a nation of entrepreneurs, a plethora of large and mid-sized companies and resource-related businesses and a legislative infrastructure based on English Common law.
a progressive jurisdiction, well-respected for its
quality compliance, transparency and regulatory infrastructure, also based on English common law, with a forty-plus year history of a developed captive insurance industry.
The world of clinical trials is changing in Canada and around the globe, and with these changes comes a need for innovative solutions. These solutions are critical as organisations transition from conducting trials for pharmaceutical companies (registration trials or randomised controlled trials (RCTs)) to conducting trials that are investigator initiated (IITs). IITs typically rely on multiple sources of funding including government and non-government grants, but in general, institutions run these studies on limited budgets.
A prime example of this is Hamilton Health Sciences’ Population Health Research Institute (PHRI). PHRI is a global powerhouse in conducting large clinical trials and population studies out of its facilities in Hamilton, Ontario, Canada. PHRI works in 86 countries on six continents producing research leading to citation classics (studies cited by other researchers in academic journals more 1,000 times) that include HOPE Ramipril1 (New England Journal of Medicine), INTERHEART2 (Lancet), HOPE Albumineria3 (Journal of the American Medical Association), and the Global Burden of Cardiovascular Disease4 (Circulation). PHRI’s research changes the way health professionals treat cardiovascular disease, diabetes, and many other health conditions. Thousands of people participate in PHRI studies annually and thousands more benefit from the research.
In 2002, 59 percent of the studies conducted through Hamilton Health Sciences (HHS) were industry funded5. By 2011, this number dropped to 23 percent and the trend towards more IITs continues. The challenge created by this trend is that industry-sponsored trials typically came with industry-provided insurance for both the institution and the study participants. How do we insure study participants in multiple countries when we as a Canadian hospital are responsible as sponsors of the trial?
Our approach to this was to evaluate developing a ‘self-insurance’ pool of internal funds versus going to the insurance marketplace versus creating a captive. With the help of Dion Strategic Consultants and Actuaries and Highcourt Partners Limited, we conducted an analysis of our three options. It became clear quickly that having a simple self-insurance pool of funds created an unacceptable level of risk for the hospital (minor exposure to a lawsuit in the US where the plaintiffs requested access to our data resulted in costs of over $1 million CAD). The actuarial study demonstrated that purchasing insurance had a cost of approximately $150 CAD per participant. With an active (currently participating in a trial) participant pool of roughly 33,000, we faced a cost of $4.95 million CAD per year. A captive model approach appeared to have much lower costs of approximately $44 CAD per participant or $1.45 million. We chose option #3.
With legal help from Miller Thomson LLP in Toronto and Strategic Risk Solutions Incorporated in the Cayman Islands, we supported the development of Research Insurance Corporation (RIC) and became its first client. HHS occupies its own cell within RIC where we are better able to influence claims and loss control. We are also able to access the re-insurance market directly and use our ‘self-insurance’ pool of funds; we are able to leverage those funds into much better protection for study participants. The captive allows us to minimise insurance costs, control risk, improve cash flow, and protect our assets.
The complexity of supporting research projects in multiple jurisdictions, many with unique local licensed insurance requirements, continues to grow. The local licensed insurance requirements typically must be compliant with local statutes, and contract and language regulations. The captive again, solved this problem.
After almost two years of participating in RIC, we recognise that the Cayman Islands provides the strong regulatory framework we were looking for along with reliable banking and investment management. Furthermore, as we learned more about ourselves and about the insurance and re-insurance marketplace, we have been able to enhance our protection while at the same lowering our costs. Participants in HHS and PHRI studies have never been better protected.
1 Yusuf, S., Sleight, P., Pogue, J. Bosch, J., Davies, R., & Dagenais, G. (2000). Effects of an angiotensin-converting-enzyme inhibitor, Ramipril, on cardiovascular events in high-risk patients. NEJM, 342(3), 145-153. DOI: 10.1056/NEJM200001203420301
2 Yusuf, S., Hawken, S., Ounpuu, S., Dans, T., Avezem, A., Lanas, F., McQueen, M., Budaj, A., Pais, P., Varigos, J.,& Lisheng, L. (2004). Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet, 9438, 937-952. DOI: 10.1016/S0140-6736(04)17018-9
3 Gerstein, H. C., Mann, J. F., Yi, Q., Zinman, B., Dinneen, S. F., Hoogwerf, B., Halle, J. P., Young, J., Rashkow, A., Joyce, C., Nawaz, S., & Yusuf, S. (2001) Albuminuria and risk of cardiovascular events, death, and heart failure in diabetic and nondiabetic individuals. JAMA, 286(4), 421-426. DOI: 10.1001/jama.286.4.421
4 Yusuf, S., Reddy, S., Ounpuu, S., & Anand, S. (2001). Global burden of cardiovascular diseases. Circulation, 104, 2746-2753. DOI: 10.1161/hc4601.099487
5 Piche, C., Arnosti, T., & Salama, S. (2012, April). Change in the scope of studies over a decade: Implications to the Research Ethics Board in a large teaching hospital in Ontario. Presented at Canadian Association of Research Ethics Boards conference.