[Ip-health] Commission's response to MEPs on the lack of safeguards in ACTA and access to medicines

Malini Aisola malini.aisola at keionline.org
Mon Oct 4 16:47:05 PDT 2010


The written question by MEPs Yannick Jadot, Carl Schlyter, Sandrine
Bélier, Christian Engström, Karima Delli and Oriol Junqueras Vies, and
Commission's response:

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+WQ
+E-2010-4292+0+DOC+XML+V0//EN&language=EN

        
        Subject: Lack of safeguards in ACTA undermining access to
        medicines

        In the WTO Council for Trade-Related Aspects of Intellectual
        Property Rights (TRIPS Council), the enforcement of intellectual
        property rights is a topic of formal discussion including, but
        not limited to, discussion of the Anti-Counterfeiting Trade
        Agreement (ACTA). The WTO is also the forum in which India and
        Brazil are pursuing consultations with the EU over seizures of
        in-transit generic drugs on grounds of alleged patent
        infringement.
                
        Our reading of ACTA is that it pursues tighter enforcement but
        without the balance and safeguards embodied in the TRIPS
        Agreement (e.g. Articles 1, 6, 7, 8, 30, 31, 40, 41, 42 and
        44(2) thereof).
        
        Certain provisions in ACTA may present barriers to trade in
        legitimate generic medicines by failing to provide protection
        for goods in transit through countries with differing national
        patent rules, thus allowing inappropriate seizures of medicines
        on the strength of mere allegations that trademarks are similar;
        by 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 countries’ efforts to avail themselves of TRIPS
        flexibilities to ensure access to medicine, and may conflict
        with the recently adopted ‘Council Conclusions on the EU role in
        Global Health’ (e.g. paragraph 16(a) thereof).
        
        Will the Commission act on Parliament’s request of 10 March 2010
        for an impact assessment of ACTA and ‘consult with Parliament in
        a timely manner about the results of the assessment’?
        Specifically, will it address the issue of access to medicines,
        including the concerns we have outlined? How will the Commission
        reconcile the EU’s stated commitments to promoting global health
        with the goals being pursued in ACTA?
        

E-4292/10EN Answer given by Mr De Gucht on behalf of the Commission
(27.9.2010)

http://en.act-on-acta.eu/E_4292_10

        The Commission can assure the Honourable Members that there are
        no provisions in the Anti Counterfeiting Trade Agreement (ACTA)
        text being currently negotiated that could directly or
        indirectly affect the legitimate trade in generic medicines.
        This important principle has been re-affirmed in by all the ACTA
        negotiating parties in recent joint communiqués [1].
        
        It is important to note in this context that ACTA will not
        oblige the parties to introduce customs controls (including for
        transit) or criminal sanctions for patent infringements.
        Likewise, the balance and safeguards embodied in the
        trade-related aspects of intellectual property rights (TRIPS)
        Agreement will not be affected by ACTA, since ACTA only deals
        with enforcement of rights, without altering the substance of
        those rights. Nevertheless, in order to keep the balance
        achieved in TRIPs, the ACTA will include a provision ensuring
        that it will not derogate from the Parties' obligations pursuant
        to that agreement, which includes provisions such as the ones of
        Articles 1, 6, 7, 8, 30, 31 of TRIPs, but also wider commitments
        such as those contained in the Doha Declaration on TRIPs and
        Public Health.
        
        At this stage of the negotiations, where numerous options remain
        open, it is impossible to provide definitive replies to the
        specific situations mentioned by the Honourable Members.
        However, it is possible to clarify some of these issues:
        
        a) on the protection for goods in transit through countries with
        differing national patent rules – ACTA will contain no
        provisions on customs controls for patent infringing goods.
        Regarding infringement of other intellectual property
        rights (IPRs), it is not yet decided whether transit will be
        covered by ACTA or not;
        
        b) on the inappropriate seizures of medicines on the strength of
        mere allegations that trademarks are similar – the introduction
        of the concept of "confusingly similar trademark is proposed by
        one of the ACTA partners but not supported by any of the other;
        
        c) on providing brand-name companies with inappropriate access
        to confidential information about suppliers or customers – ACTA
        will clearly require that all issues regarding confidentiality
        and privacy of information are done in accordance with the
        domestic laws and previous international agreements undertaken
        by the Parties. EU acquis in this field (like in all others)
        will not be modified;
        
        d) on the introduction of 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 – all the norms being discussed in ACTA
        in this field already exist in the EU and all of its Member
        States and will not be modified by ACTA. ACTA's rules on third
        party liability will most likely apply to copyright
        infringements (with no impact on the pharmaceutical sector) and
        any rules on the criminal liability for aiding and abetting only
        apply to wilful infringements of copyright and trademarks on a
        commercial scale, which is certainly not affecting distributors
        of generics;
        
        e) on the concern that collectively these news norms may
        frustrate countries’ efforts to avail themselves of TRIPS
        flexibilities to ensure access to medicine, and may conflict
        with the recently adopted ‘Council Conclusions on the EU role in
        Global Health’ (e.g. paragraph 16(a) thereof) - there is clear
        language in the draft text ensuring that ACTA will not serve as
        a basis to interfere with the access to medicines and more
        particularly with the trade in generic medicines. ACTA will be
        consistent with the Declaration on TRIPS and Public Health of
        2001, whilst, as mentioned above, there will be no obligation to
        apply border controls to suspected patent infringements, which
        is the most sensitive ²issue as regards access to medicines for
        countries depending on imported pharmaceuticals.
        
        Regarding the conduct of an impact assessment of the
        implementation of ACTA, the Commission notes that, since it is
        bound not to go beyond the EU acquis it has based its assessment
        of the impact of ACTA on the studies made for the 2004 Directive
        on the enforcement of Intellectual Property Rights (Directive
        2004/48/EC2) and for the 2006 proposal for a Directive on
        criminal enforcement of IPR (COM (2006)168 final) (not
        adopted). 
        
        [1] Press release of 16April 2010: "ACTA […] will be consistent
        with the WTO Agreement on Trade Related Aspects of Intellectual
        Property Rights (TRIPS Agreement) and will respect the
        Declaration on TRIPS and Public Health". Press release of 1 July
        2010: "ACTA will be consistent with the WTO Agreement on Trade
        Related Aspects of Intellectual Property Rights (TRIPS
        Agreement) and the Declaration on TRIPS and Public Health.
        Participants reiterated that ACTA will not hinder the
        cross-border transit of legitimate generic medicines, and
        reaffirmed that patents will not be covered in the Section on
        Border Measures."



-- 
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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