This presentation will discuss the evolution of the mutual recognition of marketing authorizations for pharmaceuticals in the European Union. Pharmaceuticals are heavily regulated products and are subject to a marketing authorization requirement that can either be granted centrally on EU level for certain categories of innovative products or at national level for products that do not fall into the former category. It is in the context of these national procedures that mutual recognition plays a role. However, due to the political sensitive nature of pharmaceutical policy with its impact on human health, the national health care systems and certainly also matters of industrial policy, mutual recognition did not succeed on the basis of the principle alone, but required Europeanized procedures. This has led to the creation of sui generis mutual recognition procedural mechanisms and also to institutional innovations, which will be discussed in this presentation.
This presentation will discuss the role of the principle of mutual recognition in relation to the EU agricultural policy and the marketing of agricultural products. While agriculture may be seen as the cradle of mutual recognition, since the landmark decisions on this principle concerned agricultural products, the specific characteristics of this strongly centralized policy made it an infertile ground for the application of this principle. However, the evolution of the Common Agricultural Policy (CAP) and of the case law of the Court of Justice paved the way for an enhanced role of free movement principles and of mutual recognition in this field. In the light of this evolution and of the debates ongoing on the reform of CAP, a wider application of the principle of mutual recognition in agriculture may be envisaged.
Traffic does not stop at borders, but the effect of a driving license does, at least technically. For many decades, the underlying principle of territoriality of administrative acts has been overcome by law (first public international law, then European secondary law) requiring states to mutually recognize driving licenses. The evolution of this law reflects a shift in focus from facilitating mutual recognition to harmonising the requirements to obtain a driving license and to preventing “driving license tourism”. This development is in line with the increasing integration of other areas of the internal market, and it shows the importance of common standards (and their observation) as a basis for mutual recognition. Considering mutual recognition a core element of the internal market, it has to be observed that there is still no such “market” for driving licenses.
The principle of mutual recognition in the EU legal order has many connotations and refers to different situations. The paper examines and compares three legal mechanisms aimed at facilitating the free circulation of goods in the common market. These are:
a) Mutual recognition under the Treaty. In order to facilitate the functioning of this mechanism, the European legislator has laid down specific regulations (see now the Regulation No 2019/515);
b) The transnational administrative act;
c) The legal and technical harmonisation and the certification issued by the so-called notified bodies regarding the safety of products.
The paper aims at showing that in the common market transnationality – i.e. the possibility of carrying out an action across national borders – has characteristics that change slightly with these three mechanisms.