Drugs – Photo Rodrigo Senna
(BRUSSELS) – An EU Parliament committee adopted proposals Wednesday to revamp EU pharmaceutical legislation to foster innovation and enhance the security of supply, accessibility and affordability of medicines.
In the proposals for comprehensive reform of the EU’s pharmaceutical policy, MEPs want, in order to reward innovation, 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 authorisation.
Pharmaceutical companies would be eligible for additional periods of data protection if the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for 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 a marketing authorisation 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”.
MEPs underlined the need to boost the research and development of novel antimicrobials, notably through market entry rewards and milestone reward payment schemes (e.g. early-stage financial support upon achieving certain R&D objectives prior to market approval). These would be complemented by a subscription model-based voluntary joint procurement scheme, to encourage investment in antimicrobials.
A ‘transferable data exclusivity voucher’ for priority antimicrobials would be introduced, providing for a maximum 12 additional months of data protection for an authorised product. The voucher could not be used for a product which has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorisation holder.
Among the new measures to promote the prudent use of antimicrobials, MEPs want stricter requirements, such as restricting the prescriptions and dispensation to the amount required for the treatment and limiting the duration for which they are prescribed.
The new rules would require companies to submit an environmental risk assessment (ERA) when requesting a marketing authorisation. To ensure adequate evaluation of ERAs, MEPs want the creation, within the European Medicines Agency, of a new ad-hoc environmental risk assessment working party. MEPs insist that the risk mitigation measures (taken to avoid and limit emissions to air, water and soil) should address the entire life cycle of medicines.
Further information, European Parliament
Compromise amendments (directive)
