Keywords

Summary



Keywords

1. Action for failure to fulfil obligations – Subject-matter of the dispute – Division of powers between the Member States and the Community in the area of public health – Conditions for intervention by the Commission

(Arts 152(5) EC and 211 EC)

2. Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Obstacles resulting from national provisions regulating selling arrangements in a non-discriminatory way

(Arts 28 EC and 30 EC)

Summary

1. Community 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 and the organisation and delivery of health services and medical care.

However, in exercising that power, the Member States must comply with Community law, in particular the provisions of the Treaty on the free movement of goods. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sector.

Accordingly, the Commission’s action, as part of the performance of its tasks, which, under Article 211 EC, include ensuring that the provisions of the Treaty are applied, is restricted to determining whether the Member States have acted in compliance with the rules of that Treaty relating to the free movement of goods.

Furthermore, as Community law stands at present, since there has been no harmonisation at Community level of the rules on the provision of medicinal products to hospitals, the Member States continue to be empowered to lay down rules on that subject, subject to compliance with the provisions of the Treaty, in particular the provisions on the free movement of goods.

(see paras 22-25)

2. National provisions which determine the requirements which external pharmacies must meet if they are to be eligible to supply medicinal products to hospitals and which do not concern the characteristics of the medicinal products, but concern solely the arrangements permitting their sale, must be regarded as concerning selling arrangements. Although such provisions apply indiscriminately to all the operators concerned who carry out their business on the territory of the Member State which has adopted them, they are such as to make the supply of medicinal products to hospitals in that Member State more difficult and more costly for pharmacies established in other Member States than for pharmacies established in the Member State concerned, since they lay down a series of cumulative criteria which in practice require a degree of geographical proximity between the pharmacy supplying the medicinal products and the hospital for which those products are intended. Consequently, such provisions are liable to hinder intra-Community trade and constitute a measure having equivalent effect to a quantitative restriction on imports prohibited by Article 28 EC.

However, legislation which is such as to restrict a fundamental freedom guaranteed by the Treaty, such as the free movement of goods, can be justified on grounds of the protection of public health if it is appropriate for securing the attainment of the objective pursued and does not go beyond what is necessary in order to attain it. In that regard, first, the provisions in question are such as to achieve the objective of ensuring that the supply of products to the hospitals of the Member State concerned is reliable and of good quality and therefore of protecting public health. Secondly, the fact of the matter is that the provisions in question transpose to the system of external provision of supplies requirements analogous to those which characterise the system of internal provision of supplies. To the extent that conclusion of the supply contract with the pharmacy of another hospital or with an external pharmacy is subject to the provisions in question, which lay down conditions analogous to those applicable in the system of internal provision of supplies, namely the requirement that there be one pharmacist who is, first, responsible for the supply of medicinal products and, secondly, generally and quickly available in situ, those provisions ensure that all the elements of the system for the supply of medicinal products to hospitals in the Member State concerned are equivalent and mutually compatible, and thereby guarantee the unity and balance of that system. Accordingly, those provisions can be seen to be necessary to the achievement of the objective of ensuring a high level of public health protection and clearly do not go beyond what is necessary.

(see paras 30-31, 33-35, 44, 48-49, 55-57)