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.
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.
EU Critical Medicines Act Seeks to Enhance Supply and Access Requirements
The European Commission has proposed a new Critical Medicines Act aimed at reinforcing the security of supply and ensuring the availability of critical medicines and medicines of common interest across the EU. The Act introduces new obligations for pharmaceutical companies such as enhanced supply chain transparency, mandatory stockpiling, and regular reporting obligations. At the same time, it creates opportunities for investment and funding to expand EU-based manufacturing, diversify supply chains, and foster innovation. By shifting procurement practices to include award criteria beyond price considerations by prioritizing quality, supply security, and EU production, the Act aims to address vulnerabilities in the current supply system and reduce reliance on third countries. However, to avoid becoming another layer of red tape for industry, a final Critical Medicines Act must carefully balance new regulatory requirements with the need to maintain competitiveness and support a resilient, innovative pharmaceutical sector.
UK Life Sciences Sector Boosted By Raft Of New Policy Measures
A new policy document from the U.K. Government makes the life sciences sector a major focus for changes aimed at facilitating industrial growth. Marie Manley and Dr. Kwabena Tenkorang explain the relevant proposed changes, including reforms to speed up clinical trials, regulatory reforms, the introduction of low-friction procurement and the creation of a Health Data Research Service.
U.S. Executive Orders Shine Spotlight on India’s Life Sciences Industry
Three recent U.S. Executive Orders have significant consequences for India with its outsized role in global generic drug supply. The policy changes offer both opportunity and increased scrutiny for Indian drug manufacturers. Arif Noorani and Ryan Tan discuss proactive steps manufacturers can take.
As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare
The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.
How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law
Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andrew Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law.
Impact Of Inflation Reduction Act On Drug Development For U.S. Market
The U.S. Inflation Reduction Act (IRA) is reshaping the commercial landscape for drug development, with smaller biotechs and investors in particular thinking hard about how to adapt to the new environment. Meena Datta explains the challenges posed to the biopharma industry by the IRA.