Fifteen organisations sign up to the Code on Data Protection in Clinical Trials in its first year
Farmaindustria states that it is “the first sectoral code approved by the AEPD and a reference at European level”
Source: espaciosanitario.com
Farmaindustria has announced that a total of 15 companies, centres and research groups adhered to the Code of data protection in clinical trials in its first year, which is “the first sectoral code approved by the Spanish Data Protection Agency (AEPD) and a reference at European level”.
According to the employers’ association, at the end of March 2022 “the Governing Body of the Code of Conduct was constituted, which acts with full independence from Farmaindustria and the adhering entities”, which is “composed of three members and their alternates – persons of recognised experience and proven knowledge in the law and practice of data protection, in particular” and “is responsible for the dissemination, interpretation, compliance and control of the application of the Code of Conduct”.
“It is also in charge of dealing with queries from member entities regarding compliance with the Code and of promoting, developing and executing training activities aimed at these entities”, continues Farmaindustria, which specifies that the laboratories Casen Recordati, Bial, Roche, Janssen, Ferrer, Novartis, Norgine, Eisai, Daichii Sankyo, AstraZeneca, Kyowa Kirin, Pfizer and Amgen are joined by the Spanish Breast Cancer Research Group Foundation (Geicam) and the Clínica Universidad de Navarra.
Future additions
In this regard, the organisation explains that “five other international companies have also confirmed to Farmaindustria their willingness to adhere to the Code and are currently finalising the documentation”. “This means that more than 70 percent of the clinical R&D carried out by companies associated with Farmaindustria will be covered by the Code,” it explains.
“It is necessary to continue to raise awareness of this important document among companies, research groups and centres, patient associations and other organisations in the sector,” says the director of Farmaindustria’s Legal Department, Ana Bosch, who considers that “it represents a step forward in the protection of the data of those who participate and intervene in the activities it regulates and will strengthen clinical research and pharmacovigilance in Spain”.
