On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
The EMA continues its work towards the implementation of the Policy on the publication and access to clinical trial data
A press release published by the EMA on 17 December 2013 suggests that the Agency may be moving away from its original plan to have its planned policy governing publication of and access to clinical trial data that has been submitted to the Agency by pharmaceutical companies operational on 1 January 2014. As acknowledged in the press release, this delay is, at least partly, due to the nature of comments received during public consultation on the Policy and the consequent need for further analysis and clarification of the Policy.
On 24 June 2013, the European Medicines Agency ("EMA") published a draft Policy governing publication of and access to clinical trial data that is submitted to the Agency by pharmaceutical companies. The draft Policy was released for public consultation on the same day. The public consultation process was open until 30 September 2013. The EMA received a large number of comments during the consultation.
A press release published by the EMA on 17 December 2013, states that "there is large support for the Agency’s plans to allow access to clinical trial data". The press release also acknowledges, however, that the comments received "highlighted that there is a need for further analysis and clarification of certain aspects". The press release does not specify which aspects of the Policy require further analysis and clarification.
According to the press release, the Policy and the related implementation plan will be discussed at the EMA Management Board Meeting scheduled to take place in March 2014. There is, however, no indication of when the Policy will be adopted or enter into force.
Scope of the draft Policy
The draft Policy governs the proactive publication by the EMA of clinical trial data submitted to the Agency by applicants for marketing authorisation for medicinal products. According to the draft Policy, such proactive publication would take place after the end of the marketing authorisation procedure.
If adopted in its current form, the Policy would apply to clinical trial data submitted to the EMA after entry into force of the Policy. Clinical trial data submitted to the EMA before that date would not be proactively disclosed by the Agency.
Objectives of the draft Policy
The draft Policy is intended to accommodate and balance a number of potentially competing objectives. These include:
- transparency of the results of the secondary analysis of clinical trial data;
- public scrutiny and secondary analysis of clinical trial data;
- protection of public health from the negative consequences of inappropriate secondary data analysis;
- protection of personal data, including guarantees that any public disclosure of clinical trial data would be within the limits of the informed consent granted by the clinical trial patients;
- protection of commercially confidential information;
- encouragement of future investment in research and development of medicinal products;
- protecting the independence of the EMA's and the European Commission's decision-making process.
Types of clinical trial data
Not all clinical trial data will be made publically available. The draft Policy distinguishes between three types of clinical trial data:
- clinical trial data containing commercially confidential information:
- this type of clinical data will not be disclosed proactively by the EMA;
- clinical trial data not containing personal data or commercially confidential information:
- this type of clinical data would be disclosed proactively by the EMA without any restrictions;
- clinical trial data containing personal data:
- access to this type of clinical data will be restricted and controlled by the EMA. Only entities of physical persons who satisfy a number of requirements would be granted access to clinical trial data containing personal data.
Annexes I, II and III to the draft Policy list the elements of the clinical trial data that would fall into each of the above categories.
The EMA foresees the introduction of additional control procedures prior to grant of access to clinical trial data. These procedures would be intended to address the risk of unfair commercial use of requested clinical trial data.
Other factors that may potentially affect the date of entry into force of the Policy
The EMA acknowledges in the press release that the content of the Policy would be influenced by the proposed Clinical Trials Regulation currently being discussed by the EU Institutions. It remains unclear if the proposal will be adopted before the current Parliament rises in June 2014. If adoption does not occur by that time this could delay the adoption and entry into force of the Policy.
Another element that may influence the adoption and entry into force of the Policy are the forthcoming rulings of the General Court of the European Union (“General Court”) in pending cases concerning the EMA's decisions to grant third party access to clinical trial data. AbbVie and InterMune have challenged decisions by the EMA to grant access by requesting third parties to clinical trial data submitted by these companies. The rulings of the General Court are not expected before the second half of 2014.
On 28 November 2013, the Court of Justice of the European Union set aside orders of the General Court suspending the decisions of the EMA until final judgement in the cases. The Court referred the interim measures cases back to the General Court for re-examination. These orders of the Court of Justice of the European Union are discussed in more detail in our previous blog post.
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