[Co-authors : Westley Trimble, Jon Botham, Santa Nekrasova, Uendi Barreti, Paola Paccani (Knowledge)]
We're delighted to share our Knowledge team's insights on the most important legal changes affecting the Health & Life Sciences sector around the globe.
Global: OECD maps AI training data collection mechanisms
Summary: On October 3, the Organisation for Economic Co-operation and Development (OECD) published a policy paper mapping key data collection methods used to train AI systems.
The paper focuses on the sources from which data are typically obtained: directly from individuals and organizations, and from third-party providers. Within these categories, the paper identifies mechanisms that play a relevant role in the creation of AI training datasets.
The paper also proposes a taxonomy to support discussions on privacy, data governance, and responsible AI development.
Impact: Businesses developing AI should:
- assess how they source training data and ensure transparency in their methods
- monitor any developments, and
- engage with policymakers to shape future governance
Global: WHO update on essential medicines boosts access to cancer and diabetes treatments
Summary: On September 5, the World Health Organization updated its Model Lists of Essential Medicines (EML & EMLc) to add treatments for various cancers, type 2 diabetes (with comorbidities like cardiovascular or kidney disease and obesity), cystic fibrosis, haemophilia, psoriasis and other blood disorders.
The revision includes additions of GLP‑1 receptor agonists and a GLP‑1/GIP dual receptor agonist for certain diabetic patients. The lists, used by over 150 countries, guide public procurement, reimbursement schemes and access to medicine.
Impact:. Health systems may incur higher pharmaceutical spending as more advanced therapeutics become essential. Governments and payers may need to adjust formularies, procurement policies and reimbursement frameworks. Pharmaceutical companies may see increased demand for newly listed medicines and pressure to reduce prices or enhance licensing and generic competition. Access disparities may decrease if lower‐income countries align with the updated lists and secure supply chains.
UK and US collaborate on medical technologies and AI
Summary: On October 8, the Medicines and Healthcare products Regulatory Agency (MHRA) announced strengthened collaboration with the US Food and Drug Administration (FDA) on medical technology regulation.
The initiative seeks to boost innovation, enhance patient safety, and ease transatlantic market access.
Key take away points:
- MHRA launched a new AI Commission with UK and US experts and tech firms
- the Commission will develop recommendations to support safe and transparent use of AI in healthcare
- MHRA is in a process of planning new rules to speed up UK access for FDA-approved devices
Impact: Potential impacts on businesses over the next few years:
- smoother transatlantic market access, reducing duplication in regulatory submissions
- faster UK entry for US-approved medical devices
- closer alignment between UK and US rules, making requirements clearer for developers
- opportunities to help shape emerging AI and medical device regulations
- companies may need to adjust their compliance plans to meet shared UK–US standards
UK and Japan sign memorandum to strengthen competition law cooperation
Summary: On October 1, the CMA published a memorandum of co-operation (MoC) with the Japan Fair Trade Commission (JFTC), establishing a non-binding framework to enhance collaboration on competition law enforcement. The MoC provides for mutual notification of enforcement activities and coordination where appropriate. It also covers the exchange of views and non-confidential information to improve understanding of each authority’s policies and practices.
Impact: The arrangement aims to facilitate communication between the JFTC and UK concurrent regulators, and outlines procedures for information sharing while safeguarding confidentiality. The MoC excludes criminal enforcement matters but reflects a broader commitment to international cooperation. It could help in addressing global competition challenges.
EU and India announce new strategic agenda
Summary: On September 17, the EU unveiled a New Strategic EU-India Agenda to deepen cooperation across key sectors and priorities. It proposes finalizing a Free Trade Agreement and strengthens bilateral ties in trade, security, technology, and sustainability.
Five action areas include clean energy transition, digital innovation, defense cooperation, regional connectivity, and multilateral engagement. Security collaboration expands to crisis management, cyber defense, and maritime safety, reinforcing strategic autonomy and shared values. Tech cooperation includes a startup partnership and Horizon Europe association, fostering joint innovation and green finance. Mobility frameworks support study, work, and research exchanges, with a pilot legal gateway for labor mobility.
