Lif, the research-based pharmaceutical companies, notes that Sweden has had a consistent line against growth-retarding parts in the original proposal, but the compromise as a whole means a deterioration (stated in a press release (in Swedish)).

The data protection period for new medicines will remain unchanged at eight years

The agreement within the Council of Ministers (Coreper I) on EU pharmaceutical legislation means, among other things, that the data protection period for new medicines will remain unchanged at eight years. This is compared to the original proposal from the European Commission of a data protection period of six years. Since the countries agreed on the compromise proposal from the Polish Presidency June 4, a so-called trilogue, negotiations between the Council, the European Parliament and the European Commission, is now pending, which will begin later in June.

The bill would mean worse conditions and reduced competitiveness for Europe and thus for Sweden, in relation to primarily the USA and China.

Sweden and some other leading life science countries, such as Germany and Denmark, have been strong opponents of the significant deteriorations in data protection contained in the EU Commission’s proposal, states Lif.

“I really want to praise the government for standing up for the preservation of the data protection era, and pushing for new medicines to be researched and developed in Europe in the future. This is of utmost importance for Sweden as a leading life science nation,” says Sofia Wallström, CEO of Lif.

Regulatory data protection has a very significant impact on where pharmaceutical companies choose to invest in research and development. The bill would mean worse conditions and reduced competitiveness for Europe and thus for Sweden, in relation to primarily the USA and China. But the agreement also entails several deteriorations compared to the current system, Lif states. The European Council wants to reduce the period of market exclusivity, which is an addition to data protection. Furthermore, intellectual property rights are eroded in several ways.

Lif believes that the EU is at a crossroads. A year ago, the so-called Draghi report showed that the EU must radically increase the pace of investment, especially in key sectors such as life sciences. This is even more important today, given the uncertain geopolitical situation, they state.

The new pharmaceutical legislation must ensure conditions for the life science industry that lead to increased competitiveness, economic growth and increased prosperity in the EU countries.

“The compromise is overall a deterioration compared to the current system, and not the improvement Europe needs at a time of significant global uncertainty. Pharmaceutical companies need good and long-term predictable conditions to dare to decide on major investments in research, development and production, and Europe’s patients need early access to new life-saving medicines,” says Sofia Wallström. “Now it is important for Sweden to be the driving force in the continued negotiations within the trilogue. The new pharmaceutical legislation must ensure conditions for the life science industry that lead to increased competitiveness, economic growth and increased prosperity in the EU countries.”