Pharmaceuticals

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Spanish Competition Authority analyses distribution of medicines in Spain
On June 22, 2022, the Spanish Competition Authority (“CNMC”) published a study about the wholesale distribution market for medicines in Spain (the “Study”). In particular, the CNMC addresses a number of barriers of entry to the market due to applicable national legislation and provides some recommendations to the legislative and executive powers aiming to ensure effective competition 1. Context and background In the European Union and its Member States, the principle of prevention is one...
July 18, 2022
6 min read
To opt-out or not? The UPC will change the rules of...
Early this year it became clear that the long-pending reform...
June 1, 2022
7 min read
New Draft Implementing Regulations propose key changes...
On 9 May 2022, the National Medical Products Administration (the...
May 19, 2022
5 min read
The UPC Committees rule!
Start of the Provisional Application Phase and first...
April 7, 2022
12 min read
The Return of Biosimilar Substitution in France
Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting...
March 28, 2022
3 min read
International Comparative Legal Guide to Digital Health 2022
Our Life Sciences IP, Regulatory and Data Protection experts Sally Shorthose, Toby Bond, Emma Drake and...
March 17, 2022
1 min read
Renewal of early access and compassionate use frameworks in France
On 1 July 2021, the early access and compassionate use reform entered into force. A medical treatment...
November 10, 2021
6 min read
Healthcare research and the GDPR – which legal basis is appropriate?
Establishing the correct legal basis under the GDPR is essential for any project involving use of...
October 4, 2021
13 min read
Dutch competition authority ACM imposes EUR 20 million fine on orphan drug manufacturer Leadiant for excessive pricing
The Netherlands Authority for the Consumer and Markets’ ("ACM") announced focus on drug...
July 21, 2021
6 min read
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