Background
Scholars have begun probing the connections between neoliberal political ideologies and forms of territorial and institutional reform within healthcare systems. Arguments have been made regarding the reorganization and restructuring of power by neoliberal ideologies [
1]; its influence on the operations of health systems [
2]; the impact of varied levels of privatization [
3] and its role in strengthening the public health complex [
4]. Additionally, a body of literature has examined the various impacts of these reforms on healthcare practitioners’ capacities to provide quality care to patients [
5,
6]. Less attention has been given to how governing styles influence the processes through which new health technologies, such as molecular genetic tests, are developed and adopted into publicly-financed health systems. (By ‘governing style, we mean the set of processes and assumptions that work to inform how policy decisions are reached.) While the socio-political and economic impacts of genetic testing have been analyzed in the literature [
7‐
9], few studies have examined relationships between governing styles and decisions to adopt these new platforms. In this paper, we address these gaps, arguing that governing styles have a significant influence the processes through which health technologies come to be adopted and delivered by publicly-financed health systems.
One relatively new genetic test is cell-free fetal DNA (cffDNA) screening, also known as non-invasive prenatal testing (NIPT). In 1997, Lo and colleagues [
10] determined that fragments of fetal DNA are present in maternal blood. The commercialization of NIPT for atypical fetal chromosome counts began once researchers could analyze cffDNA from maternal blood in high volumes [
11‐
14]. Within four years of the first tests entering the market in 2011, NIPT was being used in 60 countries around the world [
15,
16] to screen for trisomies 21, 18, and 13.
While NIPT is currently available for purchase by all pregnant women in Canada, not every province covers its costs under their health insurance schemes. Canada’s two most populous provinces, Ontario and Quebec, offer publicly-financed NIPT for high-risk pregnancies (e.g., maternal age above 40 years, the existence of trisomies 21, 18, and 13 within the family, or a twin pregnancy), though each has chosen a different pathway to innovation and adoption.
We argue that the approach to adoption of NIPT in Ontario was influenced by the province’s ‘New Public Management’ (NPM) governing style. NPM can be understood as an ‘administrative doctrine’ seeking to slow down or reverse government growth in terms of public spending and staffing, while expressing a preference towards privatization [
17,
18]. NPM is part of neoliberal trends that emerged in the 1980s. Neoliberalism constitutes a set of socio-economic and political assumptions, grounded in classic ‘laissez-faire’ economics, that maintain economic growth and development, and are contingent upon the following: reducing public deficits; broadening the tax base, reducing corporate taxes and domestic sector subsidies, and privatizing government-controlled industries [
19]. Within the context of healthcare, this governing style has manifested as forms of ‘contracting out’ services to private entities, to lower government expenditures [
3,
20,
21]. This decision can lead to favouring efficiency over transparency as private entities are not required to publicly share proprietary information [
22]. Additionally, decisions to cut public spending overall led to decreased healthcare spending. In Ontario, this translated into, “overcrowded emergency rooms, understaffed and underequipped cancer and cardiac treatment centers, and shortages of new high-technology diagnostic equipment …” [
23].
Conversely, the Quebec approach to the adoption of NIPT can be understood as a form of economic and industrial ‘nationalism,’ which sought to promote a ‘Quebec-first’ stance, encouraging investment in Quebec through the deployment of a directed industrial policy. Quebec’s approach to adoption of NIPT reflects a resurgence of interest in industrial policy in both Canada and globally after the global financial crisis (against a background of longstanding, if hidden, developmental state activity) [
24,
25]. Occurring within the majority-French ‘nation within a state’ that is Quebec, this approach to adoption of NIPT confirms the insights of existing studies on sub-national politics and stateless nations. Scholars highlight the importance of public policy for maintaining and strengthening forms of sub-nationalist mobilization [
26], contributing to a ‘sense of difference’ and institutional distinctiveness through state ‘ownership’ of public policies that are designed to respond to the needs of the nation [
27].
Through a comparative analysis of the distinctive approaches to NIPT in Ontario and Quebec, this article explores how the technology’s development, adoption, and delivery was shaped by the governing styles in each province.
Methods
This paper presents a comparative, qualitative investigation of key documents blended with semi-structured interviews. This study was granted ethics approval by the Office of Research Ethics at the University of Toronto (Protocol #00,033,786).
We conducted twenty-one interviews with physicians, geneticists, and representatives from both regulatory bodies and pharmaceutical companies between 2019–21. Recognizing the existence of professional relationship networks amongst individuals working in this space, a snowball sampling approach was used to recruit participants, primarily within the Canadian provinces of Ontario and Quebec [
28].
