Insights : sector - Osborne Clarke

Life Sciences and Healthcare

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Regulatory Outlook

Products | UK Regulatory Outlook November 2025

General and Digital: European Commission consults on product safety and market surveillance | Council of the EU adopts 'one substance...

26/11/2025

Read time 9m

Life Sciences and Healthcare

Framework to fallout: Care Quality Commission launches single assessment framework review in England

Reforms could revert to a regime that social and health care providers were familiar with prior to changes in 2024

24/11/2025

Read time 5m

Life Sciences and Healthcare

Implications of the German GEMA ./. OpenAI judgment on the Life Sciences and Healthcare Sector

The District Court of Munich I has issued a landmark ruling on copyright infringement involving AI (11 November 2025, case...

24/11/2025

Read time 5m

Life Sciences and Healthcare

UK's biotech sector builds global life sciences status

TechBio conference showcases UK world-class research and biotech innovation

21/11/2025

Read time 4m

Intellectual property

Munich court grants Germany's first pan-EU cross-border patent injunction post-BSH v Electrolux

Munich Regional Court relied on BSH v Electrolux to injunct Formycon's aflibercept formulation in 22 countries based on doctrine of...

18/11/2025

Read time 8m

Life Sciences and Healthcare

European Medicines Agency encourages regulatory integration of patient experience data

Digital health gains ground in new EU paper discussing real-world evidence in pharma development

03/11/2025

Read time 6m

Health and safety regulation

Beauty and the health claims 'beast': a legal face lift for beauty marketing in Germany

On 9 October 2025 the German Federal Court of Justice (“BGH”) delivered a highly relevant judgment (I ZR 135/24 –...

24/10/2025

Read time 5m

Life Sciences and Healthcare

New regulatory framework established for the medicinal use of cannabis in Spain

The decree aims to balance therapeutic access to cannabis with guarantees of quality, safety and health control

24/10/2025

Read time 3m

International expansion and growth

Setting sail globally: launching internationally in an interconnected world

Launching a business internationally can be a game-changer but comes with its own set of challenges and considerations

23/10/2025

Read time 3m

Unified Patent Court

Life sciences at the fore of preliminary injunction trends emerging from Europe's UPC

Half of PIs granted at first instance on inter partes basis, with invalidity and non-infringement main points of refusal

10/10/2025

Read time 1m

Life Sciences and Healthcare

EU establishes mandatory CE marking for electronic health record systems

New framework creates regulatory pathway for electronic health systems while harmonising cross-border health data exchange requirements

01/10/2025

Read time 6m

Life Sciences and Healthcare

Healthcare providers to play pivotal role in reducing patient backlogs under NHS 10-year plan

A data-driven Care Quality Commission and neighbourhood care models are reforms with big opportunities for providers

30/09/2025

Read time 4m

Life Sciences and Healthcare

EU advocate general clarifies medical device classification and distributor duties

Preliminary MDR distributor guidance emerges from German dental equipment classification court case

30/09/2025

Read time 5m

Life Sciences and Healthcare

EU progresses targeted revision of medical device rules amid industry pressure

Commission seeks industry input on streamlining MDR and IVDR requirements before upcoming legislative proposal

29/09/2025

Read time 5m

Competition regulation

Belgian Competition Authority clarifies rules on exchange of information between pharmas for combination therapy

BCA guidance outlines framework for joint reimbursement applications to the NIHDI to comply with competition law

29/09/2025

Read time 6m

View all insights

Regulatory Outlook

Products | UK Regulatory Outlook November 2025

General and Digital: European Commission consults on product safety and market surveillance | Council of the EU adopts 'one substance...

26/11/2025

Read time 9m

Life Sciences and Healthcare

Framework to fallout: Care Quality Commission launches single assessment framework review in England

Reforms could revert to a regime that social and health care providers were familiar with prior to changes in 2024

24/11/2025

Read time 5m

Life Sciences and Healthcare

Implications of the German GEMA ./. OpenAI judgment on the Life Sciences and Healthcare Sector

The District Court of Munich I has issued a landmark ruling on copyright infringement involving AI (11 November 2025, case...

24/11/2025

Read time 5m

Life Sciences and Healthcare

UK's biotech sector builds global life sciences status

TechBio conference showcases UK world-class research and biotech innovation

21/11/2025

Read time 4m

Intellectual property

Munich court grants Germany's first pan-EU cross-border patent injunction post-BSH v Electrolux

Munich Regional Court relied on BSH v Electrolux to injunct Formycon's aflibercept formulation in 22 countries based on doctrine of...

