Back innovation, boost access
At the outset of the Pharmaceutical Strategy, President von der Leyen highlighted two clear priorities; to ensure Europe has the supply of affordable medicines to meet its needs and to support the European pharmaceutical industry to ensure that it remains an innovator and world leader. In our response to the Commission’s public consultation on the review of the general pharmaceutical legislation and supporting annexe, EFPIA has outlined a series of proposals designed to deliver a step change in faster, more equitable access to medicines for patients and ensure that Europe can be at the forefront of the development and authorisation of the next generation of diagnostics, treatments and vaccines through future-proofing the EU regulatory framework. Only by addressing these two elements in unison can we realise a shared vision of a healthier future for Europe. A future based on innovation that can address unmet medical needs, increased access to new treatments, better outcomes for patients in a more resilient and prosperous Europe.
With over 8,000 potential medicines and vaccines in our pipeline, our researchers are delivering significant advances in patient care. Our capacity to keep on developing and deploying the results of these efforts, however, requires fresh thinking about Europe’s research ecosystem and healthcare infrastructure. Today, only 22% of global new treatments originate in Europe, while almost half of them come from the United States. This represents a complete reversal of the situation just 25 years ago, and latest numbers show a continued widening of the gap between Europe and the US. The stark reality is that Europe’s research and development (R&D) base is gradually eroding.
In order to realise President von der Leyen’s objective to be a world leader in medical innovation then the time for action is now. Any new policy ecosystem must be globally competitive to stem the tide of cutting-edge technologies leaving Europe for the US, China, other parts of Asia and the UK. Only through a future-proof, innovation-minded regulatory framework, and a world-class, robust and predictable intellectual property and incentives ecosystem, can Europe become a true world-leader in health, life science and innovation.
Innovation is only meaningful if patients get access to it.
Ensuring that patients get faster, more equitable and sustainable access to innovative medicines in Europe is a common ambition that we share with patients, EU institutions, and national governments. However, patient access to innovative treatments depends on several interlinked factors, mostly at Member States level, that cannot be solved through EU legislation. To make real progress requires a shared, evidence-based understanding of root causes of barriers and delays to access as well as the reasons behind any shortages of medicines. This is the foundation on which to develop collaborative solutions in partnership with the broader healthcare community including Member States. EFPIA’s consultation response contains a number of proposals for discussion that could be deployed to create a step change in the access and availability of medicines to patients across Europe.
EFPIA intends to work together with EU institutions, Member States and stakeholders to speed up access and create a system where pharmaceutical companies can file Pricing and Reimbursement applications in all EU countries within 2 years of EU market authorisation. A number of proposals and initiatives would create the right environment for this to be successful, including:
- A framework for Equity-Based Tiered Pricing, to ensure that the price of innovative medicines can vary between countries depending on their economic level and ability to pay, anchored in a principle of solidarity between countries.
- The creation of a portal where Marketing Authorisation Holders (MAH) can provide timely information regarding the timing and processing of Pricing and Reimbursement (P&R) applications in the various EU-27 countries within a 2-year time frame following the grant of the Marketing Authorisation including the reasons why there is a delay in the P&R decision or why the MAH has not filed for P&R in a particular market. The increased transparency of the barrier and delays to access will allow stakeholders to identify and address delays and barriers in partnership.
With patients in some European countries waiting around 6 times as long to access the same medicines as patients in neighbouring countries, EFPIA believes a collaborative, multi-stakeholder discussion around these proposals can make tangible difference to patients across the region. At the same time, Europe has a clear innovation and economic challenge to address and these positive developments on access are contingent on creating a policy framework that can support the industry to be a world leader in medical innovation.
Innovate or stagnate
Our industry employs 830,000 people in Europe including over 125,000 in research and development roles. Indirectly the industry supports around 2.7 million jobs across the region. The activities of pharmaceutical companies contributed over € 100 billion directly to the EU economy, with an additional € 106 billion provided through the supply chain and employee spending. It represents the highest contribution to the EU trade balance of any high-tech sector. The industry invests around € 39 billion in research and development in Europe, investing a greater percentage of its revenue in R&D than any other research-based sector in Europe. While there is considerable in-house research and development, medical innovation is a connected eco-system benefitting European academic and healthcare institutions, SMEs and research organisations.
The stakes could not be higher, the choices that we make today will define our innovation and economic future. As a region we can chose to innovate or stagnate, and if innovation happens elsewhere then high value, highly skilled jobs, research investment and advanced manufacturing will move with it.
By backing innovation and boosting access, I firmly believe that we can achieve the ambitions laid out in the EU Pharmaceutical Strategy. It means choosing the right policy lever to address the right issue and ensuring the right competencies are around the table. The proposals included in EFPIA’s consultation response on both access and innovation go hand in hand and are clear evidence of our commitment to building a healthier future for Europe.
 The Pharmaceutical Industry in Figures, Key data 2021, Pharmaprojects & SCRIP, March 2021