Amongst the participants, six were geneticists/obstetricians based in Ontario, seven were geneticists/obstetricians based in Quebec, five worked with national regulatory bodies, two were representatives from an international pharmaceutical company, and one was a researcher/clinician based in British Columbia. Given the limited scope of the study, the research team concluded that the collected interviews, when supplemented with additional sources (i.e., government publications, journal articles, etc.), offered a sufficient base to answer research questions [
29].
The interviews were conducted both in-person and virtually by three research team members. All participants were given a set of interview questions in advance, and all participants provided written informed consent to participate. Interview data was later anonymized by the research team. Interviews ranged from approximately forty-minutes to one hour, were recorded, and transcribed verbatim. All interviews were conducted in English.
Transcripts were analyzed using a thematic analysis approach [
30]. Two researchers successively read and coded the transcripts, documenting codes they perceived to be relevant to the research question. Both researchers then actively discussed their interpretations of the data and identified themes. To ensure consistency, a third team member independently coded a sample of interview transcripts, which were then compared against the first team members’ coding. From the perspective of the authors, this collaborative and conversational style of coding allowed for author reflexivity by acknowledging the role of subjectivity in data analysis [
29].
Discussion
Policy decisions regarding the development, adoption, and delivery of a health technology are often understood as a technical exercise for governments. Using the example of NIPT in Ontario and Quebec, this study explored the argument that these processes are also political. Specifically, that the political ideologies of governments shape health development, adoption, and delivery are approached by publicly-financed healthcare systems. Following public policy researchers Geva-May and Maslove [
40], we illustrate that “health technology moves along the fault lines of other politics.”
In Canada, the delivery of health services is primarily the responsibility of the provinces, and each has responded uniquely to NPM-inspired political pressures [
23]. NPM-style reforms across Canada were triggered by the political struggles between the federal and provincial governments and other health system stakeholders arising in the 1990s [
41]. Scholars argue that Ontario and Alberta have adopted NPM “the most fully” [
21], while Quebec has adopted it “the least” [
42]. NPM rhetoric within Canadian healthcare, thus, must be understood with reference to each province’s political context and climate.
Pressures to increase for-profit entities’ participation have long been a political issue in Ontario. In the 1990s, Ontario’s government sought to slash healthcare spending [
43], ultimately cutting $800 million CAD from hospital budgets, creating system-wide issues and bottlenecks. These cuts set the stage for private entities’ entrance as a means of addressing the issues of access, equity, and quality of care. Ontario introduced a system of ‘contract bidding’ that sought to maintain/promote reductions in spending, while ensuring patient access to basic services. These competitive bidding processes have been maintained by subsequent governments, despite non-profit entities’ criticisms that the private sector is capable of underbidding [
23].
Our study of the case of NIPT adoption in Ontario demonstrates this political valuation. Ontario’s decision to partner with
Dynacare and
LifeLabs by awarding them exclusive contracts to perform the testing not only evidenced the government’s desire to slow down and reduce government growth and spending, but also its comfort with private entities’ involvement in the health system [
20]. Through these contracts, Ontario’s government sought to make use of existing infrastructure (i.e., private labs) as a quick, low-cost means to provide a service. But what have been the consequences of this political decision? While it is still too early to fully assess the effectiveness of Ontario’s NIPT adoption and delivery strategy, there are reasons to believe that greater efficiency and cost-savings may not be realized.
First, private entities’ participation raises concerns about financial transparency. The process through which Ontario awarded lab contracts appears to be something of a ‘black box,’ a concern given the democratic ideal of public oversight vis-à-vis government spending. Our participants make little to no mention of public participation in the ‘open process’ through which the NIPT contracts were awarded, aligning with the observations of critics who note that the awarding of contracts through NPM-style reforms is often exclusionary, lacking stakeholder involvement [
44].
Second, skepticism of NPM’s promise that implementing business and private sector ideas into public services would reduce costs and inefficiencies is warranted. Chief amongst these ideas is the promotion of competition [
17]. NPM holds that the ‘trust’ placed in civil servants to oversee the management and operation of public services and organizations is misplaced because inefficiencies are continually funded [
45]. Introducing elements of competition, through contracting out, is presented as a solution to these inefficiencies [
46].
NIPT adoption in Ontario, however, appears to serve as a counterexample. As LifeLabs and Dynacare enjoy their exclusive licenses, other labs cannot offer NIPT. Consequently, these two labs capture all patient-pay testing in the province, allowing them to charge higher fees for the service. Further, private entities are not subject to routine audits, meaning LifeLabs and Dynacare are not required to disclose data pertaining to their profit margins. Thus, it is unclear whether outsourcing of this nature produces cost-savings.
Importantly, our findings parallel the work of scholars in other geographic contexts [
46]. In Britain, Simonet [
47] argues that there is “little evidence” suggesting that contracting out led to cost reductions, and in fact, may have contributed to worsening health outcomes for patients. More than twenty-five years of NPM experimentation has not produced greater accountability or reduced fraud because complexity has made the development of adequate controls challenging [
47].
