KEY POINTS:
Any debate on the use of embryos must consider the Health and Disability Commissioner Act and the Code of Health and Disability Consumer Rights which set the legal framework on which decisions are to be made.
This legislation was enacted in 1995 after the recommendation by the Cartwright Inquiry in 1988.
The report recommended a commissioner be appointed and patient's rights be defined, which should include rights in relation to informed consent and research.
The first task of the new commissioner was to draft a code of rights. After extensive public consultation with providers, consumer groups and the public, a draft code was presented to Parliament and became a regulation in July 1996.
The act and code are aimed at defining and protecting the rights of health consumers. This code has remained in force since 2006 with only two amendments - one to assist in the complaint process and the second a change to the informed consent rights in respect to body parts.
Several areas of the code are relevant to the use/disposal of embryos, especially Right 7 (9) which states: "Every consumer has the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a health-care procedure."
Also relevant is Right 7(10): "Any body parts or bodily substances removed or obtained in the course of a health-care procedure may be stored, preserved, or utilised only with the informed consent of the consumer ..."
This proved acceptable to the public following the legal consultation process set out in the act.
At the time, the public and provider participation in the drafting was immense and the code received the highest number of submissions received for a new regulation.
Rights in relation to informed consent and research were the crucial issues to the Cartwright inquiry. Further, the use of body parts was a critical issue for Maori with whom there was special consultation.
With the above wording of Right 7(10), health consumers were clearly given the sole right to decide current and future use. Accordingly there should be little debate now over the use/disposal of embryos because no provider or researcher should store, preserve or use them without informed consent.
So why did the two Labour health ministers sit on the report by the advisory committee to commence "beneficial health research"? The answer lies in a decision by an earlier Health Minister, Annette King, who altered the code in 2004 under section 75 of the act and, in doing so, gave away consumers' rights to informed consent in the interests of so-called public benefit research.
The change resulted in a new Right 7(10) which transfers power to researchers and providers: "No body part or bodily substance removed or obtained in the course of a health-care procedure may be stored, preserved or used otherwise than (a) with the informed consent of the consumer; or (b) for the purpose of research that has received the approval of an ethics committee; or (c) for the purpose of a professionally recognised quality assurance programme or an external audit or evaluation of services that is undertaken to assure or improve the quality of services."
This was a significant change and contrary to the fundamental consumer focus. It was made in favour of the special interests of the Ministry of Health, researchers and pathologists.
In May 2004, the minister tabled the following statement in Parliament to explain the amendment: "The ... [amendment has] ... been made in the absence of a formal recommendation by the Health and Disability Commissioner. The reasons for this are the need to respond to immediate concerns about the practicability of Right 7(10) ..."
Yet Ms King had first recommended the change in a 2001 Cabinet paper, some three years earlier - which makes rather a farce of the word "immediate".
Further, the commissioner had formally rejected submissions from researchers and pathologists who sought this change in 1999.
Additionally, in early 2004, the second commissioner undertook another review of the code and, while the public were not specifically asked about Right 7(10), nevertheless consumer groups and the Director of Advocacy strongly objected to the amendment in terms of the outcome and the fact that it occurred without public participation.
Interestingly, this consultation process had commenced before the code was altered in May 2004. So the current debacle on the use of embryos is a direct result of ministerial intervention.
Yet the current public response to the use/disposal of embryos makes it clear that the original code continues to represent the public view.
The Minister of Health, Tony Ryall, should act with urgency to return to consumers their fundamental right to informed consent and ownership of body parts.
The code should revert to its original wording so it, once again, empowers consumers and provides some balance to the control vested in health providers and the establishment.
An appropriate vehicle for reversing the 2004 amendment could be the commissioner's consultation document (www.hdc.org.nz) where consumer groups have already lobbied for Right 7(10) to be altered.
* Robyn Stent was the first Health and Disability Commissioner from 1995 to 2000.
