Europe’s Brighter Tomorrow

Write an end of year blog, they said.
It won’t take long, they said.
Just a quick review of the big issues of 2018 and the things we can look forward to in 2019.

Perhaps in a different festive season I would have fallen for it, but not this time. 

As we bring 2018 to a close and look forward to 2019 there are so many issues in play, issues that affect citizens across Europe and beyond. Issues that are salient now and the impact of which will be felt for generations to come.

So where to start? Well, if we hold patients at the heart of everything we do, we can’t go far wrong. So let’s start there.

September 2018 marked the 40th Anniversary of the WHO Declaration of Alma-Ata. It underlined that people have the right and duty to participate individually and collectively in the planning and implementation of their healthcare. For the research-based pharmaceutical industry that means not only in healthcare delivery, but also in how medicines are researched, developed and introduced.

At EFPIA that means actively listening to patient experiences, patient challenges and exchanging insights that must shape how EFPIA develops its thinking, its dialogue with others, its policy and the positions we advocate. It is only through open and transparent dialogue between patients and industry that we can ensure that the patient perspective becomes an integral part of how medicines are researched, developed and delivered to patients. Inclusion of the patient perspective has the potential to co-create and co-develop better health care management and patient outcomes, delivering greater efficiencies in healthcare utilisation. This has been a priority for EFPIA in 2018 through the development of the EFPIA Patient [Organisation] Engagement Strategy and will continue to be a core part of EFPIA’s organisational culture in 2019. I am excited to see the EFPIA Patient Think Tank, the Health Collaboration Guide, PARADIGM and a host of other projects really advancing the field of meaningful patient engagement.

The biggest impact we can have for patients in Europe is to continue to discover, develop and deliver life changing, transformative treatments and cures. It is what drives us through the long, complex and risky process of developing a new medicine. From 10,000 molecule candidates to just one medicine, through 10-15 years, investing a phenomenal amount of energy, expertise and resource. The foundation of all that investment, in fact of all medical innovation, is intellectual property (IP). It’s what gives innovators the confidence to invest in that moonshot, to find that new treatment or cure. 

And yet, in the face of intense competition for pharmaceutical research and development investment from around the world, 2018 saw Europe send a signal to the rest of the world that it has decided to devalue its IP framework through the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver. Driven by specific interests, based on incomplete economic analysis and misrepresented as a debate about access to medicines, the waiver is bad for Europe’s trade balance, bad for research and development, bad for academia, bad for employment and most importantly bad for patients across Europe and beyond. 

Devalue IP and very soon you will hit the ceiling of medical innovation. The outcomes achievable today with yesterday’s medicines will be the best patients can hope for. It is not the Europe I believe in, live and work in, or want to bring my children up in. I want to see Europe at the forefront of medical innovation, I want Europe to recover its position as an engine room of new treatments and cures. If the proposal goes ahead in 2019, then we are in damage limitation mode. How do we ensure that the wrong signal to the world is not further amplified? That its implementation without appropriate safeguards does not further erode Europe’s formerly world class IP system at a time when others are strengthening theirs? That means:

• Not allowing stockpiling of generic/biosimilar medicines while the innovative medicine is still under SPC protection.
• A timely, effective and transparent notification system.
• Effective labelling measures which prevent products manufactured under the manufacturing waiver for export from being re-directed back to the EU or being launched on the EU market before SPC expiry.
• Non-retroactive implementation.

2018 did have a significant European legislative proposal that looked to improve the speed of access to new treatments across of Europe. The HTA regulation should not have been complicated. Suggesting that Member States get together and pool clinical expertise to review and analyse medicinal products should have been a no-brainier. It meant defining, together which evidence they expect from innovator companies and agreeing  together whether the evidence submitted is strong or not, conclusive or not, and whether anything more is needed, all this via joint clinical assessments.

