Finland has completed pharmaceuticals legislation reform that will transform the country’s programme of mandatory substitution of generics for brandname drugs, which was first enacted in April 2003.
The new Medicines Act, signed into law on January 13, does away with a loophole in earlier laws that allowed generics to be introduced onto the Finnish market earlier than in other member states of the European Union.
The 2003 mandatory substitution rules allowed generics to replace brandname drugs even if the originator product was still under patent, and this was exacerbated by a quirk of Finnish patent law that allowed generics to reach the market after as little six years, or 10 years for so-called ‘high-technology’ products.
The Medicines Act brings the EU’s 2004 pharmaceutical legislation reforms to bear, so products in Finland will now operate under the same across-the-board 10-year market exclusivity rules as other member states. Meanwhile, from February 1 companies will be able to apply to have generics taken off the official substitution list, provided they can show their original product remains patent protected.
For generic manufacturers, the new legislation allows them to carry out development of their products before the patent on the branded drug expires. This measure, designed to speed up the roll-out of generics and help reduce healthcare costs, brings Finland into line with the 2004 EU reform package.
Finland’s generic drugs market is served by around 20 companies and the mandatory substitution programme has raised their share of the total 1.6 billion euro pharmaceuticals market to nearly 50%, according to figures published last year in newspaper Kauppalehti.
Meanwhile, the legislation expands the scope of the substitution programme. For example, it now allows different salts of the same active ingredient to be substitutable, while pharmacists can also swap tablets for capsules containing the same ingredient, and vice versa. Furthermore, drugs to treat schizophrenia and dementia have, for the first time, been included on the list of 500 products that are substitutable.
Other amendments to the Medicines Act have made it illegal for pharmaceutical companies to offer discounts to individual pharmacies and deregulated nicotine replacement products for smoking cessation, so they can now be sold in retail outlets as well as pharmacies.