E-DRUG: EU Trade document on TRIPS
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[copied from Pharm-Policy; WB]
I obtained an uncleared background statement on by the EU/DG Trade, on
the TACD resolutions on access to medicines and the early working issue.
I was told in Washington DC at the February 10-12 meetings that the
statement was controversial within the EU, and was not official policy,
but it is interesting none-the-less.
For example, the EU asserts that in Thailand there is no patent on ddI,
which should come as a surprise to those working on the Thail/ddI
compulsory licensing issue.
The EU says it does not support patent exceptions for production for
export, and has "argued that such production is not in compliance with
Article 28" of the TRIPS in the EU Canada case.
"the problem of access in the developing world is not going to be solved
by simply making products available at a cheap price. There is a risk
that countries become flooded with drugs which patients cannot use or
even worse that counterfeit products are entering the market, causing
great safety risks for consumers."
Regarding allegations that the EU has asked for TRIPS Plus legislation:
"This allegation is false, at least as far as the EU is concerned. The
EU has urged South Africa to comply with the carefully negotiated
wording of Article 31 of the TRIPS." This makes it sound as if the EU
has had some correpondence with SA that we don't know about yet.
Regarding Africa and production for export exceptions in patent laws (an
issue mostly relevant to a post transition TRIPS environment when major
producers are TRIPS compliant), the EU says "enhanced production for
export appears to make no difference for the developing countries,"
based upon its observation that people can't afford drugs in country
that don't have patents today.
Without mention of its use in the EU context, the EU says: "the issue of
compulsory licenses is unlikely to offer an effective solution to access
to medicines in developing countries."
"The R&D based pharmaceutical industry is carrying out approx. 90% of
all R&D in new pharmaceuticals."
"Without [adequate levels of IP rights] it is not possible to share the
benefits dervvied from public/private research co-operation or to
finance non-profit research initiative(e.g. suchas the WHO Malaria
Venture)."
"It should be examined why the generic industry has not entered into
markets where there is no patent protection."
"To conclude, it appears that the TACD recommendations regarding
intellectual property rights and Access to Medicines are not justified
for legal and practical reasons. The services of the Commission propose
that the TACD acknowledge that: The issue of Access to Medicine is very
complex and of greaet concern to the EU. However, the matter is a
question of providing sufficient developing aid and health care
infrastructure assistance rather than intellectual property rights'
issue."
This EU statement is an odd way to frame the isssue of fast tract CL:
"There is no lead to use 'fast track compulsory licenses' if it makes no
practial or legal difference, in particular in countries where no patent
protection is avaiable on a given product."
"Production for export during the patent term, in developing or
developed countries, mayh be inconsistent with Articles 28 and 31 of
TRIPS and shoud not be pursued by the EU."
Ignoring licensing alternatives, the EU says: "differential pricing only
works if the principle of national/regional exhaustion is applied."
"the EU should stress that it does not consider that the proposed early
working provision of patented pharmaceuticals is consistent with
Articles 27.1. 28 and 33 of the TRIPS agreement."
ANALYSIS:
Well, it could have been (may have been) written by the IFPMA). We'll
try to get the whole thing put on the web page by next week. It would
seem that the EU positions are worse than the current USTR positions.
Jamie
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