The European Health Data Space Regulation (EHDS Regulation) took effect on March 26, 2025. Most of its secondary use provisions will apply from March 2029, and implementation at EU and Member State level will have to take place between 2027 and 2035. Health data represents over 30% of the world’s data assets, yet less than 3% is utilized for secondary purposes such as research, regulatory, or public health purposes, a persistent “data-to-value” gap. This update examines how the EHDS Regulation seeks to close that gap by introducing a more prescriptive legal framework for access to health data for (certain) secondary use purposes whilst still aligning with requirements under EU privacy law; and what life sciences companies should be doing now to anticipate such secondary use obligations, data access requests, and opportunities.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2026-04-14 03:00:092026-04-14 10:12:15Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR
Earnouts are a common feature of life sciences deals, and a 2024 Chancery Court decision had increased the financial risk for buyers agreeing to an earnout. However, the Delaware Supreme Court’s partial reversal of Johnson & Johnson v. Fortis Advisors LLC has addressed this issue by limiting the application of the implied covenant of good faith and fair dealing.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24014_GoodLifeSci-Blog-Imagery-Refresh18.jpg606833Sharon Flanaganhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSharon Flanagan2026-01-27 10:55:582026-02-03 12:07:10Delaware Supreme Court Makes Earnouts Less Risky For Buyers Earnout Decision Partially Reversed Because Buyer Did Not Have to Pursue an Alternative Regulatory Pathway
Last week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical legislation, most significantly the introduction of new launch and supply obligations with only limited safeguards and a reduction and modulation of regulatory data protection and market protection, requiring companies to re-think their pipeline strategies. The provisional agreement now needs to be endorsed by both the Council and the Parliament before being formally adopted and entering into force upon publication in the Official Journal of the European Union. The final text is expected to become available in the coming weeks.
Federal drug pricing pressures intensified in 2025 with the second Trump administration. This Update reviews the year’s pivotal shifts and outlines what manufacturers should expect as they prepare for a more complex 2026.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24014_GoodLifeSci-Blog-Imagery-Refresh11.jpg606833Meenakshi Dattahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeenakshi Datta2025-12-12 11:11:252025-12-12 11:11:25U.S. Drug Pricing Year in Review: Reflections on 2025 and Getting Ready for 2026
The new U.S.–UK agreement in principle on pharmaceutical pricing offers more than tariff relief and adjusted UK drug pricing and reimbursement measures – it provides an early window into how U.S. Most Favored Nation (MFN) policies may interact with UK and EU policy to shape drug pricing, launch strategies, and investment across Europe. Sidley’s transatlantic team breaks down what this means for manufacturers and explains why the continued focus on MFN and other drug pricing policy initiatives that is anticipated through the first half of 2026 is likely to be of major significance to manufacturers both in the U.S. and in Europe.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2025-12-10 11:08:362025-12-10 11:11:42What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU
As global markets continue to contend with a complex mix of macroeconomic pressures, development-stage biotech companies are being urged to proactively strengthen their financial resilience. The ability to anticipate and respond to liquidity challenges has become a defining factor in determining which companies emerge from this period of volatility with momentum and stability.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24014_GoodLifeSci-Blog-Imagery-Refresh29.jpg606833Sam Newmanhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSam Newman2025-11-18 09:03:522025-11-18 09:55:19Navigating an Uncertain Market Amidst Cautious Optimism: Steps Biotech Companies Can Take to Hedge Against Financial Fluctuations
On September 5, 2025, the U.S. Securities and Exchange Commission (SEC) announced a US$1.25 million settlement with biopharmaceutical company, FibroGen, Inc. (FibroGen), finding that FibroGen made false and misleading statements regarding the results of cardiovascular safety analyses of FibroGen’s anemia drug candidate, Roxadustat.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Lara Mehrabanhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngLara Mehraban2025-10-29 09:03:292025-10-28 15:49:10SEC Remains Focused on Public Disclosures Made By Life Sciences Companies
Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR
The European Health Data Space Regulation (EHDS Regulation) took effect on March 26, 2025. Most of its secondary use provisions will apply from March 2029, and implementation at EU and Member State level will have to take place between 2027 and 2035. Health data represents over 30% of the world’s data assets, yet less than 3% is utilized for secondary purposes such as research, regulatory, or public health purposes, a persistent “data-to-value” gap. This update examines how the EHDS Regulation seeks to close that gap by introducing a more prescriptive legal framework for access to health data for (certain) secondary use purposes whilst still aligning with requirements under EU privacy law; and what life sciences companies should be doing now to anticipate such secondary use obligations, data access requests, and opportunities.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Francesca Blythe
London
fblythe@sidley.com
Eleanor Dodding
London
edodding@sidley.com
Belinda Baum
Brussels
belinda.baum@sidley.com
Delaware Supreme Court Makes Earnouts Less Risky For Buyers
Earnout Decision Partially Reversed Because Buyer Did Not Have to Pursue an Alternative Regulatory Pathway
Earnouts are a common feature of life sciences deals, and a 2024 Chancery Court decision had increased the financial risk for buyers agreeing to an earnout. However, the Delaware Supreme Court’s partial reversal of Johnson & Johnson v. Fortis Advisors LLC has addressed this issue by limiting the application of the implied covenant of good faith and fair dealing.
