September 16, 2014
Honourable senators, on June 16 of this year, a very important piece of legislation passed in the other place. Bill C-17, the proposed “Protecting Canadians from Unsafe Drugs Act,” or “Vanessa’s Law,” represents a significant step forward for prescription drug safety in Canada.
The last substantial changes made to the Food and Drugs Act were passed in December 1962, over 50 years ago.
As many of you know, Bill C-17 has received all-party support in the other place. The bill is also widely supported by stakeholders, including patient groups, professional associations, academics and industry, in recognition of the important drug safety improvements that Vanessa’s Law will deliver.
This bill would not be before us today without the extraordinary dedication of our colleague, Member of Parliament Terence Young, who has been advocating for these changes since the death of his daughter, Vanessa. Bill C-17 carries Vanessa’s name and with it a reminder to do everything in our power to ensure that the prescription pharmaceuticals we use are safe.
Honourable senators, the Standing Senate Committee on Social Affairs, Science and Technology is in the process of completing the final stage of a four-part study on prescription pharmaceuticals. This study has been ongoing since March 2012 and has included a comprehensive review of the clinical trials infrastructure in Canada; the state of post-market surveillance systems; the impact of off-label drug use; and, finally, the unintended consequences of prescription pharmaceuticals, which include the critical issues of antibiotic resistance, abuse, misuse and addiction.
Throughout this study, we became aware of a number of recurring themes. These include the particular circumstances of population subgroups such as women, children and the elderly, who are often excluded from clinical trials; the lack of available data on adverse drugs reactions and the inconsistent uptake of electronic health systems; and the benefits of a life-cycle approach to drug management, which include equal emphasis on pre- and post-market oversight.
Honourable senators, Bill C-17 asks for significant changes that will protect Canadian families from unsafe prescription pharmaceuticals. These changes will enable Health Canada, through its minister, to perform a number of critical new functions.
Under Bill C-17, health-care institutions will be required to report serious adverse drug reactions and incidents related to medical devices, giving Health Canada access to critical drug- safety information. Drug and medical-device companies will be compelled to revise labels to clearly reflect health-risk information. The minister will have the power to recall unsafe products and take them off the market.
Contraventions of the law will be met with tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000. In addition, the courts will have discretion to impose even stronger fines if violations were caused intentionally.
The minister will be able to compel drug and medical-device companies to do further testing on a product, including when issues are identified in certain vulnerable populations, such as children. The minister will be able to order a drug or medical- device company to conduct an assessment of a product and provide the minister with the results. Also, through regulation, the minister will be able to place conditions on a market authorization of a drug or medical device. These terms and conditions can be used to require a drug company to submit a risk-management plan and any follow-ups as a condition of sale in Canada.
Honourable senators, it is important to note that thanks to amendments introduced by Mr. Young, “Vanessa’s Law” includes additional patient safety measures, which were adopted by the Standing Committee on Health in the other place. These amendments respond directly to feedback from medical and legal experts and greatly improve transparency measures to ensure that Canadian patients, clinicians and researchers, are able to access critical drug-safety information. These amendments require that both positive and negative decisions about drug authorizations be disclosed and explained on a public website; they define the scope of confidential business information, CBI, and allow the Minister of Health to disclose CBI about a product if the minister believes the product may pose a serious risk to Canadians; and they oblige the disclosure of clinical trial information on a public registry.
I am pleased to note that the Standing Committee on Health in the other place strengthened the bill by introducing these amendments; they will result in greater transparency of Health Canada’s post-approval activities.
Bill C-17 places an obligation on the minister to make publicly available all regulatory decisions and the reasons for them.
I would also like to take a moment to expand on another important change that Bill C-17 will make to the Food and Drugs Act. Bill C-17 places a mandatory reporting obligation on health- care institutions to report all serious adverse drug reactions to Health Canada. This obligation allows Health Canada to access important drug-safety information, allowing it to act quickly to prevent further harm, for example, by ordering a drug-label change or issuing a recall. The ultimate objective of this provision is to reduce deaths and injuries caused by adverse drug reactions.
The bill contains an accompanying provision that requires the Governor-in-Council to ensure that regulations developed in respect of this reporting obligation do not impose any unnecessary administrative burdens on health-care institutions. Provinces and territories were consulted in the development of this provision, and the Governor-in-Council plans to continue to work with them to develop regulations.
Honourable senators, Bill C-17 will revolutionize the Food and Drugs Act and allow Health Canada to finally institute a life-cycle approach to drug management. The minister will oversee the publication of a modernized regulatory framework for drugs that includes long-term studies of drug safety.
There is no doubt that this bill represents a sea change in drug management and patient safety in Canada.
As the Senate considers this transformative piece of legislation, we must recognize a number of people who have contributed to it: the Minister of Health, who has affirmed her commitment to this issue and pledged to ensure Health Canada works towards greater transparency and openness; Terence Young, whose passion and devotion to this issue has resulted in a bill that fosters strong patient-safety provisions in this country; the members of the Standing Committee on Health in the other place, who worked collaboratively to pass amendments that greatly enhance transparency; and the members of the Standing Senate Committee on Social Affairs, Science and Technology, for undertaking a rigorous study of this subject matter and making a unique contribution to an area of increasing concern and importance.
Bill C-17 is a fine example of the high-calibre work that our parliamentary system can accomplish. However, the process has yet to be completed; the bill must be studied by Senate committee.
Finally, honourable senators, I would like to draw your thoughts back to Vanessa, who is, ultimately, at the very essence of this bill.