Skip to main content
Back to Bills
FederalPassed41st Parliament, 2nd Session

Bill C-17 explained in plain English

An Act to amend the Food and Drugs Act

Federal Parliament bill summary, status, timeline, sponsor, votes, and official sources.

At a glance

Jurisdiction
Federal Parliament
Legislature / Parliament
Parliament of Canada
Session
41st Parliament, 2nd Session
Bill number
Bill C-17
Full title
An Act to amend the Food and Drugs Act
Current status
Passed
Latest event
Royal assent received
Last updated
Nov 6, 2014

Official Parliament of Canada snapshot for 41st Parliament, 2nd Session. MP vote breakdowns appear when the House of Commons publishes a recorded division export for that bill. Senate and House stage details include official debate/sitting links when LEGISinfo publishes them.

Chamber
Parliament of Canada
Current Stage
Royal assent received
Latest Activity
Nov 6, 2014
Plain-language explanation
In plain English (our explanation)

Our plain-language take, written for civic education.

Source: By PoliticalData.ca

AI-assisted, reviewed before publishing
Short Version

Bill C-17 strengthens federal safety oversight of drugs and medical devices by expanding the Minister's powers to gather safety information, issue recalls and orders, and disclose confidential information when there is a serious health risk, while increasing reporting obligations for health care institutions and imposing stronger penalties for non-compliance.

What It Means

Bill C-17, also known as the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), amends the federal Food and Drugs Act to strengthen the safety oversight of therapeutic products (drugs and medical devices) throughout their life cycle. The bill gives the federal Minister of Health new powers to order persons to provide safety information about therapeutic products, to disclose confidential business information when there is a serious health risk, to order recalls or corrective actions, and to require assessments and monitoring. The bill also creates new obligations for health care institutions to report serious adverse drug reactions and medical device incidents to the Minister. It establishes stronger penalties for contraventions, including larger fines and longer prison sentences for offences related to therapeutic products. The bill introduces new definitions for therapeutic products, therapeutic product authorizations, and confidential business information, and requires greater public transparency in regulatory decisions affecting these products.

