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Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

Topics

Access and Benefit-Sharing

An EU Biodiversity Market by 2027?  The new EU’s Roadmap towards Nature CreditsChina’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know

Africa

EU Talking Life Sciences Audiocast: Regulatory and Policy Developments from South Africa - SAHPRA's Proposed Black Economic Empowerment (BEE) PolicyEU Talking Life Sciences Audiocast: Developments in the African Medicines Agency and Regulatory Convergence

Anti-Corruption

Germany Headed to Stricter Criminal Laws Against “Corruption In The Healthcare Sector”Deferred Prosecution Agreements in the UK: One Step Closer to the Introduction of a New Enforcement Tool in Bribery and Corruption Cases

Artificial Intelligence (AI)

MHRA Outlines New Strategic Approach to Artificial IntelligenceWHO Publishes Regulatory Considerations on AI for Health

Brexit

Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional materialEuropean Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices

CE Mark

UK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices

China

China’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know

Clinical Trial Applications

Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle

Commercial Structures

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

Compassionate Use

New Early Access and Off-Label Use Rules in FranceBelgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

Competition

European Commission Publishes Exceptional Antitrust Guidance for Undertakings Collaborating to Address the Shortage of Essential Products and Services during COVID-19DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19

Conformity Assessment

UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)

Corporate

The CDA - Five Practical ConsiderationsThe Unintended Consequences of Non-Disclosure Agreements

Corporate Reporting and Disclosures

Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

Cosmetics

The Cali Fund and Why Legal Certainty Matters for Life Sciences R&DJust Weeks After COP16: CBD Secretariat Launches Stakeholder Consultations for the Operationalization of the DSI Mechanism. How Should Companies Engage?

COVID19

What Companies Should Know About the WHO Pandemic AgreementEU Health Emergency Mechanisms: Impact on Medical Devices

Employment

European Regulators Set Out Data Anonymization StandardsNew Directors’ Remuneration Regime: The Facts for Life Sciences Companies

Environmental & Clean Technology

New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsHistoric Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies

Environmental, Social and Governance (ESG)

An EU Biodiversity Market by 2027?  The new EU’s Roadmap towards Nature CreditsThe EPR Obligations of the New Urban Wastewater Treatment Directive: Key Questions and Next Steps for Member States

EU Pharma Law Revision

European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for IndustryEU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast

EU State aid rules

German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules

European Union

An EU Biodiversity Market by 2027?  The new EU’s Roadmap towards Nature CreditsEuropean Health Data Space Published

Export

UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)The Implications of the Windsor Framework

Extended Producer Responsibility

The EPR Obligations of the New Urban Wastewater Treatment Directive: Key Questions and Next Steps for Member StatesNew EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products

Financial

Synthetic Royalty and Drug Development Financings – A Funding Structure Growing in EuropeNon-Dilutive Financing: The U.S. Trend Catching on in Europe’s Life Sciences Sector

Food & Beverage

EU Court Overturns EU-wide Botanical Food BanFood Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

Food & Drug Regulatory

What Companies Should Know About the WHO Pandemic AgreementEU Joint Procurement – An Overview

Food Labelling

UK Judge Permits “Raw” Label for Honey

Gene Editing

EU Pharma Legislation Review Series:  GMO MedicinesEU Pharma Legislation Review Series: Addressing Environmental Risks

Global Supply Chain

Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companiesEU Pharma Legislation Review Series: Decentralized Manufacturing

GMOs

EU Pharma Legislation Review Series:  GMO Medicines

Greenwashing

EU Adopts New Rules on Greenwashing and Social Impact ClaimsEU Pharma Legislation Review Series: Addressing Environmental Risks

HEALTH PRIVACY

European Health Data Space PublishedEuropean Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers

Healthcare system

The Updated NHS Commercial Framework for New MedicinesEuropean Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers

Intellectual Property

What Companies Should Know About the WHO Pandemic AgreementUK HRA Consults on a New Model Investigator-Initiated Study Agreement

Legal Title

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

Life Sciences

An EU Biodiversity Market by 2027?  The new EU’s Roadmap towards Nature CreditsSynthetic Royalty and Drug Development Financings – A Funding Structure Growing in Europe

M&A

EU Talking Life Sciences Audiocast: Current Trends in M&A and Licensing in the Life Sciences Industry

Marketing authorisation

Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional materialEuropean Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided

Medical Devices

EU Joint Procurement – An OverviewThe Covington European Life Sciences Symposium 2025

Medical Devices

What Companies Should Know About the WHO Pandemic AgreementEU Joint Procurement – An Overview

Medicinal Products

What Companies Should Know About the WHO Pandemic AgreementEU Joint Procurement – An Overview

Medicinal Products

EU Joint Procurement – An OverviewThe Updated NHS Commercial Framework for New Medicines

Miscellaneous

UK Government Announces Launch of Pilot Scheme to Accelerate Access to Innovative Medical DevicesUK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

Novel Food

Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

Patents

Single Market Emergency Instrument: Potential Impact on Medical DevicesEU Talking Life Sciences Audiocast: Supplementary Protection Certificates – What It Means for a Product to Be Protected by a Basic Patent in Force and Future Proposals in the EU

Pharma

Re-Launch of UK’s Innovative Licensing and Access Pathway (“ILAP”)European Commission Consults on Update to Pharmacovigilance Rules

Pharmaceutical Advertising and Communications

European Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain dividedNew ABPI Code and PMCPA Constitution and Procedure Published

Pharmaceutical companies

What Companies Should Know About the WHO Pandemic AgreementThe Cali Fund and Why Legal Certainty Matters for Life Sciences R&D

Pharmaceutical Rules

European Commission Consults on Update to Pharmacovigilance RulesEuropean Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided

Privacy & Data Security

European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare ProvidersGermany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

social media

EU Talking Life Sciences Audiocast: Episode 3 – Social Media Challenges for Pharma Companies - Comparing Approaches in Europe and the USUK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

Supply Chain Due Diligence

Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

Tax

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

Tax Structures

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

UKCA Mark

MHRA Consults on New UK Pre-Market Medical Device MeasuresUK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

Uncategorized

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesNew EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products

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Covington advises established and emerging life sciences companies, including many of the major multinational pharmaceutical manufacturers, biotechnology companies, and major producers of medical devices, cosmetics, foods, food additives, food packaging, dietary supplements, pesticides and specialty chemicals, and other consumer products.

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