Companies respond to EMA's efforts to release clinical trial data

By Melissa Fassbender contact

- Last updated on GMT

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

Related tags: European union, Ema

The EMA recently appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.

The rulings were made as part of court cases brought by PTC Therapeutics and Intervet.

The EMA holds that the decision to release the documents, which were requested by third parties under the Transparency Regulation, is consistent with the EU’s regulation.

Our approach to transparency has been welcomed by many of our stakeholders and these court cases are a good opportunity to test our rules on making available to the general public the documents on which EMA’s scientific opinions on medicines are based​,” said Stefano Marino, EMA’s Head of Legal Department in a press release.

The EMA describes the regulation as the EU’s “central instrument to achieve transparency​,” and while it has previously been challenged, the Court of Justice has never released a judgment on any of the cases. Instead, the orders were set aside by the Court of Justice and the marketing authorization holders withdrew the main cases.

The EMA described the case at hand as an “opportunity to receive clarity from the Court of Justice as to whether EMA’s approach is correct or not and to eliminate operational uncertainties for the Agency or the stakeholders using its system​.”

The EMA isn’t providing any additional comment at this time.

PTC offered to 'engage with requester'

In a statement to Outsourcing-Pharma.com, PTC Therapeutics confirmed that it is challenging the EMA’s decision “regarding an information request from another pharmaceutical company to disclose parts of documents contained in PTC’s marketing authorization application (MAA) for Translarna™ (ataluren)​.”

The company explained, “Disclosure of these 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."

PTC added that “premature disclosure​” of the documents could challenge its ability to effectively patent future discoveries, as the documents have the potential to “form the basis for future patent applications​.”

According to PTC, the company offered to meet with the requesting pharmaceutical company to discuss “any data or information needs​” prior to initiating litigation. However, it said the EMA has declined to provide the requesting pharmaceutical company’s identity, “or to facilitate any efforts by PTC to engage with the requester (who remains anonymous) to discuss appropriate protections for PTC’s confidential information​.”

The company said that is supports the transparency of clinical research and safety information and that “as much information about medicinal products as practicable​” should be made publically available. However, it added that the various interests need to be balanced.

As such, PTC said it intends to oppose the EMA’s appeal of the President’s interim in order to “protect its interests until the General Court can consider the complex issues involved in this matter and make a final ruling​.”

Such a final ruling will provide important clarity to all affected parties on the framework for disclosure requests in the future,​” it said.

Intervet confident decision to be upheld on appeal

When asked to comment on the case, MSD Animal Health (Intervet) told Outsourcing-Pharma.com that it is committed to transparency through publishing data in scientific journals, on applicable databases, and making available data to academics “subject to appropriate confidentiality undertakings in place​.”

According to the company, the EMA has concluded that the benefit-risk profile of the medicine in question, Bravecto, is positive, and that summaries have been published in the European Public Assessment Report (EPAR).

However, in its statement to us, MSD Animal Health added:

“In contrast to the EPAR, the toxicology studies themselves contain various categories of detailed commercially confidential information and trade secrets, all of which have long been considered confidential by regulators and courts. They should not be disclosed to competitors (as was the case in this instance) who could use the data to their commercial advantage.”

The company said that is it pleased the President of the General Court has upheld “this longstanding principle​,” and is confident the decision will be upheld on appeal.

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