[e-drug] WHO Medicines Strategy 2008-2013 Consultation

e-drug
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E-DRUG: WHO Medicines Strategy 2008-2013 Consultation
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[The new, re-merged WHO unit on Essential Medicines & Policies (EMP) has
its Medium Term Strategic Plan for 2008-2013 out for discussion on the
EMP website. The actual paper is downloadable from:
http://www.who.int/entity/medicines/publications/Medicines_Strategy_draf
t08-13.pdf
Comments need to be in by 1 October at empinfo@who.int
Debate about this 5-years strategy is obviously also welcome here in
E-drug! WB]

http://www.who.int/medicines/areas/policy/medstrategy_consultation/en/in
dex.html

Over the last decade, WHO's activities in the field of medicines have
been guided by the WHO Medicines Strategies for 2000-2003 and 2004-2007.
Based on these good experiences and to ensure a strong foundation for
the 'new' Department of Essential Medicines and Pharmaceutical Policies,
we have decided to develop a third WHO Medicines Strategy to formulate
our strategic approaches within the scope of WHO's Medium Term Strategic
Plan for 2008-2013.
The purposes of the WHO Medicines Strategy 2008-2013 are:

    * For WHO and major stakeholders to reflect on the future needs and
WHO's comparative strengths in the medicines area
    * To present how WHO proposes to contribute towards the achievement
of the health-related Millennium Development Goals and the
implementation of the relevant World Health Assembly resolutions and the
Medium-Term Strategic Plan for 2008-2013
    * Within this strategic landscape, to develop and present priorities
for action by WHO and guide future investment and planning decisions
    * To create a tool for advocacy and information for stakeholders;
showing the overall picture within which WHO Medicines Programme
operates.

The Strategy document is not intended to repeat existing information on
the global pharmaceutical situation and past achievements. It summarizes
the changes that have occurred since 2003 and the key challenges going
forward from 2008. The strategy presents major strategic directions and
approaches but does not include operational details or workplans.
We are pleased to share with you the current draft of the WHO Medicines
Strategy 2008-2013, for your review and comments. To help get you
started we are specifically interested in your feedback on the following
questions:

    * Do you agree with our analysis of global trends and gaps in the
pharmaceutical sector?
    * Do you agree with the strategic directions and priority activities
we have identified?
    * Is there any important activity or strategic direction missing?
    * In case we have to define our priorities in view of limited
resources, which component(s) of the strategy would you consider of
lowest priority for WHO?

Please feel free to share the draft strategy with your colleagues and
partners. Comments may be sent by email to: empinfo@who.int or by mail
to Director, Department of Essential Medicines and Pharmaceutical
Policies, World Health Organization, 20 avenue Appia, 1211 Geneva,
Switzerland. We look forward to receiving your comments before 1 October
2008. We look forward to receiving your comments before 1 October 2008.
If we have not heard from you by that time, we will assume that you will
not be submitting comments.

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E-DRUG: WHO Medicines Strategy 2008-2013 Consultation (2)
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Dear Colleagues,

I have read the the whole 24-page of the WHO medicines strategy, 2008-2013,
and I do agree to some extend of the analysis of the global trends and
gaps in the pharmaceutical sector. What truly was missing is the role local
pharmaceutical industries play in the public health of the nations, and how
WHO can empower these industries through technical and financial assistance
to enable them produce quality medicines, in high quantities which will
reduce the drug prices, and ensure sustainable supply to their citizens.
All you hear from WHO is that they can only give Technical Assistance to
manufacturers in developing countries. How do they find funds to improve the
facilities, processes, and quality of their manufactured products? How long
can they depend on imported goods, looking at the times involved in
procurement and supply of these essential medicines from prequalified
companies in developed countries and the emerging markets.

I am sure we all will agree that, so many pharmaceutical companies have
struggled in India to reach the their current WHO-accepted standards, with
the help from their government and donors.

If you read the National Drug Policy of Ghana:
Articles 5.3.6 states that:
The Government shall support the private sector through industrial funds and
foreign grants available to it to develop the raw material base for the
pharmaceutical and herbal industries.
5.3.7 also states, The Government shall provide the needed finance and
technical support to promote the development and growth of local
pharmaceutical industries.
These are laudable and bold statements in our National Drugs Policy. But
what is the reality on the ground? There are 35 local pharmaceutical
industries in Ghana, of which 10 are supplying about 80% of the total
industry output. The estimated pharmaceutical market is around US$250
million. The budgetary allocation for medicines by Ministry of Health is
US$5million per annum in their 5-year programme of work.

So where do you think the US$ 245 million will come from? Some come through
drug donations of sub-standard products, which because of poverty, you are
forced to receive. How long will developing countries continue to depend on
external donations'? With the population of 260 million people in the
Sub-Saharan region, can WHO in collaboration with Donors identify some local
pharmaceutical companies in this region, as well as local Regulatory
Authority, assist them to receive grants/loans to improve their facilities
to meet international standards to serve their people.

Some of these local pharmacetical companies have the capacity to produce
large quantities of quality pharmaceuticals to meet the health needs of its
citizenry, rather than depend on imported Antimalarials, Antiretrovirals,
and others.

So in short, I believe the WHO Startegy direction should include Assistance
to local Pharmaceutical companies to access loans at reasonable interest
rates and some grants to build their companies just like Roche, Novartis,
GSK and others, and also convince the Donors to look at supporting local
manufacturers to meet the cahllenges facing their people.

Lastly, we are also STAKEHOLDERS to the health issues affecting our people
and must be considered in decision making or matters that affect us and our
relatives. We need the assistance of WHO and the DONORS to enable us to rise
up to the health challenges and plagues facing our people. Thanks

Dr. Yaw Adu Gyamfi
CEO
Danadams Pharmaceuticals Ind. Ltd
Accra, Ghana'
E-MAIL: danadamsgh@gmail.com

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E-DRUG: WHO Medicines Strategy 2008-2013 Consultation (3)
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I could not agree more with your appeal for assistance to strengthen local manufacturers so that they would be able to compete at international level for the supply of essential medicines, not only for the local population but also for export. I must inform the audience that some donors such as USAID, through one of their cooperative agreements (United States Pharmacopeia Drug Quality and Infomation Program) is already offering technical assistance to developing country manufacturers to improve their compliance with cGMP and international standards. Please visit www. uspdqi.org for more details about this assistance.

I however agree that more needs to be done by donors, particularly in the area of capital investment which is a major limiting factor in getting companies ready for inspection against international standards. Here, it is a two-way street- manufacturers should not expect a hand out but should come up with concrete proposals about payment options toward a possible loan or other forms of financial assistance. I would even suggest that such a proposal could include- the manufacturer supplying the local government with goods for a limited duration in exchange for financial assistance. It is time for local governments to request from donors, assistance that would build or strengthen local capacity and bring about sustainable and long-lasting development. Some donors are already doing this- others need to follow suit.

Patrick Lukulay, Ph.D.
Director, United States Pharmacopeia-
Drug Quality and Information Program.
USA