Summary Report: Benefit-Risk Roundtable

On Friday, March 5, 2010, over thirty Canadian health stakeholders (representing patients, providers, government, academics and industry) participated in a roundtable meeting to discuss the new paradigm of benefit-risk introduced in Bill C-51.

The day featured a rich discussion (moderated by Dr. Stuart MacLeod) that effectively framed the issues in benefit-risk evaluation and set the stage for a continuing dialogue.

While many issues were raised during the vigorous discussions, five key themes emerged from the Roundtable meeting:

1. Consideration of quality of life should be central to the new approach to evaluation of benefit from innovative therapies. The evaluation will require a combination of quantitative and qualitative methods.
2. Enhanced patient engagement (including the relationship with stakeholder advocacy groups) is certain to be a key feature of any future process.
3. There should be a change in emphasis to benefit-risk from risk-benefit. This shift is appropriate and significant as it leads to a more patient-centered approach where costs aren't the only deciding factor.
4. Change in the drug regulatory system (and by extension in the review of drug reimbursement/access decisions) is inevitable. The active process of change in which we are now engaged is driven by our vastly improved understanding of the social and biological determinants of health and these will affect the assessment of drug benefits and drug safety.
5. New approaches and new methods are needed for the assessment of both benefit and risk. Importantly, methodological innovation is required and will be facilitated by the legislative renewal process as described by David Lee and Robyn Lim from the Office of Legislative and Regulatory Modernization. Canada's forthcoming renewed legislation describing a life-cycle approach to the evaluation of new therapies will be a driver of therapeutic innovation and will facilitate a more patient-centered approach to treatment, which should correspond to improved access to new drug treatments.

For more information, the complete summary report is attached.