European Union: Disclosure Of Clinical Trial Data By The EMA: Where Are We Now?

Jackie Mulryne and Louise Strom, Arnold & Porter Kaye Scholer LLP, consider the issues that continue to arise in relation to access to clinical trial data

When, and in what circumstances, a third party can access clinical trial data submitted to the European Medicines Agency (EMA) once a product has been authorized continues to be a hot topic in the European Union (EU). The EMA has stated that one of its key goals is the publication of clinical trial data once the decision-making process is complete. This is because, it is said, it is important to establish trust and confidence in the regulatory system so the public has a better understanding of the regulatory decision-making process.

The EMA's position has received the support of academic researchers and patient groups. There appears to be a perception that companies have, in the past, hidden "unhelpful" data and have not been pro-active in publishing negative results, so that many believe companies cannot be trusted to independently release data about their products. Indeed, a recent academic study, published in the British Medical Journal, systematically assessed the disclosure policies of pharmaceutical company clinical trial sponsors, and found them to be "highly variable."

On the other side of the debate, while industry has broadly welcomed increased transparency, and the increased confidence in the industry this brings, companies have been more cautious about the wholesale disclosure of their data, particularly where those data can be accessed and used by competitors. Individual companies have also been unable to convey to the public, and the EMA, why certain data should be withheld from disclosure. As a result, the Courts have become involved, in a recent string of cases seeking to define the boundaries of the requirement to disclose clinical trial data.

What is the current state of play?

Aside from the wealth of information included in the European Public Assessment Report, and other documents published at the time of authorization of a medicinal product, there are two main avenues for someone to access clinical trial data that have been submitted to the EMA:

  • The EMA provides copies of clinical study reports to third parties who request them under Regulation 1049/2001/EC on access to documents, and the EMA's implementing Policy 0043. Under the Regulation and the EMA's policy, EU citizens and legal entities have an express right to access documents held by public authorities, including the EMA. An exception to this right exists where disclosure would undermine the commercial interests of a natural or legal person, including intellectual property rights, unless there is an overriding public interest in disclosure. This is known as commercially confidential information (CCI). Any person can make a request for documents, without giving a reason, and there is no restriction on how such documents can be used once released
  • The EMA publishes clinical data on a dedicated website after the grant of a marketing authorization (or refusal, or withdrawal of the application) in accordance with its Policy 0070. The data are available in two forms: (i) to view by those who register for the website, and (ii) to download and re-use by academics and for non-commercial research purposes. All use is subject to the EMA's terms of use, whereby the use of the data must be for non-commercial purposes only. CCI may be redacted before the data are released

The EMA has defined CCI, which applies to its implementation of both policies, as any information that is not in the public domain or publicly available, and where disclosure may undermine the legitimate economic interests of the document owner. What this means in practice is still up for debate.

What are the ongoing issues?

Firstly, the broad scope of the EMA's proactive Policy 0070 is still being realized by industry. The proactive policy was developed in the absence of a clear legal provision requiring the EMA to publish documents submitted by third parties – although the Clinical Trials Regulation 536/2014/EU, when applicable in 2019, will require full clinical study reports to be released after authorization (or refusal or withdrawal). Policy 0070 is clearly a compromise between the position of academics and patient groups on the one hand, and industry on the other. The EMA believes it does not have any flexibility to allow controlled-release of documents where there is a request for access to documents. In contrast, the proactive policy allows the EMA – and arguably the company – to retain some control over the subsequent use of the data, and to protect the rights in those data. At present, only 27 of the 231 procedures that fall under Policy 0070 have been published. The process has been noted by both sides to be very resource intensive, and a number of questions continue to be raised about how exactly the process should be undertaken and what should be released.

The second issue has been the definition of CCI, and there is a disconnect between what the EMA and what industry considers should be withheld from disclosure. There have been a number of cases broughtby companies due to the uncontrolled use that a third party can make of data received under the EMA's reactive policy, and challenging the EMA's interpretation of its policy. These cases have been broader than access to clinical trial data specifically, but the core issue to be determined is the meaning of CCI. However, two of these cases (Case T-718/15, PTC Therapeutics International v EMA and Case T-33/17, Amicus v EMA) relate to requests by third parties to a company's clinical study reports. It is likely that over the coming months, the Court of Justice of the European Union will give its judgment on these cases. Stakeholders on both sides hope this will give some much needed clarity on the issues, and that the Court finds the correct balance between access to data, and protection of commercial interests.

Originally published in Clinical Trials Arena

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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