EUCOPE Member Spotlight: Q&A with Hogan Lovells Life Sciences
Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In March, we spoke with Fabien Roy, Partner, Hogan Lovells Life Sciences practice.
Fabien Roy is a partner at Hogan Lovells, a global law firm with more than 15 years of experience advising life sciences clients in the regulation of their medicinal products or medical devices in the EU. Based in Brussels, Fabien follows the new regulations on medical devices (MDR and IVDR) and the GDPR very closely and regularly advises clients on the requirements applicable to their digital health technologies. He is also a qualified lead auditor for ISO 13485 quality management systems.
Tell us about your organisation and its mission and how you drive innovation internally?
At Hogan Lovells, we are dedicated to working with our clients to successfully compete in the life sciences space. Navigating complexities in the life sciences and health care industries can be challenging. With more than 500 life sciences and health care lawyers across the globe, we work closely with clients to offer increasingly creative strategies and integrated solutions that protect and support their business day in and day out.
How do your organisation’s activities help patients now and into the future?
A key aim for our team is to ensure our clients stay ahead of the curve and on top of opportunities. We do this in a variety of ways, including providing bespoke training and regularly writing articles covering key trends and hot topics for Life Sciences & Health Care companies. Our 2023 Horizons guide offers creative strategies for your most promising opportunities and integrated solutions that protect and support your business, with global perspectives from Asia-Pacific, Europe, Latin America and the United States.
Alongside our Horizons guide is a series of regional events that tackle issues shaping the future of the life sciences and health care industry. From spotting trends and innovation, navigating cross-border deals and investments to mitigating regulatory risk and liability, the series will feature informative presentations, cutting-edge analysis, and engaging panel discussions. Our European Horizons event covering key industry updates will take place on 28 June in Zurich, Switzerland.
What do you see as the biggest challenge facing the life sciences industry today?
The digitalization trend that began before the pandemic continues at a lightning pace, driving innovations in AI, virtual health solutions, clinical trials, telehealth products, and related cybersecurity measures, and raises questions on how to appropriately access patient health data and how best to manage social media. Information technology, big data, and AI/ML can be used to collect, share, analyse, and use data to enable health care professionals (HCPs) to make informed decisions and improve health care, and has a great potential for net benefit on patients and society. While these technologies often struggle to fit within existing frameworks (and borders), this has not stopped regulatory authorities from taking notice.
What are the major health policy issues and themes that you are most focused on in 2023?
Continuing with this theme, we expect that innovative products and approaches, especially those in digital health, will continue to provide opportunities within evolving regulatory frameworks that are as complex as their underlying technologies. Digital health – including e-health, telehealth, electronic patient records, remote monitoring, connected devices, digital therapeutics, and the like – are now involved at every stage of the medicinal product and medical device development life cycle and application of these technologies has a profound impact on the relationships between industry, patients, HCPs, health institutions, and regulators.
Specifically in 2023, stakeholders should closely monitor the implementation of a number of recent legislative and policy framework developments for the impact that these will have on their operations. These include (1) the MDR/IVDR amendments (Regulations (EU) 2017/745 and (EU) 2017/746) regarding transitional provisions relevant to the conformity assessment of devices placed on the EU market, as well as (2) the data privacy and cybersecurity impacts of the NIS2 Directive, which regards the manufacture of medical devices and in vitro diagnostic devices as a “critical sector” under the Directive.
We also see particular challenges and opportunities for pharmaceutical companies seeking to enter this space. Implementing digital health technologies requires a nuanced view of, amongst others, the regulatory and product liability aspects of incorporating digital products and interacting with patients and HCPs in a different way. We are continuing to support pharmaceutical stakeholders who are entering into a space that can often feel very unfamiliar. The release of the proposed revisions to the EU’s regulatory framework for medicinal products will also be a key element to watch in the coming months.
What attracted you to join EUCOPE and how can we help you achieve your business goals?
Hogan Lovells has been a member of EUCOPE for several years. We value the unique opportunity to leverage the EUCOPE network, gain greater awareness of key issues and concerns faced by industry members as well as contributing to the conversations within the industry.
Our corporate membership is accessible to the whole team, members of our team often join and participate in EUCOPE member meetings, working group calls and attend events hosted by EUCOPE. These opportunities also provide a unique insight. This greater awareness and expert insights into EU policies and legislation enables us better serve our clients.