The legislative package, covering medicinal products for human use, consists of a new directive (adopted by 495 votes for, 57 against and 45 abstentions) and a regulation (adopted by 488 votes for, 67 against and 34 abstentions).
Incentives for innovation
MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic products , hybrids or biosimilars cannot be sold), following a marketing authorization.
Pharmaceutical companies would be eligible for additional data protection periods if their particular product meets an unmet medical need (+12 months), if comparative clinical trials are underway on the product (+6 months), and if a significant part of the research and development of the product takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want the cumulative duration of data protection to be capped at eight and a half years.
A one-time extension (+12 months) of the two-year market protection This period could be granted if the company obtains marketing authorization for an additional therapeutic indication providing significant clinical benefits compared to existing therapies.
Orphan drugs (drugs developed to treat rare diseases) would benefit from market exclusivity of up to 11 years if they meet a “significant unmet medical need.”
Combating antimicrobial resistance (AMR)
To boost research and development of new antimicrobials, MEPs want to introduce systems of rewards for market entry and milestone payments (e.g. financial support at an early stage when certain R&D targets are reached before marketing authorization). These would be complemented by a subscription model system through voluntary joint purchasing agreements, to encourage investment in antimicrobials.
They support the introduction of a “transferable data exclusivity voucher” for priority antimicrobials, providing a maximum of 12 additional months of data protection for an authorized product. The coupon could not be used for a product that has already benefited from maximum regulatory data protection and would only be transferable once to another marketing authorization holder.
More details on MEPs’ specific proposals are available here.
Citations
Rapporteur for the directive Pernille Weiss (EPP, DK) said: “The revision of European pharmaceutical legislation is vital for patients, industry and society. Today’s vote is a step towards providing the tools needed to address current and future healthcare challenges, particularly regarding the attractiveness of our market and access to medicines in countries of the EU. We hope that the Council will take note of our ambition and commitment to creating a strong legislative framework, paving the way for effective negotiations.
Rapporteur for the regulation Tiemo Wölken (S&D, DE) said: “This revision paves the way for solving critical challenges such as shortages of medicines and antimicrobial resistance. We are strengthening our health infrastructure and building our collective resilience to future health crises – an important step in our quest for fairer and more accessible healthcare for all Europeans. Measures improving access to medicines, while encouraging areas where medical needs are not met, are crucial elements of this reform.
Next steps
The file will be followed by the new Parliament after the European elections from June 6 to 9.
Background
On 26 April 2023, the Commission proposed a ‘pharmaceutical package’ to revise EU pharmaceutical legislation. It includes proposals for a new directive and a new regulation which aim to make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the European pharmaceutical industry, through stricter environmental standards.
By adopting this report, Parliament responds to citizens’ expectations to ensure the EU’s strategic autonomy in medicines and access to quality and affordable treatments across the EU, to resolve safety issues procurement, to invest in strategic sectors and to reduce bureaucracy, as expressed in the proposals. 8(3), 10(2), 12(4), 12(6), 12(12), 12(17), 17(3) and 17(7) of the conclusions of the Conference on the Future of ‘Europe.
Originally published in The European Times.
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