[Ip-health] De Gucht response on whether ACTA undermines delinkage of medicine prices and R & D costs

Malini Aisola malini.aisola at keionline.org
Wed Aug 25 13:33:03 PDT 2010

Commissioner De Gucht has replied to a question posed by Greens/EFA MEPs
Yannick Jadot, Carl Schlyter, Christian Engström, Sandrine Bélier,
Karima Delli and Oriol Junqueras Vies. The question and answer furnished
by the Commission are below.

        June 16, 2010
        Does ACTA undermine delinkage of medicine prices and R & D

        The 63rd World Health Assembly in May 2010 gave the World Health
        Organisation (WHO) a mandate to identify new financing and
        incentive mechanisms for R & D, to examine proposals for
        delinking the price of health products from R & D costs —
        including through innovation inducement prizes and new
        open-source drug development models — and to explore instruments
        for global coordination and norm setting, such as a biomedical
        R & D treaty.
        Norms for injunctions and damages laid down in the
        Anti-Counterfeiting Trade Agreement (ACTA) may foreclose the
        possibility of new ‘liability rule’ approaches to intellectual
        property rights as part of a policy framework delinking R & D
        costs from product prices. The ACTA text conspicuously lacks
        legally binding references to the Doha Declaration on the TRIPS
        Agreement and Public Health and the WHO Global Strategy and Plan
        of Action on Public Health, Innovation and Intellectual Property
        (WHO resolution WHA61.21).
        We remain troubled by the absence of policy coherence
        reconciling ACTA’s focus on enforcement at any cost with
        obligations under the Doha Declaration to interpret and
        implement the TRIPS Agreement ‘in a manner supportive of WTO
        members’ right to protect public health and, in particular, to
        promote access to medicines for all’.
        We note that the Council ‘Conclusions on the EU role in global
        health’, of 10 May 2010, advocate ‘exploring models that
        dissociate the cost of Research and Development and the prices
        of medicines in relation to the Global Strategy’. ACTA could
        constrain future policy options in this regard.
        Can the Commission comment on this obvious lack of policy
        coherence and indicate whether the fact of the Union being party
        to ACTA and its negotiating positions in that context are
        consistent with its obligations under the other international
        agreements mentioned?
Answer given by Mr De Gucht on behalf of the Commission:


        August 13, 2010
        The Anti-Counterfeiting Trade Agreement (ACTA) deals exclusively
        with the enforcement of intellectual property rights. It will
        not include provisions modifying substantive intellectual
        property law. It should set minimum rules on how innovators can
        enforce their rights — as already defined in each of the ACTA
        countries — in courts, at the borders or over the Internet.
        Any rules on injunctions and damages contained in the final text
        of the agreement will be fully in line with the EU acquis,
        therefore they will already be in force in Europe. ACTA will not
        create new obligations in Europe and will have no impact
        whatsoever on current debates or future policies about new
        liability rule approaches or about Research and Development
        (R&D) costs and prices for health products.
        ACTA will only apply in those cases where a product is protected
        by intellectual property rights. In those cases where an
        inventor would opt for alternative approaches, other than
        intellectual property rights, for recovering his investment,
        ACTA would of course not apply. 
        All ACTA parties have reaffirmed in a public statement of
        1 July 2010 that ACTA will be consistent with the World Trade
        Organisation (WTO) Agreement on Trade Related Aspects of
        Intellectual Property Rights (TRIPS Agreement) and the
        Declaration on TRIPS and Public Health. They added that ACTA
        will not hinder the cross-border transit of legitimate generic
        The WTO Declaration on TRIPs and Public Health is about how WTO
        Members wish to transpose their substantial TRIPs Commitments in
        national law. Once a choice has been made by a WTO member on,
        for instance, the situations under which a compulsory license
        can be issue for medicines, ACTA, which is about enforcing
        intellectual property rights in so far as they are granted and
        applied, can not interfere with that.
        Furthermore there will be a specific reference in the ACTA text
        to the need for all parties to comply with the obligations of
        the World Trade Organisation's Agreement on Trade Related
        Aspects of Intellectual Property Rights, including the
        flexibilities and exceptions that it contains, as well as with
        the obligations under other existing agreements. 
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola at keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673

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