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Montserrat Llopart

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

The Government of Catalonia has recently published a guide on the advertising of medicinal products for human use. This guide provides new and updated advice on the understanding of the regulations on advertising on medicinal products. In particular, it focuses on advertising in the digital environment, analyzing the use of digital platforms and tools and providing recommendations for responsible advertising in accordance with the current sectorial regulatory framework.

In order to set the regulatory framework for a products containing cannabis, the Ministry of Health has launched a public consultation on a draft Royal Decree establishing the conditions for the preparation and dispensing of magistral formula based on standardized preparations of these substances. In this regard, the interested parties were able to present allegations until 4 March 2024.

The Canary Islands Government has decided to reduce the tax rate applicable to different goods and services including medical devices, veterinary medicines and veterinary services. These changes are expected to facilitate patients’ access to these products and services by reducing their costs.

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 European Medicines Agency (EMA) has published an artificial intelligence workplan to 2028, setting out new strategy on its use.
Taking into account the implications of AI in different areas of the healthcare sector, the EMA has focused its efforts on four dimensions that should contribute to improving the understanding and use of AI in a responsible way. The proposed workplan will be subject to future modifications as this technology evolves.

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.

At the end of June 2023, the new Royal Decree 5/2023 was published, introducing various health and social measures. Among the different legislative changes that have taken place, the most important is the modification of the Law on Guarantees and Rational Use of Medicines and Medical Devices. From now on, the autonomous communities are allowed to establish measures for dispensing medicines and medical devices remotely if there are circumstances that justify it due to the situation of the patients.

The European Medicines Agency (EMA) has published a number of recommendations on good practices in securing the supply of medicinal products for human use with the aim of avoiding stockouts and reducing their possible consequences. The document states that ensuring the availability of authorized medicines in the European Union is a priority for the EMA. Among the recommendations published are the obligation to inform the national authorities of shortages of medicines as early as possible and to provide detailed information so that preventive measures can be implemented.