Financial interests and the IVF industry: the Australian case

Australia's key body for medical research released a new set of ethical guidelines last month on the use of Assisted Reproduction Technologies (ART) with a welcome and unusual surprise: a section on conflicts of interest.

The use of ART, such as IVF, is increasingly common in Australia. In 2013, 12,637 babies were born as a result of IVF in Australian clinics, and in 2012 one in 25 babies was born as a result of ART use more broadly. Australia’s health system is complex and mixes public and private provision of services. Virtually all IVF takes place in private (for-profit) clinics and is eligible for Medicare (public funding), which reimburses 75-80 percent of the standard fee. The rest of the cost is paid by the patient and can vary from a few hundred dollars to many thousands of dollars, as actual fees are set by individual doctors. And there is no Medicare limit to the number of cycles or the age of the woman receiving IVF, meaning that public funding support for IVF is very high in Australia compared with other countries.

The National Health and Medical Research Council of Australia (NHMRC) released 'Ethical guidelines on the use of assisted reproductive technology in clinical practice and research' on 20 April, with the aim of steering how clinical practice and research are carried out (see BioNews 897). Discussion of ethics in ART has tended to have a strong focus on embryos – what you can and can’t do with them – and consideration of the financial arrangements surrounding ART provision has not been a priority. The new guidelines are fairly broad in scope, however, and include a section on conflicts of interest.

IVF is a lucrative business and some of Australia’s biggest clinics have floated on the stock exchange. In at least one major clinic, all staff (including doctors) are reminded that their primary interest is to company shareholders. It is also not uncommon for doctors to have financial stakes in the clinics and laboratories that provide IVF services; this means that the more IVF is provided, the higher the profits. At a system level, Australia’s healthcare is provided on a fee-for-service basis. That means that doctors receive higher remuneration the more (or the more expensive) care they provide. No cap on the number of Medicare rebates means that there is little incentive on the part of doctors or patients to view IVF as a limited resource. It is requested, and provided, even when there is very little (and sometimes no) chance of success

The success rates of Australian IVF clinics are a closely guarded secret. It is difficult for consumers to make informed decisions about who they are buying IVF services from. There is significant variation between the clinics with the highest rates of live birth per cycle (24.8 percent) and the lowest rates (9.5 percent). Clinics may have differing rates of success for several reasons. It may be due to different doctors’ skills, clinic practices, and/or the demographic of the women served by a particular clinic. Women are much less likely to achieve a successful pregnancy via IVF as they age, for example, so clinics who provide services to older women will have lower success rates. Australian transparency advocates call for a system such as the UK's HFEA, arguing that women must have access to success rate comparisons in order to make informed financial decisions.

So how do the guidelines address these issues with IVF provision? Transparency is a guiding principle, and section 4.1.2 states that the clinic and clinician must disclose the extent of their experience and success rates with a particular procedure. There is no call on the industry as a whole or on its peak body, Fertility Australia, to make comparative information available to the public. This means that individuals must do a lot of leg work to get information and may receive it only after they have engaged the services of a particular doctor or clinic.

The new section about conflicts of interest is encouraging (though it is shorter than the section on conflict of interests among the guideline committee members themselves) as clinics and doctors are reminded that their primary interest should be to the patient's 'safety and wellbeing' and not to financial or other concerns. They are further counselled to 'avoid interactions that do not further patient care and which have the potential to bias professional judgment', though such interactions are not specified. Finally, clinics should ensure their clinical teams disclose 'commercial, financial, and personal' interests relating to services they recommend or provide. Declaration is an initial step in managing conflict of interest, and clinics are encouraged to put such procedures in place.

However, this is where it all becomes a bit confusing. Clinics are overwhelmingly for-profit enterprises, and by default they have a financial interest in any IVF they provide. It is unclear from the guidelines what is therefore supposed to be disclosed and how clinics could possibly 'manage' conflict of interest as they are advised to do. Finally, the guidelines are just that – the only restrictions private ART clinics are bound by are laws. So while acknowledging the role of conflict of interest in ART is a positive move, in their current form the recommendations are likely to amount to little more than lip service. Entangled business and patient interests are an integral part of current IVF industry structure and funding. Adequately addressing conflict of interest would require broad system changes; right now there is nothing to suggest this will happen.