Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia.

IF 1.8 3区哲学 Q2 ETHICS

Health Care Analysis Pub Date : 2023-12-01 Epub Date: 2023-07-21 DOI:10.1007/s10728-023-00465-9

Haniff Ahamat, Hairanie Sa'ban, Nazura Abdul Manap

{"title":"Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia.","authors":"Haniff Ahamat, Hairanie Sa'ban, Nazura Abdul Manap","doi":"10.1007/s10728-023-00465-9","DOIUrl":null,"url":null,"abstract":"<p><p>The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"196-207"},"PeriodicalIF":1.8000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health Care Analysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10728-023-00465-9","RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/7/21 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}

引用次数: 0

Abstract

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.

查看原文本刊更多论文

在马来西亚Covid-19疫苗注册中平衡知识产权保护和法律风险评估。

COVID-19大流行的严重性要求研究COVID-19疫苗药品注册规则的实施情况。在紧急情况下，疫苗作为一种生物制品，需要全面和持续的前后注册规则，以确保其安全性和有效性。这项研究的重点是马来西亚，该国的药物注册规则已成功应用于疫苗。研究表明，这些规则是为紧急情况量身定制的。目前，已经出台了特别规定，包括允许将COVID-19疫苗作为未注册产品使用。对COVID-19疫苗全球可及性(COVAX)设施的认可和仅限政府销售的要求是其中的安全阀。然而，研究表明，这些都是针对私人参与者可能进入疫苗接种过程的背景采取的临时措施。因此，在该领域进一步开展研究之前，在渐进式规则中需要对与知识产权(IP)相关的药物注册条件作出监管反应，并采取措施确保疫苗生产、批准和管理中涉及的风险管理。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Health Care Analysis Multiple-

CiteScore

4.20

自引率

0.00%

发文量

期刊介绍： Health Care Analysis is a journal that promotes dialogue and debate about conceptual and normative issues related to health and health care, including health systems, healthcare provision, health law, public policy and health, professional health practice, health services organization and decision-making, and health-related education at all levels of clinical medicine, public health and global health. Health Care Analysis seeks to support the conversation between philosophy and policy, in particular illustrating the importance of conceptual and normative analysis to health policy, practice and research. As such, papers accepted for publication are likely to analyse philosophical questions related to health, health care or health policy that focus on one or more of the following: aims or ends, theories, frameworks, concepts, principles, values or ideology. All styles of theoretical analysis are welcome providing that they illuminate conceptual or normative issues and encourage debate between those interested in health, philosophy and policy. Papers must be rigorous, but should strive for accessibility – with care being taken to ensure that their arguments and implications are plain to a broad academic and international audience. In addition to purely theoretical papers, papers grounded in empirical research or case-studies are very welcome so long as they explore the conceptual or normative implications of such work. Authors are encouraged, where possible, to have regard to the social contexts of the issues they are discussing, and all authors should ensure that they indicate the ‘real world’ implications of their work. Health Care Analysis publishes contributions from philosophers, lawyers, social scientists, healthcare educators, healthcare professionals and administrators, and other health-related academics and policy analysts.