Executive Director European Medicines Agency

 

Dear Ms X,

I was pleased to learn that the European Medicines Agency (EMA) has decided to relaunch its policy of proactively publishing clinical trial data for medicinal products for human use (‘Policy 0070’),[1] starting from September 2023.

I commended the initial launch of this policy in 2016 as a paradigm shift in the transparency of clinical trial data in the EU.[2] I understand that the policy has been suspended until now due to the relocation of EMA staff and premises to Amsterdam and the need to prioritise other urgent tasks related to the COVID-19 pandemic.

I welcome the decision by EMA to relaunch the policy. Transparency of clinical trial data helps avoid unnecessary testing of pharmaceutical products by making the data freely available to the public, including industry and scientists in the EU and beyond. It also fosters scientific progress and innovation. Moreover, it increases the accountability of regulators.

The principle of transparency of clinical trial data is enshrined in EMA’s founding regulation, both in terms of reactive transparency[3] and proactive transparency. As regards proactive transparency, EMA is required to ensure the public availability of scientific information concerning the authorisation or supervision of medicinal products.[4]

In May 2023, EMA announced[5] that Policy 0070 will be partly relaunched with regard to products containing new active substances. According to this announcement, the relevant companies will be required to submit the publishable versions of clinical study reports and other documents when submitting applications for authorisation. EMA has emphasised that only very limited redactions of confidential commercial information may be made in these documents, if any at all, and that EMA will apply this policy prospectively from September 2023.

Given the great importance of the transparency of clinical trial data, I would be grateful if EMA could provide some further information as regards its plans to deal with the backlog of procedures concerning clinical trial data for medicinal products that were completed when Policy 0070 was suspended, that is, between 2018 and 2023. Moreover, I consider that it would be useful to receive more information regarding the next steps in expanding the scope of Policy 0070.

In particular, I would appreciate if EMA could reply to the following questions:

1) What is the current plan and timeline regarding the publication of clinical trial data relating to the backlog of procedures completed during the suspension of Policy 0070 (2018-2023) and other procedures that may not immediately fall within the scope of the relaunched policy? Has EMA consulted stakeholders (both the pharmaceutical industry and civil society) in the development of the current plan and timeline (and, if not, why not)?

2) Has EMA considered whether the partial relaunch of Policy 0070 could be based on priority areas (such as the publication of data pertaining to the treatment of specific conditions other than COVID-19), rather than on the temporal criterion and the criterion of new active substances? In this context, has EMA considered other criteria and if so, what criteria?

3) What is the current timeline and plan for the next phases of expanding Policy 0070?

I would be grateful if EMA could reply to these questions by the end of September 2023.

Based on the replies received, I may also consider it useful for Ombudsman staff members to meet with representatives of EMA for further information and clarifications.

Yours sincerely,

Emily O'Reilly
European Ombudsman

Strasbourg, 23/06/2023

 

[1] European Medicines Agency policy on publication of clinical data for medicinal products for human use, EMA/144064/2019, https://www.ema.europa.eu/en/documents/other/european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use_en.pdf

[2] Decision on own-initiative inquiry OI/3/2014/FOR concerning the partial refusal of the European Medicines Agency to give public access to studies related to the approval of a medicinal product, paragraph 71, https://www.ombudsman.europa.eu/en/decision/en/68107

[3] Article 73 of Regulation 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136/1, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32004R0726 (hereinafter ‘Regulation 726/2004’)

[4] Article 80 of Regulation 726/2004

[5] See https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar