Proposed Amendments to the Food and Drugs Act Impose Stricter After-Market Regulation on Drugs and Medical Devices

May 20, 2014

The Minister of Health has introduced Bill C-17 An Act to Amend the Food and Drugs Act in the House of Commons, which is currently at the second reading stage. The proposed amendments, which deal with post-market regulation of medical devices and pharmaceutical products, are the first substantive changes to the Food and Drugs Act in fifty years. The purpose of the proposed amendments is to “strengthen safety oversight of therapeutic products through their life cycle” and “improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products.”[1]

The bill adds a new definition for “therapeutic products”. A therapeutic product is a drug or a device, or a combination of the two. A “drug” is currently broadly defined by the Food and Drugs Act to include any substance or mixture of substances used to diagnose or treat diseases, or to modify organic functions in humans or animals. The proposed amendments expand the definition of a “device” to include an “instrument, apparatus, contrivance or other similar article” and in vitro reagents.

The amendments will apply to prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices. They will not apply to natural health products, which will continue to be regulated under the existing Natural Health Product Regulations of the Food and Drugs Act.

The proposed amendments would provide the Minister of Health with the power to:

  • order the production of information relating to therapeutic products that present a serious risk of injury to human health, or information that the Minister believes is necessary to determine whether the product presents such a risk.[2]
  • order that the labels on therapeutic products be modified if the Minister believes that doing so is necessary to prevent an injury to health;[3]
  • recall therapeutic products that present a serious or imminent risk of injury to human health;[4] and
  • order testing for the purpose of obtaining additional information about a therapeutic product’s effect on health or safety.[5]

Prescribed health care institutions would be required to report serious adverse drug reactions or incidents involving medical devices to the Minister.[6]

The proposed amendments introduce new penalties for contravention of the Act or its regulations:

  • on indictment, fines would be increased from $5,000 a day to $5 million a day or up to two years or jail, or both;
  • on summary conviction, for a first offence, a fine up to $250,000 or up to six months in jail, or both; for a subsequent offence, a fine up to $500,000 or up to 18 months  in jail or both.[7]

The amendments also include penalties for knowingly making a false or misleading statement to the Minister of Health, or wilful or reckless contravention of the Act which causes a serious risk of injury to human health. No due diligence defence is available for these offences, and offenders could be subject to:

  • on indictment, an unlimited fine within the Court’s discretion and a maximum of five years imprisonment;
  • on summary conviction, for a first offence, a fine up to $500,000 or up to 18 months in jail, or both; for a subsequent offence, to a fine not exceeding $1,000,000 or to imprisonment for a term not exceeding two years or to both.[8]

Additionally, if an offence is committed by a corporation, certain directors, officers, agents or mandataries of the corporation may be criminally liable.[9]
Some of the new powers in the proposed amendments, such as the increased fines and penalties, would become law immediately upon Royal Assent. Other changes would not come into force until supporting regulations are published. Industry participants will have an opportunity to comment on the supporting regulations as part of the regulatory development process.

The bill was introduced on December 6, 2013 and on March 28, 2014 the second reading began.

[1]Bill C-17 An Act to Amend the Food and Drugs Act, 41st Parliament, 2nd Session, Summary.

[2] Ibid. s. 2, adding s. 21.1.

[3] Ibid.s. 2, adding s. 21.2.

[4]Ibid. s. 2, adding s. 21.3.

[5] Ibid. s. 2, adding s. 21.32.

[6]Ibid. s. 2, adding s. 21.8.

[7] Ibid. s. 9, adding s. 31.2.

[8] Ibid. s. 9, adding s. 31.4.

[9]Ibid. s. 9, adding s. 31.6.

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