European Commission v Republic of Poland.
Date: 2012-03-29
26. It must be noted at the outset that Article 6(1) of Directive 2001/83 provides that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that State in accordance with that directive or unless an authorisation has been issued in accordance with the centralised procedure provided for in Regulation No 726/2004 for medicinal products referred to in the annex to that regulation.
27. This requirement is intended to fulfil the objectives which Directive 2001/83 seeks to attain, namely, first, the elimination of hindrances to trade in medicinal products between the Member States and, second, the protection of public health (see Case C‑84/06 Antroposana and Others [2007] ECR  I‑7609, paragraph 36). As the Advocate General stated in points 19 to 21 of his Opinion, the harmonised marketing authorisation procedure enables cost-efficient and non-discriminatory market access, while ensuring that the requirements of safeguarding public health are achieved.
29. Under Article 5(1) of the directive, a Member State may exclude from the directive’s scope, in order to fulfil special needs, medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.
31. In order to interpret that provision, it must be taken into account that, generally, provisions which are in the nature of exceptions to a principle must, according to settled case-law, be interpreted strictly (see in particular, to this effect, Case C‑3/09 Erotic Center [2010] ECR I‑2361, paragraph 15 and the case-law cited).
32. More specifically, as regards the derogation referred to in Article 5(1) of Directive 2001/83, the Court has already pointed out that the possibility of importing non-approved medicinal products, provided for under national legislation implementing the power laid down in that provision, must remain exceptional in order to preserve the practical effect of the marketing authorisation procedure (see, to this effect, Case C‑143/06 Ludwigs-Apotheke [2007] ECR I‑9623, paragraphs 33 and 35).
35. Also, the requirement that medicinal products are supplied in response to a ‘bona fide unsolicited order’ means that the medicinal product must have been prescribed by the doctor as a result of an actual examination of his patients and on the basis of purely therapeutic considerations.
36. It is apparent from the conditions as a whole set out in Article 5(1) of Directive 2001/83, read in the light of the fundamental objectives of that directive, and in particular the objective seeking to safeguard public health, that the derogation provided for in that provision can only concern situations in which the doctor considers that the state of health of his individual patients requires that a medicinal product be administered for which there is no authorised equivalent on the national market or which is unavailable on that market.
37. Where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market, there cannot in fact be a question of ‘special needs’, within the meaning of Article 5(1) of Directive 2001/83, necessitating a derogation from the requirement for a marketing authorisation under Article 6(1) of that directive.
47. It must be noted in that respect, first, that although EU law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions intended to govern the consumption of pharmaceutical products in order to promote the financial stability of their health‑care insurance schemes, the Member States must, however, comply with EU law in exercising that power (Joined Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07 A. Menarini Industrie Farmaceutiche Riunite and Others  [2009] ECR I‑2495, paragraphs 19 and 20).
48. It must be pointed out, next, that Article 5(1) of Directive 2001/83 is not concerned with the organisation of the health-care system or its financial stability, but is a specific derogating provision, which must be interpreted strictly, applicable in exceptional cases where it is appropriate to meet special medical needs.