EU outlines its plan to equalize drug access and lower prices
A molecular biologist examines wastewater samples for pathogens in the safety laboratory at the Max Delbrück Center for Molecular Medicine in Mitte.
The European Union on Wednesday launched its long-awaited overhaul of existing pharmaceutical legislation, reflecting the bloc's biggest shake-up of laws governing the industry in decades.
The European Commission, the EU's executive arm, says the reforms will make the industry more agile as well as making medicines "more available, accessible and affordable."
One of the EU's key aims is to deliver more timely and equitable patient access to medicines across the 27-nation bloc.
It takes patients in Germany roughly 133 days to access new medicines, versus 899 days for patients in Romania, according to the European Federation of Pharmaceutical Industries and Associations. The group also found 92% of "innovative medicines" were available in Germany, compared with 30% in smaller and Eastern European EU member states.
The proposal reduces the exclusivity period given to newly-developed drugs entering the market from 10 years to eight. Companies can extend it up to 10 years if they launch the drug in all 27 EU member states within two years.
One side-effect — a positive one for consumers — would be a drop in the drugs' price at an earlier time.
However, pharmaceutical firms and lobby groups say the move could hamper innovation and the overall availability of drugs.
They argue the measures may prove tricky and costly for companies, which may decide not to develop or launch new medicines within the EU at all, putting the bloc behind the U.S. and China.
The head of German biotech firm Bayer's pharmaceutical division, Stefan Oelrich, told Reuters last week the changes could have a "catastrophic impact" as companies drop development projects.
Source: CNBC
