Artificial Intelligence

UK

  • The National Institute for Health and Care Excellence (NICE) has published a draft guidance document for consultation on the use of Artificial Intelligence (AI) technologies to help professionals detect fractures in urgent care settings. For further information and the draft consultation document see here

Clinical Trials

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an article following release of a report commissioned by it, which showed the European Economic Area’s share of commercial clinical trials has significantly reduced. The EFPIA article states there are “over 60,000 fewer clinical trial places for Europeans, despite [a] global surge in research projects”. See EFPIA article for further information.
  • The European Medicines Authority (EMA) has extended its pilot on using clinical study data in medicines evaluation. For further information on the pilot, see here

UK

  • In a webinar on 15 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) stated that it expects the new UK clinical trial regulation to be implemented by January 2026. The MHRA Chief Executive, Dr June Raine clarified that the MHRA intends to lay in parliament the new clinical trials legislative framework before the end of 2024.
  • The Health Research Authority (HRA) and the MHRA are working together to help improve the diversity of participants in research. They are developing a set of questions and supporting guidance for researchers to consider when designing clinical trials and clinical investigations and have announced an informal consultation on the questions and guidance, which is open until 9 December 2024. See here for further information.

Codes of Practice

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has advertised sanctions in respect of four cases, including Novo Nordisk – Case AUTH/3717/12/22 which concerned an advert published in the Sunday Times, in which a statement made by a Global senior leader misleadingly promoted a prescription only medicine. See advert for further information.

Data Privacy

UK

  • The Information Commissioner’s Office (ICO) has published a statement in response to the UK government’s plans for NHS digital transformation. See ICO statement for further information.
  • The Data (Use and Access) Bill was introduced to the UK Parliament on 3 October 2024 and aims to amend the UK data protection framework. Supporting documents assessing the impact of the Bill were introduced to parliament on 23 October 2024. The Department of Science, Innovation and Technology and Department of Health and Social Care published further information and supporting documents on the Bill on 23 October 2024. See here for further information. The ICO has also published a statement on the Bill.
  • The HRA has updated its GDPR Transparency Wording Template for all sponsors to ensure research participants have all the information they need to make an informed decision about the use of their data. See here for further information.

Innovative Medicines

UK

  • A Statutory Instrument has been laid before the UK parliament setting out a new regulatory framework for the regulation of innovative products manufactured at or close to the location where a patient receives care. The new framework will allow the safe development of innovative, personalised medicines, such as cell or gene therapy that need to be manufactured close to the patient. See MHRA press release for further information.

Market Access

EU

  • On 22 October 2024 the Official Journal of the European Union published the second of six Implementing Regulations of the Regulation on Health Technology Assessment Regulation (EU) 2021/2282 . The Second Implementing Regulation defines the scope of the exchanging of information and ensures information is exchanged securely. It will apply from 12 January 2025. See  Second Implementing Regulation for further information.

UK

  • Lilly’s donanemab has been licensed for the early stages of Alzheimer’s disease in adult patients, but NICE says more evidence is needed on the clinical and cost-effectiveness of donanemab and it does not currently demonstrate value for the NHS. See MHRA press release and NICE press release for further information.

Medical Devices

EU

  • On 23 October 2024 the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation and the In Vitro Diagnostics Regulation in order to address ongoing challenges. See here for further information. MedTech Europe has welcomed the European Parliament’s resolution. See here for the MedTech statement.

UK

  • The Post-market Surveillance Statutory Instrument was laid before the UK parliament on 21st October 2024, marking the first major update to the Medical Device Regulations framework. The new Statutory Instrument will introduce clearer and more robust requirements for post-market surveillance in order to improve patient safety. See MHRA press release for further information.

Radiopharmaceuticals

EU

  • The EMA has released a concept paper for a future guideline on the clinical evaluation of therapeutic radiopharmaceuticals in oncology in order to address requests for scientific advice for these products. The concept paper is open to public consultation until 31 January 2025. See concept paper and EMA statement for further information.

Regulatory

EU

  • The EMA has published its Human Medicines Highlights Newsletter for October, including information on new medicines and new medicines recommended for approval. See here for further information

UK

  • The UK government has launched a new Regulatory Innovation Office aimed at reducing the burden of red tape and speeding up access to new technologies. See Department of Science, Innovation and Technology press release for further information.

Urban Wastewater Treatment Directive

EU

  • EFPIA has published a statement on the Urban Wastewater Directive expressing concern about the impact that the Urban Wastewater Treatment Directive will have on European patients and the competitiveness of the pharmaceutical industry. See EFPIA statement for further information.

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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