European Union: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

Bridging The Gap: An Insight Into Europe’s Biotech Proposals

The European Commission has released a detailed Staff Working Document outlining the evidential basis for the European Biotech Act, revealing how the EU plans to address its biotechnology innovation...

European Union Healthcare

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Arthur Cox

Dutch FDI Regime Scope Expanded: Six New Technology Categories Will Qualify As Highly Sensitive From 1 January 2027

The Dutch government has announced a significant expansion of its foreign direct investment screening regime, adding six new technology categories to the list of "sensitive technologies" subject to mandatory notification requirements. These additions reflect growing concerns about technological competition and national security risks associated with emerging technologies that could be weaponized or create strategic dependencies.

Netherlands Technology

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Loyens & Loeff

LD Düsseldorf, June 10, 2026, Decision Of The Court Of First Instance, UPC_CFI_758/2024, UPC_CFI_259/2025

Headnote: The claimant’s legitimate interest in the publication of a decision (Art. 80 UPCA) may, depending on the circumstances of the individual case, follow from the fact that the defendant has marketed the attacked embodiment by explicitly referencing to the key technology protected by the patent

BP

Bardehle Pagenberg

Biotechnology Patents And Project Hail Mary: Are Space Bugs Patentable?

The cinematic release of the 2021 novel, Project Hail Mary, has received rave reviews, with audiences praising the film as a faithful and visually stunning adaptation of the book.

European Union IP

NG

Novagraaf Group

Big News For The EU Pharma Sector!

European Union IP

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aera

Court Of Appeal, June 10, 2026, Order, UPC_CoA_85/2026

BP

Bardehle Pagenberg

Dutch FDI Screening Set To Expand To Six New Sensitive Technology Categories

Netherlands Government

JD

Jones Day

LD Düsseldorf, June 1, 2026, Order On Procedural Security, UPC_CFI_998/2026 Et Al

BP

Bardehle Pagenberg

Are You Ready For EUDAMED?

Denmark Healthcare

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aera

Life Sciences Patents Monthly Roundup—May 2026

European Union IP

AO

A&O Shearman

UPC Confirms Jurisdiction Over Foreign Manufacturers And Their European Distributors

AO

A&O Shearman

[Blog] Brevets et innovation : l’Amérique latine face au défi de la valorisation économique

NG

Novagraaf Group

Neue Anonymisierungspraxis des Bundesverwaltungsgerichts bei Urteilen zur Spezialitätenliste

Germany Healthcare

BK

Bär & Karrer

Update To The CNIL’s Reference Methodologies MR-001 And MR-003

DA

Delsol Avocats

The Maples Irish Employment Law Podcast – Legal Update For Employers In Ireland – AI Regulation Of Workforce Practices

Ireland Technology

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Maples Group

Pay Attention - Episode 19: Italy And The PTD - Il Secondo (Podcast)

Italy Employment

LS

Lewis Silkin

Arbitration And Business Decision (Video)

Ireland Litigation

Aceris Law

La preuve numérique au travail (adresse IP, signature électronique...) (Video)

France Employment

HA

Haas Avocats

Success Stories At CSB Group - Jan's Journey (Video)

CG

CSB Group

Evolving Private Equity Strategies: A More Selective, Operational Approach To Value Creation

At our European Health & Life Sciences Symposium 2026, conversations highlighted a market that remains active and attractive...

France Healthcare

SR

McDermott Will & Schulte

New EU Sample Retention Rules Coming Up For Veterinary Medicines Repackaged For Parallel Trade

The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn...

European Union Healthcare

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Altius

The UPC Clarifies The Threshold For “imminent Infringement”

On 13 August, the UPC Court of Appeal held that a marketing authorisation alone is not enough, but once a health technology assessment (HTA), pricing and reimbursement are completed, imminent infringement may be established. Pharmaceutical companies must therefore monitor regulatory steps closely to act in time.

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aera

European Medicines Agency SME Status – A Quick Guide

The European Medicines Agency offers special status to micro, small and medium-sized enterprises developing medicines, providing financial incentives, translation services, and regulatory guidance to foster innovation. Companies meeting specific employee and financial thresholds can access fee reductions, deferred payments, and expert support through the EMA's SME office.

Ireland Healthcare

AC

Arthur Cox

[Blog] EPO Technology Dashboard 2025 : Croissance Modérée Des Brevets Et Essor Des Technologies Numériques

NG

Novagraaf Group

EU AI Act Omnibus Deal Reached: Postponed Deadlines, Watermarking Compromise, And The Nudificiation Prohibition

Ireland Technology

WF

William Fry

EU Pharma Package: Advertising Compromise Proposal

Belgium Healthcare

CM

Crowell & Moring LLP

PCOS Name Changes To PMOS: Will PCOS’ Name Change Impact Patent Applications

PC

Potter Clarkson

Court Of Appeal, April 27, 2026, Order On Provisional Measures, UPC_CoA_917/2025

BP

Bardehle Pagenberg

EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections For Life Sciences Companies

Belgium Healthcare

AP

Arnold & Porter

European Health & Life Sciences Symposium 2026: Key Takeaways From Paris

France Healthcare

SR

McDermott Will & Schulte

L’actualité juridique numérique de la semaine – 5 mai 2026

France Technology

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Haas Avocats

UPC Court Of Appeal Lowers Threshold In Establishing Imminent Patent Infringement For Generic Launch

PC

Potter Clarkson

The European Commission’s Draft Merger Guidelines: Considerations For Technology, Pharmaceutical, And Life Sciences

European Union Anti-trust

GP

Goodwin Procter LLP

European Health & Life Sciences Symposium 2026: Key Takeaways From Paris

At McDermott’s European Health & Life Sciences Symposium 2026, more than 350 leaders gathered in Paris from across the life sciences and healthcare ecosystem to discuss the trends that are defining the sector’s future.