Unfortunately the sensitivities of subsidiarity seem to be delaying and subverting better decision making on new treatments for patients. Member States have underlined their concern that clinical assessment reports may not meet their needs, or be of sufficient quality. This objection seems difficult to understand in the context of how the regulation defines the process, as a joint one.  And subsidiarity concerns may be related to the perception that joint clinical assessments lie at the top of a perceived slippery slope to loosing control of a country’s ability to decide on prices. It is true that clinical assessments feed directly into pricing mechanisms, however pricing is, and should continue to be, a national competence. It is inextricably linked to a country’s economic conditions and the organisation of its healthcare system. Put simply, if you take a statin in Sweden or Bulgaria the impact on your cholesterol will be similar. The cost of care for the heart attack that that statin prevents would be significantly different. Clinical assessments you can do across Europe, cost effectiveness has to be done country by country.

Together with many partners from across the healthcare community, we hope that those Member States that have raised objections can see their concerns have been addressed and that the Council will endorse the approach proposed by both the Commission and the European Parliament.

I am excited by the potential to build on the European Research Framework Programmes that have such a proven track record of directly supporting medical and health system innovation, patient access to innovative healthcare solutions, Europe’s cohesion and growth, as well as the continuing attractiveness of Europe as a location for life sciences and investment. The pharmaceutical industry along with other life science industries plays an essential part in this process, also bearing most of the risks of failures if the scientific idea does not prove as promising as anticipated.

Having successfully tested the concept of radical collaboration and pushed boundaries of pre-competitive research in one sector in the Innovative Medicines Initiative (IMI), we are ready to push it into new and completely uncharted territory where different sectors could join forces with research and healthcare communities and maintain Europe at the forefront of medical and health systems innovation. As we look to 2019, we need a quick adoption of Horizon Europe and an adapted legal framework for public private partnership to explore these uncharted and globally unique territories to address the health challenges of the future.

Of course Brexit has loomed large on the political agenda throughout the negations in 2018 and will continue to dominate the headlines in 2019. While for most sectors the issues are primarily economic, for the healthcare sector the primary concerns are patient safety and public health. A no deal exit from the EU by the UK has very real and tangible consequences for patient safety and public health in both the UK and across Europe. As I write this, the future relationship between the UK and the EU remains uncertain. And in that uncertainty the burden has fallen to industry to work tirelessly to prepare for every eventuality.

Our hope is that a deal is agreed and then immediate and intense focus is given to regulation and supply of medicines in the post-Brexit relationship. We, along with many others in the healthcare community and across the life sciences sector, believe that an explicit commitment to securing long-term, extensive cooperation around the regulation of medicines and medical technologies is in the best interests of patients and public health. This has to be priority in 2019.

Uppermost in the mind of many in Brussels is of course, the EU elections in 2019. It is chance to reflect on the last five years and think about the things that over the next legislature can help make Europe a happier, healthier place to be.

For EFPIA, that means looking at both the health and economic prosperity of Europe. What can we, as an industry, contribute? And what are the things that the European Union can do to realise the ambition of a healthier, more prosperous Europe.

We have outlined our vision in the EFPIA Manifesto focused around three key areas:
• Bringing innovative health solutions to all patients
• Making the EU a world leader in research and development
• Being stronger together; joining forces to fast track results.

I firmly believe that building a strong European economy and cohesive European society largely depends on a healthy population. It’s why ensuring all European citizens live healthier lives must be a priority for the new legislative mandate, supported by more patient centred health systems and a smart sectorial industrial policy and pro-innovation environment.

The health of European citizens depends on all of us - policy-makers, healthcare professionals, civil society and industry. Pooling our resources and expertise will ensure that what we do brings tangible benefits to EU citizens and strengthen the EU’s global reputation for outstanding R&D and innovation. It one of the reasons I was delighted to be part of the EU Health Summit, organised by over 25 healthcare organisations to look at a shared vision of health.

There is much to be excited and optimistic about in 2019. We are undoubtedly in an age of rapidly advancing science making the previously untreatable, treatable, transforming the lives of patients and how we manage our healthcare. How we introduce these exciting new technologies into our healthcare systems needs new approaches, new levels of partnership and collaboration to continue the evolution towards increasingly patient-centred, outcomes focused systems. As in 2018, there will be many challenges, and my Team and I are committed to working in collaboration with partners in research and development, health and social care to deliver more for patients across Europe.

Wishing you all a happy festive season and a wonderful start to 2019!

Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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