Belgium: Healthcare

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Belgian Pharma Law Summer Blog Series (Part 3): The Recently Passed ‘Bill Containing Various Provisions On Health’

Belgium's federal Chamber of Representatives has adopted a comprehensive bill introducing significant changes to pharmaceutical reimbursement procedures, including simplified approval tracks, new combination therapy rules, and an 80 million EUR annual industry contribution. The legislation also addresses drug unavailability issues and postpones certain 2024 reforms until 2028, fundamentally reshaping the financial and operational landscape for pharmaceutical companies operating in Belgium.

Belgium Healthcare

A

Altius

Belgian Pharma Law Summer Blog Series (Part 2): The New ‘Article 10 Guidance’ On Pharmaceutical Promotion

The Belgian Federal Agency for Medicines and Health Products has issued comprehensive new guidance on pharmaceutical promotion to healthcare professionals, consolidating previous circulars and introducing stricter...

Belgium Healthcare

A

Altius

Belgian Pharma Law Summer Blog Series (Part 1): The Act Of 30 May 2026 Containing Various Provisions On Medicinal And Health Products

Belgium introduces significant reforms to pharmaceutical law through the Act of 30 May 2026, addressing critical medicine shortages through enhanced export controls and stock allocation measures. The legislation also modernizes the Federal Agency for Medicines and Health Products' operational framework and adapts clinical trial regulations to support decentralized research models.

Belgium Healthcare

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Altius

European Commission Opens First Formal Antitrust Investigation In The Medical Devices Sector

The European Commission has launched its first formal antitrust investigation in the medical devices sector, examining whether Align Technology may have abused its dominant position by restricting interoperability between its Invisalign clear aligners and competing intra-oral scanners. The investigation focuses on allegations that the company created a closed ecosystem, forcing dental professionals to purchase iTero scanners to access Invisalign products for their patients.

European Union Anti-trust

AO

A&O Shearman

EU Pharma Package: Advertising Compromise Proposal

Belgium Healthcare

CM

Crowell & Moring LLP

The Council And Parliament Agree To Slim Down And Delay Parts Of The EU AI Act

Belgium Technology

LS

Lewis Silkin

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

Belgium Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Access Conditionalities And Shortage Measures Compromise Proposal

Belgium Healthcare

CM

Crowell & Moring LLP

EU General Court Bars Patient Association From Challenging Medicine Authorisation Refusal

European Union Healthcare

A

Altius

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

Belgium Healthcare

A

Altius

The Belgian Competition Authority's 2026 Priorities: What In-House Counsel Need To Know

Belgium Anti-trust

CM

Crowell & Moring LLP

The EU Pharma Package: Formal Adoption In Sight

European Union Healthcare

CM

Crowell & Moring LLP

The New Product Liability Directive

Belgium Consumer

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Altius

Belgian Parliament Has Adopted Urgent 2026 Healthcare Budget Measures: What's The Impact On The Pharma Industry?

Belgium Healthcare

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Altius

Constitutional Court On New Article 444 ITC: Good Faith Prevails, But Not On All Levels

LL

Loyens & Loeff

APAC Quarterly Newsletter, August 2026

Belgium Employment

IL

Ius Laboris

Limited Payment Terms In B2B Relationships

Belgium Commercial

A

Altius

EU AI Act Amendments Enter Into Force

Belgium Strategy

SJ

Steptoe LLP

Raising the bar: The European Broadcasting Union’s guidelines to prevent the sexualization of female athletes

Belgium Media & IT

GW

Gowling WLG

European Commission Proposes Biotech Act To Boost Health Biotechnology In The EU

The Biotech Act aims to help Europe in its struggle to translate world-class life sciences research into commercial success by tackling the structural barriers that have driven start-ups abroad...

Belgium Healthcare

CM

Crowell & Moring LLP

EU Reaches Pharma Package Deal: Key Changes At A Glance

On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here).

Belgium Healthcare

A

Altius

European Institutions Agree On The Reform To The EU Regulatory Framework For Medicinal Products

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union ("Council") and the European Commission...

European Union Healthcare

AP

Arnold & Porter

Under Pressure: Mental Health At Work In Times Of Uncertainty

Today is World Mental Health Day. To mark the occasion, we have republished our article exploring the important area of workplace mental health...

