How does the entry into force of the whistleblower law affect the pharmaceutical industry?

11 Apr 2023

The pharmaceutical industry is one of the most regulated sectors and is subject to constant scrutiny by authorities and society. Transparency, ethics and regulatory compliance are essential to ensure the trust and reputation of companies involved in the research, development, manufacture and marketing of medicines.

In this context, a few days ago, law 2/2023 of February 20 came into force, regulating the protection of persons who report regulatory infringements and the fight against corruption. Also known as the ‘whistleblower law’ represents a new challenge and an opportunity for the pharmaceutical industry.

This law aims to encourage internal reporting of illicit conduct or conduct contrary to the legal system, whether serious or very serious, in both the public and private sectors, by creating specific channels of communication and guaranteeing the protection and anonymity of the persons who report, avoiding any reprisal or discrimination.

The law establishes that companies must implement an internal information system (SIC) to receive, manage and resolve complaints filed by their employees, shareholders, managers or related third parties. This system must comply with a series of formal and technical requirements, such as guaranteeing the anonymity of the informant, ensuring the confidentiality of the data, designating a person responsible for the SIC or establishing a procedure for investigating and resolving complaints.

It also establishes sanctions for companies that do not comply with the law, which can reach up to one million euros, and a three-month period for those companies, administrations, organizations and other entities obliged to set up their internal complaints channel.

In addition, the law provides incentives for companies with an adequate CIS, such as attenuation or exemption from criminal or administrative liability in case of infringements committed by their employees or managers.

The whistleblower law is, therefore, an opportunity to strengthen the culture of ethics and compliance in the pharmaceutical industry and improve its image, reputation and trust in the eyes of stakeholders.

To this end, companies need to adapt their internal policies and systems to the standard’s requirements and promote fluid and transparent communication with their stakeholders, which Outcomes’10 has been doing for years thanks to the ISO 9001 Quality and ISO 27001 Information Security, Cybersecurity and Privacy Protection standards, which, together with the Data Protection Law, make up the Integrated Management System we have in place, thus guaranteeing the transparency of our organization and communication with our stakeholders.

If you would like to learn more about the advisory services we offer our clients, please visit our Services page.

How does the entry into force of the whistleblower law affect the pharmaceutical industry?

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