The WHO Medicines Strategy 2008-2013, and the Global Action Plan on Public Health, Innovation and Intellectual Property Hans V. Hogerzeil, MD, PhD, FRCP Edin Director, Essential Medicines and Pharmaceutical Policies March 2009
Jan 18, 2018
The WHO Medicines Strategy 2008-2013, andthe Global Action Plan on Public Health,
Innovation and Intellectual Property
Hans V. Hogerzeil, MD, PhD, FRCP Edin
Director, Essential Medicines and Pharmaceutical Policies
March 2009
2 WHO Essential Medicines
Outline of the presentation
Trends in the pharmaceutical scene, strategic landscape The WHO Medicines Strategy for 2008-2013:
Access Quality Rational use
The Global Action Plan of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property
The relation between WMS and IGWG The Essential Medicines Family Potential areas of collaboration
3 WHO Essential Medicines
Trends in global pharmaceutical situation,new challenges for 2008-2013 (1)
Recognition that vertical programmes need an integrated approach with horizontal health systems, supply systems
More interest in medicine quality and quality assurance systems; this implies the need for practical global standards and support to national regulatory agencies
Several new global funding mechanisms for essential medicines; these need global health policy direction, global standards and technical support from WHO
More players and partnerships, complicating the landscape; these need a multi-stakeholder ("MOH-plus") approach and coordination at country level
4 WHO Essential Medicines
Trends in global pharmaceutical situation,new challenges for 2008-2013 (2)
IPR interest shifting from global TRIPS discussion towards technical support to countries; new focus on innovation and public health, inter-governmental process
More interest of Middle Income Countries in medicine issues such as pricing, reimbursement and quality; need for relevant standards and high-level technical support
DG priorities (PHC, Africa, women) implies the need to re-shape PHC, renewed focus on public sector and essential medicines, new focus on reimbursement schemes
Recent WHA resolutions (prices, IPR, rational use, medicines for children); this implies the need for fundraising and recruitment to expand work in these areas
5 WHO Essential Medicines
Example of impact of earlier Medicine Strategies:
Progress in national medicine policies
0
20
40
60
80
100
1999 2003 2007
Perc
enta
ge s
elf-
repo
rted Countries with
national assessmentconductedCountries withnew/updated nationalmedicine policyCountries withupdated policyimplementation plan
6 WHO Essential Medicines
Examples of country progress in supply:
Country progress in supply
0102030405060708090
100
1999 2003 2007
Perc
enta
ge s
elf-r
epor
ted Public sector
procurement largelylimited to national EML
HIV/AIDS medicinesprovided free in publicfacilities
Generic substitutionallowed in privatepharmacies
7 WHO Essential Medicines
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, IGWG Strategic Plan 2008-15 Stated priorities of the new Director-General
MDGs, Universal Access through PHC/Health Systems; evidence-based policies; partnerships; health-in-all-policies
Other country needs (if not included in above)
8 WHO Essential Medicines
Strategic landscape:Medicine-related Millennium Development Goals
MDGs Medicine-related targets by 2015 Medicine-related indicatorsGoal 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
9 WHO Essential Medicines
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)
10 WHO Essential Medicines
WHO strategic directions in medicines1: Policy, access (1)
National medicine policies: Continue national policies; new focus on comprehensive PHC, health insurance; in countries more focus on strategic components of medicines policy
Intellectual Property Rights: Continue technical support; new focus on IPR and innovation, new approach to medicine patents
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
11 WHO Essential Medicines
WHO strategic directions in medicines1: Policy, access (2)
Comprehensive supply systems: Continue promotion of best practices; new focus on private sector, transparency and regulatory approach
Transparency and good governance: New policy guidance on transparency and good governance in pricing, procurement, registration; use to strengthen comprehensive 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
New global funding mechanisms: Continue country support; new focus on guidance and technical support to global funds
12 WHO Essential Medicines
WHO strategic directions in medicines2: Quality
Nomenclature: Continue INN and other nomenclatures; new focus on methods to assign names to biological products
Controlled drugs: Continue treaty obligations on scheduling; new focus on improving access to controlled medicines
Quality: Continue normative work (Expert Committees); new focus on missing EMs for priority diseases and children; tools for assessment of regulatory and supply agencies; regional coordination (link to economic blocs)
Prequalification: Continue PQ of priority medicines; new focus on QClabs, APIs, CROs; advice to diagnostics, RH commodities, vaccines; strong focus on capacity building
