Clasificación de las RAM

Professional self-regulation has a principal role in the control and regulation of ART in Aotearoa/New Zealand.

In 1992, the RNZCOG [Royal New Zealand College of Obstetricians and Gynaecologists] formulated a policy that all providers of ART, including DI services, in New Zealand, be accredited with the Australian Reproductive Technologies Accreditation Committee to set minimum professional standards and allow peer review. (MCART, 1994:11)

The Australian based Reproductive Technologies Accreditation Committee (RTAC) is one of two bodies with specific control over ART and surrogacy in Aotearoa/New Zealand. RTAC monitors the practical aspects of ART provision and provides procedural guidelines for the professional qualifications of clinic staff, the prevention of diseases, the collection of information, informed consent, the provision of laboratory facilities, ethics and research, and the provision of support services including counselling (MCART, 1994:11; RTAC, 1999). Nevertheless, commentators have expressed concern about the use of an Australian based organisation to oversee Aotearoa/New Zealand clinics.

Standards for recognition or accreditation of ART clinics in New Zealand are currently based on Australian standards. The values and perspectives of Australia, however, are not necessarily appropriate for New Zealand. (Dyall, 1999:37)

66 _{Clinics may lose their accreditation with RTAC if they do not comply with NECAHR’s findings. The}

Similarly, Ken Daniels (Associate Professor, Department of Social Work, University of Canterbury) expressed concern about the lack of accountability or sanctions provided by relying on an offshore accreditation committee that has no regulatory obligations to the Government of Aotearoa/New Zealand.

RTAC is in no way answerable to the New Zealand Government. So, there is an accountability issue and if the Government is interested in protecting the interests and welfare of children and of families and so on, how do they actually monitor that? And, there is no process for any input into RTAC standards or for RTAC to report back to anybody in New Zealand. So it is very much a self-regulatory system and while that has quite a lot going for it, it also has weaknesses. How does it actually tie in? I mean if the professional group says, “This is what we are going to do” and the Government does not like it, then what can they do about it?

(Ken Daniels, Interview: 31 August 2000)

Others involved in the policy debate argue that disparate health systems and cultures make it inappropriate for an Australian-based organisation to oversee ART practices in Aotearoa/New Zealand.

It is not appropriate. I do not see how they can. I think there are several issues. One is around differences in the structure of the health system and the other is in cultural differences that they would not be able to deal with and the third is just the practicalities of being able to perform as an accreditation body.

(Sandra Coney, Executive Director, Women's Health Action Trust, Interview: 13 July 2000)

All Aotearoa/New Zealand ART providers are presently accredited through RTAC, as originally required by the RNZCOG (Ministry of Justice & Ministry of Health, 1997). However, there is no legal requirement for the clinics to be accredited. As a self-regulatory organisation, the RNZCOG and, latterly, the RANZCOG67 _{has no power to enforce their members to comply with}

their standards and guidelines (MCART, 1994:12). Similarly, there are no legal sanctions in place if providers fail to comply with RTAC’s guidelines or lose their accreditation.

There are [no sanctions] in New Zealand. It is the stigma really. In Australia if you are not accredited you are not eligible to get the drugs from the federal government which means that your patients would be severely disadvantaged so [they would go somewhere else]. (John Peek, Interview: 12 July 2000

Mark Leggett (Business Manager, The Fertility Centre, Christchurch) suggests that market forces would ensure that clinics maintained their accreditation, as loss of reputation would be a consequence of not being accredited by RTAC.

Reputation probably more than anything else. No one would recommend you I would think. ... If we do not provide a very good service people would not come back. They will go somewhere else, out of town.

(Mark Leggett, Interview: 22 September 1999)

67 _{In 1998, the Australian and New Zealand Colleges amalgamated to form the Royal Australian and New}

This observation fails to take into account the small number of clinics and geographical limitations that restrict the options available to consumers. MCART (1994:12) argues that those providers who negotiate purchase agreements for publicly funded ART services would be disadvantaged if they did not hold RTAC accreditation. As Helen Williams (Policy Analyst, Elective Services Project, HFA) maintains

If you were not accredited I do not think the HFA would purchase from you. (Helen Williams, Interview: 29 August 2000)

However, this is only effective as a sanction if the clinic is involved in applying for government contracts. The smallness of the ART community and the role of the NZIS and affiliated regional infertility societies in educating and informing consumers about the standards of services they can expect may work to ensure that non-accredited clinics are disadvantaged. On the other hand, the small number and geographical location of clinics may offset any disadvantages by limiting consumers’ options for treatment. Helen Lockyer (Senior Policy Analyst, Ministry of Health) sees the lack of effective sanctions as one of the reasons for making accreditation mandatory.

