EMA data transparency regulation upheld in ‘landmark rulings’

By Melissa Fassbender

- Last updated on GMT

(Image: iStock/AlexStar)
(Image: iStock/AlexStar)

Related tags European union

The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.

The European Medicines Agency (EMA) appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trials documents in October 2016. The rulings were made as part of court cases brought by PTC Therapeutics and Intervet (MSD Animal Health).

This week, the EMA announced that the General Court delivered “landmark rulings​” for the agency, which uphold its decision to release documents.

According to the EMA​, this is the first time that the Court of Justice of the EU has “had the opportunity to pronounce itself on the application of the Transparency Regulation to documents held by EMA​.”

Stefano Marino, EMA’s Head of Legal Department said the ruling affirms the information contained in the requested documents “cannot be considered commercially confidential in its entirety​.”

We understand that with these rulings the General Court endorses our implementation of the Transparency Regulation that focuses on the interest of patients and public health​,” she said in a press release.

The court rejected claims by Pari Pharma​, PTC Therapeutics​, and MSD Animal Health Innovation and Intervet​, explaining the companies failed to prove the release of the contested documents would undermine commercial interests.

Moving forward, the EMA said it will continue to assess individual requests for access to documents submitted under the Transparency Regulation

Industry determining the next steps

In a statement to Outsourcing-Pharma, PTC said the company and its legal advisors are carefully reviewing the judgment to determine next steps.

PTC undertook the initial legal action because disclosure of the affected parts of PTC’s MAA could undermine our ability to protect our regulatory and patent rights within Europe and elsewhere, as they could be taken by potential competitors and used to obtain regulatory approvals for competing versions of Translarna in other countries before patent expiration​,” the company explained.

The statement continued: “PTC supports the transparency of clinical research and safety information for the benefit of healthcare professionals and patients and we believe that as much information about medicinal products as practicable should be made available to the public​.

The company noted it has published results from its clinical trials in peer-reviewed journals and has presented data at scientific meetings. Additionally, PTC provides academic institutions and independent investigators access to its data, for those wanting to study the drug and its effectiveness in various rare diseases.

However, in line with the European and international regulations, there are various interests to be balanced, including data privacy rights and the rights of pharmaceutical innovators to keep certain information confidential until such time as its disclosure would not harm the company's legitimate commercial interests​,” the statement concluded.

MSD Animal Health also sent us a statement explaining that it will weigh the decision to determine the company’s options and next steps.

The statement read: “MSD Animal Health is committed to transparency​. MSD Animal Health has been seeking a well-balanced regulatory framework that would satisfy the legitimate public interest in understanding the important efficacy and safety data on which regulatory decisions are based, and that would at the same time effectively safeguard legitimate needs to protect certain commercially confidential information.”

The company said it would be inappropriate for it to comment any further out of respect for the court as well as for the other parties involved.

Related news

Show more

Related products

show more

Saama accelerates data review processes

Saama accelerates data review processes

Content provided by Saama | 25-Mar-2024 | Infographic

In this new infographic, learn how Saama accelerates data review processes. Only Saama has AI/ML models trained for life sciences on over 300 million data...

More Data, More Insights, More Progress

More Data, More Insights, More Progress

Content provided by Saama | 04-Mar-2024 | Case Study

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Related suppliers

Follow us


View more