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Published online by Cambridge University Press: 20 January 2017
Opponents of the transatlantic trade and investment partnership treaty (TTIP) fear that the EUmight lose the capacity to protect public health as it deems appropriate. The freedomto regulate would be jeopardized because TTIP would bind the EU to the United States’ regulatory interests, which are expressly or implicitly assumed to live up to a ‘lower’ standard than those in the EU. The ‘TTIP–leaks’ provide a good opportunity to examine the potential impact of the agreement on EU public health regulation. This brief contribution uses as its starting point the document “Tactical State of Play of the TTIP negotiations” (hereafter “Tactical Document”) of March 2016, and focuses on pharmaceuticals and medical devices. In light of the statements in this document, we query what would change for the EU consumer, and what would be the impact on the EU regulators’ role in protecting public health.
1 Editorial, Warning: TTIP could be hazardous to your health, Journal of Public Health, Vol 37 No 3, pp 367-369.
2 Author not specified, Note – Tactical State of Play of TTIP Negotiations – March 2016. This negotiation document was leaked in March 2016. It is accessible via https://www.ttip-leaks.org/ (consulted 27 May 2016).
3 Article 8(ha) of Directive 2001/83/EC.
4 Article 46(f) of Directive 2001/83/EC.
5 Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
6 Agreement on mutual recognition between the European Community and Canada, OJ 16 October 1998 L280/3, chapter 6 on good manufacturing practices, points 3.1, 3.2 and 3.3 general considerations.
7 Idem.
8 S. Milmo, Collaborating on GMP inspections, Pharmaceutical Technology, Volume 39, Issue 9, September 2015.
9 The Active Implantable Medical Devices Directive 90/385/EEC, the Medical Devices Directive 93/42/EEC, and the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
10 The future legislative package on medical devices consists of the new Medical Devices Regulation and the new Regulation on Invitro Diagnostic Medical Devices. Once adopted, the new rules on medical devices will enter into force three years later; those on invitro medical devices five years later.
11 European Commission, Recommendation (2013/172/EU) of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union.
12 See, for example, European Commission, EU Position Paper on Medical Devices, 15 April 2015, which states that “there is no intention to use TTIP to harmonise EU and US QMS regulatory requirements.”
13 See, for example, BEUC, How will TTIP affect the health of Europeans?, 21 September 2014.
14 Some non–governmental associations warn that TTIP measures may be presented as harmless while in fact harming patient health.