Policy at National, Provincial and Laboratory Levels
Funding for genetic testing varies widely across Canada . The Canadian health care system is essentially comprised of a grouping of provincial systems and health care delivery is considered a provincial matter with each province allocating funds for services slightly differently. These structural variations help to create different approaches to the funding of genetic tests. Surveyed lab directors and clinicians were asked to explain how predictive genetic tests were funded at their facility. Their responses identified two predominant funding models. In provinces such as Quebec, Nova Scotia, Alberta and Ontario, participants explained that funding is allocated to hospital and regional budgets. The hospital or region in turn makes decisions about the overall yearly budget for their respective genetic laboratories. For example, one participant from Ontario explained:
What happens in Ontario, the genetic testing comes out of the hospital budget, the hospital gives X number of dollars to genetic testing. In other provinces the funding goes directly for genetic testing. In some cases, there is a mix. For BRCA1 there is targeted [funding] for a few centres. For the majority of the other 200 DNA tests it comes through the global hospital budget.
In provinces such as British Columbia and Manitoba, funding is allocated directly to the genetic laboratory under the province's respective Ministry of Health. The hospital does not intervene in resource allocation decisions. A participant from one of these provinces explained:
Predictive genetic tests are funded through the Molecular Diagnostic Laboratory budget which in turn is provided through the local regional health authority budget.
In all provinces surveyed, the lab directors or head clinicians generally played a significant role in allocating the funds they received to specific tests and services, influencing day-to-day utilization decisions.
It was also found that participants were largely making such everyday allocation decisions without consultation with government representatives. Respondents were queried on the nature of their relationship with national and provincial government representatives. Participants were asked: "Who in the federal and/or provincial government has a role in the implementation of predictive genetic tests and resource allocation at your facility? Do you work with them?" While, a third of respondents (5/16) were able to identify a process for contacting the provincial government, two thirds of participants (11/16) indicated, in fact, that there was no one in the federal or provincial government that they could pinpoint as having a role. For example, one person stated "the contact person changes all the time, right now no one actually knows who the contact person is." Another explained:
No one in the provincial government, as far as I know, has a role in implementing predictive genetic tests. We, geneticists, have written proposals to implement genetic tests either in-house or through an out-of-centre laboratory. I do know that only a handful of proposals are brought forward to the attention of the provincial Minister of Health's office. Which proposals that are moved forward is decided by senior regional health authority officials and which ones are ultimately funded is decided by governmental officials.
These responses support a picture of an allocation process that is largely regional and localized to the health care community.
Respondents from across Canada also revealed that allocation decisions related to the distribution of funds for predictive genetic tests at the laboratory level were being influenced by a variety of factors. Underfunding for genetic tests was a recurrent theme in the discussion. When asked "are there any tests that have received premature funding," only one response indicated such incidents (1/16). In contrast, when asked, "are there tests that are not currently funded that your facility would like to provide" almost all respondents (15/16) answered in the affirmative. Participants were also asked to rate on a scale of 1–5, with 5 being very important and 1 not important, a list of potential factors influencing resource allocation decisions for predictive genetic testing at their facility These included: cost effectiveness, length of wait times, access to the appropriate equipment, access to new technologies, evidential basis, availability of preventative strategies, ethical/legal consideration, and media coverage. Participant responses varied, but for each of the factors listed, over half of the participants gave a rating of 3 or higher, with evidential basis and cost effectiveness consistently receiving the highest ratings. Such ratings suggest that all the above factors influence resource allocation decisions for predictive genetic testing in Canada at the laboratory level.
A number of participants then offered recommendations for changes to resource allocations specifically related to the mechanisms used to fund predictive genetic tests. When asked: "How do you think predictive genetic tests should be funded?" participants expressed a range of views. Some participants (5/16) indicated a preference for funding on a per test basis, e.g., "We need to be funded for each test that we are doing." A small minority (2/16) identified a preference for specific set of funds allocated to each type of genetic test, e.g., "It would be better to have funds specifically allocated for [predictive genetic testing] so if there is a need for further funding the lab would have the ability to justify itself."
Others noted (5/16) that the current mechanism through which funds were being allocated was satisfactory, in particular those that were funded under a global budget. One of these participants supported the evaluation process at a hospital-based laboratory, whereby funding for genetic testing was allocated after an evidence-based committee review, explaining:
We have a committee that decides if it is a novel test. The person that is requesting this goes in front of a committee that decides if it is scientifically sound, and how it is going to impact on our hospital... This [is] fairly straightforward.