EU-India trilateral cooperation and global governance engagement reflect India’s rising global influence and shared democratic principles.
Impact: The Agenda is a political roadmap which describes strategies to strengthen commercial ties, but most measures remain subject to negotiation, ratification and implementation at EU and Member State level.
The expectations are that businesses may benefit strategically through expanded trade, investment, and talent mobility opportunities across key sectors.
China: Amended measures for medical device production
Summary: On November 4, the National Medical Products Administration released the Medical Device Production Quality Management Specifications. It outlines mandatory requirements for medical device registrants, filing entities, and contract manufacturers. The aim is to ensure the safety and effectiveness of medical devices throughout their lifecycle, from design to after-sales service.
The measures outline appropriate environments, equipment maintenance, document control, and traceability. Special attention is given to the validation of processes, cleaning methods, and computer software. The regulations also cover product identification, labelling, nonconforming product handling, and unique device identification implementation.
Impact:The measures come into force on November 1, 2026. Regular internal audits and management reviews are required to ensure the continued effectiveness of quality management systems. Medical device companies should use the next 12 months to ensures their compliance processes meet the new requirements.
China: New biomedical research regulations
Summary: On October 10, Prime Minister Li Qiang signed a State Council order for new regulations on clinical research and the application of biomedical technologies.
The regulations aim to standardize the clinical research and application of new biomedical technologies, promote scientific innovation, ensure safety, and protect human health. Clinical research should respect participants' rights and not charge them fees. The State Council will monitor risks and may halt unsafe studies. Proven technologies may be approved for clinical use after review. The regulations include legal penalties for violations.
Impact: These rules take effect May 1, 2026. The Government has indicated biomedical technologies have the potential for preventing, diagnosing and treating diseases. The new regulations could provide clarity, opening a path for greater commercialization for biomedical companies.
Businesses should ensure they meet the new requirements before conducting clinical research. They should prepare for stricter oversight and update risk management policies accordingly.
China: New tax rules for online platforms
Summary: On September 25, the State Administration for Market Regulation announced new tax regulations for internet platforms would take effect from October 1, 2025.
Platforms will now have to report identity and income data of users and register as market entities if annual sales exceed ¥100,000. Multiple stores under one operator must combine sales for registration. Illegal income splitting and false reporting will face legal consequences.
The measures aim to ensure proper market registration, accurate tax declarations, and curb illegal activities. The intention is to ensure fairer competition, improved consumer protection, and a more regulated platform economy.
Impact: From October 2025 platform operators should remind users to register and disclose licenses, submit accurate tax-related data regularly and prevent income concealment and false invoicing.
China: AI emergency response guide published
Summary: On September 22, the National Information Security Standardization Technical Committee published a guide for managing security incidents in GenAI services.
The guide introduces a four-level grading system based on system importance, business impact, and social harm. It outlines a four-phase response process: preparedness, monitoring and early warning, incident handling, and review. Each phase includes technical and management measures.
Impact: The guide aims to help AI providers and departments respond quickly and reduce risks. AI service providers should adopt the guide's emergency response strategies to enhance security and mitigate risks effectively.
EU: Commission launches COMPASS-AI for healthcare
Summary: On October 21, the European Commission launched COMPASS-AI to promote responsible AI integration in clinical settings. The initiative is part of the Apply AI Strategy, adopted on October 8, 2025, to accelerate AI use in key sectors.
Healthcare is a key area: the initiative aims to improve diagnostics, personalize prevention, and support medical professionals.
It prioritizes cancer care and remote healthcare, seeking to enhance access. It aims to create an expert community to guide safe and effective AI use in healthcare environments. An interactive platform will be launched to share best practices. Deployment guidelines and AI literacy programs will target professionals, managers, and patients.
The initiative builds on the European Health Data Space and aligns with the upcoming Biotech Act.
Impact: Businesses may be impacted through rising demand for AI healthcare solutions and evolving data and biotech compliance requirements. They may also need to invest in workforce training to support responsible AI integration in clinical environments.
