EUCOPE Resources / News / Press Releases - July 29, 2021
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
EUCOPE Resources / News - July 28, 2021
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
EUCOPE Resources / News - July 28, 2021
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 Resources - July 8, 2021
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
News / Press Releases - June 11, 2021
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
News - April 26, 2021
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
News - February 26, 2021
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
News - January 19, 2021
The recent years have seen a number of high-end innovative therapies becoming accessible to patients in Europe. These products offer groundbreaking new opportunities to patients living with rare diseases or cancer, with the capacity of often one-time disease-modifying and potentially curative treatments. This new generation… read more
EUCOPE Resources / Press Releases - January 7, 2021
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
News - January 1, 2021
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
