Human Genome Editing Science, Ethics, and Governance (2017) / Chapter Skim
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Appendix B: International Research Oversight and Regulations
Appendix B: International Research Oversight and Regulations
Pages 261-272
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From page 261... ...
By incorporating public comment, such public scrutiny creates political pressure that can drive decisions in one way or another, and it allows for some interplay between government expertise/authority and public consultation. Canada, when it looked at assisted reproduction across many different forms, formed a royal commission on new reproductive technologies that traveled the country from east to west, holding public hearings on the topic.
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From page 262... ...
These are self-imposed rules that are seriously constraining with respect to donation of tissues, recruitment of donors, and experimentation that raises concerns, such as the use of chimeras. Examples include the guidelines adopted by the International Society for Stem Cell Research,
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From page 263... ...
On the other hand, criticisms levied included that the processes and modalities were rule-guided rather than based on dialogue and deliberation, and that there was a lack of identifiable links between the consulta tion and the ultimate legislative outcome. which have been amended to cover all forms of embryo research, from basic science to clinical trials with stem cells (ISSCR, 2016)
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From page 264... ...
Japan has also added a conditional approval pathway specifically for regenerative medicine and gene therapy products, but it is too new for evaluation (Charo, 2016b)
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From page 265... ...
Mexico addresses genetic engineering in the context of GMOs and biosecurity in its general health law and in its research regulations.2 Brazil addresses gene editing in its Biosafety Law, implicitly permitting at least some somatic gene-editing research in humans, although its primary focus is clearly on GMOs.3 Similarly, Ecuador's Constitution has provisions addressing genomic heritage in the setting of GMOs and biopiracy, and in its guarantee of personal integrity it prohibits the use of genetic material for scientific research in violation of human rights.4 A few jurisdictions in Latin America have explicitly addressed somatic genome editing, typically imposing restrictions aimed at prohibiting uses that might be perceived as "enhancement" rather than treatment or prevention of disease and injury. Chile states that gene editing "in somatic cells will be authorized only for the treatment of diseases or to prevent their occurrence" in a far-reaching law that also addresses intellectual property, discrimination, and protection of genetic identity, as well as prohibiting "eugenic practices" (with an exception for genetic counseling)
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From page 266... ...
. Within the current regulatory framework, human somatic cell genome editing may be considered a third category therapeutic technology rather than a drug.
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From page 267... ...
Consultations would likely occur with agencies such as the Ministry of Science and Technology, Chinese Academy of Sciences, Chinese Academy of Medical Sciences, and Chinese Academy of Engineering to enable their positions to be incorporated into regulations. HERITABLE GENETIC MODIFICATIONS RAISE ADDITIONAL ISSUES A number of special regulatory and governance issues may arise around use of human embryos and the potential for genetic changes to be made to the human germline.
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From page 268... ...
. Harmonized standards also provide economies of scale for regulators, reduce administrative costs in adopting and administering national laws, and increase opportunities to share regulatory resources and workload.
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From page 269... ...
. Informal mechanisms of international coordination and cooperation do not create legal requirements to implement specific provisions, but 9 An example of the challenges associated with negotiating and enforcing treaties was the unsuccessful attempt through the United Nations system in the early 2000s to create a binding international treaty banning human cloning (Cameron and Henderson, 2008)
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From page 270... ...
. International cooperation and coordination approaches can also be achieved through nongovernmental organizations, such as scientific societies, for example through the International Society for Stem Cell Research (ISSCR)
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2007. The ISSCR guidelines for human embryonic stem cell research.
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From page 272... ...
Washington, DC: The National Academies Press. ISSCR (International Society for Stem Cell Research)
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