On Tuesday 19 March, the European Parliament’s Environment Committee (ENVI) amended the initial proposals on the ‘pharmaceuticals package’ by adopting the draft reports by Pernille Weiss (EPP, Danish) on the directive (66 votes in favour, 2 against and 9 abstentions) and Tiemo Wölken (S&D, German) on the regulation (67 votes in favour, 6 against and 7 abstentions).
MEPs introduced a regulatory data protection period of at least seven and a half years (during which time other companies will not be able to access product data). This would be in addition to a period of market protection of more than two years following market authorisation.
Pharmaceutical companies will be able to benefit from additional data protection periods if the product concerned meets an unmet medical need (+12 months), if comparative clinical trials are conducted for 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 in part in collaboration with EU research entities (+6 months).
MEPs advocate capping the combined data protection period at eight and a half years. A one-off extension (+12 months) of the two-year market protection period may be granted if the company obtains market authorisation for an additional therapeutic indication that offers significant clinical advantages over existing therapies.
Orphan medicines would be granted market exclusivity for up to 11 years if they meet a “high unmet medical need”.
MEPs insist on the need to encourage the research and development of new antimicrobials, through market entry rewards and milestone reward payment schemes (early-stage financial support upon achieving certain R&D targets before market approval). These will be complemented by a system of voluntary joint procurement, based on a subscription model, to encourage investment in antimicrobials.
MEPs plan to introduce a “transferable data exclusivity title” for priority antimicrobials (with a maximum of 12 months of additional data protection for an authorised product). This title could not be used for a product that has already benefited from maximum regulatory data protection and would only be transferable once, to another market authorisation holder (see EUROPE 13287/13).
The new rules will require companies to submit an environmental risk assessment when applying for market authorisation.
The European Health Emergency Preparedness and Response Authority (HERA, currently a Commission department) should, according to the amendments, become a separate structure within the European Centre for Disease Prevention and Control (ECDC). The European Parliament is due to vote on these reports on 11 April. (Original version in French by Lionel Changeur)