Artificial Intelligence

EU

  • The European Medicines Agency (EMA) has published its guiding principles for how the industry should use large language models (LLMs) in a safe, responsible and effective manner. See EMA press release with guiding principles for further information.

EU/UK

  • The EU, United Kingdom and US have signed a new legally binding international treaty governing the safe use of AI. Officially known as the “Council of Europe Framework Convention on Artificial Intelligence and Human Rights, Democracy and the Rule of Law” (the “AI Convention”), the AI Convention aims to “ensure that activities within the lifecycle of artificial intelligence systems are fully consistent with human rights, democracy and the rule of law”. See UK government press release here

Clinical Trials

UK

  • The Association of the British Pharmaceutical Industry (ABPI) has published a report on the value of industry clinical trials to the UK and calls on the government to boost investment in clinical trial capacity. For further information and a link to the report see here

Codes of Practice

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has published its Annual Report 2022 and 2023. See here for further information.

Competition Law

EU

  • The European Commission has published findings of evaluation of the EU antitrust enforcement framework. For further information see European Commission press release
  • The Court of Justice of the European Union (CJEU) has ruled that the European Commission lacks jurisdiction to review the proposed acquisition of GRAIL by Illumina. See here for further information.

UK

  • The Competition and Markets Authority (CMA) has now concluded its investigation into anti-competitive agreements in the pharmaceutical sector. See CMA press release for further information.
  • The Court of Appeal has upheld a finding of cartel infringement relating to an illegal market sharing agreement in the supply of hydrocortisone tablets. See here for further information, including a link to the Court of Appeal judgement.

Competitiveness

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its response to the Mario Draghi EU competitiveness report. See here for EFPIA response.

Data Privacy

EU

  • The CJEU has published its judgement on the lawfulness of processing personal information for the performance of a contract to which the data subject is party. The case concerns whether Articles 6(1)(b) and 6(1)(f) of the GDPR must be interpreted as meaning that the processing of personal data, which consists of disclosing information, at the request of a partner of an investment fund, which may be regarded as being necessary for the performance of a contract to which the data subjects are parties or for the purposes of legitimate interests pursued by the controller or by a third party. See the judgement here
  • The CJEU has published the Advocate General’s Opinion on the right to access and automated decision-making. The case relates to a request for a preliminary ruling concerning an application for enforcement of a court order requiring a credit assessment undertaking to provide meaningful information about the logic involved in profiling relating to the defendant’s personal data. See Opinion for further information.

Netherlands

  • The Dutch data protection authority has imposed a fine of 290 million Euros on Uber because of transfers of drivers’ data to the United States. See Dutch Data Protection Authority press release for further information.

Early Access

UK

  • The MHRA has published Guidance on the Early Access to Medicines Scheme (EAMS) including updated Guidance on how to submit new applications to EAMS. See here and here for further information.

Health Data

EU

  • EFPIA has published a statement looking at the measurement of the value of data disclosure following its engagement of a specialist research organisation, Lygature, to assess the impact of current disclosure activities. The EFPIA statement and Report are available here

Manufacturing

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance to support manufacturers and wholesale dealers authorised by the MHRA and the associated Qualified Persons (QPs), Responsible Persons (RPs) and Responsible Persons for Import (RPis), in order to implement the arrangements of the Windsor Framework for human medicines. See MHRA Guidance for further information.

Pharmacovigilance

UK

  • The MHRA has published guidance information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework. See Guidance for further information.

Pricing and Reimbursement

UK

  • The Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) Investment Programme commenced on 28 August 2024. It will channel significant investment into the UK’s health and life sciences sector over the next 5 years, boosting economic growth and the global competitiveness of the UK’s life sciences sector. For further information see here

Regulatory

UK

  • The MHRA has updated its Guidance on the UK-wide licensing for human medicines following the agreement of the Windsor Framework document. See updated Guidance 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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