Keywords
Summary

Keywords

1. Approximation of laws – Medicinal products – Directive 89/105 – Medicinal products for human use

(Council Directive 89/105, Art. 4(1))

2. Acts of the institutions – Directives – Direct effect

(Council Directive 89/105, Art. 4(1))

3. Approximation of laws – Medicinal products – Directive 89/105 – Medicinal products for human use

(Council Directive 89/105, Art. 4(1))

Summary

1. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems must be interpreted as meaning that it is for the Member States to determine, in compliance with the objective of transparency pursued by that directive and the requirements laid down by that provision, the criteria on the basis of which the review of macro-economic conditions referred to in that provision is to be carried out, provided that those criteria are based on objective and verifiable factors.

In that respect, Member States can take account of healthcare expenditure alone or of other macro-economic conditions, such as those in the pharmaceutical industry sector. Equally, Article 4(1) of Directive 89/105 does not preclude the annual review of macro-economic conditions provided for in that provision from being based on a general trend or trends, such as the financial balance of national healthcare systems. A contrary interpretation would constitute interference in the organisation by Member States of their domestic social security policies and affect the Member States’ policies for pricing medicinal products to an extent going beyond what is necessary to ensure transparency for the purposes of Directive 89/105.

(see paras 20-22, 24, operative part 1)

2. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems must be interpreted as not being, so far as its subject-matter is concerned, sufficiently precise for an individual to be able to rely on it before a national court against a Member State.

Although, in the event of a price freeze imposed on all medicinal products or on certain categories of medicinal products, Article 4(1) of Directive 89/105 requires Member States unconditionally to carry out a review, at least once a year, to ascertain whether the macro-economic conditions justify continuing the freeze, that provision contains no indication as regards the matters on the basis of which measures to control the prices of medicinal products must be adopted and does not specify either the criteria in the light of which such an annual review is to be carried out or the method or procedure for that review.

(see paras 27, 29, operative part 2)

3. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems must be interpreted as meaning that a Member State may, 18 months after the end of a general price freeze in respect of refundable medicinal products which lasted eight years, adopt a new measure freezing the prices of medicinal products without carrying out the review of macro-economic conditions which is provided for in that provision.

The wording of Article 4(1) of Directive 89/105 thus shows that the purpose of the Member States’ obligation to carry out an annual review of macro-economic conditions is to ensure that, where the prices of medicinal products have been frozen, those macro-economic conditions justify continuation of the freeze. Once a measure freezing the prices of medicinal products has been adopted by a Member State, that review must be carried out every time the Member State proposes to continue that price freeze unchanged. By contrast, Article 4(1) of Directive 89/105 does not require Member States to conduct such a review when a measure freezing prices is adopted, even where it is adopted 18 months after the end of an earlier measure freezing the prices of medicinal products.

(see paras 32-35, operative part 3)