The legislation, proposed by the European Commission in April last year, aims to slash the time it takes to approve new medicines, incentivise production of medicines for antibiotic-resistant bacteria, improve patient access and “future-proof” the rules to account for technological leaps like artificial intelligence
EU lawmakers have gone part of the way to meeting pharmaceutical industry concerns about the exclusivity period for new medicines after reaching a compromise on the biggest overhaul of EU pharmaceutical rules in 20 years, a parliament proposal showed.
A European parliamentary committee is set to vote on its position on March 19 before a plenary vote on April 11. The legislation, proposed by the European Commission in April last year, aims to slash the time it takes to approve new medicines, incentivise production of medicines for antibiotic-resistant bacteria, improve patient access and “future-proof” the rules to account for technological leaps like artificial intelligence.
Europe’s pharmaceutical industry has been critical of the proposal. The Brussels industry group, EFPIA, has cautioned that it risks speeding up a decline in innovation and research on the continent, already down by 25%.
At issue is the new linking of a medicine’s exclusivity period to access across all 27 member states, where the length of approval can vary by years. In the draft compromise, seen by Reuters, committee members have agreed to raise baseline data protection to 7.5 years with one extra year of incentives if the medication meets “unmet medical needs”, and if clinical trials are held in the EU.
A company would also receive three years of market protection from generics, taking the total exclusivity period to a maximum 11.5 years, up from 10 years as proposed by the Commission.
Further, parliament’s position would shift the onus of launching a new medicine to member states who would first have to request the new medication, rather than obliging a company to initiate the process in 27 countries at once.
As for orphan diseases – which are very rare and therefore less immediately lucrative for the pharmaceutical industry – the baseline exclusivity would be nine years, unchanged from the Commission proposal, and 11 years if a new medicine fulfils an unmet medical need, up from the Commission proposal of 10 years.
To “future-proof” the legislation against technological advances, the committee would keep a so-called “regulatory sandbox” proposed by the Commission with extra safeguards.
“Regulatory sandboxes can provide…a structured context for experimentation, enable where appropriate in a real-world environment the testing,” the document said, “especially in the context of digitalisation or the use of artificial intelligence and machine learning.”
EU member states have fallen behind in trawling through the mega proposal and will not start discussions on exclusivity and incentives until next week.