Regulatory Transparency and Openness Framework and Action Plan Annual Report 2015-16

Table of contents

• About this Report
• Our Plan for 2015-16
• Delivering on Our Commitment to Canadians
• Going Above and Beyond
• What's Next?
• Be informed
• Let us know what you think
• Summary: Planned and Delivered Activities Regulatory Transparency and Openness Framework Action Plan 2015-16

About this Report

In June 2015, Health Canada's Regulatory Transparency and Openness Framework and Action Plan (RTOF) for 2015-2018 was launched. The RTOF commits Health Canada to improve access to timely, useful and relevant health and safety information.

This Annual Report summarizes steps Health Canada took in 2015-16 to provide Canadians with new tools and information to assist them in making health decisions for themselves and their families.

To read more about activities done in 2014-15, see the annual report.

Our Plan for 2015-16

Health Canada identified 16 specific opportunities to increase transparency on topics of interest to Canadians under the three RTOF themes: Inform and Engage, Enable and Enforce.

This Report will highlight how Health Canada delivered on its commitments in 2015-16. This Report also identifies several other initiatives that were completed in 2015-16 and that contributed to regulatory transparency. More information about these accomplishments can be found in the Going Above and Beyond section of this Report.

Delivering on Our Commitment to Canadians

Theme: Inform and Engage

In order to provide Canadians with the latest information on important health and safety issues to support decision-making and increase opportunities for engagement, the following activities were undertaken:

• More information was included in the Drug and Health Product Register, an easy-to-use, mobile-friendly search tool that provides quick access to information on hundreds of prescription drugs and other health products. This included more information on prescription drugs, and the inclusion of summary safety reviews.
• To strengthen public engagement activities, guidelines for Health Canada staff were developed to promote an effective, consistent, and flexible approach to conducting public engagement activities.

Theme: Enable

In order to support compliance with regulatory requirements, several new pieces of industry-focussed guidance were posted, including:

• Policies, guidance and information bulletins for licensed producers of marijuana for medical purposes.
• Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall) to implement the new powers under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).
• A Plain Language Summary providing an overview of Health Canada's Consumer Product Safety Risk Characterization Method.

Several new information pieces were launched to better explain regulatory decisions for drugs, food, and high risk medical devices. These included:

• A list of submissions under review, for new drug submissions (NDSs) that are currently being reviewed. These submissions are for drugs containing new active substances (pharmaceuticals and biologics with an active ingredient not approved in Canada). This list applies to submissions accepted into review on or after April 1, 2015.
• Plain language summaries of novel foods decisions, to give Canadians more information on how Health Canada reviews 'novel foods'- food products that are made through new processes, do not have a history of safe use in Canada or that have been genetically-modified - and the reasons why they were approved. In 2015-16, Health Canada posted three summaries of novel foods decisions.
• Regulatory Decision Summaries (RDS) for positive decisions to authorize new drug submissions and submissions for new uses, and for high risk medical devices. This year, Health Canada posted 71 RDS documents for drugs and 53 for medical devices.
• Summaries of rejections or cancellations of applications for the sale of novel pharmaceuticals and biologics are being posted.

To support transparency and the scientific community, data sets were posted on Open.canada.ca.

Theme: Enforce

In order to show Canadians how industry follows the rules that have been put in place to protect their health and safety, the following activities have been undertaken:

• To enhance inspection reporting, the Drug and Health Product Inspections Database was launched. It is an online resource designed to provide ready access to inspection information about drug manufacturing, clinical trials, medical devices, pharmacovigilance practices and cells, tissues and organs.
• More information was included in the Inspection Tracker, a tool to inform Canadians about potential drug manufacturing safety issues that Health Canada is tracking with drug manufacturing establishments.
• Summaries of inspection information for pesticides were provided in the annual compliance and enforcement report on pesticides.
• Quarterly inspection reports for marijuana for medical purposes were posted for the first time.
• Annual (2014-15) compliance and enforcement reports for marijuana for medical purposes and pesticides were posted for the first time.

A listing of all 16 planned activities can be found at the end of this report.

Going Above and Beyond

Health Canada is continually identifying new opportunities to improve regulatory transparency and provide Canadians with information they can use. This section outlines additional actions taken and accomplishments made in 2015-16.

