The WHO Medicines Strategy 2008-2013 Kees de Joncheere Essential Medicines and Health products November 2012

The WHO Medicines Strategy 2008-2013

Kees de JoncheereEssential Medicines and Health products

November 2012

http://apps.who.int/medicinedocs/documents/s16821e/s16821e.pdf

http://apps.who.int/medicinedocs/en/m/abstract/Js16880e/

2 WHO Essential Medicines

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


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


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


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


Examples of country progress in supply:

Country progress in supply

0

10

20

30

40

50

60

70

80

90

100

1999 2003 2007

Pe

rce

nta

ge

se

lf-r

ep

ort

ed 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, 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


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


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 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



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



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


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



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;


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.


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


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)


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


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


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

Documents

The WHO Medicines Strategy 2008-2013 Kees de Joncheere Essential Medicines and Health products November 2012