#HEORInsights

The policy on “publication of clinical data for medicinal products for human use”, also referred to as the “policy 0070” was launched in 2015 by the European Medicines Agency (EMA), to comply with the growing demand from stakeholders for additional transparency in the clinical data that form the basis of regulatory decisions. (1-3)

Policy 0070 allows global access to regulatory documents for non-commercial reasons. The policy defines ‘clinical data’ to include clinical overviews, summaries, and clinical study reports (CSRs), along with the CSR appendices [including protocol and protocol amendments, sample case report form(s) and documentation of statistical methods (clinical study statistical analysis plan (SAP)]. Under this policy, clinical data is published through central regulatory applications in an anonymised portable document format. The reason for anonymity is to ensure that the public disclosure of data will lower the risk of re-identification of trial participants from the information available contained within these documents, including any retained narrative information relating to individual participants.(4, 5) In simple words, this policy enables people, including researchers and academics, to precisely access information from the CSRs submitted by pharmaceutical companies to EMA pertaining to the marketing authorisation applications for new medicines.(6)

The original Policy 0070 document had two phases, phase 1 was about the publication of only CSRs; while phase 2 was slated for a later implementation and will look into the publication of individual patient data (IPD).(1, 3) However, the revision of the policy in 2019 covered both CSRs and IPD under ‘clinical data’.(2)

EMA believes that such refined transparency initiative will bring regulators one step closer to the EU citizens and promote well-informed use of medicines. Additionally, it is also estimated that the access to clinical data will benefit future public health. By creating a platform for all medicine developers to learn from the past successes and failures, the policy has demonstrated the ability for a more efficient medicine development. Furthermore, it will help the global scientific community to make use of a wide range of clinical data to establish new evidence in the interest of public health. Access to clinical data will facilitate third party verification of the original research to further analyse and assess the regulators’ positions and challenge them where deemed fit.(3)

Going by the same principles, the EMA launched exceptional measures during the COVID-19 pandemic to enhance the transparency of its regulatory activities on COVID-19 treatments and vaccines that are either approved or are under evaluation for approval. The purpose of these measures is to regulate the high interest for information while supporting the worldwide research on COVID-19 treatments.(7, 8)

Globally, EMA is the first regulatory body to offer open access to clinical data submitted by companies for marketing authorisation applications. Moreover, this proactive transparency policy has moved the worldwide conversation towards more transparency, as other regulators, like the US Food and Drug Administration (USFDA) and Health Canada, have eventually implemented – or are planning to implement – similar transparency initiatives.(6)

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References

1. European Medicines Agency policy on publication of clinical data for medicinal products for human use. (EMA/240810/2013)
2. European Medicines Agency policy on publication of clinical data for medicinal products for human use. 2019 Revision. (EMA/144064/2019). Available at: https://www.ema.europa.eu/en/documents/other/european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use_en.pdf
3. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. (EMA/90915/2016). Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data_en-1.pdf
4. Ferran JM, Nevitt SJ. European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research. BMC Med Res Methodol 2019; 19(204).
5. European Medicines Agency: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use, Revision 3. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001799.jsp&mid=WC0b01ac0580b2f6ba
6. European Medicines Agency: News: EMA’s proactive publication of clinical data a success. July 2018. Available at: https://www.ema.europa.eu/en/news/emas-proactive-publication-clinical-data-success
7. European Medicines Agency: News: Extra transparency measures for COVID-19 vaccines and therapeutics. October 2019. Available at: https://www.ema.europa.eu/en/news/extra-transparency-measures-covid-19-vaccines-therapeutics
8. European Medicines Agency. Transparency: exceptional measures for COVID-19 medicines, Available at: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/transparency-exceptional-measures-covid-19-medicines