Artificial Intelligence

EU

  • AI Act final vote due to take place on 13th March. See press release.
  • The Information Commissioner’s Office has opened a second call for evidence on generative AI. The consultation is open until 12th April 2024. For further information see here.

Competition Law

UK

  • The CMA is to appeal the Competition Appeals Tribunal’s decision in the hydrocortisone tablets case concerning alleged excessive and unfair pricing, anticompetitive agreements and abusive conduct (50277). The CAT published two judgements on 8th March. In the first, the CAT found that the decision was right on the facts and that all the grounds of appeal by the defendants fail. In the second, the CAT found that the appeals by the defendants must nonetheless be allowed because the CMA did not fully put its case to a witness during cross-examination at trial. The CMA has stated that it completely disagrees with the CAT decision to allow the appeals on what it considers is a “fundamentally misconceived procedural point” and will seek leave to appeal. For further information see here.

Data Privacy

EU

  • The European Data Protection Board has launched its coordinated enforcement framework action for 2024 on the right of access – See press release.
  • The Information Commissioner’s Office has launched a call for views on the ‘consent or pay’ mechanism and updates on cookie compliance work. For further information see  press release.

EU

  • EFPIA has issued a statement of concerns over the European Health Data Space and sets out ten fundamental issues which have not been satisfactorily addressed in the legislative positions. For further information see EFPIA press release.

Intellectual Property

EU

  • The UPC Court of Appeal has overturned a first instance preliminary injunction ordered by the Munich local division against NanoString in its conflict with US biotech company 10xGenomics. The Court of Appeal decision is based on the fact that on the balance of probabilities the patent would likely not prove to be valid. The decision focusses largely on the assessment of obviousness and it is the first Court of Appeal decision to do so. It does not however look at the methodology to assess a preliminary injunction covered in the first instance decision. See the Order of the Court of Appeal of the United Patent Court issued on 26 February 2024.

Market Access

UK

  • NICE launches public consultation on its new approach to prioritising guidance. The consultation is open until Thursday 4th April 2024. For further information see here.

Marketing Authorisations

UK

  • MHRA has published new guidance to help assessment of established medicines. For further information see press release.
  • The pilot phase of the Innovative Device Access Pathway (IDAP) has entered the next stage. Eight technologies have now been selected. For further details of the pilot phase of the IDAP see press release.
  • MHRA grants its first approval via the new International Recognition Procedure. See press release.

Pharmaceutical Regulation

EU

  • As key discussions on the future of regulatory data protection (RDP) draw near, EFPIA has set out a warning on the Commission’s proposal to cut RDP by 2 years. See EFPIA statement.

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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