[Ip-health] MSF letters to EC after seizure of legitimate generics under EC customs Regulations

[James ARKINSTALL]

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Dear all,=0D
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Please find below the text of letters sent by Medecins Sans Frontieres to=
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Mr L=C3=A1szl=C3=B3 Kov=C3=A1cs, European Commissioner for Taxation and Cus=
toms Union, and=0D
to Baroness Catherine Ashton, European Commissioner for Trade, following=0D
the seizure of medicines in transit in the EU to develping countries for=0D
alleged patent infringement.=0D
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James=0D
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Senior Communications Officer=0D
MSF Access Campaign=0D
www.msfaccess.org=0D
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Geneva, February 12th,2009=0D
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Dear Commissioner,=0D
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On behalf of M=C3=A9decins Sans Fronti=C3=A8res (MSF), we are writing to ex=
press our=0D
concerns about the potential consequences of the recent seizure of=0D
medicines in transit in the EU to developing countries for alleged patent=
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infringements on the basis of the Council Regulation (EC) No 1383/2003 by=
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Dutch customs authorities.=0D
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>From our understanding, the recent case involves seizure by customs=0D
authorities in Holland of losartan potassium, a generic version of the=0D
active ingredient for a patented drug used to treat high blood pressure,=0D
manufactured in India by the generic company Dr Reddy and in transit to=0D
Brazil. It was not for use within the EU. The drug in question is not under=
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patent in India or Brazil but is under patent in the Netherlands.=0D
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MSF is concerned that the establishment of a precedent in EU countries to=
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use such provisions to intercept legitimate trade between generic=0D
manufacturers and developing countries could severely impact the=0D
affordability and availability of medicines in developing countries.=0D
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We are aware of the statement by the European Union at the WTO General=0D
Council on February 3rd, 2009:=0D
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=E2=80=9CIn the present case, it appears that, following a request by a com=
pany=0D
which has patent rights over the medicine in question in the Netherlands,=
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the Dutch authorities temporarily detained (which does not mean seize,=0D
confiscate or destroy) a small shipment of drugs worth 55.000 euros in a=0D
Dutch airport, in order to control it. This action is allowed by TRIPS and=
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is based on provisions in EU customs law that allow customs to temporarily=
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detain.=E2=80=9D=0D
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We would like to point out that the EC Regulation No 1383/2003 goes beyond=
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the obligations required under the TRIPS Agreement in relation to customs=
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authorities as set out in Article 51 of the TRIPS Agreement. The footnote=
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of the same article states that =E2=80=9CIt is understood that there shall =
be no=0D
obligation to apply such procedures to imports of goods put on the market=
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in another country by or with the consent of the right holder, or to goods=
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in transit.=E2=80=9D  The EC Regulation No 1383/2003 nonetheless applies su=
ch=0D
procedures to goods in transit.  Any implementation of TRIPS obligations or=
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provisions which exceed those obligations must be assessed in light of the=
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2001 Doha Declaration on TRIPS and Public Health =E2=80=93 signed by the me=
mbers of=0D
the European Union - notably in the light of the paragraph 4 of that=0D
Declaration, according to which =E2=80=9Cthe [TRIPS] Agreement can and shou=
ld be=0D
interpreted and implemented in a manner supportive of WTO Members' right to=
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protect public health and, in particular, to promote access to medicines=0D
for all.=E2=80=9D  In addition, article 41 of the TRIPS Agreement states th=
at any=0D
intellectual enforcement measures should =E2=80=9Cbe applied in such a mann=
er as to=0D
avoid the creation of barriers to legitimate trade.=E2=80=9D=0D
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The World Health Organisation resolution WHA61.21, calls upon member states=
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to =E2=80=9Ctake into account, where appropriate, the impact on public heal=
th when=0D
considering adopting or implementing more extensive intellectual property=
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protection than is required by the Agreement on Trade-Related Aspects of=0D
Intellectual Property Rights.=E2=80=9D=0D
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Many countries do not have manufacturing capacity to produce medicines, or=
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rely on importing more affordable generic medicines from abroad in order to=
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treat their population. As such, the trade in legitimate medicines between=
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countries is fundamental to ensuring access to medicines for millions.=0D
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Provisions to ensure such countries can access medicines, enshrined in the=
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Doha Declaration and the WTO August 30th decision, provisions cannot be=0D
implemented effectively if on key transit routes the risk exists that=0D
supplies can be regularly subject to interception based on assertion of=0D
patent infringement in the transit country.=0D
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We are concerned that MSF's own medicine procurement activities may be=0D
affected by the EU customs authorities use of the Regulation. Such actions=
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may have a chilling effect on exporters and require alternative and=0D
potentially more expensive transit routes to be used that would inhibit the=
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supply of generic medicines both to developing countries and to=0D
humanitarian organisations such as MSF who have logistical centres based in=
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Europe.=0D
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We, therefore, call on the European Commission to:=0D
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Clarify its position regarding the implementation of the EC Regulation No=
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1383/2003 with regard to pharmaceutical products;=0D
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Review the effect of the EC Regulation No 1383/2003 on the supply of=0D
legitimate medicines, given the EU stated commitment to the full=0D
implementation of the Doha Declaration on TRIPS and Public health and the=
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WTO August 30th decision;=0D
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Clarify whether such provisions are proposed for inclusion in European=0D
Partnership Agreements and in the current negotiations of the EU Free Trade=
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Agreements.=0D
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We look forward to hearing your response as soon as possible.=0D
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Yours sincerely,=0D
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Kris Torgeson=0D
Secretary General=0D
MSF International=0D
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Tido von Schoen-Angerer=0D
Executive Director=0D
Campaign for Access to Essential Medicines=0D
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=0D
CC=0D
Mr Louis Michel, European Commissioner for Development=0D
Ms Androulla Vassiliou, European Commissioner for Health and Consumer=0D
Protection=0D
Mr G=C3=BCnter Verheugen , European Commissioner for Enterprise and Industr=
y=0D
Mrs Morgantini, Member of the European Parliament, Vice President of the=0D
European parliament=0D
Mr Markhov, Member of the European Parliament, Chair of the INTA Committee,=
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Mr Borrell Fontelles, Member of the European Parliament, Chair of the DEVE=
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Committee=0D
Mr Martin, Mr Susta, Mr Arif, Mr Agnoletto, Mr Schlyter, Mrs Corbey, Mrs=0D
Kinnock, Members of the European Parliament,