The WHO Medicines Strategy 2008-2013
Kees de JoncheereEssential Medicines and Health products
November 2012
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Outline of the presentation
The global pharmaceutical scene, and the strategic landscape
The WHO Medicines Strategy for 2008-2013: Access Quality Rational use
The Essential Medicines Family
Potential areas of collaboration
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Trends in global pharmaceutical situation,challenges for 2008-2013 (1)
Recognition that disease-oriented vertical programmes need an integrated approach with horizontal health systems, supply systems
More interest in medicine regulation and quality assurance systems; this implies the need for practical global standards and support to national regulatory agencies
Global funding mechanisms for essential medicines; these need global health policy direction, global standards and technical support from WHO
More players and partnerships, changing the landscape; these need a multi-stakeholder ("MOH-plus") approach and coordination at country level
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Trends in global pharmaceutical situation,new challenges for 2008-2013 (2)
IPR interest moving from global TRIPS discussion towards technical support to countries; focus on innovation and public health
Move towards Universal Health Coverage and with it comprehensive policies on access to medical products
WHO Reform and DG priorities : PHC and UHC, Access to medical products, Africa, women and children, NCD
Recent WHA resolutions (prices, IPR, rational use, medicines for children, SSFFC, UHC); this implies the need for additional funding to expand work in these areas
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Example of impact of earlier Medicine Strategies:
Progress in national medicine policies
0
20
40
60
80
100
1999 2003 2007
Pe
rce
nta
ge
se
lf-r
ep
ort
ed
Countries withnational assessmentconducted
Countries withnew/updated nationalmedicine policy
Countries withupdated policyimplementation plan
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Examples of country progress in supply:
Country progress in supply
0
10
20
30
40
50
60
70
80
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100
1999 2003 2007
Pe
rce
nta
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se
lf-r
ep
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ed Public sector
procurement largelylimited to national EML
HIV/AIDS medicinesprovided free in publicfacilities
Generic substitutionallowed in privatepharmacies
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WHO Medicines Strategy 2008-2013 Strategic landscape
Experiences from 2000-03 and 2004-07 Medicine Strategies Millennium Development Goals 2000-2015 WHO Medium Term Strategic Plan 2008-2013
Strategic Objective 11 covers access, quality, rational use
Recent WHA resolutions Rational use, EMs for children, Global strategy on PH/I/IP 2008-
15, SSFFC, UHC, NCDs, …
Stated priorities of the Director-General NCDs, Women and children, UHC, Access to medical products
Global Programme of Work 2014-2018 and post-MDG agenda
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Strategic landscape:Medicine-related Millennium Development Goals
MDGs Medicine-related targets by 2015 Medicine-related indicators
Goal 4: Reduce child mortality
Target 5: Reduce <5 mortality rate by 2/3 13. Under-five mortality rate14. Infant mortality rate
Goal 5: Improve maternal health
Target 6: Reduce maternal mortality by ¾ 16. Maternal mortality ratio
Goal 6: Combat HIV/AIDS, malaria and other diseases
Target 7: Reversed spread of HIV/AIDS 18. HIV prevalence in pregnancy19. % condom use in contraception
Target 8: Reversed malaria incidence 21. Malaria prevalence and death rates22. Use of malaria prevention and treatment23. TB prevalence and death rates24. Proportion cured with DOTS
Goal 8: Develop a global partnership for development
Target 12: Open, rule-based, predictable, non-discriminatory trading and financial system
Target 13: Address special needs of least developed countries
Target 17: In cooperation with pharmaceutical companies, provide access to affordable, essential drugs in developing countries
46: Proportion of population with sustainable access to affordable essential drugs
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New standard set of indicators for measuring access for WHO/MTSP, UNDP/MDG8 Gap Analysisand Lancet assessment
Government commitment: Access to essential medicines/technologies as part of the fulfillment of the
right to health, recognized in the constitution or national legislation (S) Existence and year of a published national medicines policy (S)Rational selection: Existence and year of a published national list of essential medicines (S)Affordable prices: Legal provisions to allow generic substitution in private sector (S) Median consumer price ratio of 30 selected EMs in pub/private facilities (P) Percentage mark-up between manufacturers' and consumer price (P)Sustainable financing: Public and private per capita expenditure on medicines (P) % of population covered by national health service or health insurance (P)Reliable systems: Average availability of 30 selected EMs in public/private health facilities (O)
Number of people (billions)
0
1
2
3
4
5
6
1977 1987 1997
No regularaccess
Regularaccess toessentialdrugs
(Quantified intuition)
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WHO strategic directions in medicines
1: Policy, access (1)
National medicine policies: Continue strengthening national policies; new focus on comprehensive PHC, health insurance, UHC;
Intellectual Property Rights: Global discussions to continue; provide technical support to countries; new focus on IPR and innovation, renewed interest in local production
Traditional medicine: Continue support on regulating quality and safety; new focus on integrating with allopathic medicine policies, promoting evidence on efficacy, regulating products and professionals
Access: New focus on separate access indicators and on activities to promote availability, price and affordability
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WHO strategic directions in medicines
1: Policy, access (2)
Comprehensive supply systems: Continue promotion of best practices; focus on system building with procurement and supply, how to work with private sector, reimbursement arrangements, implementing policies on pricing of medicines
Transparency and good governance: New policy guidance on transparency and good governance in national pharmaceutical systems
Information and planning: Improve indicators and household surveys; new link with NHAs, IMS-data, IEP surveys to create package of country data and improve planning; new focus on sex-disaggregated statistics
