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Thoughts on Transatlantic Regulatory Cooperation in Pharmaceuticals after #TTIPleaks
Published online by Cambridge University Press: 20 January 2017
Extract
The leak of confidential documents on 2 May 2016 by GreenpeaceNetherlands allows some preliminary conclusions on both the scope and success of the negotiations so far. As regards the pharmaceuticalmarket, the current state of affairs combines the promise of steps forward with the prospect of concerning standstills. This short opinion follows key points emerging from the leaked documents n.9 (“RegulatoryCooperation”) andn.16 (“TacticalState ofPlay”) that are directly relevant to the pharmaceutical market. The themes that will be briefly discussed are, first, the regulatory cooperation mechanisms emerging fromdoc. n.9 in comparison to current cooperation processes in pharmaceutical regulation. The leaked papers suggest positive and commendable (yet far from conclusive) developments towards amore transparent and regulated framework for cooperation, while perpetuating concerns regarding fundamental policy choices and prevalence ofmercantile imperatives over competing public interests.
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References
1 Identified as a relevant sector in EU Commission, “EU position on pharmaceutical products”, 14 May 2014, available on the internet at <http://trade.ec.europa.eu/doclib/docs/2014/may/tradoc_152471.pdf> (last accessed 19 May 2016).
2 TTIP leaks, Document n.9, “Initial Provisions for Chapter [ ] [EU: Regulatory Cooperation] [US: Regulatory Coherence, Transparency, and other good Regulatory Practices]”, available on the internet at <https://ttip-leaks.org/#docdoc9> (last accessed on 19 May 2016).
3 TTIP leaks, Document n.16, “Note – Tactical State of Play of the TTIP Negotiations”, available on the internet at <https://ttip-leaks.org/#docdoc16> (last accessed on 19 May 2016).
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11 Rizzi, “Non–Measurable Negotiations”, supra note 9, at p. 285.
12 TTIP leaks, Document n.9, supra note 2, Artt. X.23 “Establishment of the Regulatory Cooperation Body”, X.24 “Participation of stakeholders”, X.6 “Early Information on Planned Acts”, X.7 “Stakeholder Consultation”, X.8 “Transparent Development of Regulation”.
13 Alemanno, “The Regulatory Cooperation Chapter of the Transatlantic Trade and Investment Partnership”, supra note 5, at pp. 636 et sqq., describing the mechanisms under Art. 218 TFEU.
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17 TTIP leaks, Document n.10, “Chapter [_] Technical Barriers to Trade”, Art. 6, available on the internet at <https://ttip-leaks.org/#docdoc10> (last accessed 19 May 2016).
18 On the accountability deficit of such a prospect see Petersmann, Ernst–Ulrich, “Transformative Transatlantic Free Trade Agreements without Rights and Remedies of Citizens?”, 18 Journal of International Economic Law (2015), pp. 579 et sqq. CrossRefGoogle Scholar
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21 On the controversial nature of the GCP guidelines see Rizzi, “Non-Measurable Negotiations”, supra note 9, at p. 283.
22 EU Commission, “Technical Paper for Regulatory Cooperation on Generic Medicines – Proposal of the European Union”, 26 January 2016, available on the internet at <http://trade.ec.europa.eu/doclib/docs/2016/january/tradoc_154172.pdf> (last accessed 19 May 2016).
23 TTIP leaks, Document n.16, supra note 3, para. 2.4.
24 TTIP leaks, Document n.9, supra note 2, Art. X.14 “Decision–Making Based on Evidence”.
25 Regulation (EU) No 536/2014, supra note 19.
26 Marco Rizzi, “The Complex Case for Another Hard Look – Transnational Pharmaceutical Regulation and the Pedagogical Role of Courts” (PhD thesis on file at the European University Institute, 2015), pp. 155 et sqq.
27 Ibid.; for a recent discussion on the comparatively smaller role of product liability in the EU see Leeuwen, Barend Van and Verbruggen, Paul, “Resuscitating EU Product Liability Law?”, 5 European Review of Private Law (2015), pp. 899 et sqq.Google Scholar
28 As established for failure to warn claims by the US Supreme Court decision PLIVA, Inc. v Mensing 131 S. Ct. 2567, 2581 (2011) on the basis that if federal law requires generic manufacturers to use the same labeling as their brand-name counterparts it is impossible for them to simultaneously comply both with federal law and a state tort law duty to provide an enhanced label.
29 TTIP leaks, Document n.9, supra note 2, Art. X.13 “[EU: Analytical Tools] [US: Regulatory Impact Assessment]”.
30 EU Commission, “Technical Paper for Regulatory Cooperation on Generic Medicines”, supra note 22, at p. 1.
31 Wiener, Jonathan and Alemanno, Alberto, “The Future of International Regulatory Cooperation: TTIP as a Learning Process Towards a Global Policy Laboratory”, 78 Law and Contemporary Problems (2015), pp. 103 et sqq., at p. 104Google Scholar: “empirical research finds that U.S. and European risk regulation over the past four decades has exhibited overall average parity, with occasional divergences as selective precaution is applied on both sides to particular risks”.