The new European Data Protection Regulation, which will fully be in force by May 2018, constitutes
a change to continuos advancement in biomedical research projects which require the reuse of data, including the appropriate guarantees to secure a maximum benefit for patients, always under the supervision of the Research Ethics Committes. This point was made in Seville by the Head of Farmaindustria’s Platform for Innovative Medicines, Amelia Martín Uranga, within her keynote speech for the XIV Healthcare Data Protection & Safety Forum, organized by the Spanish Society of Health Informatics.
As Farmaindustria had recently reminded, the Regulation stresses the great importance of scientific research when allowing a wider use of patients’ informed consent, in a way that it is valid both for healthcare provision aims, as well as for scientific researches purposes. In this regard, it is crucial that the Spanish legislation, which will apply said European regulation, includes this flexibility and taking into account that this provides a chance for Spain when attracting R&D investments, as well as advancing in personalized medicine and the development of new medicines through the exploitation of the so called “health big data”
In fact, the European Regulation leaves it up to Member States to regulate some of their aspects, which, in Farmaindustria’s opinion, is necessary in order to harmonize on a European level so as to grant legal certainty to all international biomedical research projects which are ongoing or will be undertaken in the future. The new European legislation fosters, on the other hand, the so called ethic codes with regards to data protection, a field in which Farmaindustria started in 2009 with the publication of the Standard Code on Personal Data Protection in Clinical Research and Pharmacovigilance.
During her speech, Martín Uranga valued, as very positive, the acknowledgment of the added value of these codes by the European, as a model of co-regulation in which all responsibilities and rights are shared between all agents, highlighting that Farmaindustria’s Code will be updated according to the new legal framework.
This Farmaindustria’s tool bring an outstanding added value and legal certainty to the management of data in the fields on clinical research and pharmacovigilance, increasing, if possible, trust in an industry which has always been extremely scrupulous when processing this kind of data.