After striking a compromise on the largest revision to EU pharmaceutical regulations in 20 years, a proposal from the parliament indicated that EU lawmakers had partially addressed the concerns of the pharmaceutical industry on the exclusivity period for new medications.
Before a vote in plenary on April 11, a European Parliamentary committee is scheduled to vote on its opinion on March 19.
The legislation, which was put forth by the European Commission in April of last year, intends to shorten the time it takes to approve new medications, encourage the development of drugs for bacteria resistant to antibiotics, enhance patient access, and “future-proof” the regulations to take artificial intelligence and other technological advancements into account.
The plan has drawn criticism from the pharmaceutical industry in Europe. The industrial association EFPIA, based in Brussels, has issued a warning, stating that there is a chance of exacerbating the already 25% decrease in innovation and research on the continent. The new linkage of a medicine’s exclusivity time to access in each of the 27 member states—where approval durations can differ by year—is at question.
Committee members have decided to increase baseline data protection to 7.5 years in the proposed compromise, which was seen by Reuters. An additional year of incentives will be granted if the treatment satisfies “unmet medical needs” and if clinical trials are conducted in the EU.
Additionally, a business would be shielded from generic competition for three years, bringing the total exclusivity period to a maximum of 11.5 years.
Furthermore, rather than forcing a corporation to start the procedure across 27 nations at once, the stance taken by the parliament would transfer the burden of introducing a new medication to the member states, who would have to first request it.
The baseline exclusivity period for orphan diseases, which are extremely rare and hence less immediately profitable for the pharmaceutical industry, would remain at nine years, unaltered from the Commission proposal, and would increase to eleven years if a new medication meets an unmet medical need, up from the Commission proposal’s 10 years.
The committee decided to maintain additional safeguards in the “regulatory sandbox” that the Commission had recommended, in order to “future-proof” the legislation against technological advancements.
“Regulatory sandboxes can provide…a structured context for experimentation, enable where appropriate in a real-world environment the testing,” according to the document “, especially in the context of digitalisation or the use of artificial intelligence and machine learning.”
The EU member states are running behind schedule in going over the massive proposal, and they won’t begin talking about incentives and exclusivity until the next week.