What This Bill Does
  • Expands the definition of 'device' (medical device) to clarify what products fall under the Food and Drugs Act oversight
  • Adds new definitions for 'therapeutic product' (drugs and devices but not natural health products), 'therapeutic product authorization' (licences and approvals), and 'confidential business information'
  • Grants the Minister power to order persons to provide information about therapeutic products if the Minister believes they may present a serious risk of injury to human health
  • Allows the Minister to disclose confidential business information without consent when there is a serious health risk or when disclosure relates to protecting human health or public safety
  • Authorizes the Minister to order changes to labels or packaging of therapeutic products when necessary to prevent injury to health
  • Authorizes the Minister to order recalls of therapeutic products that present a serious or imminent risk, with option for corrective action instead of return in some cases
  • Allows the Minister to authorize sale of recalled products under specified conditions
  • Requires health care institutions designated by regulation to report serious adverse drug reactions and medical device incidents to the Minister
  • Requires holders of therapeutic product authorizations to provide safety information to the Minister, including information about risks, labelling changes, and recalls outside Canada
  • Requires clinical trial authorizations to make prescribed information public within prescribed timeframes
  • Authorizes the Minister to order assessments of therapeutic products and to order compilation of safety information and monitoring
  • Makes all Minister's orders related to therapeutic products publicly available
  • Prohibits false or misleading statements to the Minister regarding therapeutic products
  • Creates new offence categories with enhanced penalties: up to $5,000,000 fine and 2 years imprisonment on indictment for standard contraventions; up to $1,000,000 fine and 2 years imprisonment for repeat summary convictions for more serious offences involving knowingly causing serious risk
  • Establishes that due diligence is a defence for most offences, but not for offences involving knowingly causing serious health risk or making false statements
  • Requires courts to consider harm, risk of harm, and vulnerability of consumers when sentencing for therapeutic product offences
  • Makes directors, officers, and agents of corporations liable for offences committed by their organization
  • Expands regulation-making power to govern issuance, suspension, and revocation of therapeutic product authorizations, impose conditions, and require public disclosure of regulatory decisions with reasons
  • Clarifies that regulations can incorporate documents by reference regardless of source
  • Requires the Minister to consider existing information management systems before recommending regulations that would impose administrative burdens
  • Strengthens the Minister's evidence in prosecutions through analyst certificates
Who Is Affected
  • Manufacturers, importers, and sellers of drugs and medical devices (therapeutic products)
  • Holders of therapeutic product authorizations (licences and approvals)
  • Health care institutions (hospitals, clinics, and other prescribed facilities) that must report adverse reactions and device incidents
  • Companies that conduct clinical trials with therapeutic products
  • Persons or organizations with confidential business information related to therapeutic products
  • The general public and consumers who use therapeutic products
  • The federal Minister of Health and Health Canada officials who enforce the Act
  • Directors, officers, and agents of organizations that violate the Act
Rights, Duties, Or Obligations
  • Persons must comply with any order from the Minister to provide information about therapeutic products that may present a serious health risk
  • Persons holding therapeutic product authorizations must comply with any conditions imposed or amended by the Minister under regulations
  • Holders of authorizations for clinical trials must ensure prescribed information is made public within prescribed timeframes and manner
  • Health care institutions must provide the Minister with prescribed information about serious adverse drug reactions and medical device incidents within prescribed timeframes
  • Persons who sell therapeutic products must comply with recall orders issued by the Minister, or else face criminal penalties, unless authorized otherwise
  • Persons cannot knowingly make false or misleading statements to the Minister regarding therapeutic products
  • Sellers of therapeutic products must comply with orders to modify labels or packaging when ordered by the Minister
  • Holders of therapeutic product authorizations must provide the Minister with safety information they receive or become aware of regarding risks, labelling changes, and regulatory actions outside Canada
  • The Minister has the right to disclose confidential business information when necessary to protect health or safety or when dealing with a serious health risk
  • The public has the right to access all orders made by the Minister under sections 21.1 to 21.32
  • The public has the right to access regulatory decisions about issuance, amendment, suspension, and revocation of therapeutic product authorizations, along with the reasons for those decisions
Important Dates
  • Royal assent received: 6 November 2014
  • Some sections (4, 6(2), 10, 11) come into force on a day to be fixed by order of the Governor in Council
  • Other sections (5, 6(3), 6(4)) come into force on a different day to be fixed by order of the Governor in Council
  • The definition of 'therapeutic product authorization' applies to authorizations issued before the section comes into force
Financial Or Tax Impacts
  • Potential significant financial penalties for companies and individuals violating the Act, ranging from $250,000 to $5,000,000 depending on the offence and whether it is a first or subsequent offence
  • Administrative costs for health care institutions to establish systems for reporting serious adverse drug reactions and medical device incidents
  • Administrative costs for therapeutic product manufacturers and importers to respond to Minister's orders for information, assessments, and safety monitoring
  • Potential costs for companies to implement corrective actions on recalled products rather than collecting returns
Enforcement Or Penalties
  • Contravention of the Act or regulations relating to therapeutic products: up to $5,000,000 fine and/or 2 years imprisonment on indictment; on summary conviction, first offence up to $250,000 fine and/or 6 months imprisonment; subsequent offence up to $500,000 fine and/or 18 months imprisonment
  • Making false or misleading statements to the Minister regarding therapeutic products, or knowingly causing serious risk of injury to health: indictment with discretionary fine and/or up to 5 years imprisonment; on summary conviction, first offence up to $500,000 fine and/or 18 months imprisonment; subsequent offence up to $1,000,000 fine and/or 2 years imprisonment
  • Each day an offence continues constitutes a separate offence
  • Directors, officers, agents, and mandataries of organizations are personally liable for offences committed by their organization if they directed, authorized, assented to, or acquiesced in the offence
  • Due diligence is a defence to most charges, except for charges of making false statements or knowingly causing serious health risk
  • Courts must consider the harm or risk of harm and the vulnerability of consumers when sentencing for therapeutic product offences
Uncertainties Or Limits
  • The bill text does not specify which health care institutions are 'prescribed' to report adverse reactions and incidents—this will be determined by future regulations
  • The bill does not provide specific timelines for when health care institutions must report incidents, stating only that reporting must occur 'within the prescribed time'
  • The definition of 'serious adverse drug reaction' and 'medical device incident' are to be defined by regulation, not in the Act itself
  • The bill does not specify which therapeutic products or types of authorizations will be subject to requirements for public disclosure of clinical trial information
  • The criteria for when information 'ceases to be' confidential business information are to be determined by regulation
  • The bill does not explain how the Minister will determine that a product 'may present' a serious risk or 'presents a serious or imminent risk'—these are subjective assessments
  • The bill does not specify what 'corrective action' means in the context of recalls, leaving this to be defined through regulations or case-by-case application
  • The commencement date for most provisions is to be fixed by order of the Governor in Council, meaning the bill's key provisions do not automatically come into force on royal assent
  • The bill references 'prescribed' timeframes and manners for various requirements, but these are not provided in the bill itself
  • It is unclear whether the ban on selling recalled products applies retroactively to recalls ordered before the Act comes into force
Laws Or Regulations Affected
Food and Drugs Act
amended

The Act is amended to add new sections creating powers for the Minister to order information provision, disclose confidential information, order recalls and label changes, and require assessments and monitoring of therapeutic products. New offence categories and penalties are introduced. Existing regulation-making powers are expanded to cover therapeutic product authorizations, public disclosure of decisions, and health care institution reporting requirements.

