The use of telemedicine in Spain has increased in recent years, and although there is currently no national regulation in this regard, it is possible to find sectoral provisions that provide guidance for its practice. In this sense, the companies that engage in telemedicine must take into account the legal implications that may affect them, such as data protection or the treatment of patient information.
The Ministry of Health has issued a note in which it promotes the use of QR codes to show the technical data sheet of medicinal products in promotional materials aimed at healthcare professionals. However, some information must remain in physical format to comply with the regulations on the advertising of medicinal products.
The Spanish National Court annulled the evaluation system of newly approved medicinal products set up in 2020 by the Spanish Ministry of Health because the system was created without following the legally established procedure and was approved by a body that did not have the authority to do so. The court states that the Therapeutic Positioning Reports cannot be considered as a mandatory instrument for the evaluation of medicines prior to the financing decision and clarifies that the Spanish Agency of Medicines and Medical Devices has the exclusive competence to issue such reports. The annulment of the Plan is expected to shorten the timeframe for financing new medicinal products.
A modification of the current fertiliser products regulation (Royal Decree 529/2023) has been published. This new Royal Decree 529/2023 improves the alignment of national regulations with Regulation (EU) 2019/1009 on EU fertiliser products to avoid tensions between these two regimes. The new regulation introduces provisions on certain mixtures of micronutrients, inorganic fertilisers based on ammonium nitrate and the criteria that sub-products must meet in order to be classified as such.
The Spanish Government has approved a new Royal Decree 666/2023 completing the regulatory framework for veterinary medicinal products. This regulation seeks to update the regulations governing veterinary medicinal products in accordance with current scientific advances and economic conditions. Among other considerations, it aims to improve the protection of animal health, the environment and the public health.
“Communication 1/2023, of 13 June on the criteria that shall govern the prohibition for companies that distort competition to enter into contracts with the public sector by the National Commission for Markets and Competition” (the “Communication”) has been approved. The Communication sets out the criteria that will guide the CNMC when determining the prohibition to contract with the Public Sector and the scope of the prohibition. The CNMC will follow the criteria set out in the Communication in its future infringement decisions.
The Government of Spain has approved the creation and operating regulation of the Ultimate Beneficial Ownership Registry, by means of Royal Decree 609/2023 of 11 July 2023, which was published today in the Official State Gazette. This registry is configured as a central and public registry, through which information on ultimate beneficial ownership of Spanish legal entities and other entities or structures without legal personality can be generally accessed.
The Spanish State Gazette published yesterday contains the Royal Decree 571/2023, of 4 July, on Foreign Investments which is intended to (i) update the procedure for declaring foreign investments for statistical and information purposes (both foreign investments in Spain and Spanish investments abroad); and (ii) develop certain features of Law 19/2003, of 4 July, on the legal regime of capital movements and foreign economic transactions and its implementing regulations, particularly with regard to the introduction of Article 7bis, relating to the suspension of the liberalization regime, in order to provide greater legal certainty to the authorization procedure, for the cases in which this is meant to be mandatory.
On 4 July 2023, the Spanish Government approved Royal Decree 571/2023 on Foreign Investments, with immediate effect from 1 September 2023, which introduces amendments to and provides further details on the screening mechanism for certain foreign direct investments in Spain.
The Spanish Registry of Food Contracts has become fully operative on 30 June 2023, which means that, as of that date, operators are obliged to register all food contracts concluded with primary producers, as well as their amendments.