Keywords
Summary

Keywords

1. Approximation of laws - Proprietary medicinal products - Directive 89/105 - Medicinal products for human use - Cost automatically borne or reimbursed by the national health insurance scheme - Conditions

(Council Directive 89/105, Arts. 1 and 6)

2. Approximation of laws - Proprietary medicinal products - Directive 89/105 - Medicinal products for human use - Decision refusing to include a medicinal product on a list of medicinal products covered by the national health insurance scheme - Right of legal action - National legislation providing only for appeals to bodies consisting of independent experts - Not permissible

(Council Directive 89/105, Art. 6(2))

Summary

1. It is clear from Article 6 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, that that provision is intended to apply where inclusion of a medicinal product on a list means that its cost will automatically be reimbursed or borne by the scheme. Thus, the fact that in a Member State there is a register and not a positive list and that, in that State, the cost of medicinal products not included on the register may likewise be borne by the scheme if the medicinal product prescribed by the doctor is necessary for the condition affecting the patient in no way detracts from the sole determining factor, namely that inclusion of a medicinal product on the register normally means that its cost will automatically be borne by the scheme.

That interpretation is, moreover, corroborated by the purpose of the directive which, under Article 1 thereof, is to ensure that any national measure to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by national health insurance systems complies with the requirements of the directive.

( see paras 29-30 )

2. The requirement of judicial review reflects a general principle of Community law stemming from the constitutional traditions common to the Member States and enshrined in Articles 6 and 13 of the European Convention for the Protection of Human Rights and Fundamental Freedoms.

National legislation providing for appeals to independent experts satisfies neither that requirement nor the provisions of Article 6(2) of Directive 89/105 under which persons concerned must be able to avail themselves of remedies ensuring effective legal protection against a decision not to include a medicinal product in the list of products covered by the health insurance system. Such appeals are to supervisory bodies made up of experts belonging to the Member State concerned, and thus to an administrative authority and not to genuine judicial bodies. Moreover, since those bodies can issue only recommendations they have no decision-making power, which rests with the Member State concerned.

( see paras 42-45 )