Source: Multiple sections amended: Section 2 (definitions), new sections 21.1-21.8, 21.31-21.32, section 30 (regulation-making), section 31 and following (offences and penalties)

Generated using AI from official bill text. Not legal advice. It is written by PoliticalData.ca for civic education, automatically checked and spot-reviewed before publishing.

Official text
Official summary
Official summary (Parliament of Canada)

The official summary published alongside the bill, shown exactly as written.

Source: Parliament of Canada (LEGISinfo)

Third-party sourceView on LEGISinfo

A legislative summary is currently being prepared for this bill by the Parliamentary Information and Research Service of the Library of Parliament. Meanwhile, the following executive summary is available. On 6 December 2013, the Minister of Health introduced Bill C-17, An Act to amend the Food and Drugs Act (Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)) in the House of Commons and it was given first reading. Bill C-17 amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things, • strengthen safety oversight of therapeutic products throughout their life cycle; and • improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products.

This is the official summary published by the Parliament of Canada, shown verbatim. Not legal advice. PoliticalData.ca did not write or edit this text.

View on LEGISinfo

Parliamentary Process

Step 1
First reading
Jun 17, 2014
Completed

The Senate held its first reading of Bill C-17 on June 17, 2014, which subsequently passed through both chambers and received royal assent.

First reading, Jun 17, 2014
End of stage activity, Jun 17, 2014
Chamber sittings
First reading - Jun 16, 2014

During a Senate sitting on June 16, 2014, tributes were paid to retiring Senator Dallaire, proposed regulations were tabled, and debates occurred on various bills, including extensive discussion on privacy and data protection in relation to Bill S-4, culminating in Senator Dallaire's final address.

Step 2
Second reading
Sep 18, 2014
Completed

The Senate completed its Second Reading stage for Bill C-17 on September 18, 2014, leading to subsequent committee review and eventual Royal Assent.

Second reading, Sep 18, 2014
Referral to committee, Sep 18, 2014
End of stage activity, Sep 18, 2014
Chamber sittings
Debate at second reading - Sep 16, 2014

During a Senate sitting on September 16, 2014, the second reading debate of Bill C-17, "Vanessa's Law," concerning drug safety, was initiated and subsequently adjourned.

During a Senate debate on September 16, 2014, Senator Judith Seidman introduced Bill C-17 (Vanessa's Law) to enhance prescription drug safety, sparking discussion on its provisions and Health Canada's capacity to implement them, before the debate was adjourned.

Debate at second reading - Sep 18, 2014

In a Senate sitting on September 18, 2014, Bill C-17, concerning amendments to the Food and Drugs Act, was debated at second reading and referred to committee, with senators discussing its merits and potential improvements.

During the Senate's second reading debate on Bill C-17, "An Act to amend the Food and Drugs Act," senators discussed proposed changes to drug safety regulations, with one senator supporting the bill while suggesting improvements.

Step 3
Consideration in committee
Oct 9, 2014
Completed

The Senate Committee concluded its consideration of Bill C-17 on October 9, 2014, after multiple meetings.

Committee report presented without amendment, Oct 9, 2014
End of stage activity, Oct 9, 2014
Chamber sittings
Committee report presented without amendment - Oct 9, 2014

During a Senate sitting on October 9, 2014, the Social Affairs, Science and Technology Committee presented its report on Bill C-17 without amendments, and other routine parliamentary business and debates occurred.

Step 4
Third reading
Oct 23, 2014
Completed

The Senate completed the third reading of Bill C-17, An Act to amend the Food and Drugs Act, on October 23, 2014, after which it received Royal Assent.

Third reading, Oct 23, 2014
End of stage activity, Oct 23, 2014
Chamber sittings
Debate at third reading - Oct 21, 2014

On October 21, 2014, the Senate observed a moment of silence for a soldier, debated and passed Bill S-6, began debate on Bill C-36, and adopted a motion to grant honorary Canadian citizenship to Malala Yousafzai, while the third reading debate on Bill C-17 was adjourned.

Debate at third reading - Oct 23, 2014

On October 23, 2014, the Senate began its sitting with tributes to victims of the previous day's attack on Parliament Hill, after which it proceeded to debate and pass Bill C-17, An Act to amend the Food and Drugs Act, at its third reading.