EU: Industry groups raise concerns on UWWTD cost study
Summary: On October 15, the Association of the European Self-Care Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and Medicines for Europe issued a joint statement. They raised concerns over the European Commission's upcoming study on quaternary-level treatment costs under the Urban Wastewater Treatment Directive (UWWTD). The groups said the study does not fully assess impacts on the pharmaceutical and cosmetics sectors. They highlighted flawed toxic load calculations and missing industry consultation. They called for a pause in the Extended Producer Responsibility (EPR) scheme. They requested a more comprehensive and transparent impact assessment.
Impact: Expected H1 2026. Pharmaceutical and cosmetics businesses may face increased costs due to the EPR scheme under the UWWTD. The lack of proper consultation and flawed assessments could lead to disproportionate financial burdens on these sectors. Businesses may need to allocate resources to address compliance and potential legal challenges, impacting their operational budgets and strategic planning.
EU: AI in Science Strategy launched
Summary: On October 9, the European Commission published its AI in Science Strategy to enhance AI integration in EU research.
It proposes creating a Resource for AI Science in Europe (RAISE), a virtual institute to coordinate AI-science infrastructure across Member States and sectors.
The strategy includes an AI in Science Action Plan structured around five pillars: talent, computation, data, funding, and collaboration. Up to €600 million from Horizon Europe will support researcher access to AI Gigafactories and scientific automation. €58 million will fund Networks of Excellence and Doctoral Networks to attract and retain top AI and science talent.
Horizon Europe AI investments will double to over €3 billion by 2028, supporting foundational model development. RAISE will include Data Labs in AI Factories and a European Network of Frontier AI Labs for cross-disciplinary work. The Joint Research Centre will lead an AI Evaluation Hub to assess models in strategic scientific domains. Initial RAISE funding totals €108 million, with phased expansion under future EU frameworks.
The strategy complements the Apply AI Strategy and AI Continent Action Plan.
Impact: The AI in Science Strategy gives businesses access to advanced infrastructure, funding, and scientific automation tools. Businesses can collaborate through RAISE, benefit from AI Gigafactories, and tap into Horizon Europe’s €600 million support. Private sector involvement is encouraged via pledging campaigns and cross-disciplinary labs for innovation and AI tool commercialization.
Tailored training and automation resources help businesses upskill teams and accelerate development in science-driven sectors. However, participation may entail increased contractual complexity around IP ownership, data access and liability allocation in cross-border research collaborations.
EU: Apply AI strategy launched
Summary: On October 8, the European Commission (EC) launched its ‘Apply AI Strategy’, aiming to promote EU technological sovereignty. It complements the AI Continent Action Plan, and it is accompanied by the AI in Science Strategy.
The Strategy aims to boost AI adoption with an ‘AI first’ policy and a ‘buy European’ approach, with public administrations driving innovation and startups growth. It includes support measures to boost innovation via AI Factories and Experience Centers for AI, and a new governance system led by the Apply AI Alliance. It also launches a Frontier AI Initiative, bringing together industry and academic stakeholders. An AI Observatory will track sectoral trends and labor market shifts to support strategic planning and investment decisions.
The EC plans to mobilize €1 billion from existing EU funding programs to implement the Strategy.
Impact: Expected in 2026, the Strategy sets out sector-specific actions across 11 industries. They include AI screening centers in healthcare, scaled autonomous driving in mobility, and a robotics catalyst to connect developers and users. It also promotes frontier models and agentic AI for manufacturing, environment, and pharmaceuticals. Tailored AI literacy training aims to help businesses upskill their workforce and adapt to sector-specific innovations.
Eversheds Sutherland Flash Update
EU: AI Act Service Desk and Single Information Platform launched
Summary: On October 8, the European Commission launched tools to support AI Act implementation across the EU.
The AI Act Service Desk and Single Information Platform aim to ensure legal certainty and promote trustworthy AI innovation. The platform offers resources, FAQs, and guidance, including Member State materials and interactive digital tools. These include a Compliance Checker to assess legal obligations and an AI Act Explorer for intuitive navigation of the legislation.
