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European Union › Data Protection › Pharmaceutical Industry

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Jones Day

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

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 120

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Jones Day

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

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 118

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 117

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

Hogan Lovells

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

Hogan Lovells on

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

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Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

Spilman Thomas & Battle, PLLC on

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

Nelson Mullins Riley & Scarborough LLP on

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data...

Goodwin on

We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

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This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 95

Jones Day on

This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 85

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COMPETITION & STATE AID - State Aid - European Commission approves new and amended Member State measures to support the economy - Since the onset of the coronavirus outbreak, the Commission has adopted a significant number...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 80

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more

Hogan Lovells

Heads up! New Spanish Code of Conduct on personal data in clinical trials and pharmacovigilance

Hogan Lovells on

The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 73

Jones Day on

COMPETITION & STATE AID - Competition - Commission publishes Competition Policy – 2021 at a glance. On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance. ...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.72

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COMPETITION & STATE AID - Competition- European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions - On 16 December 2021, the...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 71

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COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more

Jones Day

COVID-19 KEY EU Developments, Policy & Regulatory Update No. 70

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COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

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COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 68

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COMPETION & STATE AID - European Commission adopts Communication on a Competition Policy Fit for New Challenges - On 18 November 2021, the European Commission adopted a Communication on a Competition Policy Fit for New...more

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