In Quebec, our participants’ insights reflect its unique positioning amongst the provinces as ‘a nation within a state’. This ‘exceptionalism’ manifests politically as Quebec’s occasional refusal to participate in federally initiated programmes [
48]. Consequently, Quebeckers have, at times, been denied access to health, education, and welfare provisions available elsewhere in Canada [
27]. Quebec’s national identity is often expressed in the institutions and policies of the Quebec state. Connections between nation and state have justified governmental intervention in social, economic, and cultural policies. It is not enough that Quebeckers have access to the same social welfare provisions as other Canadians, but that these policies were “developed, financed, and provided by the government of Quebec” [
27].
Canadian provinces, therefore, have a history of pragmatically deploying public policy to support industrial policies reflective of current “political realities” [
24]. Quebec’s willingness to intervene to preserve its national identity and maintain control over particular economic sectors is a well-documented example of this phenomenon. Indeed, Quebec’s industrial policy has long sought to both support the province’s economy, reinforcing a ‘Quebec-first’ stance. In pursuit of this, the Quebec government has stressed the function of provincially-owned corporations [
49].
Our analysis of NIPT in Quebec exists within this political context. PEGASUS can be understood as Quebec’s desire to support itself and avoid reliance on others/outsiders. First, the study was premised on the need to validate the data generated outside Quebec/by others. Second, Quebec created its ‘homebrew’ test to weaken its ties to and reliance on tests produced by industry. By weakening these ties vis-à-vis NIPT, Quebec’s strategy worked to strengthen and invest in state-owned institutions. While private labs do offer NIPT as a fee-for-service, the only provincially-financed test is the ‘homebrew.’
Two points emerge: first, the government of Quebec sought to reinforce its caretaker role vis-à-vis the health of Quebeckers, promoting its exceptionalism; second, the government’s insistence on offering of NIPT through public labs paints a clear policy picture, where the state prioritized itself and its objective of control by investing in its institutions (i.e., job creation and keeping money within Quebec), without sacrificing state power to private entities.
But what are the consequences of this strategy? We can speculate that the use of the ‘homebrew’ test is a low-cost option for the province. Quebec is largely freed from navigating costly contracts with private labs or litigious commercial manufacturers. Potentially most seriously is the criticism that has been levelled against Quebec’s nationalist strategy. PEGASUS led to delays in service provision for pregnant women in Quebec, as the publicly-financed NIPT (using the ‘homebrew’ test) was not made available until 2020 (more than five years after it was funded in Ontario). This delay raises important questions for further research to explore regarding the province’s prioritization of nationalist goals over the delivery of certain health services.
Our analysis of NIPT in Quebec also confirms the insights of others regarding the connections between national identity and healthcare. In Cuba, political scientist Johnson [
50] argues that “health” is conceived as an expression of its commitment to socialism becoming “indispensable to that country’s sense of nation and source of legitimacy.” “Health” in Cuba works to “defend […] against competing [socio-political] visions at home and abroad” [
50]. In Britain, public health researcher Cowan [
51] similarly discusses the “backlash” from activists concerning the “international policy trend to contract healthcare out to (often multinational) private companies.” Health activists, Cowan argues [
51] frame the National Health Service as the “beacon of equality,” using it to justify British distinctiveness. In Austria, political scientist Metzler [
50] argues that the enshrinement of a particular “set of visions” into legislation and implemented within the public healthcare system created a unified vision of what prenatal care ought to contain. The pre-existence of this vision, she [
52] argues allowed NIPT to spread easily within Austria because it could “travel in and through the moral and material grounds of an extant imaginary of prenatal testing while also reifying it.” While most Canadians likely have strong feelings about the country’s public provision of health services vis-à-vis other countries, the example of NIPT in Quebec works to connect the province’s unique identity and feelings of difference to healthcare.
Study strengths and limitations
This study seeks to be an early contribution to a health policy literature exploring the connections between political ideologies of governance and health technology adoption and innovation. Out study has several strengths. First, our research participants included individuals working within both the private and public sectors, allowing for better comparison between the two spaces. Second, we supplement and cross-reference these interviews with information taken from key government reports and publications, thereby adding additional context to the opinions and experiences of participants. And third, our study raises important questions regarding the relationship between the achievement of political and economic goals and women’s ability to access reproductive information. Despite these strengths, more research is needed to compare the longer-term effectiveness of these strategies. Such work, however, will be challenging given industry’s penchant for privacy and unwillingness to release financial information/records. Additionally, a subsequent study able to include French-language participants could add greater nuance to perspectives on NIPT in Quebec, particularly regarding the province’s unique positioning within Canadian politics. Further, while our comparative work has focused on the cases of Quebec and Ontario, provincial control over healthcare in Canada creates fertile ground for further comparative work on health technology adoption across provinces.
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