The initiative aims to support democracy, safety, and the rule of law while fostering responsible AI development.
Impact: Stakeholders can submit questions via an online form to experts at the AI Act Service Desk. However, the Service Desk does not replace formal legal interpretation, companies remain responsible for compliance assessment.
AI Act full implementation is scheduled by 2 August 2027, with progressive application across sectors.
EU: Strengthening water resilience through updated pollutant standards
Summary: On September 24, the European Commission (EC) reached a political agreement to update the lists of water pollutants. The changes will align rules with scientific advice and add new harmful substances, including PFAS, pesticides, and pharmaceuticals. Three directives will be amended. The update also introduces simplification measures and clearer monitoring. Member States must transpose the new rules by 22 December 2027. The goal is to improve water resilience and support the EU’s zero-pollution ambition under the Green Deal.
Impact: Businesses may face stricter environmental compliance obligations due to the inclusion of new pollutants and lower thresholds in EU water legislation. Industries using PFAS, pesticides, plastics, or pharmaceuticals may need to review production processes and invest in safer alternatives or water treatment systems. Reporting and monitoring requirements could increase, particularly for sectors discharging into surface or groundwater. While this may raise short-term costs, clearer standards and simplified procedures may support regulatory certainty and level the playing field across Member States.
EU: New strategy to strengthen Europe's research and technology infrastructures
Summary: On September 15, the EU launched a new strategy to boost research and technology infrastructures across Europe. The strategy enhances access to state-of-the-art research infrastructure, such as biobanks, clean rooms, and advanced laboratories. These are critical for developing innovative therapies, diagnostics, and medical technologies. It also streamlines access to high-quality data and specialized services across the EU.
Impact: The strategy could enable broader participation from researchers, startups, and industry, and accelerate scientific collaboration and innovation.
EU: PRAC initiates safety review of Levamisole over brain condition concerns
Summary: On September 5, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) initiated a safety review of levamisole, a medication used to treat parasitic worm infections.
The review addresses concerns about leukoencephalopathy, a serious brain condition, following new data and reported cases, including one fatality. PRAC will assess the benefit-risk balance and determine whether the marketing authorizations of levamisole-containing medicines should be maintained, modified, suspended, or withdrawn across the EU.
Impact: Businesses may need to monitor the safety of levamisole more carefully – especially if new data or concerns arise. Changes to labels or restrictions on products may be necessary, depending on regulatory decisions.
If levamisole is suspended or retired, there may be interruptions in availability that could affect supply. Businesses may face more reporting and compliance duties. Market access may be affected by regulatory decisions.
UK: MHRA sets out major changes for rare disease treatments
Summary: On November 2, the Medicines and Healthcare Products Regulatory Agency (MHRA) released a policy paper setting out plans to overhaul rulebook for rare disease therapies. The aim is to speed up development and approval, with only 5% of rare diseases having approved treatments at presents.
The policy paper suggests a single approval for trials and marketing based on limited evidence. Real-world data and safety monitoring will support this. The Rare Disease Consortium aims to guide reforms, involving patients, academics, and industry. Advances in genomics and AI could enable more personalized treatments and technologies like mRNA and CRISPR.
Impact: The new rulebook is expected to be published in 2026. The MHRA wants to make the UK a global leader in rare disease innovation. This could offer health and life science businesses opportunities to shape the regulatory process and speed up pathways to innovative new treatments.
UK: Government unveils blueprint for AI regulation
Summary: On October 21, the Department for Science, Innovation and Technology (DSIT) unveiled a new blueprint for AI regulation to help drive growth.
The blueprint introduces AI sandboxes, where companies can safely test AI products under relaxed regulatory conditions. It also launches an AI Growth Lab to pilot responsible AI and gathers evidence of its real-world benefits. The blueprint forms part of the government’s broader “Plan for Change”, which seeks to cut bureaucracy and unlock economic growth through smarter regulation.
Impact: These measures aim to unlock AI’s potential in sectors like healthcare, planning, and transport, while maintaining public trust.
