department for essential medicines and health products (emp) - areas of work

WHO-Technical Briefing Seminar | October-November 2012Gilles Forte

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WHO Technical Briefing Seminar Geneva 29 October- 02 November 2012

WHO Strategy for working with and in countries

Dr Gilles ForteEssential Medicines and

Health Product DepartmentMedicine Programme Coordination (MPC)

WHO Technical Briefing Seminar Geneva 29 October- 02 November 2012

WHO Strategy for working with and in countries

Dr Gilles ForteEssential Medicines and

Health Product DepartmentMedicine Programme Coordination (MPC)


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Department for Essential Medicines and Health Products (EMP) - areas of work

Department for Essential Medicines and Health Products (EMP) - areas of work

Medicines Access and Rational UseRational use and ant-microbial resistanceSelection of essential medicinesSupply systems; Psychotropics & narcotics, including substance evaluationAccess controlled meds

Quality Assurance and Safety: MedicinesNorms/standards (nomenclature)Quality assurance (incl. blood products)Safety / pharmacovigilancePrequalification of medicines; Regulation

Medicines Policy, Information and Country SupportIndicators and tools for pharmaceutical sector monitoring & assessmentMedicines Policy; country collaboration and supportTransparency & Good governance in medicinesPublications & website

Medical Devices and Diagnostics Policies, norms/standardsPrequalification, quality and safetyManagement; Access & use; Regulation


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Mandate and ResolutionsMandate and Resolutions

WHO Constitution:

Article 1: “The Objective of WHO shall be the attainment by all peoples of the highest possible level of health”;

Article 2: “(a) to establish and maintain effective collaboration with governmental health administrations; (b) to assist Governments upon request, in strengthening health services; (c) to furnish appropriate technical assistance and, in emergencies, necessary aid upon the request or acceptance of Governments”;

Resolutions: Rational use WHA 60.16/2007; Essential Medicines for Children WHA 60.20/2007; Pricing: WHA 54.11/2001; Availability WHA 57.14/2004;


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Implementation of the WHO Medium-Term Implementation of the WHO Medium-Term Strategic Plan 2008-2013 :Strategic Plan 2008-2013 :

Implementation of the WHO Medium-Term Implementation of the WHO Medium-Term Strategic Plan 2008-2013 :Strategic Plan 2008-2013 :

Strategic Objective (SO-11) : To ensure improved access, quality and use of medical products and technologies

Organization-wide expected results : (OWERs)11.1 Formulation and monitoring of comprehensive national policies on

access, quality and use of essential medical products and technologies advocated and supported;

11.2 International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies developed and their national and/or regional implementation advocated and supported;

11.3 Evidence-based policy guidance on promoting scientifically sound and cost-effective use of medical products and technologies by health workers and consumers developed and supported within the Secretariat and regional and national programmes.


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WHO added value for working with countries

WHO added value for working with countries

Development of norms, standards, guidelines; (e.g. Expert Committees; Advisory Committees)

Access to information and expertise in the health and pharmaceutical sector for global advocacy (e.g. pool of experts; collaborating centres).

Expertise and operational capacity at country level for advocacy, policy advice and capacity building in line with country needs;

Convening power for effective collaboration, coordination and policy dialogue among national and international stakeholders;

Monitoring and evaluation of policies: development of methodologies, tools and strengthening of countries' capacities.


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Regional Office AFRO Regional Office EMRO

Regional Office EURO Regional Office WPRO

Regional Office SEARO Regional Office AMRO

WHO: 193 Member States Regional and Sub-Regional Offices

WHO: 193 Member States Regional and Sub-Regional Offices

)Source: http://www.who.int/about/regions/en/index.html(

WHO HQ Geneva


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WHO Country Medicines Advisers and Collaborating Centres

WHO Country Medicines Advisers and Collaborating Centres

Collaborating CentreMedicines Adviser


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Coordination mechanisms for a sustainable collaboration with countries

WHO

HSS

EMP

AFRO

AMRO

EMRO

EURO

SEARO

WPRO

TanzaniaGhana

CameroonMaliUganda

PakistanEgypt

LybiaSudan

Jordan

Brazil

Zambia


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The WHO Country Medicines Advisers Network for Africa

