The WHO Medicines Strategy 2008-2013, and the Global Action Plan on Public Health, Innovation and...

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


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


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


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


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


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)


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


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)


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


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


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


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


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)


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


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


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


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)


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


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


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)


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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