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Interview with Nathalie Moll, European Federation of Pharmaceutical Industries and Associations (EFPIA)

1. 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? How far is Europe from this ideal?

With over 7000 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 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 in to areas of unmet medical need is maintained as well as developed where needed. We need to ensure we value innovation, we need to be more flexible about how we finance innovation, removing siloes and taking a longer-term view. We need to continue to drive an innovation eco-system which fosters, supports and finances SMEs in the sector.

2. You 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? And how do you address them?

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.

3. How important is it that the general population engages with biotech and pharma? (For example, does it foster greater support for the industry at government level, or help grow the pipeline for its workforce)

I see it as a privilege to work for an industry on the cutting edge of science delivering life saving, life changing treatments. 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.

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

Absolutely. European Biotech Week was created as a concept to foster dialogue between experts in biotech and the general public. Five editions later, we have whitnessed how the initiative has grown year after year from 12 participating countries and just under one hundred events in 2013 to 19 countries and 149 events this past week. 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 dbeate, 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.

5. 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, life saving treatments, the sector is unique and we owe it patients in the UK and the EU to ensure that the right transitional arrangements are in place to safe-guard patients.

6. What was the response to the letter issued in July 2017? 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.

7. 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 support 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.

8. 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 outcome 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.

9. 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? (Particularly in the case of rare diseases and the ongoing development of personalised medicine)

Access to new, innovative treatments is a shared goal. No one would spend 12 to 15 years, investing all their time, their expertise and resource to develop a new medicine to not see it benefit patients. Medicines’ prices are subject to a negotiation with governments, go through more rigorous cost-effectiveness assessments that 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 percentage of overall healthcare budgets over time. However, managing the introduction of new, transformative medicines in to 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.

10. 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 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.