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Will the EU Pharmaceutical Strategy help Europe become a world leader in medical innovation once again?

Published today, the EU Pharmaceutical Strategy contains a number of proposals that can help Europe stem the 25-year trend of cutting-edge science and investment leaving Europe for the US and China. But choosing the right policy option to address the right issue will be critical to prevent further loss of competitiveness as the EU endeavours to regain its position as a world leader in medical innovation.
 
We welcome the recognition in the EU Pharmaceutical Strategy of the critical importance of incentives in driving research into areas of unmet medical need. Learning the lessons from the COVID-19 crisis, the inclusion in the Strategy of a series of measures to tackle antimicrobial resistance, including pull and even more importantly new types of incentives for novel antimicrobials, underlines the central role incentives play in finding answers to our health challenges.
 
Similarly, the pandemic has underlined the importance of health data in driving medical research, managing our healthcare and the supply of diagnostics, treatments and vaccines. The Strategy includes critical new initiatives to support the effective use of health data, in particular establishing the European Health Data Space and creating an interoperable data access infrastructure to facilitate secure analysis of data across Europe.
 
The research-based pharmaceutical industry has been on the frontline of the fight against the coronavirus from the very start, by ensuring the supply of all medicines to patients throughout the pandemic, supporting health systems on the ground and researching and finding diagnostics, treatments and vaccines to help the world come out from under the cloud of this global pandemic. We have made immense and incredibly swift progress in all these areas and many lessons have been learned not least in how we regulate the research, development, manufacture and supply of new diagnostics, treatments and vaccines. There are a series of proposals in the Strategy closely aligned to EFPIA’s Regulatory Road to Innovation which we look forward to working on with all stakeholders to evolve Europe’s world-class regulatory system, including strengthening the iterative scientific dialogue and the dynamic regulatory assessment, using of RWE in the regulatory decision making, creating a pathway to streamline regulation of drug/device combinations and promoting the innovative trial designs.

Addressing the disparities, barriers and delays to access to medicines for patients and affordability for health systems is a goal we share with patients, clinicians, Member States and the EU institutions. However, the approach to addressing access and affordability outlined in the Strategy is the wrong one.
 
Commenting on publication of the strategy, EFPIA Director General, Nathalie Moll said. “In tackling AMR, the Strategy recognises the importance of incentives in driving research into unmet medical need. However, at the same time, the Strategy suggests destabilising and weakening incentives designed to support innovation in multiple areas including for medicines for rare diseases and children, as a way of addressing issues of access and affordability of medicines. As well as being ineffective, it risks undermining the overall objectives of the strategy by creating uncertainty and accelerating the flow of life-science investment away from the EU to the US, UK and China. By adopting the right multi-stakeholder collaborative approach and by choosing the right policy options to address issues of access and affordability, we believe we can avoid these negative consequences and create, faster, more equitable and sustainable access for patients across Europe while supporting innovation.”
 
Together with a number of Health bodies, we urge the Commission to work with all stakeholders to address access issues through a High-Level Forum on Better Access to Health Innovation and to open the somewhat opaque EU Pharmaceutical Committee to relevant stakeholders, including the industry that discovers, develops and delivers pharmaceutical innovation. Lessons forged in the COVID-19 crisis have underlined what can be achieved through collaborative approaches and these can be utilised to identify multi-stakeholder solutions for introducing new technologies that can broaden access, reduce delays and mitigate the impact of shortages.
 
COVID-19 has focused the regulatory, research and healthcare communities on finding collaborative solutions. Solutions to get medicines to patients despite lockdowns, solutions to find new diagnostics, to scan product libraries to find candidate treatments and vaccines, to collaborate in research, development, manufacture, to innovate and deliver. Despite losing ground to other regions, Europe has a strong and stable research ecosystem, world class research centres, committed research-based pharma companies large and small, predictable incentives that reassure investors and a newly found regulatory flexibility tried and tested under COVID-19, that ensures safety and efficacy at pace with trying to beat a global pandemic. The Strategy makes a number of positive contributions to enhancing Europe’s research, manufacturing and bio-preparedness eco-system. If collectively we can avoid endangering Europe’s competitiveness by choosing the right policy options to address issues of access and affordability, we can improve outcomes for patients, build resilience and drive our economic recovery.

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