Health Canada Regulatory Transparency and Openness Framework Action Plan 2014-2015, Interim Report
Purpose of this Report…
This is an Interim Report of the 2014-15 Action Plan that is part of Health Canada’s Regulatory Transparency and Openness Framework (RTOF) launched in April 2014. The Report provides an overview of the progress that has been made over the first 6 months of the Action Plan (April 1 – September 30, 2014).
What we set out to improve…
Health Canada plays an important role in protecting the health and safety of Canadians and in informing Canadians to help them make healthy choices.
Canadians want the opportunity to engage in an ongoing dialogue about policies and priorities that will affect their health and the health of their families. They want to better understand the regulatory decisions that are being made by Health Canada, and they want improved access to information.
For Health Canada, this means making transparency the default way of doing business, while respecting the legitimate interests of businesses as necessary, protecting privacy and meeting other legal obligations. Making our work more transparent and open will take time, but important progress has been made in key areas.
How we planned to do it…
The Action Plan for 2014-15 commits Health Canada to addressing 15 activities where the Department identified opportunities to improve transparency. Each of these activities fall under one of the following themes:
- Making Information Easier to Understand
Health Canada will ensure that information Canadians want to make decisions about their health is presented in easy to understand formats. - Making More Information Available
To ensure that Canadians have access to information they are interested in, Health Canada will proactively report on key regulatory activities. - Making Decision-Making Processes More Open
Health Canada will continue to seek opportunities to invite, hear and consider diverse points of views as it undertakes its decision-making processes.
Health Canada committed to updating Canadians about progress on the Regulatory Transparency and Openness Framework on an annual basis. This Interim Report is part of that commitment.
What we have achieved to date…
There are many highlights from the first 6 months of implementing the Action Plan, including:
Making Information Easier to Understand
- Health Canada has started developing and posting updated nutrition information and tools for Canadians on the Healthy Canadians website. The information includes information and tips on healthy eating including a fact sheet on vegetables and fruit, hydration, and, how to use the serving size and % Daily Value in the Nutrition Facts tables on packaged foods to make healthy food choices.
- Health Canada has consulted on regulatory amendments for Plain Language Labelling Regulations so that drug product labels and packages are easier to read and understand. Canadians, industry and stakeholders were given an opportunity to review the proposed regulations and provide feedback to Health Canada that will be used to further improve the critical information on drug product labels and packages about the safe and effective use of these products. Improvements to drug product labelling and packaging are needed so health professionals, patients and consumers can more easily find out how to use the drug, how often to take it, and when it should not be taken. The final regulations were posted in the Canada Gazette in June 2014.
- Health Canada has consulted with Canadians, industry and stakeholders about the development of a Consumer Product Safety Risk Assessment Framework. A final summary of the consultations will be sent to the stakeholders who provided comments during the consultation period.
Making More Information Available
- Since April 2014, information on approximately 355 new clinical trials has been posted to the Health Canada Clinical Trials Database. There are now over 1000 approved clinical trials in the database. This is a central source of information about Phase I, II, III clinical trials in patients. Each year, Health Canada authorizes approximately 900 clinical trials. Information is posted in the database as Health Canada authorizes them.
- Since April 2014, 14 Summary Basis of Decision documents on drugs and medical devices have been posted to the Health Canada website, as well as 50 updates of post-market information on 42 new drugs and medical devices. These Phase II Summary Basis of Decision documents outline the scientific and benefit/risk-based considerations that factor into Health Canada's decisions to grant market authorization for a drug or medical device.
- Health Canada published the second issue of the Chemicals Management Plan Progress Report with Environment Canada. These reports provide Canadians and stakeholders with up-to-date information about the activities and programs related to Canada's Chemicals Management Plan (CMP). It also provides information about coming events, dates of interest and how to get involved.
- Annual Inspection Summary Reports for 2012-2013 and 2013-2014 were posted in April and August 2014 respectively. These Reports provide compliance information of health products such as blood, cells, tissues and organs for transplantation, drugs, medical devices, and semen. Health Canada is committed to making compliance information available to Canadians as a way of demonstrating the effectiveness of the inspection programs, and revealing how well regulated parties are complying with the regulations.
- Health Canada began publishing summaries of its Drug Safety Reviews, in April 2014. The first summary was for Diane-35. Between April and October 2014, 10 safety reviews have been published on the Health Canada website. These summaries complement other safety-related information and can help Canadians make informed decisions about medication choices. They summarize the evaluation of potential health product-related safety issues and contain information such as: reports on adverse reactions, new safety information from foreign regulators, and medical and scientific literature. The Drug Safety Reviews provide Canadians with access to the safety review information, specifically; what was assessed, what was found, and what action was taken. Routine posting of safety reviews will follow.
Going Beyond Our Current Commitments…
As we move forward in the implementation of the 2014-15 Action Plan, we are also identifying and initiating other activities outside the Action Plan to improve transparency and openness at Health Canada. Health Canada’s Transparency and Openness webpage is being used as a platform for promoting consultation processes such as those for Safety Code 6, Drug Shortages and tamper resistance regulations. The website provides an additional platform for Canadians to learn about these types of processes and opportunities to provide comments and inform decisions.
