HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK. The UK left the European Union (EU) in January 2020 but is...

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5 Questions with a Health Lawyer: Steven J. Schnelle

Steven J. Schnelle Practice Focus Area: Healthcare Office: New York Years at Firm: 2.5 years What is your favorite part about practicing healthcare law at McDermott? Without a doubt, the people! Every day I have the pleasure and honor of working with brilliant and unique colleagues that recognize and appreciate one another’s contributions to our team, both personal and professional. And I’m not just talking about my colleagues with signatures bearing the McDermott logo—our clients are doing amazing things and give us the opportunity every day to engage creatively and collaboratively to make a difference. There’s nothing better than celebrating an achievement with people you care about! What is the biggest opportunity and greatest challenge facing clients in your area of focus today? I think they’re one and the same—the dynamism of the healthcare system in the United States. With constantly evolving laws, regulations, interpretive guidance, enforcement...

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Physician Enterprises After COVID-19: Capturing and Assessing Opportunities

Independent physician enterprises continue to experience unprecedented challenges as a result of the ongoing COVID-19 pandemic. These challenges will linger for the foreseeable future and will have lasting impacts on operations and the provision of care. As a result, transactional opportunities have also shifted, and physician enterprises must be prepared to identify and evaluate new opportunities wherever they may occur. Our recent webinar with leaders from Providence St. Joseph Health, SullivanCotter, DMG Physician Organization, Veralon Partners and Golden State Dermatology explores the key challenges facing physician enterprises at this time and what healthcare providers and investors are looking for in transaction partners for today's healthcare landscape. Click here to listen to the webinar recording and read on for key takeaways from the program.   Independent physician interest in management service organization (MSO) models continues to increase....

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Public Hospital M&A: Know Your Stakeholders

Hospital transactional activity has soared over the last decade, and many public hospitals are evaluating M&A opportunities against the backdrop of the Coronavirus (COVID-19) pandemic. In our previous post on public hospital M&A, we discussed financial pressures on public hospitals, trends driving M&A, and external factors shaping public hospitals’ choices of M&A partners and formats. In this installment, we’ll cover strategies for gaining stakeholder buy-in as hospital board members, senior leaders and advisors move through the transaction process. For a deeper dive into these topics, listen to our podcast, Driving the Deal: Public Hospital M&A and Stakeholder Buy-In. Stakeholders: Who’s Who Public hospital M&A is a team sport. Assessing and advancing a potential deal involves engagement with a wide variety of stakeholders, each with their own perspectives, objectives and priorities. Key players can include elected public officials,...

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5 Questions with a Health Policy Specialist: Rodney L. Whitlock of McDermott+Consulting

Rodney L. Whitlock, Ph.D Vice President, McDermott+Consulting Focus Area: Healthcare Policy Years at M+: 1.5 years What is your favorite part about your health policy work at McDermott+Consulting? Healthcare policy, politics and process is complicated. It is a constant challenge to discern and anticipate the future of healthcare policy for clients. It is the constant intellectual challenge of operating in healthcare policy that I enjoy most about what I do. Specifically, I like that I can bring my 21 years of experience in Congress to my clients, move from subject matter to subject matter and play at a high level. For example, I can go from talking about prescription drugs in the morning then later on in the day dealing with an issue very specific to a client. It’s the challenge of having to be in different spaces at different times of the day that I actually enjoy. What is the biggest opportunity and greatest challenge facing clients in your area of focus...

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What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?

In the second installment of McDermott’s webinar series, HPE Europe 2020: What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?, moderator and McDermott partner Emmanuelle Trombe and industry experts Joseph El Khoury of Natixis, Cédric Garcia of EY’s Life Science Group, Dr. Erich Tauber of Themis Bioscience and Daniel Teper of CYTOVIA Therapeutics shared lessons learned from the first half of 2020, when COVID-19 changed the world. The panelists also discussed the outlook for life sciences transaction trends in the second half of the year and beyond. Kicking off the discussion, Trombe noted, “As the healthcare and life sciences industries came under intense pressure to deliver innovative therapeutics, vaccines, medical devices and other solutions, on the transaction front, the crisis was at the same time having a wide-ranging impact across even the most traditionally resilient subsectors.” Agreed El Khoury, “When it comes to M&A...

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What Impact has Coronavirus had on Doing Healthcare Deals?

In the fifth and final installment of McDermott’s HPE Europe 2020 Summer Webinar Series, McDermott partner Tom Whelan hosted a discussion with Marc Benatar of Apax Partners, Markus Peterseim of Alvarez & Marsal, and fellow McDermott partner Dr. Nikolaus von Jacobs to examine how the Coronavirus (COVID-19) pandemic is affecting deal making in the healthcare industry. Whelan led the group through a wide-ranging conversation centered on five key pandemic deal impact areas: pricing, process, timing, regulation and future prospects. Read on for discussion highlights, and click here to access the full webinar. Pricing “You’ve clearly seen a polarization,” Benatar said. “Nonessential businesses were hit hard by the lockdown effect and remain impacted, while those that were related to essential elements of healthcare were hit but started to experience a catch-up at the beginning of May and are already getting close to the normal run rate volume. I think that...

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What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott partner Dr. Stephan Rau and industry experts Karthic Jayaraman of TPG Capital, Max Müller of Bayer, Ben Faircloth of L.E.K. Consulting and Dr. Ulrich Wandschneider, former CEO of Asklepios AG, currently at Trilantic Capital Partners and Supervisory Board member of BioNTech SE, the Nasdaq-listed developer of COVID vaccine, headquartered in Germany, discussed the impact that COVID-19 and the government measures to address it have had on investments in healthcare and life sciences in Europe. “I think it's about as interesting a time as any in my last 20 years investing,” said Jayaraman. “People are beginning to focus a lot more on innovation, the speed of innovation and how innovation is brought to market. I think the question is, “How can...

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European Healthcare Innovation & Investment in a Post-Pandemic World

As part of McDermott’s HPE Europe 2020: Where Do the Opportunities Exist for Investment in the Healthcare Sector? webinar, McDermott London Managing Partner Hamid Yunis moderated a panel of industry experts including; Dr. Michelle Tempest of Candesic, Dr. Joanne Hackett of IZY Capital, Dr. Charles Niehaus and Professor Karol Sikora of Rutherford Cancer Centres, who collectively shared their perspectives on healthcare innovation and investment in a post-pandemic world. The panelists agreed that COVID-19 has served as a catalyst for change and which has revealed important prospects for the future. “There has been this zest for change which we’ve been talking about for a long period of time, and this has finally been that breakthrough,” said Dr. Tempest. “Both the professionals and the consumers have suddenly woken up to this new dawn.” “What I’ve actually seen in the past couple of months is a lot of innovation that we were really wanting to accelerate are now...

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Top Takeaways: New Steps for Compliance: A Closer Look at the DOJ’s Revised Corporate Compliance Program

The US Department of Justice’s (DOJ) revised compliance program document “The Evaluation of Corporate Compliance Programs,” released June 1, 2020, helps organizations understand how DOJ evaluates compliance programs for effectiveness. Below are the the top takeaways from this revision that you should be aware of. For a deeper dive into this revision, listen to our webinar recording. Three questions the DOJ looks to answer are: Is the corporation’s program well designed? Is the program being applied earnestly and in good faith? (In other words, is the program adequately resourced and empowered to function effectively?) Does the corporation’s program work in practice? Under the June 2020 updates, the DOJ will increase its focus on evaluating how effectively compliance programs are tailored to the organization’s risk profile, including the company’s size, industry, geographic footprint, regulatory landscape and other factors. Compliance programs should...

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