Bernice Azzopardi Meli, Anthony G. Fenech, Maria Cordina, Bridget Ellul, Emmanuel Agius
{"title":"Challenges in public policy for the implementation of pharmacogenetic tests in Europe","authors":"Bernice Azzopardi Meli, Anthony G. Fenech, Maria Cordina, Bridget Ellul, Emmanuel Agius","doi":"10.1057/s41292-023-00323-w","DOIUrl":null,"url":null,"abstract":"<p>Pharmacogenetics innovation in biomedicine has fostered new hope in pharmacotherapeutics and in the prevention and management of adverse drug reactions. Proponents argue that pharmacogenetics will improve drug safety and efficacy while also revolutionising marketing. Integral to this survey is the recognition that pharmacogenetics has been hailed as a revolutionary frontier within biomedicine. This expectation amplifies the anticipation and promise associated with the emergence of new biotechnologies. This progress, however, raises several policy concerns with the need to balance the creation of a unified legal framework. We outline the European regulatory framework, and discuss the current challenges and opportunities related to licensing, the development of innovative medicines, cost-effectiveness, resource allocation, and stratification. There is the need to substantiate the value of a regulatory framework and vigilant monitoring to ensure equitable access and just distribution of the benefits of pharmacogenetics in Europe.</p>","PeriodicalId":46976,"journal":{"name":"Biosocieties","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biosocieties","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1057/s41292-023-00323-w","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"SOCIAL SCIENCES, BIOMEDICAL","Score":null,"Total":0}
引用次数: 0
Abstract
Pharmacogenetics innovation in biomedicine has fostered new hope in pharmacotherapeutics and in the prevention and management of adverse drug reactions. Proponents argue that pharmacogenetics will improve drug safety and efficacy while also revolutionising marketing. Integral to this survey is the recognition that pharmacogenetics has been hailed as a revolutionary frontier within biomedicine. This expectation amplifies the anticipation and promise associated with the emergence of new biotechnologies. This progress, however, raises several policy concerns with the need to balance the creation of a unified legal framework. We outline the European regulatory framework, and discuss the current challenges and opportunities related to licensing, the development of innovative medicines, cost-effectiveness, resource allocation, and stratification. There is the need to substantiate the value of a regulatory framework and vigilant monitoring to ensure equitable access and just distribution of the benefits of pharmacogenetics in Europe.
期刊介绍：
BioSocieties is committed to the scholarly exploration of the crucial social, ethical and policy implications of developments in the life sciences and biomedicine. These developments are increasing our ability to control our own biology; enabling us to create novel life forms; changing our ideas of ‘normality’ and ‘abnormality’; transforming our understanding of personal identity, family relations, ancestry and ‘race’; altering our social and personal expectations and responsibilities; reshaping global economic opportunities and inequalities; creating new global security challenges; and generating new social, ethical, legal and regulatory dilemmas. To address these dilemmas requires us to break out from narrow disciplinary boundaries within the social sciences and humanities, and between these disciplines and the natural sciences, and to develop new ways of thinking about the relations between biology and sociality and between the life sciences and society.
BioSocieties provides a crucial forum where the most rigorous social research and critical analysis of these issues can intersect with the work of leading scientists, social researchers, clinicians, regulators and other stakeholders. BioSocieties defines the key intellectual issues at the science-society interface, and offers pathways to the resolution of the critical local, national and global socio-political challenges that arise from scientific and biomedical advances.
As the first journal of its kind, BioSocieties publishes scholarship across the social science disciplines, and represents a lively and balanced array of perspectives on controversial issues. In its inaugural year BioSocieties demonstrated the constructive potential of interdisciplinary dialogue and debate across the social and natural sciences. We are becoming the journal of choice not only for social scientists, but also for life scientists interested in the larger social, ethical and policy implications of their work. The journal is international in scope, spanning research and developments in all corners of the globe.
BioSocieties is published quarterly, with occasional themed issues that highlight some of the critical questions and problematics of modern biotechnologies. Articles, response pieces, review essays, and self-standing editorial pieces by social and life scientists form a regular part of the journal.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
