Bill C-17, An Act to Amend the Food and Drugs Act, was introduced into Parliament by the Minister of Health on December 6, 2013. The Bill passed Third Reading stage in the House of Commons on June 16, 2014. It has passed first reading stage in the Senate, and as such, the Bill is not law as yet. However, this is an important development given that the impact of these amendments could be significant.
As reported in our earlier Pharma-in-brief, the main amendments in Bill C-17 as it was introduced include provisions amending the Food and Drugs Act (FDA) to address patient safety, strengthen Health Canada’s enforcement powers over pharmaceuticals and medical devices, require certain prescribed healthcare institutions, as set out regulation, to report adverse events associated with those products, and ensure that products may be recalled by the Minister. At the Third Reading stage of the Bill, several amendments were introduced, including amendments to allow the public disclosure of confidential business information in certain circumstances, and amendments that would require disclosure of certain prescribed information concerning clinical trials.
Key provisions of bill as passed by the House of Commons
Disclosure of confidential business information
- Section 21.1 would permit the Minister to disclose “confidential business information” about a therapeutic product without notice to the owner of the information if it is believed that there may be a serious risk to Canadians. The term “confidential business information” is added as a definition in the FDA.
- Section 30 (1.2)(d.1) of the Bill would allow regulations to be made to specify that certain information is not confidential business information.
Disclosure of clinical trial information
- Section 21.71 provides that the holder of a therapeutic product authorization shall ensure that prescribed information concerning certain clinical trials or investigational tests are made public within the prescribed time and in the prescribed manner.
Authorities for the Minister of Health
New authorities would be granted to the Minister, including:
- Section 21.1 would authorize the Minister to order the provision of any information the Minister deems necessary regarding a therapeutic product where it “may present a serious risk of injury to human health”.
- Section 21.2 would authorize the Minister to order changes to the labeling or packaging for therapeutic products if it is believed that doing so will “prevent injury to health”.
- Section 21.3 would authorize the Minister to order a recall of a product or have the product sent to a specified location if that product “presents a serious or imminent risk of injury to health”.
- Sections 21.31 and 21.32 would authorize the Minister to order the market authorization holder (manufacturer) to conduct assessments on the therapeutic product, compile information, and conduct studies or tests in respect of a therapeutic product and submit this requested information to the Minister.
Health care institutions to report adverse events
Section 21.8 would require “prescribed” health care institutions to provide the Minister with information regarding a serious adverse drug reaction that involves the therapeutic product, within the prescribed time and in the prescribed manner. Regulations specifying the prescribed items in this provision are expected to follow.
Penalties specific to the contravention of provisions of the FDA as they relate to therapeutic products would be added to the Offences and Punishment section of the FDA. These provisions would allow for significantly higher fines than what is currently possible under section 31 of the FDA. A person who is found guilty of an offence is liable:
- To a maximum fine of $5 million or imprisonment for a maximum term of 2 years, or both, upon conviction by indictment; and
- To a maximum fine of $250,000 or imprisonment for a maximum term of 6 months, or both, upon summary conviction and a first time offence, and a maximum fine of $500,000 or imprisonment or a maximum term of 18 months upon conviction of a subsequent offence, or both.
Unlimited fines and up to 5 years imprisonment would be possible upon indictment for those who wilfully provide false or misleading information to the Minister, or knowingly or recklessly cause serious risk of injury to human health by contravening any other provision in respect of therapeutic products.
Link to Bill C-17 as passed by the House of Commons: