Non-binding Guidance: European Life Sciences Regulatory Trends with Dr. Lincoln Tsang

This installation of Ropes & Gray’s podcast series Non-binding Guidance introduces Dr. Lincoln Tsang, a new Ropes & Gray lateral partner based in London, and head of the firm’s European life sciences practice. Join Greg Levine, partner and chair of the life sciences regulatory and compliance practice at Ropes & Gray, as he interviews and explores Lincoln’s unique career path as well as Lincoln’s thoughts on Brexit and other regulatory developments that may affect the life sciences industry in the UK and Europe in the coming years.

Transcript:

Greg Levine: Hi, I'm Greg Levine, a partner and chair of the life sciences regulatory and compliance practice group at Ropes & Gray. Welcome to Non-binding Guidance, a podcast series from Ropes & Gray focused on current trends in FDA regulatory law as well as other important developments affecting the life sciences industry. I'm here today with my colleague, Lincoln Tsang, a new Ropes & Gray partner based in London, and head of our European life sciences practice. Lincoln, you and I have known each other for more than 15 years and I'm just absolutely thrilled that you have joined the firm and so excited to have you on our podcast today and to introduce you to our podcast audience. On today's podcast, we'll talk about your career path as well as your thoughts on the effects of Brexit and other developments that are happening in the UK and in Europe. Why don't we start with you telling us a little bit about your background?

Lincoln Tsang: Thank you, Greg. It is a pleasure to be part of the Ropes & Gray family, and it's good to reconnect with you and work with you as a colleague again. My original training was in pharmacy, toxicology and cancer pharmacology, focusing on new molecular targets for new anti-cancer drugs. Early in my career, I worked in the National Health Service in the UK. I spent nearly 13 years with the UK regulator authority—the Medicines & Healthcare Products Regulatory Authority—and I was appointed to be head of biologicals and biotechnology with the responsibility of overseeing the safety, quality and efficacy of all biological products marketed in the UK as well as, at that time, the European Union, such as vaccines, blood products and biotech products. I was also involved in a number of key national vaccine immunization programs and certain high-profile public health matters, including my involvement in the BSE inquiry, and vaccine and blood product safety. And during my tenure with the UK agency, I was appointed by the UK government to serve as an advisor to the European Medicines Agency, the European Commission, the European Council, the Council of Europe and the World Health Organization in a number of legislative and public policy matters. I worked briefly on secondment to the government legal services involved in legislative drafting, policy and litigation. And I spent nearly 18 years—a little over 18 years, in fact—with another international law firm based in London, where I practiced as a partner specializing in matters concerning regulatory compliance enforcement and litigation as well as market access.

Greg Levine: That's quite an impressive background, and obviously shows why we're so excited to have you bring that experience and expertise, and the breadth and depth of that expertise, to Ropes & Gray. You had quite an extensive and successful career in government, and now you've been in the private legal practice for quite some time. How would you say your background, both in government and working in a private law firm, informs the way you practice?

Lincoln Tsang: I've worked in this area, in this sector, for over 30 years now. The experience I've gained over the last 30+ years in the public and private sector, certainly from my perspective, has shaped the way I practice law as well as public policy matters, and also sharpened my ability to deal with novel, cutting-edge regulatory legal issues, and issues that will be of importance to clients handling commercially-sensitive matters. Those issues include the way we manage crisis and manage risks relating to regulatory compliance, the way we strategize, regulatory approval process and how we learn to craft, for example, the terms of the conditions of use. In Europe, there's a document called Summary of Product Characteristics—it’s a quite important document because the conditions set out in the SmPC will have tremendous impact on the way you determine how you are going to get the market access approval downstream, and negotiate with the health technology authorities based on your determination of the product profile, the therapeutic position, and for you to negotiate the price for the purpose of market access.. So I think that, certainly from my perspective, and in discussion with clients, they've found it beneficial to have my insight to gauge the attitude of the regulators as well as policymakers to provide, most importantly, practical solutions for some business sensitive legal questions.

Greg Levine: Thanks, Lincoln. Yes, we can see how that could be of tremendous value to clients. And I know you've also continued to maintain contacts with government officials throughout Europe and the UK, so quite a value to clients. Let's turn to talk a little bit about Brexit. This has been quite a drama, looking at it from the outside, from our side of the Atlantic. I guess the original vote was in 2016. It's been almost five years now, and there seems to have been a lot of uncertainty and back and forth on how things were going to look. And in the end, I guess the biggest question from my perspective and our clients has been, "How different will things be once Brexit is fully resolved versus what was in effect before?” So could you enlighten us on what's happening there, how things are currently and how you think this plays out now?

