Book contents
- Law and Legacy in Medical Jurisprudence
- Law and Legacy in Medical Jurisprudence
- Copyright page
- Contents
- Contributors
- Foreword
- Preface
- Table of Cases
- Table of Legislation
- Abbreviations
- Introduction
- 1 ‘Doing’ Medical Law and Ethics
- 2 A Philosopher Looks at ‘Law and Medical Ethics’
- 3 Thinking Outside the Box
- 4 The Public Interest in Health Research
- 5 Taking the Legacy Forward
- 6 On the Importance of Impact on Policy and Legacy
- 7 Breathing Life into Law
- 8 Biomedical Research Policy
- 9 The Burden of History
- 10 Body Parts and Baleful Stars?
- 11 The Legacy of the Warnock Report
- 12 ‘Only Time Will Tell’
- 13 Integrating the Biological and the Technological
- 14 UK Biobank and the Legal Regulation of Genetic Research
- 15 Overcoming Regulatory Impasse in Stem Cell Research and Advanced Therapy Medicines in Argentina through Shared Norms and Values
- 16 Institutions, Interpretive Communities and Legacy in Decision-Making
- 17 Towards a New Privacy
- 18 A Tale of Two Legacies
- Afterword
- Index
15 - Overcoming Regulatory Impasse in Stem Cell Research and Advanced Therapy Medicines in Argentina through Shared Norms and Values
Published online by Cambridge University Press: 23 December 2021
- Law and Legacy in Medical Jurisprudence
- Law and Legacy in Medical Jurisprudence
- Copyright page
- Contents
- Contributors
- Foreword
- Preface
- Table of Cases
- Table of Legislation
- Abbreviations
- Introduction
- 1 ‘Doing’ Medical Law and Ethics
- 2 A Philosopher Looks at ‘Law and Medical Ethics’
- 3 Thinking Outside the Box
- 4 The Public Interest in Health Research
- 5 Taking the Legacy Forward
- 6 On the Importance of Impact on Policy and Legacy
- 7 Breathing Life into Law
- 8 Biomedical Research Policy
- 9 The Burden of History
- 10 Body Parts and Baleful Stars?
- 11 The Legacy of the Warnock Report
- 12 ‘Only Time Will Tell’
- 13 Integrating the Biological and the Technological
- 14 UK Biobank and the Legal Regulation of Genetic Research
- 15 Overcoming Regulatory Impasse in Stem Cell Research and Advanced Therapy Medicines in Argentina through Shared Norms and Values
- 16 Institutions, Interpretive Communities and Legacy in Decision-Making
- 17 Towards a New Privacy
- 18 A Tale of Two Legacies
- Afterword
- Index
Summary
The construction of governance frameworks for new health technologies is a complex process for most countries, particularly for developing countries. They must grapple with ‘old’ structures and ways of doing things while striving to plant the seeds of the ‘new’, which will put them on a higher level to promote science as well as access to new drugs and treatments. To achieve these goals, international collaboration is a key element. Argentina issued a regulation for advanced therapy medicinal products at the end of 2018. This chapter describes the objectives and actors involved in that process. It focuses on how internal tensions regarding whether to regulate were solved, considering the regulatory harmonisation process promoted by the European Medicines Agency and the US Food and Drug Administration, and the self-regulatory diversification promoted by China and other countries. Special mention is made of the importance of identifying social values and constructing a vision to guide the exercise of ‘foresight’ in law, which resulted in the design and implementation of the new regulation and governance of the system.
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- Chapter
- Information
- Law and Legacy in Medical JurisprudenceEssays in Honour of Graeme Laurie, pp. 332 - 344Publisher: Cambridge University PressPrint publication year: 2022