All Insights

Life Sciences and Healthcare

European courts and regulators target the intersection of regulatory and patent trends in the life sciences

The Tecfidera case and provisional pharma reform agreement put regulatory exclusivity and patent protection in focus
Life Sciences and Healthcare

EU pharma regulators publish annual AI observatory report

The EMA and HMA signal a shift from AI adoption to implementation, with coordinated AI pharma guidance underway
Life Sciences and Healthcare

CJEU judgment redraws the perimeter of EU medical device rules

Ruling on unprinted patient wristbands tightens qualification, marketing claims and distributor duties
Regulatory Outlook

Products | UK Regulatory Outlook July 2026

General/digital products updates: UK Government sets out regulatory 'sandbox' plans under forthcoming Regulating for Growth Bill | UK Government launches
Life Sciences and Healthcare

Spain rewrites pricing and funding rules for medical products and devices

The Ministry of Health is driving the most significant reform for medicines within the Spanish NHS in more than a
Life Sciences and Healthcare

Reimbursement in Poland — What's changing?

The PPO President formally transmitted a comprehensive review of accession conditions to the Minister of Justice the first structured inter-institutional
Life Sciences and Healthcare

English High Court finds government acted unlawfully in introducing regulations on lighter-touch approach to gene editing

Uncertainty remains about what will happen to the regulations as minister acted irrationally and failed to make adequate enquiries over
Life Sciences and Healthcare

EU approves lighter-touch regulation of gene editing in plants after long legislative process

New rules published in the Official Journal; last-minute amendments that would have restricted patentability of NGT plants are rejected
Life Sciences and Healthcare

EU introduces harmonised template for clinical trial recruitment and consent

A single EU-wide structure now governs how sponsors document recruitment and informed consent across all member states
Life Sciences and Healthcare

EU draft guidelines sharpen high-risk AI classification for medtech and digital health

European Commission offers draft guidance on risk classification for medtech, biometrics, triage and health insurance
Artificial intelligence

European Commission publishes draft AI Act guidelines on high-risk classification and targeted consultation

Affected businesses have until 23 July 2026 to suggest changes to the current draft guidelines, and should develop appropriate AI
Knowledge Notes

The UK King's Speech – what can business expect this year?

The government has set out its agenda for the new Parliamentary session, with continued emphasis on economic growth