Mr. Speaker, the Protecting Canadians from Unsafe Drugs Act, Vanessa’s Law, received royal assent on November 6, 2014.
Many of its provisions came into effect when the legislation received royal assent. These provisions include important new safety measures, such as the ability of the Minister of Health to recall unsafe drugs and medical devices, compel information, order a label change, and disclose confidential business information when needed to prevent a serious risk of injury to human health. It also gave the court the ability to impose tougher fines and penalties, and to obtain an injunction to stop or prevent the commission of an offence. This allows Health Canada to take necessary action when there is a risk to the health of Canadians.
Other Vanessa’s Law measures require consultations with stakeholders and the development of regulations before they can be implemented. When developing regulations, Health Canada must consult broadly, including with the stakeholders who will be required to follow those regulations, as well as interested and impacted Canadians. Input is sought in many different ways, including publication of discussion papers, face-to-face meetings, webinars, and the publication of the proposed regulations in the Canada Gazette. All regulatory proposals must obtain governor in council approval and undergo publication in the Canada Gazette, part I and part II. This gives all Canadians a chance to provide meaningful input on the policy and development of regulations.
A number of regulatory proposals are under development, as outlined in the notice of intent published in June 2016, to require industry to undertake further tests and studies; require therapeutic products authorization holders to disclose foreign risk information; allow the minister to impose terms and conditions on marketing authorizations; and allow the minister to order a reassessment.
Three of these, namely, tests and studies, reassessment, and foreign risk information, were pre-published in the Canada Gazette, part I, in June 2017 for public consultation. Additionally, white paper consultations were held this past spring for two other Vanessa’s Law measures: public release of clinical information in drug submissions and medical device applications; and mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions. These regulatory proposals are targeted for Canada Gazette, part I, pre-publication in late 2017 and spring 2018, respectively. The remaining Vanessa’s Law proposals, including disclosure of clinical information, are under development.