Entries by Dr. Chris Boyle

19 12 '25

EU Pharma Package: Sharp New Tools With Limited Protections

/in , , , , , , , /by

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.

10 12 '25

What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU

/in , , , , , , , , , /by

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.

28 08 '25

EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing

/in , , , , , , /by

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.

07 05 '25

UK Windsor Framework Enters Into Force

/in , , , , , , , /by

Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.

29 10 '24

European Court of Justice Judgment Relating to Orphan Market Exclusivity

/in , , , , , , , , /by

In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.

09 09 '24

Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?

/in , , , /by

The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.

19 03 '24

EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises

/in , , , /by

On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.

26 01 '24

FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients

/in , , , , /by

FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs. Following a consultation period, it is also expected to be implemented in Japan, the EU, and the UK. Chris Fanelli, Dr. Chris Boyle, and Dan Roberts discuss what the new guidance means for animal drug manufacturers.

28 04 '23

The EU’s Pharmaceutical Review Needs To Remain Grounded In Economic Reality

/in , , /by

The Review proposes to reduce IP rights across the board, with incentives to prolong them. Can any of these incentives work? Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou discuss how the real-world effects of the Review have not been assessed, and where there is room for improvement in its critical provisions.