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November 2013

The European Medicines Agency (EMA) is currently developing a policy on the proactive publication of clinical-trial data. Formerly, the EMA had adopted a policy on access to its documents, which the EMA stated would allow documents submitted to it as part of a marketing authorisation application, such as clinical trial reports, to be disclosed, provided that the decision-making process for the application in question was finalised. However, in interim proceedings, the European Union General Court (EGC) suspended the operation of such EMA decisions concerning the grant of third party access to documents held by the EMA which contain information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market.

Background

On 24 June 2013, the EMA released a new draft policy on publication and access to clinical trial data for a three-month public consultation. The draft follows a process which the EMA started in 2010. Before 2010 the EMA refused access to clinical study reports because it would undermine the commercial interests of the manufacturers of those medicinal products. However, after a complaint filed by a research and information centre to the European Ombudsman and his conclusion that the relevant reports did not contain commercially confidential information, the EMA decided to grant access to those reports and committed itself to taking appropriate measures in order to implement the Ombudsman’s recommendations.

Therefore, on 30 November 2010 the EMA adopted a new policy on access to its documents. It raised the possibility of the EMA disclosing documents submitted to it as part of a marketing authorisation application, such as clinical trial reports, if the decision-making process for the application in question was finalised. However, the EMA committed to continuing to extend its approach to transparency. A key goal in this process would be the proactive publication of clinical trial data for medicines once the decision-making process on an application for an EU-wide marketing authorisation is complete. As a consequence, and following the publication of the draft, the EMA started a consultation process with the participation of a broad range of stakeholders and European bodies. Five advisory groups met between January and April 2013 with the aim of developing the now published draft policy on publication and access to clinical trial data.

The EMA´s approach to publication of clinical-trial data

According to the EMA, gaining access to clinical trial data will benefit public health in future and will make drug development more efficient. Nevertheless, the EMA acknowledges that the protection of personal data is enshrined in EU legislation and is a fundamental right of EU citizens. The policy on publication and access to clinical trial data must, therefore, ensure adequate protection of personal data in compliance with Regulation (EC) No 45/2001 and Directive 95/46/EC and must respect the boundaries of patients' informed consent. Furthermore, the EMA will respect and refrain from divulging commercially confidential data or information. In general, however, according to the EMA view, clinical trial data cannot be considered as commercially confidential information because the interests of public health outweigh such considerations.

The policy of the EMA concerns only clinical trial data that will be submitted to the EMA after the policy comes into effect. All other clinical trial data currently held by the EMA (e.g. on products already on the market) or pre-existing clinical trial data in respect of marketed products that will be submitted to the EMA (e.g. in the context of a referral procedure) continues to be made available to external requesters on a “reactive” basis. Data from clinical trials that are not held by the EMA are outside the scope of the draft policy. This also applies for pharmacovigilance data based on Individual Case Safety Reports (ICSRs).

Apparently, the EMA considers only a small amount of clinical trial data as containing commercially confidential information, such as details of the investigational medicinal product itself, some in vitro studies, or bioanalytical data characterising the product. However, the EMA will only deem this information as commercially confidential information in duly justified cases. Moreover, such documents could still be requested under the EMA's policy on access to documents, which encompasses Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents.

The EMA intends that all clinical trial data without protection of personal data concerns are “open access” which means that such data will be available as downloads from the EMA's website, at the time of publication of the European Public Assessment Report (EPAR) for positive decisions, negative decisions or withdrawals (or 30 days following withdrawal, in the event no withdrawal EPAR is published). Clinical trial data without protection of personal data concerns is, according to the EMA draft, all documents where:

• the document does not contain personal data in the first place (e.g. summary tables presenting only aggregated data), or;
• any personal data in the document has been adequately anonymised, or;
• there are public-health reasons why personal data can be made public, overriding considerations of protection of personal data.

All clinical trial data with protection of personal data concerns are “controlled access”, which means that access to data will only be granted after the requester has fulfilled certain requirements, e.g:

• to identify itself, and the EMA has verified the identity of the requester;
• the requester is established in the EU;
• the requester has agreed, by way of legally binding data-sharing agreement, to access controlled data for the sole purpose of addressing a question or conducting analyses that are in the interest of public health, in line with the spirit of informed consent.

EGC decisions concerning third party access to documents

These interim proceedings concern EMA decisions granting third party access under Regulation No. 1049/2001 to clinical study reports in regard to the medicinal product Humira (Case T-44/13) and for the medicinal product Esbriet (Case T-73/13). The Court held that the operation of these EMA decisions should be suspended and that the EMA is ordered not to disclose the documents in question. According to the Court, the applicants’ interest must prevail over that of the party requesting access in order to protect the effectiveness of a judgement in the main action: if the application for interim measures were to be dismissed, the EMA would be free immediately to grant access to the reports and therefore the future decision in the main action would be de facto prejudged – a judgment ordering annulment would be rendered illusory and would be deprived of its effectiveness. Moreover, while the rights of the parties requesting disclosure would merely be delayed if the preliminary injunction was granted, the corresponding right of the applicants to protection of confidentiality of those reports would be reduced to nothing if the application for interim relief were dismissed. The Court stated:

It is common ground that, before the EMA amended its policy on disclosure of clinical study reports, the EMA itself classified those reports as confidential and refused to disclose them to third parties under Regulation No 1049/2001. Moreover, although the EMA has stated that the contested decision is based on its new policy on access to documents, it should be noted that the lawfulness of that policy, which has been in place since 2010, has not yet been ruled on by the European Union courts. Furthermore, the EMA expressly recognises that, in the present case, it is the first time since its new policy was implemented that a marketing authorisation holder has requested the suspension of operation of a decision to disclose such reports under Regulation No 1049/2001.

In the case of Esbriet (T-73/13) the reasoning of the Court is ultimately the same as above. However, the Court clarified that

… there is nothing to indicate that any specific public interest justifies disclosure of the information at issue. Consequently, there is no specific public interest liable to prevail for the purposes of Art. 4 (2) of Regulation No. 1049/2001, over the harm which the applicants would suffer, a fortiori because much of the information about the safety and efficacy of Esbriet is already publicly available.

Furthermore, the Court criticised the EMA for applying “an inflexible, purely mechanical policy approach of complete disclosure of the disputed documents, on the basis of an alleged automatic priority in favour of the general public interest in transparency”.

Recent EFPIA and PhRMA initiative

On 24 July 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) published new “Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients”. According to the new commitments, the members of EFPIA and PhRMA will increase the amount of information available to researchers, patients, and members of the public. Therefore, clinical trial data (patient-level, study-level, full study reports) and protocols from clinical trials for medicines approved in the United States and the European Union shall be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. The implementation of the commitments begins on 1 January 2014.

Outlook

Whilst the pharmaceutical industry itself has most recently taken the initiative to give easier access to clinical trial data the data publishing policy of the EMA is still under review by the European Courts despite EMA’s new discussion paper summarizing its envisaged new policy. According to most recent statements the EMA intends to apply its new publication policy as of 1 January 2014 which is a little surprising given the fact that that European Court of Justice by then will not have had their final say on the pending cases.

A careful monitoring of the ongoing process on an EU-level by the concerned industry seems to be advisable.

Please see the latest on this issue from the CJEU.

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