Order Fixing the Day After the Day on Which this Order is Made as the day on Which Certain Provisions of that Act Come into Force: SI/2020-39
Canada Gazette, Part II, Volume 154, Number 12
SI/2020-39 June 10, 2020
BUDGET IMPLEMENTATION ACT, 2019, NO. 1
Order Fixing the Day After the Day on Which this Order is Made as the day on Which Certain Provisions of that Act Come into Force
P.C. 2020-371 May 22, 2020
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 184 of the Budget Implementation Act, 2019, No. 1, chapter 29 of the Statutes of Canada, 2019, fixes the day after the day on which this Order is made as the day on which subsections 163(2) and (4), section 166 and subsections 168(2), 172(2), (7) and (8), 173(2), 174(2) and 175(2) of that Act come into force.
(This note is not part of the Order.)
This Order in Council brings into force the day after the Order is made subsections 163(2) and (4), section 166 and subsections 168(2), 172(2), (7) and (8), 173(2), 174(2) and 175(2) of An Act to implement certain provisions of the budget tabled in Parliament on March 19, 2019 and other measures, also known as the Budget Implementation Act, 2019, No. 1 (BIA 2019).
Subsection 163(2) amends the definition of “therapeutic product authorization” in section 2 of the Food and Drugs Act (the Act) to include an authorization or licence that authorizes the conduct of a clinical trial in respect of a therapeutic product.
Subsection 163(4) amends section 2 of the Act to add new definitions of “clinical trial” and “food for special dietary purpose.”
Section 166 amends the Act by adding new sections 3.1 through 3.3 that prohibit any person from conducting a clinical trial in respect of a drug, device or prescribed food unless authorized; requires holders of a clinical trial authorization to comply with any terms and conditions imposed on an authorization by the Minister; and requires that clinical trial authorization holders ensure that prescribed information respecting the clinical trial is made public within the prescribed time and manner.
Subsection 168(2) replaces section 21.71 of the Act with a provision that requires the holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) of the Act to ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.
Subsection 172(2) amends subsection 30(1) permitting the Governor in Council to make regulations respecting the conduct of clinical trials, the issuance of authorizations to conduct clinical trials, authorizing the Minister to impose terms and conditions on those authorizations, requiring the Minister to make publicly available decisions respecting authorizations and the reasons for them, and requiring holders or former holders of clinical trial authorizations to provide the Minister with safety information they become aware of after the trial has been completed or discontinued or after the authorization has been suspended or revoked.
Subsection 172(7) replaces paragraph 30(1.2)(c) of the Act with a provision that allows the Governor in Council to make regulations requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial, or former holders of such an authorization, to provide the Minister with safety information they become aware of after the trial has been completed or discontinued or after the authorization has been suspended or revoked.
Subsection 172(8) repeals paragraph 30(1.2)(c.1) of the Act that allowed the Governor in Council the ability to make regulations defining the terms “clinical trial” and “investigational test” for the purposes of the Act.
Subsection 173(2) amends subsection 31.1(2) of the Act to indicate an offence under subsection 31.1(1) would apply in respect of clinical trials for a food or terms and conditions imposed on an authorization in respect of the conduct of a clinical trial for a food.
Subsection 174(2) amends subsections 31.2(2) and 31.4(2) of the Act to indicate an offence under subsections 31.2(1) and 31.4(1) respectively would apply in respect of clinical trials for a therapeutic product or terms and conditions imposed on an authorization in respect of the conduct of a clinical trial for a therapeutic product.
The objective of the proposal is to bring into force sections and subsections of BIA 2019 to allow the Minister of Health to make an interim order under subsection 30.1(1) of the Food and Drugs Act that will create an agile framework that introduces efficiencies expediting the evaluation of and access to Canadian clinical trials for COVID-19-related drugs and medical devices.
COVID-19 is the infectious respiratory disease caused by the most recently discovered coronavirus, SARS-CoV-2. The outbreak of COVID-19 began in Wuhan, China, in December 2019. COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death.
The World Health Organisation (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. There are now more than 2 400 000 cases worldwide and over 152 500 people have died. The number of confirmed cases in Canada as of April 19, 2020, has exceeded 34 700 and 1 580 people have died; however, this is changing rapidly.
