Competition Law
UK
- The Competition and Markets Authority (CMA) is reviewing the Assimilated Technology Transfer Block Exemption Regulation (Assimilated TTBER) to inform the CMA’s recommendation to government on whether to replace the Assimilated TTBER on its expiry on 30 April 2026. The consultation is open until 6th September 2024. Further details of the review and how to respond to the consultation can be accessed here
Data Privacy
UK
- The Information Commissioner’s Office (ICO) has issued a provisional decision to impose a £6 million fine on a software provider following an August 2022 ransomware attack which disrupted NHS and social care services. Personal information belonging to 82,946 people was stolen following the attack. See here for further information.
Health Data
UK
- The Association of the British Pharmaceutical Industry (ABPI) has responded to the government’s commitment to boost research by improving access to health data. See ABPI response for further information.
Intellectual Property
UK
- The Court of Appeal has handed down its judgement in Comptroller – General of Patents, Designs and Trade Marks v Emotional Perception AI Limited [2024] EWCA Civ 825 , overturning the decision of the High Court and upholding the findings of the UKIPO Hearing Officer. Emotional Perception’s patent application for an AI music recommendation neural network was refused by UKIPO as a computer program “as such”, and therefore excluded from patentability under s.1(2) of the Patents Act 1977. The decision once again puts the spotlight on the patentability of AI inventions. Emotional Perception has indicated that it plans to appeal the decision to the Supreme Court.
US
- The United States Patent and Trade Mark Office (USPTO) has issued a guidance update on patent subject matter eligibility to address innovation in critical and emerging technologies, including in artificial intelligence (AI). See press release and guidance for further information.
Manufacturing
EU
- The European Medicines Agency (EMA) has released a draft guideline on information which the agency expects to see in submissions seeking EU marketing authorizations for new or existing active substances used in medicinal products. The deadline for comments is 31st January 2025. See draft guideline for further information.
Medical Devices
EU
- EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the EU. The programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation. See EMA press release for further information.
UK
- The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Guidance on registering medical devices to place on the market. See updated Guidance for further information.
- The MHRA has updated its Guidance on notifying the MHRA about carrying out a clinical investigation for medical devices. See updated Guidance for further information.
Medicines Shortages
EU
- EMA has published further information on the European Shortages Monitoring Platform (ESMP), which has been set up to gather information about medicine supply and demand in order to prevent, detect, and manage human medicine shortages in the European Union (EU) and European Economic Area (EEA). Details of planned communication initiatives with key stakeholders and guidance and training materials to support stakeholders have now been published. See here for further information.
- Ursula von der Leyen has announced an intention to introduce a Critical Medicines Act to address medicines shortages. The European Commission’s Political Guidelines for the next European Commission 2024-2029 state “We must make our economy more resilient and less dependent. This is notably important in the health and pharmaceutical sector. The EU has been confronted with severe shortages of medical devices and medicines, with antibiotics, insulin, painkillers and other products becoming particularly difficult to obtain. To remedy this, we will propose a Critical Medicines Act to reduce dependencies relating to critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries.”
UK
- The MHRA has updated its List of medicines that cannot be exported from the UK or hoarded. For further information see
Pricing and Reimbursement
UK
- The National Institute for Health and Care Excellence (NICE) has issued positive guidance recommending the use of exagamglogene autotemcel (CASGEVY™) in the NHS. The recommendation follows conclusion of a reimbursement agreement between Vertex (the manufacturer of CASGEVY™) and NHS England for eligible transfusion-dependent beta thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy. CASGEVY™ received the first authorization in the world for a CRISPR-based gene-editing therapy on November 15, 2023. See NICE press release and Vertex press release for further information.
Regulatory
EU
- EMA’s human medicines committee (CHMP) recommended 14 medicines for approval and 11 medicines for extensions of therapeutic indications at its July 2024 meeting. See Meeting Highlights for further information.
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