…that would be one of the advantages of making such accreditation or something similar mandatory and actually having some sanctions. Penalties [is] one of the issues that [is] covered by both of the bills.

(Helen Lockyer, Interview: 24 July 2000)

All of the provider representatives interviewed supported the use of RTAC as their accrediting agency, suggesting that setting up an independent Aotearoa/New Zealand accrediting organisation would be extreme and costly considering the small number of clinics in this country.

RTAC is pretty good. The industry is not so huge and diverse in New Zealand and Australia that people would get away with anything, really.

(Mark Leggett, Interview: 22 June 2000)

Similarly, Helen Williams (Policy Analyst, Elective Services Project, HFA) identifies the size of the Aotearoa/New Zealand ART ‘industry’ as too small to warrant setting up its own self-regulating organisation.

Because we are too small a country to have a New Zealand based one and that happens with a lot of specialities. I think it is absolutely fine for it to be an Australian based; it has New Zealand input as well.

(Helen Williams, Interview: 29 August 2000)

John Peek agrees that, as far as overseeing the technical aspects of ART practices is concerned, RTAC is a prudent choice. However, he argues that there is a need for local guidelines to be added to RTAC’s ‘Code of Practice’ to take into account the cultural differences between Aotearoa/New Zealand and Australia.

I think that RTAC was mainly to look at technical things and especially at the tradition of counselling and looking after people from that aspect and that you went through ethics committees and all that sort of stuff. So, I think those are similar enough that probably makes no difference. I think it is really good to have an offshore body in one way, in that New Zealand is pretty small, in terms that trying to cobble together something that can look after five or six clinics, whereas in Australia there are 25 or 30. I think is really sensible. … [There are] definitely New Zealand dimensions that should be looked after. New Zealand cultural things, not just Mäori, but New Zealand’s culture of openness about donor insemination…. So, I think it should have some New Zealand guidelines. At the moment, it has New Zealand participants in that a member of the local Infertility Society is the local person, counsellors are local, one of the doctors is local, but there are no actual New Zealand guidelines or part to it

(John Peek, Interview: 12 July 2000)

Although there are two Aotearoa/New Zealand representatives on RTAC, a gynaecologist/obstetrician and a consumer (Ministry of Justice & Ministry of Health, 1997), the RTAC ‘Code of Practice for Centres Using Assisted Reproductive Technology’ (1999) contains no Aotearoa/New Zealand-specific guidelines. In 1994, MCART (1994:37 & 40) acknowledged that accreditation of Aotearoa/New Zealand clinics by RTAC served “a vital purpose in ensuring that appropriate standards are set at an international level”. However, they recommended that an Aotearoa/New Zealand supplement to the guidelines be given priority.

MCART (1994:40) recommended that the Royal College of Obstetricians and Gynaecologists (RNZCOG) undertake this task in “consultation with providers, consumers, public officials”, and their proposed overseeing body (Council on Assisted Human Reproduction). Although there have been repeated calls for the development of a Aotearoa/New Zealand supplement to the RTAC guidelines, this supplement has not eventuated. While acknowledging the need for such a supplement, Ken Daniels (Associate Professor, Department of Social Work, University of Canterbury) suggests the difficulty of the task may have been the reason for the delay.

The job of drawing up that supplement has been pushed from pillar to post. But, it was given to the Royal College of Obstetricians and Gynaecologists to do and, to my knowledge, they have never done it, although they have been pushed by Ministers and they have been pushed by NECAHR. I mean it is a very difficult thing to do; it is an extremely difficult thing to do. … But, there is still no

standard; no specification as to what should be looked at in terms of determining whether New Zealand clinics are operating in an appropriately culturally sensitive way. That supplement is the missing part….

(Ken Daniels, Interview: 31 August 2000)

However, MCART (1994:40) did not foresee the task as being too difficult and claimed that RTAC was willing to include an Aotearoa/New Zealand-specific supplement developed by New Zealanders. It appears that, while it is still the intention of the Ministry of Health to include the proposed supplement, the timing and form that this inclusion takes is dependent on the outcome of the Health Select Committee’s consideration of the two bills.

