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Vers un marché transatlantique de la santé ou les enjeux de la coopération réglementaire du projet de Partenariat transatlantique de commerce et d’investissement (TTIP) dans le domaine pharmaceutique

Clotilde Jourdain-Fortier

Revue internationale de droit économique, 2016, vol. t. XXX, issue 4, 519-540

Abstract: The Transatlantic Trade and Investment Partnership project, known as TTIP, covers various industrial sectors, including pharmaceuticals and medical devices. Its aim is fundamentally of a commercial, economic nature, as far as its negotiators tend to create a transatlantic health market, ie a geographical area within which health products will circulate more easily than elsewhere, due in particular to the lowering of the many technical trade barriers (non tariff barriers) in the sector. In other words, the project seeks to create a market close to an internal one. To do so, i.e. to reduce or even eliminate non-tariff barriers, the project proposes mainly to develop regulatory cooperation between the American (the Food and Drug Administration) and the European (European Medicines Agency) agencies, regulatory convergence in those sectors, so as to eliminate duplication, administrative complications and thus facilitate trades. It is nevertheless necessary to examine the scope of this regulatory cooperation, its modalities and limits, in order to determine its potential consequences on States? regulatory autonomy and on the legitimacy of governments? regulations in the area of health. One issue is whether such regulatory cooperation is thought out and organized in favor of the pharmaceutical companies? private interests alone or whether it takes into account other considerations, in particular non-commercial ones which are favorable to citizens and consumers? interests, hitherto untreated or little at the multilateral level.

Keywords: Free Trade Agreement; technical trade barriers; regulatory cooperation; health products; drug agencies; regulatory autonomy (search for similar items in EconPapers)
Date: 2016
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