Familial Cancer (2006) 5:117–121 DOI 10.1007/s10689-005-2582-4
Ó Springer 2006
Democratising access to genetic services Bryn Williams-Jones1,* and Michael M. Burgess2 1
Cardiff Institute of Society, Health and Ethics, Cardiff University, CF10 3AT Cardiff, Wales, United Kingdom; W. Maurice Young Centre for Applied Ethics and Department of Medical Genetics, University of British Columbia, V6T 1Z2, Vancouver, BC, Canada 2
Key words: Canada, clinical genetics, genetic testing, health care, hereditary breast cancer, insurance, justice, resource allocation
Abstract Professional and policy discussions about the appropriate funding and allocation of health cares services are an essential part of the management of public and private health care insurance plans. However, the ability of governments and health professionals to equitably decide on the distribution of health care is being challenged by the increasing drive to patent health care technologies. Referring to the case of genetic testing for hereditary breast cancer (and Myriad Genetics’ patenting of the BRCA1 & BRCA2 genes), this paper applies some concepts from moral philosophy to think through the effects of the commercialisation of genetic technologies, and what would constitute a more just and rational approach to health care decision-making, in the context of the Canadian health insurance system. Abbreviations: BRCA: breast cancer, referring to either the genes (in italics) or the genetic test; CHA: Canada Health Act; DTC: direct-to-consumer; HCP: Hereditary Cancer Program, British Columbia Cancer Agency
Introduction Every health care insurance system spreads the cost of health care services across a population, whether through private or public insurance, and some mechanisms are required to make such decisions. In the context of genetic testing, the situation is complicated by gene patents that are intended to stimulate innovation and investment but also have the effect of increasing the cost of testing and restricting provision to particular licensees that have an interest in marketing products to patients to build demand [1, 2]. A consequence of increased innovation and demand for genetic testing is a further burdening of publicly supported ancillary health care services, such as genetic counselling. The potential costs raise serious concerns about the ability of public health care insurance to cover a growing number of genetic tests. In this paper, were refer to the case of genetic testing for hereditary breast cancer (BRCA testing) in Canada to explore the
elements that would be necessary, along with a framework in which to evaluate them, to support a more rational and just decision-making process.
Resource allocation in public health insurance Health is fundamental to a person’s ability to enjoy a range of important social goods (e.g., family, career, education). Advocates of national universal health care insurance systems thus argue that it is the responsibility of a just society to ensure that all citizens have access to needed health care, regardless of ability to pay. This egalitarian ethic is, for example, enshrined in the Canada Health Act (CHA) and would appear to entail the public provision of all needed health care services and possibly the prohibition of private purchase [3, 4]. But these requirements apply only to an agreed upon set of ‘listed’ hospital and physician services. For those services
Correspondence to: Cardiff Institute of Society, Health and Ethics, 53 Park Place, Cardiff University, Cardiff, Wales, United Kingdom, CF10 3AT; Tel.: +44-0-29-2087-9609; Fax: +44-0-29-2087-9054; E-mail:
[email protected] *Present address: De´partement de Me´dicine Sociale et pre´ventive, Universite´ de Mointre´al, C.P. 6128, succ. Centre-Ville, Montre´al. (Que´bec) Canada H3C 3J7; Tel.: (514) 343-6111 #4881; fax: (514) 343-5738; E-mail:
[email protected]
118 falling outside these areas (e.g., dental care, pharmaceuticals used outside hospitals), commercial provision and private purchase is in fact permitted. The current political reality in Canada (and other countries for that matter) is one of limited financial resources available for health care (in part due to mounting costs of service provision), and the need to fund other important goods such as social services, education, or public works. Yet in such an environment, decisions about what services to cover through public health insurance are often not made in a rational manner, but are instead interest-driven and influenced by social, economic and political factors [5]. As a result, it is almost inevitable that the benefits of health care will be unevenly distributed. Some people will receive the medical services they need while others will not, or will only obtain services if they have sufficient wealth or private health insurance [6, 7]. A just decision making process One way to think about developing a more just system for allocating limited health care resources is to engage in philosophical reflection and conduct a ‘thought experiment’. In this experiment, one imagines a group of hypothetical rational decision-makers who are tasked with developing principles for a just health care system. These decision-makers do not know their current or future positions in society (e.g., wealth, education, health needs), and can thus be trusted to be impartial. Of a range of principles that might be arrived at, one that has achieved some prominence is ‘equality of opportunity’ [8, 9]. This principle can be thought of as aiming for a ‘fair or level playing field’, and requires the reduction of social factors such as poverty or illness that limit opportunity. In this view, one of the important aims of health care is to help people who are disadvantaged have a fair chance at pursuing their life goals in order to become full members of society [10]. In basing a resource allocation decision-making process on this principle, a health care system would only cover those services that are effective at helping individuals maintain their health; other services that do not meet this principle could reasonably be denied funding. However, the efficacy of a genetic test (or any health care service) depends largely on the social context – risks and benefits are different depending on existing treatments, family relationships, economic status, etc. An equality of opportunity perspective would thus ask whether the health service is useful in general, then invoke clinical judgment and patient autonomy for details of specific clinical applications. In pluralistic liberal democratic societies such as Canada, there will be different views about which substantive principles should underpin just health care decision-making; equality of opportunity may be only one amongst many such principles. This difficulty can be resolved by deploying a procedural decision-making system in which a diversity of substantive principles
