The complexities related to delivering some Advanced Therapy Medicinal Products (ATMPs) most likely will require highly specialized clinical expertise and infrastructures, which currently do not exist in all EU counties. Therefore, relocating or crossing borders often represent the only solution for many patients. A well-developed… 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
On 7 May, the European Commission opened its public consultation on the revision of EU rules on medicines for children and rare diseases. The consultation, aimed at stakeholders and members of the general public, including patients and doctors, will explore several options to address the shortcomings… read more
Working group of European rare disease experts developed nine principles to foster greater consistency in Value Assessment and Funding Process in rare diseases. The group explored the pricing and reimbursement systems for OMPs in selected European countries to analyse where they align with or diverge from… read more
Multi-stakeholder initiative commissioned by the Belgian National Institute of Health and Disability Insurance (INAMI-RIZIV) aimed at fostering stakeholders’ agreement of what real-world data (RWD) can be collected for highly innovative technologies, to generate real-world evidence (RWE) that informs decisions by healthcare systems, clinicians and patients…. read more
Multidisciplinary expert group including researchers, academia, patient representatives, investors and industry Input to strengthen the OMP Incentives Environment in Europe focusing on addressing unmet needs and supporting delivery of continued innovation where treatments exist; finding ways to optimise and accelerate OD regulatory pathways and identifying… read more
EUCOPE has the pleasure to participate to the 1st International Conference on Rare Diseases organised under the patronage of H.E. the President of the Hellenic Republic. The event, entitled “Building a Pathway from Diagnosis to Access” will take place virtually on the first and second… 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
Following a successful launch event, the TRANSFORM MEP Interest Group, a multi-stakeholder alliance of Members of European Parliament, patient groups, academia and industry, published two important documents to lay the foundations of an open discussion on key priorities for gene and cell therapies, namely a… read more
Published on 8 December, the European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) Joint Strategy looks into six strategic focus areas: (1) Availability and accessibility of medicines, (2) Digital tools and digital transformation, (3) Innovation, (4) Antimicrobial resistance, (5) Supply chain challenges, and… read more
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