Die Idee hinter einem EU-HTA: die bislang nationalen Nutzenbewertungen von neuen Arzneimitteln und Medizinprodukten auf europäischer Ebene zu harmonisieren. Foto: ©iStock.com/artJazz
Die Idee hinter einem EU-HTA: die bislang nationalen Nutzenbewertungen von neuen Arzneimitteln und Medizinprodukten auf europäischer Ebene zu harmonisieren. Foto: ©iStock.com/artJazz

Pharmaceutical Innovation: Europe needs an “ambitious industrial strategy”

Protecting and improving health for a population of approximately half a billion people, equal access to modern and efficient healthcare for all Europeans, disease prevention and response – these are just a few topics on the health agenda of the European Union (EU). But regarding pharmaceutical research and development (R&D) the EU is at risk of losing touch with the rest of the world, says EFPIA, the European Federation of Pharmaceutical Industries and Associations. In an interview with the German news portal Pharma Fakten EFPIA´s Director General, Nathalie Moll, demands an “ambitious industrial strategy.”
EFPIA´s Director General: Nathalie Moll. Photo: ©EFPIA / Philippe Veldeman Photographer
EFPIA´s Director General: Nathalie Moll. Photo: ©EFPIA / Philippe Veldeman Photographer

With the new EU Commission in place: What has to be done in terms of healthcare policy on European level? What are your expectations on Ursula von der Leyen and her team?

Nathalie Moll: Considering the challenges faced by health systems in Europe we need to focus on delivering more patient-centred, outcomes-focused health systems. That means allocating resources to and incentivising the interventions that really deliver what patients need and creating a health data infrastructure that makes the most of the advances in data capture and analytics.

We need to continue to incentivise medical innovation to meet the challenges of an ageing population and increased prevalence of chronic diseases. And we need to work together to ensure that patients get access to the new wave of medical innovation.

President von der Leyen’s Commission can play a key role through maintaining Europe’s framework of incentives and a stable, predictable regulatory framework to drive medical innovation. Developing a new industrial strategy for Europe is key to supporting innovative industries in the face of strong global competition. Driving the Commission’s HTA proposal would improve the quality and speed of decision making on new medicines in Europe. Bringing together stakeholders in a high-level forum to address issues around access to health innovation could spark a more collaborative, solution focused approach.

EFPIA is one of the 149 sector Associations who signed Industry4Europe, calling for “an ambitious and long-term EU industrial strategy.” Do you think that Europe is not ambitious enough?

Von der Leyen. Photo: ©European Union, 2020/Photographer: Etienne Ansotte
Von der Leyen. Photo: ©European Union, 2020/Photographer: Etienne Ansotte

Moll: The Industry4Europe coalition is a large and unprecedented coalition of organisations dedicated to raising awareness about the need for an ambitious industrial strategy for and in Europe. The industry organisations behind Industry4Europe stand united in our repeated calls for an ambitious and long-term EU industrial strategy. Europe needs to be more ambitious, for example in remaining a hub for leading, smart, innovative and sustainable industries such as ours, that provide quality jobs and benefit all Europeans and future generations.

The EFPIA Manifesto calls for European excellence, making the EU a world leader in medical R&D. Where do we stand compared to other countries or regions?

Moll: Historically Europe has been one of the primary engine rooms of medical innovation. However, this preeminent position has been eroded in recent years. We have witnessed increasing competition from emerging economies and, in the last five years, the US has moved ahead of Europe in the number and speed of new chemical and biological entities approved by regulatory authorities.

To remain a world-leader in medical R&D Europe needs to support and maintain its robust regulatory and intellectual property (IP) frameworks so as to remain attractive for industry and investors alike and be at forefront of the development of innovative treatments. The stability and predictability of these frameworks are a significant factor in attracting the €35 billion annual industry investment in European research and development (see EFPIA: The Pharmaceutical Industry in Figures).

As science develops rapidly, evolving the regulatory systems and processes within the current framework will be critical to remain at the forefront of medicine development. For example, the acceptance of Real World Evidence, the development of dynamic regulatory pathways, and of complex clinical trials approaches are critical to foster the research and development of the next generation of medicines and can be done without changing legislation.

More and more gene- and immunotherapies are on the horizon. ©iStock.com/Design Cells
More and more gene- and immunotherapies are on the horizon. ©iStock.com/Design Cells

With more and more gene- and immunotherapies on the horizon there is a growing concern of policymakers regarding pricing and sustainability of healthcare systems and access to innovations. What is your position on this issue?

Moll: Traditional medicine reimbursement models cover the time between diagnosis through treatment and until a patient is cured or their condition is better managed. In the case of many chronic conditions this can be over the lifetime of the patient. Companies are reimbursed each time their medicine is used, spreading the costs for the healthcare system across the patient pathway. 

One-time cell and gene therapies change that paradigm. Not only in the complexity of their development, diagnosis and use, but also by delivering a one-time treatment with potentially a life-time of patient benefit where the costs are borne by the health system upfront. Clearly this is extremely challenging for health systems already under pressure from increased demand for their services. When viewed as a one-time cost these new treatments may seem expensive and should be valued as investments and in the context of replacing the costs of a lifetime of treatment, transforming the life of the patient and the ground-breaking science involved.

We as an industry have also developed a series of novel pricing mechanisms that are in use on a case by case basis in several EU countries to manage the introduction of these and other innovative treatments. More dialogue needs to take place among the various players involved in the health pathway, to ensure that every element of healthcare is valued and used while optimising outcomes for patients and expenditure.

We are facing huge challenges in the future. One of them: demographic change. Is Europe prepared?

Moll: All European health systems are struggling with the consequences of an ageing population and increasing multimorbidity and there are of course differences in how far the different countries have come in reforming their health systems.

Some countries still have health systems that to a large extent are centred around hospitals, which reflects a legacy where health services were mostly built to deal with emergencies and acute care. Many countries are now moving to a more integrated approach, where primary care, home care and eHealth services play a much more important role, and the focus is increasingly on prevention, early intervention and disease management. We believe that this is the right direction to go in knowing that reforming health systems is both a complex and long-term endeavour. What is needed is clear political leadership and close involvement of all stakeholders, such as healthcare professionals, providers, patients, payers and the private sector to make that transition happen as well as investments, for instance in health information systems that will enable integrated care, improve research and allow access for patients to their own health records.

We are facing huge challenges in the future. One of them: demographic change. Is Europe prepared? Photo: CC0 (Stencil)
We are facing huge challenges in the future. One of them: demographic change. Is Europe prepared? Photo: CC0 (Stencil)

We will need to spend more on healthcare in order to invest in the future models and meet the growing demands as well as to better use our current resources. According to the OECD, around 20% of healthcare expenditure is wasted. This means that we can already do a lot more with what we already have if we are able to identify and eliminate this waste. Again, better use of health data can enable us to better understand which interventions work well and which ones we should do less or not at all, and tailor health services and treatments to patients according to their needs. We are therefore fully supportive of the vision of the new Commission for a European Health Data Space, and believe that tools and methods already developed e.g. in the Innovative Medicines Initiative (IMI), co-funded by EFPIA companies and the European Commission, can provide valuable insights and building blocks in this regard.*

As EFPIA we look forward to being part of the dialogue that will help us ensure the best possible patient-outcomes at optimal expenditure for today’s patients as well as ensuring sufficient investment and possibilities for tomorrow’s patients. Time is ticking and patients rightly expect nothing less from us all. 

*See for example the European Health Data and Evidence Network: https://www.ehden.eu/.

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