Fasken was retained by several pharmaceutical manufacturers to assist with the implementation of novel patient support program that provide healthcare institutions with companion diagnostics that could be used in determining the efficacy of a drug for a particular patient. In particular, companion diagnostics aim to measure the specific biomarker and guide optimal clinical management by identifying subpopulations of patients who are most likely to benefit from a given drug. They are very innovative tools to enhance patient outcomes, but because they lack a clear regulatory framework, clients often find it very difficult to manage support programs involving these tools.
Insofar as companion diagnostics reveals a preference for a particular drug, the free provision of these devices can be seen as incentivizing a healthcare professional to prescribe particular drug, contrary to Canadian law. It was therefore crucial to structure the patient support programs in a manner that precluded any appearance of undue influence and to carefully craft contractual agreements to ensure same.
This was particularly difficult in a context where both the regulatory and reimbursement processes are still unclear. From a practical standpoint, we collected and assembled all the relevant regulations, policies and guidelines at the federal and provincial levels and we built a realistic, practical roadmap to guide the client in the preparation and implementation of its program involving companion devices.
Fasken team was composed of Mathieu Gagné, Jean-Raphaël Champagne and Dara Jospé.
