Launch of EUCOPE’s Life Science Lectures: Webinar Series
In November 2020, the European Commission adopted the EU Pharmaceutical Strategy, aimed at creating a future-proof regulatory framework and at supporting the industry in promoting research and technologies that reach patients in order to fulfil their therapeutic needs while addressing market failures. As part of this, the European Commission will publish the EU Pharmaceutical Package in April 2023, proposing the revision of the General Pharmaceutical Legislation, the Regulation on Orphan Medicinal Products (OMPs) and the Paediatric Regulation.
A definition of (high) unmet medical needs (H-UMN), launch conditionality, a modulation of regulatory data protection (RDP) and orphan market exclusivity (OME), as well as provisions to streamline regulatory procedures, are among the Commission’s proposals, will undergo the legislative scrutiny of the European Parliament and the Member States in the Council.
It is crucial that these proposals do not undermine EU competitiveness and innovation, especially for small and mid-sized pharmaceutical companies, which are at the core of R&D and innovation of novel therapies. For this reason, EUCOPE has launched a new webinar series: Life Science Lectures to discuss the necessary conditions needed, as part of the revision of the pharmaceutical framework, to foster EU competitiveness over the next decades and develop a sustainable and innovative environment for small and mid-sized life sciences companies.
Episode themes & guests
Each episode will promote a multi-stakeholder exchange, involving representatives of EU Institutions, patients, clinicians, researchers, payers and industry. The webinars are public and open to a broad audience. Each episode will focus on different aspects of the EU Pharma Package that are crucial to building and sustaining a competitive pharmaceutical ecosystem in Europe. We will discuss solutions needed to further improve the existing framework and fulfil the needs of those who require the most care – patients across the various therapeutic areas, in all EU Member States – without hampering the solid base that has been built in the past 20 years.
Following each episode, we will publish a thought report, with key takeaways and main messages from the webinar, to disseminate among the interested audience.
Episode One – 30 May (16:00 – 17:00 CET)
Attaching conditionalities to incentives: the right path to improve access?
Episode Two – 6 July (16:00 – 17:00 CET)
Defining (H)UMN: will it steer innovation towards filling existing gaps?
Episode Three – 7 September (16:00 – 17:00 CET)
EU HTA Regulation: How will the revised Pharma Package impact value assessment of therapies?
Episode Four – 12 October (16:00 – 17:00 CET)
Regulatory pathways: how to speed up processes for small and mid-sized companies?
For further questions about the Life Science Lectures webinar series, how to get involved or technical issues, please contact EUCOPE’s Government Affairs Manager Stefano Romanelli.