ACTA undermining access to medicines (E-4292/2010)

Parliamentary questions 16 June 2010 E-4292/2010 Question for written answer to the Commission  Rule 117
Yannick Jadot (Verts/ALE) , Carl Schlyter (Verts/ALE) , Sandrine Bélier (Verts/ALE) , Christian Engström (Verts/ALE) , Karima Delli (Verts/ALE) and Oriol Junqueras Vies (Verts/ALE)

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?

Parliamentary questions 27 September 2010 E-4292/2010

Answer given by Mr De Gucht on behalf of the Commission

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 sensitive² issue 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/EC(2)) 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.”
(2) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights, OJ L 157, 30.4.2004

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