ART: Moving Towards Universal Access - By Dr. William Buckett (Spring 2010)

ASSISTED REPRODUCTIVE TECHNOLOGIES: MOVING TOWARD UNIVERSAL ACCESS
Québec government to provide public funding

by Dr. William Buckett

Spring 2010

In the run up to last year’s provincial election in Québec, all the major political parties had promised funding for assisted reproductive technologies (ART) through the Québec provincial healthcare plan (RAMQ) as part of their pre-election platform. Therefore, following the election of the Parti Libéral du Québec in December 2008, plans have continued to turn this election promise into a reality.

In Ontario, the expert panel on adoption and infertility has strongly recommended that public funding for ART become available through the Ontario provincial healthcare plan (OHIP). Although no definitive time frame has been given, the Ontario government has committed to consider the report’s findings.

In the other Canadian provinces, change is on horizon; the Lieutenant governor of Manitoba recently announced that a new refundable tax credit will be implemented in the coming year to help Manitobans with the cost of fertility treatment.1

Elsewhere in the world, increasing numbers of countries offer extensive and often complete coverage for ART through public healthcare. Historically, countries such as France, Denmark, Sweden, the United Kingdom and Israel were quick to offer partial or complete coverage of ART within their national healthcare plans. Other countries such as Slovenia, Croatia, and Turkey have started to publicly fund ART to some extent over the past decade. Data published in 2007 detailing international comparisons is shown in Table 1.2

With these exciting developments in Quebec and Ontario – themselves the results of tireless campaigning by many groups across Canada including IAAC and its executive director – Canada is being brought more into line with most West European countries, as well as Australia and New Zealand.

Even in the United States, more and more individual states are mandating complete or partial coverage for ART in all insurance plans – these now include Arkansas, California, Connecticut, Hawaii, Illinois, Louisiana, Maryland, Massachusetts, Montana, New Jersey, New York, Ohio, Rhode Island, Texas and West Virginia.2

Table 1.

Countries that completely publicly fund ART
Belgium
France
Greece
Israel
Slovenia
Sweden

Countries that partially publicly fund ART
Australia
Austria
Bulgaria
Croatia
Czech Republic
Denmark
Finland
Germany
Hungary
Italy
Japan
Netherlands
New Zealand
Norway
Portugal
Tunisia
Turkey
United Kingdom

Countries that do not fund ART
Argentina
Brazil
Canada
Chile
China
Columbia
Ecuador
Egypt
Hong Kong
India
Ireland
Korea
Latvia
Mexico
Philippines
Russia
South Africa
Switzerland
Taiwan
Thailand
Vietnam

Why fund ART?

Funding of ART has long been controversial. There are five main reasons that governments fund ART: because infertility is a disease, because there is a medical need, because access to treatment is a human right, because inequalities in healthcare are fundamentally unfair, and because, with other measures, it will increase the total fertility rate in any given country.

The question of whether infertility is a disease is under constant debate. The inability to have biologically related children is devastating for those who wish to have them, but infertility does not involve obvious morbidity or mortality. It is therefore perceived by some as not deserving the same priority in public funding as conditions that are physically debilitating or life threatening. However, infertility is known to affect many other aspects of mental and physical health. Indeed, the United Nations definition of reproductive health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity in all matters relating to the reproductive system and to its functions and processes.”5

The question in Canada as to whether infertility is a disease is relatively uncontentious. Both the Royal Commission on New Reproductive Technologies and provincial ministries of health have explicitly affirmed infertility as a legitimate medical concern and infertility treatment as legitimate medical care for public funding.4 Indeed, “lower-tech” infertility treatments such as ovulation induction and tubal surgery have been covered without contest by most provincial healthcare plans.

The second reason many governments publicly fund ART is that there is a perceived medical need – quite apart from whether infertility is a disease or not. Medical need arises when there is disruption of normal species function which results in limitation of opportunity – in this case the opportunity to be a parent. Therefore, even if infertility is not a disease, there still may be a medical need. This is best illustrated by a survey conducted in the United States, Australia, and six European countries, which found that 70% of respondents, when confronted with the knowledge that the cost of three IVF cycles was roughly equivalent to the cost of a hip replacement, agreed that ART should be reimbursable or publicly-funded. This is despite the fact that, interestingly, only 38% of the respondents perceived infertility as a “disease.”6

The right to have children is based on the United Nations Declaration of Human Rights, promulgated in 1948, in which Article 16 recognizes that “Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and found a family.”7 However, it has been pointed out that this is not relevant to a discussion of ART, since it relates to people who have been debarred from having children, not those unable to have children.

