Insights : sector - Osborne Clarke

Life Sciences and Healthcare

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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

31/07/2026

Read time 5m

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

New -

31/07/2026

Read time 8m

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...

29/07/2026

Read time 13m

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...

22/07/2026

Read time 3m

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...

10/07/2026

Read time 9m

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...

09/07/2026

Read time 4m

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

07/07/2026

Read time 4m

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

18/06/2026

Read time 6m

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European Commission offers draft guidance on risk classification for medtech, biometrics, triage and health insurance

18/06/2026

Read time 7m

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...

18/06/2026

Read time 8m

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

15/05/2026

Read time 19m

Life Sciences and Healthcare

US-UK deal reshapes pharma trade and pricing for life sciences businesses

The agreement marks a structural shift in trading conditions, pricing and market access for life sciences companies in both markets

30/04/2026

Read time 5m

Regulatory Outlook

Products | UK Regulatory Outlook April 2026

UK and EU regulatory and legal developments affecting general and digital, life science and healthcare, and sustainable products, including the...

30/04/2026

Read time 10m

Life Sciences and Healthcare

EU privacy regulators adopt a single data-processing lawful basis for clinical trials

The EDPB and the EDPS back the proposed European Biotech Act but urge stronger safeguards for health and genetic data

24/04/2026

Read time 5m

Life Sciences and Healthcare

UK clinical trials regulation undergoes its biggest overhaul in 20 years

New framework streamlines approvals and reporting for sponsors while tightening transparency and pharmacovigilance duties

23/04/2026

Read time 6m

View all insights

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

31/07/2026

Read time 5m

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

New -

31/07/2026

Read time 8m

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...

29/07/2026

Read time 13m

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...

22/07/2026

Read time 3m

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...

10/07/2026

Read time 9m

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...

09/07/2026

Read time 4m

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

07/07/2026

Read time 4m

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

18/06/2026

Read time 6m

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

18/06/2026

Read time 7m

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...

18/06/2026

Read time 8m

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

15/05/2026

Read time 19m

Life Sciences and Healthcare

US-UK deal reshapes pharma trade and pricing for life sciences businesses

The agreement marks a structural shift in trading conditions, pricing and market access for life sciences companies in both markets

30/04/2026

Read time 5m

Regulatory Outlook

Products | UK Regulatory Outlook April 2026

UK and EU regulatory and legal developments affecting general and digital, life science and healthcare, and sustainable products, including the...

30/04/2026

Read time 10m

Life Sciences and Healthcare

EU privacy regulators adopt a single data-processing lawful basis for clinical trials

The EDPB and the EDPS back the proposed European Biotech Act but urge stronger safeguards for health and genetic data

24/04/2026

Read time 5m

Life Sciences and Healthcare

UK clinical trials regulation undergoes its biggest overhaul in 20 years

New framework streamlines approvals and reporting for sponsors while tightening transparency and pharmacovigilance duties

23/04/2026

Read time 6m

View all insights

Will James

Partner, International Life Sciences and Healthcare Sector Co-Leader

+44 207 105 7774 Email Will Full bio UK

Dr. Andrea Schmoll

Partner, International Life Sciences and Healthcare Sector Co-Leader

+49 221 5108 4408 Email Andrea Full bio Germany

Thomas Devred

Partner, Head of Life Sciences and Healthcare - Paris

+ 33 1 84 82 41 06 Email Thomas Full bio France

Silvia Steiner

Partner

+34 93 419 18 18 Email Silvia Full bio Spain

Maria Grazia Medici

Partner, Head of Life Sciences & Healthcare

+39 06 3269 5015 Email Maria Grazia Full bio Italy

Herke van Hulst

Co-chair of the International Council, Partner, Lawyer

+31 207 02 86 72 Email Herke Full bio The Netherlands

Catherine Wolfenden

Partner, Disputes & Risk Practice Group Head

+44 117 917 3600 Email Catherine Full bio UK

Marcus Vass

Partner, Head of Digital Health

UK +44 2071 057 634 Email Marcus Full bio UK

Rafael García del Poyo

Partner

+34 91 576 44 76 Email Rafael Full bio Spain

Dr Agnieszka Sztoldman

Partner, Head of IP

+48 503 973 626 Email Dr Agnieszka Full bio Poland

Tim Harris

Partner

+44 207 105 7144 Email Tim Full bio UK

Giulia Verusio

Senior Associate

+39 06 3269 5008 Email Giulia Full bio Italy

J. Carlos Suárez

Counsel

+39 02 5413 1772 Email J. Carlos Full bio Italy

David Haex

Co-Managing Partner

+32 2 515 9322 Email David Full bio Belgium

Xavier Pican

Partner, IP/IT/Data

+33 1 84 82 45 88 Email Xavier Full bio France

Julia Kaufmann, LL.M.

Partner

+49 89 5434 8068 Email Julia Full bio Germany

Dr Flemming Moos

Partner, Specialist lawyer for IT law

+49 40 55436 4054 Email Flemming Full bio Germany

Dr Tim Reinhard

Partner, Head of Intellectual Property Germany, Wirtschaftsmediator (MuCDR)

+49 89 5434 8024 Email Tim Full bio Germany

Dr Martin Sundermann

Partner, Wirtschaftsmediator (MuCDR)

+49 89 5434 8026 Email Martin Full bio Germany

Steve Wilson

Managing Partner

+1 917 545 3672 Email Steve Full bio US

Jordi Casas

Co-Managing Partner

+34 93 419 18 18 Email Jordi Full bio Spain

Vladimir Murovec

Counsel, Head of Life Sciences Regulatory

+32 472 607 628 Email Vladimir Full bio Belgium

Hadrien Chef

Partner

+32 2 515 93 24 Email Hadrien Full bio Belgium

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Life Sciences and Healthcare

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