The coming months will be crucial for the so-called “Pharma Package”, the largest revision of EU pharmaceutical law since 1965. So-called “trilogue” negotiations are being held between the European Commission (“Commission”), the European Parliament (“Parliament”) and the Council of the European Union (“Council”), based on documents showing their positions (see draft Pharmaceutical Directive (“PD”) and draft Pharmaceutical Regulation (“PR”) published on 17 June 2025). Will the Pharma Package make the EU more competitive as has been claimed, despite reducing and ‘modulating’ IP rights and regulatory exclusivities? The stakes are high. For one of the proposals being considered (obliging companies to launch in all EU Member States), the stakes have been raised further by the growing risk that the U.S. administration will use prices in certain EU Member States as a “Most Favored Nation” (“MFN”) benchmark for U.S. prices. Maarten Meulenbelt, Josefine Sommer, Chris Boyle and Zina Chatzidimitriadou discuss the EU institutions’ trilogue positions in the context of broader legal, economic and political changes.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24012_FCA-Blog-Imagery-Refresh-B_10.jpg606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2025-08-28 11:28:502025-08-28 15:07:55EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on how life sciences companies can take steps to implement key concepts from the Draft Report.
On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process for U.S.-based drug manufacturing facilities. Notably, the announcement also included information regarding an upcoming public meeting about the PreCheck framework and opportunity to comment and engage with the FDA on the program itself.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24012_FCA-Blog-Imagery-Refresh-B_15.jpg606833James R. Johnsonhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJames R. Johnson2025-08-13 10:16:082025-08-13 10:16:08FDA Launches “PreCheck” Program to Support U.S. Pharmaceutical Manufacturing: What Industry Stakeholders Should Know
GB based Chemical manufacturers or importers that relied on EU REACH registrations to continue marketing their products in Great Britain following Brexit have until 8 September 2025 to respond to a UK Government consultation on proposed revised transitional registration deadlines under UK REACH. Marie Manley and Victoria Kerr explain the background to the consultation, and why stakeholders should consider engaging with it.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2025-07-31 09:48:172025-07-31 09:48:17UK proposes to extend transitional chemical registration deadlines under UK REACH
The European Commission made a lofty commitment in its recently published Life Sciences Strategy to position the EU as the world’s most attractive place for life sciences by 2030. To succeed with this vision, EU lawmakers must ensure that these efforts will truly cut red tape and accelerate innovation rather than simply adding new layers of regulation. They must also ensure that these efforts are not undermined by other legislative changes affecting the EU’s biotech industry.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/07/AdobeStock_508538592-2.jpg330495Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2025-07-28 10:07:032025-08-29 10:44:33Will the EU Become the Most Attractive Place for Life Sciences? How the EU Woos Biotech
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.
The Trump administration’s Executive Order entitled, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” notes a desire to bolster supply chains, enhance national security, and ensure compliance with evolving regulatory frameworks. Nevertheless, the decision to relocate manufacturing operations for U.S. Food and Drug Administration (FDA)-approved drugs is fraught with regulatory obligations – including those administered by the FDA – and strategic considerations that must be thoroughly analyzed.
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EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing
The coming months will be crucial for the so-called “Pharma Package”, the largest revision of EU pharmaceutical law since 1965. So-called “trilogue” negotiations are being held between the European Commission (“Commission”), the European Parliament (“Parliament”) and the Council of the European Union (“Council”), based on documents showing their positions (see draft Pharmaceutical Directive (“PD”) and draft Pharmaceutical Regulation (“PR”) published on 17 June 2025). Will the Pharma Package make the EU more competitive as has been claimed, despite reducing and ‘modulating’ IP rights and regulatory exclusivities? The stakes are high. For one of the proposals being considered (obliging companies to launch in all EU Member States), the stakes have been raised further by the growing risk that the U.S. administration will use prices in certain EU Member States as a “Most Favored Nation” (“MFN”) benchmark for U.S. prices. Maarten Meulenbelt, Josefine Sommer, Chris Boyle and Zina Chatzidimitriadou discuss the EU institutions’ trilogue positions in the context of broader legal, economic and political changes.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Key Steps Toward Using Artificial Intelligence in Pharmacovigilance – Sidley Insights on the Recent CIOMS Draft Report
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on how life sciences companies can take steps to implement key concepts from the Draft Report.
Torrey Cope
Washington, D.C.
tcope@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Andrew James
Washington, D.C.
andrew.james@sidley.com
FDA Launches “PreCheck” Program to Support U.S. Pharmaceutical Manufacturing: What Industry Stakeholders Should Know
On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process for U.S.-based drug manufacturing facilities. Notably, the announcement also included information regarding an upcoming public meeting about the PreCheck framework and opportunity to comment and engage with the FDA on the program itself.
(more…)
James R. Johnson
Washington, D.C.
james.johnson@sidley.com
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Michael Varrone
Washington, D.C.
michael.varrone@sidley.com
Mia R. Harris
Boston
mharris@sidley.com
UK proposes to extend transitional chemical registration deadlines under UK REACH
GB based Chemical manufacturers or importers that relied on EU REACH registrations to continue marketing their products in Great Britain following Brexit have until 8 September 2025 to respond to a UK Government consultation on proposed revised transitional registration deadlines under UK REACH. Marie Manley and Victoria Kerr explain the background to the consultation, and why stakeholders should consider engaging with it.
Maria Isabel Manley
London
mmanley@sidley.com
Victoria Kerr
London
vkerr@sidley.com
Will the EU Become the Most Attractive Place for Life Sciences? How the EU Woos Biotech
The European Commission made a lofty commitment in its recently published Life Sciences Strategy to position the EU as the world’s most attractive place for life sciences by 2030. To succeed with this vision, EU lawmakers must ensure that these efforts will truly cut red tape and accelerate innovation rather than simply adding new layers of regulation. They must also ensure that these efforts are not undermined by other legislative changes affecting the EU’s biotech industry.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Alix Vermulst
Brussels
alix.vermulst@sidley.com
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.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Belinda Baum
Brussels
belinda.baum@sidley.com
On-shoring Pharmaceutical Manufacturing: Navigating Regulatory Obligations and Strategic Considerations
The Trump administration’s Executive Order entitled, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” notes a desire to bolster supply chains, enhance national security, and ensure compliance with evolving regulatory frameworks. Nevertheless, the decision to relocate manufacturing operations for U.S. Food and Drug Administration (FDA)-approved drugs is fraught with regulatory obligations – including those administered by the FDA – and strategic considerations that must be thoroughly analyzed.
Michael Varrone
Washington, D.C.
michael.varrone@sidley.com
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