On 17 September 2024, the European Public Prosecutor’s Office (EPPO), an EU body that prosecutes among others financial crimes that affect the EU budget, announced that it is seeking criminal penalties from two companies and five of their directors of more than 8 years imprisonment along with a fine of over EUR 25 million. Over 30 properties linked to the defendants were seized to ensure that the defendants can meet their financial liabilities.

The Spanish Agency for Medicines and Medical Devices (AEMPS) has implemented a new system for the payment of clinical trial fees in Spain. The Application, which is available on the AEMPS website, facilitates the payment process and eliminates payment errors that existed in the previous system.

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 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.

Türkiye is one of the developing countries that take actions and precautions regarding climate change. The Turkish government has taken many significant steps toward climate change in line with global developments. This article outlines the latest developments occurring in Türkiye in this framework of climate change.

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.

We are delighted to invite you to the Baker McKenzie Middle East Tax Forum in Dubai on Wednesday, 18 October 2023 – a full day of interactive discussions on tax updates across the Middle East and a special focus on the impact of global tax policy developments such as Pillar 1 and Pillar 2 (Global Minimum Tax).

Development and integration of critical infrastructure for electric vertical take-off and landing (“eVTOL”) aircraft remains critical for the wide-scale adoption and the future of Advanced Air Mobility. With the path towards certification rapidly gaining momentum, the first commercial eVTOL operations are likely to begin as early as 2025.