The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified.

These amendments are designed to better protect a patient’s health and safety, and increase consumer confidence in therapeutic products on the market. The Act applies to therapeutic products, including: prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices. The amendments brought to the Food and Drugs Act by Vanessa’s Law do not apply to natural health products, which continue to be regulated under the existing Natural Health Product Regulations (NHPR) of the Food and Drugs Act.

Key amendments to the Food and Drugs Act include:

New power for the Minister to require companies to modify or replace drug or medical device labels or packaging

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.

New power for the Minister to recall unsafe therapeutic products

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.

New powers for the Minister to compel information, gather more information, require new tests or studies, monitor experience, and conduct product assessments

Over the course of a therapeutic product’s lifecycle, new information may raise questions about the product’s 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.

Tougher measures for those who do not comply

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.

Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions

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. Certain healthcare institutions will now be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.

New ability for the Minister to disclose confidential business information related to therapeutic product safety

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. This disclosure of info is authorized if the purpose of the disclosure is related to the protection or promotion of human health, or the safety of the public.

Obligation on therapeutic product authorization holders to make information about clinical trials publicly available

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.

If you want to be sure you are in compliance with the Canadian regulatory requirements, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.