The “right to health,” as expressed in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), is defined as “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” If health is defined as “the absence of disease,” the human rights argument might be difficult to maintain, given the problems attributing disease status to infertility. However, by employing the broader definition of reproductive health as defined by the UN,3 the “right to health” rationale could be defended in relation to public IVF provision.

One of the most politically important reasons to publicly fund ART is the perceived inequality associated with ART being available only to those who can afford to pay.

In the United States, the almost total lack of public funding for ART and a permissive regulatory regime have resulted in a niche ”luxury” market in assisted reproduction, where only 36% of infertile women seek medical assistance and only 1% go on to utilise ART.8 The cost of services is high, both relative to costs in other countries, with the mean cost per IVF cycle found to be 271% higher than the mean cost in 25 other countries,9 and relative to the gross national per capita income. Unsurprisingly, those that access ART services are wealthier and better educated than average, suggesting that many infertile women are excluded from treatment because of its cost. Reinforcing this point is the fact that demand for fertility services has dramatically increased in states such as Massachusetts where coverage of fertility treatment is mandated for private health insurance companies and cost is therefore less of a barrier.7

Inequality may persist even in countries with publicly funded ART services. In Finland a large proportion of IVF cycles were provided by the private sector between 1992 and 1999. While inequalities in access were observed in the private sector, where women in the highest socioeconomic position were over-represented, this was not the case in the public sector, where the number of cycles did not differ by socioeconomic group.10

A final reason given for publicly funding ART is that it will increase a country’s total fertility rate and therefore reduce population ageing. The ageing of the North American and European populations has led to concerns about the sustainability of public pensions, healthcare plans, and levels of productivity. Recent studies by RAND and others have sought to broaden the range of possible policy responses to population ageing by employing a cost-analysis to argue that increasing the uptake of ART could be considered as part of a policy mix to increase fertility.

The RAND study applies the rate of live births resulting from ART in Denmark (4.2%) to United Kingdom data, where the current rate is much lower (1.4%), calculating that the resulting hypothetical increase in births would raise the total fertility rate in the UK by 0.04, from 1.64 to 1.68 children.11 Although this is only a small increase, the authors argue that it could be important since it would stave off entering a “low fertility trap.” While it sparked considerable interest and media attention, the idea that publicly funded ART could redress population ageing in a cost-effective manner needs to be treated with caution, not least because there is very little experience with it and thus minimal supporting evidence.

Europe’s experience with pro-natalist policies has focused mainly on family-support measures; France and Luxembourg, as well as some former communist states, are the few countries to employ such policies explicitly to increase fertility. This is probably because government intervention in fertility rates is difficult to justify and the main policies that have been employed by governments to address population ageing can be divided into two groups: 1) demographic policies, specifically immigration and family support measures aimed at increasing fertility and 2) welfare-related policies. These also fit broadly into the current plans in Québec.

A low fertility trap entails a country’s TFR falling to less than 1.5, causing a relatively rapid decline in the birth rate, as has happened in many European countries. The total fertility rate in Canada in 1.59 (See Figure 1).12

Figure 1. (Not available online)

Benefits

The benefits of publicly funding ART based on the reasons above appear self-evident: a reduction in disease, an increased quality of life, an end to inequality, and, along with other measures, a possible increase in the total fertility rate.

However, another major benefit will be to enable couples to have assisted reproductive treatment at a younger age. This is best illustrated by a case history. I first saw a couple with a 5-year history of primary infertility about 6 years ago. The woman was 35 years old and the man was 36 years old. They underwent evaluation for their infertility (which was covered by the RAMQ) and discovered that they had severe male factor infertility which was only treatable by IVF/ICSI. A single cycle of this treatment would give the couple a 40% chance of a healthy child. Unfortunately, this was not covered by the RAMQ and they were unable to pay. I saw them again this year. They had saved and borrowed enough money in the intervening 6 years to be in a position to pay for a single cycle of treatment. The female partner is now 41 years old and her most recent evaluation of ovarian function suggests some pre-menopausal changes. Their chance of a healthy child is now, at best, 5%.

