E-DRUG: UNAIDS: Compulsory Licensing may not be necessary
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Dear all,
UNAIDS is grateful to Richard Stern and to this forum for disseminating
information on the WHO/UNAIDS study on the patent situation of HIV-related
drugs.
However, we would like to stress that the paper distributed in Paris at the 4th
International Conference on Home and Community Care for Persons Living with
HIV/AIDS is a pre-release version. The data in this paper are in the process of
verification and therefore should be taken as preliminary data only.
Let me just remind you about some essential elements of our advocacy:
The availability of HIV/AIDS drugs, like others, depends upon at least three
main factors:
(i) sustainable financing for drug procurement at the national level;
(ii) national and local health infrastructure for delivering drugs and
monitoring patient compliance;
(iii) affordable drug prices.
The UNAIDS Secretariat supports patent protection as an incentive for innovative
research and development of new HIV/AIDS drugs and, hopefully, the discovery of
HIV vaccines, in particular vaccines suitable for use in developing countries.
At the same time, however, intellectual property rights must be considered in
the context of other social interests, such as the human rights concerning health
and the benefits of scientific progress and its applications.
The UNAIDS Secretariat further supports:
1) Preferential pricing of HIV/AIDS goods, including male and female condoms,
and HIV/AIDS drugs and other pharmaceutical products, so that these products are
priced affordably at levels consistent with local purchasing power.
2) Reduction or elimination of import duties, customs and taxes on HIV/AIDS
goods, including condoms and pharmaceutical products.
3) Measures to promote generic drug competition and the "early working" of
patented drugs (e.g., the so-called "Bolar amendment") so that generic HIV/AIDS
drugs can be made available more rapidly.
4) The UNAIDS secretariat recognizes that recourse to compulsory licensing may
be necessary, as provided for under the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS), such as in countries where HIV/AIDS
constitutes a national emergency.
To got prices down a number of things need to be done:
Support preferential pricing. There is a range of options which might be used
to achieve preferential pricing, including voluntary licensing with transfer of
know-how. Preferential pricing is already a reality today, but the patent
holders need protection in their home markets to ensure that they will be able
to recover their R&D cost and ensure their survival, i.e. remain profitable if
we want the price differentials to become more important than they are today.
In my personal opinion the support needed now is that activist groups in
developed countries should state openly that they support the idea that purchase
power pricing is not only acceptable, but good, meaning that they accept that
(those paying the drugs of) their members should pay more than patients in
developing countries.
Create a 'generic friendly' climate. Experience from countries with
"generic-friendly" policies demonstrates that competition greatly increases
affordability of medicines, stimulates innovation within the research-based
industry, and increases efficiency in the generic industry. Compulsory
licensing and the Bolar exception are among an array of tools a government
might use to create such a 'generic friendly' climate.
Go beyond what small generic companies might achieve. This will require
collaboration with those companies who developed the drugs in the first place,
because they would likely be best positioned to get into cost+ pricing
efficiently. (Cost+ pricing factors in only the cost of raw materials,
production facilities, labor and a fixed profit margin to produce the goods, not
marketing or development costs.)
This list is of course incomplete, but gives an idea of the complexity of the
path to increased drug availability.
With this reminder, we would welcome input on the accuracy of our data. We hope
to have the final version ready within the next one or two months.
Dr Joseph Perriens
UNAIDS
Email: perriensj@who.ch
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