Transcript WHO Technical Briefing Seminar Geneva 31 October- 04 November 2011 WHO Collaboration with Countries on Pharmaceutical Policies Mrs Helen Tata Essential Medicines and Pharmaceutical Policies 1| WHO-Technical Briefing.

WHO Technical Briefing Seminar
Geneva 31 October- 04 November 2011
WHO Collaboration with Countries on
Pharmaceutical Policies
Mrs Helen Tata
Essential Medicines and
Pharmaceutical Policies
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WHO-Technical Briefing Seminar | November 2011
Gilles Forte
WHO Medicines Strategy as part of WHO
Medium-term 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-Technical Briefing Seminar | November 2011
Gilles Forte
New challenges in the global
pharmaceutical landscape
 More players and partnerships in pharmaceutical sector
with specific niches and/or unaware of countries priorities,
overstretch experts and decision making capacity in
countries
 Diseases specific programs and new global funding
initiatives with specific delivery mechanisms and
substantial funding could undermine health systems
strengthening efforts in countries
 Less WHO core budget < 30%; more specified project
Funding >70%
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Added-value of WHO
 Development of norms and standards; access to information and
expertise in the health sector (e.g. collaborating centres).
 Experience and operational capacity in countries; capacity of staff is
being strengthened to better respond to countries' needs and to
ensure effective coordination and policy dialogue.
 Promote partnership and put people together: WHO is a neutral
partner with long-term experience and this facilitates dialogue
among players.
 Monitoring and evaluation of policies: development of tools and
strengthening of countries' capacities.
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WHO: 193 Member States
6 Regional Offices
Regional Office AFRO
Regional Office EMRO
Regional Office EURO
Regional Office WPRO
Regional Office SEARO
Regional Office AMRO
WHO HQ Geneva
(Source: http://www.who.int/about/regions/en/index.html)
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Coordination mechanisms
for a sustainable collaboration with countries
AFRO
AMRO
EMRO
WHO
HSS
EMP
EURO
SEARO
WPRO
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WHO Country Medicines Advisers and
Collaborating Centres
Medicines Adviser
Collaborating Centre
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WHO-Technical Briefing Seminar | November 2011
Gilles Forte
The WHO Country Medicines Advisers Network
for Africa
Medicines Advisers in 15 countries in
Africa for:
UEMOA
Burundi
Cameroon
Central African Rep.
Chad
Congo
Democratic Rep. of the Congo
Ethiopia
Ghana
Kenya
Mali
Nigeria
Rwanda
Senegal
Uganda
United Rep. of Tanzania
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CEMAC
EAC
SADC
WHO-Technical Briefing Seminar | November 2011
Gilles Forte
• Assessing national medicines needs &
priorities;
• Planning, implementing, monitoring
WHO interventions;
• Facilitating coordination of partners;
• Contributing to WHO Regional work
on medicines and health systems;
Principles for collaboration with countries
EC/ACP/WHO Partnership 2004-2010
 Focus on countries and regions' needs rather than on
development of tools.
 Build on work done, innovate and ensure sustainability.
 Technical assistance and country ownership:
 data collection and analysis
 Formulation of plans, policies and good practices
 Advocacy and capacity-building
 Promote collaboration and ensure synergies with other
partners.
 Promote Regional and Sub-Regional Collaboration
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Assessment of pharmaceutical situation and development of national
policies and implementation plans
• Data on pharmaceutical situation (Level 1) collected in 68 ACP
countries in 2007 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 local experts to increase
capacity; advocacy on the importance of monitoring for policy
implementation.
• 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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WHO-Technical Briefing Seminar | November 2011
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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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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.
Standard Therapeutic Guidelines available
 Technical and financial
support to establish Drugs and
90%
Therapeutics Committees in seven countries (Cameroon,
80%
Ethiopia, Ghana, Kenya,
Nigeria, Senegal and Uganda.
70%
60%
 Rational use campaigns
in 9 countries (Mali, Sudan,
50%
Zambia, Uganda, Kiribati,
Solomon Islands, Tonga, Tuvalu
40%
and Vanuatu). Between
the interventions there is the
approval of laws to30%
regulate medicines promotion (Mali and
Zambia) and information
campaigns using mass-media like
20%
radio and journals10%
(Sudan, Uganda and Zambia). Pacific
Islands have used 0%
theatre to better involved the public in
rational use issues.
1
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2003
2007
"Success stories"
 After a survey on medicines prices, the goverment of Mali decided to
regulate the prices of around 100 widely-sold generic medicines. A
study from M. Maiga and B William-Jones published in 2010 showed
that the regulation was successuful and that between 2006 and 2009
medicines prices in Mali fell by about 23%.
D Maiga and B Williams-Jones (2010), Assessment of the impact of market regulation in Mali on
the price of essential medicines provided through the private sector, Health Policy 97 (2010):
130–135.
 In Ghana, WHO contributed to assess the situation of human
resources for the pharmaceutical sector and to develop a national
strategy for the production, recruitment and retainment of personnel
based on the findings of the assessment. As part of the strategy, the
programme of the degree in pharmacy has been modified to align it
with the skills nowadays required by practising pharmacists.
 Availability of medicines has increased in Uganda. Monitoring of
medicines prices and availability was established with WHO support.
The information collected showed that between 2004 and 2008,
availability of medicines in the public sector of Uganda grew from less
than 40% to over 60%.
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WHO-Technical Briefing Seminar | November 2011
Gilles Forte
Results of sub-regional collaboration
 CEMAC, SADC 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).
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WHO-Technical Briefing Seminar | November 2011
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Renewed Partnership between EU, ACP countries and
WHO
Principles:
- The Renewed Partnership will focus on
the implementation.
- Pharmaceutical Policies should be
given higer profile in the health sector of
target countries.
- Key partners and donors should be
involved and coordination should be
improved.
- Promote intercountry collaboration to
strengthen capacity and reinforce
integration.
- Collect quality information to increase
transparency in the pharmaceutical
sector.
- Give more intense support to a limited
number of countries.
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Expected results:
1) Average availability of key essential
medicines in the public sector increased by
10%.
2) Final prices of key essential medicines in
the public and private sector is reduced by
10%.
3) Number of essential medicines that comply
with national quality standards increased by
5%.
4) Number of prescriptions that comply with
national Standard Treatment Guidelines
increased by 10%.
5) Good-quality data on the pharmaceutical
sector of 20 countries is collected, analyzed
and mada publicly available.
WHO partners at global and country levels
WHO Department of EMP
WHO:
Regional Offices
Country Offices
MOH
HSS, EIP
HIV, MAL,
TB, RH,
Collaborat.
Centres
UN: IPC
NGOs:
UNICEF,
UNAIDS,
UNFPA,
WBank,
GFATM,
UNITAID
MSF, HAI,
MSH, JSI
FIP, IGPA,
IFPMA, etc
Outside MOH:
Drug regulatory agencies,
insurance, universities,
missions, NGOs, consumers
National programmes for health professionals, patients and consumers
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WHO-Technical Briefing Seminar | November 2011
Gilles Forte