France Healthcare

SR

McDermott Will & Schulte

L’actualité juridique numérique de la semaine – 5 mai 2026

Gérard Haas et son équipe ont compilé pour vous les actualités clés afin de vous permettre de rester à jour sur les dernières tendances et évolutions des secteurs juridique et numérique.

France Technology

HA

Haas Avocats

UPC Court Of Appeal Lowers Threshold In Establishing Imminent Patent Infringement For Generic Launch

Boehringer sought injunctive relief against Zentiva Portugal in respect of the launch of a generic version of its drug marketed as Ofev® (containing nintedanib used for treating chronic lung diseases).

PC

Potter Clarkson

The European Commission’s Draft Merger Guidelines: Considerations For Technology, Pharmaceutical, And Life Sciences

The European Commission has published Draft Merger Guidelines consolidating two decades of enforcement practice into a single framework that emphasizes dynamic competition, innovation, and ecosystem effects. While retaining the existing legal test, the guidelines articulate a more explicit analytical approach that brings greater prominence to scale, resilience, and non-price dimensions of competition, with particular implications for technology and life sciences transactions.

European Union Anti-trust

GP

Goodwin Procter LLP

LD Brussels, April 14, 2026, Procedural Order, UPC_CFI_1357/2025; UPC_CFI_629/2025

BP

Bardehle Pagenberg

Getting Ready For The EU Pharma Package Part 3: Accelerating Drug Development And Authorization

From expanded approaches to scientific advice and a shift away from animal testing to new frameworks for platform technologies...

European Union Healthcare

AO

A&O Shearman

NIS 2 – A New Era For The Life Sciences Sector

There is no doubt that the Network and Information Security Directive (EU) 2022/2555 (“NIS 2”) significantly raises the bar for cybersecurity requirements in the EU.

Ireland Technology

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Matheson

Le nouveau décret « hébergeurs » s’aligne sur le référentiel de certification s’agissant du lieu d’hébergement

Le décret n° 2026-209 du 24 mars 2026, publié au Journal officiel du 26 mars 2026, modifie la partie réglementaire du code de la santé publique afin d’y inscrire les obligations relatives à la localisation...

France Healthcare

DA

Delsol Avocats

Despite EU Harmonisation, Member States May Impose Authorisation Requirements On Pharmacy-prepared Medicines, Rules EU Court Of Justice

Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use).

Belgium Healthcare

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Altius

EDPB Publishes Draft Guidelines On Processing Of Personal Data For Scientific Research Purposes

Ireland Privacy

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Matheson

The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal

European Union Healthcare

CM

Crowell & Moring LLP

CJEU Rules On GDPR Access Rights And Abuse Of Rights: What The Brillen Rottler Judgment Means For Life Sciences Companies

Belgium Healthcare

AP

Arnold & Porter

Pricing And Reimbursement Of Medicines In Ireland: New Framework Agreement 2026-2029 Published

Ireland Healthcare

AC

Arthur Cox

Getting Ready For The EU Pharma Package Part 2: Stricter Rules On Environmental Risk Assessment – Everything You Need To Know

European Union Healthcare

AO

A&O Shearman

Non-compliance To The Interoperability, Ethics, And Security Standards May Be Penalized

France Healthcare

DA

Delsol Avocats

For Medical Devices, “Possible Use” Amounts To Infringement Only If The Use Is In Line With Medical Practice

AO

A&O Shearman

Belgium’s Healthcare Plans For 2026 – And Where Pharma Fits In

Belgium Healthcare

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Altius

La non-conformité aux exigences des référentiels d'interopérabilité, d'éthique et de sécurité désormais sanctionnable

France Healthcare

DA

Delsol Avocats

The EU Pharma Package: Formal Adoption In Sight

European Union Healthcare

CM

Crowell & Moring LLP

The CNIL And The French National Authority For Health Join Forces To Support Digital Health Stakeholders

France Healthcare

DA

Delsol Avocats

La CNIL et la HAS s’associent pour accompagner les acteurs du numérique en santé

France Technology

DA

Delsol Avocats

Getting Ready For The EU Pharma Package: Key Changes To Regulatory Exclusivities, Orphan Medicinal Products And The “Bolar” Exemption Provisions

European Union Healthcare

AO

A&O Shearman

Movement On The Pharma Package: Formal Adoption Within Reach

Ireland Healthcare

AC

Arthur Cox

Greece’s New Ministerial Decision On Clinical Trial Contracts: Standardization, Timelines And E-signatures

Greece Healthcare

BL

Bernitsas

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Latest Videos

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What Regulatory Challenges Are Facing The Life Sciences Sector? (Video)

WF

William Fry

Webinar Video | Lunch & Learn: Life Sciences : Morceaux Choisis

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Altius

Webinar Video | Life Sciences Session #2: Vaccine Liability: What If Vaccination Goes Wrong?

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Altius

Launch Of Our Medical Device Publication (Video)

WF

William Fry

Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)

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Hogan Lovells

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