The Code of Conduct regulating the processing of personal data in clinical trials approved in 2022 makes it easier for companies and researchers to correctly comply with their obligations in the protection of data for scientific research purposes.
That of the pharmaceutical industry was the first sectoral code approved by the Spanish Data Protection Agency since the entry into force of the General Data Protection Regulation and represents a guarantee for all participants in clinical trials and other research in our country.
Farmaindustria has held a conference at the Royal Academy of Pharmacy of Catalonia on the role of self-regulation in the protection of data in research, with the participation of experts from different areas in this field.
“We are living in a time of great hope and ambition in the advances for patients thanks to precision medicine and advanced therapies, which is why it is more necessary than ever to provide greater security for the treatment of the data of the people who participate in this research”. In this way, the director general of Farmaindustria, Juan Yermo, today highlighted the current importance of data protection in research at a conference organised by Farmaindustria on this topical issue at the Royal Academy of Pharmacy of Catalonia, in Barcelona.
At the conference, entitled The role of self-regulation in data protection in clinical research and pharmacovigilance, Yermo recalled that in 2009 Farmaindustria approved the first standard code for the protection of personal data in research and pharmacovigilance. Subsequently, faced with the need to adopt this first code to the new regulations approved at European (General Data Protection Regulation) and national level (Organic Law on Personal Data Protection and guarantee of digital rights), the Association drafted a new data protection code with the collaboration of pharmaceutical companies, the Spanish Medicines Agency (AEMPS) and the Spanish Data Protection Agency (AEPD).
This new code, called the Code of Conduct regulating the processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance, became in February 2022 the first sectoral code approved by the AEPD since the entry into force of the General Data Protection Regulation (GDPR). “Since then, the Farmaindustria code has become the reference for the development of the European code on which our European employers’ organisation Efpia is already working,” Yermo emphasised.
“This recognition is further proof of the pharmaceutical industry’s commitment to transparency and good practices and the sector’s respect for the fundamental rights of citizens in the processing of personal data,” Yermo emphasised. “In addition, having this Code in Spain is a guarantee for participants in clinical trials and other research, given the obligation of the adhering entities to respect the regulations in force and the other obligations imposed by the code”.
The Director General of Farmaindustria finally added that the pioneering status of the code “is also a key element in promoting the development of clinical trials in our country, a field in which Spain is already a world leader and in which we aspire to continue growing in order to turn our country into an international hub for biomedical research”.
A code open to the sector
For her part, the director of Farmaindustria’s Legal Department, Ana Bosch, stressed the advantages of adhering to this Code. “The processing of personal data for scientific research purposes, both in the public and private spheres, and especially in the framework of clinical trials, must be approached from a responsible perspective, so this Code is a valuable instrument that makes it easier for companies and researchers to correctly comply with their obligations regarding the protection of personal data in these areas”.
In particular, the Code resolves certain issues related to the notification of breaches or fundamental security breaches in a scenario of potential cyber-attacks on research healthcare institutions. In addition, it identifies technical and organisational measures to ensure the availability, integrity and confidentiality of clinical research data.
And he reminded that the Code aims to be the Code of the entire pharmaceutical industry in Spain, as it can be adhered to not only by companies associated with Farmaindustria but also by all entities that conduct clinical trials or are subject to pharmacovigilance obligations, as well as CROs acting on their behalf. Currently, companies representing 80% of clinical research in Spain (in addition to the University Clinic of Navarra and the Spanish Breast Cancer Research Group Foundation (GEICAM)) are members of the code.