The digital transformation of biomedical research must be deployed with full safeguards for patients

The creation of the European Health Data Space is emerging as a great opportunity to boost R&D for new medicines.

Public-private collaboration, once again, at the heart of the advances that can be made in the expansion of precision medicine.


Research and development of new medicines is becoming increasingly open, collaborative and international. The unprecedented race for vaccines and medicines against the coronavirus has been a case in point. The pharmaceutical industry responded to the urgent need for appropriate treatments by reaching an unprecedented milestone: developing effective and safe vaccines in just one year.

“So the global pharmaceutical R&D model, underpinned by industrial protection, pharmaceutical company leadership and increasing collaboration with the scientific community, has worked. We have known this for a long time,” said the director of Farmaindustria’s Technical Department, Emili Esteve, opening the symposium on public-private collaboration at the 15th Conference of Biomedical Research Platforms on Wednesday.

It has worked particularly well in Spain, as evidenced by the fact that it has become the first country in Europe to carry out clinical trials for Covid-19, thanks to the fact that the aforementioned cooperation has been taking place for years. “Generating an ecosystem that improves our country’s competitiveness in this field is a great opportunity”, because clinical research represents benefits for patients, who can access potential answers to their disease sooner; for healthcare professionals, who are at the forefront of scientific knowledge and receive a stimulus for the development of daily clinical practice; for healthcare systems, because it is a source of income and a plus for the quality of care; and for the country as a whole, because it feeds the flow of knowledge, resources and international prestige, explained Esteve.

This path that has been traced and, in a first stretch, walked “has brought us to the gates of personalised medicine, through greater knowledge of the so-called omic sciences, and instruments such as digitalisation, the use of big data and artificial intelligence in the field of health offer great opportunities and it is time to make the most of them for the benefit of patients,” he said.

The associate director of Clinical and Translational Research at Farmaindustria, Amelia Martín Uranga, spoke about the “accelerated digital transformation” at the same forum, where she also highlighted the value of what was learned during the pandemic, when the Spanish Data Protection Agency (AEPD) and the Spanish Agency for Medicines and Health Products (AEMPS) worked collaboratively with the pharmaceutical industry to ensure that clinical trials did not stop, implementing remote monitoring, but always guaranteeing “an appropriate legal framework to provide security for patients”.

The aforementioned remote monitoring, electronic consent and digital recruitment are some of the steps that have been taken in the last two years and are the gateway to progress in the decentralisation of clinical trials in Spain, currently concentrated in Madrid and Catalonia. “Digital health must be inclusive and complement face-to-face for the benefit of patients,” said Martín Uranga.

The legal framework, in this sense, is key to harmonising European legislation on digitisation applied to biomedical research and, in turn, to provide all the guarantees for the research process and the use of patient data. “We are at a time when the European Union is deploying a lot of important legislation on data, especially in the field of health. But we need this to be done in a harmonised way. Biomedical research projects are pan-European and need the same legal framework. This needs to be corrected so as not to hinder the progress of biomedical research and to ensure that the required procedures and governance are for the good of the patient, not over-regulation,” he said.

The great value of the re-use of health data

It is also a time for social pedagogy, he added, explaining the value of the re-use of health data and recalling that informed consent is the basis for the participation of patients in a clinical trial or research, although there are additional legal bases for processing patient data other than consent.

The new legal framework being put in place to create the European Health Data Space “gives us an opportunity to shape the health data and digital ecosystem of the future and ensure that Europe continues to innovate while removing barriers to health data for scientific research. In any case, it must be a flexible legal framework that maintains a balance between data protection and the promotion of research,” he reflected.

Farmaindustria has been actively working in this area for years and it is already bearing fruit. A few months ago, the first sectoral code of conduct based on the new General Data Protection Regulation (GDPR) was presented at the AEPD headquarters. This is 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, which regulates how promoters of clinical studies with medicinal products and contract research organisations (CROs) that decide to join must apply data protection regulations. Martín Uranga called on these agents to join the new code, “a benchmark in Europe, as it is the first of its kind in the region”. “We are building a legal framework for data protection that gives a lot of confidence to patients, researchers and clinical trial sponsors,” he concluded.

For more information on the new Code of Conduct or to sign up to it, please use this link.

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