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4 Comparative Regulatory and Legal Frameworks
4 Comparative Regulatory and Legal Frameworks
Pages 25-40
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From page 25... ...
BOX 4-1 Summary Points from Individual Speakers About Regulatory and Legal Issues Related to Stem Cell Therapies • In the United States, stem cell therapies are regulated as biologics and are subject to premarket approval under the risk-based approach to approving cellular and tissue-based products. Treatments that are "minimally manipulated" are exceptions to this regulation, but this phrase could use further clarification.
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From page 26... ...
(Zhou) REGULATORY AND LEGAL FRAMEWORKS IN THE UNITED STATES If regulations for stem cell therapies were only just now being developed in the United States, they would look much different than the ones that exist today, said Margaret Foster Riley, professor of law at the University of Virginia School of Law.
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From page 27... ...
The FDA has sent warning letters to several clinics that claim to offer treatments, prevention, or even cures using stem cell therapies that are not approved. For example, the FDA took action against Regenerative Sciences, LLC, which manufactured a product called Regenexx™, which consisted of autologous mesenchymal stem cells that were manipulated outside of the body and injected back into patients with orthopedic injuries (FDA, 2009)
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From page 28... ...
In 2013 the FDA obtained a guilty plea from an assistant professor of pathology and laboratory medicine at the Medical University of South Carolina for "causing the introduction of stem cells into interstate commerce without the approval of the FDA."3 The laboratory for which the defendant worked was authorized to conduct research on kidney cancer, but it was not permitted to use, harvest, or process stem cells for other purposes, and the defendant sold stem cells to unauthorized recipients, Vladeck said. Generally, but not always, the FTC has principal responsibility with respect to advertising, Vladeck said, while both the FTC and the FDA have authority over Internet marketing.
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From page 29... ...
FDA," • "The stem cell protocols we offer are not approved in the United States as treatments, therapies, drugs, new drugs, or investiga tional drugs," • "We do not claim that our treatment protocols are approved by the U.S. FDA or proven to be effective in the United States for any condition that appears on this site or for any other condition," • "There could be significant and unknown risks associated with adult stem cell treatment as long-term studies have not yet been performed," and • "Very few randomized controlled trials of adult stem cells have been performed; therefore, no guarantee of safety or effective ness is made or implied."
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From page 30... ...
REGULATORY AND LEGAL FRAMEWORKS IN ITALY Most of the regulatory framework that dictates how to use stem cells in Italy derives from a set of European regulations, based largely on the
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From page 31... ...
(EMA, 2007) In April 2013 the Senate in Italy voted to reclassify the infusion of mesenchymal stem cells as a transplants procedure, which abrogated the
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From page 32... ...
These gaps have been used in some countries by unauthorized stem cells clinics, Bianco said. For example, the private Stamina Foundation in Italy gained substantial support from the public for stem cell therapies they promoted to treat a wide range of medical conditions (Abbott, 2013)
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From page 33... ...
The translation of science to the marketplace needs to be considered, not just the translation of science to medicine. REGULATORY AND LEGAL FRAMEWORKS IN JAPAN Japan has a very similar regulatory framework to that of the United States and the European Union, said Toshio Miyata, executive director of the Health and Global Policy Institute in Japan.
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From page 34... ...
For example, it has labeled therapies that use stem cells as "regenerative medicine products" and has introduced a new definition of regenerative and cellular therapeutic products that sets them apart from pharmaceuticals and medical devices. It also has developed an approval system for earlier commercialization of regenerative medicine products, with the introduction of a tentative approval after which safety and efficacy are further confirmed.
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From page 35... ...
It outlines a number of safety measures including prior notification to authorities to ensure the safety of the treatment, establishing a permitting and notification system for cellprocessing facilities, and obtaining informed consent, and it also calls for the protection of personal information and the reporting of adverse events to authorities, Miyata said. REGULATORY AND LEGAL FRAMEWORKS IN MEXICO The medical tourism industry is an important business in Mexico, which has been a popular destination for foreign patients who are seeking stem cell treatments, said María de Jesús Medina Arellano, an attorney from Universidad Autonoma de Nayarit who has studied health law and human rights in Mexico.
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From page 36... ...
However, none of these regulations specifically applies to stem cell therapies. The General Health Law prohibits false advertising of treatments or clinical interventions that are not supported by scientific evidence and at least five official Mexican standards prohibit and regulate the advertising of medical products and services, Arellano said.
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From page 37... ...
International regulation or harmonization in the area of stem cells, despite skepticism about international regulations, could help address many of the challenges Mexico faces. REGULATORY AND LEGAL FRAMEWORKS IN CHINA The Ministry of Science and Technology, the Chinese Academy of Sciences (CAS)
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From page 38... ...
Organizations involved in these guidelines include the National Health and Family Planning Commission of China, the China Food and Drug Administration, the National Leading Group of Clinical Stem Cells Study, and the National Stem Cell Experts Committee. The guidelines cover the isolation, purification, culture, amplification, modification, differentiation, cryopreservation and resuscitation, and in vivo implantation of stem cells, including embryonic stem cells, induced pluripotent stem cells, mesenchymal stem cells, hematopoietic stem cells, and other progenitor cells or precursor cells.
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From page 39... ...
International harmonization for stem cell therapies can be difficult in a domain characterized by complexity and powerful commercial interests, Riley said, but harmonization could be pursued through international societies working together with government agencies. Multi-site international clinical trials would be one avenue toward greater harmonization, she said.
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From page 40... ...
40 STEM CELL THERAPIES ous approval in different countries would also be helpful, Miyata said. Perhaps working through groups like the United Nations Educational Scientific and Cultural Organization is also a possibility, Arellano suggested.
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