E-DRUG: MSF Letter to EC Commissioner of Trade Regarding EU-India FTA
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Karel de Gucht
European Commissioner for Trade
European Commission
Directorate General for Trade
Rue de la Loi, 200
1049 Bruxelles- Belgium
Geneva, April 6 2010
Dear Commissioner,
I write to you on behalf of Médecins Sans Frontières (MSF), an
international aid organisation that provides emergency medical assistance
to populations in distress in more than 80 countries. MSF has been
providing antiretroviral therapy (ART) to people living with HIV/AIDS
(PLHAs) since 2000.
We understand that both informal and formal negotiations between India and
the European Union towards the signing of a Free Trade Agreement (FTA) are
about to conclude. MSF would like to draw your attention to the harmful
effects on access to medicines of proposals likely to be contained in the
FTA.
India has played a pivotal role in supplying affordable generic versions of
drugs used throughout the developing world. MSF for example sources over
80% of its antiretroviral medicines used in its AIDS projects around the
world from India. The availability of fixed-dose combination therapy (or
three-in-one pills) has revolutionised AIDS treatment, a fact we have
witnessed first hand in our own programmes. Providing this form of
treatment adapted to resource-poor settings in developing countries has
only been possible because there were no patent constraints in India on
putting these medicines together in one tablet. Currently 92% of people
living with HIV on treatment in low- and middle-income countries use
generic antiretrovirals manufactured in India.
Since 2005, India has developed a patent law that balances the need of
patients to access life-saving medicines at affordable prices with
pharmaceutical company profits. Specifically, India’s Patents Act allows
patient groups and other interested parties to oppose frivolous or abusive
patenting through pre- or post-grant oppositions, and by defining stricter
patentability criteria has prevented a practice known as evergreening where
company monopolies can be endlessly extended.
Yet we are concerned that the EU-India FTA may contain provisions that
dismantle this progress and represent a considerable step backwards, with
dire consequences for access to medicines in India and the rest of the
developing world. Restrictive provisions will have one major consequence
with regard to access to medicines: they will strengthen and extend the
monopoly rights of multinational pharmaceutical manufacturers at the
expense of patients in India and beyond. More specifically, these
provisions all seek to limit, and in some cases completely block, generic
competition. Generic competition has proven to be key in lowering the
prices of medicines, thereby improving access to medicines.
We would like specifically to call your attention to the following concerns
in FTAs negotiated by the European Union:
§ Data Exclusivity: Data exclusivity provisions being pushed by the EU in
FTA negotiations will delay, and could even prevent, the registration
of generic versions of medicines - even when there is no patent on a
medicine. The only alternative for a generic company would be to repeat
clinical trials, which would be costly and wasteful, and would be
medically unethical as it would involve replicating tests in humans to
demonstrate what is already known to be effective. Further, data
exclusivity could effectively block compulsory licenses.
§ Patent term extensions: At present, patents on drugs in most countries
last for 20 years from the date of filing. The EU seeks to extend the
life of the patent by the length of time the drug regulatory authority
takes to examine an application for registration, or a patent office
takes to examine a patent application. The life of the patent would be
extended beyond 20 years, extending the patent holder’s monopoly
position and preventing generic competition.
§ Enforcement and border measures: Border measures that seek to detain
imports or exports of good suspected of infringing intellectual
property rights are of great concern to other developing countries as
well as international agencies like MSF that procure their medicines
from India. In 2009, Indian generic medicines, including crucial AIDS
drugs, transiting through the EU en route to Africa and Latin America
were detained by the European Union. The EU is now seeking to export
the provisions of its customs regulations that allow such detentions to
developing countries which could hinder the flow of lifesaving generic
medicines.
The impact of such detentions is felt directly by patients awaiting the
arrival of crucial generic medicines. Many countries do not have
manufacturing capacity to produce medicines, or rely on importing more
affordable generic medicines from India in order to treat their population.
As such, the trade in legitimate medicines between countries is fundamental
to ensuring access to medicines for millions.
None of these restrictive provisions are required under the World Trade
Organization (WTO) Agreement on Trade-related Aspects of Intellectual
Property Rights (TRIPS), and this is reaffirmed by the November 2001 Doha
Declaration on TRIPS and Public Health.
Both the EU and India committed to the Doha Declaration and the Global
Strategy and Plan of Action on Intellectual Property (GSPA), Innovation and
Public Health adopted by the World Health Assembly in May 2008.
The GSPA adopts the principle of placing public health protection over
commercial interests, and 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.”
In addition, the European Parliament, during its previous legislature,
passed a Resolution on 12 July 2007 calling on the European Council “to
restrict the Commission's mandate so as to prevent it from negotiating
pharmaceutical-related TRIPS-plus provisions affecting public health and
access to medicines, such as data exclusivity, patent extensions and
limitation of grounds of compulsory licences, within the framework of the
(…) future bilateral and regional agreements with developing countries.”
During the hearing for your investiture, as new Commissioner for Trade, at
the European Parliament on 12 January 2010, responding to concerns raised
by MEP David Martin, chair of the European Parliament Working Group on
Innovation, Access to Medicines and Poverty-related diseases, you promised
to monitor “very closely” the continuing negotiations with India, to make
sure the terms of any trade agreement reached “do not impede free trade in
generic medicines” and said “I will take care of that”. Nevertheless, the
policy currently being implemented by the Direction General for Trade,
through this negotiation, does not reflect the political direction and
commitment you made, either the EU commitment to the Doha Declaration, to
the GSPA and to the European Parliament’s position, as cited above.
For patients living in India and all over the developing world, these
provisions could mean the difference between life or death. It is crucial
that generic competition remains possible in India. So many lives depend on
it worldwide.
We therefore urge you to ensure that the negotiations lead by the European
Commission’s representatives, on behalf of the European Union, do not
contain intellectual property proposals that go beyond the requirements of
the TRIPS Agreement.
Yours sincerely,
Tido von Schoen-Angerer, MD
Executive Director
Campaign for Access to Essential Medicines
Médecins Sans Frontières International
C.C
Andris Piebalgs
Commissioner for Development
Jerzy Buzek
President of the European Parliament
MEP David Martin
Chair of the European Parliament Working Group on Innovation, Access to
Medicines and Poverty-related diseases
Mr Vital Moreira
President of INTA Committee, European Parliament
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Kind regards,
Michelle Vilk
Coordination and Communications Assistant
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva, Switzerland
Tel: + 41(0) 22 849 89 02
Fax: + 41 (0) 22 849 84 04
michelle.vilk@geneva.msf.org