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Elisabet Cots

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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.
In ESG

Spain: New regulation on observational studies with medicinal products for human use

by 4 Mins Read

On 26 November 2020, the Spanish Official State Bulletin published the Royal Decree 957/2020, of 3 November, regulating observational studies with medicinal products for human use, which will come into effect on 2 January 2021. This royal decree intends to ease the administrative procedures applicable to observational studies in light of recently adopted instruments at EU level (with the European Medicines Agency-approved guidance on post-authorization efficacy studies) and Spanish level (with the enactment of Royal Decree 1090/2015 on clinical trials with medicinal products, which introduced the legal concept of observational study). Observational studies are an essential tool to gather personal health data on conditions for use, safety and effectiveness of medicinal products, and to ultimately enhance clinical practice in the interest of patients.