EUCOPE, in partnership with the Swedish Industry Association for Small and Medium-Sized Life Sciences Companies (IML), hosted a roundtable on the Revision of the European Orphan & Paediatric Regulation with Nordic stakeholders on 7 September. Over the last 20 years, the orphan and paediatric legislation… 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 European Commission has launched an evaluation of the Orphan Medicinal Product (OMP) and Paediatric Regulations. EUCOPE seizes the opportunity to outline ways to strengthen the EU environment for the development of rare and paediatric disease treatments, of which the Regulation (EC) No 1901/2006 on… read more
The European Commission launched an evaluation of the legislation on medicines for rare diseases and children. EUCOPE seizes the opportunity to outline ways to strengthen the whole EU environment for the development of rare diseases treatments, of which the Regulation (EC) No 141/2000 on orphan… read more
EUCOPE, in partnership with FranceBiotech, hosted a roundtable on the revision of the orphan medicine and paediatric regulations with French stakeholders on 30 June. The orphan and paediatric legislation has considerably accelerated research efforts over the last two decades and has contributed to the development… read more
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