B. Williams-Jones and M. M. Burgess (such as equality of opportunity) could be considered. Any decisions would be judged acceptable and just because the decision making process was fair. Specifically, this process should be ‘accountable for reasonableness’, that is, based on appeals to reasons that are ‘‘not only...publicly available, but [are also] those that ‘fair-minded’ people can agree are relevant to pursuing appropriate patient care under necessary resource constraints’’ [11, p.51]. The rationales for coverage must be transparent, publicly accessible and reasonable (i.e., based on appeals to relevant evidence). There should also be an appeals mechanism for ongoing review and revision of decisions, and the whole process must be publicly regulated [11]. This decision-making process explicitly invokes a rationalist, expert-driven model that evaluates effectiveness and interprets substantive principles. Decisionmakers are expected to be ‘fair minded’ and willing to reason openly, seek mutually acceptable rules to narrow and resolve disagreements, and aim for the common good. This demanding standard of transparency is necessary for patients who are excluded from health care to evaluate whether their exclusion is reasonable, and not arbitrary or unfounded. However, such a decision-making process would not supplant the need for broader public democratic deliberation about the overall objectives of public health care. Instead, decisions resulting from such a process would be part of larger democratic public deliberation. In the following section, we apply the concepts of equality of opportunity and accountability for reasonableness to the case of BRCA testing in a national health insurance system (Canada), and explore the types of information, reasons and principles that would be needed to evaluate whether this service should be covered by public health care insurance.
BRCA testing Genetic susceptibility testing for risk of hereditary breast cancer (BRCA testing) has been a clinical service in North America and Europe since the mid-1990s. Offered through most public and private health insurance plans, BRCA testing in conjunction with genetic counselling aims to provide information that may facilitate life planning, anxiety reduction, and access to appropriate surveillance and prevention strategies. However, as with many other clinical services, the provision of BRCA testing has, where it is available, been restricted to a small sub-set of the population at risk for breast cancer, i.e., those people with a strong family history [12]. Testing is not available to a ‘person off the street’ with little or no family history of disease because for these people the test will almost certainly deliver negative or uninformative test results. Only 5–10% of breast cancers are hereditary, and in practice BRCA testing will detect positive mutations in only 17–25% of high risk individuals [13–15]; for those
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Democratising access individuals in which no family mutation is identified in the two BRCA genes, the nature of their hereditary cancer remains unknown and they continue to be at high risk due to a strong family history. Provision to the general population has thus been considered inappropriate. The ability of health care providers to constrain access to BRCA testing has been threatened by the patenting and commercialisation of the BRCA genes by the American diagnostics company Myriad Genetics. With its broad U.S. and Canadian patents (Myriad’s European patents have recently been either revoked or severely constrained), Myriad has gained the ability to strongly influence service provision and the terms of access. In the U.S., Myriad was successful in forcing all hospitals and insurers to stop local laboratory-based testing and purchase their much more costly BRACAnalysis test (C$3800 compared with less than C$1000 in-house). Further, to maximize the size of its market, Myriad’s has set its access criteria much lower than those in the public health care system – patients with one family member (younger than 50) affected by breast cancer qualify [16, 17]. Myriad also sent cease and desist letters to Canadian and European health care institutions to convince them to follow their American counterparts, a move that was met by strong professional and government opposition. With the exception of the provinces of British Columbia (which for 2 years complied with Myriad’s demands and ceased in-house testing) and Quebec (which early on reached an agreement with Myriad), Canadian and European institutions have ignored Myriad’s demands and continued with local test provision [18]. In complying with the Canadian BRCA patents, the British Columbia Ministry of Health Services arguably took a stand in favour of protecting intellectual property rights over and above the provision of a health care service. But the government did not provide the financial resources to allow the local provider of BRCA testing, the Hereditary Cancer Program (HCP), to manage the increased cost of purchasing Myriad’s test, and thus test provision had to be halted. In effect, the Ministry engaged in de facto priority-setting that created two categories of patients, those who could and those who could not afford the test. The Ministry reversed its decision in February 2003 and authorized the resumption of in-house BRCA testing [19]. Benefits & costs Living with hereditary breast cancer in one’s family can seriously compromise equality of opportunity. Anxiety of being at-risk and the objective risk of developing the disease, regular high risk screening, care for affected family members, etc. all serve to limit the extent to which family members can fully pursue their chosen life goals. In this context, access to genetic testing can be extremely important. Genetic information may help facilitate life planning or family discussions about social
and psychological support, guilt, and responsibility [20], or help people make changes in career plans. But genetic tests are not without costs. Positive test results may lead to fatalistic attitudes and increase fear, anxiety and disease searching. Genetic information presents potentially difficult choices about whether and how to discuss results with others, as well as more general concerns about discrimination and stigmatisation. Commercial BRCA testing also raises other longterm social costs. People may opt for private purchase of testing when the service is not provided through the public health care system, or when medical professionals do not deem them to be at sufficient risk, because the information is valued for ‘non-clinical’ uses [21, 22]. But these reasons are likely to be shaped by directto-consumer (DTC) advertising. In the U.S., Myriad has marketed its BRACAnalysis test both to physicians and the general public through TV and print media, and has established an Internet presence in order to reach a global audience [2]. This advertising has been criticized for being reductionist, deterministic, and for exploiting public anxiety about breast cancer as a way to convince people that they need and should purchase (or demand from their physicians), an expensive genetic test that is unlikely to be clinically useful [1, 23]. While DTC advertising is not permitted in Canada or Europe, the globalisation of media means that people outside the U.S. can access advertising about Myriad’s genetic test (most Canadians will access some U.S. TV channels, and thus see DTC advertising). When patients need only convince their physician that they should have the test, or can purchase it directly over the Internet – DNADirect is now marketing the test direct to consumers [24] – the public health care system loses its former ability to constrain utilisation to those people for whom the tests will provide accurate and useful information [12, 25].