Combating counterfeits: Continue developing IMPACT partnership; focus on practical implementation of strategy
13 WHO Essential Medicines
WHO strategic directions in medicines3: Rational use
Selection: Continue evidence-based Model List and EM Library; new focus on EMs for children, methodological guidance within WHO (Guidelines Development Group)
Rational use: Continue global database; 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; fund-raising
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
14 WHO Essential Medicines
Intergovernmental Working Group on Public Health, Innovation and Intellectual Property
WHO Commission on Intellectual Property Rights, Innovation and Public Health established in 2004, report in April 2006 (53 recommendations)
WHA resolution (2006) establishes an Intergovernmental Working Group (IGWG) to draw up a global strategy and plan of action for needs-driven, essential health research and development for diseases that disproportionately affect developing countries
WHA resolution (2008) endorses Global Plan of Action Aim: Promote innovation, build capacity, improve access,
mobilize resources Global Plan of Action has 8 components (see next slides)
15 WHO Essential Medicines
The Global Strategy on Public Health, Innovation and Intellectual Property
1. Prioritizing research and development needs2. Promoting research and development3. Building and improving innovative capacity4. Transfer of technology5. Management of IPR to contribute to innovation and promote public
health6. Improving delivery and access 7. Promoting sustainable financing mechanisms 8. Establishing monitoring and reporting systems
16 WHO Essential Medicines
The Global strategy onPublic Health, Innovation and Intellectual PropertyFollow-up action
WHO prepares timeframes, progress indicators and estimated funding needs for Executive Board and WHA in 2009
WHO expert working group on R&D financing for expertise and strategic guidance
Quick Start Programme to implement a number of specific actions under the responsibility of WHO
(i) mapping of global R&D activities, identification of research gaps (ii) supporting R&D and standards setting for traditional medicines (iii) strengthening regulatory capacity in developing countries (iv) development of a monitoring and reporting framework
Create a database of possible sources of financing for R&D Global costing of the Global Action Plan
17 WHO Essential Medicines
Relation between the WHO Medicines Strategy 2008-2013 and the Global Plan of Action for 2008-2015
WHO Medicines StrategyGlobal Strategy on Public Health, Innovation and Intellectual Property Rights
Quality norms, standards,medicine policies,rational use, PHC, human rights, good governance
R&D gaps,selection,
prequalification,traditional medicines,
regulatory support,transfer of technology,
production,access,supply
IPR issues, R&D capacity, vaccines, technology, health care financing
18 WHO Essential Medicines
Global Medicines Family
Geneva: Department of Essential Medicines and Pharmaceutical Policies 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) Interagency Pharmaceutical Coordination (all UN agencies)
19 WHO Essential Medicines
WHO/EMP has many implementation channels
MOH Outside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers
Regional Offices
WHO:
HIV, MAL, TB, RH, MSD,CAH
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
20 WHO Essential Medicines
Essential Medicines and Pharmaceutical Policies (EMP)
MARMedicine Accessand Rational Use
C.Ondari, Coordinator
TRMTraditionalMedicine
X.Zhang, Coordinator
QSMQuality and Safety:
MedicinesL.Rägo, Coordinator
Hans V. HogerzeilDirector
MIEMedicine Information
and Evidence for PolicyR.Laing, Team Leader
International Medical ProductsAnti Counterfeit Taskforce
(IMPACT) SecretariatV.Reggi,
Executive Secretary
• Selection of ess. medicines• Pricing and financing• Supply management• Rational Use• Good governance
• INN programme• Quality Assurance• Safety and Efficacy• Prequalification
• Assessment• Inspection• Capacity building
• Regulatory support• Controlled medicines• Blood products and related biologicals
• Norms and standards• Policy and regulation• Technical Support
MPCMedicine Programme
CoordinationG.Forte, Coordinator
21 WHO Essential Medicines
New areas of work (currently unfunded)
Combating counterfeit medicines Access to controlled medicines (analgesics, drug abuse) Promoting rational medicine use, antimicrobial resistance Access to therapeutic sera (antirabies, snake, scorpions) Production of global reference standards (Sweden withdrew)Recently (partly) funded Essential Medicines for Children (Gates Foundation) Pharmacovigilance for new EMs for HIV (Gates Foundation) Good Governance for Medicines (Germany)
22 WHO Essential Medicines
Conclusion: Essential Medicines in March 2009
Good news: World Medicines Strategy 2008-2013 nearly complete Better access indicators now used for UN/MDGs, MTSP, others 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: WHO Medicines Programme has nearly become an NGO
RB 12-20%, CVC 10-12%, Specified Project Funding >70% Government contributions stable, foundations strongly increasing No donor interest in rational use, comprehensive country support