Global funding mechanisms: Continue country support; new focus on guidance and technical support
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WHO strategic directions in medicines
2: Regulation and Quality (1)
Nomenclature: Continue INN and other nomenclatures; new focus on methods to assign names to biological products
Controlled drugs: Continue Treaty obligations on scheduling substances for international controls; focus on improving access to controlled medicines
Quality: Continue normative work (Expert Committees); the International Pharmacopeia; new focus on missing EMs for priority diseases and children;
Prequalification: Continue PQ of priority medicines; new focus on QClabs, APIs, CROs; advice to diagnostics, RH commodities, vaccines; strong focus on capacity building
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WHO strategic directions in medicines2: Regulation and Quality (2)
Strengthening national regulatory authorities and regulatory networking : ICDRA, regional and subregional initiatives, new drive towards global collaboration and convergence in medicines and medical products regulation
Combating SSFFC counterfeit medical products : designing and implementing a new Member State Mechanism
Pharmacovigilance: Continue global ADR programme; new focus on disease-specific cohort methods for priority diseases (malaria, HIV) and active steering of new global interest in pharmacovigilance
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WHO strategic directions in medicines
3: Rational use
Selection: Continue evidence-based Model List and EM Library; next meeting April 2013; include focus on EMs for children, methodological guidance within WHO (Guidelines Review Committee )
Rational use: Continue global database on medicines use indicators; new focus on national RU programmes (situation analysis, multi-
stakeholder approach, comprehensive health systems, national RU body);
new focus on antimicrobial resistance and adherence to chronic treatment;
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World Medicines Situation 2011
The third edition of the World Medicines Situation Report brings together new data on 24 key topics relating to pharmaceutical production and consumption, innovation, regulation and safety - in one place.
Topics include selection, procurement, supply management, rational use, financing and pricing. Cross-cutting chapters cover household medicines use, access and human rights, good governance, human resources and national medicines policies.
Each chapter of this report is written by a different author. Chapters are being published electronically, in batches, between April and December 2011. The new report updates the 1988 and 2004 reports.
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World Medicines Situation 2011
Introduction Global health trends: global burden of disease
and pharmaceutical needs Pharmaceutical consumption Medicine expenditures Released August 2011 Financing medicines Medicines prices, availability and affordability
Released April 2011 Access to medicines at the household level
(access to health care and medicines: burden of expenditures and risk protection)
Research and development of medicines Intellectual property, trade and medicines Regulation of medicines prices Quality of medicines: the challenge of
globalization Pharmacovigilance and Safety of Medicines
Released August 2011
Selection of Essential Medicines Released August 2011
Rational use of medicines Released April 2011 Medicines Information and regulation of promotion Procurement of Medicines Released August 2011 Storage and supply chain management of
medicines Traditional medicines: global situation, issues and
challenges Released April 2011 Access to controlled medicines Released April 2011 Good governance of pharmaceutical Sector
Released April 2011 Human resources in pharmaceuticals Access to Essential Medicines as Part of the Right
to Health Released August 2011 National medicines policy Conclusion
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Global Medicines Family
Geneva: Department of Essential Medicines and Health products EMP (about 100 staff)
Six regional offices: 2-5 professionals per office
40 of 100 WHO country offices have full-time pharmaceutical policy experts (about half of them funded through EC funds)
Many external networks: Six Expert Advisory Panels (quality, policy, narcotics, selection, etc) About 50 WHO Collaborating Centres (centres of excellence) Regulators, inspectors, laboratories, INRUD, HAI, safety, INN, pricing E-drug, Re-med, e-farmacos, india-drug, etc (over 8000 subscribers) Mednet Interagency Pharmaceutical Coordination (all UN agencies)
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WHO/EMP has many collaboration and implementation channels
MOH Outside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers
Regional Offices
WHO:
HIV, MAL, TB, RH, MSD,CAH, HSS (Trad Med)
UN:
UNICEF, UNAIDS, UNFPA, WBank, GFATM,WIPO, etc
Country Offices
WHO Department of EMP
NGOs:
MSF, HAI, MSH, JSI churches, networks, WMA, FIP, IGPA, IFPMA, WSMI, etc
National programmes for health professionals, patients and consumers
IPC
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Essential Medicines and Health Products
MARMedicine Accessand Rational Use
C.Ondari, Coordinator
QSMQuality and Safety:
MedicinesL.Rägo, Coordinator
• Selection of Ess. medicines• Pricing and financing• Supply management• Rational Use• Controlled medicines
• INN programme• Quality Assurance• Safety and Efficacy• Prequalification
• Assessment• Inspection• Capacity building
• Regulatory support• Blood products and related biologicals
MPCMedicine Programme
CoordinationG.Forte, Coordinator
Incorporating MIE
• Country programme coordination & support
• Policy guidance• Country profiles• Good governance &
MeTA
DIM and DLT Essential Health Technology
& Medical devicesGaby Vercauteren and
Adriana Velazquez,Coordinators
• Prequalification of Diagnostics
• Policy guidance on Technology and medical devices
• Country Surveys• HTA
EMP : Kees de Joncheere, Director
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Conclusion: Essential Medicines in November 2012
Good news:
Working towards a new Essential Medicines Action Plan 2014 -2018
Better access indicators now used for UN/MDGs, and national programmes
Global norms/standards, prequalification, WHO/HAI pricing methods,
80 country projects and innovative public health thinking lead to solid international reputation, trust by Member States
Bad news:
Financial uncertainty RB + CVC 10-15%, Specified Project Funding >80%, and “pockets of
poverty” , i.e. rational use, supply issues