The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure...
October 7, 2022
1 min read
Regulatory
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The Activation of Payback on Medical Devices
Final(ly) Rules of Procedure of the UPC
Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations,...
July 18, 2022
1 min read
Spanish Competition Authority analyses distribution of medicines in Spain
On June 22, 2022, the Spanish Competition Authority (“CNMC”) published a study about the wholesale...
July 18, 2022
6 min read
New Draft Implementing Regulations propose key changes for pharmaceuticals in China
On 9 May 2022, the National Medical Products Administration (the “NMPA”) published the Implementing Regulations...
May 19, 2022
5 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
Katrina Dang
Johanna Harelimana
Hester Borger
Carmen Miriam Martorano
Emma Stok
Marta Sznajder
Pieter Erasmus
Patrick Brown
Enrique Rivas
Jonathan Edwards
Ana María Sánchez-Valdepeñas
Wolfgang Ernst
Telemedicine has been available to healthcare providers for several years. However, it was not until quite...
January 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
UK medical devices regime set for an upgrade
Just 7 months after the expiry of the Brexit transition period, the Medicines and Healthcare products...
October 7, 2021
4 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