Step 1
First reading
Dec 6, 2013
Completed

Bill C-17, concerning amendments to the Food and Drugs Act, completed its first reading in the House of Commons on December 6, 2013, and later received Royal Assent on November 6, 2014.

Introduction and first reading, Dec 6, 2013
End of stage activity, Dec 6, 2013
Chamber sittings
Introduction and first reading - Dec 6, 2013

The House of Commons commenced the first reading of Bill C-17, An Act to amend the Food and Drugs Act, during a sitting that included other parliamentary business.

Step 2
Second reading
May 30, 2014
Completed

The House of Commons completed the second reading of Bill C-17 on May 30, 2014, after which it was referred to committee.

Second reading and referral to committee, May 30, 2014
End of stage activity, May 30, 2014
Chamber sittings
Debate at second reading - Mar 28, 2014

In a House of Commons debate on March 28, 2014, Members discussed Bill C-17, an act to amend the Food and Drugs Act, focusing on enhancing drug safety through improved labelling and reporting of adverse reactions, and concluding with the bill being referred to committee.

During the House of Commons second reading debate on Bill C-17, members from multiple parties expressed support for the bill aimed at improving drug safety, with the bill's sponsor sharing a personal story that motivated his advocacy.

In a House of Commons debate, Members of Parliament discussed Bill C-17, an Act to amend the Food and Drugs Act, focusing on improving drug safety and transparency, with broad support expressed for the bill's intent and potential improvements.

Debate at second reading - May 27, 2014

In the House of Commons on May 27, 2014, members debated Bill C-17 (Vanessa's Law) at second reading, discussing its proposals to give the Minister of Health powers to recall drugs and enhance drug safety, with many supporting the bill while suggesting improvements.

During the second reading debate on Bill C-17, MPs discussed giving the Health Minister more power to recall unsafe drugs and improve drug safety oversight, while also suggesting amendments for greater transparency and stronger measures.

Second reading and referral to committee - May 30, 2014

On May 30, 2014, the House of Commons debated and moved Bill C-17, "Vanessa's Law", to a committee stage, alongside other House business including statements by members and oral questions on various topics.

Step 3
Consideration in committee
Jun 13, 2014
Completed

The House of Commons committee examined Bill C-17 in June 2014, a procedural step that has been completed.

Committee report presented with amendments, Jun 13, 2014
End of stage activity, Jun 13, 2014
Chamber sittings
Committee report presented with amendments - Jun 13, 2014

This document records a House of Commons sitting on June 13, 2014, featuring debates on Bill C-18 (Agricultural Growth Act), statements by members on various topics, and oral questions directed at government ministers.

Step 4
Report stage
Jun 16, 2014
Completed

The House of Commons completed Report Stage and Third Reading for Bill C-17 on June 16, 2014, before it received Royal Assent on November 6, 2014.

Concurrence at report stage, Jun 16, 2014
End of stage activity, Jun 16, 2014
Chamber sittings
Debate at report stage - Jun 16, 2014

On June 16, 2014, the House of Commons debated and passed Bill C-17, the 'Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)', at its report stage and third reading.

Step 5
Third reading
Jun 16, 2014
Completed

Bill C-17 completed its Third Reading in the House of Commons on June 16, 2014, and then moved to the Senate.

Third reading, Jun 16, 2014
End of stage activity, Jun 16, 2014
Chamber sittings
Debate at third reading - Jun 16, 2014

The House of Commons debated and passed Bill C-17, An Act to amend the Food and Drugs Act, during its third reading on June 16, 2014, following discussions on various other parliamentary matters.

Step 1
Royal assent
Nov 6, 2014
Royal assent, Nov 6, 2014
End of stage activity, Nov 6, 2014
Chamber sittings
Royal assent - Nov 6, 2014

We don't have a plain-language summary for Debates of the Senate yet. The official source linked below is the full record.

Debate and sitting links point to official parliamentary sources when LEGISinfo publishes them. Any plain-language discussion summaries should be generated from those official texts and reviewed before public display.

Vote Summary

No published recorded division

This bill does not have a published recorded division in the current official sources, so representative-by-representative vote counts are not shown.

Sponsor
Rona Ambrose
Sponsor party or district not listed
Jurisdiction
Federal Parliament

No published representative vote breakdown

The current official sources do not publish a recorded division breakdown for this bill, so there is no representative-by-representative table to show.

Official sources

Status, sponsor, votes, and timeline on this page are drawn from these official legislative sources and public records. Each summary above is attributed to its own source.

How this data is sourced