How To Be Prepared For A Catastrophic Data Breach

Pharmaceutical companies will be directly affected by the EU’s General Data Protection Regulation because they often hold large amounts of personal health information, such as clinical trial data, and any accidental disclosure of those data will be taken very seriously by the regulatory authorities. Richard Dickinson, Jacqueline Mulryne and Zoe Walkinshaw look at what companies should be doing to limit the impact of a catastrophic data breach on their corporate reputation, the individuals affected, and the validity of the data.

DataBreach
Pharma firms need to know how to deal with a data breach • Source: Shutterstock

The EU privacy landscape underwent a seismic shift in May 2018 when the General Data Protection Regulation (GDPR) was introduced. In the post-GDPR world, all companies face tougher fines if they experience a personal data breach – up to €20m or 4% of worldwide annual turnover.

About the Authors

Richard Dickinson and Jacqueline Mulryne are partners, and Zoe Walkinshaw is an associate, at law firm Arnold & Porter.

There are also tougher obligations to report breaches, in particular those that pose a risk to people’s rights and freedoms. Compliance with the GDPR, including the implementation of sufficient measures...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By 

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.