Lincoln Tsang: Since the early referendum in the UK, I was heavily involved in the preparation for Brexit and representing the industry and trade associations to ensure business continuity. And also at the same time, I still continued to serve as an advisor to the UK government as well, so I have my own perspective about Brexit. I think that you're right in pointing out the effect and the impact of Brexit—it has caused widespread disruption, as one may characterize that, in terms of the relationship between the UK and the EU regulatory systems. But hearing what the UK government has done, and also hearing what MHRA (the UK authorities) has published, I think that the overall effect is that the UK departure from Europe will become a catalyst for change in the UK in the way that the agency, as well as the UK government, will have to deal with medicines and medical devices and how they will be regulated under the single body of the MHRA. Obviously, the UK government and the MHRA would like to focus on a smooth transition or transfer to the new system, as the UK MHRA becomes a standalone regulatory authority, severing the tie with the European Union.

At the same time, I think Brexit gives the UK government an agency to take a fresher look, a more fundamental examination of the principles on which medicines' regulation, and also regulation of medical devices, will be based in the future. You might have already heard most recently, the Parliament has passed a new piece of legislation, Medicines and Medical Devices Act. Essentially, the Act will give the UK ministers and the UK government the ability to promote innovation, reflecting the policy already published by the UK government to focus on the life sciences sector as an important business pillar in the UK, following the publication of the life sciences sectors strategy review. And one particular element that I can glean from various publications from the UK government as well as from the UK regulatory authorities, including the health technology authorities such as NICE, is that a greater focus is now placed on a patient's voice at the very heart of regulation and market access, in the area of clinical trials, product development or safety monitoring. And there's quite a big shift in terms of how we regulate medicines and medical devices or any health care products in the UK.

Now obviously, with the recent event of the COVID pandemic, the impact of COVID-19 cannot be underestimated in terms of how the UK will have to initiate regulatory transformation, to make risk-proportionate, scientific judgments in the context of COVID-19, particularly in relation to how they can respond more positively in relation to new therapeutics and new diagnostics for them to introduce into the national health system. And I think that the MHRA should be praised for what they have done in a very positive and responsive manner to initiate essentially rolling regulatory review, to allow the first vaccine to be introduced in the UK, the Pfizer vaccine, which was in collaboration with the BioNTech manufacturer in Germany. And if you look at the most recent uptake figure from the UK, we have vaccinated over 53% of the UK population, and with a significant reduction in the COVID infections across the UK. So that is a very significant shift in terms of the way we regulate and the way we introduce new medicines and therapeutics post-Brexit and also post-COVID-19 pandemic.

Greg Levine: Very interesting. Some of those trends like the increased focus on patient voice and the lessons from the COVID-19 pandemic are also things that are heavily on the minds of the FDA and those of us who work with FDA-regulated entities over here as well.

Lincoln Tsang: One important element that I think is important to note is that since January 2021, the UK MHRA has introduced a new pathway to speed up approval and also market access of innovative medicines. The pathway is called the Innovative Licensing and Access Pathway. The pathway is actually a quite interesting system for people to consider because this is the first time that the UK regulatory authority will create a new process for it to work more closely in collaboration with bodies responsible for determining market access conditions, such as the National Institute for Clinical Care and Excellence, so-called NICE, and the National Health Service, in order to ensure that there is convergency in relation to how to develop a process and a pathway for new innovative therapeutics to be introduced in a timely manner. So there would be greater use of the same dataset as agreed with the MHRA through this innovative regulatory pathway, to allow this same dataset to determine the market access conditions and also to guide the market access agreement and in what circumstances products can be used within the National Health Service, to benefit, most importantly, patients and public health.

Greg Levine: That sounds like quite an interesting program. The FDA as well has been developing a variety of programs, both on the drug-side and as well as devices, to try to facilitate the path to market for innovative products, and also to some extent, to try to coordinate that with some of the payment reimbursement systems. But obviously, a lot that regulators across the globe potentially can learn from each other and try to bring the most innovative thinking and the things that work, and figure out what works best and try to coordinate that over time.

Lincoln Tsang: I agree with you—I think that that is a very important aspect. Over the last two or three decades, in increasing international collaboration amongst regulatory bodies resulted in the creation of the International Council for Harmonisation paved a way for a greater collaboration and coordination in many public health issues. I probably see that this trend will continue in the forthcoming years and months, and I think that there's so much that we can learn from each other.

Greg Levine: So how about we turn now to talk a little bit about Europe. The European Medicines Agency, in particular, already relocated some time ago from the UK to the Netherlands, to continental Europe. But that one change aside, how would you describe what's happening with the life sciences sector in Europe, its regulation and just any new key trends that you think are worth highlighting?

