Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), explores Europe’s shared goals and shared responsibilities
When EU Commission President, von der Leyen, wrote her mission letter to Stella Kyriakides, she asked the new Commissioner for Health ‘to look at ways to help ensure Europe has the supply of affordable medicines to meet its needs. In doing so, you should support the European pharmaceutical industry to ensure that it remains an innovator and world leader.’
As the voice of the European research-based pharmaceutical industry, we have been considering how Europe can realise these ambitions. It means delivering fast, equitable and sustainable access to existing treatments for patients across the region. It means delivering access to new treatments for patients where their outcomes can be improved or where no treatment options exist. And finally, it means delivering this in a pro-innovation environment that ensures that the European pharmaceutical industry can remain an innovator and world leader.
Identifying the right policy driver(s) for the right issue is critical. Broadly speaking, that means novel, flexible and collaborative models to solve issues of access to and shortages of medicines. It means supporting a stable, predictable regulatory environment with strong incentives to drive research into the next generation of treatments; and the adoption of a renewed industrial strategy for Europe to ensure the industry remains an innovator and world leader.
A better way
Taking each ambition in turn, the first priority is to achieve fast, equitable and sustainable access to existing treatments for patients across Europe.
In recent years, we have seen the lives of many European patients transformed by the development of new treatments. Despite the progress, for many patients in Europe, access to new treatments is subject to delays, shortages or a collective failure to reach an agreement between medicine companies and governments to ensure patients get access. As a result, quality of life and even life expectancy can vary greatly across the European Union.
We recognise the pressure on resources facing our health systems. Demand for services is increasing, driven by Europe’s health success story: increased life expectancy and an ageing population. From vaccinations to antiretrovirals, beta-blockers to statins, medical innovation has long held the key to addressing societies’ healthcare challenges.
However, as new treatments offer a one-time cure in place of ‘a pill a day’ over the lifetime of a patient, introducing them into health systems presents significant challenges. The costs, particularly of a cure, are often siloed to the medicines budget and borne entirely in the first (financial) year. Whereas, for the benefits, the true value is realised right across society and over the lifetime of the patient. Clearly the current approach presents huge challenges to health systems and companies, but ultimately it impacts on patients. Everyone in healthcare has a collective responsibility to find a better way.
The starting point is to understand the reasons why patients in Europe either do not get access to treatments or endure significant delays, then it is about co-creating solutions. From an industry perspective, we can increase the transparency and understanding of how the value of a new treatment is determined. We can work with colleagues in health ministries and National Competent Authorities in Member States responsible for national pricing and reimbursement in order to better explain the processes, how they work and how decisions are made.
As an industry, we are committed to bringing forward solutions. In December 2019, we endorsed a paper on novel pricing and payment approaches to try and address the needs of patients, health systems and governments.
These approaches include combination-based pricing, indication-based pricing, outcomes-based payments, incremental payments over a fixed period of time and subscription payments; and represent new ways of ensuring that health systems only pay for the value delivered to patients and financial tools to manage the costs over time. They will require a collaborative, flexible approach from across industry and the healthcare community.
Frameworks for the future
The second and equally important dimension to access to medicines is ensuring access to new treatments for patients where their outcomes could be improved or where no treatment options currently exist.
Despite the significant progress in transforming the outlook for patients, there is so much more to be done. For example, 95% of rare diseases have no licensed treatment. A predictable, stable regulatory and incentives framework is essential to secure the investment in discovering the treatments that patients need.
It means supporting the EU Orphan Regulation that has been central to developing treatment options for previously untreatable conditions. The regulation has resulted in 164 new treatments for people living with a rare disease since it came into force. Similarly, we have to work together to support the continued implementation of the EU Paediatric Regulation, developing more treatment options for children.
We have to invest in Europe’s health data infrastructure to realise the potential of data capture and analytics, shaping the future of medical research and the direction of patient care. Supporting a flexible legal framework for a public-private partnership in health will enable radical collaboration across sectors, regulators, health and research communities helping to turn fundamental science into new solutions for patients.
Investing in innovation
The final ambition is supporting the European pharmaceutical industry to remain an innovator and world leader.
Competition to attract global life science investment is intense. Other global economies are moving quickly to create a pro-innovation environment. If Europe is to retain, sustain and develop the sector’s €206bn gross value added to European economy, the 2.5 million jobs, 642,000 of which are employed directly by pharmaceutical companies; and over €35bn a year investment in European research and development, it has to surpass or at least match the developments in other regions. A renewed industrial strategy for Europe is critical to realise the region’s potential to be a world leader in medical innovation and put Europe in the best possible position to compete on the global stage.
The life science-related components of an industrial strategy reflect the conditions needed to generate access to the next generation of treatments for patients. It is predicated on a predictable, competitive, world class regulatory system that embraces advances in science, technology and medicines, accelerating access to innovative healthcare solutions and optimised patient outcomes. IP-related policies have to promote sustainable innovation, create opportunities for jobs and growth and retain Europe’s attractiveness as an investment location.
Establishing a European Health Data Space that encourages the use of digital tools – such as Artificial Intelligence, machine learning and mHealth – would enable Europe to become a centre of excellence in medical research and manufacturing. Advancing Europe’s smart trade agenda would promote quality standards and investment, as well as actively use trade policy to promote Europe’s regulatory and IP frameworks globally.
Finally, utilising EU funding instruments to further encourage research to assess the impact on pharmaceuticals in the environment, through public-private partnerships as well as research programmes such as Horizon Europe, would support the industry in Europe in its commitment to actively engage in minimising the impact of pharma activities on the environment.
EFPIA and its member companies are committed to working with partners across the health, research and policy communities in Brussels and across Member States to achieve these shared goals.
European Federation of Pharmaceutical Industries and Associations
Please note, this article will appear in issue 12 of Health Europa Quarterly, which will be available to read in February 2020.