(more…)
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
Sally Wagner Partin
San Francisco, Palo Alto
swagnerpartin@sidley.com
Sacha Jamal
Knowledge Management Lawyer
sjamal@sidley.com
Earnout Decision Partially Reversed Because Buyer Did Not Have to Pursue an Alternative Regulatory Pathway
EU Pharma Package: Sharp New Tools With Limited Protections
Last week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical legislation, most significantly the introduction of new launch and supply obligations with only limited safeguards and a reduction and modulation of regulatory data protection and market protection, requiring companies to re-think their pipeline strategies. The provisional agreement now needs to be endorsed by both the Council and the Parliament before being formally adopted and entering into force upon publication in the Official Journal of the European Union. The final text is expected to become available in the coming weeks.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Anne Robert
Brussels
arobert@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Alix Vermulst
Brussels
alix.vermulst@sidley.com
U.S. Drug Pricing Year in Review: Reflections on 2025 and Getting Ready for 2026
Federal drug pricing pressures intensified in 2025 with the second Trump administration. This Update reviews the year’s pivotal shifts and outlines what manufacturers should expect as they prepare for a more complex 2026.
Meenakshi Datta
Chicago
mdatta@sidley.com
Steve Komorek
Century City
skomorek@sidley.com
What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU
The new U.S.–UK agreement in principle on pharmaceutical pricing offers more than tariff relief and adjusted UK drug pricing and reimbursement measures – it provides an early window into how U.S. Most Favored Nation (MFN) policies may interact with UK and EU policy to shape drug pricing, launch strategies, and investment across Europe. Sidley’s transatlantic team breaks down what this means for manufacturers and explains why the continued focus on MFN and other drug pricing policy initiatives that is anticipated through the first half of 2026 is likely to be of major significance to manufacturers both in the U.S. and in Europe.
Dr. Chris Boyle
London
cboyle@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Navigating an Uncertain Market Amidst Cautious Optimism: Steps Biotech Companies Can Take to Hedge Against Financial Fluctuations
As global markets continue to contend with a complex mix of macroeconomic pressures, development-stage biotech companies are being urged to proactively strengthen their financial resilience. The ability to anticipate and respond to liquidity challenges has become a defining factor in determining which companies emerge from this period of volatility with momentum and stability.
(more…)
Sam Newman
Century City
sam.newman@sidley.com
SEC Remains Focused on Public Disclosures Made By Life Sciences Companies
On September 5, 2025, the U.S. Securities and Exchange Commission (SEC) announced a US$1.25 million settlement with biopharmaceutical company, FibroGen, Inc. (FibroGen), finding that FibroGen made false and misleading statements regarding the results of cardiovascular safety analyses of FibroGen’s anemia drug candidate, Roxadustat.
Lara Mehraban
New York
lmehraban@sidley.com
Ike Adams
Washington, D.C.
iadams@sidley.com
Martha O. Tabor
New York
martha.tabor@sidley.com
Ada G. Dovell
New York
adovell@sidley.com
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