European Parliament committee adopts proposals to revamp pharma legislation

The European Parliament’s health committee has voted in favor of proposals to overhaul pharmaceutical legislation, passing a raft of amendments to advance the lawmaking process to the next stage.

Tuesday, members of the Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) met to vote on potential amendments to the European Commission’s proposals and on the overall texts. The politicians overwhelmingly voted in favor of changes to the current pharmaceutical directive and for the creation of a new regulation. Around 85% of votes were cast in favor of the proposals.

Speaking during the vote, Tiemo Wölken, the ENVI rapporteur for the proposed regulations, said that “when we started this mandate, we didn't know that we would be in the middle of the biggest health crisis in the European Union and the world so far.” The pandemic shaped Wölken’s goals for the proposal.

“With this proposal by the Commission, enhanced through our votes today, I think we really draw the lessons learned from the pandemic,” Wölken said. “We enhance the capacity of our medical agency. We do have more incentives to fight the crisis when it comes to the shortages of antibiotics. We do tackle the much-needed orphan drugs where we don't have treatments for so many Europeans.”

ENVI members cast their votes on the overall texts after ruling on tens of compromise amendments. All of the more than 50 compromise amendments to the proposed regulation were adopted by the health committee.

The clean sweep of positive votes covered changes to key, and in some cases contentious, aspects of the Commission’s plan. ENVI adopted compromise amendment 48, which proposed increasing the exclusivity period for orphan medicines that address a high unmet medical need from 10 to 11 years while cutting a year of protection from products authorized under so-called bibliographic applications.

Despite some industry-friendly amendments to the Commission’s proposal, Nathalie Moll, executive director of the European Federation of Pharmaceutical Industries and Associations (EFPIA), warned that the revision will take a toll on the EU pharma industry. “Despite pragmatic improvements to the initial text, the industry remains concerned that the net impact of the proposals will make Europe less competitive and less attractive as a region for researching and developing medicines and vaccines. It is hard to comprehend how reducing incentives for companies to discover, develop and deliver new treatments in Europe is in the best interests of patients in the region,” she said, warning that companies are “highly likely” to shift research and development, clinical trials, and manufacturing out of the region.

ENVI also voted in favor of changes to the incentives for antimicrobial drug development. Amendment 52 outlined the creation of a “milestone payment reward scheme,” through which the Commission will pay developers of certain priority antimicrobial products. The amendment also set out the creation of a subscription model for joint antimicrobial procurement and changes to the Commission’s voucher plan.

The committee has retained the Commission’s transferable data exclusivity voucher proposal but passed changes to the eligibility criteria. Submission of a global access plan to supply third countries in critical need, “including through development partners or voluntarily licensing” is now one of the requirements. Other changes include banning the use of vouchers for products that have already benefited from the maximum regulatory data protection period and a revision to the rules on the trade of vouchers.

“The monetary value paid for the transfer of the voucher shall be directed to the Authority, which shall in yearly installments transfer the amount to the marketing authorization holder, in order to ensure the manufacturing capacity and supply of the priority antimicrobial,” one amendment states. ENVI also voted to make the Commission review the effectiveness of the antimicrobial schemes after five years.

In the vote on changes to the existing directive, ENVI members passed the consensus amendments but rejected another set of changes. The politicians voted against amendments 406 to 411, which proposed changes related to the sale, supply or use of medicinal products as contraceptives or abortifacients.

The rest of the Parliament is scheduled to debate and vote on the directive and regulation on 10 and 11 April. European elections in June will then disrupt the process but the new Parliament will follow up the legislative file once it is in place.

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European Parliament committee adopts proposals to revamp pharma legislation

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