Free movement of Medicine products in the EU The market Territory : EU et Turquey with the EC-Turquey Customs Union (Ankara Association Agreement 1963 and the Decision n° 1/95 of the Association) Products : medicinal products (the definition come from EU law )

Free movement of Medicine products in the EU The EU competence : rules Compétence given by member states The principle of subsidiarity and proportionality The EU competence : in matter of public health The rules about internal maket : article 30 et 36 ofTFUE, article 115 of TFUE The rules about public health protection:

Free movement of Medicine products in the EU The EU competence in matter of public health Shared competence between Union and Member States: art. 4 du TFUE Union have competence to carry out actions to support, coordinate or supplement the actions f Member states : art. 6 du TFUE Complementation of national policies : art. 168 TFUE Art. 35 Charter of Fundamental Rights of the Europea Union

Free movement of Medicine products in the EU Case law interpretation Art. 34 and 35 of TFUE « Quantitative restrictions on imports and exports, and all measures having equivalent effect, shall be prohibited between Member States » Art. 36 of TFUE « The provisions of Article 34 and 35 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on ground of public morality, public policy or public security ; the protection of health and lif of humans, animals or plants ; the protection of national treasures possessing artistic, historic or archeological value ; or the protection of industrial and commercila property. Such prohibitions or restrictions shall not, however, constitue a means of arbitrary discrimination or disguised restriction on trade between Member States».

Free movement of Medicine products in the EU Interprétation of public health Not an exclusive competence for Member States A strict and proportioned interpretation Le precaution principle Examples CJCE, 20 février 1979, Rewe Zentral CJCE, 5 février 2004;Commission c/ Italie, aff. C- 270/02 CJCE, 30 novembre 1983, Van Bennekom, aff. 227/82

Free movement of Medicine products in the EU Paralell trade in medecines Définition : when medicinal products produced genuinely under protection of IP rights, placed into internal market and then imported by and intermediary into a second market without the autorisation of the owner of IP rights. Illustrations : CJCE, 1 avril 2004, Kohlpharma, aff. C- 112/02 Communication of Commission COM (2003) 839 final

Free movement of Medicine products in the EU Repackaging : to reduce the effect of the fragmentation of the EU market Conditions of repackaging CJCE, 13 février 1979, Hoffmann Laroche, aff. 85/76 Difference between the necessity of repackaging and the shape of the repackaging CJCE, 22 décembre 2008, The Wellcome Foundation c/ paranova CJUE, 28 juillet 2011, Oripharm c/ Merck, concl avocat général

Free movement of Medicine products in the EU Rules adopted by EU institutions Art. 114 of TFUE : Approximation of laws « The European Parliament and the Council shall acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation and administrative action in Member States which have their object the establishment and functioninf of the Internal Market ». Définition of drugs: directive 2001on the Community Code relating to medicinal products for human use Medicinal products defined by presentation Medicinal products defined by function

Free movement of Medicine products in the EU The European marketing authorisations The European Medicines Agency Centralised procedure