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  • Webinar: Precision medicine and regulation of healthcare

Date: 24th February

Venue: Zoom

Price: Free

Time: 10:00 - 11:30 CET

Time: 10:00 - 11:30 CET

How to register:

Please email post@nordicpermedlaw.org to register. You will be sent a zoom link shortly before the event.

Speakers:

Jameson Garland, LL.D., Medical Law, Senior Lecturer at Uppsala University Faculty of Law

“Precision medicine, standards of care, and scientific method”

Precision medicine, like evidence-based medicine, purports to bring specific scientific advantages to determining medical benefits and risks for patients, as well as the quality of care that they receive. This presentation will examine the strengths and weaknesses of both of these scientific approaches in light of what is generally thought of as a "standard of care". It will also ask if these two methods can coexist or be compatible or complementary.  International standards of care will open for discussion regarding scientific quality, in light of the challenges of fusing medicine and legal approaches to patient care.

Jakob Wested, Ph.D. Industrual post doc, Danish Medicines Agency's data analytics center (DAC) & Center for Advanced Studies in Biomedical Innovation Law (CeBIL)

“Regulatory issues of bridging the gap between population and individual”

Significant resources are spent on clinical trials (CTs) that are obligatory to get a marketing authorization (MA’s) for a medicinal product. The objective of MA-clinical trials is to get data on safety and efficacy at a population level, while personalized medicine seeks data on the effect of interventions on an individual. Personalized medicine revolves around high-quality data and CT data is an obvious resource to utilize, but how can we bridge the gap between population and individual data? And more specifically: Does the regulatory framework support the bridging from population to individual?

Lea Larsen Skovgaard,  Ph.D. Fellow at University of Copenhagen, Center for Medical Science and Technology Studies 

“Public legitimacy of data sourcing for personalized medicine”

Personalized medicine aims at tailoring prevention, diagnostics, and treatment to the individual. Individualization of healthcare presupposes access to data from a broad part of the population to use for comparison and for further research. This raises questions about who should be able to access which data, for which purposes, and how this access and use should be regulated. In this talk, I discuss these questions from an empirical perspective: I have studied the opinions of patients, clinicians, civil servants, and “the broader public” through a questionnaire, interviews, participant observation, and a public debate about personalized medicine. I address the challenges in making questions about the data economy that are relevant for people who are not professionally involved in personalized medicine. Finally, I point to how there are aspects of the health data economy regarding trust, transnational data sharing, commercial involvement, and use of data as a national economic resource, which challenge the legitimacy of the reuse of health data in Denmark.