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Spain: The implementation of European Union Whistleblower Directive

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In brief

Spanish Official State Gazette published Law 2/2023 on 20 February 2023 (Ley Reguladora de la Protección de las Personas que Informen sobre Infracciones Normativas y de Lucha contra la Corrupción), which transposes the EU Whistleblower Directive (Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of European Union law) into Spanish law (Ley Reguladora de la Protección de las Personas que Informen Sobre Infracciones Normativas y de Lucha Contra la Corrupción) (“Law“). The full text of the Law is available here.

The main compliance obligations imposed by the Law on entities with more than 50 employees are the following:

  • Have a reporting System that complies with legal requirements (e.g., that accepts anonymous reports and acknowledges receipt within seven calendar days) and is approved by the entity’s management or governing body
  • Making the whistleblowing channel available not only to employees, but also to shareholders, board members, suppliers, intermediaries, etc.
  • The channel should be able to report, in addition to the possible infringements of European Union law provided for in the Directive, any “serious” or “very serious” administrative offenses and infringements as those terms are understood under Spanish law.
  • Appoint a first-level manager as the person in charge of the reporting system, who must perform his or her functions independently and autonomously from the rest of the organization’s bodies
  • Process the information received and respond to it within three months, which may be extended for a further three months in particularly complex matters
  • Guarantee confidentiality, apply the presumption of innocence, minimize risk of defamation, and prohibit retaliation
  • Forward the information to the Public Prosecutor’s Office “immediately” when the facts could be indicative of a crime. In the event that the facts affect the financial interests of the European Union, the referral must be made to the European Public Prosecutor’s Office
  • Comply with a number of specific data protection obligations

Click here to access the full alert.

For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.

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Author

Cecilia Pastor is highly knowledgeable in the areas of mergers, acquisitions and pharmaceutical law. She is a lecturer at ICADE on international agreements for the university’s Masters in Law degree program. Ms. Pastor is a regular contributor to the Spanish chapters of Promoting Medical Products in Europe & North America, Pharmaceutical Advertising, and other publications. She is a member of the Madrid Bar Association.

Author

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.

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