Report shows the future of meeting unmet medical needs relies on developing tailored EU pathways for value added medicines
Widely researched and resourced during the early stages of the COVID-19 pandemic, repurposing has shown its worth in an emergency. Facilitating repurposing beyond the pandemic promises sustainable developments and patient centric health outcomes in a range of therapy areas.
The upcoming EU pharmaceutical legislation revision is the opportunity to recognise and support the concept of Value Added Medicines, including repurposed medicines and, in doing so, to recognise the potential for Europe.
To make medicine repurposing a success we need to employ all resources at hand to connect different actors. One such connection which can uniquely be addressed by the EU is to assist academia and non-commercial stakeholders in conducting research, as well as facilitating their partnering with the industry in making repurposed medicines available to patients.
The early involvement of industry in repurposing projects opens a range of opportunities like new indications, different/adjusted delivery forms, changing dosage and combining different therapies to meet the needs of the patient community and to bring to market new treatment options in an accessible and affordable way.
The legislative framework must also foresee proportionate incentives, such as 4 years of data exclusivity and a dedicated regulatory route, which, in combination with a fit-for-purpose evaluation framework to assess the benefits, would enable Value Added Medicines (including repurposed medicines) to benefit patients in Europe. These are essential steps in recognising the investment and resources that need to be dedicated to developing a medicine based on a well-known substance.
The Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan (Viatris) commented “One of the very few solutions available to manage the early stages of the COVID-19 pandemic was to deploy wide ranging repurposing of known medicines, for those who were critically ill. While we found promising options during that emergency, there is no reason not to support this type of innovation for all disease areas. The EU significantly lags behind other regions of the world, notably the US, in supporting value added medicines with a dedicated regulatory pathway and appropriate incentives. My hope is to see this addressed in the upcoming revision of the EU pharmaceutical legislation so our industry’s capabilities may be dedicated to bringing these solutions to patients.”
Report – Advancing medicines repurposing in the EU, March 2022, available here.
About the Value Added Medicines Group
The Value Added Medicines Group is a sector group of Medicines for Europe which aims at optimizing, rethinking and reinventing medicines based on known molecules and by bringing untapped innovation to improve care delivery. The Value Added Medicines Group adopts a complementary perspective compared to the other Medicines for Europe sector groups: by tackling the targeted portion of patients’ needs that remain unmet to this day, delivering additional improvement to the healthcare community as a whole.
About Medicines for Europe
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.