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Commission proposal for a new European legal framework for GMOs

In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more

European Commission publishes proposal for an EU regulation on the Compulsory Licensing of Patents

On 27 April 2023, the European Commission (the Commission) published its Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing for crisis management (the Proposed Compulsory Licensing...more

Potential EU regulation for the compulsory licensing of patents to be studied by the European Commission

The European Commission has recently announced its intention to launch a call for evidence and public consultation on a potential new EU regulation concerning the compulsory licensing of patents....more

EC consults on revision to pharmaceutical legislation

The European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation....more

EU Court says off-label treatments must not be considered when assessing the significant benefit criterion in orphan drugs

On 23 September 2020, the General Court of the European Union (GC) annulled a decision of the European Commission (Commission) that had withdrawn the orphan drug status of Trecondi (Treosulfan)....more

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