PHA-Exchange> WHO Executive Board

[Fawzia Rasheed]

http://www.accessmed-msf.org/prod/publications.asp?scntid=14120021123512&contenttype=PARA&

MSF Statement for the WHO Executive Board
14 January, 2002


Contents: 
Next steps for the Essential Drugs List (EDL) 
Equity pricing 
Pre-qualification of low cost producers 
The Doha declaration on TRIPS and public health 
Gap in research and development 

MSF would like to take the opportunity of the WHO Executive Board to
highlight a series of issues related to the WHO and the important role
it must play in increasing access to essential medicines in developing
countries. 

Next steps for the Essential Drugs List (EDL) 

The EDL is one of the most important public health tools, promoting
access to vital medicines and their rational selection and use.
Essential drugs are those that satisfy the health care needs of the
majority of the population; they should therefore be available at all
times in adequate amounts and in the appropriate dosage forms, and at a
price that individuals and their communities can afford. The Essential
Drugs concept guides countries in selection of drugs, in decisions about
procurement and pricing policies and rational drugs use. The essential
drugs concept also provides guiding principles for NGOs. 

MSF welcomes the revised procedure for updating WHO’s Model List of
Essential Drugs as outlined in document EB109/8. The procedure ensures
an evidence-based, transparent, and independent process for revising the
EDL. We particularly welcome the fact that expensive drugs, when their
use is justified, will no longer be excluded from the list solely
because of price. 

The expansion of the EDL should go hand-in-hand with measures to ensure
that these medicines become affordable for the individuals and
communities involved. 

Equity pricing 

WHO should actively support equity pricing of essential medicines, many
of which are currently too expensive for developing countries. While
some progress has been made in bringing the prices of certain medicines
down, a lot remains to be done by governments and international
organisations. An equity pricing system should include political and
legal measures to increase generic competition, global/regional
procurement and distribution, local production through compulsory or
voluntary licensing and technology transfer. 

MSF would like to warn against unwarranted optimism with regard to the
multinational industry’s willingness to bring drug prices down to an
affordable level. Equity pricing will not be achieved by relying on
voluntary actions by pharmaceutical companies only. Without decisive
action from key players such as the WHO, the price of medicines for many
diseases will remain too high. For example, the price of an essential
drug used to treat AIDS-related meningitis, fluconazole, varies greatly
depending on who produces it and where it is sold: in Thailand, a
generic producer sells it for US$ 0.29 (per 200 mg capsule; June 2000)
but in Guatemala, where the drug is patented and manufactured by Pfizer,
it costs as much as US$ 27.60. 

In the case of a high-profile disease such as AIDS, where public
pressure and media attention is intense, lack of transparency from the
pharmaceutical companies about pricing their products in different
countries is emerging as a new challenge. Obtaining up-to-date pricing
information is difficult, and negotiating drug prices with different
companies for each individual product is time-consuming for the
governments of poor countries. WHO should support across the border
negotiations regarding the pricing of medicines for neighbouring
countries with similar needs. 

MSF is pleased to work with the WHO, UNAIDS and UNICEF on providing
information on drug prices and welcomes the collaboration within the NGO
Roundtable process on development of price monitoring methodology for
NGOs. We hope to expand the work on drug price information even further
in the future. 

Pre-qualification of low cost producers 

Medicines should be essential, available, affordable and of quality. To
offer treatment to the highest number of people possible in developing
countries, it is essential that all funds be used to buy quality
medicines at the best possible price. This is simple mathematics: using
the lowest cost suppliers, whether proprietary or generic companies,
will increase the number of people who can be treated and will allow for
greater investments in other important components of care and
prevention. 

The WHO should support countries and NGO’s in procuring affordable
medicines for these particular diseases by identifying quality producers
through a pre-qualification process. This will also facilitate
procurement that will take place as a result of the activities of the
Global Fund for TB, malaria and HIV/AIDS. Cheaper alternatives of
important products, such as antiretrovirals, are becoming available on
the markets of developing countries, and it is paramount to assist
countries to assure the quality of these products. The added value of
the pre-qualification process cannot be underestimated. 

The Doha declaration on TRIPS and Public Health 

2001 was marked by progress in the discussions on patent barriers to
access to medicines at the World Trade Organisation (WTO). The Doha
declaration on TRIPS and Public Health lays out the options countries
have to take measures when prices of existing patented drugs are too
high for their populations. 2002 is the perfect opportunity for the WHO
to take up the challenge, together with other relevant international
organisations, to provide practical technical assistance to make sure
that the Doha declaration makes a difference at the national level. One
pragmatic and effective way of doing this is to provide countries with
examples or models of intellectual property legislation that will allow
them to develop TRIPS compliant laws – all the while making maximum use
of the safeguards of the TRIPS agreement to ensure that pharmaceutical
patents do not hamper access to medicines. 

Gap in research and development 

2002 is also the time to improve the availability of essential medicines
to treat neglected diseases, such as leishmaniasis, sleeping sickness
and Chagas disease, affecting populations with no purchasing power and
no vocal advocacy groups. MSF would like to see firm action to
compensate for the lack of research and development into these diseases,
and other infectious diseases such as malaria and tuberculosis – an
issue that was flagged in Doha but not resolved. 

Again, this is where the WHO clearly must play a major role, along with
governments and donor countries, in determining the R&D needs and
stimulating R&D activities. R&D for neglected diseases cannot be left to
the market place. Public Private partnerships alone will not offer a
solution because there is insufficient market incentive. Radical new
approaches are needed to kick-start R&D, including new funding
mechanisms in areas that are now totally abandoned. Not-for-profit drug
development initiatives should be explored to take drug R&D for
neglected diseases out of the marketplace altogether. 


MSF looks forward to contributing to an active dialogue and joint action
to resolve the issues addressed above.

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