Digital pills for the remote monitoring of medication intake : a stakeholder analysis and assessment of marketing approval and patent granting policies
- Author
- Katerina Sideri (UGent) , Julian Cockbain, Sigrid Sterckx (UGent) , Johan Decruyenaere (UGent) , Marc De Hert and Wim Van Biesen (UGent)
- Organization
- Project
- Abstract
- This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required.
- Keywords
- FDA, adherence, compliance, digital pill, ingestible event marker, patents
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Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-8771556
- MLA
- Sideri, Katerina, et al. “Digital Pills for the Remote Monitoring of Medication Intake : A Stakeholder Analysis and Assessment of Marketing Approval and Patent Granting Policies.” JOURNAL OF LAW AND THE BIOSCIENCES, vol. 9, no. 2, 2022, doi:10.1093/jlb/lsac029.
- APA
- Sideri, K., Cockbain, J., Sterckx, S., Decruyenaere, J., De Hert, M., & Van Biesen, W. (2022). Digital pills for the remote monitoring of medication intake : a stakeholder analysis and assessment of marketing approval and patent granting policies. JOURNAL OF LAW AND THE BIOSCIENCES, 9(2). https://doi.org/10.1093/jlb/lsac029
- Chicago author-date
- Sideri, Katerina, Julian Cockbain, Sigrid Sterckx, Johan Decruyenaere, Marc De Hert, and Wim Van Biesen. 2022. “Digital Pills for the Remote Monitoring of Medication Intake : A Stakeholder Analysis and Assessment of Marketing Approval and Patent Granting Policies.” JOURNAL OF LAW AND THE BIOSCIENCES 9 (2). https://doi.org/10.1093/jlb/lsac029.
- Chicago author-date (all authors)
- Sideri, Katerina, Julian Cockbain, Sigrid Sterckx, Johan Decruyenaere, Marc De Hert, and Wim Van Biesen. 2022. “Digital Pills for the Remote Monitoring of Medication Intake : A Stakeholder Analysis and Assessment of Marketing Approval and Patent Granting Policies.” JOURNAL OF LAW AND THE BIOSCIENCES 9 (2). doi:10.1093/jlb/lsac029.
- Vancouver
- 1.Sideri K, Cockbain J, Sterckx S, Decruyenaere J, De Hert M, Van Biesen W. Digital pills for the remote monitoring of medication intake : a stakeholder analysis and assessment of marketing approval and patent granting policies. JOURNAL OF LAW AND THE BIOSCIENCES. 2022;9(2).
- IEEE
- [1]K. Sideri, J. Cockbain, S. Sterckx, J. Decruyenaere, M. De Hert, and W. Van Biesen, “Digital pills for the remote monitoring of medication intake : a stakeholder analysis and assessment of marketing approval and patent granting policies,” JOURNAL OF LAW AND THE BIOSCIENCES, vol. 9, no. 2, 2022.
@article{8771556,
abstract = {{This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required.}},
articleno = {{lsac029}},
author = {{Sideri, Katerina and Cockbain, Julian and Sterckx, Sigrid and Decruyenaere, Johan and De Hert, Marc and Van Biesen, Wim}},
issn = {{2053-9711}},
journal = {{JOURNAL OF LAW AND THE BIOSCIENCES}},
keywords = {{FDA,adherence,compliance,digital pill,ingestible event marker,patents}},
language = {{eng}},
number = {{2}},
pages = {{38}},
title = {{Digital pills for the remote monitoring of medication intake : a stakeholder analysis and assessment of marketing approval and patent granting policies}},
url = {{http://doi.org/10.1093/jlb/lsac029}},
volume = {{9}},
year = {{2022}},
}
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