E-DRUG: MSF letters to EC after seizure of legitimate generics
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Dear all,
Please find below the text of letters sent by Medecins Sans Frontieres to
Mr László Kovács, European Commissioner for Taxation and Customs Union, and to Baroness Catherine Ashton, European Commissioner for Trade, following the seizure of medicines in transit in the EU to develping countries for alleged patent infringement.
James
Senior Communications Officer
MSF Access Campaign
www.msfaccess.org
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Geneva, February 12th,2009
Dear Commissioner,
On behalf of Medecins Sans Frontieres (MSF), we are writing to express our
concerns about the potential consequences of the recent seizure of
medicines in transit in the EU to developing countries for alleged patent
infringements on the basis of the Council Regulation (EC) No 1383/2003 by
Dutch customs authorities.
From our understanding, the recent case involves seizure by customs
authorities in Holland of losartan potassium, a generic version of the
active ingredient for a patented drug used to treat high blood pressure,
manufactured in India by the generic company Dr Reddy and in transit to
Brazil. It was not for use within the EU. The drug in question is not under
patent in India or Brazil but is under patent in the Netherlands.
MSF is concerned that the establishment of a precedent in EU countries to
use such provisions to intercept legitimate trade between generic
manufacturers and developing countries could severely impact the
affordability and availability of medicines in developing countries.
We are aware of the statement by the European Union at the WTO General
Council on February 3rd, 2009:
'In the present case, it appears that, following a request by a company
which has patent rights over the medicine in question in the Netherlands,
the Dutch authorities temporarily detained (which does not mean seize,
confiscate or destroy) a small shipment of drugs worth 55.000 euros in a
Dutch airport, in order to control it. This action is allowed by TRIPS and
is based on provisions in EU customs law that allow customs to temporarily
detain.'
We would like to point out that the EC Regulation No 1383/2003 goes beyond
the obligations required under the TRIPS Agreement in relation to customs
authorities as set out in Article 51 of the TRIPS Agreement. The footnote
of the same article states that 'It is understood that there shall be no
obligation to apply such procedures to imports of goods put on the market
in another country by or with the consent of the right holder, or to goods
in transit.' The EC Regulation No 1383/2003 nonetheless applies such
procedures to goods in transit. Any implementation of TRIPS obligations or
provisions which exceed those obligations must be assessed in light of the
2001 Doha Declaration on TRIPS and Public Health - signed by the members of
the European Union - notably in the light of the paragraph 4 of that
Declaration, according to which 'the [TRIPS] Agreement can and should be
interpreted and implemented in a manner supportive of WTO Members' right to
protect public health and, in particular, to promote access to medicines
for all.' In addition, article 41 of the TRIPS Agreement states that any
intellectual enforcement measures should 'be applied in such a manner as to
avoid the creation of barriers to legitimate trade.'
The World Health Organisation resolution WHA61.21, calls upon member states
to 'take into account, where appropriate, the impact on public health when
considering adopting or implementing more extensive intellectual property
protection than is required by the Agreement on Trade-Related Aspects of
Intellectual Property Rights.'
Many countries do not have manufacturing capacity to produce medicines, or
rely on importing more affordable generic medicines from abroad in order to
treat their population. As such, the trade in legitimate medicines between
countries is fundamental to ensuring access to medicines for millions.
Provisions to ensure such countries can access medicines, enshrined in the
Doha Declaration and the WTO August 30th decision, provisions cannot be
implemented effectively if on key transit routes the risk exists that
supplies can be regularly subject to interception based on assertion of
patent infringement in the transit country.
We are concerned that MSF's own medicine procurement activities may be
affected by the EU customs authorities use of the Regulation. Such actions
may have a chilling effect on exporters and require alternative and
potentially more expensive transit routes to be used that would inhibit the
supply of generic medicines both to developing countries and to
humanitarian organisations such as MSF who have logistical centres based in
Europe.
We, therefore, call on the European Commission to:
Clarify its position regarding the implementation of the EC Regulation No
1383/2003 with regard to pharmaceutical products;
Review the effect of the EC Regulation No 1383/2003 on the supply of
legitimate medicines, given the EU stated commitment to the full
implementation of the Doha Declaration on TRIPS and Public health and the
WTO August 30th decision;
Clarify whether such provisions are proposed for inclusion in European
Partnership Agreements and in the current negotiations of the EU Free Trade
Agreements.
We look forward to hearing your response as soon as possible.
Yours sincerely,
Kris Torgeson
Secretary General
MSF International
Tido von Schoen-Angerer
Executive Director
Campaign for Access to Essential Medicines
CC
Mr Louis Michel, European Commissioner for Development
Ms Androulla Vassiliou, European Commissioner for Health and Consumer
Protection
Mr Günter Verheugen , European Commissioner for Enterprise and Industry
Mrs Morgantini, Member of the European Parliament, Vice President of the
European parliament
Mr Markhov, Member of the European Parliament, Chair of the INTA Committee,
Mr Borrell Fontelles, Member of the European Parliament, Chair of the DEVE
Committee
Mr Martin, Mr Susta, Mr Arif, Mr Agnoletto, Mr Schlyter, Mrs Corbey, Mrs
Kinnock, Members of the European Parliament,