On 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. Here, initial impressions of the biggest surprises in the document are given by Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou.
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.
Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review
Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.
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
Maria-Oraiozili Koutsoupia
The CJEU Provides Further Clarity on the Application of the Global Marketing Authorisation Concept
On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment[1] for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.
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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
Victoria Kerr
London
vkerr@sidley.com
Four Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain
The UK veterinary medicines industry needs to respond by March 31 to a consultation on proposed changes to the UK Veterinary Medicines Regulations which could boost data protection for regulatory submissions, incentivising innovation. However, companies need to be wary of potential increases in regulatory burden in other areas. Chris Boyle explains.
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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.
Dr. Chris Boyle
London
cboyle@sidley.com
A Challenging Regulatory Environment Means More Care Needed with FDA Submissions
In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions.
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.
Torrey Cope
Washington, D.C.
tcope@sidley.com
The Windsor Framework’s Implications for Pharmaceutical Companies
The original agreement for the UK’s withdrawal from the EU affected the availability of medicines in Northern Ireland and created issues for importers of medicinal products. The new ‘Windsor Framework’ is better for the industry, as Marie Manley and Bronwyn Tonelli 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.
Maria Isabel Manley
London
mmanley@sidley.com
Bronwyn Tonelli
Trainee Solicitor
btonelli@sidley.com
Healthcare Providers Laud Remote Monitoring as Medicare Contractors Look Forward
This week, U.S. healthcare providers met with a Medicare reimbursement panel to discuss remote patient monitoring, remote therapeutic monitoring, and considerations for determining reimbursement. Jon Zucker, Meenakshi Datta, and Sama Kahook analyze some key themes.
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.
Meenakshi Datta
Chicago
mdatta@sidley.com
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Sama E. Kahook
Washington, D.C.
skahook@sidley.com
Consultations On EU’s New Law Aimed At Boosting Novel Animal Medicines
One year after the EU Veterinary Medicines Regulation (VMR) came into force, novel medicine developers have an important opportunity to shape its implementation. Chris Boyle and Bronwyn Tonelli look at what’s at stake for an industry which is embracing technological advancement, but which faces twice the administrative burden of the human medicine industry.
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.
Dr. Chris Boyle
London
cboyle@sidley.com
Bronwyn Tonelli
Trainee Solicitor
btonelli@sidley.com
International Pharma Can Now Use U.S.-based Accountants in Russia
The pharma industry was unhappy about a rule which prevented U.S. accountants and consultants, and even some in-house staff at pharma companies, from providing services to medical services companies in Russia. Carys Golesworthy explains how this has now changed.
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.
Carys Golesworthy
Washington, D.C.
cgolesworthy@sidley.com
Six Surprises In The Leaked European Pharmaceutical Review
On 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. Here, initial impressions of the biggest surprises in the document are given by Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou.
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
It Is Now More Difficult For International Pharma To Transfer Data Out Of China
New measures for the security assessment of data transfers from China to other countries could make it harder for international pharma companies with China operations to transfer health data out of the country. Lianying Wang explains.
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.
Lianying Wang
Beijing
lianying.wang@sidley.com