PHA-Exchange> EU proposal for August 30th solution implementation

[claudio at hcmc.netnam.vn]

>
> Access to medicines: Commission proposes to allow export of generic
> medicines to poor countries
> Brussels, 29 October 2004

> The European Commission has proposed a Regulation to allow manufacturers
of
> generic pharmaceuticals to produce patented medicines for export to
> "countries in need" without sufficient capacity to produce them. The
> Regulation would implement within the EU a WTO decision of 30th August
2003
> under which national authorities can grant "compulsory licences" for such
> production if certain conditions are fulfilled. One requirement is that
the
> destination country must have notified the WTO that it is seeking the
> medicine covered by the licence. The proposed Regulation 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.
>
> 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."
>
> 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."
>
> The proposed 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.
>
>
>


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