Nathalie Moll, Secretary General and Ludovic Lacaine, Healthcare Director of EuropaBio
Nathalie Moll, Secretary General and Ludovic Lacaine, Healthcare Director of EuropaBio detail the challenges of liaising with biotech companies in Europe and the role of personalised medicine in healthcare
Could you explain the aim of EuropaBio and what you seek to deliver?
NM: EuropaBio is an industry association not unlike many of the others, but where it differs is that instead of being a product-specific association, it is a technology association. We represent all of the sectors active in biotechnology, from healthcare, to industrial, to agricultural applications, as well as the SME dimension and the national biotech associations in Europe. We aim to create the right environment for all the biotech companies in Europe to operate in the best possible way and create innovation, value and products meeting society’s needs in Europe.
LL: Our strength compared with other associations is that we rely exclusively on the expertise of our members, allowing us to be truly representative of the expectations that the different industry sectors have.
Could you describe some of the ways you achieve these aims?
NM: Since we are a member-driven organisation, we work with the experts of different sectors on specific priorities they may have, whether it’s a new area of biotech that hasn’t been legislated before, or an area that is highly regulated and needs attention. We seek consensus within a given expert group and develop communication or outreach tools that explain our position to our interlocutors, be they institutional players or the press. We also work on projects with regard to improving the understanding and appreciation of the value that the biotechnology industry and biotech in general brings to everyday life.
As the European Association for Bioindustries, what role does EuropaBio play in promoting healthcare through biotechnology-based industry in Europe?
NM: The main area that we work on in healthcare is achieving better policy making, adapted to and coherent with scientific developments. Legislation and policy has a hard time keeping up with the extremely fast-paced development of science, especially biotechnology, and its applications in fields such as healthcare. Healthcare biotechnology has a tremendous impact on meeting the needs of patients and their families – it not only encompasses medicines and diagnostics that are manufactured using a biotechnological process, but also gene and cell therapies and tissue-engineered products. Today, the majority of innovative medicines, whether manufactured using biotechnology or via a chemical synthesis like a traditional small molecule medicine, and many diagnostic products, are made available by applying modern biotechnology in their development and/or manufacturing processes. It is very challenging for policy makers to write a regulation that companies are going to be able to follow. As an industry association representing the interests of our members and their expertise, we aim to ensure that whatever legislation is developed will be workable and useful.
Could you outline some of the ways in which EuropaBio is advocating this?
NM: What is particularly interesting is that apart from the industry expert groups we have, and our work with the national associations, we also involve patient groups and other stakeholders in our discussions. We have a patient advisory group that meets a few times a year to ensure that we really put the patients at the centre of what we are doing. We work with a lot of other bodies such as trade and pharmaceutical associations. We try to be as inclusive as we can in terms of perspective, because biotech applies to different areas and is ultimately aimed at solving society’s grand challenges.
LL: One important factor is the educational element. Because we work with extremely complex and conceptually novel technologies such as gene and cell therapies, our role is also to educate stakeholders and policy makers in such areas.
What sort of trends in policy making do you think are helping to drive healthcare and biotech?
LL: Personalised medicine is a major driver. The principle behind it is to identify which patient will most benefit from a treatment – and who will not – by using appropriate diagnostic tools. This offers huge opportunities to increase the efficacy of treatments and potentially help national healthcare budget holders to allocate their resources more efficiently.
NM: We are also part of the corporate social responsibility initiative by the Commission where we bring the biotech perspective which can be different from a purely pharmaceutical viewpoint. We would like to be in a position to contribute to the Commission’s first Innovation Partnership on Healthy and Active Ageing in the same way.
What are the main challenges of personalised medicine, and how do you think they can be tackled?
LL: Personalised medicine is going to remain an important issue for several years, not only for the industry, but also for society at large, because this approach is driven by social necessity, in terms of patients’ wellbeing and the need to better allocate resources, supporting policy makers in the management of their constrained healthcare budgets.
NM: One of the biggest challenges today seems to be getting stakeholders to think about the paradigm shift that personalised medicines will bring to our systems.
LL: We need the industry players and policy makers to think in the long term because personalised medicine is not an approach that will be delivered quickly. Significant investment will be needed to make it happen – at all levels, European and national.
In terms of supporting and promoting SMEs, what is EuropaBio doing?
NM: We are looking at making project funding more adapted to high tech biotech SMEs. The risk-sharing finance facilities that the European Investment Bank has are an excellent start but don’t apply to biotechnology SMEs because they require co-funding and biotech companies often don’t have any RoI for the first 10 or 15 years of their existence. On another level, we are trying to raise awareness about innovative SMEs because they are incredible: they are the backbone of healthcare. As an example, we launched our first award for the most innovative biotech SME in Europe in 2010. In six weeks we received a total of 32 applications from 12 Member States and all sectors of biotechnology, and the finalist as well as the four runners up were recognised for the cutting-edge solutions they are developing to meet society’s grand challenges by President Barroso and Commissioner Dalli during our Benefits of Biotech Event. We are delighted to be repeating the award in 2011 with the objective of showcasing the incredible value and potential of biotech SMEs.
What are the main legislative developments EuropaBio will focus on in the coming months?
LL: We will be very focused on one major piece of legislation, which is the revision of the Clinical Trials Directive. We will advocate for a simplified framework, keeping in mind all the benefits for patients because there is a paradox in clinical trials and their regulation. From one side you need to have a framework that can guarantee that all the data you gather from the trials is robust, so in that case you need to have very strong regulatory framework. On the other side you don’t want to have a regulatory framework so inflexible that it will prevent innovation.
What plans for the future do you have? Do you see the need to extend your work further afield?
NM: In the healthcare area we know that in addition to working on EU legislation and the general innovation climate, we also need to work with our national associations to ensure that the innovation, investment and industrial environments in Member States are conducive to biotech companies researching, developing and producing in Europe and that patients have equal access to medicines and treatments wherever they are on the continent.
LL: One of the major challenges for EuropaBio is to work at EU level with the national associations and company members to define and communicate our positions, but once something has been adopted at EU level, much of the work still remains to be done to ensure consistent implementation of the EU legislation, particularly when it is a directive and therefore open to more interpretation across nations.
Would you like to discuss any other aspect of your work?
NM: We are delighted with the EU 2020 strategy and we believe that the biotech industry can and is already playing a key role in the agenda of the EU2020 strategy. No other industrial sector sits so comfortably at the intersection of enhancing quality of life, knowledge, innovation, productivity and environmental protection. If the grand challenges are feeding ourselves, healing ourselves and looking after our environment, then our industry responds to each of them like no other does, through healthcare, industrial and agricultural biotechnology.