De nouveaux commandants pour la Flottille 35F et le CENTEX Hélicoptères

Le capitaine de corvette Lorélie Féraud est entrée à l’École Navale en 2003. Brevetée chef de quart et parachutiste militaire, elle débute sa formation de pilote en 2007 puis obtient son brevet de pilote d’hélicoptères embarqué en 2010. Elle intègre la Flottille 36F sur Panther, où elle réalise de nombreux embarquements sur les bâtiments de la Marine nationale afin de participer à des opérations de lutte contre la piraterie, le narcotrafic ou encore le terrorisme partout dans le monde. En 2017, elle prend les fonctions de commandant des opérations de la Flottille 35F spécialisée dans le sauvetage en mer, puis commandant en second en 2019. Le CC Féraud, cumule 950 jours de mer et 2200 heures de vol.

23, the European Commission put forward proposals for changes to the existing pharmaceutical legislation. This constitutes the largest reform in over 20 years, bringing new rules to the existing directives, regulations and guidelines governing medicinal products for human use. These proposals are still at the negotiation stage, with a final deal not expected until late 2024 or early 2025. This article explores some key areas of reform which have attracted attention and controversy. It covers changes related to market exclusivity periods, conditional marketing authorisations, antimicrobial resistance, environmental risk assessments, and the role of pharmacies. It also briefly touches on the implications for orphan and rare disease medicines. It aims to provide a snapshot of the current state of play.Key areas of reform for pharmaceutical legislation in the European Union have been proposed, with a deal expected in late 2024 or early 2025. The reforms include changes to market exclusivity periods, conditional marketing authorisations, antimicrobial resistance, environmental risk assessments, and the role of pharmacies, as well as implications for orphan and rare disease medicines. This article explores the current state of play and highlights areas of attention and controversy. Market exclusivity periods are designed to balance the need for innovation with affordability and access. The proposals suggest a standard regulatory data protection period of 8 years, extendable by 1 or 2 years for specific conditions. This is a reduction from the current standard of 10 years, which has caused concern among some pharmaceutical companies who argue it may disincentivise research and development, particularly for smaller companies and those developing innovative therapies. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has voiced strong opposition, stating that the proposed changes could lead to a significant drop in investment and an exodus of pharmaceutical innovation from Europe. Conversely, patient advocacy groups and some Member States have welcomed the proposals, arguing that shorter exclusivity periods could accelerate the availability of generic and biosimilar medicines, thereby reducing healthcare costs and improving patient access. Conditional marketing authorisations (CMAs) are granted to medicines that address unmet medical needs, often for severe or life-threatening conditions, where comprehensive clinical data is not yet available but the benefits outweigh the risks. The new proposals aim to streamline the process for CMAs, making them more agile and responsive to emerging health crises. They also introduce stricter requirements for post-authorisation data collection, ensuring that companies provide robust evidence of efficacy and safety after the medicine is on the market. This aims to strike a balance between rapid access to innovative treatments and ensuring patient safety. The European Medicines Agency (EMA) has generally supported these changes, emphasizing the importance of robust real-world data collection post-authorisation. Antimicrobial resistance (AMR) is a growing global health threat, with the current pharmaceutical legislation failing to adequately incentivize the development of new antibiotics. The Commission’s proposals introduce a novel 'transferable voucher' system, where companies developing new antimicrobials could receive a voucher that allows for an additional year of data protection for any product in their portfolio. This aims to stimulate investment in AMR research, an area often deemed financially unviable due to the limited and short-term use of antibiotics. However, this voucher system has been met with mixed reactions. While some public health experts support its potential to address the AMR crisis, others, including some Member States, have raised concerns about its impact on market access and affordability of other medicines, as well as the potential for it to create 'evergreening' of existing blockbuster drugs. The proposed reforms also place a stronger emphasis on environmental risk assessments (ERAs) for medicinal products. This aims to address the growing concern about pharmaceutical residues in the environment, which can have detrimental effects on ecosystems and potentially human health. Companies will be required to submit more comprehensive data on the environmental impact of their products throughout their lifecycle, from manufacturing to disposal. This represents a significant shift towards a more holistic and sustainable approach to pharmaceutical regulation. Environmental groups have largely welcomed this move, advocating for even stronger measures, while the pharmaceutical industry is evaluating the practical implications and potential costs of these new requirements. Pharmacies are recognized as crucial access points for medicines and healthcare services. The proposals aim to strengthen their role, particularly in rural and underserved areas, by allowing them to offer a wider range of services, such as vaccinations and basic diagnostic tests. This aligns with broader European efforts to leverage the primary healthcare network and improve patient convenience. The European Association of Hospital Pharmacists (EAHP) and community pharmacy associations have expressed support for these measures, viewing them as an opportunity to expand their professional scope and contribute more effectively to public health. The proposals also include specific provisions for orphan medicines, which are developed to treat rare diseases. These medicines currently benefit from 10 years of market exclusivity. The new proposals suggest maintaining this 10-year period but introduce conditions for extensions, such as addressing high unmet medical needs or developing medicines for a large number of patients within a rare disease indication. The aim is to incentivize the development of truly innovative treatments for rare diseases while preventing companies from benefiting from extended exclusivity for medicines that offer only marginal benefits or address less severe conditions. Patient organizations for rare diseases have expressed concerns about potential reductions in incentives, arguing that any weakening of exclusivity could deter investment in this already challenging area. Overall, the proposed pharmaceutical reforms are a complex and ambitious undertaking, aiming to modernize a critical piece of European legislation. The negotiations are ongoing, with stakeholders from industry, patient groups, healthcare providers, and Member States all vying to shape the final outcome. The final version will significantly impact the pharmaceutical landscape in Europe for years to come, influencing drug development, market access, and public health outcomes. This article has provided a snapshot of some of the key areas of debate and change. The ultimate success of these reforms will depend on their ability to strike a delicate balance between fostering innovation, ensuring patient access, and addressing public health challenges effectively.Market exclusivity periods for orphan medicines, currently at 10 years, could be subject to new conditions for extensions, aiming to incentivize truly innovative treatments while preventing extended exclusivity for marginal benefits. This has raised concerns among patient organizations for rare diseases. These discussions are part of a broader, complex reform of EU pharmaceutical legislation, with ongoing negotiations between various stakeholders to balance innovation, patient access, and public health. The final outcome will shape the European pharmaceutical landscape for years, with this article highlighting key areas of debate and change.