• Assessing national medicines needs & priorities;

• Planning, Implementing, Monitoring and Evaluate WHO interventions;

• Facilitating coordination of partners;• WHO Regional work on medicines and

health systems;

50 Medicines Advisers in 40 countries (15 in Africa) contribute to:

BurundiCameroonCentral African Rep.CongoDemocratic Rep. of the CongoEthiopiaGhanaKenyaMaliNigeriaRwandaSenegalUgandaUnited Rep. of TanzaniaZambia

EAC

UEMOA

CEMAC

SADC


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EMP partners at global, regional and country levelsCoordination mechanisms for a sustainable

collaboration with countries

EMP partners at global, regional and country levelsCoordination mechanisms for a sustainable

collaboration with countries

MoH Outside MOH: Drug regulatory agencies, national procurement centres, insurance, universities, missions, NGOs, consumers

WHO Regional Offices

WHO: HIV, MAL, TB, RH,Collaborat.Centres

UN:

UNICEF, UNAIDS, UNFPA, WBank, GFATM,UNITAID

WHO Country Offices

EMP Department

NGOs:

MSF, HAI, MSH, MDM, JSI, FIP, etc

National programmes with improved access to quality medicines for patients

IPC

WHO/HSS

Private sector: IGPA, IFPMA, etc


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Highlights on major WHO Medicines Programmes in Countries

Highlights on major WHO Medicines Programmes in Countries

Country Support programmes for improved access to and use of medicines:– Support to individual countries upon demand (e.g. China; India; Viet

Nam etc.); – Regional (multi-country) collaboration programmes:1. EU/WHO/African Countries (15) for Health Related MDGs & UHC;2. Muskoka Initiative to improve access to and use of essential medicines

for women and children in 7 African countries & contribute to the achievements of MGDs 4 and 5;

Support to Transparency and Good Governance in Pharmaceutical Sector:– Good Governance for Medicines Programme– Medicines Transparency Alliance initiativeSupport to countries Regulatory Authorities and sub-regional

Harmonization


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Renewed Partnership between Renewed Partnership between EU, WHO & Countries in Africa (2012-2016)EU, WHO & Countries in Africa (2012-2016)


To contribute to the achievement of health-related MDGs and of Universal Health Coverage in 15 countries in Africa;

By improving availability, affordability and use of safe, effective and quality assured essential medicines;

Key principles:– Focus on implementation of national pharmaceutical policies;– Focus on countries and regions' needs and priorities;– Build on work done, ensure sustainability and country ownership;– Improve coordination among key partners and donors;– Promote inter-country collaboration and sharing of expertise in order to

strengthen capacity and reinforce regional integration;– Improve transparency and good governance of the pharmaceutical sector in

countries;


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Expected results:

1) Mean availability of key essential medicines in the public sector increased by up to 10%; 2) Median consumer price ratio of key essential medicines in the public and private sector is reduced by up to 10%;3) Proportion of essential medicines complying with required national quality & safety regulatory standards increased by up to 5%;4) Number of prescriptions that comply with National Essential Medicines List/Standard Treatment Guidelines increased by up to 10%. 5) Reliable data on the pharmaceutical sector of countries is collected, analyzed and disseminated; trasparency and good governance improved;


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Result from the EU/WHO/ACP Partnership (2004-2010)Assessment of pharmaceutical situation and development

of national policies and implementation plans

Result from the EU/WHO/ACP Partnership (2004-2010)Assessment of pharmaceutical situation and development

of national policies and implementation plans

• Data on pharmaceutical situation collected in 68 ACP countries in 2007, data analysed and Regional reports have been published.

• In-depth assessment of pharmaceutical policy at health-centre and household levels of 20 ACP countries; Large quantity of data collected and analyzed by national experts for advocacy and for policy implementation and monitoring.

• 40 countries supported to develop national medicine policies and implementation plans. 15 of them have officially approved their policies. Common policies have been developed in CEMAC and SADC.


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Result from the EU/WHO/ACP Partnership(2004-2010); Regulation and Quality Assurance

Result from the EU/WHO/ACP Partnership(2004-2010); Regulation and Quality Assurance

Between 2004 and 2010:

More than 30 countries have received support to evaluate their Medicines Regulatory Authorities.

