Antimicrobial Resistance

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new team to support the international community tackle antimicrobial resistance and has pledged funding of £85 million to support the international community. See here for further information.

International

  • IFPMA has published a new report reviewing antibiotic pipeline data against bacterial pathogens identified by the WHO and other public health agencies of the greatest concern and setting out modelling data on the pipeline’s future. See here for further information and a copy of the Report.

Artificial Intelligence

EU

  • The European Data Protection Supervisor (EDPS) has highlighted its high-level plan for artificial intelligence (AI) comprising governance, risk management and supervision. See EDPS blog for further information.

Competition Law

EU

  • The European Commission has approved under State Aid rules, the first Important Project of Common European Interest (‘IPCEI’) to support research, innovation and the first industrial deployment of healthcare products, as well as innovative production processes of pharmaceuticals. See press release for further information.

UK

  • The Competition and Markets Authority (CMA) has confirmed it is moving ahead with a full investigation into the veterinary sector. See press release for further information and next steps.
  • The Digital Markets, Competition and Consumers Act has become law after receiving Royal Assent. For further information see here.

Data Privacy

EU

UK

  • The EDPS has delivered a speech at the Computers, Privacy and Data Protection Conference on “Devising a trajectory towards a just and fair future: the identity of data protection in times of AI”. See here for further information.

Health Technology Assessment

EU

  • The European Commission has announced a public consultation on conflict-of-interest rules under the EU Health Technology Assessment Regulation. The consultation is open until 26 June 2024. See here for further information.
  • The European Commission’s Implementing Act on Joint Clinical Assessments for medicines for human use was finally adopted on 23rd May 2024. This is the first of six Implementing Acts for the EU HTA Regulation. The HTA Regulation becomes applicable in January 2025. See Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024.

Intellectual Property

EU

  • EFPIA has published an article on the value of regulatory data protection and its impact on European competitiveness and patient access to medicines. See article for further information.

USA

  • The United States Patent and Trade Mark Office (USPTO) has issued a request for comments regarding the impact of AI on patentability. Comments are due by 29 July 2024. See press release for further information.

UK

  • The UK Intellectual Property Office (IPO) has updated its Guidance “Examining patent applications relating to artificial intelligence (AI) inventions”. See here for further information.

Medical Devices

EU

  • The European Medicines Agency (EMA) has published new guidance for industry and notified bodies clarifying regulatory requirements for devices used in combination with medicines. See here for further information.

UK

  • The MHRA has announced a consultation on improved safety for high risk in vitro diagnostic devices. The consultation is open for four weeks. See further information on the consultation and press release.
  • The MHRA has announced a proposed framework and policy intent for international recognition of medical devices. See press release for further information.
  • National Institute for Health and Care Excellence (NICE) and NHS England have announced a proposal to enable innovative technology to be adopted faster. The proposals set out in a joint NHS England and NICE consultation outline a new route for MedTech developers to access NHS funding to fast-track clinically and cost-effective products for use by the healthcare system. See NICE announcement for further information.

Regulatory

EU

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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