E-DRUG: EU's response to TACD pharmaceutcial recommendations
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[copied from PHARM-POLICY with thanks; WB]
[The WTO Seattle meeting from 30 Nov and the Amsterdam Access
to medicines meeting 25-26 Nov will cause a flurry of E-drug messages
in the coming weeks re Intellectual Property Rights & essential
drugs. This might be strange language to some of us.
E-druggers, please put your questions if you don't understand the
issues! WB]
I have just seen the European Commission's response to the Trans
Atlantic Consumer Dialogue's recommendations from its April 1999 meeting
in Brussels. These are the EU's response to the 5 TACD recommendations
concerning pharmaceuticals. In general the EU recommendations were a
disappointment. For example, in response to the recommendation that
countries in WTO proceedings be permitted to request a report from the
WHO on the public health consequences of a dispute, the EU said:
WHO papers . . often do not reflect the official WHO
points of view, but are only financially supported by
the WHO.
and
The effectiveness (for all parties) of the Dispute
Settlement mechanism could be significantly damaged
if the parties had to await the delivery of WHO
reports before a Panel would be in a position to
conclude. The Dispute Settlement procedure includes
several fixed deadlines for interventions, written
submissions etc.
Which seems fairly non-responsive.
There was a glimmer of hope in the EU response to recommendation 2
concerning patent exceptions for exports, what the EU called "domestic
production for export only." The EU seemed to be saying that it did not
support TACD's proposal for a "general exception" to patent rights,
which was confusing, since TACD's proposal was quite limited. But on
the positive side the EU said that "domestic production for export only"
falls under the rights of Article 28, and that the TRIPS does permit
exemptions to this Article, in Article 30. But it was pretty hard to
figure out where the EU was coming out on this point.
On the question of parallel imports, the EU offered a PhRMA/IFPMA type
statement, which was surprisingly different from the statement it gave
in a different question regarding parallel imports and e-commerce.
On compulsory licensing, the EU seemed ok with using the TRIPS, Article
31, as a sufficient public interest protection, and unlike USTR, was not
pushing for TRIPS plus.
Jamie
<----------TACD RECOMMENDATION ON PHARMACEUTICALS--------->
The TACD recommends that the governments of the US and the EU should
consider the following:
1. Regarding World Health Assembly and the World Trade Organization:
Require that a country engaged in WTO dispute resolution proceedings be
permitted to request a report from the WHO on the public health aspects
of the policies that are subject to review by the WTO.
2. Regarding Patents and Exemptions for Exports:
Agree that a country may provide exemptions to patent rights to
companies who are exporting the product to another country where patent
rights have expired or where patent rights have been licensed under
compulsory licensing and the legitimate interests of the patent owner
has been protected under Article 31 of the WTO TRIPS agreement.
3. Regarding Parallel Imports of Pharmaceuticals:
Not bring trade sanctions against poor countries that seek to use
parallel imports to obtain cheaper access to pharmaceuticals.
4. Regarding developing countries and medical patents
Not use trade pressures against developing countries over access to
essential medicines if those countries have satisfied WTO/TRIPS
requirements for the protection of patents. Developing counties should
not be prevented from using compulsory licensing to expand access to
medicines, if the compulsory licenses are
issued in compliance with Article 31 of the TRIPS agreement.
5. Regarding compulsory licensing:
Agree that governments, the World Health Organisation (WHO) and the
World Intellectual Property Organisation (WIPO) should consult with the
academic community, consumer groups and a wide range of industry groups
to determine where compulsory licensing of medical technologies is
needed to overcome market failures,
such as those that are related to complex inventions, follow on
inventions, or for providing access to inventions on reasonable terms.
<--------EUROPEAN COMMISSION SERVICES RESPONSE---------------->
1. Regarding World Health Assembly and the World Trade Organisation
Cases which concern the lack of correct implementation of the relevant
WTO agreements e.g. such as the TRIPs Agreement are subject to WTO's
Dispute Settlement mechanism. However, the procedure for conducting
Dispute Settlement cases is in the hands of the parties involved,
including their rights (and obligations) to submit relevant evidence for
their complaints, e.g. such as WHO conclusions and reports. The Panel
can also make use of all relevant documentation to support its report.
WHO papers, however, often do not reflect the official WHO points of
view, but are only financially supported by the WHO.
The effectiveness (for all parties) of the Dispute Settlement mechanism
could be significantly damaged if the parties had to await the delivery
of WHO reports before a Panel would be in a position to conclude. The
Dispute Settlement procedure includes several fixed deadlines for
interventions, written submissions etc.
2. Regarding Patents and Exemptions for Exports
Article 28 of the TRIPs Agreement states that a patent shall confer on
its owner the following exclusive rights: where the subject matter of a
patent is a product or a process making, using offering for sale,
selling or importing for these purposes that product of this process.
Article 30 of the TRIPs Agreement provides for exceptions to the rights
conferred by a patent. Members may provide for limited exceptions to the
exclusive rights conferred by a patent, provided that such exceptions do
not unreasonably conflict with the normal exploitation of the patent and
do not unreasonably prejudice the legitimate interests of the patent
owner.
Domestic production for export only, in a country where a product or a
process is covered by a patent, falls under the exclusive rights
conferred by a patent. Whilst the European Commission services would
not support a general exception from the rights conferred by a patent as
proposed in the TACD recommendation, it should be noted that a country
may provide for exclusions to the exclusive rights conferred by a patent
in accordance with Article 28 of the TRIPs Agreement within the limited
exceptions as provided for in Article 30 of the TRIPs Agreement.
3. Regarding Parallel Imports of Pharmaceuticals
It is not clear what this recommendation means as notions such as trade
sanctions , poor countries and cheaper access to pharmaceuticals
are not well defined.
In relation to the issue of parallel import of pharmaceuticals, Article
6 of the TRIPs Agreement provides that for the purposeof dispute
settlement under this Agreement nothing in this Agreement shall be used
to address the issue of exhaustion of intellectual property rights .
Nevertheless, the rights conferred by a patent (Article 28 of the TRIPs
Agreement) may not be contravened, these rights include the right to
prevent importation of patented products.
The European Commission services believe that further evidence would be
valuable about whether parallel importation of pharmaceutical products
affects the prices of pharmaceuticals and in particular, whether,
parallel importation will increase the prices of pharmaceuticals on the
global market and if it has an influence on the consumer safety.
4. Regarding developing countries and medical patents and,
5. Regarding compulsory licensing
The first sentence of this recommendation is unclear as the notion
trade pressure is not defined. If developing countriescomply with the
minimum requirements of the TRIPs Agreement, they will clearly not be
faced with an EU request to bring their legislation into compliance with
the TRIPs Agreement. Most of the essential drugs on the WHO's essential
drug list are anywayproducts whose patent has expired.
In setting up national legislation for granting compulsory licenses the
minimum requirements of Article 31 of the TRIPs Agreement should be met.
In particular, it must be ensured that the rights conferred by a patent
are not affected.
However, the European Commission services believe that developing
countries may implement national legislation on compulsory licenses so
long as, in doing so, the minimum requirements of Article 31 of the
TRIPs Agreement are taken into account.
--
James Love / Director, Consumer Project on Technology
http://www.cptech.org / love@cptech.org
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
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