Artificial Intelligence 

EU 

  • The European Parliamentary Research Service (EPRS) has published a proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence (AI). See the directive proposal here 

Netherlands 

  • The Dutch data protection authority has called for feedback on manipulative and exploitative AI systems under the AI Act. See here for further information. 

UK 

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications from manufacturers and developers of AI medical devices to join its AI Airlock regulatory sandbox. See here and here for further information. 

Clinical Trials 

EU 

  • The European Medicines Agency (EMA) has published a reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation. See EMA reflection paper and further information here 

Codes of Practice 

UK 

  • The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for the pharmaceutical industry. See press release and Code of Practice for further information.
  • The PMCPA has ruled that Moderna has brought discredit on the pharmaceutical industry in two separate cases. The first case related to the use of social media to recruit children into a clinical trial using unapproved financial incentives – See AUTH/3886/3/24 . The second decision related to allegations regarding the promotion of Spikevax, which occurred prior to Moderna becoming a member of the ABPI – See AUTH/3746/2/23 

Competition Law 

UK 

  • The Competition and Markets Authority has provided an update on its market investigation into the veterinary services market for household pets in the UK. It has appointed a new advisory panel to provide clinical and practical insight and analysis. See press release for further information. 

Data Privacy 

Belgium 

  • The Belgium data protection authority has published guidance on AI and data protection. See guidance for further information. 

EU 

  • The Court of Justice of the European Union (CJEU) has issued a judgement on the corrective powers of data protection authorities in the event of personal data breaches. See judgement for further information. 

Health Data 

EU 

  • The European Commission has published guidance on the Data Governance Act, a key part of the European strategy for data. For further information see the  guidance document
  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted key challenges and suggestions that should be taken into account when implementing the opt-out mechanism in the proposed European Health Data Space (EHDS) framework.  See EFPIA statement for further information. 

Health Technology Assessment 

EU 

  • The European Commission has published guidance on the validity of studies for joint clinical assessments under the EU Health Technology Assessment Regulation. See  Guidance for further information.
  • The European Commission has updated its rolling plan on the implementation of the Regulation on health technology assessment. See here for further information.
  • The European Commission has launched an online public consultation on the draft implementing act on joint scientific consultations on medicinal products for human use at Union level under the Health Technology Assessment (HTA) Regulation. The online consultation is open until 29 October 2024. See here for further information including details of how to contribute to the consultation. 

Medical Devices 

Northern Ireland 

  • The recent implementation of a submission route for manufacturers for performance studies has now enabled the submission and approval of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland. See MHRA press release for further information. 

UK 

  • The MHRA has updated its guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. See here for further information. 

Medicine Shortages 

France 

  • The French National Agency for the Safety of Medicines and Health Products (ANSM) has fined 11 pharmaceutical companies a total of 8 million Euros for failing to comply with regulations to prevent drug shortages.  French legislation now requires companies to maintain a minimum safety stock of four months for essential medicines to secure their supply if the medicines have been subject to shortages in the last two years. See ANSM press release (in French) for further information. 

Pharma Reform

EU 

  • EFPIA has published a blog article on the challenges and importance of establishing criteria for unmet medical needs as part of the ongoing revision of the General Pharmaceutical Legislation. See EFPIA article here 

Patient Safety 

Germany 

  • The German Federal Social Court (BSG) has ruled in connection with a question of whether persons insured under the statutory health insurance system are also entitled to a medicinal product that has been negatively assessed by the European Medicines Agency (EMA) during the marketing authorisation procedure as part of their treatment for a fatal disease. The court ruled that the purpose of the medicinal products authorisation is to protect patients with serious illnesses from incalculable risks. The German Medicinal Products Act also provides a structured quality assurance system, providing simplified approvals and exceptions in case of hardship but if a case fell outside the exceptions in the Act, then no further exception could be granted. See judgement (in German) for further information. 

UK 

  • The MHRA has introduced a new strategy for improving safety communications. The strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices. See MHRA press release for further information. 

Pricing and Reimbursement 

UK 

  • The Board of the National Institute for Health and Care Excellence (NICE) has determined that the severity modifier, which was introduced to allow extra weight to be given to medicines that address severe diseases, is working as intended. The Board has agreed to continue monitoring the severity modifier’s introduction. See NICE press release . However, the ABPI has released a statement indicating its disappointment that NICE has decided not to change how it values medicines for those with severe conditions. See ABPI statement for further information. 

Regulatory

EU 

  • EMA has published its Human Medicines Highlights with information on new medicines approved. See Newsletter here 

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

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.