26.1.2008   

EN

Official Journal of the European Union

C 22/22

1.

Since the period for transposition of Council Directive of 21 December 1988 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 (89/105/EEC) (1) expired on 31 December 1989, must Article 4(1) of that directive be considered to be directly applicable in the domestic legal systems of the Member States?

2.

May Article 4(1) of Directive 89/105/EEC of 21 December 1988 be interpreted as meaning that the resumption for one year, after an absence of 18 months, of a general price freeze in respect of refundable medicinal products which had lasted eight years exempts the Member State from carrying out a review, when the freeze is resumed, of the macro-economic conditions affected by that freeze?

3.

Is the review of macro-economic conditions referred to in Article 4(1) of Council Directive 89/105/EEC of 21 December 1988, cited above, to be understood as meaning only review as to whether healthcare expenditure is manageable, or must it also extend to macro-economic conditions in the pharmaceutical industry sector whose products are liable to be made subject to a price freeze?

4.

May the review of macro-economic conditions referred to in Article 4(1) of Council Directive 89/105/EEC of 21 December 1988, cited above, be based on a general trend or trends, such as, for example, ensuring balance in healthcare, or must it be based on more specific criteria?