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Price of medicinal products for human use: pricing and health insurance
Through this Directive, the European Union plans to obtain an overall picture of national pricing agreements and to try to remove the existing disparities between Member States in order to move closer to the goal of a common market in medicinal products.
Council Directive 89/105/EEC of 21 December 1988 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.
The Directive lays down certain requirements which Member States must follow when they legislate on the prices of medicinal products.
If the marketing of a medicinal product is permitted only after a Member State has approved the price of the product, certain rules must be followed:
- the Member State must take the decision within 90 days;
- in the event of refusal, the grounds of the decision must be given;
- at least once a year, the Member State must publish a list of the medicinal products the price of which has been fixed during the relevant period, together with the prices which may be charged for such products.
The same rules apply if an increase in the price of a medicinal product is permitted only after prior approval has been obtained from the competent authorities of the Member State.
In the event of a price freeze imposed on all medicinal products by the competent authorities of a Member State, that Member State must ascertain, at least once a year, whether the macro-economic conditions justify that the freeze be continued unchanged. In exceptional cases a derogation from a price freeze may be requested.
Where a Member State adopts a system of direct or indirect controls on the profits of persons responsible for placing medicinal products on the market, the Member State concerned must communicate certain information to the Commission.
Member States must follow certain rules if they decide that health insurance will only cover listed medicinal products.
Certain specific provisions must be complied with if a Member State decides to exclude certain medicinal products from the coverage of its national health insurance system.
A Committee is set up to examine any question relating to the application of the Directive.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 89/105/EEC of the Council of 21 December 1988||27.12.1988||-||OJ L of 11.02.1989|