SYDNEY, September 19, 2003 ( – Australian Senator Brian Harradine welcomed new draft regulations which were tabled by the Australian Government in the Senate Tuesday. The regulations would ensure consumers are informed when human embryos or human embryonic stem cells or materials derived from embryos or stem cells are used in the manufacture or testing of pharmaceuticals.  Senator Harradine, Australia’s longest serving senator, said “the draft Therapeutic Goods Regulations are a significant step forward for consumers right to know.”  The regulations are a result of work Senator Harradine began in December last year, when he tried to amend the Research Involving Human Embryos Act. In May this year Senator Harradine proposed amendments to the Therapeutic Goods Act to ensure consumers have access to this information.  The Government agreed to consider these issues further and has negotiated with Senator Harradine for the past four months.  The passage of the Research Involving Human Embryos Act late last year allowed a wide variety of research using human embryos.  One of the principal uses of human embryos and human embryonic stem cells is expected to be the testing and manufacture of drugs.  “I was very concerned that consumers with an ethical objection to the destruction of human embryos would be forced to be morally complicit in the use of these drugs, simply because information was hidden from them,” said Harradine.  “These regulations are a small consolation for the tragic passage last year of legislation which allows the destruction of human embryos for research.”  The Government has agreed to require pharmaceutical companies to provide plain English advice in Product Information (pamphlets for medical professionals) and Consumer Medicine Information (pamphlets for consumers), which are available for all registered drugs in Australia.  The information will be available for all drugs registered after 1 July 2004.


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