Publicly accountable processes Public pessimism about the way government representatives reach decisions is arguably connected to a pervasive lack of transparency on the part of decisionmakers. Rational decisions about health care resource allocation, even if based on ‘reasonable’ evidence or principles, will be insufficient if the decisions rendered and their rationales are not also publicized. In the case of access to BRCA testing in British Columbia, the government did not publicize its reasoning for complying with the Myriad patents. Staff at the HCP, however, did publicize the rationale behind their decision to cease BRCA testing. They informed their patients and the wider public (through letters and a website), that the HCP could no longer afford to provide testing because the government’s requirement to purchase testing from Myriad would triple the cost of service provision and undermine the program’s ability to provide services to patients with a diversity of hereditary cancers.
120 Without disclosure of the reasons for the government’s decision, it is not possible to evaluate whether they were based on a rational and careful consideration of the threat of a patent infringement suit from Myriad balanced against the benefits of continued service provision. Transparency and relevance alone, however, are insufficient for public accountability; there must also be appeal mechanisms to challenge and review decisions in light of new evidence and changing social and political realities of health care technology development. It is difficult to assess to what extent the British Columbia government’s change in policy was the result of appeals, but in any event, the official appeals mechanisms are not well publicized and thus only the well-informed are likely aware of how to register their concerns. While an accountability for reasonableness approach is consistent with democratic deliberation, it does not necessarily entail active public participation in decisionmaking processes. The power of decision-making may, for the most part, be best left in the hands of experts in health policy, science and medicine as many of the issues in question will be beyond the capacity or interest of most citizens [26]. In general, society benefits from having scientific and medical professionals determine which technologies are safe and useful, and for which population (e.g., prescription access to pharmaceuticals). It may be that the place for more active public involvement is as part of broader deliberative democratic processes. Without citizen participation and consultation, elected officials and bureaucrats are left to their own understandings, and are overly dependent on the media and lobby groups to translate the diverse perspectives and concerns of the population. By consulting the public around questions of health policy development, the hope is that resulting policy will integrate a full range of values and concerns and lead to widespread acceptance, as well as constructively direct subsequent critique [27, 28]. More importantly, accountability usually implies that the decision-makers are held responsible for their decisions and policy outcomes. Thus broader consultations to identify the range of interests that are relevant to the diverse public is arguably an essential first step in a just decision-making process [29].
Conclusion Given the multiplicity of beneficial health care services that could be covered under health insurance, genetic testing will have to meet very high standards to warrant inclusion [7]. The case of BRCA testing in Canada lucidly illustrates the difficulty of integrating technical or practical considerations with more theoretical discussions. We have not argued in this paper for or against the coverage of BRCA testing as such, but instead sought to elucidate the relevant factors needed for such a decision, and to describe a process that could be
B. Williams-Jones and M. M. Burgess employed to make the decision-making more fair and publicly accountable. There is no easy way to make decisions about what services to fund with a limited health care budget. At a minimum, a more systematic analysis is to be desired over the current interest driven and inconsistent decision-making environment. In addition to scientific and clinical expertise and public consultation, there is an important place for clear reasoning about substantive principles of justice such as equality of opportunity. Employing procedural justice mechanisms to support decision-making that is accountable for reasonableness is not only good politics, but also a strong requisite for justice.
Acknowledgements Williams-Jones was supported by fellowships from the Social Sciences and Humanities Research Council of Canada and Homerton College, Cambridge. Burgess’ research into the moral experience of hereditary breast cancer was supported by the Canadian Breast Cancer Foundation, and collaboration with the members of the B.C. Hereditary Cancer Program made the research possible.
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