The remainder of those interviewed (4/16) explained their funding systems but did not comment on their level of satisfaction.
The study sought to discover whether there was support for further policy development for technology assessment for genomic health technologies, initiated at the national level. When asked: "Do you think a national evaluation process for all predictive testing would be useful?" three quarters of participants (12/16) responded in the affirmative, e.g., "Canadian national guidelines would be a good place to start" and " [it would be] useful to have national standards on what is paid for and for those to be informed by expertise." Of those interviewed, the difficulty of coordinating or implementing a national evaluation process was raised (6/16), including by four of the participants who were supportive of new standards, e.g.:
We live in a country where healthcare is the provincial jurisdiction. Whatever we say national is unlikely to impact resources. But the federal government could put money into the Canadian College of Medical Genetics to push standardization, to ensure tests are performed in an excellent fashion, standards for genetic counseling – that would be great.
These participants also emphasized the need for sensitivity to the local and provincial nature of health care, cautioning, e.g., " [there are] very big regional differences and pressures per region."
Legal, Ethical and Social Issues
The study also focused on the relationship between resource allocation and the legal and ethical duties of care owed by health care providers involved in the provision of genetic services in the context of resource allocation policies [4, 6, 19]. Respondents were asked, "Assuming patient consent, who makes the decision about whether a predictive genetic test will be done?" Four options were provided: the primary care physician, the specialist, the genetic counselor or the laboratory. The majority of participants (11/16) indicated that more than one professional is involved in this process. Many respondents suggested that determining the professional responsible for making a decision on testing is dependant on the type of test. e.g., "There are certain tests where we would allow the primary care physician to make the decision, and there are certain tests where we need a genetic counselor to make the decision." One respondent deferred to policies rather than individual decision-making, suggesting "I am not sure if there is much of a decision because there are protocols in place so if they meet the protocols they get the test." This variability raises questions about the ethical responsibilities of each professional, as well as questions with regard to clarity regarding who has ultimate legal responsibility in relation to the decision making process.
Respondents were also questioned on a scenario that poses legal and ethical challenges for health care providers. They were asked "When should a patient's desire to have a specific test overrule the clinical indication for the test?" and offered three options – always, sometimes, never. Three quarters of respondents (12/16) replied that this decision should be made sometimes, depending on other social factors or the strength of the request. Generally, participant responses focused on the standard of care that they should be providing as health care professionals, e.g., "there are times when people are so stressed out that that might be an indication on its own." While those surveyed offered little insight into the nature of the legal obligations they owed in this role, the responses seem to represent a thoughtful balancing of an evidence based approach and a consideration of ethical obligations.
The study also investigated genetics health care providers' perceptions of social factors influencing patient decisions about predictive genetic testing. Respondents were asked to rate the influence of patients' concern about genetic discrimination, impact on family members, ability to obtain insurance, and additional costs associated with a positive result, on decisions regarding testing [20–22]. Providers offered a range of perceptions on patients' influences. In particular, genetic discrimination was viewed as both, e.g., "A high concern for most patients" and something that " [does not come] up all too often, in our health care system." Overall, half of the participants (8/16) rated the influence of patients' concern about genetic discrimination, as a 3 or higher, on a scale of 1 to 5, with 5 being very important and 1 not important. Interestingly, a couple respondents (2/16) also commented that factors such as genetic discrimination and the ability to obtain insurance are not normally influential until raised by health providers: "That's often an issue, again often one that we raise that they may not have thought about." In other words, providers expressed that patients were often unaware of the potential for genetic discrimination or difficulty obtaining insurance before their genetic health provider raised these issues.
Finally, the study queried genetic health care providers' perceptions of the influence of the media. When asked to rate the influence of "media portrayals of genetics on patient requests for genetic tests," on a scale, with 5 being very influential and 1 not influential, a majority of respondents (11/16) affirmed that media portrayals were either rated as a 4 or a 5. These findings emphasize the role of the media as an information conduit and a public education tool that assists in the introduction of new genetic technologies; one participant noted " [the media] have done a better job than the medical community." Respondents were also cautious about the tendency for information on genetic issues to become disproportionately emphasized, e.g., "The press is great for advocacy, not so good on issues requiring a perspective. That said, the media does keep us on our toes and does have a role." These findings confirm what other research has found regarding the media in the context of genetic technologies [23–25], including an awareness of genomics hype through media attention, and underscore the importance of accounting for social pressures on resource allocation structures.