News Release
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Pascal Lamy |
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No. 154/04
October 29, 2004
EU PROPOSES LEGISLATION TO ALLOW EXPORT OF GENERIC MEDICINES
TO POOR COUNTRIES
Today the European Commission proposed
legislation to allow manufacturers of generic pharmaceuticals to produce patented
medicines for export to “countries in need” without sufficient capacity to produce
them. Legislation would implement within the EU a WTO decision of 30th August
2003 under which national authorities can grant “compulsory licences” for such
production under certain conditions. One requirement is that the destination country
notify the WTO it is seeking the medicine covered by the licence. The draft legislation
puts no further restriction on the medicines and diseases to be covered. To help
ensure that medicines get to the patients who need them and to protect patent
holders, customs authorities will be able to prevent the re-importation into the
EU of medicines produced under the system.
EU Trade Commissioner
Pascal Lamy
said: “By adopting this proposal the EU leads the way in ensuring access to
affordable medicines for poor countries. It shows that we are delivering on our
promises in the Doha
Development Agenda. I now hope that it can be taken forward quickly by the
EU Member States and the European
Parliament.”
EU Internal
Market Commissioner Frits
Bolkestein said: “The WTO decision and our proposed Regulation can help
save lives by helping countries in need to acquire affordable medicines, without
undermining the patent system, which is one of the main incentives for the research
and development of new medicines.”
The draft legislation (called a "Regulation") would set up a system
for companies who wish to manufacture medicines for export to apply to national
authorities for the grant of a “compulsory licence” from a patent holder who has
exclusive rights over the manufacture and sale of the products concerned. Most
national laws at present do not allow compulsory licences for export because until
recently the WTO TRIPS Agreement provided for compulsory licences only “predominantly
for the supply of the domestic market.” The Doha declaration on trade and health
adopted in November 2001 agreed to address the difficulties raised by this restriction
for developing countries with no manufacturing capacity. After long negotiations,
on 30 August 2003 WTO members agreed on a waiver giving these countries access
to much needed generics.
Provided countries in need notify to the WTO the medicines they need, it would
be up to generic companies to decide to apply for licences to manufacture them.
Once export takes place, all parties have an interest in seeing that medicines
are not diverted from those who need them. The Commission’s proposal would prohibit
re-importation into the EU and provide for customs authorities to take action
against goods being re-imported. The patent holder could use existing national
procedures to enforce its rights against re-imported goods if they do enter the
EU, and the licence could be terminated.
While the EU does not require a medicinal marketing authorisation for exported
products, importing countries may want to ensure that medicines are safe and effective.
In the proposal provision is made for use of the EU’s scientific opinion procedure
for evaluating medicines under Regulation
(EC) No 726/2004.
The rules also ensure that marketing authorisations do not lapse for reason
of non-use in the EU, and set out exemptions from data protection rules which
usually require manufacturers of generic medicines to wait for eight years before
they can obtain authorisations using data from previous clinical trials conducted
by others.
Additional information is at:
http://www.europa.eu.int/comm/internal_market/en/indprop/patent/index.htm
http://europa.eu.int/comm/trade/issues/sectoral/intell_property/index_en.htm
