Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) Voir le document au format PDF
Table des matières
Afficher le documentAbbreviations and acronyms used in this report
Ouvrir ce répertoire et afficher son contenuOpening ceremony
Ouvrir ce répertoire et afficher son contenuHerbal medicines
Ouvrir ce répertoire et afficher son contenuKeynote address
Ouvrir ce répertoire et afficher son contenuSafety of blood-derived products
Ouvrir ce répertoire et afficher son contenuAntimicrobial resistance - new initiatives
Ouvrir ce répertoire et afficher son contenuHarmonization I
Ouvrir ce répertoire et afficher son contenuHarmonization II
Ouvrir ce répertoire et afficher son contenuProtection of trial subjects in clinical trials
Ouvrir ce répertoire et afficher son contenuRegulating biotechnology products
Ouvrir ce répertoire et afficher son contenuRegulatory challenges: health sector reform and drug regulatory capacity
Ouvrir ce répertoire et afficher son contenuAccess to drugs and vaccines I
Ouvrir ce répertoire et afficher son contenuAccess to drugs and vaccines II
Ouvrir ce répertoire et afficher son contenuCounterfeit pharmaceutical products
Ouvrir ce répertoire et afficher son contenuHomoeopathy
Ouvrir ce répertoire et afficher son contenuSafety monitoring
Ouvrir ce répertoire et afficher son contenuE-Commerce
Fermer ce répertoireCurrent topics
Afficher le document“For export only” manufactured drugs and cosmetics that are not legally used in country of manufacture
Afficher le documentWHO Certification Scheme: input for implementation
Afficher le documentValue of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
Afficher le documentPharmacopoeial specifications for new drug entities
Afficher le documentImproving the impact of drug regulatory authorities on public health
Afficher le documentStrengthening drug regulatory authorities in small Pacific Island nations
Afficher le documentTransparency of data
Afficher le documentKava
Afficher le documentXenotransplantation and xenotourism: time for concerted regulatory action
Afficher le documentRecommendations
Ouvrir ce répertoire et afficher son contenuRegulatory challenges of new technologies
Afficher le documentList of participants
Afficher le 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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