There is currently no specific vaccine or treatment for COVID-19 authorized in Canada, but there are active research and development underway around the world to develop therapies for it. The last stage of research and development is human clinical trials, which assess the therapy’s safety and effectiveness.
Currently, Health Canada regulates the importation and sale of drugs and devices for the purpose of clinical trials through Divisions 3 and 5 of the Food and Drug Regulations (FDR), Part 4 of the Natural Health Product Regulations (NHPR) and Part 3 of the Medical Devices Regulations (MDR). However, the existing regulatory requirements under these authorization pathways may not be appropriate and require enhancement to address the rapidly evolving national health emergency presented by COVID-19.
BIA 2019, which received royal assent on June 21, 2019, included numerous provisions related to the conduct of clinical trials, including a new prohibition, definitions and regulation-making authorities. While many of the provisions respecting the Food and Drugs Act came into force immediately, others were to come into force on a date fixed by the Governor in Council in order to allow the time for supporting regulations to be developed.
The emergence of COVID-19 has given rise to the need for an expedited authorization and implementation pathway for clinical trials for COVID-19-related drugs and medical devices. The design of such a pathway requires the flexibility provided by the clinical trial provisions currently housed in BIA 2019 which will be brought into force by this Order in Council.
Currently, clinical trials are regulated through the sale of drugs and devices into a clinical trial. However, BIA 2019 introduced a prohibition which prohibits the conduct of a clinical trial without authorization and the supporting authorities to make regulations respecting that conduct. The Order in Council will bring these provisions into force. Once the prohibition respecting the conduct of clinical trials is in effect, it will apply to
- clinical trials to be approved through the interim order for COVID-19 drugs and devices which are currently under development;
- clinical trials which have been approved through the existing regulatory frameworks; and
- upcoming clinical trials which will continue to be approved through the existing regulatory frameworks.
In the case of clinical trials related to COVID-19, the interim order will provide an optional expedited pathway for the issuance of authorizations to conduct these clinical trials and to exempt them from the application of the current regulatory frameworks.
In the case of those who hold authorizations under the existing regulatory framework, the interim order will contain provisions that will provide for the non-application of the prohibition and allow for the maintenance of these regulatory pathways. Existing authorization holders will, at the time of coming into force of the new provisions, be deemed to be holders of an authorization to conduct a clinical trial as a result of transition provisions which are contained in BIA 2019. These holders will continue to also hold the authorizations they currently hold under the regulatory framework under which they were approved. The interim order will place no requirements on these authorizations other than to state that when the authorization under the existing regulatory framework is suspended or revoked in whole or in part, the authorization for conduct is suspended or revoked to the same extent. The result is to make the holding of this deemed authorization overall neutral in its effect.
With respect to clinical trials which are not in place at the time of the coming into force of the new provisions (which may include both non-COVID-19-related clinical trials and COVID-19-related clinical trials where the authorization holder has chosen to proceed under the existing regulatory framework rather than via the expedited pathway), the anticipated interim order will exempt these clinical trials from the new prohibition and allow for the maintenance of the existing regulatory pathways for these trials so that they can begin in the same manner as existing clinical trials (i.e. with an authorization for the sale of the drug or device for use in a clinical trial and a deemed authorization for conduct).
If approved by the Governor in Council, the interim order will have effect for a period of one year from the date it is made. As a result, a Governor in Council regulation will need to be made within that year to continue exempting clinical trials authorized under the current regulatory framework from the new prohibition. These exemptions would remain in place until a more comprehensive clinical trial framework, which will be fully consulted on, is ready to be made to allow the new prohibition to apply more broadly.
Due to the urgent nature of the interim order, broad stakeholder consultation on the coming into force of these provisions of the Act was not possible.
External stakeholders, including the pharmaceutical, medical device and food industry sectors, academia and provincial and territorial partners, are aware of the new authorities provided under BIA 2019 and the provisions of the Food and Drugs Act that will be brought into force but may be surprised by the fact that these authorities are being brought into force much earlier than anticipated. This, however, will be mitigated by the fact that the application of these new authorities will be limited in scope to clinical trials related to COVID-19 and the fact that the pathway is optional.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Department of Health
Holland Cross, Suite 14
11 Holland Avenue
Address locator: 3000A