“Our code of conduct on data protection in clinical trials and pharmacovigilance is a benchmark for the future European code”.

El académico Fidel Ortega, Ana Bosch (Farmaindustria) y Jesús Rubí (AEPD).

Farmaindustria’s self-regulation document is the focus of a scientific meeting organised by the Royal National Academy of Pharmacy.

 

Source: www.farmaindustria.es

Less than a month ago the Spanish Data Protection Agency (AEPD) approved the Code of Conduct regulating the processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance promoted by Farmaindustria, and it has already aroused great interest among companies, research organisations, patient associations and other entities in the sector.

In fact, on 7 April, the document was the protagonist of a scientific conference dedicated to the Protection of personal data in the field of health and medicine, organised by the Royal National Academy of Pharmacy (RANF) and the José Casares Gil Foundation, of Friends of the RANF, in which Jesús Rubí, coordinating member of the Support and Institutional Relations Unit of the AEPD, and Ana Bosch, director of the Legal Department of Farmaindustria, participated as speakers.

As Bosch recalled, this code, which replaces the previous one, from 2009, has become the first sectoral manual of conduct approved since the entry into force of the General Data Protection Regulation (GDPR) and the first of its characteristics in Europe: “It is a reference for the European Data Protection Code on which work is already underway”, she stated.

The document, which regulates how the data protection regulations should be applied by the promoters of clinical studies with medicines and the Contract Research Organisations (CROs) that decide to join, “is not intended to be a code only for the companies associated with Farmaindustria, but for all those involved in these processes and for the entire pharmaceutical industry in Spain”, said Bosch.

He also stressed that it entails “important benefits for both member companies and patients participating in clinical trials” and is “a further demonstration of the innovative pharmaceutical industry’s commitment to transparency and the fundamental rights of citizens in the treatment of personal data”.

“It is a living document, whose revision is foreseen when necessary or, at the most, every four years, so that its updating is guaranteed and it always serves the purpose for which it was created,” she defended.

In addition, the director of Farmaindustria’s Legal Department informed academics and attendees at the conference that an independent control body has already been set up to ensure proper compliance with the code. This Governing Body will be made up of three full members and three substitutes, plus a Secretariat, whose members are renowned experts in this field.

This system of self-regulation through an independent body, within the framework of a code of conduct, has already become a characteristic feature of this sector, as demonstrated by the effective operation over the last two decades of the Code of Good Practice for the Pharmaceutical Industry.

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