Lincoln Tsang: The way I would characterize it is that the life sciences, itself, has always been the focus of the European legislatures, policymakers such as the European Commission, and the national governments across all 27 member states. Since 2002, when the European Commission first developed a White Paper focusing on the debate on how to make Europe an attractive place to invest in so far as the life sciences sector is concerned, the European legislature and the national governments have all agreed that life sciences should be considered the next wave of a knowledge economy, and most importantly, that the sector would create opportunities for economic growth and improvement in the health outcomes. And at the same time, I think that Europe, by comparison, is probably the second-largest regional economy for the health care sector, and we see a lot of transformation or change within the sector. Globally, medical technology, data, digital technologies are informing and changing the sector itself. And that's a growing area—medtech, digital health itself as an element, which is now the largest medtech segment, and artificial intelligence is increasingly becoming the focal point of debate amongst the legislatures.

The growth in AI has now increased by double digits, for example, in the UK in the last four to five years. And if you look at the way we regulate our medicines in Europe over the last 10 years, the therapeutic drugs being reviewed by the European Medicines Agency are largely biological and biotech products. Increasingly for the last five years, we’ve seen increasing number of applications being filed for so-called advanced therapies, including gene and cell therapies as well as tissue-engineered products, which will revolutionize the way we treat our patients. At the same time, we are focusing a lot more on personalized, individualized therapies by developing more targeted therapies, coupling drugs or biologics with companion diagnostics. All those endeavors will change the way we manage patients. And I think in Europe as a whole, and the European agency, will have to respond quite positively to those external changes and the external environments to make the European system a lot more regionally competitive and responsive to changes.

I think this conversation's very timely because most recently, the European Commission and the European legislature published a road map, which will shape the way that medicines' regulation will be developed in the next five years. Most likely that there will be some potential changes in relation to the regulatory structure, to make it more agile, more responsive to innovation. One particular element which has created some problems in terms of introducing novel therapeutics into the National Health System is disparity in the market access environment across all 27 member states. And this is one area that the European Commission is very keen to revisit and seeking to harmonize the health technology appraisal process, especially in terms of the dataset underpinning the cost-effectiveness assessment. So there's going to be a lot of changes within the European system. And the agency has already set a number of priorities, focusing not only on better protection of public health and animal health, but also how can make the regulatory environment be more agile to adapt to external environmental changes.

Greg Levine: Yes, it's really interesting to hear your perspective on that, the European perspective and UK. Over here as well, change is happening at a pace that's really mind-boggling with digital health, with personalized medicine, companion diagnostics, and now companion diagnostics themselves involve digital health and artificial intelligence and machine learning. The regulatory systems and statutes and regulations really were not set up with those kinds of things in mind, right? So the ability to be flexible and adapt and even stay on top of these, the knowledge of the technology and what's happening, is quite a challenge.

Lincoln Tsang: Yes, you are right about the need to adapt and innovate in order to respond to those technological innovations and public health challenges. The legislation does not always keep in pace with speed of innovation and science and technology. This is a real challenge for this highly-regulated sector. In addition, the COVID-19 pandemic is placing enormous pressure on the global health sector’s workforce, infrastructure, supply chain, and exposing social inequities in health and care. COVID-19 is also accelerating change across the sector’s ecosystem and forcing public and private health systems to adapt and innovate in a very short period. A number of basic shifts are arising from and being exacerbated by COVID. For example, consumers’ increasing involvement in health care decision-making; the rapid adoption of virtual health and other digital innovations; the push for interoperable data and data analytics use; and unprecedented public private collaborations in vaccine and therapeutics development. Among those dynamics, governments, health care professionals and providers, payers, and other stakeholders around the globe are being challenged to quickly pivot, adapt, and innovate. It strikes me agility is the key.

Greg Levine: Yes. Well, I could talk to you for hours, Lincoln, and I'm sure we will talk for hours. And I think we'll have many more opportunities to talk about developments in the United States and Europe, and in Asia and China with our colleague, Katherine Wang. I look forward to having so many more chances to serve our clients. As you know, since you've joined us, only not so many weeks ago, the demand for the kind of cross-border regulatory understanding is absolutely tremendous. So, we'll spend many more hours on these issues, but for today's podcast, I think we'll have to bring it to a close. Thank you so much, Lincoln, for taking the time. And I'm just so excited that you joined the firm.

Lincoln Tsang: Thank you very much for having me, and it is a privilege here to work with you again and also with our colleagues.

Greg Levine: Thank you very much, Lincoln. And thank you to your listeners. For more information on the topics that we've discussed today, please visit our website at www.ropesgray.com. And, of course, if we can help you navigate any of these topics, please don't hesitate to get in touch with us. You can also subscribe to this podcast series wherever you regularly listen to podcasts, including on Apple and Spotify. Thanks again for listening.