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
 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

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 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

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 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

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 Example of impact of earlier Medicine Strategies:
Progress in national medicine policies

100
Percentage self-reported

Countries with
80 national assessment
conducted
60
Countries with
40 new/updated national
medicine policy
20 Countries with
updated policy
0 implementation plan
1999 2003 2007

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 Examples of country progress in supply:

Country progress in supply

100
90
Percentage self-reported

Public sector
80 procurement largely
70 limited to national EML
60 HIV/AIDS medicines
50 provided free in public
40 facilities
30 Generic substitution
20 allowed in private
10 pharmacies
0
1999 2003 2007

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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, 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)

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 Strategic landscape:
Medicine-related Millennium Development Goals
MDGs Medicine-related targets by 2015 Medicine-related indicators
Goal 4: Reduce Target 5: Reduce <5 mortality rate by 2/3 13. Under-five mortality rate
child mortality 14. Infant mortality rate
Goal 5: Improve Target 6: Reduce maternal mortality by ¾ 16. Maternal mortality ratio
maternal health
Goal 6: Combat Target 7: Reversed spread of HIV/AIDS 18. HIV prevalence in pregnancy
HIV/AIDS, malaria 19. % condom use in contraception
and other diseases
Target 8: Reversed malaria incidence 21. Malaria prevalence and death rates
22. Use of malaria prevention and treatment
23. TB prevalence and death rates
24. Proportion cured with DOTS
Goal 8: Develop a Target 12: Open, rule-based, predictable,
global partnership non-discriminatory trading and financial
for development system
Target 13: Address special needs of least
developed countries
Target 17: In cooperation with 46: Proportion of population with
pharmaceutical companies, provide access to sustainable access to affordable essential
affordable, essential drugs in developing drugs
countries

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 (Quantified
Number intuition)
of people (billions)
6
5
New standard set of indicators for measuring 4
No regular
access

access for WHO/MTSP, UNDP/MDG8 Gap Analysis 3

2
Regular
access to
essential

and Lancet assessment 1 drugs

0
1977 1987 1997

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)

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 WHO strategic directions in medicines
1: 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

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 WHO strategic directions in medicines
1: 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

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 WHO strategic directions in medicines
2: 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
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 WHO strategic directions in medicines
3: 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

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 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)

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 The Global Strategy on
Public Health, Innovation and Intellectual Property

1. Prioritizing research and development needs

2. Promoting research and development
3. Building and improving innovative capacity
4. Transfer of technology
5. Management of IPR to contribute to innovation and promote public
health
6. Improving delivery and access
7. Promoting sustainable financing mechanisms
8. Establishing monitoring and reporting systems

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 The Global strategy on
Public Health, Innovation and Intellectual Property
Follow-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

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 Relation between the WHO Medicines Strategy 2008-2013
and the Global Plan of Action for 2008-2015

Global Strategy on Public

WHO Medicines Strategy Health, Innovation and
Intellectual Property Rights

R&D gaps,
Quality norms, selection, IPR issues,
standards, prequalification, R&D capacity,
medicine traditional medicines, vaccines,
policies, regulatory support, technology,
rational use, transfer of technology, health care
PHC, human production, financing
rights, good access,
governance supply

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 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)

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 WHO/EMP has many implementation channels

WHO Department of EMP

WHO: UN: IPC NGOs:

Regional Offices HIV, MAL, UNICEF, MSF, HAI,

TB, RH, UNAIDS, MSH, JSI
MSD,CAH UNFPA, churches,
Country Offices WBank, networks,
GFATM, WMA, FIP,
WIPO, etc IGPA,
IFPMA,
MOH Outside MOH: WSMI, etc
Drug regul. agency, insurance,
collab.centers, universities,
missions, NGOs, consumers

National programmes for health professionals, patients and consumers

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 Essential Medicines and Pharmaceutical Policies (EMP)
Hans V. Hogerzeil
Director
International Medical Products
Anti Counterfeit Taskforce
(IMPACT) Secretariat
MIE MPC V.Reggi,
Medicine Information Medicine Programme
Executive Secretary
and Evidence for Policy Coordination
R.Laing, Team Leader G.Forte, Coordinator

MAR QSM TRM

Medicine Access Quality and Safety: Traditional
and Rational Use Medicines Medicine
C.Ondari, Coordinator L.Rägo, Coordinator X.Zhang, Coordinator
• Selection of ess. medicines • INN programme • Norms and standards
• Pricing and financing • Quality Assurance • Policy and regulation
• Supply management • Safety and Efficacy • Technical Support
• Rational Use • Prequalification
• Good governance • Assessment
• Inspection
• Capacity building
• Regulatory support
• Controlled medicines
• Blood products and
related biologicals
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 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)

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 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

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