EC Pharmaceutical Strategy – Time for a Modern Approach to Value

EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the European Commission Communication on the Pharmaceutical Strategy for Europe.

EUCOPE calls for a comprehensive Pharmaceutical Strategy that adopts a value chain approach, encompassing European manufacturing and sustainable biopharmaceutical innovation leadership.

EUCOPE believes that the proposed implementing measures provide a unique opportunity to deliver on the Strategy’s objectives to ensure the quality and safety of medicines while boosting the sector’s global competitiveness. However, EUCOPE notes a disconnect between the objectives and some of the actions proposed by the Commission.

The EU needs to be effective and result-oriented when implementing the Pharmaceutical Strategy. We call for a balanced approach, opting for a targeted revision of the pharmaceutical legislation. The COVID-19 pandemic has proven that the ‘cost minimisation’ model is more expensive in the long run; instead, the EU needs to foster a ‘value optimisation’ model by integrating the value for patients at the core of the healthcare systems.  In the midst of the pandemic, the effort of the European institutions to work together and deliver policy actions in real-time has been unprecedented. COVID-19 demonstrates that a healthy environment for biopharmaceutical innovation is a key element of crisis’ preparedness and response.

The EU incentives environment needs to be strengthened, building on its achievements to date, to sustain investments and planning cycles required to foster research in areas of high unmet needs, as well as to support the delivery of continued innovation where treatments exist. Alexander Natz, EUCOPE Secretary General

We note the European Commission proposals to review pharmaceutical incentives, including the development of more incentives in the rare disease area.  EUCOPE is committed to actively contribute to the policy process with concrete ideas and proposals, both as a representative of the small to mid-size biopharmaceutical companies and as a co-lead of the European Expert Group of Orphan Drug Incentives, a multi-stakeholder coalition that brings together the broad rare disease community, working at recommendations to contribute to the Orphan Medicinal Products (OMP) Evaluation.

EUCOPE’s members 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 OMPs and Advanced Therapy Medicinal Products (ATMPs). These companies invest in R&D extensively and across entire portfolios of products. COVID-19 shed light on the lengthy and complex journey of medicines development, being a magnifying glass of the issues that the rare disease community has long been facing, e.g. lack of awareness on the diseases, evidential uncertainty, scarcity of data and fragmented national regulatory systems.

In light of these hurdles, allocating R&D to a specific treatment and predicting its return of investment is close to impossible. Therefore, linking incentives to these conditions might defy the very objectives of the strategy, both of ensuring patient access and boost competitiveness and innovation in Europe.

We welcome other provisions of the communication including the initiatives on regulatory flexibility and enhancing dialogue and cooperation among regulatory authorities, HTA and national payers. We are also looking forward to seeing more provisions on the EU Health Data Space and other initiatives that support the uptake of real-world evidence which is an effective complementary approach in addressing the benefits and risks of a medicinal product that cannot be sufficiently answered with data from clinical trials.

COVID-19 showcases that European responses to new and emerging health crises do not happen in a vacuum but rather have an important international dimension. In view of this, we welcome the European Commission’s intention to continue ensuring a level playing field and a regulatory environment that is conducive to innovation and competitiveness and building resilient and diversified European supply chains.