Australia: Recent developments in embryonic stem cell research and biological therapies

Health Law Bulletin
Last Updated: 18 November 2010
Article by Alison Choy Flannigan
This article is part of a series: Click Emergency Department Medical Malpractice Cases for the previous article.

Why are stem cells important ?

Stem cells are seen as the next frontier of medical research as it is hoped their capacity to repair damaged cells may provide clues to the treatment of many currently incurable diseases. Stem cells are categorised as adult, embryonic or induced pluripotent (adult cells that are reprogrammed to act as embryonic stem cells).

Embryonic stem cells (ESC), found on the fifth day of a fertilised egg, are able to replicate and transform into any of the body's cell types. Adult stem cells are found in the body's tissue or umbilical cord blood. Whilst adult stem cells can only develop into one type of cell, ESC are able to become any cell, and thus are seen to have wider application. Extraction of ESC involves the destruction of the embryo, which certain people find morally unacceptable.

The Catholic view

The Catholic Church is strongly against ESC research, for in their view an embryo is a human being and its destruction is therefore unjustifiable. However, in 2007 Pope Benedict XVI spoke in support of adult stem cell research as a means of scientific research without endangering a person's life.

US stem cell saga

In March 2009, President Obama overturned the ban on funding of ESC research put in place by his predecessor 8 years prior. This was eagerly met by the scientific community who could now 'make up for lost ground' with access to the funds that would facilitate their research.

However, on 23 August 2010, Justice Lamberth in the District of Columbia ruled that the National Institute of Health guidelines to provide funding for ESC research were contrary to the Dickey-Wicker amendment, a 1996 law that prohibits the use of Federal money for research in which an embryo is destroyed, stating: 'Congress has mandated that the public interest is served by preventing taxpayer funding of research that entails the destruction of human embryos.'

On 9 September 2010, the Court of Appeal for the District of Columbia made an interim ruling allowing the research to continue pending the current appeal.

The decision has the potential to place in jeopardy millions of dollars of grants for stem cell research in the US and has sparked heated debate in the US.

The Australian situation - New Biologicals Framework passed

Permitted stem cell research

In Australia the law is stated in the Prohibition of Human Cloning for Reproduction Act 2002 (Cth), the Research Involving Human Embryos Act 2002 (Cth) and the Gene Technology Act 2000 (Cth).

Human embryos must only be created from the process of the fertilisation of a human egg by a human sperm outside the body of a woman with the intention of achieving pregnancy of that woman.

In this context, ESC research using a human embryo is only permitted if:

  • the embryo was created for in vitro fertilisation, but is no longer needed for that purpose;
  • the embryo has not been developed for more than 14 days;
  • specific proper consent from both people whose genetic material is in the embryo has been granted to use the embryo for ESC research; and
  • the ESC research is conducted by a person who is licensed under the Research Involving Human Embryos Act 2002 (Cth) and in accordance with the conditions of the licence. Thus human embryos that do not meet the above criteria cannot be used in ESC research in Australia and would otherwise be discarded.

New biological framework

The Therapeutic Goods Amendment (2009 Measures No 3) Act 2010 (Cth) (the TGA) was passed on 13 May 2010, which will introduce into Australia a new framework for the regulation of biologicals. The TGA has a maximum of 12 months to implement the new regulatory framework.

Meaning of biological

As defined in the proposed new section 32A of the TGA, subject to legislative exemptions, a biological is a thing that:

a) either:

  • comprises, contains, or is derived from human cells or human tissues; or
  • is specified in subsection (2); and

b) is represented in any way to be, or is, whether because of the way in which it is presented, or for any other reason, likely to be taken to be:

  • for use in the treatment or prevention of a disease, ailment, defect or injury affecting persons; or
  • for use in making a medical diagnosis of the conditions of a person; or
  • for use in influencing, inhibiting or modifying a physiological process in persons; or
  • for use in testing the susceptibility of persons to a disease or ailment; or
  • for use in the replacement or modification of parts of the anatomy in persons.

The biological framework excludes reproductive tissue and solid organs.

The TGA has released in October 2010 the following documents:

  • Consultation Paper on the Amendments to the Therapeutic Goods Regulations 1990 for the implementation of the Biologicals Framework;
  • Resource Guide - Overview of the Biologicals Framework.

Conclusion

These recent developments clearly demonstrate the precarious balance that the law strives to achieve between health and ethics, and how the law is required to develop alongside technological advances in the area of stem cell research and biological therapies. Health providers and life science organisations who operate in this area must constantly keep up to date with legal, ethical and regulatory requirements.

© DLA Phillips Fox

DLA Phillips Fox is one of the largest legal firms in Australasia and a member of DLA Piper Group, an alliance of independent legal practices. It is a separate and distinct legal entity. For more information visit www.dlaphillipsfox.com

This publication is intended as a first point of reference and should not be relied on as a substitute for professional advice. Specialist legal advice should always be sought in relation to any particular circumstances.

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This article is part of a series: Click Emergency Department Medical Malpractice Cases for the previous article.
This article is part of a series: Click New code of good manufacturing practice for medicinal products for the next article.
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