(The Italian version is also published on Diritto 14 – Il Sole 24 Ore)

On 2 October, the European Medicines Agency (“EMA”) adopted its new policy on the publication of clinical data for medicinal products for human use. The details of the policy, which will enter into force on 1 January 2015, are in particular the clinical reports submitted to the EMA by pharmaceutical companies applying for marketing authorisations (“MAs”) through the centralised procedure.

The issue of whether the data in question should be accessible to third parties has been largely discussed in recent years, bringing also to legal proceedings commenced against the EMA by pharmaceutical companies claiming that the disclosure of the same – made by the EMA in the past upon the request of third parties – infringed their IP rights (we talked about this here on this blog). In fact, the new EMA policy follows a significant consultation with the relevant stakeholders, including companies, patients and healthcare professionals.

The new policy — which was adopted in the wake of Regulation (EU) no. 536/14 on clinical trials – is characterised by the fact that it provides for the pro-active publication of data, and no longer for the sole accessibility of the same at the request of the concerned third party. Based on this, clinical reports will in fact be published as soon as a decision on the relevant MA application has been issued for applications submitted after 1 January 2015 (or after 1 July 2015 for extension of indication and line extension applications). The policy shall not apply retroactively, therefore, as regards the extension of indication and line extension applications, publication shall only concern the new data provided to the EMA after the abovementioned date.

The public shall be allowed to access the clinical reports in two ways: on-screen, for general information purposes, with no possibility to save, download or print them, upon registration by the user and acceptance of the relevant Terms of Use (“ToU”); or for academic and other non-commercial research purposes, with the possibility to download, save and print the data, after providing the EMA – in addition to the registration and acceptance of the ToU – with the data and documents identifying the user and his/her position within the company/organisation to which he/she belongs. In any case, no commercial use of the data is allowed, as expressly provided by the ToU. Nevertheless, the policy points out that of course the EMA shall not be responsible for the breach of the ToU by the users.

The policy also addresses the issue of the protection of confidential commercial information. The general position of the EMA in this regard is that the clinical reports should in principle not contain confidential information. However, where they do contain confidential information, the latter will be redacted, according to the redaction rules provided by the policy itself; but it will be up to the EMA to evaluate, in light of the observations submitted by the MA (Application) holder, whether the information is actually confidential and its disclosure would undermine the economic/competitive position of the company, and  should therefore be redacted.

This last point is of course a matter of concern for pharmaceutical companies: the risk is that the clinical reports to be published contain confidential information the publication of which – in case the redaction is denied by the EMA – might lead to a subsequent impossibility to register a patent (for prior disclosure) or to obtain protection for the confidential information per se (as they might no longer qualify as confidential), particularly in countries outside the EU that provide lower protection for intellectual property. To this we add the foreseeable difficulties to act against persons who, in violation of the ToU, use the data for commercial purposes, maybe not even getting them directly from the portal – and thus without being bound by the ToU – but getting them from third-party users of the portal.

The new policy therefore does not seem to have satisfied the interests of pharmaceutical companies, in balancing them and the transparency requirements that motivated the policy itself. In conclusion, companies might complain that this diminished protection of their IP rights harm them so as to impair their research and development of new drugs, new formulations and new uses of known drugs. We therefore expect further discussions and disputes on the subject, and look forward to the final decision of the EU courts in the proceedings InterMune v. EMA, which we discussed here on this blog, dealing with the possibility of clinical reports qualifying as confidential information.

On a different level, the policy does not regulate the disclosure of the individual patient data, which are also part of the clinical data accompanying centralised MA applications. The EMA has announced its intention to make them public, amending the policy as the result  of consultations with stakeholders. In this respect, the main problems that arise are clearly related to the protection of the privacy of the individuals involved, and in particular to the need for their data to be anonymised so that their identities cannot be discovered.