JOIN US: Roundtable ‘The future of rare diseases in Europe’ 7 September 12:00 – 13.30
The European legislation on paediatric medicines (EC 1901/2006) and Orphan Medicinal Products (OMPs) (EC 141/2000), which regulates the procedure for designation of OMPs and defined incentives for their research and development (R&D), is currently under review. Over the last two decades, this legislation has changed the R&D in the field of rare diseases (RDs) and contributed to the approval of 190 OMPs.
Although the regulation has had significant success in incentivising R&D for OMPs, there remains a large unmet medical need with no treatments available for 95% of RDs. Considering that RD patients are scattered all over Europe, we believe that the outcome of this ongoing review will also have an impact on the Nordic RD patient community and society as a whole.
During the first phase of the consultations, very few organisations in the Nordics responded. As the revision of the legislation takes shape, there is an urgent need to raise awareness and mobilise all stakeholders in shaping a future legislation which continues to incentivise R&D for RD therapies.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and IML invite you to participate in a multi-stakeholder roundtable discussion to debate how to best ensure that the regulatory environment is both conducive to innovation and contributes to Nordic patients’ access to innovative therapies.
Please register here