Mr. Chair and honourable members, thank you for inviting Rx&D to appear before Bill C-17 today.
My name is Walter Robinson. I'm vice-president of government affairs at Rx&D, and I'm joined by my colleague, Keith McIntosh, our senior director of scientific and regulatory affairs.
By way of background, Rx&D is the national trade association that represents 55 research-based pharmaceutical companies and members who discover, develop, and deliver innovative medicines and vaccines to Canadians. To be perfectly clear we support Bill C-17.
Legislative and regulatory modernization of the Food and Drugs Act that enhances and promotes patient safety is good public policy. We have been consistently supportive of these efforts and those of previous governments.
By way of background as well, we invest over $1 billion each year into Canada, with approximately 75% of this amount directed to over 3,000 clinical trials across the country. As you have heard before, clinical trials are required to bring safe, innovative, and effective medicines, vaccines, and devices to the Canadian marketplace. These trials are conducted in highly controlled, monitored, and regulated settings. The successful completion of trials provides the confidence to bring new drugs and procedures into clinical practice. Clinical trials also provide hope to patients and their families who have failed on or do not respond to conventional therapies.
We are proud of our long-standing partnerships with the Canadian Institutes of Health Research (and its predecessor, the Medical Research Council of Canada) and various provincial and para-public agencies.
But our most important contribution is working together to better the lives of all Canadians. It is here where the proper diagnosis, appropriate prescribing, and optimal utilization of medicines enable health system sustainability by reducing the need for physician visits, unnecessary hospitalizations, or avoiding costly and invasive surgical procedures.
Our industry is also on the front lines of health care provision with our federal and provincial partners in the delivery of vaccination campaigns. And we play a key role in supporting provincial health system strategies, such as primary care reform, age in place efforts, and community delivery of health care through pharmaceutical and other services.
As we have highlighted to this committee before, our members' activities are guided by a clear code of ethical practices. Acceptance of and adherence to this code in letter and in spirit are mandatory conditions of membership in Rx&D.
Rx&D and its members support Bill C-17, as I have stated, and other related efforts to improve patient safety across all stages of the development, approval, and use of all therapeutic products. And we agree with you that Health Canada must have a modern, efficient, and effective compliance and safety regime, a regime that is world-leading in its scope and receives the confidence of Canadians.
We also note that prior to any specific powers now proposed in Bill C-17, which essentially codifies the way we have been working with government, Rx&D members work closely with Health Canada to recall products, update or change labels, and implement any other important safety-related actions, either of their own accord or these warranted by Health Canada.
The foundation of any decision or regulatory intervention must be evidence-based and arrived at through rigorous scientific inquiry and standards.
Critical to this line of inquiry is a fulsome exchange of information among manufacturers, Health Canada, health care professionals and, increasingly, Canadian patients.
We pledge to work with the government, parliamentarians, and all stakeholders to make Bill C-17 and its adoption, if passed into law, as clear, efficient, and effective as possible. We would also suggest that the committee consider a number of aspects to further enhance and strengthen patient safety within Bill C-17. These include improving the exchange of information around reporting adverse events, which we support; encouraging and promoting the consistent dispensing of approved Canadian labels in pharmacy settings for innovative and generic medicines; additional oversight regarding counterfeit medications; and at a more practical level, more collaboration with international regulators such as the U.S. FDA, the European Medicines Agency, and their peers. As you heard in testimony before this committee, in several aspects they are further ahead than Health Canada on present safety regimes.
Every product has benefits and, yes, risks that are determined on the best available information and scientific practices. These benefits and risks are studied throughout a product's life cycle, and as the committee is aware, the vast majority of developmental therapeutic products fail for a wide variety of reasons, including unacceptable safety profiles, lack of efficacy, or situations where established risks clearly outweigh the benefits of a given therapy. Only one of 10,000 molecules in study ever makes it to market and to patients.
Vigorous and continuous attention to safety is a fundamental part of the development process from the early stages of drug development through to the entire life cycle of product even after discontinuance or product withdrawal. As other experts have testified before you, this process can span 30 to 50 or more years.