Biotech, Brexit and big data: Nathalie Moll on the state of Europe’s pharma industry

13 Oct 2017

Image: Allexxandar/Shutterstock

In a Q&A with EFPIA director general Nathalie Moll, we find out her thoughts on Brexit, public engagement with biotech, big data and drug pricing.

Nathalie Moll is the newly appointed director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), assuming the role in April this year.

Moll is set to come to Ireland in 2018 as a headline speaker at BioPharma Ambition, the international conference that will be hosted for the second time in Dublin next February.

As director general, Moll’s chief goal is to work with the EFPIA community to foster an environment that supports continued innovation and drives better outcomes for patients across the European Union. Earlier this year, she was one of many European pharma leaders to sign a joint letter to the chief negotiators of Brexit, urging them to secure ongoing cooperation on the supply of medicines and not to impede access for UK patients.

Keen to promote public engagement with biotech and biopharma, Moll is also the person who founded European Biotech Week in 2013, during her time working at EuropaBio.

On your appointment as director general of EFPIA, you said you looked forward to building an environment that supports innovation and drives better outcomes for patients. What, for you, is the ideal environment for pharma innovation, and how far is Europe from this ideal?

With over 7,000 medicines in development and new treatments –and even cures – that would have sounded like science-fiction just a decade ago, there is much to be positive about. We have fantastic dedicated people in small and large companies, collaborative relationships like IMI [the Innovative Medicines Initiative] and a proactive patient community. In order to ensure that Europe continues to be an attractive region to invest in in terms of innovation, there are issues we need to address. We need to ensure that the IP framework that protects innovation and drives investment into areas of unmet medical need is maintained as well as developed where needed. We need to ensure we value innovation and we need to be more flexible about how we finance innovation, removing silos and taking a longer-term view. We need to continue to drive an innovation ecosystem that fosters, supports and finances SMEs in the sector.

You also said previously that you enjoy the challenge of addressing misconceptions or misunderstandings about biotech or pharma – what are the most common ones that you encounter?

In the context of an ageing population and rising healthcare demand, bizarrely, innovation and the industry behind that innovation are often seen as part of the problem and not a key part of the solution. The reality is that if we are to address these challenges faced by our healthcare systems, we need innovative treatments for diseases like dementia.

There will be challenges in introducing high-value, high-impact new treatments or even cures. Often, the costs are borne upfront and solely by the medicines’ bill but the value is delivered over the lifetime of the patient and across society. How do we change this? How do we look at the impact throughout whole health system? There is no quick fix. It has to be about dialogue, partnership and collaboration, utilising advances in data analytics and finding more flexible solutions.

How important is it that the general population engages with biotech and pharma?

I see it as a privilege to work for an industry on the cutting edge of science delivering lifesaving, life-changing treatments. But the inherent tension between profit and healthcare makes developing those more public relationships difficult. It is critical and we have to continually strive to ensure that the role of innovation in public is understood but also that the role of investment and profit in driving that innovation is better articulated.

The issue with cutting-edge science is that it can feel far removed for anyone not witnessing it 24/7. Misunderstanding breeds mistrust and, in an area as fundamental as health, we must do everything in our power to better explain and engage in debate on what it is that we do, how we do it and why.

Do you think initiatives such as European Biotech Week have helped in this regard?

Absolutely. There are so many amazing stories across the industry, from the science to the impact on patients. Events like Biotech Week create a focal point around which our many innovators can tell their stories and surface the issues they are facing.

European Biotech Week was created as a concept to foster dialogue between experts in biotech and the general public. Five editions later, we have witnessed how the initiative has grown year after year, from 12 participating countries and just under 100 events in 2013, to 19 countries and 149 events this year. The true value of Biotech Week is that it belongs to everyone. Anyone who has an interest in biotech can organise an event or an activity in which debate, discussion or simply fun are had around the theme of the most revolutionary science of the 21st century. The mere fact that the initiative grows year upon year shows that there is a continued appetite to share and learn more about biotech as it transforms our future for the benefit of society.

What are the risks and opportunities facing European pharma and biotech with Brexit on the horizon?

Brexit is challenging. The UK has long been an integral part of the EU life sciences infrastructure, from research collaboration and regulation, to supply and manufacture. We deal in medicines, lifesaving treatments. The sector is unique and we owe it to patients in the UK and the EU to ensure that the right transitional arrangements are in place to safeguard patients.

How have negotiations progressed on post-Brexit UK-EU cooperation on the regulation and supply of medicines?

The phased nature of the negotiations means that dealing with sector-specific issues at this early stage is difficult at the EU level.

What are your views on the relocation of the EMA? What kind of location is preferred?

The decision on the location is a matter for member states. What is critical is that the decision is based on objective criteria that supports the continuity of the agency’s critical functions. Its ability to retain staff and access expert networks is central to its future and to public health.

How is the exponential growth of big data and development of technologies such as AI impacting the pharma industry?

We see two key opportunities: to develop more outcomes-focused healthcare predicated on the use of real-world evidence, and the use of big data to shape the research and development of new medicines.

The fragmented nature of healthcare systems, data collection and analysis means we are a long way off realising the full potential of healthcare data. Through projects like IMI’s Big Data for Better Outcomes and the European Health Data Network, we are actively engaged in creating the infrastructure by which Europe can work towards its big data ambitions.

In terms of access, how can we make it so that innovations in pharma and biotech are for the benefit of all, not just those who can afford it?

Access to new, innovative treatments is a shared goal. No one would spend 12 to 15 years investing all their time, their expertise and resources to develop a new medicine to not see it benefit patients.

Medicine prices are subject to a negotiation with governments, go through more rigorous cost-effectiveness assessments than any other element of healthcare spending and are only reimbursed if they meet the cost-effectiveness criteria against existing standards of care.

OECD data tells us that, overall, medicines spending has stayed constant as a percentage of overall healthcare budgets. However, managing the introduction of new, transformative medicines into the system is challenging for healthcare systems under pressure from an ageing population and increased levels of chronic disease. These game-changing treatments require new levels of partnership to adapt regulatory pathways, develop new ways of valuing innovation, as well as create new, more flexible pricing models that can address departmental and annual silos. We need to evolve service design for new treatments and realise the potential of real-world evidence. There is huge scope to work more collaboratively on the introduction of new medicines and it’s a journey that EFPIA and its members are committed to working with healthcare systems and governments on.

Do you think the industry needs to be more transparent in its approach to drug pricing?

We certainly need to build understanding of the considerations used in determining the price of a new medicine. Industry works with governments in each EU member state to establish a medicine’s price that reflects the value it provides to patients and the healthcare system. In addition to their local assessment of value, governments often use prices of other countries as a benchmark.

Updated, 5.20pm, Friday 13 October: This article has been updated to reflect that Nathalie Moll is the founder of European Biotech Week. We have also included further comments from Moll on public engagement with biotech and pharma, and European Biotech Week, by request.