On 7 July, EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs – hosted the second episode of its Life Science Lectures webinar series. The focus of the webinar, titled ‘’Defining (high) unmet medical need: will it steer innovation towards filling existing gaps?’’, was to dive… read more
On 12 July 2023, EUCOPE’s HERA Steering Group released its White Paper “EU-wide Stockpiling: Better Preparedness for Cross-Border Health Threats.” Stockpiling of critical biomedical countermeasures is crucial for an effective EU preparedness against priority cross-border health threats with a potentially large health and societal impact…. read more
On 30 May, EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs hosted the inaugural episode of its Life Science Lectures webinar series, “Attaching conditionalities to incentives: the right path to improve access?” The episode delved into the incentive system outlined in the EU Pharmaceutical Package,… read more
On 4 May 2023, EUCOPE was announced as a member of the Health Technology Assessment (HTA) Stakeholder Network. The Network has been established to facilitate contributions by a wide range of stakeholders to policy development related to HTAs in the European Union (EU). Since its… read more
On the Commission’s proposal for the EU Pharmaceutical Package On 26 April, the European Commission published the EU Pharmaceutical Package, revising how the pharmaceutical system is regulated in the EU, which includes a proposal for a “master” Regulation, merging Commission Regulation No 726/2004, Orphan Medicinal… read more
As previously outlined in the EPSCO Council (Health) meeting on 9 December 2022 (Information Note), the European Commission adopted draft legislation on 6 January 2023 amending Regulations (EU) 2017/745 (Medical Devices Regulation – MDR) and (EU) 2017/746 (In Vitro Diagnostics Regulation – IVDR) as regards the transitional… read more
A large consortium of European health-related stakeholders, including industry players, academia, healthcare professionals and patients, share their satisfaction on the draft adequacy decision on the UK data protection regime issued by the European Commission on 19th February 2021. Protecting the benefits of the free flow… read more
Last January, the European Commission launched the consultation on the European Health Emergency Preparedness and Response Authority, HERA for short. How can we make sure this new agency finds its way? Clarity on its roles and responsibilities will be needed. See our take in this… read more
EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies submitted its response to the Paediatric and Orphan Medicinal Products (OMPs) inception impact assessment. EUCOPE represents 130 companies, many focused on rare diseases, largely small to medium-sized, playing a key role… read more
EUCOPE’s approach to the EU environment for the development of OMPs On 11 August 2020, the European Commission published its evaluation on the legislation for medicines for rare diseases and for children. In November this was followed by an Inception Impact Assessment outlining policy options… read more
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