Working with Countries, Harmonisation and Regional

Initiatives

Technical Briefing Seminar

MP Matsoso

Director Department of Technical Cooperation for Essential Drugs and Traditional Medicine

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BackgroundBackground

UN Reform

Working within the UN

Working with countries

Working with partners

Working with Regional Economic Blocs

A case for coordination

The case for harmonisation

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UN ReformUN Reform

An objective: Harmonisation to reach MDG– Maximise harmonisation– increase alignment – reduce transaction costs

Why UN– trusted partner– Respected honest broker– Convener– MDG advocate for human rights– Advocate for global norms and standards

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Framework for coordinationFramework for coordination

UNDG

30 members

Executive committee: UNICEF, UNDP, UNFPA, WFP

Harmonisation alignment to reach MDGs

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Medicines Strategy - the pharmaceutical foundation for improved health outcomes and stronger health systemsMedicines Strategy - the pharmaceutical foundation for improved health outcomes and stronger health systems

WHO medicines strategy 1. National drug policy - guide to coordination of action by all stakeholders

2. Access to essential medicines - financing, pricing, supply systems

3. Quality and safety - standards, effective regulation, information support

4. Rational use - health professionals and consumers, public and private sectors

Health systems • delivery systems• financing• regulatory• creating resources

Health outcomes• malaria - tuberculosis• HIV/AIDS• childhood illnesses• non-communicable diseases

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Pharmaceutical supply system

ProductionImportationQuantification of needsSelection Procurement ( tender, bids, negotiations)Purchasing, paymentFinance managementsInventory, tracking, audit, accountabilityDistribution, transportInformation, stock file, electronic data basepatents

Pharmaceutical supply system

ProductionImportationQuantification of needsSelection Procurement ( tender, bids, negotiations)Purchasing, paymentFinance managementsInventory, tracking, audit, accountabilityDistribution, transportInformation, stock file, electronic data basepatents

Pharmaceutical financing systemBudgets and expenditures (public and private)Donor fundsRevolving fundsDrug benefits in health insurance (public/private)Cost recovery, payment systemOut of pocket paymentsDirect purchase in private sector

Pharmaceutical financing systemBudgets and expenditures (public and private)Donor fundsRevolving fundsDrug benefits in health insurance (public/private)Cost recovery, payment systemOut of pocket paymentsDirect purchase in private sector

Pharmaceutical informationWHO specific--country profile & baseline data, MOH specific

-- basic and vital statisticsMOF specific--fiscal & budget

expenditures, trading, private revenue on pharmaceutical sales

Pharmaceutical informationWHO specific--country profile & baseline data, MOH specific

-- basic and vital statisticsMOF specific--fiscal & budget

expenditures, trading, private revenue on pharmaceutical sales

Human resourceNeeds, norms and basic qualificationPersonnel in pharmaceutical sector (licensed,

practicing)Population/health worker ratioG/P staff ratioInterns/volunteersCommunity service recruits, community health

workers, middle level workersManagerial/supervisoryFinancial investment on human resource

Human resourceNeeds, norms and basic qualificationPersonnel in pharmaceutical sector (licensed,

practicing)Population/health worker ratioG/P staff ratioInterns/volunteersCommunity service recruits, community health

workers, middle level workersManagerial/supervisoryFinancial investment on human resource

Medicine regulatory systemEnforcement of drug laws and regulationsDrug registrationLicensingInspectionPost marketing surveillanceQuality controlHarmonisation (regional)Ethical practicesPatents, TRIPS

Medicine regulatory systemEnforcement of drug laws and regulationsDrug registrationLicensingInspectionPost marketing surveillanceQuality controlHarmonisation (regional)Ethical practicesPatents, TRIPS

Health Systems

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Type B: Specific technical support

• Ad hoc or regular support Usually focused on a subset of the following areas: policy; access: quality, safety & efficacy; and rational use

Type C: Comprehensive programme support

• Time frame may cover one or more biennia • Usually involves a full-time national programme officer• Covers most or all of the following areas: policy; access, quality, safety & efficacy, and rational use

Type A: Situation analysis & Monitoring

• Assessment of pharmaceutical situation, identify priority needs – recommendations for interventions

Type IC: Inter-country

• Ad hoc or regular support involving two or more countries often in the same region • Usually focused on a subset of the following areas: policy; access; quality, safety & efficacy; and rational use

Activities Driven by Country Needs & PrioritiesActivities Driven by Country Needs & Priorities

Initiation of most activities are in response to requests by member states. Other activities are proposed by WHO based on public health needs of specific countries

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Headquarters (TCM):

• Partnerships and technical collaboration and cooperation

• Medicines strategy planning and assist in policy development

• Support specific technical & policy issues

• Strategy in support of HR development & training

Collaborative Activities Across the WHO- Continuum Supporting WHO Medicine Strategy

Collaborative Activities Across the WHO- Continuum Supporting WHO Medicine Strategy

Guidance, Advocacy, Resource mobilization

Regional Office:

• Oversee country operations

• Planning and monitoring

• Technical, policy and management support

• Human resources development & training

• Partnerships and collaborations(Regional economic Blocs)

Country Offices:

Assess needs and identify priorities for technical support(NRA capacity, procurement and supply, patentlandscape, TRM)

• Plan & implement WHO work

• Partnerships & collaborations

•Feed back and reporting

Ministries of Health:

Identify needs & priorities

• Plan, implement and monitor action

• Coordinate with bilateral and multilateral agencies and CSO's.

