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Pharmaceuticals

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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 is generally only available to patients after being granted a market authorisation (“MA”). However, certain conditions call for a medicinal product not yet approved. In recent years, different derogatory procedures have been designed and implemented in France to give patients who are suffering from rare, serious or disabling conditions access to medicinal product where there is no...
November 10, 2021
6 min read
Healthcare research and the GDPR – which legal basis...
Establishing the correct legal basis under the GDPR is essential...
October 4, 2021
13 min read
Dutch competition authority ACM imposes EUR 20 million...
The Netherlands Authority for the Consumer and Markets’ ("ACM")...
July 21, 2021
6 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns...
Operation Pangea is a yearly recurring operation in which Interpol...
June 24, 2021
2 min read
Spanish courts say “no” to the evergreening on data exclusivity of medicines.
Three recent judgments handed down by the Central Administrative Courts Nos. 4, 10 and 2 on 30 March,...
June 14, 2021
8 min read
First medicinal cannabis drug listed on the Australian Pharmaceuticals Benefits Scheme
On 1 May 2021 Epidyolex, the first medicinal cannabis drug product was listed on the Pharmaceutical Benefits...
May 6, 2021
1 min read
Chinese patent linkage system – the Chinese Supreme Court issues Draft Judicial Interpretations
The Chinese Supreme Court (“SPC”) released on 29 October 2020 the “Provisions on Several...
November 13, 2020
6 min read
Australian Courts apply “European Support” test to find key Wyeth’s Prevnar 13 patent invalid
In the recent decision in the Australian front of the Prevnar 13 patent litigation, Merck...
November 4, 2020
10 min read
AstraZeneca held liable for additional healthcare costs
In a judgment of 14 October 2020 the District Court The Hague ruled in a landslide decision that AstraZeneca...
October 15, 2020
10 min read
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