Interview with... Olivier Fréget, Founding Partner and Liliana Eskenazi, Partner, at Freget Glaser & Associés

1) How does Fréget Glaser & Associés envision working within the EuropaBio community?
Fréget Glaser & Associés is a law firm based in Paris, France, focusing on EU competition, regulatory and public economic law. We have been advising pharmaceutical and innovative companies for more than 20 years. We have seen the life sciences sector evolve around the major technological and scientific developments, particularly in biotech. These have raised numerous regulatory challenges that continue to stimulate the debate. We would be glad if we could contribute to these thought exchanges from our modest legal perspective.

We have been monitoring on a regular basis the EU and French regulatory framework in the life-sciences, as well as the technology sector and would be happy to contribute to working groups reflecting on those issues and trying to steer new rules from a business and practical perspective, making them work better and serve the purpose of improving innovation incentives in a secure legal framework.

2) What are the policy areas of significance for your clients in the EU?
A major priority for most highly innovative industries is to secure R&D investment, required to continue funding research and delivering high-value products. In the life sciences sector, this general imperative goes hand in hand with the need to comply with extremely strict regulations, aiming to make sure not only that products reaching the market are efficient and safe, but also that they remain accessible for patients who need them.

From this perspective, one of the main policy areas of interest remains market access and, as far as medicinal products are concerned, pricing and reimbursement. This is an area where public authorities need to balance several objectives: make sure that innovative medicinal products, addressing unmet medical needs, reach their patients as quickly as possible; keep public spending low, while stimulating innovation, providing incentives for high-risk investments in these areas.

Aside from pricing and reimbursement regulations that are part of public health policies, state support to the innovative industries (MedTech, e-health…) may also come earlier in the process from direct subsidies or other industrial policy tools, including public investment funds, public-private partnerships. These may in turn be scrutinized under specific regulations, such as the EU rules on State aid. From a private funding perspective, foreign investments in sensitive sectors (such as health and high tech) may draw the regulators’ attention, as can technology transfer, consortium agreements, or mergers and acquisitions susceptible to affect actual or potential competition on the market.

3) Where do you see the greatest investment and growth opportunities for European biotechnology?
Clearly, the development of gene and cell therapies is among the top areas of interest, both from an R&D perspective and in terms of public health objectives. The ground-breaking innovations these biotechnologies have brought raise immense hope and expectations for human health, as well as opportunities for companies at all levels of the value chain, from R&D, through clinical trials, to manufacturing and delivering the treatment. While they offer novel solutions for curing rare diseases and unlock the potential of personalised therapies, they remain subject to huge – and long-term – investment commitments.

4) How does France want to position itself within the European biotech economy?
With more than 2,000 HealthTech companies (including Biotech, MedTech, eHealth/digital health and diagnostics, among others), totalling more than €800 million turnover in 2020 and more than 10,000 direct jobs (source: France Biotech, Panorama France HealthTech 2021), France has a vibrant industry in that sector and is among the European ‘champions’. The Government has set up a Strategic Council for the Healthcare Industries to steer policy and regulatory developments in that area and has also promoted the 2030 Health Innovation Plan as a funding and policy tool. Announced in 2021 by the French President, the plan currently allocates €7.5 billion for measures aimed at making France the leading innovative and sovereign European country in healthcare.

The Health Innovation Plan 2030 has a particular focus on biotherapies, digital health, emerging infectious diseases and medical technologies. The idea is to encourage breakthrough innovations in biomedical research, MedTech and e-health, by facilitating the growth of promising start-ups in these sectors, by training the talents of tomorrow, and by simplifying administrative procedures to encourage clinical research in France, for “medicine that is more predictive, more preventive, and more innovative.”