Law 21/2014 was published on the 16th of April (“Law 21/2014”) in the Official Gazette (“Diário da República”), which introduces a new legal framework for clinical research in Portugal, and repeals Law 46/2014, of 24th of August (“Law 46/2004”). The approval of this new law aims to bring together, in a single diploma, the most relevant aspects of the clinical research activity.
This new law presents a broader scope in comparison with the legal regime of Law 46/2004, by having as its object, other than the clinical trials with medicinal products for human use, the majority of clinical studies, which includes: clinical studies of medical devices; clinical studies of cosmetic and hygiene products; and clinical studies on diets. On the other hand, it also regulates other important aspects in regards to the organization of the ethics commissions.
In parallel, the new regulation of the European Parliament and of the Council (“Regulation”) on clinical trials of medicinal products for human use was approved on the 14th of April, which repeals Directive 2001/20/EC, of 4th of April (“Directive 2001/20/EC”) – its transposition represents the previous legal framework applicable to clinical trials within the European Union (“EU”). The main purpose of this new regulation regarding clinical trials, is to create a favorable environment for the development of clinical research in Europe, countering the relocation of these activities to emerging nations, which has been the evident trend in recent years.
Following the criticism that has been shared in relation to impacts resulting from Directive 2011/20/EC, an essential aspect of the new European legislation consists precisely in its approval in the form of regulation, which is an instrument directly applicable in all Member-States, being, therefore, a suitable instrument to achieve the desired legislative uniformity.
Although Law 21/2014 has a broader scope in comparison with the Regulation, there is an overlap between the legal regimes, in respect to certain matters relating t o clinical trials, and a contradiction between some aspects of National Legislation and the Regulation, namely in respect to the rules for submission of requests, to the terms and rules of tacit approval, to the cooperation with competent authorities of other Member- States (the Law on clinical research does not include any rules of this sort for situations involving multinational clinical trials) and in regards to the advertising of relevant information from clinical trials.
Taking into account the principle of precedence of the EU law over National law, the EU law will always prevail in case of contradiction between the two. However, this duality of regimes will certainly raise practical doubts. Therefore, a clarification by Infarmed, regarding the specific regime to follow whenever there is an overlapping of the two, would be useful.