Health and Safety Information and Engagement

• The Nutrition Facts Education Campaign was launched. It provides new tools to help consumers understand food labels that are displayed on food packaging.
• A consultation on health product transparency initiatives was held early in 2016. Topics included: Summary Basis of Decisions (SBD); Regulatory Decision Summaries (RDS); Submissions Under Review (SUR); Summary Safety Reviews (SSR); Advertising Complaints list; and a New Safety Reviews list. The consultation sought feedback from stakeholders on the next steps regarding these transparency initiatives in order to meet the needs of Canadians and further strengthen their understanding of our regulatory decisions.
• Regulations on drug shortages information were proposed that would require manufacturers to provide advance notice of anticipated shortages of drugs or discontinuations on a public website.

Enabling Guidance and Science Information

• The Science of Health blog was launched. In this blog you can read about Health Canada's science and research activities, explore opportunities for professional development, find out about our partnerships and how we invest in research, and access reports or publications related to the scientific activities.
• A Notice of Intent was posted to inform Canadians and interested stakeholders about the plan to discontinue granting new conditional registrations under the Pest Control Products Regulations, effective June 1, 2016.
• The Plain Language Labelling Regulations came into force starting with new requirements for manufacturers of prescription drugs to provide mock-ups of labels and packages for Health Canada review and to provide evidence that proposed brand names will not be confused with previously approved brand names.
• A new pesticide label mobile app was launched to allow users to access pesticide labels that have been registered for use in Canada. This free app will help homeowners, farmers, industry, as well as provincial and federal organizations look up specific pesticide label instructions from the convenience of their smartphone or tablet. With this new user-friendly tool, users can access the most up-to-date health and safety information right at their fingertips.

Enforcement Information

• A table of advertising complaints was posted to summarize health product advertising complaints that Health Canada has received and addressed, or is currently assessing for next steps.
• Information about companies who have received Administrative Monetary Penalties under the Canada Consumer Product Safety Act is now being posted.

What's Next?

Work is already underway to expand the Department's transparency work in 2016-17. The 2016-17 activities planned under the 2015-18 Action Plan for the Regulatory Transparency and Openness Framework have been posted to the website.

The 2016-17 activities will continue to build on the 2015-16 themes of Inform and Engage, Enable and Enforce.

Be informed

There are many opportunities for Canadians and stakeholders to contribute to our decision-making through consultations on various topics, such as those found on the Government of Canada's Consulting with Canadians website.

To be advised of, and have your voice heard in, public consultations on various topics that Health Canada holds, sign-up to receive information on topics of interest to you through the Consultation and Stakeholder Information Management System.

For useful health and safety information, you can visit the Canada.ca website, where you can access social media tools like the Healthy Canadians Facebook page.

To learn more about additional regulatory transparency initiatives, visit our Regulatory Transparency and Openness website.

To stay on top of breaking health news, including transparency initiatives, subscribe to one of Health Canada's free news services.

Let us know what you think

Health Canada values your comments. We welcome your thoughts on the Regulatory Transparency and Openness Framework and Action Plan Annual Report 2015-2016. You can comment by sending an email to transparency_transparence@hc-sc.gc.ca.

Summary: Planned and Delivered Activities Regulatory Transparency and Openness Framework Action Plan 2015-16

Inform and Engage

• Developed information to explain Health Canada's regulatory role.
• Expanded content in the Drug and Health Product Register.
• Developed guidance to increase capacity for consistent and coherent public engagement activities.

Enable

• Posted new guidance on:
  • Marijuana for medical purposes;
  • New powers under Vanessa's Law; and
  • Consumer Product Safety Risk Characterization Method.
• Posted several new information pieces to better explain regulatory decisions for drugs, food, and high risk medical devices
• Posted datasets on Open.canada.ca.

Enforce

• Launched the Drug and Health Product Inspections Database and included information on establishment inspections for:
  • Drugs;
  • Medical devices; and
  • Other health products.
• Expanded information in the Inspection Tracker.
• Summaries of inspection information for pesticides were provided in the annual compliance and enforcement report on pesticides.
• Started posting quarterly inspection information for marijuana for medical purposes.
• Posted the first annual compliance and enforcement reports for:
  • Marijuana for medical purposes; and
  • Pesticides.