E-drug: Response to Linda Horton (FDA)
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I am grateful for Linda Horton's comments to the e-drug discussion list
on the topic of generic drugs in developing countries, and I would to
expand upon the context upon which the TACD was discussing these issues,
and the positions taken by the US government, in this case, represented
by Linda Horton. Then I will ask Dr. Horton if the US government is
willing to work with TACD on the quality issue, an issue Dr. Horton
claims to be concerned about.
1. TACD had asked the US and EU governments to support production for
export exceptions in patent laws, under Article 30 of the TRIPS, so that
countries with generic drug producers could supply smaller markets that
do not have an efficient domestic industry. This could be done from
European, US, Canadian, Israel, or developing country producers -- if
such production for export patent exceptions were accepted by the WTO.
Linda Horton said the US opposed this.
2. TACD asked if the US or the EU would support the creation of a
working group on access to medicine, to address technical issues in the
TRIPS that might present issues for access to medicine. Linda Horton
said the US was completely opposed to this.
3. TACD asked if the US or EU would permit global donor efforts to
purchase drugs from the cheapest suppliers, even if they were from the
South, such as from India, Brazil, Thailand, Korea or China. Linda
Horton spoke at some length about problems with counterfeit, fake
drugs, or poor quality drugs. No data was presented, and it was
impossible to engage Dr. Horton on the question of whether or not
there were any mechanisms to deal with this issue, other than Dr.
Horton's recommendation, which was to buy from EU and US big pharma
companies. During this discussion, Dr. Horton lumped all developing
country manufacturers into the same unreliable and risky category;
rather surprising, given the fact that the US FDA was getting ready
to approve a Chinese firm to supply the USA with RU486.
4. TACD specifically asked Dr. Horton if the US government would be
willing to work with TACD to identify constructive solutions to the
quality issue, in order to improve confidence in generic products. Dr.
Horton said no, the US FDA would not work with TACD, would not hold
meetings with TACD, would not agree to engage at all on this issue.
This was, in fact, the most bitter moment of the 2 day TACD meeting in
Brussels.
My questions to Dr. Horton are:
1. Will the US support, in the WTO, "production for export" exceptions
to patent laws, under Article 30 of the TRIPS, so that generic
producers can supply small market countries with low cost generic drugs
of acceptable quality (so long as the legitimate interests of the patent
owners are protected in the country where the drugs are consumed, such
as, for example, payment of a reasonable royalty). Note that this would
permit the generic producers from the North to supply high quality
products to the South, if, as Dr. Horton seems to believe, this is the
only safe place to make generic drugs.
2. Will the US support in the WTO a working group on access to
medicines? If not, why not?
3. Will the US permit the World Bank or other donor agencies to buy
drugs from generic suppliers, when, for example, there are no patents in
a country, or if the country issues a valid compulsory license?
4. Finally, will the US FDA work with the TACD to find constructive
solutions to improving confidence in generic products in developing
countries. If not, why not.
If the US FDA can give a positive answer to even one of these questions,
then we are making some progress.
Jamie
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org
love@cptech.org
1.202.387.8030 fax 1.202.234.5176
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