The director of Farmaindustria’s Research Department participates in a round table on the regulation of this project held at the European Parliament Office in Madrid.
“For the pharmaceutical industry, the secondary use of data can complement the information from clinical trials and therefore improve the effectiveness of medicines,” says Pedro Luis Sánchez.
The use of artificial intelligence and data science can enable the use of citizens’ health data to help in disease prevention and improve the efficacy of medicines to improve patient treatment. The challenge is how to make good use of this personal data. To address this challenge, the European Commission has launched the European Health Data Space (EEDS), whose proposed regulation was presented in May 2022, and which aims to unlock its full potential by ensuring that electronic health data is as open as possible and as closed as necessary.
The three objectives of this project are, firstly, to help people control their own health data; secondly, to support its use to improve healthcare delivery, research, innovation and policy making; and thirdly, to enable the European Union to fully exploit the potential offered by the exchange, use and secure re-use of health data.
Farmaindustria “fully supports the objectives of the EEDS regulation proposal and considers it a unique opportunity for European society as a whole”, as Pedro Luis Sánchez, director of Farmaindustria’s Research Department, stated at a conference on the regulation of this project organised by the company MSD at the European Parliament Office in Madrid.
For the pharmaceutical industry, he said, “the main interest lies in the so-called secondary use of data, as it opens up great opportunities for research and innovation”. Secondary use of data is generated by the processing of aggregated health information to improve, for example, healthcare, drug development or research. Whereas information related to our health that is used for the healthcare of patients is the so-called primary use of health data.
The Farmaindustria spokesperson pointed to a number of advantages that secondary use of health data can achieve for biomedical innovation. “The first is that it can complement information from clinical trials,” he said. “It can never be a substitute for clinical research, but it is a perfect complement to it,” he added. It will also reduce uncertainty in the use and evaluation of new medicines. “Research using real-life data has the potential to reduce the uncertainty with which some drugs come to market. Similarly, the use of these data has the ability to define subpopulations of patients for whom a given drug is more or less appropriate compared to other therapies, “which will increase both the effectiveness and efficiency of delivery,” he said.
In addition, this secondary use of data, said Sánchez, can provide highly relevant information for the economic regulation of medicines, as well as improve patient access to innovation through the generation of real-life evidence, boost research into new medicines and reduce R&D costs.
The issue of consent to the use of data was also discussed during the conference. The European Parliament is currently debating whether the regulation should leave it up to each Member State to decide whether users can opt out of sharing certain types of health data.
For the director of Farmaindustria’s Research Department, a general opt-out mechanism would be unnecessary because all the protections and safeguards set out in the EEDS are aimed precisely at avoiding any direct impact on citizens when their electronic health data is used. “An opt-out will discourage rather than incentivise scientific research; it could compromise the integrity of some datasets; and it would conflict with some provisions expected to be adopted in the Artificial Intelligence Act since training algorithms on real-life data to avoid bias is essential,” he said.