Search for:
Author

Elisabet Cots

Browsing
Elisabet is a Senior Associate experienced Public Law/ Regulatory lawyer in Baker McKenzie's Barcelona office. She has more than 10 years' experience advising heavyweight companies on public law and regulatory issues. Elisabet advises both national and multinational companies on public procurement, administrative compliance, license schemes, environmental, ESG, regulatory, and products-related matters (circular economy and sustainability requirements, green claims, consumer protection issues, etc), including assistance before regulators, authorities, and courts. In addition, she regularly advises private companies on regulatory issues related to business expansion and the opening of new plants/premises. She also advises on litigation and trials related to the areas of specialization. She has extensive experience in the consumer & goods and life sciences sectors. Regarding the life sciences sector, she offers advice to Spanish and foreign life sciences companies and represent them before authorities and courts regarding public procurement issues, price & reimbursement procedures, authorization and registration, promotion and advertising of medicines, and other regulatory issues related to medicinal products, medical devices, cosmetics, food supplements and other foods for particular nutritional uses. She also professor at Pompeu Fabra University, UPF Barcelona School of Management and ESADE Law School in the field of Public Law. She regularly participates in publications and articles related to her specialty.

The Spanish legal framework on packaging and packaging waste that entered into force in December 2022 substantially modified the regulation of packaging and packaging waste in an effort to implement a circular economy in Spain. Most of the obligations have already entered into force. However, certain marking and information obligations will enter into force on 1 January 2025.

On 28 June 2024, the European Ecodesign Regulation (2024/1781/EU) (“Ecodesign Regulation”) was published in the Official Journal of the European Union and entered into force on 18 July 2024. This Regulation means a radical change in the manufacturing method of a wide variety of products and directly affects the supply chain of all those companies that intend to introduce products into the European Union. Its fundamental aim is to make products more sustainable by introducing a series of requirements and prohibitions that will be adapted to each product group by means of delegated acts of the European Commission.

The European Commission launched the European (EU) Green Deal in 2019. The EU Green Deal is a package of policy initiatives, one of which is a commitment to tackle false environmental claims by requiring that consumers receive reliable, comparable, and verifiable information to enable them to make more sustainable decisions and reduce the risk of greenwashing.

As part of the European Union (EU)’s European Green Deal, one of the areas of EU law that has developed most rapidly and profoundly is that relating to corporate sustainability governance. Most recently, the Corporate Sustainability Due Diligence Directive (“CS3D”), has been provisionally agreed at a political level in December 2023, and confirmed by COREPER in a revised version in March 2024. The final text of the CS3D must still be formally adopted by the European Parliament and the Council of Ministers before it enters into force.

The 2024 edition of Baker McKenzie’s International Guide to Contaminated Land offers an overview of national laws and regulations in over 30 countries governing the discovery, management and clean-up of environmental impacts at industrial sites. The guide addresses the key legal issues and risks that must be understood and assessed to ensure the effectiveness of any response to environmental contamination.

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.

As part of the EU Green Deal launched in 2019, a strong mandate has been issued to ensure consumers receive reliable, comparable and verifiable information to enable them to make more sustainable decisions and to reduce the risk of greenwashing.
The proposed European Union (EU) Green Claims Directive was tabled by the European Commission in March 2023 and aims to address greenwashing and introduces stringent requirements on various aspects in tackling false environmental claims.