pharmaceutical sectorTransparencyAccountabilityParticipationConsensusEthicsEfficiencyInformationRule of lawRegulationLeadershipEquityEfficacyPolicy formulation & planningThere is no ideal/universal definition of Good GovernanceSelection of Good Governance elements is based on established hypothesis (e.g. MeTA); country contexts and priorities; and on principles and values
6WHO contribution to good governance in the pharmaceutical sector World Health Organization8 April 2017GGMMeTALeadershipEthicsAnti-corruptionRule of lawRegulationTransparencyParticipationAccountabilityEfficiencyPolicyInformationCurrently WHO is implementing two programmes to improve transparency and good governance in the pharmaceutical sectorThe 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 partnershipBetter access to medicines
7WHO Good Governance for Medicines programme (GGM) GoalTo contribute to health systems strengthening and to prevent corruption by promoting good governance in the pharmaceutical sectorSpecific objectivesTo raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agendaTo increase transparency and accountability in medicine regulatory and supply management systemsTo promote individual and institutional integrity in the pharmaceutical sectorTo institutionalize good governance in pharmaceutical systems by building national capacity and leadershipToday we will focus on the Good Governance for Medicines programme, called GGM
8Good Governance for Medicines programme: a model process PHASE IIDevelopmentnational GGMframeworkPHASE IIIImplementationprogrammePHASE INationaltransparencyassessmentClearanceMOHGGM integratedin MoH planGGM 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 reportGGM frameworkofficiallyadopted
9World Health Organization 8 April 2017Today 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.
10National Transparency Assessment PHASE IIPHASE IPHASE IIINational Transparency AssessmentAssesses transparency and vulnerability to corruption of pharmaceutical systemsLooks at key functions such as:Regulation: registration, licensing, inspection, promotion, clinical trialsSupply: selection, procurement, distributionElements evaluated:Regulations and official documentsWritten procedures and decision-making processesCommittees, criteria for membership and conflict of interest policyAppeals mechanisms and other monitoring systemsAssessment reportNational transparency assessments available (33 countries) and published (17 countries)
11Development of a GGM Framework PHASE IIPHASE IPHASE IIIDevelopment of a GGM Framework"Discipline-based approach"Aims to put into place laws, policies and procedures for the pharmaceutical sector and against corruptionAttempts to prevent unethical and corrupt practices through fear of sanctions on reprehensible acts"Values-based approach"Attempts to motivate ethical conduct of public servantsPromotes institutional and individual integrity through promotion of ethical principlesGGM 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 frameworkofficiallyadopted
12Implementation of National GGM Programme PHASE IIPHASE IPHASE IIIIncrease 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 placeAdoption of codes of conduct for people working in the pharmaceutical sector; Development and adoption of policies on conflicts of interestClarification of TORs and selection criteria for various committeesGGM fully institutionalized, funded by government budget and part of the anti-corruption national planRegular training sessions on ethical leadership and Good Governance at national and regional levelGGM included in the curricula of pharmacy studentsGGM integratedin MoH planTranslation 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 activity1- Mongolia and Thailand2- Lebanon and Philipinnes3- Malaysia, Jordan, Thailand4- Mongolia, Malawi5- Thailand, Philipinnes6- Malaysia, Mongolia7- Mongolia, Thailand
13Next 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.