The European Parliament adopted on 10 April 2024 the proposal to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.
The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45 abstentions) and regulation (adopted with 488 votes in favour, 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, hybrid or biosimilar products cannot be sold), following a marketing authorization.
Pharmaceutical companies would be eligible for additional periods of data protection if their particular product addresses an unmet medical need (+12 months), if comparative clinical trials are being conducted on the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and half years.
A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains marketing authorization for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.
Orphan drugs (medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”.
Combatting antimicrobial resistance (AMR)
To boost research and the development of novel antimicrobials, MEPs want to introduce market entry rewards and milestone payment reward schemes (e.g. early-stage financial support when certain R&D objectives are achieved prior to market approval). These would be complemented by a subscription model scheme through voluntary joint procurement agreements, to encourage investment in antimicrobials.
They support the introduction of a “transferable data exclusivity voucher” for priority antimicrobials, providing for a maximum of 12 additional months of data protection for an authorized product. The voucher could not be used for a product that has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorization holder.
Next steps
The file will be followed up by the new Parliament after the 6 – 9 June European elections.
Background
On 26 April 2023, the Commission put forward a “pharmaceutical package” to revise the EU’s 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 EU pharmaceutical industry, with higher environmental standards.