•Coordination with other sectors

Implementation

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HQHQ Regional Offices Regional Offices Country OfficesCountry Offices Ministries of HealthMinistries of Health

Partners in Country SupportPartners in Country Support

WHO operational WHO operational partnerspartners

UNAIDS, bilateral UNAIDS, bilateral and multilateral and multilateral agencies, public agencies, public interest NGOs in interest NGOs in health, UNDP, health, UNDP, UNFPA, UNCTADUNFPA, UNCTAD

WHO scientific WHO scientific partnerspartners

WHO Collaborating WHO Collaborating Centres in medicines, Centres in medicines, TRM, academic and TRM, academic and research institutions, research institutions, international health international health professional professional associationsassociations

WHO strategic WHO strategic partnerspartners

World Bank and World Bank and development banks, development banks, Donor Agencies Donor Agencies pharmaceutical pharmaceutical industry, WTO, industry, WTO, WIPO, EUWIPO, EU

WHO Collaborative PartnersWHO Collaborative Partners

WHO Countries

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DRA 4

DRA 3

DRA 2

DRA 1

SADC/WHO

DRA 2

DRA 3

DRA 1

SADC/WHO

Sharing basic information: a common data and file repositoryis created for a limited number of participating countries

Adding scope and functionality: additional countries participate and make available selected national medicines registration data (off-line)

Shared information repository on regulatory and pharmaceutical activities and data

Angola

Botswana

Democratic Republic of Congo

Lesotho

Malawi

Madagascar

Mauritius

Mozambique

Namibia

South Africa

Swaziland

Tanzania

Zambia

Zimbabwe

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A case for coordinationA case for coordination

Changing aid environment

Principle of better ways of working together

High level of trust

Other initiatives may be linked

Pursuit for better country support

Opportunity for achieving MDG's

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The case for harmonisationThe case for harmonisation

There are regional and subregional approaches and global initiatives that are considered for pooling resources to deal with capacity challenges

Current regional medicine regulatory initiatives:– AFRO (EAC,ECOWAS,CEMAC,SADC,UEMOA)– AMRO (PAHNDRA, ANDEAN, MECOSUR)– SEARO/WPRO (ASEAN)– EURO (EMEA,NIS, CADREAC)– EMRO (GCC)

Global Initiatives :– WHO Prequalification (supports procurement, but has strong regulatory focus) – DCVRN (vaccine regulatory network of 9 countries established by WHO)– EU Article 58, Scientific Opinion for medicines exported from EU but not for sale

in EU, partnership with WHO– FDA Tentative approval of PEPFAR linked products, confidentiality agreement

with WHO– ICH GCG- Participation of some subregional blocs, SADC, ASEAN, PANDRA

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Strategic ThrustStrategic Thrust

Medicines regulatory issues – Quality, Registration; Joint action, inspections, dossier evaluation and information exchange. Translation of WHO normative work to implementation at subregional and country level

Strengthen medicine regulation both at country and regional levels

Deliberate efforts to support quality and increase confidence in local products

Legal issues - including intellectual property rights and TRIPS compliance; and Strengthen patent searching capacities of national and regional offices.

Patent data on essential medicines is a key component for decision-making.

Review regulatory requirements to facilitate patent searching as in the case of developed countries

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Strategic ThrustStrategic Thrust

Policy issues - a review of public health and access to medicines issues in the regions, and also industrial policy objectives in the regions

Utilization of spare capacity and ensuring economies of scale

Infrastructural needs - industrial and infrastructural requirements, need for complementary and support industries such as packaging, bottling, etc.

Facilitate technology transfer

Encourage investment in domestic sources for essential medicines for economic development

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Conclusion: What can a partnership bring?Conclusion: What can a partnership bring?

Partnerships:

Provide a mechanism: each partner brings specific skills, competencies and interests, common problems or opportunities

Mobilize more resources: combines technical, human, physical and financial resources as well as information

Ensure greater awareness: of the priorities, needs and roles Create dynamic contact networks: offer channels of influence that both engage a wider community and impact policy agendas

Replace conflict with cooperation: the cost of conflict is greater in time and resources than the cost of cooperation