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Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – EAPM is busy at the moment preparing for its upcoming Pharmaceutical Legislation event on 15 March as well as internal events on the liquid biopsies as well as on the implementation of the IVDR legislation at the country level, writes EAPM Executive Director Dr. […]
The European Commission has launched a public consultation inviting all interested parties to comment on two draft revised Horizontal Block Exemption Regulations on Research & Development (‘R&D') and Specialisation agreements (‘R&D BER' and ‘Specialisation BER' respectively, together ‘HBERs') and the draft revised Horizontal Guidelines. The draft revised HBERs and Horizontal Guidelines follow a review and […]
The regulation of standard-essential patents (SEPs) has increasingly attracted the attention of policymakers in recent years. This includes the European Commission, which institutes...
7 April 2020 October 2020 6 May 2021 Key findings of the Staff Working Document The Staff Working Document responds to feedback that the Commission has received in consultations to date, and concludes that the H-BERs and the Horizontal Guidelines are useful instruments and remain relevant for stakeholders, but that they require revision in certain areas. The key feedback identified by the Commission includes: General issues Discrepancies in definitions compared to other EU legislation (e.g., non-full functionality joint ventures, potential competitors) Insufficient clarity on the centre of gr...