[Ip-health] MEPs questions to the Commission on ACTA and access to medicines

Malini Aisola malini.aisola at keionline.org
Thu Jun 3 14:36:56 PDT 2010

Below are 3 written questions that some members of the European
Parliament have posed to the Commission about whether ACTA may undermine
access to medicines and constrain future policy options. 


1. Written question by MEPs Yannik Jadot, Carl Schlyter, Christian
Engstrom, Sandrine Belier, June 3, 2010  

        Does ACTA undermine delinkage of medicine prices and R&D costs?
        The 63rd World Health Assembly in May 2010 gave the WHO a
        mandate to identify new financing and incentive mechanisms for
        R&D, examine proposals that de-link the price of health products
        from costs of R&D including through the award of innovation
        inducement prize funds, new open source drug development models,
        and to explore instruments for global coordination and norm
        setting such as a Biomedical R&D Treaty.
        ACTA norms for injunctions and damages may foreclose new
        "liability rule" approaches for IP that operate within a policy
        framework that de-links R&D costs from product prices. The ACTA
        text conspicuously lacks legally binding references to the Doha
        Declaration on TRIPS and Public Health, and the WHO Global
        Strategy and Plan of Action on Public Health, Innovation and
        Intellectual Property (WHA61.21) in ACTA.
        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" endorses "exploring models that dissociate the cost of
        Research and Development and the prices of medicines in relation
        to" the Global Strategy. ACTA may constrain future policy
        options to implement such policies.
        Can the Commission provide an answer regarding the obvious lack
        of policy coherence and an assessment of whether the EU's being
        party to ACTA and its negotiating positions in this context are
        consistent with its obligations under the other international
        agreements mentioned?

2. Written question by MEPs Yannik Jadot, Carl Schlyter, Christian
Engstrom, Sandrine Belier, June 3, 2010


        Lack of safeguards in ACTA undermining access to medicines
        In the WTO TRIPS Council, the enforcement of intellectual
        property is a topic of formal discussions, including but not
        limited to discussion of ACTA. The WTO is also the forum at
        which India and Brazil are pursuing consultations with the EU
        over the seizures of in-transit generic drugs on the grounds of
        alleged patent infringement.
        In our reading, ACTA pursues heightened enforcement but without
        the balance and safeguards embodied in the TRIPS Agreement, such
        as Article 1, 6, 7, 8, 30, 31, 40, 41, 42 and 44.2 of the TRIPS.
        Certain measures in ACTA may present barriers to trade in
        legitimate generic medicines, by failing to provide protections
        for goods-in-transit where national patent landscapes differ,
        allowing inappropriate seizures of medicines on mere allegations
        that trademarks are similar, providing brand name companies with
        inappropriate access to confidential information about suppliers
        or customers, or by introducing new global norms on third party
        liability and criminal sanctions for aiding and abetting
        infringement that will deter distributors and customers from
        working with legitimate generic firms. Collectively these news
        norms may frustrate the ability of countries to avail themselves
        of TRIPS flexibilities needed to ensure access to medicine, and
        present a conflict with the recently adopted "Council
        Conclusions on the EU role in Global Health." (e.g. para 16. a.)
        Will the Commission fulfil the EP's March 10 request for an
        impact assessment of ACTA and "consult with Parliament in a
        timely manner about the results of the assessment"?
        Specifically, will it address access to medicines including the
        concerns we have put forth? How will the Commission reconcile
        the EU's stated commitments to promote global health with what
        is being pursued in ACTA?
3. Priority written question by MEP Ska Keller, May 31, 2010


        ACTA and ongoing WTO dispute settlement proceedings
        India and Brazil have initiated action against the EU over the
        seizures of generic drugs in transit through the WTO dispute
        settlement process. I hope that the matter will be resolved in
        this initial phase during the period of consultation.
        Is the Commission aware of concerns voiced by India during a
        Greens/EFA briefing on ACTA on May 4, related to proposed TRIPS
        plus provisions in ACTA that could threaten legitimate trade in
        generic medicines and global public health?
        How can the Commission pursue such provisions in ACTA that
        clearly breach commitments under the Doha Declaration on the
        TRIPS Agreement and Public Health and the "Global strategy and
        plan of action on public health, innovation and intellectual
        property", WHA Resolution 61.21 and are obviously linked to the
        dispute settlement proceedings against the EU?
        How will the Commission ensure that these unjustifiable
        provisions being pursued in ACTA and that would endanger access
        to medicines, will stop immediately? In the March 10 Resolution
        on the transparency and state of play of the ACTA negotiations,
        we clearly asked the Commission to limit the ACTA negotiations
        to combating only counterfeiting. I want to know if patents are
        still being considered within the scope of ACTA. I also want to
        know whether the Commission has made any effort to consult with
        public health groups to understand their concerns regarding the
        impact proposed ACTA provisions could have on innovation and
        access to medicines.

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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