Keywords
Summary

Keywords

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

(Council Directive 89/105, Arts 1(1) and 4(1))

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

(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))

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

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

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

(Council Directive 89/105, Art. 4(2))

Summary

1. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems is to be interpreted as meaning that, provided the requirements laid down by that provision are met, the competent authorities of a Member State may adopt general measures reducing the prices of all, or of certain categories of, medicinal products, even if the adoption of those measures is not preceded by a freeze on those prices.

First, the meaning of a ‘price freeze … on all medicinal products or on certain categories of medicinal products’ in Article 4(1) of Directive 89/105 encompasses all national measures controlling the prices of medicinal products even if those measures are not preceded by a freeze on those prices. National measures reducing the prices of all, or of certain categories of, medicinal products are national measures to control the prices of medicinal products, within the meaning of Article 1(1) of Directive 89/105. Consequently, such measures must comply with the requirements of that directive, particularly those laid down in Article 4 thereof. A contrary interpretation would be tantamount to excluding from that provision’s scope measures reducing the prices of all, or of certain categories of, medicinal products, if such measures are not preceded by a freeze on those prices.

Secondly, Directive 89/105 has as its underlying principle the idea of minimum interference in the organisation by Member States of their domestic social security policies. Therefore, an interpretation according to which the adoption of measures reducing the prices of all, or of certain categories of, medicinal products must be preceded by a freeze on those prices would affect the Member States’ price-setting policies to an extent going beyond what is necessary to ensure transparency for the purposes of that directive, since its effect would be to constrain them to adopt measures freezing the prices of the medicinal products before reducing those prices.

(see paras 29-32, 34, 36-38, operative part 1)

2. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems is to be interpreted as meaning that, provided the requirements laid down by that provision are met, the adoption of measures reducing the prices of all, or of certain categories of, medicinal products is possible more than once a year and for several years.

It follows from the wording of the said Article 4(1) that the annual review of the macro-economic conditions required by that provision is a minimum requirement which does not preclude a Member State from carrying out such a review more than once a year, or, if the results of those reviews justify it, from deciding to maintain a price freeze on all, or on certain categories of, medicinal products or to adopt measures increasing or reducing those prices.

Likewise, if those results also justify it, that provision does not prevent a Member State deciding to adopt or continue such measures for several years.

(see paras 41-43, operative part 2)

3. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems is to be interpreted as meaning that it does not preclude measures controlling the prices of all, or of certain categories of, medicinal products from being adopted on the basis of predicted expenditure, provided that the requirements laid down by that provision are met and that the predictions are based on objective and verifiable data.

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 47, 49, operative part 3)

4. Article 4(1) of Directive 89/105 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems is to 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 the macro‑economic conditions referred to in that provision is to be conducted and that those criteria may consist in pharmaceutical expenditure alone, in health expenditure overall or even in other types of expenditure.

(see para. 55, operative part 4)

5. Article 4(2) of Directive 89/105 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems is to be interpreted as meaning:

– that the Member States must, in all cases, provide for the possibility for an undertaking, which is concerned by a measure freezing or reducing the prices of all, or of certain categories of, medicinal products, of applying for a derogation from the price imposed pursuant to such measure;

– that they are to ensure that a reasoned decision on any such application is adopted, and

that the genuine participation of the undertaking concerned consists, first, in the submission of an adequate statement of the particular reasons justifying its application for derogation and, second, in the provision of detailed additional information if the information supporting the application is inadequate.

(see para. 61, operative part 5)