I want to thank you for giving me the opportunity to come here today on this very important issue that's critical to patients living in this country.
The Best Medicines Coalition is a national alliance of organizations and individuals representing those living with or affected by chronic disease or illness. We have a core mandate of ensuring access to the best evidence-based medicines for Canadians.
BMC's patient representatives are actively involved in discussions about drug review reform, patient safety, and general health policy development. Improvement of post-market pharmaceutical surveillance in Canada is one of our key goals.
This coalition encourages implementation of a robust system of comprehensive reporting, monitoring, analyzing, disclosing, and communicating a prescription drug's adverse effects throughout its use over time. Even though drugs are studied extensively before being approved for sale in Canada, an adverse event might not emerge until it's been widely available in a real-world setting.
Identifying adverse events is critical, but we caution against knee-jerk responses that cut off medications from an entire population when only a particular subset are affected. We seek a national system whereby patients have full, timely access to medications and full disclosure of each medicine's known risks and benefits profile.
I am just going to speak to a few initiatives we've been involved with. One is the progressive licensing framework. We fully support the work of Health Canada's progressive licensing framework and the proposed life cycle concept. Ongoing work in modernizing the regulatory framework while working towards harmonizing Canada with international regulatory standards is imperative.
We recognize that the current outdated regulations are insufficient to address the current and future need for the complex and sophisticated treatment approaches needed by Canadian patients. We support the life cycle approach because we believe it will improve health outcomes while enhancing collective, ongoing knowledge of how each medication works, good and bad, in the real world.
We believe that adherence to the progressive licensing framework will enhance ongoing drug safety in Canada by better reflecting the safety, quality, and efficacy mandate of Health Canada. This approach will allow for a more comprehensive range of responses to drug safety issues, rather than necessitating a full retraction from the market, as prompted by current legislation.
Further, BMC applauds the Health Canada team, under the direction of David Lee of the therapeutic products directorate, for the inclusive, consultative, and, I would say, comprehensive approach to this policy development, and particularly for welcoming and inviting patient input throughout the whole process.
We also believe that you need multistakeholder involvement in any solutions moving forward. To move towards effective post-market surveillance, the system requires major advances and comprehensive adverse event reporting. The current statistics provided to the Expert Advisory Committee on Vigilance in Health Products at a recent meeting show that only 1% to 10% of current adverse events are reported.
It is incumbent on Health Canada to increase this reporting quickly and drastically. We recommended broadening the base of sources for adverse event reporting. All players in the health care system--patients, caregivers, professionals, institutions, industry, and government--have a role in ensuring comprehensive reporting of adverse events. Reforms must move forward that will balance responsibilities in the reporting of adverse events, which currently lie primarily within the pharmaceutical industry. Although controversial, we recommend exploring some measure of mandatory reporting.
Here are some suggestions for improving reporting within various sectors.
I'll begin with patients. Currently most patients are not aware that they can even report an adverse event directly. This warrants a major public education campaign. Through such a campaign, those taking medications and some over-the-counter products could learn to provide necessary feedback regarding their negative experiences. A newly developed, consumer-friendly form is in the final stages of development. Ideally, this could be handed out to patients when a prescription is filled.
In addition to being the conduit for information transfer to the patient, pharmacies could display reporting information notices and MedEffect banners to direct patients on how to report an adverse event.
Currently health professionals only report the most serious adverse events, and there is little evidence that reporting goes beyond this. Attitudes and practices regarding reporting must be addressed within the community, with a goal to increasing reporting rates. Medical education curricula, as well as those of all health professionals, should include a module on adverse reporting and the importance. Continuing education on this topic for practising professionals, as well as awareness campaigns aimed at these audiences, could be beneficial.
On hospitals, despite many obstacles and resourcing considerations, mandatory hospital reporting is integral to a comprehensive system.
I'll finish with resourcing and infrastructure. In any meaningful discussion about the future of post-market surveillance, resources must be addressed. This includes human and financial resources, in addition to infrastructure development. We encourage the Government of Canada to provide Health Canada with the authority and adequate funding for all components necessary to ensure a viable program. In addition, the Government of Canada must allocate resources so that other players in the system, including patients, professionals, and hospitals, can serve a meaningful role.
Post-market surveillance is uniquely complex and involves all stakeholders, and to date there have been some successful improvements in contributions to extending trying to improve the rates, and we hope these will continue.