[Ip-health] Joint Civil Society letter to DG Trade Commissioner de Gucht: ACTA and its impact on access to medicines

Teresa Alves Teresa at haiweb.org
Fri Jul 30 01:45:37 PDT 2010

Dear IP-health list ,

Please find below a civil society letter sent yesterday  to DG Trade
Commissioner De Gucht and his colleagues regarding the
Anti-Counterfeiting Trade Agreement (ACTA) and its impact on access to
medicines. This letter has been endorsed by Oxfam International, Health
Action International (Europe), Knowledge Ecology International, Public
Citizen and Vrijschrift.

Should you have any queries regarding this Open Letter, please do not
hesitate to contact the endorsing organisations.

With best wishes,

Teresa Alves

Teresa Leonardo Alves

European Coordinator

Health Action International (HAI) Europe


Overtoom 60 II

1054 HK Amsterdam

The Netherlands

Mobile:+31 6 246 867 71

Tel: +31 20 489 1864

Fax: +31 20685 5002

Email:teresa at haiweb.org

Web site: http://www.haiweb.org <http://www.haiweb.org/> 


Health Action International (HAI) is an independent, global network
working to increase access to essential medicines and improve their
rational use through research excellence and evidence-based advocacy.

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29 July, 2010


Dear Commissioner De Gucht,


We are writing to you regarding the on-going negotiations of the Anti
Counterfeiting Trade Agreement (ACTA) and in response to your comments
on ACTA before the LIBE committee. 


Our organizations have discussed with both pharmaceutical companies and
governments for decades measures to improve access to safe medicines in
developing countries. We are concerned that trade policies promulgated
by DG Trade undermine access to affordable medicines and sustainability
of treatment regimes and contradict the EU's broad commitment to improve
access to health care in developing countries. 

On multiple occasions, our organizations have warned DG Trade that new
and unbalanced intellectual property rules, such as those included under
ACTA, would condone overzealous and erroneous enforcement of
intellectual property for medicines and thereby pose a danger to public
health, while doing little to protect consumers from unsafe products.
Despite these serious concerns the Commission still considers an impact
assessment regarding access to medicines or public health irrelevant.

In recent comments before the European Parliament, you publicly affirmed
that patents have been removed from the border measures chapter in ACTA,
and that this collective decision would ensure that access to affordable
medicines would not be hindered by the Agreement. 


Despite numerous requests for transparency, the ACTA negotiating parties
have decided to continue this negotiation in secret and the public has
not had access to the latest version of the text. However, our
organizations have had access to a recent text - dated July 1st - and
strongly disagree with your assessment that ACTA will not affect public


We would like to share some on-going concerns that should be urgently
addressed by the negotiating parties to ensure ACTA will not harm public


1)      Patents remain in the Agreement.  The border measures chapter
still could apply to all intellectual property rights, including
patents.  This would raise serious concerns that border measures would
be used, especially within in-transit countries, to interfere with the
lawful trade in generic medicines.  Furthermore, patents are still
included in Article 1.X as part of the definition of 'intellectual
property' and can therefore apply to several parts of the agreement.
Patents have no bearing upon whether a product is counterfeit.
Including patents in ACTA will do nothing to arrest the proliferation of
counterfeit products, including counterfeit medicines.  Instead, it will
discourage legitimate challenges to multinational pharmaceutical
companies' patenting practices and will limit important flexibilities
included in the TRIPS agreement. 


2)      ACTA, including in the border measures chapter, still fails to
differentiate between trademark infringement and trademark
counterfeiting. ACTA should only be concerned with enforcement rules
that reduce or eliminate trademark counterfeiting.  


3)      ACTA still could allow for in-transit seizure of goods that
infringe intellectual property in the transit country, even when it does
not infringe intellectual property rules in either the exporting or
importing country. As part of the EU Council Regulation 1383/2003 this
provision is currently subject to a WTO case. It is not clear what it
would mean if ACTA were finalized before the case concludes. 


4)      ACTA will extend intermediary liability to innocent active
pharmaceutical ingredient (APIs) suppliers whose materials are used in
mislabelled products without their knowledge and therefore could
discourage the provision of APIs to generic producers under the risk of
liability. Article 2.X.2, if enacted, would allow right holders to apply
for injunctions against "[infringing] intermediaries whose services are
used by a third party to infringe an intellectual property right." 


5)      ACTA will create a new entity outside of the World Trade
Organization and the World Intellectual Property Organization, which
will lack transparency and accountability to non-Parties and public
interest organizations, and may push for ever-higher levels of
intellectual property protection and enforcement around the world
without adequate safeguards and evidence-based policy making. 


6)      ACTA will limit key flexibilities necessary to promote the
public interest, including flexibilities included in the TRIPS Agreement
on the award of injunctions as remedies. The EU should support the
proposal offered by Canada and Australia in Article 2.X that would allow
each Party to preserve or introduce statutory exceptions to injunctive
relief in their national laws. 


7)      ACTA lacks safeguards already included under the TRIPS Agreement
that ensure a proper balance in the enforcement of intellectual property
rules. A lack of safeguards will delay generic competition and endanger
the ability of governments to adopt innovation policies that dissociate
the cost of research and development from the price of products.  Our
expectation is that basic safeguards and protections included under
TRIPS will be introduced into the final Agreement to ensure that
national governments can maintain an appropriate balance.


As the European Union looks ahead to the next round of negotiations, our
organizations hope that these concerns will be taken seriously. We would
be happy to further discuss these issues with you and share our ideas
and expertise on safeguards for public interests.



Yours sincerely,

Jeremy Hobbs, Executive Director, Oxfam International

Teresa Leonardo Alves, HAI Europe Coordinator

James Love, Director, Knowledge Ecology International 

Robert Weissman, President, Public Citizen

Ante Vessels, Analyst, Vrijschrift




Commissioner Dalli (SANCO)

Commissioner Piebalgs (DEV)

Commissioner Geoghegan-Quinn (R&D)

INTA Committee, European Parliament

DEVE Committee, European Parliament

European Parliament Working Group on Innovation, Access to Medicines and
Poverty-Related Diseases





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