Introduction:

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17)

On December 6, 2013, the Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). On November 6, 2014 it received Royal Assent.

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 will improve better protection of patient health and safety and increase consumer confidence in therapeutic products on the market.

Key amendments to the Food and Drugs Act include:

• Power to require information, tests or studies

• Power to require a label change/package modification

• Power to recall unsafe therapeutic products

• Ability to disclose information in certain circumstances

• Tougher measures for those that do not comply

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

Overview of Vanessa’s Law

The Act includes the following changes:

Definition of a therapeutic product

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.

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.

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.

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.

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

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.

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.

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.

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.

New ability to incorporate by reference

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.

An obligation on the Minister to make orders publicly available

The Minister of Health must make any orders issued under these new powers publicly available.

New authorities for the Governor in Council to make supporting regulations

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.

Implementation of Vanessa’s Law

Upon Royal Assent, many of the key provisions of Vanessa’s Law came into force immediately, including:

• Ability to recall unsafe therapeutic products
• Ability to impose tougher fines and penalties
• Ability to direct label change/package, and
• Ability to seek an injunction

Additionally, Vanessa’s Law provides Health Canada with the necessary authorities to implement a life-cycle approach to regulating drugs and medical devices. Bringing the life-cycle amendments into force will require change to current regulations and the development of new regulations. The life-cycle approach provisions which require regulations prior to coming into force include:

• Ability to require tests and studies
• Ability to order a reassessment
• Ability to attach terms and conditions to market authorizations

Health Canada will consult with key stakeholders including patients, academia and industry on the development of the regulatory proposals. As per the usual process, the regulatory proposals will also follow the key objectives set out in the  Cabinet Directive on Regulatory Management.

Transparency Measures

Vanessa’s Law promotes greater confidence in the oversight of therapeutic products through the implementation of new transparency measures. These provisions clarify for Health Canada and its stakeholders when the department will actively publish, or disclose upon request, documents, especially those considered as confidential business information during the evaluation process of applications for marketing authorizations and when issuance decisions are taken.

The transparency measures introduced by Vanessa’s Law:

• Require the Minister of Health to make public decisions regarding therapeutic product authorizations and details of any orders issued respecting a recall, test and study, label change and reassessments;
• Subject to regulations, mandate the public disclosure of information by sponsors concerning clinical trials, such as mandatory registration and the disclosure of summary results; and
• Allow the Minister to disclose confidential business information to the public when it is in the public interest because there may be a serious risk of injury to the health of Canadians.

Some of these measures require regulations to come into force. As part of the regulatory development process, Health Canada will consult Canadians to establish their transparency needs. This consultation will be used to determine how to best meet the end-users' needs and to ensure that information disclosed is meaningful. End-users include patients, healthcare professionals, and academic researchers.

Vanessa's Law: Questions/Answers

What is the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)?

The  Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) amends the Food and Drugs Act. It includes new rules that strengthen the regulation of therapeutic products and improve the reporting of adverse reactions by healthcare institutions. As well, these measures are intended to improve Health Canada’s ability to collect post-market safety information and take appropriate action when a serious health risk is identified.

The law is named after Vanessa Young, daughter of the Member of Parliament from Oakville.

Where can I find a copy of this Act?

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) can be found on the Parliament of Canada website. (Attached)

What products are affected by this Act?

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.

What are the key parts of the new legislation?

The new legislation will update the law that apply to drugs and medical devices to increase patient safety in key areas of concern and will enable the Government to:

• Require strong surveillance, including mandatory adverse drug reaction reporting by healthcare institutions;
• Recall unsafe therapeutic products;
• Impose 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;
• Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
• Compel drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children; and
• Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.

How will this Act benefit Canadians?

The Act increases patient safety in Canada by improving Health Canada's ability to collect safety information on marketed therapeutic products.

The Act also allows Health Canada to take quick and appropriate action when a serious health risk is identified, such as ordering a product recall or requiring a label change/package modification to make new safety information available to patients and consumers.

Fines and penalties are increased to better reflect the seriousness of the violation.

In addition to these measures, the Act was also amended by the House of Commons Standing Committee on Health to include new transparency authorities related to clinical trial registration, Health Canada’s regulatory decisions, and disclosure of confidential business information.

Together, these changes will lead to improved patient safety and better health outcomes for Canadians, including vulnerable populations such as children, seniors, and pregnant or nursing women.

The Act enables Health Canada to continue strengthening its Regulatory Transparency and Openness Framework that was announced in April, 2014 by the Minister of Health. The Framework commits Health Canada to a set of concrete initiatives that would make easy to understand regulatory health and safety information more available to Canadians. With this information, Canadians can make well-informed decisions concerning their health and that of their families.

What else will the Act do?

The primary focus of the legislation is to improve patient safety. The Act also provides a new authority to reference technical standards, lists, guidelines or other documents in regulations. Currently, the contents of these kinds of documents or lists are found within the regulations, and can only be changed with a regulatory amendment. The new authority will help to reduce red tape and allow science-based decisions to be made more rapidly.

How does the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) compare with legislation in other countries?

Canada has one of the safest and most rigorous drug and medical device approval systems in the world. However, the Food and Drugs Act has not been updated in over 50 years. Science and medicine have evolved considerably in those 50 years, and there has been significant progress internationally to improve patient safety through enhanced regulatory oversight of products on the market.

Implementation of this Act will improve patient safety and health outcomes by providing Health Canada with the post-market authorities it needs to better understand the benefits and harms associated with a therapeutic product.

When will the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) become enforceable?

Some of the new powers in the  Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), come into force immediately upon Royal Assent. These include:

• Ability to recall unsafe therapeutic products
• Ability to impose tougher fines and penalties
• Ability to direct label change/modification, and
• Ability to seek an injunction

Other changes to the Food and Drugs Act cannot come into force until supporting regulations are published. There will be an opportunity for Canadians to comment on the supporting regulations as part of the regulatory development process.

Several regulatory frameworks, which are linked to the Act, are being developed. These are being developed as part of the Regulatory Roadmap for Health Products and Food.