In April 2014, Health Canada launched its Regulatory Transparency and Openness Framework (“RTOF”) to support its commitment to the Government’s “Open Government” initiative and to help support Canadians in accessing health and safety information about the products in the Canadian marketplace. Health Canada recently released its Interim Report: Health Canada Regulatory Transparency and Openness Framework - Action Plan 2014-2015 to provide an update on the progress of the RTOF made in the first six months.
The RTOF involves three key themes for Health Canada:
- Making information easier to understand;
- Proactively making more information available to Canadians; and
- Making its decision making processes more open.
As part of the 2014-2015 Action Plan, Health Canada has committed to undertaking 15 specific activities that have been identified as opportunities where transparency and openness can be improved and that fall within the three above-mentioned themes. Some of the key activities Health Canada has undertaken to support the RTOF are summarized below.
Bill C-17: An act to amend the Food and Drugs Act
Bill C-17 came into force in November 2014, including amending theFood and Drugs Act to increase the powers of the Minister of Health to compel the disclosure of information relating to clinical trials, drug safety, and confidential business information in certain circumstances. For more information on Bill C-17, please see our previously published Pharma in Brief here.
The Drug and Health Product Register
The Drug and Health Product Register (“DHPR”) is an online database that gives Canadians centralized access to consumer information on a drug product, its use, safety and common and reported side effects.
The DHPR was launched on February 12th, 2015 and is currently a pilot project. It contains information on the top 100 prescribed brand name drug products based on IMS’ Canadian sales data from 2013. An additional 250 drug products are included in the DHPR that largely consist of generic versions (and some brand name products) of the top 100 prescribed brand name drugs.
Health Canada plans to expand the DHPR in the future to include natural health products and medical devices.
Drug shortage reporting
Health Canada is advancing the mandatory reporting of actual and anticipated drug shortages, which will be hosted on a new website. Currently, drug manufacturers and importers are expected to voluntarily post drug shortage and discontinuance information on the industry-led database, the Canadian Drug Shortage website. The new system will eventually be set out in regulation. In the interim, the Public Notification Register for Drug Shortages is intended to enhance industry accountability by having manufacturers and importers commit to providing public notification of drug shortage and discontinuance information on the industry-run database. Under the interim system, in the event of non-compliance with the timely reporting of drug shortage information, Health Canada may issue letters of non-compliance to the manufacturer, and the letter will be posted on the Public Notification Register.
Annual Inspection Summary Reports
The Annual Inspection Summary Reports were posted on Health Canada’s website in April and August 2014 for the 2012-2013 and 2013-2014 years, respectively. These reports provide compliance information on how regulated parties, for example, drug manufacturers, are complying with the regulatory scheme.
Drug Safety Reviews
In April 2014, Health Canada began publicly publishing Drug Safety Review summaries that provide information on the evaluation of potential health product safety issues, including reports of adverse reactions, new safety information from foreign regulators and medical literature. Since the first Drug Safety Review was published in April 2014, Health Canada has published at least 26 safety reviews, 15 of which were published in 2015. Health Canada is expected to continue routine posting of these summaries. The Drug Safety Reviews can be found here.
Pediatric labelling on drug products
Health Canada recognizes that there is a gap in the available product and safety information for pediatric populations. Accordingly, Health Canada has published an administrative list of marketed therapeutic products on the Health Canada website, including biologics and vaccines, to consolidate the group of products that have pediatric information available on the product label.
New commitments for March 2015
Health Canada has committed to completing the following activities by the end of March:
Advertising Complaints – Health Canada will post complaints about health product advertising, including those for pharmaceuticals, biologics, natural health products, and medical devices.
Drug Establishment Information – Health Canada will post information about Drug Establishment Licenses. The extent of information to be publicly disclosed is not known at this time, however, Health Canada has stated that this could include information about compliance with the regulations.
Information from Inspections - Health Canada is exploring options to post information about Good Manufacturing Practices inspections of non-compliant drug establishments.
Health Canada will release its Action Plan for April 2015 – March 2016 next month and has committed to reviewing and updating the RTOF Action Plan annually.
Link to Health Canada’s interim report: