Eversheds Sutherland Nicea’s Madrid-based partner Kiko Carrión says maintaining revenue levels in the face of patent expiration and cheaper competition is an ongoing problem for innovative companies in the pharmaceutical industry
Interview with KIKO CARRIÓN partner, EVERSHEDS SUTHERLAND NICEA
LEADERS LEAGUE: What are the main opportunities for law firms in the area of life sciences and pharmaceuticals?
Kiko Carrión: The life sciences sector encompasses many practice areas and needs advice with an international dimension and therefore experts in each of the different practice areas are required to work together. This created opportunities for different departments within firms. Law firms that are able to join forces with qualified consultants that share a culture, sector knowledge and client-focussed ‘soft skills’ will be the firms that lead the market. The opportunities we are currently seeing relate to the defence of intellectual property, the implementation of rigorous policies regarding health data, patient privacy, and codes of good practice, as well as advice on innovative public procurement. Clients also seek our advice on market access, internal investigations, complex antitrust issues, joint-ventures (including co-marketing and co-promotion agreements), and corporate mergers and acquisitions. Finally, there are also opportunities to advise clients on obtaining authorisations related to their manufacturing activities, importing and distributing medicines and medical devices, and obtaining GMP (Good Manufacturing Practices) certificates.
What are the biggest challenges life sciences and pharmaceuticals clients face in relation to intellectual property?
The big challenge for health companies is the creation, exploitation and protection of intellectual property throughout its life cycle. This includes all forms of intellectual property and associated rights including patents, industrial designs, trademarks, trade secrets, and copyrights. One of the permanent challenges in the innovative health industry is the ability to maintain revenues in the face of patent expiration and cheaper generic and not so cheap biosimilar competition. Another major challenge for the industry is combatting a tendency to reduce protection for intellectual property related to innovations on the basis of arguments including those related to public interest and patient access to medicines and medical devices. Finally, we must mention the need to strengthen the protection of what has been called incremental innovation, which is consistent in the creation of medicines that are highly effective from a preventive and curative perspective due to an unprecedented combination of various active pharmaceutical ingredients.
What impact has the coronavirus pandemic had on your practice?
During the coronavirus pandemic our legal and consulting service for healthcare companies has been greatly strengthened. Firstly, because, during a pandemic, our clients (hospitals, pharmaceutical and healthcare laboratories and medical devices producers) have channelled all their efforts into remedying or at least alleviating the healthcare crisis. Secondly, companies that have never been involved in the health sector before have developed manufacturing processes for products such as personal protective equipment, mechanical ventilation devices, uninterruptable power supplies for use with emergency assisted breathing machines and ventilators and thermal cameras for body temperature detection systems. The arrival of such companies in the market has required our advice on regulatory issues and in-depth analysis of the legal risks. Raising product liability shields has always been a major concern for clients. During the pandemic, the health authorities established many rules applicable to our clients' activity including:
- the promotion of their products
- the occupation of their facilities
- their manufacturing activity and the marketing of medicines and medical devices, as well as the safety and hygiene of their workers
- continuity in the supply of products
- the prevention of shortages.
Finally, our innovative customers have initiated clinical trials and studies related to the application of their medicines, medical devices and medical technologies in the context of Covid-19 – all these situations and initiatives have required urgent legal advice, which has triggered a lot of work for different teams across the firm.
What do you think will be the emerging trends in life sciences and pharmaceuticals over the course of the coming year?
In our daily professional practice we are observing the following trends in the life science and pharmaceutical industry at this time:
a) a notable increase in investment in gene therapies and personalized medicine through advancements in genetics
b) the integration of artificial intelligence (AI) and machine-learning approaches within life sciences is making drug discovery and development more innovative, time-effective, and cost-effective
c) an increasing change in the public procurement process, which requires pharma companies to focus on added value, risk sharing, portfolio agreements and performance and outcome measurement
d) an increase in R&D investment related to infectious diseases and rare diseases
e) collaboration between academic science-driven institutions and pharma, biotech and medical devices companies
f) a significant improvement in digitized medicine, that is, healthcare insurers, healthcare professionals and healthcare organizations will digitalize the prescription of drugs and the assessment, diagnosis and treatment of patients.