The NZ (sic) supplement to the RTAC guidelines has not been completed. This is primarily because we are awaiting the outcome of the select committee's deliberations on the two assisted human reproduction bills. The legislation may have implications for the content of the guidelines. The Health Select Committee hopes to consider the bills in April or May of this year.

(Personal Communication, 21/01/01)68

In the meantime, gamete donors, surrogates, commissioning parents, and individuals conceived with donor gametes are offered few assurances that practices will be monitored and regulated in a way that best suits the historical, cultural, or political environment of Aotearoa/New Zealand. These issues will be discussed in more detail in Chapter Six.

As the sole method of regulation and control, professional self-regulation excludes or marginalises people outside the profession from having any input into the development or enforcement of policies and codes of practice. Medical codes that are generated without public or patient consultation rely on the traditions and judgements of the medical profession and “may do more to protect the profession’s interests than to introduce an impartial and comprehensive moral viewpoint” (Beauchamp & Childress, 1994:8). The Canadian Royal Commission on New Reproductive Technologies (1993a:57) argues that “a self-regulating profession is not necessarily best equipped to assess the social, ethical, and economic implications of the technologies and may be insufficiently accountable to those whose needs they are meant to serve, particularly in the absence of a broader regulatory system.” Correspondingly, Beauchamp and Childress (1994:7-8) argue that professional codes sometimes take too broad a view with regard to ethical requirements or claim to be more comprehensive or authoritative than they are entitled to. This approach often leads professionals to mistakenly assume that, by following the rules of the code, they will satisfy all the moral requirements. Although medical codes pay attention to general principles and rules such as ‘do no harm’ and confidentiality, only a few comprehensively address issues of honesty, openness, autonomy, and justice (Beauchamp & Childress, 1994:8).

Daniels and Taylor (1993:1474) claim that fertility specialists are not resistant to government intervention and “would prefer to operate within a set of clearly specified guidelines determined by a publicly appointed and/or approved body.” However, the preference for guidelines is undoubtedly influenced by an unwillingness to support regulatory interference with their professional autonomy when exercising clinical judgement (Daniels & Taylor, 1993:1474).

68 _{Email communication with Helen Lockyer, Team Leader, Professional Regulation & Quality, Personal &}

While fertility specialists in Aotearoa/New Zealand may be resistant to regulatory controls, they do not appear to be totally opposed to mandatory accreditation or to the establishment of some form of policy body to oversee ART practices and developments. Notably, in the early 1990s Fertility Associates in Auckland requested that the Minister of Justice establish some form of regulatory authority to supervise ART practices in Aotearoa/New Zealand. As mentioned earlier, Rodney Bycroft (Scientific Director/Manager, Artemis North Shore Fertility, Auckland) would prefer to have a government appointed committee to review reproductive practices and technology than controlling legislation.

I guess my personal opinion is that I would like to see a separate body but, in the absence of that, I think somebody has to do it and NECAHR is probably in the best position to do that at the moment. If the Government clearly do not want to set up a body that regulates the industry then NECAHR [is probably the next best thing]. (Rodney Bycroft, Interview: 13 September 2000)

Similarly, John Peek is not opposed to some form of government regulation of ART but is wary of the costs of setting up a specifically ART focused policy organisation being passed on to consumers and providers.

You can have government regulation that does not cost too much. It is just what sort of bureaucracy you put with it. I do not mind having an external thing but … it should be done very cheaply and … rely on trying to use existing laws and mechanisms as much as possible. … You would have some sort of committee just to hold it all together rather than making a new committee to do it all.

(John Peek, Interview: 12 July 2000)

The MCART (1994) report recommended the establishment of a body to oversee and coordinate policy decisions in ART and Ken Daniels supports this model of policy formulation and control.

If you had an umbrella organisation that was responsible for looking at things like ethics, standards, accountability, public education … I guess those are the main areas. Bill Aitkin and Paparangi Reid [MCART] actually made some comments about that in their report; that there needed to be a group that took a much broader brief. (Ken Daniels, Interview: 31 August 2000)

As indicated previously, there has been no progress towards establishing a policy body that would take an overseeing and policy formulating role, as well as co-ordinate the intersecting and related functions of NECAHR and RTAC in relation to ART. Consequently, issues of accountability and decision-making transparency are the central concerns for some ART commentators.