Finland: Proposed reform of the generic substitution regime

By Ella Mikkola


A recent governmental Bill has set out proposals for the introduction of a reference price system for medicinal products in Finland and for generic substitution to be extended to include pharmaceutical products that were excluded from the scope of generic substitution by amendment of the Medicines Act in 2006. According to the Bill, the proposed amendments would come into force on 1 April 2009.

Product patents for medicines were first adopted in Finland in 1995 and so a large number of patented medicines in Finland are protected, and will remain so protected until 2019, by the (analogous) process patent only. In 2006, the Medicines Act (Section 57(c)) was amended to bring the Finnish system (i.e. the effect of the combination of the patent protection and generic substitution) closer to that of other countries: in Finland generic substitution is not applied to pharmaceutical products that are protected by a valid process patent or SCP in Finland and by valid product patents or SPCs in at least five EEA countries.

Should the Finnish legislation be amended as described above (Section 57(c) in particular), a number of blockbusters would become subject to generic substitution. This could lead to a fall in the sales or, alternatively, a fall in the prices of such blockbusters and possibly even the withdrawal of these products from the Finnish market altogether as pharmaceutical companies may not be willing to run the increased risk of parallel imports to other EU countries.

The Bill is currently before the Finnish Parliament and the relevant parliamentary committees will handle the proposal over the course of the following months. The association representing generics manufacturers is supporting the reform, including the abolition of Section 57(c), whilst Pharma Industry Finland (PIF) is lobbying against the deletion of Section 57(c).