DSIT is seeking views on the AI Growth Lab, aimed at individuals/organizations who:
- are interested in using the AI Growth Lab
- are going to be affected by the AI Growth Lab
- have expert views on implementing sandboxes
Stakeholders are encouraged to participate in the consultation, which closes on January 2, 2026.
UK: MHRA expands AI Airlock Programme
Summary: On October 16, the Medicines and Healthcare Products Regulatory Agency (MHRA) launched phase two of its ‘AI Airlock’ by selecting seven AI health technologies for real-world testing.
The program provides a controlled environment to:
- trial AI as a medical device
- assess safety and effectiveness, and inform future regulatory frameworks
Technologies selected include tools for cancer diagnostics, eye disease detection, clinical note taking, and blood test interpretation.
Impact: Potential impacts on businesses:
- clearer guidance on regulatory requirements and expectations
- faster route to market for AI health technologies
- opportunities to establish themselves as leaders in safe, compliant AI innovation
- AI developers may face higher short-term costs to meet testing and regulatory standards
UK: MHRA and NICE ‘Accelerated Pathway Trial’ opens early
Summary: On October 10, the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) announced that some pharmaceutical companies will have an early access to the aligned pathway. This is six months ahead of schedule, for selected medicines.
The pathway combines MHRA’s licensing and NICE’s value assessment processes, allowing decisions to be published simultaneously.
Impact: Potential impacts on businesses:
- faster, more streamlined access to the UK market for new medicines
- clearer, earlier understanding of approval and value decisions
- competitive advantage for companies selected for early access
- potential pressure on other developers to accelerate innovation and data readiness to remain competitive
UK: New commission established to speed up NHS adoption of AI
Summary: On September 26, the UK launched a new National Commission to speed up the NHS’s use of AI.
It consists of experts from healthcare, tech and patient groups. The National Commission will help create new rules for safe AI use. It aims to improve care, reduce admin and attract tech investment. AI tools like voice assistants and remote monitoring will be a focus.
Impact: If the National Commission implements the new rules:
- businesses could benefit from clearer rules, quicker approvals
- there may be more opportunities for tech firms to sell AI tools
- it may result in more investment and boost innovation in health tech
UK: Prescription weight-loss medicine advertising rules reaffirmed
Summary: On September 26, the Medicines and Healthcare products Regulatory Agency and partners, jointly reaffirmed and published an Enforcement Notice, reconfirming rules around the advertising of prescription-only medicines (POMs) used for weight management.
The updated Enforcement Notice outlines:
- that terms like “weight-loss injection”, “obesity treatment jab” or “GLP-1” should be avoided
- imagery such as injection pens, should also be avoided
- ads for general weight-loss products must not link to other content that promotes POMs, including website landing pages
Impact: This update may affect pharmacies and other businesses that advertise these medicines. They could face closer regulatory checks and possible action if they do not adhere to the rules.
US: Government launches Medicaid pricing reform to lower drug prices
Summary:On November 6, the Centers for Medicare & Medicaid Services (CMS) announced details of a five-year voluntary model to reduce Medicaid drug spending. The GENErating cost Reductions fOr US Medicaid (GENEROUS) Model links US drug prices to those in selected countries (United Kingdom, France, Germany, Italy, Canada, Japan, Denmark, Switzerland). Drugmakers can apply to negotiate prices with CMS. States can opt in on a rolling basis through to August 31, 2026. Participating manufacturers will provide rebates to match international prices. GENEROUS aims to address the $100 billion Medicaid drug cost in 2024.
Impact: GENEROUS begins January 2026, with state enrollment open through to August 31, 2026. Although it is voluntary, drug makers may want to consider taking part to avoid potential future regulatory measures. Businesses may want to consider preparing for international reference pricing and rebate obligations.
US: FDA seeks fast track approval for cheaper biotech medicines
Summary: On October 29, the Food and Drug Administration (FDA) announced new draft guidance, proposing major updates to simplifying the process around biosimilarity studies. This includes the
reduction of clinical testing trials for biosimilars, with the aim of lowering development costs and speeding up approvals. It favors analytical testing over human clinical trials.
