Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Close this folderCurrent topics
View the document“For export only” manufactured drugs and cosmetics that are not legally used in country of manufacture
View the documentWHO Certification Scheme: input for implementation
View the documentValue of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
View the documentPharmacopoeial specifications for new drug entities
View the documentImproving the impact of drug regulatory authorities on public health
View the documentStrengthening drug regulatory authorities in small Pacific Island nations
View the documentTransparency of data
View the documentKava
View the documentXenotransplantation and xenotourism: time for concerted regulatory action
View the documentRecommendations
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Xenotransplantation and xenotourism: time for concerted regulatory action

Dr Stewart Jessamine, New Zealand

Xenotransplantation is the transplantation of living cells, tissues, or organs between species, while allotransplantation is the transplantation of cells or organs within species. Xenotransplantation is a new technology and there are many factors to be considered, such as physiology, immunology, microbiology and ethical issues.

In terms of public health implications, all xenografts contain endogenous retroviruses which can infect cultures of human cells. However, whether these endogenous retroviruses can infect human cells in vivo or can replicate in human cells, thus causing disease, is still unknown. WHO and several regulators have urged that xenotransplantation be treated with extreme caution as the consequences of any emergent new infection could be serious.

Since xenotransplantation is unlike other medical treatments, the standard approaches to regulation, informed consent and ethical review may be inadequate. WHO urges each regulator to make its own risk-benefit assessment of the associated ethical and cultural issues.

In New Zealand, the Gene Technology Advisory Committee and the Royal Commission on Genetic Modification have recommended that xenotransplantation should not proceed in New Zealand until extensive public consultation has occurred. The Medicines Act was amended to place a temporary control over three “restricted biotechnical procedures”, namely xenotransplantation, cloning and genetic modification of human embryos. A comprehensive new regulatory regimen will be developed in the next four years.

New Zealand has declined an application to conduct xenotransplantation; the applicant has since approached several nearby countries with less strict regulatory systems and offered incentives to these countries to allow patients from New Zealand to be flown there for treatment. This could be called xenotourism. However, all attempts were rejected by the governments of these countries. The international consensus is that it is ethically unacceptable for a country to allow xenotransplantation to proceed within its borders without regulatory oversight and control.

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