MTA Law Working Papers

A Jogtudományi Intézet műhelytanulmányai

Daminova, Nasiya: The European Medicines Agency ‘Transparency’ Policies, the CJEU and COVID-19: Do the CFREU Provisions Retain Any Relevance?

The approach of the European Medicines Agency (EMA) to the transparency of the documents submitted by the pharmaceutical enterprises has evolved significantly during the last decade. The gradual development of the EU’s secondary legislation, namely the adoption of EMA Policy on access to documents (Policy 0043, 2010) followed by the Policy on publication of clinical data (Policy 0070, 2014) and Clinical Trials Regulation No 536/2014 have raised more issues as they arguably question the substance of the ‘commercially confidential information’ notion. The ongoing public health crisis seems to have fuelled the discourse, in view of the EMA calls to urge transparency and collaboration on COVID-19 studies - to facilitate more robust research results. Even though the first attempts were made to investigate the CJEU’s approach to the application of the EMA Policies 0043 and 0070, a very important issue - namely, the impact of the EU Charter on the EMA transparency policies - comprising the extra transparency measures for COVID-19 vaccines and therapeutics – still remains unsolved. Considering the InterMune UK, PTC Therapeutics International, MSD Animal Health Innovation lines of reasoning, this paper aims to explore if and how the EU Court of Justice applies relevant CFREU provisions, in order to counter-balance the competing interests of the pharma enterpises (confidentiality of the clinical data) and the European Medicines Agency (public access to the documents). The main argument presented is that the CJEU’s approach to Art. 7 (‘Respect for private and family life’) and – sporadically – Arts. 16 (‘Freedom to conduct a business’), 17 (‘Right to property’) and 47 (‘Right to an effective remedy and to a fair trial’) CFREU in these cases has manifested the transition from the general presumption of confidentiality with respect to the company-issued health data to disclosure of such data - with a low likelyhood of changes in the observable future, even in view of the ongoing COVID-2019 developments.