Innovation throughout a medicine’s lifecycle is vital to bringing new solutions to address gaps in healthcare

Brussels, 30 November 2022

The added value of innovating on existing medicines may be in finding a new indication, by treating a different disease with the same medicine or treating a specific sub-population, improving efficacy of the treatment, being easier to tolerate, or improving overall adherence.

In Europe, there is significant untapped potential in innovation on existing therapies, providing an opportunity for patients, healthcare providers, payers, industry, and healthcare systems. Re-evaluating the current innovation model should lead to greater focus on ways to stimulate innovation across the lifecycle of medicines, especially on off-patent molecules.

In order to support bringing this kind of value added, sustainable innovation to market and to provide access to patients with unmet needs, we call on the EU to recognise Value Added Medicines in the EU pharmaceutical legislation as a separate group of medicines, having its own dedicated regulatory pathway with proportionate data exclusivity incentives.

The Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan (Viatris) commented “Today, more than ever, there is a need for smart and sustainable healthcare solutions that can effectively address public health needs in a safe, timely and affordable way. Value Added Medicines can deliver in every aspect of these healthcare needs. But the lack of a supportive legislative and regulatory framework in Europe blocks Value Added Medicines from reaching patients. We believe that the revision of the EU pharmaceutical legislation provides a unique opportunity to address this gap and we call for a suitable and robust framework for Value Added Medicines provided for in the new EU pharmaceutical legislation to help address both, the healthcare systems’ challenges and the patients’ needs.”

Resource hub

The future of value added medicines was discussed at the VAM22 conference in Brussels on 30 November.

Factsheet & White paper – Creating a European ecosystem for safe, timely and affordable patient centric innovation

Podcast - Value added medicines: a patient-centric approach to healthcare

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.