This is why the age of the couples undergoing ART in jurisdictions where ART is publicly funded is lower than that where couples have to pay. For many couples it takes a long time to save the necessary money, and waiting leads to poorer chances of success and increased medical risks. This situation is avoided when ART is publicly funded.13,14

Other benefits are risk reduction – and particularly reduction of the risk of multiple pregnancy by mandating single-embryo transfer. A full discussion of the benefits of minimal stimulation and single-embryo transfer are beyond the scope of this article. However, when couples pay for treatment, there is increased pressure to succeed in a single cycle. This pressure often results in the choice to use more aggressive ovarian stimulation with its attendant risks, including the risk of hospitalization (which in Canada will be paid for by the province ), and the decision to transfer more than one embryo, which increases the risk of twin and higher order multiple pregnancy. Again, these complicated pregnancies and the following neonatal care will be paid for by the provincial healthcare plans.

In countries where ART is publicly funded, legislated and recommended single embryo transfer rates are higher than in countries where there is no such funding. Similarly, multiple pregnancy rates are lower.12,13

Risks

The major concern with public funding of ART is that the cost may be high. Whether or not a treatment is considered cost-effective depends on the chosen methods for assessing cost and the outcomes. Cost-effectiveness analyses of medical treatments assess whether resources are used most efficiently; in other words, whether they yield the greatest gain when considering their expense. This approach hinges on the opportunity cost of a treatment: the value of alternative uses of the resources required for the treatment.

In evaluating ART, the wide range of indirect treatment costs also deserve consideration: these may include time off work, the psychosocial and social stress of IVF procedures, and the cost of alternative treatments and neonatal intensive care for multiple pregnancies. Best estimates suggest that costs/live birth are around $34,000 for women over 38 years old and around $9,000 for women younger than 38 years.15

Certainly this is expensive, although estimates for other treatments for infertility (such as surgery or hormonal treatments) suggest that ART is less expensive.16

Reducing the costs of multiple pregnancy were the driver behind the introduction of public-funding for ART in Belgium. When the difference in maternal, neonatal and total costs after single-embryo transfer and double-embryo transfer were compared, the transfer of a single top quality embryo is equally effective with double embryo transfer in women under 38 years of age in their first IVF/ICSI cycle, but substantially cheaper.17 Nevertheless, these savings may take up to 5 years to take effect.

Another potential saving to offset against the initial cost of ART is the long-term economic benefit attributed to ART-conceived children based on their projected lifetime net tax contributions18 – although obviously this will take several government lifetimes to come to fruition.

The current situation

Are we ready for publicly funded ART in Quebec? Certainly there will be a huge demand, and this may place some strain on the system – particularly on the hospital-based centres, in the short-term. However, the longer we delay, the more patients will have to wait. Therefore, some political leadership is needed to get the process running and allow the system to be adjusted en route. The perfect scenario will never arise by itself!

Conclusions

The beginning of publicly funded ART in Canada is an exciting, but long overdue change. Most developed countries already completely or significantly partially fund ART. As noted above, there are many medical and political reasons why this should be done. The benefits are many and the cost risks are minimal in the long-term. However, the biggest benefit will be to the millions of Canadians who struggle with infertility; increased access to this successful treatment will increase their likelihood of achieving one of their major goals and creating a family.

References
1. Speech from the Throne at the opening of the fourth session of the thirty-ninth legislature of the province of Manitoba. http://www.gov.mb.ca/throne.html
2. Jones HW, Cohen J. IFFS surveillance 07. Fertility and Sterility 2007; 87: suppl1, 20.
3. 2009 Data from Resolve: the National Infertility Association (United States)
4. Population Commission United Nations. (1996). Reproductive rights and reproductive health: A concise report. POP/623, Geneva: United Nations.
5. Royal Commission. Baird P, ed. Final report. Proceed with care. 1st ed. Ottawa, Canada: Canada Communications Group, 1994:1–1275.
6. Adashi E Y, et al. Public perception on infertility and its treatment: An international survey. The Bertarelli Foundation Scientific Board. Human Reproduction 2000; 15: 330–334.
7. United Nations. (1948). Universal Declaration of Human Rights. Adopted and proclaimed by General Assembly resolution 217 A (III) of 10 December 1948.
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12. Statistics Canada. Vital statistics – birth database.
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16. Hughes EG, et al. Funding in vitro fertilization treatment for subfertility: the pain and the politics. Fertil Steril 2001; 76: 431-442.
17. Gerris J, et al. A real-life prospective health economic study of elective single embryo transfer versus two-embryo transfer in first IVF/ICSI cycles. Hum Reprod 2004; 19: 917-23.
18. Connolly M, et al. Assessing long-run economic benefits attributed to an IVF-conceived singleton based on projected lifetime net tax contributions in the UK. Hum Reprod 2009; 24: 626-632.