The Act includes the following changes:
A therapeutic product is defined as a drug, a medical device or a combination thereof but does not include a Natural Health Product. These will continue to be regulated under the Natural Health Products Regulations.
Certain healthcare institutions will be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.
While most drugs are prescribed and used by patients outside of healthcare institutions, patients who experience serious reactions to drugs generally require hospitalization. Healthcare institutions, such as hospitals, are therefore in a unique position to identify and report serious adverse reactions.
New federal regulations setting out which information, how it is to be reported, and which healthcare institutions will be required to report, will be developed in consultation with provincial and territorial counterparts.
Over the course of a therapeutic productĺs lifecycle, new information may raise questions about the productĺs effect on health and safety.
The Minister of Health will now have the authority to gather more information about the product. This can be done either by compelling persons to provide information for the purpose of assessing serious risks to health, or by requiring a therapeutic product authorization holder to compile information, conduct new tests or studies, or monitor experience. The Minister of Health may also direct a therapeutic product authorization holder to assess the benefits, harms and uncertainties of a product.
The Minister of Health will now have the authority to disclose confidential business information about a therapeutic product if the Minister believes it is necessary to determine whether a therapeutic product presents a serious risk of injury to human health.
As well, the Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or, a person who carries out functions relating to the protection or promotion of human health or the safety of the public if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.
In certain situations, the potential harm from the use of the therapeutic product may not be adequately reflected on the approved label. In addition, similar looking or sounding brand names or similar looking packaging may pose a risk to health and lead to prescribing and dispensing errors.
When a determination is made that it is necessary to make revisions to prevent injury to health, the Minister of Health will now be able to direct an authorization holder to revise the label of a therapeutic product to include new harm information or to change the brand name or packaging.
The Minister of Health will now be able to order the removal of a therapeutic product from the marketplace when a product presents an imminent or serious risk to health.
This new section places an obligation on therapeutic product authorization holders to ensure that prescribed information concerning any clinical trial is made public in a time and manner that will be set out in regulations. This could be accomplished by requiring mandatory registration of those trials on publicly accessible, well-established clinical trial registries.
Fines and penalties for those who do not comply with the Act will be increased, to a maximum penalty of $5,000,000 or 2 years in prison, to better reflect the serious nature of the offence. Additionally, a person who knowingly makes a false or misleading statement to the Minister of Health or who knowingly or recklessly causes a serious risk of injury in contravening the Act or its regulations could face a higher fine or up to five years in jail, at the discretion of the court. An injunction power will also be added such that, upon application of the Minister of Health, a court will be able to order a person to refrain from performing an act related to the commission of an offence under the Act.
Improving the Minister of Health’s ability to enforce the provisions of the Act allows the federal government to take more effective action against those who jeopardize the safety of Canadians. The increase in the level of fines is consistent with fines under other Canadian legislation, such as the Canadian Consumer Product Safety Act and the Safe Food for Canadians Act.
This enables the incorporation by reference of technical and non-technical documents relating to therapeutic products into the Food and Drug Regulations.
Currently, these types of documents can be included within the regulations by regulatory amendment. Incorporation by reference is a simpler and less time-consuming process that does not require regulatory amendment. The process of incorporation by reference will continue to involve appropriate scientific oversight and public accessibility. This approach will reduce red tape and allow the department to focus resources where they will have the greatest impact on the health and safety of Canadians.
The Minister of Health must make any orders issued under these new powers publicly available.
These provisions set out new regulation-making authorities for the Governor in Council (GIC) that enable the implementation of the new amendments to the Act. Among other things, these authorities allow the GIC to make regulations authorizing the Minister to impose and amend terms and conditions on an authorization or licence; to require holders of clinical trial or investigational testing authorization to report safety information after the conclusion or discontinuation of the trial; to require an authorization or licence holder to report information concerning the safety of a therapeutic product issued by a foreign regulator; and to require an authorization or licence holder to conduct further test and studies. Regulation-making authorities also allow the GIC to prescribe how healthcare institution reporting requirements and recall provisions will function.
A new regulation-making authority, introduced by the House of Commons Standing Committee on Health, permits the GIC to make regulations that will require the Minister to ensure that certain decisions, and the reasons for those decisions, are made publicly available. These decisions relate to the issuance, amendment, suspension and revocation of an authorization, and the imposition or amendment of terms and conditions on a licence.