EU Pharmaceutical Strategy: Value chain approach with innovation leadership at its core

Earlier this Summer the European Commission published its Roadmap for the Pharmaceutical Strategy for Europe which paved the way for a consultation process to which EUCOPE has contributed and will continue engage in the next months. Our position paper accompanying the general consultation is available here.

EUCOPE’s members, small to medium-sized companies active in pharmaceuticals, biotechnologies and medical technologies, play a key role in the European pharmaceutical environment. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date, significant and risky R&D investments, including in Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs). Targeted incentives need to be maintained to sustain investments and planning cycles required to foster research in areas of high unmet needs, such as rare diseases and antimicrobial resistance (AMR), as well as to support the delivery of continued innovation where treatments exist. The EU’s objective of ensuring greater access, availability and affordability should go along with enabling innovation through a strong incentive ecosystem.

Patient safety is a key underlying principle of the European legislation on the authorisation of medicines. The integrity of the regulatory framework must be upheld with no exception.  European citizens deserve medicines which are proven to be safe, effective and of high quality.

We call for a strategy that adopts a value chain approach, encompassing not only European manufacturing but also innovation leadership. In this respect, the EU should also further build its ‘’innovation hub” by investing in infrastructures such as pan European disease registries, e-health systems, and biobanks and promoting public-private partnerships to do so.

Adaptable yet clearer and faster regulatory pathways, avoiding any divergent or duplicative requirements, will be key to harness the potential of new technologies, such as ATMPs, nanotechnologies, drug-device combination (DDC) products and medicinal products that are developed and used in combination with companion diagnostics.

As we face the economic and societal consequences of COVID-19, actions at EU level should also adopt a long-term vision towards economic and austerity policies. The biopharmaceutical sector, especially small to mid-sized companies are an important engine for job and growth in Europe and their potential should be harnessed through a holistic approach in the EU including the Industrial, Data and Pharmaceutical strategies.

EUCOPE’s members stand ready to do their part to contribute to patient access to safe and high- quality medicines, pursue innovation, and contribute to economic and societal growth.