Yesterday, 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (EHDS). First introduced on the 16th of September by the European Commission President Ursula von der Leyen, the Commission aims for the EHDS to form a… read more
EUCOPE’s latest position paper outlines our vision for the evolution of the EU Regulatory framework and a modernisation of the Centralised Procedure to ultimately bring novel medicines earlier to patients. The European Centralised Procedure (CP) has helped and accelerated the approval of novel medicines across… read more
As the EU trade body for small to mid-sized companies that support, invest and produce the innovative medicines and therapies of the future, EUCOPE is happy to welcome five new members to its organisation. AOP Health, Enterome, Flatiron Health, Novo Nordisk and TETEC all became… read more
The European Commission is consulting stakeholders as part of its revision process of two major pieces of legislation, on medicines for rare diseases and paediatric patients. Central to the development of innovative treatments for these specific categories of patients, this revision process represents an important… read more
The multidisciplinary European Expert Group on Orphan Drug Incentives (OD Expert Group) has developed fourteen innovative proposals along the entire lifecycle of orphan drug development to address the unmet needs in rare diseases. With over ninety percent of patients without a centrally approved treatment option,… read more
The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness. In its response to the EU roadmap/IIA on the “Evaluation and revision of… read more
The Genomics Working Group is made up of advanced diagnostics companies that have come together to ensure Europe will be able to draw benefit from the significant advances that have been made in genomic testing. The group aims to facilitate a dialogue around these technologies… read more
EUCOPE welcomes the important collaborative effort made today 16 March by the Council of the EU to reach a compromise on the EU on a Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU. The Portuguese Presidency underscored the difficulty of… 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
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
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