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European Pharmaceutical Contractor

Current Legal Issues Regarding Medicinal Products in Finland

Reimbursement for Medicinal Products

The latest ruling by the European Court of Justice (ECJ) makes the implementation of procedural changes to the Finnish reimbursement system for medicinal products imminent. The ECJ ruling is connected to the appeal filed to the Commission by Pharma Industry Finland in April 1997 based on the Finnish Government's flawed implementation of the so-called 'Transparency Directive' (89/105/EEC). The Commission brought Finland before the ECJ in June 2000.

In its judgement published on 12th June 2003, the ECJ ruled that Finland has failed to fulfil its obligations under the Transparency Directive. Finland has refused to implement the measures regulating the pricing of and reimbursement for medicinal products with regard to medicinal products that are subject to a higher rate of health insurance coverage.

Finland has a two-phased reimbursement system. In addition to the basic refund group, there are also two special refund categories that include medicinal product or generic medical products that are essential for the treatment of a serious or chronic illness and are eligible for refunds of 75 and 100 per cent. Measured by value of sales, over one-third of all medicines sold in Finland fall into the special refund categories.



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By Johan Еkermarck and Juha Vдyrynen, Partners at Castrйn & Snellman

Johan Еkermarck has handled contractual matters such as licensing, pharmaceutical marketing, advertising, distribution and competition as well as administrative matters, whilst also providing general corporate advice to the pharmaceutical industry.


Juha Vдyrynen is an expert on legal issues involving pharmaceutical, contractual and corporate matters. He recently presented to the Committee for Constitutional Law of Parliament of Finland regarding changes to the Finnish Medicines Act.


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Johan Еkermarck
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Juha Vдyrynen
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