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8 maltatoday | WEDNESDAY • 20 MARCH 2024 NEWS This article is part of a content series called Ewropej. This is a multi-newsroom initiative part-funded by the European Parliament to bring the work of the EP closer to the citizens of Malta and keep them informed about matters that affect their daily lives. This article reflects only the author's view. The action was co-financed by the European Union in the frame of the European Parliament's grant programme in the field of communication. The European Parliament was not involved in its preparation and is, in no case, responsible for or bound by the information or opinions expressed in the context of this action. In accordance with applicable law, the authors, interviewed people, publishers or programme broadcasters are solely responsible. The European Parliament can also not be held liable for direct or indirect damage that may result from the implementation of the action. MEPS adopted their proposals to revamp EU pharmaceutical legislation, to foster innova- tion and enhance the security of supply, accessibility and af- fordability of medicines. On Tuesday, the Environ- ment, Public Health and Food Safety Committee adopted its position on the new directive (66 votes in favour, two against and nine abstentions) and reg- ulation (67 votes in favour, six against and seven abstentions) covering medicinal products for human use. To reward innovation, MEPs want to introduce a minimum regulatory data protection pe- riod (during which other com- panies cannot access prod- uct data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or bi- osimilar products cannot be sold), following a marketing authorisation. Pharmaceutical companies would be eligible for addition- al periods of data protection if the particular product ad- dresses 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 devel- opment takes place in the EU and at least partly in collabo- ration with EU research enti- ties (+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 mar- ket protection period could be granted if the company obtains a marketing authorisation for an additional therapeu- tic indication which provides significant clinical benefits in comparison with existing therapies. Orphan drugs (medicines de- veloped to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a "high unmet medical need". Step up the fight against antimicrobial resistance (AMR) MEPs underline the need to boost the research and devel- opment of novel antimicrobi- als, 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 ap- proval). These would be com- plemented by a subscription model-based voluntary joint procurement scheme, to en- courage investment in antimi- crobials. They agree with the intro- duction of a "transferable data exclusivity voucher" for prior- ity antimicrobials, 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 reg- ulatory data protection and would be transferable only once to another marketing au- thorisation holder. Among the new measures to promote the prudent use of antimicrobials, MEPs want stricter requirements, such as restricting the prescrip- tions and dispensation to the amount required for the treat- ment and limiting the duration for which they are prescribed. Strengthened requirements for environmental risk assessment These new rules would re- quire companies to submit an environmental risk assess- ment (ERA) when requesting a marketing authorisation. To ensure adequate evalua- tion of ERAs, MEPs want the creation, within the European Medicines Agency, of a new ad-hoc environmental risk as- sessment 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. To effectively address public health challenges and boost European research, MEPs want the European Health Emergen- cy Preparedness and Response Authority (HERA, currently a Commission department) to become a separate structure under the European Centre for Disease Prevention and Con- trol (ECDC). HERA should primarily focus on the fight against the most urgent health threats, including antimicro- bial resistance and medicine shortages. Rapporteur for the direc- tive Pernille Weiss (EPP, DK) said: "The EU pharmaceutical legislation revision is vital for patients, industry and society. Today's vote is a step towards delivering the tools to tack- le present and future health- care challenges, particularly for our market attractiveness and medicine access across EU countries. We hope Coun- cil takes note of our ambition and commitment to create a robust legislative framework, setting the scene for prompt negotiations." Rapporteur for the regulation Tiemo Wölken (S&D, DE) said: "This revision paves the way to addressing critical challenges such as medicines shortages and antimicrobial resistance. We are strengthening our healthcare infrastructure and reinforcing our collective re- silience ahead of future health crises - a significant milestone in our pursuit of fairer, more accessible healthcare for all Europeans. Measures improv- ing access to medicines, whilst incentivising areas of unmet medical needs, are crucial parts of this reform." Next steps MEPs are scheduled to de- bate and vote on the Parlia- ment's position during the 10-11 April 2024 plenary ses- sion. The file will be followed up by the new Parliament after the European elections on 6-9 June. EU pharmaceutical policy: MEPs support comprehensive reform