STEM CELL FEATURE PART 1: Legislating the embryo

In the first part of a two-part series about Australia's new stem cell laws, Pete Young looks at the NHMRC's role and who will need to apply for a licence to do the research.

The processes through which stem cell researchers can apply for licences relating to the use of excess IVF embryos are still being finalised following passage of legislation.

The new laws give carriage of licensing issues to a committee of the National Health and Medical Research Council (NHMRC) which is promising to launch a round of information seminars on the issue for researchers around the middle of February. The offence provisions of the legislation won't take effect until June, which leaves only five months for appointment of an NHMRC licensing committee and the issuing of licences.

This year ushers in a new environment for many life sciences researchers, thanks to the two landmark pieces of legislation which wound their way through Federal Parliament late last year. Originally cast as a single Bill with the jaw-cracking title of Prohibition of Human Cloning and Research Involving Human Embryos Bill 2002, the less-controversial prohibition of cloning section was split off and passed separately.

After a much stiffer fight, the Research Involving Human Embryos Bill 2002 was eventually carried in the Senate on December 6 in a 45-26 vote, a slimmer margin than the 99-33 edge it earlier enjoyed in the House of Representatives. The Bill, which officially became the law of the land when it received Royal Assent on December 19, sets out the rules for researchers making use of excess Assisted Reproductive Technology (ART) embryos from Australian sources. Basically it forms the framework governing researcher access to stem cells or any other products derived from approximately 70,000 spare embryos created for in vitro fertility treatments before April 5, 2002 in Australia.

The new Federal legislation that opens the way for Australian researchers to create new stem cell lines from excess ART embryos also provides for a strong regulatory and licensing regime now being implemented by the NHMRC.

The new licensing provisions don't apply to researchers working with existing cell lines. While such research can continue without the need for a licence, it must also comply with the prohibition of human cloning act which provides very strong penalties for activities such as the creation of human clones.

Unlike the need to seek a licence, institutional human ethics committee (HREC), approval will be required whether the research is directed toward new cell lines or based on existing ones. Researchers working with adult stem cells will need only to seek the approval of the human ethics committee of their own institutions.

The NHMRC's Australian health ethics committee (AHEC) provided interim advice to HRECs in September 2001 relating to HREC consideration of research involving the use of embryonic stem cells.

AHEC is currently revising the NHMRC's ethical guidelines on ART which will contain updated guidance on the use of embryonic stem cells. The interim advice from AHEC indicates that HREC should not approve research involving the use of embryonic stem cell lines unless they are satisfied that the stem cells were derived in an ethical manner, including that the embryos were excess to the requirements of an approved ART program and that the couples for whom the embryos were created give informed consent.

Says the NHMRC's CEO, Alan Pettigrew, "there is some terminology that researchers need to be fully aware of and we are in the process of developing documentation to support this."

Starting around the middle of February, the NHMRC plans to launch information sessions for researchers who want to know what the licence forms will demand of them. "The forms will require [researchers] to make certain information available but I don't believe it will be a difficult burden," says Pettigrew. "Given the significance of the legislation, the requirements are quite appropriate and while they are significant, they are not onerous."

The licences will last for the life of an individual research project rather than be tied to a standard common period, like a five-year driver's licence.

IVF affected

Caught in the licensing net along with researchers will be ART facilities such as in vitro fertilisation centres.

"They will be involved in a way they haven't been before," says Pettigrew. "The legislation is directed toward any research involving excess IVF embryos, not just stem cells. So certain procedures related to this field will now be subject to a licence."

As far as researchers are concerned, the legislation has two key trigger dates. One was January 16, the day most provisions of the legislation took effect. The other is June 19, which activates the key clauses governing penalties for creation of excess embryos without a licence or for non-exempt use of embryos. Under the human embryo research Bill provisions, licences can be revoked and transgressors can face up to five years' gaol or stiff financial penalties. Offences under the prohibition of human cloning Bill carry harsher punishments of up to 15 years' imprisonment.

Anyone intentionally using an excess ART embryo without a licence commits an offence under Section 10 of the Research on Human Embryos Bill unless the use falls into one of three main exempt categories.

One consists of what might be called housekeeping purposes such as storage, transportation or observation of the excess embryos. It also includes allowing an embryo to die if such is the wish of its parents.

The second exempt usage is for certain types of diagnostic investigations, for example those aimed at determining the cause of an abnormality. A third way in which excess embryos can be used without a licence by accredited ART centres is for the purpose of achieving pregnancy in a woman other than the one for whom the embryo was originally created.

Under the legislation, no licence will be granted unless the proper consent has been granted by "each responsible person in relation to the embryo." Further, the licence applicant must report in writing to the NHMRC licensing committee that such consent has been forthcoming.

Crucially, any use that may damage or destroy the embryo requires the licence holder to confirm in writing that the embryo was created before April 5, 2002. The clause was written into the Bill to allay fears that human embryos might be created specifically for the purposes of research. However this section of the legislation has a sunset clause which allows for a review of the date within three years.

Import loophole

A major loophole left by the new Bills which is yet to be closed lies in the potential for Australian researchers to source stem cells or other viable products of cloned embryos from overseas sources. Amendments to regulations of the Customs Act to block that loophole are still under development.

Similar to the Gene Technology Act (Cth) 2000, the effectiveness of the new legislation depends in part on the passage of complementary state laws because of uncertainty about the Federal government's constitutional power to enact legislation over areas such as cloning and embryo research. The passage of complementary laws by the States can be traced back to April 5, 2002, when the Federal and State governments agreed to implement national uniform laws. However, this agreement depends on the goodwill of the State governments involved.

To date, no mirroring legislation has been put into effect by state governments, according to Sangeeta Puran, a solicitor with Freehills National Biotechnology Focus Group.

Puran points out that the passage of state-based laws in this case is complicated to an extent because some states -- notably Victoria, South Australia and Western Australia -- already have in vitro fertilisation legislation which contain provisions overlapping the areas sought to be regulated. These will need to be amended to conform with the new Federal legislation. .

Last year, in Victoria, the Health Legislation (Research Involving Embryos and Prohibition of Human Cloning) Bill was introduced into the Victorian Parliament, the objective of such was to amend its Infertility Treatment Act and bring it into line with the proposed Federal laws. However that Bill was allowed to lapse and has not yet been reintroduced, Puran says.

Says the NHMRC's Pettigrew: "This is a complex area but the intention is that there will be nationally consistent legislation and every effort will be made to bring that in as soon as possible."

Although stem cells lie at the core of the human embryo research Bill, the legislation actually deals with regulating the use of embryos and not directly with stem cells or any other products derived from human embryos.

The reasoning was that the ethical and legal issues are the same irrespective of the purpose of the research, for example to derive stem cells or to improve IVF outcomes.