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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Maria Isabel Manley
London
mmanley@sidley.com
George Herring
Private Equity Investors’ Attitudes Towards Healthcare AI Investment Opportunities
Sidley’s Chad Ehrenkranz and UK-based U.S. investor Chris Yoshida consider which AI-based healthcare applications are of most interest to private equity investors, and the way in which healthcare AI lies in a desirable spot between startups and government uses of AI.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Chad Ehrenkranz
New York, Miami
chad.ehrenkranz@sidley.com
New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Maria Isabel Manley
London
mmanley@sidley.com
Dr. Alexandra Anna Theochari
Trainee Solicitor
atheochari@sidley.com
EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Chinese Parties to International Licensing Deals Should Consider How Terms Translate
Licensing deals are still relatively new in China compared to the United States and Europe. Tom Duley and Ruchun Ji explain why this means Chinese parties need to be careful about the history of terms and the choice of governing law and arbitration venue when negotiating contracts.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Thomas Duley
San Francisco
tduley@sidley.com
Ruchun Ji
Beijing, Palo Alto
rji@sidley.com
Points To Check When Selling Food Supplements Outside The U.S.
Major U.S. companies are expanding their vitamins, minerals, and botanicals businesses into Europe. Diane McEnroe, Anna-Shari Melin, and Nadja Schwarz explain what to consider in relation to formulation, labelling, and marketing language when targeting this market.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Diane C. McEnroe
New York
dmcenroe@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Nadja Schwarz
Munich
nadja.schwarz@sidley.com
Deal Outlook for 2024 Includes GLP-1 Investments, APAC M&A, and More Spinoffs
Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
Stephen Abreu
San Francisco
sabreu@sidley.com
Robert Darwin
London
rdarwin@sidley.com
Ruchun Ji
Beijing, Palo Alto
rji@sidley.com
Carlton Fleming
San Francisco, Palo Alto
cfleming@sidley.com
Frank Rahmani
Palo Alto, San Francisco
frahmani@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Emily Marden
San Francisco
emarden@sidley.com
Torrey Cope
Washington, D.C.
tcope@sidley.com
Life Sciences Companies with Operations in EU Could Be Affected by ESG Law
EU member states are beginning to implement EU environmental, social, and governance (ESG) legislation into national law, meaning life sciences companies will need to look at its impact on their global supply chains, including for APIs. Michele Tagliaferri, Anna-Shari Melin, and Nadja Schwarz explain.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Nadja Schwarz
Munich
nadja.schwarz@sidley.com
FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Daniel J. Roberts
San Francisco
droberts@sidley.com
Beyond Technology: Embracing Blockchain for a Paradigm Shift in Life Sciences
Blockchain is not only the preserve of the fintech industry, but may have multiple uses for life sciences companies, including providing a consent structure for clinical trials to give enhanced patients more control over their own data. Sidley’s Eva von Mühlenen and Daniel Fritz, executive director of the PharmaLedger Association, explain.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com