Worldwide Employment

IL

Ius Laboris

Food Hygiene For Fish: EU General Court Requires Scientific Basis To "Clarify" The Law

Belgium Healthcare

A

Altius

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 122

European Union Strategy

JD

Jones Day

European Commission Publishes New Variation Guidelines For Medicines

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

European Union Healthcare

CM

Crowell & Moring LLP

The New EU "Pharma Package": Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions

Belgium Healthcare

CM

Crowell & Moring LLP

Two Kiwis Per Day Chase Constipation Away – European Commission Approves Health Claim For Fruit

Belgium Healthcare

A

Altius

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

European Union IP

CM

Crowell & Moring LLP

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

European Union Healthcare

CM

Crowell & Moring LLP

EU Confirms App Stores And Developers Are Subject To Medical Device Laws

European Union Healthcare

OC

Osborne Clarke

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the "Bolar" exemption.

European Union IP

CM

Crowell & Moring LLP

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 ("Regulation"), updating the EU pharmacovigilance (or "PV") rules by way of amendments...

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal...

European Union Healthcare

CM

Crowell & Moring LLP

EU Confirms App Stores And Developers Are Subject To Medical Device Laws

The latest MDCG guidelines highlight a regulatory environment in the EU that is growing in depth and reach for software-based medical devices and diagnostics

European Union Healthcare

OC

Osborne Clarke

The New EU "Pharma Package": The Transferable Exclusivity Voucher—A Comparison Of Commission/Parliament/Council Positions

European Union Healthcare

CM

Crowell & Moring LLP

Trends In Life Sciences M&A: Cybersecurity And AI Take Center Stage

Complementary perspectives on the challenges and opportunities shaping healthcare M&A. In Belgium, the implementation of the EU's NIS2 Directive has elevated cybersecurity to a central concern...

Belgium Technology

LL

Loyens & Loeff

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security...

European Union Technology

JD

Jones Day

Under Pressure: Mental Health At Work In Times Of Uncertainty

Today is the World Day for Safety and Health at Work. To mark the occasion, we take a look at the important area of mental health in the workplace...

Worldwide Employment

IL

Ius Laboris

European Health Data Space Regulation Sets Requirements For Electronic Health Record Systems

On 5 March 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive...

European Union Healthcare

AO

A&O Shearman

The New Belgian Government's Public Health Policy: 10 Key Take-Aways For Pharma Policy

Belgium Healthcare

A

Altius

CJEU's DocMorris Ruling: Where Is The Line For Pharmaceutical Advertising?

Belgium Healthcare

A

Altius

Healthy Byte | Live From HIMSS 25! (Video)

Belgium Healthcare

AB

Alston & Bird

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

European Union Technology

JD

Jones Day

AI Literacy Becomes Mandatory For Life Sciences Across The EU

Belgium Healthcare

OC

Osborne Clarke

The European Commission Launches Public Consultation On The MDR And IVDR

European Union Healthcare

AP

Arnold & Porter

Belgium Creates A New Legal Exemption For Unauthorised Medicines

Belgium Healthcare

OC

Osborne Clarke

Medtech Sector Faces New EU 'Green Deal' Recommendations

European Union Healthcare

OC

Osborne Clarke

European Medicines Agency Issues Guidance On AI Use In Pharma Regulatory Science

European Union Healthcare

OC

Osborne Clarke

Belgium Advances Digital Health As Its Parliament Calls For Action

Belgium Healthcare

OC

Osborne Clarke

EU Competitiveness Report Pushes For Greener And Digitalised Medical And IVD

European Union Healthcare

OC

Osborne Clarke

New Payment Terms In Public Procurement

Belgium Government

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Altius

Preparing For The EU's New Approach To Critical Medicines And Medicine Shortages: A New 'Critical Medicines Act'?

European Union Healthcare

CM

Crowell & Moring LLP

Belgian Regulator Introduces New Rules On Hospitality And Meals For Healthcare Professionals

Belgium Healthcare

OC

Osborne Clarke

The Impacts Of The EU Data Act On Medical And Health Devices Companies

European Union Healthcare

SJ

Steptoe LLP

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Alston & Bird

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