The Debevoise Healthcare & Life Sciences Group employs a highly coordinated, multidisciplinary approach to address transactional, litigation and intellectual property matters for leading healthcare & life sciences companies and for private equity firms investing in the industry. The team provides integrated, cross practice legal advice with efficient and seamless execution covering all aspects of healthcare & life sciences matters, including corporate and M&A, litigation and compliance, FDA/FTC regulatory, intellectual property, including licensing and collaboration agreements, and cyber security & data privacy. This approach offers clients a “one-stop-shop” for healthcare and life sciences across nearly all subsectors and stages of the industry lifecycle. The practice’s lawyers are knowledgeable about the issues faced by companies operating and investing in the sector, which enables the Group to develop comprehensive and commercial strategies and solutions.
The Group draws from a broad array of practices throughout the firm, leveraging its experience in private equity, M&A, finance, capital markets, restructuring, litigation, government and regulatory investigations, tax, intellectual property and antitrust, among others. It is well versed in the increasingly global issues facing healthcare & life sciences clients and is well positioned to address those issues through the sophisticated capabilities of the firm’s offices around the world.
The team handles significant transactions and regulatory and litigation matters in a wide variety of areas for pharmaceutical companies, hospitals, medical device manufacturers, financial sponsors, financial advisors and other key players in the industry. The Group’s transactional work includes mergers and acquisitions, financings, securities offerings, licensing, development and commercialization transactions, while its litigation work spans investigations by U.S. government agencies, “bet-the-company” defense work, compliance with U.S. regulatory requirements and defense of intellectual property rights.
The changes contemplated by the Biden administration are sure to have significant implications for every sector of the healthcare & life sciences industry. We will be closely following these developments and providing you with the information you need to stay abreast of coming changes.
10 May 2024 DEA Proposes to Reschedule Marijuana, but Impact for Financial Services Likely Limited Following an August 2023 recommendation from the Department of Health and Human Services (“HHS”), the Drug Enforcement Administration (“DEA”) reportedly will seek to reclassify marijuana from Schedule I of the federal Controlled Substances Act (the “CSA”) to Schedule III, which would recognize the use of marijuana for medical purposes. Read more. >
23 February 2024 California Lawmakers Target Private Equity and Hedge Fund Investment in Healthcare Facilities On February 16, 2024, California Assemblymember Jim Wood introduced a draft bill that specifically targets private equity and hedge fund investment, ownership and management of healthcare facilities in the state (“AB 3129” or the “Proposed Bill”). Expanding upon Assemblymember Wood’s previously introduced bill, AB 977 (which failed to pass at the end of the 2020 legislative session), AB 3129 would give the California Attorney General (“AG”) approval power over an acquisition by or change of control involving (i) a “Private Equity Group” or “Hedge Fund” and (ii) a “Health Care Facility” or “Provider Group” doing business in California. The Proposed Bill also appears to limit the ability of such entities to engage in practice management. The Proposed Bill discriminates against private equity and hedge funds by imposing substantial restrictions on their ability to invest while imposing no such restrictions on competing investors. If passed by the California legislature by the end of September 2024, the Proposed Bill would go into effect on January 1, 2025, providing very limited opportunity for existing investors to exit the market. Thus, AB 3129’s proposed expansion of the AG’s review and approval power to include for-profit healthcare entities could have a meaningful chilling effect on the California healthcare market. Read more. >
19 January 2024 Chevron Under Fire: What Healthcare and Life Sciences Investors Should Know Investors in heavily regulated business sectors—particularly healthcare and life sciences—should carefully monitor several Supreme Court opinions that may make it easier for private parties to challenge federal regulations and regulatory actions in federal court. The Supreme Court heard oral arguments for these cases on January 17, 2024 and is expected to issue an opinion by this summer. Read more. >
12 January 2024 California’s Office of Health Care Affordability Finalizes Health Care Transaction Notice Regulations New California regulations went live on January 1, 2024, requiring notice in connection with health care transactions, and effectively establishing pre-closing waiting periods of up to 38 weeks. California’s Office of Health Care Affordability (“OHCA” or the “Office”) has begun its mandate to (i) collect and report data informative to the legislature and the public regarding health care expenditures and cost trends in the state and (ii) develop data-informed policies and enforceable cost targets to improve health care services. After multiple rounds of draft regulations and solicitation of public feedback from interested stakeholders, the California Office of Administrative Law approved OHCA’s regulations (the “final regulations”) on December 18, 2023. The final regulations require “health care entities” to notify OHCA of “material change transactions” at least 90 days before closing; OHCA began receiving transaction notices on January 1, 2024, for transactions closing on or after April 1, 2024. Read more. >
4 January 2024 Top 10 Healthcare and Life Sciences Issues to Watch in 2024 Throughout 2023, industry stakeholders contended with growing economic and financial uncertainties, heightened state and federal enforcement efforts and an increasingly complex regulatory environment. These challenges are likely to continue in 2024, and stakeholders that proactively address such challenges will be best positioned to manage risk in an uncertain market. In this article, we summarize some of the most notable developments expected to impact healthcare and life sciences in the coming year. Read more. >