Firms Reluctantly Accept Labeling for Drugs Tested With Human Embryos

By Patrick Goodenough | July 7, 2008 | 8:14 PM EDT

Pacific Rim Bureau ( - Australian pharmaceutical manufacturers say they have reluctantly agreed to label new drugs that have been developed with or tested on tissue from human embryos.

The new regulations, believed to be the first of their kind anywhere, are the result of campaigning by pro-lifers and ethicists opposed to stem cell research using human embryos, in a country whose scientists are world-leaders in the field.

From mid-2004, new drugs \lang3081 created or tested using human embryonic stem cells or human embryos must be labeled as such. The requirement will enable doctors and consumers to avoid using those products if they oppose the research on ethical grounds.

\lang3081 Medicines Australia, the association representing the prescription drugs industry, has been involved in negotiations with the government body that registers drugs, the Therapeutic Goods Administration (TGA).

The TGA subsequently handed a report to the federal government, and Health Minister Kay Patterson announced the regulation changes in the Senate last week.
In response to queries, Medicines Australia CEO Kieran Schneemann has confirmed that the industry was uneasy.

"We have expressed concern throughout these discussions that the requirement ... went far beyond any regulatory requirement in other country," he said.

"This would have a significant negative impact on investment in ground-breaking stem cell research in Australia, relating to medicines as well as other applications of this research."

Nonetheless, Schneemann said, Medicines Australia had "somewhat reluctantly accepted" that, if a company manufactures a drugs using human embryos or embryonic stem cells, including in the testing of the drug, "this will be disclosed."

Pro-life campaigners in Australia, including the lawmaker who pressed for the amendment to the regulations, Senator Brian Harradine, have long contended that scientists pushing embryonic stem cell research were more interested in profitable drug-testing applications than in finding "miracle cures" for a range of diseases - the aim most often cited by proponents of the research.

Pro-lifers oppose research using human embryos because the embryos are destroyed in the process.

Worldwide, the research has become one of the new century's most contentious issues in medical ethics.

See earlier story:
Drugs Tested on Human Embryos to Carry Warning Labels (Sept. 18, 2003)

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Patrick Goodenough
Patrick Goodenough
Spencer Journalism Fellow