18/11/2025

Read time 8m

Life Sciences and Healthcare

European Medicines Agency encourages regulatory integration of patient experience data

Digital health gains ground in new EU paper discussing real-world evidence in pharma development

03/11/2025

Read time 6m

Health and safety regulation

Beauty and the health claims 'beast': a legal face lift for beauty marketing in Germany

On 9 October 2025 the German Federal Court of Justice (“BGH”) delivered a highly relevant judgment (I ZR 135/24 –...

24/10/2025

Read time 5m

Life Sciences and Healthcare

New regulatory framework established for the medicinal use of cannabis in Spain

The decree aims to balance therapeutic access to cannabis with guarantees of quality, safety and health control

24/10/2025

Read time 3m

International expansion and growth

Setting sail globally: launching internationally in an interconnected world

Launching a business internationally can be a game-changer but comes with its own set of challenges and considerations

23/10/2025

Read time 3m

Unified Patent Court

Life sciences at the fore of preliminary injunction trends emerging from Europe's UPC

Half of PIs granted at first instance on inter partes basis, with invalidity and non-infringement main points of refusal

10/10/2025

Read time 1m

Life Sciences and Healthcare

EU establishes mandatory CE marking for electronic health record systems

New framework creates regulatory pathway for electronic health systems while harmonising cross-border health data exchange requirements

01/10/2025

Read time 6m

Life Sciences and Healthcare

Healthcare providers to play pivotal role in reducing patient backlogs under NHS 10-year plan

A data-driven Care Quality Commission and neighbourhood care models are reforms with big opportunities for providers

30/09/2025

Read time 4m

Life Sciences and Healthcare

EU advocate general clarifies medical device classification and distributor duties

Preliminary MDR distributor guidance emerges from German dental equipment classification court case

30/09/2025

Read time 5m

Life Sciences and Healthcare

EU progresses targeted revision of medical device rules amid industry pressure

Commission seeks industry input on streamlining MDR and IVDR requirements before upcoming legislative proposal

29/09/2025

Read time 5m

Competition regulation

Belgian Competition Authority clarifies rules on exchange of information between pharmas for combination therapy

BCA guidance outlines framework for joint reimbursement applications to the NIHDI to comply with competition law

29/09/2025

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

Dr. Andrea Schmoll

Partner, International Life Sciences and Healthcare Sector Co-Leader

+49 221 5108 4408 Email Andrea Full bio

Thomas Devred

Partner, Head of Life Sciences and Healthcare - Paris

+ 33 1 84 82 41 06 Email Thomas Full bio

Silvia Steiner

Partner

+34 93 419 18 18 Email Silvia Full bio

Maria Grazia Medici

Partner, Head of Life Sciences & Healthcare

+39 06 3269 5015 Email Maria Grazia Full bio

Herke van Hulst

Partner, Lawyer

+31 207 02 86 72 Email Herke Full bio

Catherine Wolfenden

Partner, Disputes & Risk Practice Group Head

+44 117 917 3600 Email Catherine Full bio

Marcus Vass

Partner, Head of Digital Health

UK +44 2071 057 634 Email Marcus Full bio

Rafael García del Poyo

Partner

+34 91 576 44 76 Email Rafael Full bio

Peter Rudd-Clarke

Partner

+44 207 105 7315 Email Peter Full bio

Tim Harris

Partner

+44 207 105 7144 Email Tim Full bio

Giulia Verusio

Senior Associate

+39 06 3269 5008 Email Giulia Full bio

J. Carlos Suárez

Counsel

+39 02 5413 1772 Email J. Carlos Full bio

David Haex

Co-Managing Partner

+32 2 515 9322 Email David Full bio

Xavier Pican

Partner, IP/ IT

+33 1 84 82 45 88 Email Xavier Full bio

Julia Kaufmann, LL.M.

Partner

+49 89 5434 8068 Email Julia Full bio

Dr Flemming Moos

Partner, Specialist lawyer for IT law

+49 40 55436 4054 Email Flemming Full bio

Dr Tim Reinhard

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

+49 89 5434 8024 Email Tim Full bio

Dr Martin Sundermann

Partner, Wirtschaftsmediator (MuCDR)

+49 89 5434 8026 Email Martin Full bio

Steve Wilson

Managing Partner

+1 917 545 3672 Email Steve Full bio

Jordi Casas

Co-Managing Partner

+34 93 419 18 18 Email Jordi Full bio

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Life Sciences and Healthcare

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