Katerina Sideri, Julian Cockbain, Wim Van Biesen, Marc De Hert, Johan Decruyenaere, Sigrid Sterckx
{"title":"用于远程监测药物摄入的数字药片:对营销批准和专利授予政策的利益相关者分析和评估。","authors":"Katerina Sideri, Julian Cockbain, Wim Van Biesen, Marc De Hert, Johan Decruyenaere, Sigrid Sterckx","doi":"10.1093/jlb/lsac029","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2022-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/4a/lsac029.PMC9578571.pdf","citationCount":"0","resultStr":"{\"title\":\"Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies.\",\"authors\":\"Katerina Sideri, Julian Cockbain, Wim Van Biesen, Marc De Hert, Johan Decruyenaere, Sigrid Sterckx\",\"doi\":\"10.1093/jlb/lsac029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":56266,\"journal\":{\"name\":\"Journal of Law and the Biosciences\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2022-10-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/4a/lsac029.PMC9578571.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Law and the Biosciences\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/jlb/lsac029\",\"RegionNum\":2,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/7/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Law and the Biosciences","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jlb/lsac029","RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/7/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"ETHICS","Score":null,"Total":0}
Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies.
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.
期刊介绍:
The Journal of Law and the Biosciences (JLB) is the first fully Open Access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard University Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. The Journal contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.