Access to clinical trial dossiers and documents submitted for the marketing authorisation of a medicinal product under the provisions on access to public information

Abstract

This article is devoted to an analysis of the current regulations on the disclosure of clinical trial documentation of a medicinal product and documents submitted for the marketing authorisation of a medicinal product. Undoubtedly, due to the very high commercial value of the data obtained in the course of a clinical trial, the sponsor of such a clinical trial is interested in the widest possible coverage of its business secrecy. On the other hand, however, it is in the interest of patients and the public's health protection at large to have the widest possible access to this information.This article is devoted to an analysis of the current legal provisions on the conduct of clinical trials on medicinal products for human use and the registration of these products, both at EU and Polish level, as well as regulations on access to public information. In order to better illustrate the scale of information that may be covered by a request for access, the scope of documentation created in the course of conducting a clinical trial is also presented.The article also presents the rulings of the Court of Justice of the European Union concerning the scope of the obligation to provide access to this type of documentation and possible exceptions to the general principle of access to all documents processed by EU or national authorities. The purpose of the article is to juxtapose the interests of patients (the widest possible access to data on clinical trials and registration of medicinal products) with the interests of companies conducting clinical trials and to confront the practice of Polish regulators - the President of the Office for Medicinal Products, Medical Devices and Biocidal Products and the European Medicines Agency - with the case-law of the Court of Justice of the European Union in this respect.