Advertising 

UK 

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published four decisions following investigations into complaints about advertising for licensed products. See here for the published decisions. 

Competition Law 

UK 

  • In connection with its investigation into the anticipated acquisition by Theramex HQ UK Limited of the European Rights to Viatris’ Femoston and Duphaston Products, the Competition and Markets Authority (CMA) has accepted undertakings in lieu of reference to a phase 2 investigation. See here for further information. 

Data Privacy 

EU 

  • The European Union has requested public feedback on the EU-US Data Privacy Framework (DPF) for its first review of the DPF which will assess whether all elements of the DPF are in place and functioning as intended. The findings and conclusions of the first review will be presented by the Commission in a report. The feedback period is open until 9 September 2024. See here for further information, including how to contribute. 

Early Access  

UK 

  • The MHRA Guidance for applying for the early access to medicines scheme (EAMS) has been updated to include more EAMS scientific opinion submission dates. See here for further information. 

Pricing and Reimbursement 

UK 

  • Lecanemab has been licensed for adult patients in the early stages of Alzheimer’s disease but NICE rules the benefits are too small to justify the cost to the NHS. See NICE press release here
  • The Association of the British Pharmaceutical Industry (ABPI) has published a blog article looking at medicines access in the UK and in particular the use of the severity modifier, an approach used by NICE to decide how much value to assign to some treatments. See ABPI blog article here 

Regulatory 

EU 

  • The European Medicines Agency (EMA) has published its August edition of Human Medicines Highlights, which is available here

UK 

  • The MHRA has published two pieces of Guidance; one on pre-submission advice and support and the second covering how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA. For further information see Guidance here and here

   

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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