Safety Code 6
Health Canada has consulted with Canadians on a revised version of Safety Code 6. This is the first time Safety Codes have been open for public consultation. This Safety Code is Health Canada’s guideline for recommended human exposure limits to radiofrequency electromagnetic energy given off by various electronic devices such as cell phones and Wi-Fi, as well as cell phone towers. Development of a final revised guideline is expected to be published in Fall 2014. Health Canada’s proposed Safety Code 6 would make Canada’s limits among the most conservative in the world.
Tamper Resistance
The abuse of prescription drugs is a serious public health and safety issue for many communities across Canada. Health Canada consulted with Canadians on proposed regulations that would require drugs at high risk for abuse, like controlled-release oxycodone, to have tamper-resistant properties before they can be sold in Canada. The Department plans to continue to work in partnership with Canadians to tackle this complex issue.
Drug Shortages
Health Canada is working collaboratively with provinces and territories, as well as industry stakeholders and health care practitioners to address drug shortages and to build a more open and secure drug supply system. In Spring 2014 a new Public Notification Register for Drug Shortages was launched to capture notification of drug shortages and discontinuances. In the event of an anticipated or actual drug shortage, Health Canada may issue letters of non-compliance to companies that have failed to provide timely, comprehensive, and reliable notification to the public Canadian Drug Shortages Website. These letters will be posted on the Public Notification Register for Drug Shortages as part of ongoing efforts by Health Canada to ensure drug supplier transparency and accountability for public drug shortage and discontinuance notification.
Individual Health Facility Inspection Reports
In July 2014, Health Canada posted a Summary Report related to inspections which were carried out at ID Biomedical Corporation of Quebec (GSK) in 2012 and 2014. The Summary Report included information about inspection planning, summary of observations, manufacturing controls, quality control systems and next steps. Inspections of Good Manufacturing Practices are an important part of ensuring that standards of safety and quality are met before products are sold to Canadians. Health Canada will be further refining the tools used to make information such as this available to the public.
Greater Transparency for Drug Safety
Bill C-17, Protecting Canadians from Unsafe Drugs (Vanessa's Law) includes new transparency authorities related to the disclosure of information relating to clinical trials, Health Canada’s regulatory decisions, and disclosure of confidential business information.
New Commitments in the 2014-15 Action Plan ...
Health Canada has committed to the following three new activities that will be completed by March 31, 2015:
Posting Information About Advertising Complaints
Health Canada will begin posting health product advertising complaints for both authorized and unauthorized pharmaceuticals, biologics, natural health products (NHPs), and medical devices.
Make Information Available About Drug Establishments
Health Canada will post a list of information about drug establishment licences over several phases which will include information about compliance.
Post Plain Language Summaries of Non-Compliant Drug Establishments
Health Canada will explore options to regularly post plain language summaries about Good Manufacturing Practices inspections of non-compliant drug establishments.
What you can expect from us by March 31, 2015 ...
Over the remainder of this fiscal year (2014-15), we will continue to implement the Action Plan for the Regulatory Transparency and Openness Framework.
- The Health Product Register (HPR), a new interactive website from Health Canada, will be launched under Canada.ca. The HPR will bring together and organize health product information that is currently spread out across different areas of Health Canada's website (e.g. MedEffect, the Drug Product Database, Canada Vigilance) to improve public access to health information by presenting its information in a searchable, user-friendly web-based format. It will give Canadians easy access to information about drug product use, safety and common reported side effects. Users will also have the ability to voluntarily report a side effect through this new web application.
- As part of the Plain Language Labelling Initiative, Health Canada will be publishing the Good Label and Package Practices Guide for consultation. In collaboration with the Institute for Safe Medication Practices Canada, the Guide is being developed to provide direction to manufacturers in designing safe and clear labels and packages. This work supports the introduction of the requirement for submission of full color mock-ups of labels and packages.
- Health Canada will post summaries of scientific assessments of novel foods. These summaries will provide Canadians and the scientific community with further information related to the safety review process, what was assessed, and the scientific basis for the decision to approve the novel food for sale in Canada.
- The third issue of the Chemicals Management Plan Progress Report will be released.
- Health Canada will release the Consumer Product Safety Risk Assessment Framework and plain language summary.
- Health Canada will post the first Quarterly Consumer Product Safety Incident Report Summary and the first Consumer Product Enforcement Summary Reports.
- Health Canada, with Environment Canada, will publish risk assessment summaries for six substances new to Canada on which conditions or new-use requirements are placed and published in the Canada Gazette. The summaries provide an overview of scientific information considered and the conclusions and regulatory decisions made.
- Health Canada, with Environment Canada, will publish risk assessment summaries for a representative range of micro-organisms new to Canada.
- Health Canada will be launching the Consultation and Stakeholder Information Management System (CSIMS). CSIMS was created to improve the openness and transparency of stakeholder engagement and consultations at Health Canada. CSIMS allows stakeholders to identify the health topics they are interested in, as well as whether they want to receive information on those topics or participate in relevant consultations.
Our ongoing commitment…
Health Canada will review and update the Regulatory Transparency and Openness Framework Action Plan annually. Each year we will demonstrate our commitment to transparency and openness through concrete actions and we will report back to Canadians on how we are doing.
In March 2015, Health Canada will release the Action Plan for April 2015- March 2016.