The draft guidance suggests treating biosimilars like generics, making them easier for doctors to prescribe. The move aligns with global trends favoring generics and biosimilars.
Impact:Comments are open for 60 days after release of the draft guidance. Final guidance is expected for H1 2026. Major drug makers may want to engage with the FDA to shape the final guidance where possible. They could face innovation risks, with generic producers benefitting from the reforms. Businesses should prepare for potential regulatory shift and increase competition in the sector. They may want to increase investment in analytical testing capabilities.
US: California Governor vetoes Bill targeting PFAS
Summary: On October 13, Governor Gavin Newsom used his veto powers to stop Senate Bill 682, which has been passed by the state assembly. It would have limited per- and poly-fluoroalkyl substances (PFAS) use in various consumer products. Governor Newsom cited concerns over affordability and product availability for consumers.
The bill proposed banning PFAS in cleaning products, food packaging, and dental floss by 2028, cookware by 2030, and other products after this. Governor Newsom supported the health goals but warned of rapid market disruption and conflicts with federal regulations.
Impact: While businesses will no longer face deadlines to reformulate consumer products in California, they may want to continue to explore alternatives. PFAS products are facing increased scrutiny and litigation at federal and state level. Costs associated with the environmental cleanup of PFAS contamination are not resolved.
US: Amended Biosecure Act advances in Senate
Summary: On October 9, the Senate passed a new version of the Biosecure Act as part of the National Defense Authorization Act. The Act restricts federal funding for biotech firms linked to foreign adversaries. Unlike earlier versions, it avoids naming specific Chinese companies. It now uses broader definition for Biotechnology Companies of Concern, based on national security risks and foreign influence. It calls for the Office of Management and Budget to publish a list of entities one year after enactment.
Impact:An agreed House and Senate version of the Biosecure Act now needs to be passed before it’s signed into law.If passed, the Act could impact pharmaceutical businesses in several ways. These include businesses with US Government contracts, those in receipt of federal funding or with extensive supply chain dependency on identified through Biotechnology Companies of Concern. Businesses may want to start reviewing processes and supply chains to ensure they will be compliant with the potential consequences of the Act. They may need to diversify supply chain partnerships and manufacturing locations.
US: California Transparency in Frontier Artificial Intelligence Act (TFAIA) signed into law
Summary: On September 29, California lawmakers signed into law Senate Bill 53 (SB 53). The TFAIA is a landmark AI safety bill and has several important implications for the health and life sciences sector.
Other states are making similar legislation such as Colorado’s SB 25B-004.
Impact: Companies using AI in diagnostics, drug discovery, clinical decision support, or biotech research must now comply with new safety and transparency requirements, employees working on frontier AI in healthcare are protected when raising safety concerns, and health technology companies must report any critical AI-related safety incidents - such as autonomous behavior or data misuse - within 15 days.
US: Make America Healthy Again (MAHA) strategy
Summary: On September 9, the Make America Healthy Again MAHA Commission released a strategy report. It contains 128 recommendations on child health, nutrition, and chemical exposure. It supports precision pesticide use and front-of-package nutrition labeling. It proposes defining ultra-processed foods (UPFs) and banning petroleum-based food dyes by 2026. The report does not contain detailed implementation plans.
It follows the May 22, 2025, the Presidential Commission to MAHA which identified a health decline of American children. It stated this is driven by diet, behavior, medical, and environmental factors.
It blamed UPFs for rising childhood chronic diseases.
On September 13, the Association of American Physicians and Surgeons (AAPS) passed a resolution supporting MAHA’s scientific reform agenda.
Impact: AAPS’s endorsement of MAHA’s scientific reform agenda adds pressure on regulatory bodies to reassess long-standing policies and the MAHA strategy’s call for “gold-standard science” is prompting a shift in research priorities. Agencies like National Institutes of Health (NIH) and Food and Drug Administration (FDA) are being directed to fund studies on chronic disease prevention, environmental exposures, vaccine injury, and metabolic health.
[View source.]