10 countries have installed the software SIAMED for registering medicines.

15 countries have been supported to produce laws aimed at better regulating their pharmaceutical sector (e.g. Mali, Nigeria, Senegal, Sudan, etc.).

23 countries have received support to strengthen monitoring of adverse reactions to medicines.

15 countries have received technical assistance to test quality of medicines in the market and to fight counterfeit medicines.


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Result from the EU/WHO/ACP Partnership (2004-2010)Measuring medicines availability

0%

25%

50%

75%

100%

Apr-04 Oct-04 Apr-05 Oct-05 Apr-06 Oct-06 Apr-07 Oct-07 Apr-08 Oct-08

Median availability basket of key medicines, public , private & mission sectors 2004-8

Private median

Public median

Mission

Linear (Private median)

Linear (Public median)

Linear (Mission)

Sources de

Financement

Structure d'appro-

visionnement

1er point de stockage

2ème pointde stockage

Structure dispensatrice

ETATFONDS

MONDIALPPM

USAID

PPM

PPMDNSDRS

Systèmes d'approvisionnement des produits pharmaceutiques au MALI. Janvier 2008

DV CSCOM

DRC

OFFICINES

Magasin régional PPM

PSI

PSI

UNICEF

OMS

FNUAP

UNITAID

GAVI

MEDICAMENTS ESSENTIELS

ARVsPALUDISME

Y compris CTA TB IOARVs Ped

REACTIFS sécurité du sang

(+ test HIV)VACCINS Préservatifs Contraceptifs

DispositifsMédicaux

DPM

Etat

Bailleurs multilatéraux

Bailleurs bilatéraux

ONG/Privé

Malaria No More

USA

ESTHER

PFIZER

MSD

KFW

UNICEF

DV CS Ref

MIIMaladies tropicalesnégligées

MECTIZAN

PATIENT

Grossistes privés /

Population

DAF CLINTONOMS UNICEFGrossistes

privésFNUAPUSAIDJSIITIDIFLUCAN Site

OMS CAG

Site prise en charge

Grossistes privés

3ème pointde stockage

Site de dépistage DNS/Vacc

DRS CAG Grossistes privésPNLT

DRSGrossistes

privés

PHCSCOM

IPPF

GDF

UE

SCI

GDF BIOMALI IPPF SCI

PNLT

AMPPF

CS Ref

CS Ref

CS Ref

République du MaliMinistère de la santé


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Result from the EU/WHO/ACP Partnership (2004-2010)Selection and rational use of medicines

Result from the EU/WHO/ACP Partnership (2004-2010)Selection and rational use of medicines

Between 2004 and 2010:

40 countries supported to create or update their Essential Medicines Lists and Standard Treatment Guidelines.

More than 1,000 national personnel trained in rational use of medicines.

Technical and financial support to establish Drugs and Therapeutics Committees in seven countries (Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Senegal and Uganda.

Rational use campaigns in 9 countries (Mali, Sudan, Zambia, Uganda, Kiribati, Solomon Islands, Tonga, Tuvalu and Vanuatu). Between the interventions there is the approval of laws to regulate medicines promotion (Mali and Zambia) and information campaigns using mass-media like radio and journals (Sudan, Uganda and Zambia). Pacific Islands have used theatre to better involved the public in rational use issues.

Standard Therapeutic Guidelines available

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

1

2003

2007


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Result from the EU/WHO/ACP Partnership (2004-2010)Sub-regional collaboration

Result from the EU/WHO/ACP Partnership (2004-2010)Sub-regional collaboration

CEMAC and Caribbean: assessment and common pharmaceutical policy.

EAC, SADC, Caribbean: work on pooled procurement and on harmonization of registration of medicines.

UEMOA: work on pharmaceutical policies and harmonization of registration and inspection procedures.

PIC: work on pooled procurement of medicines and harmonization of essential medicines lists.

Caribbean: establishment of mechanism for joint monitoring of adverse reactions to medicines (VigiCarib).

Potential for collaboration: CEMAC, ACAME, ISMED

department for essential medicines and health products (emp) - areas of work

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