Regulatory Transparency and Openness Framework and Action Plan Annual Report 2016-17
Overview of Report
In June 2015, Health Canada launched the Regulatory Transparency and Openness Framework and Action Plan 2015-18. The goal of the Regulatory Transparency and Openness Framework (RTOF) is to contribute to the health and safety of Canadians and their confidence in the regulatory system through timely and open communication on issues important to their well-being. The RTOF also supports the federal government's priorities to increase transparency, openness and accountability through the Open Government Initiative.
Each year, Health Canada identifies and implements a number of concrete initiatives to increase regulatory transparency and reports on achievements. This report highlights how Health Canada delivered on, and exceeded, the 2016-17 planned commitments. To read about past and ongoing activities under the RTOF, refer to the Health Canada Regulatory Transparency and Openness Framework Action Plan 2014-15 and Regulatory Transparency and Openness Framework and Action Plan Annual Report 2015-16.
As a result of the RTOF initiatives, Canadians and stakeholders have access to even more information about health and consumer products to make well-informed decisions. They also have more information about Health Canada's regulatory role, decision-making, inspection activities and findings, enforcement actions, and opportunities to participate in consultations.
Our Plan for 2016-17
Health Canada identified 11 specific opportunities to increase regulatory transparency and openness - 2016-2017 activities on topics of interest to Canadians under the three RTOF themes: inform and engage, enable and enforce.
Delivering on Our Commitment to Canadians
Theme: Inform and Engage
These activities are intended to provide Canadians with the latest information on important health and safety issues to support decision-making and to increase opportunities for public and stakeholder engagement. In 2016-17, Health Canada undertook the following activities:
- The Drug and Health Product Register, which provides easy access to consumer information about drug use, drug safety, and common or reported side effects, was expanded to include more information on natural health products, medical devices and over-the-counter medications.
- New regulations came into effect which make public reporting of drug shortages and discontinuances by industry now mandatory on the new website, Drug Shortages Canada. The free mobile Drug Shortages Canada application is available for download on iOS and Android devices. The website and application provide important, real-time information to help Canadians and stakeholders, including health care practitioners and pharmacists, to make more informed decisions about patient treatment.
- Information about Health Canada's regulatory role was posted online to help Canadians better understand the rules and regulations we develop and enforce for thousands of products used by Canadians every day. In addition, product-specific information about what Health Canada regulates was also posted, including web pages on health products (including drugs, medical devices and natural health products), consumer products, pesticides, tobacco products, cosmetics, veterinary drugs, food, workplace safety, devices that give off radiation, and environmental health risks.
- Health Canada conducted a survey to seek feedback from the public and stakeholders to better understand whether the RTOF is meeting their needs for information and where improvements are needed. The survey results provided Health Canada with valuable insight, which is being used, along with other information sources, to inform future directions.
The objective of activities under this theme is to ensure that industry and other stakeholders have the information they need to 1) comply with the regulatory rules designed to provide Canadians with safe health and consumer products; and 2) conduct independent research that benefits Canadians. Health Canada undertook the following activities throughout last fiscal year:
- A guide to reporting drug shortages and discontinuations was made publicly available to help manufacturers understand and comply with the new mandatory requirements to post drug shortages.
- Work is underway to add new or updated guidance and information for consumer products and controlled substances. For example, the Industry Guide to Children's Jewellery has been updated and the Technical Guidance on the Requirements of the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR) - WHMIS 2015 Supplier Requirements are now available.
- The scope of the Regulatory Decision Summaries initiative was expanded to include negative decisions and cancellations for new drug submissions (pharmaceutical and biologic) and submissions for new uses. Work is underway to add summaries for negative decisions and withdrawals for high-risk medical device applications. These summaries explain the purpose of the submission and Health Canada's decision for certain health products, including drugs and medical devices, seeking market authorization.
- The scope of the drug and health product submissions under review (SUR) list initiative was expanded to include all new drug submissions (pharmaceutical and biologic) and submissions for new uses. The SUR list is updated monthly and includes the medicinal ingredient(s) and the therapeutic area for applicable drug submissions.
- An inventory of Health Canada's datasets was posted on the government's Open Data Inventory.
- Work is underway to post peer-reviewed articles so that Canadians can access publications and provide input to Health Canada's science activities.
The purpose of these activities is to enable Canadians to see how industry follows the rules that have been put in place by Health Canada to protect their health and safety. Inspections are an important way that we enforce these rules. By making public more inspection reports for more products, Canadians can better understand the systems in place to keep them safe. In 2016-17, Health Canada undertook the following activities:
- Inspection reporting has been expanded and enhanced to include:
- The launch of the pest control product registrant inspections database, an online resource which provides ready access to inspection information about companies that manufacture pesticides to help Canadians make informed decisions about the pesticides they buy and use.
- Inspections of blood and donor semen establishments were added to the drug and health product inspections database, 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. Canada aims to protect the safety of Canadian blood donors and recipients and minimize the potential risk of passing on infections and diseases through the use of donor semen for assisted conception. This is done by monitoring and inspecting establishments that handle blood and donor semen.
- The Annual Report on Compliance and Enforcement Activities (Tobacco Control) 2014-15 and the Annual Report on Compliance and Enforcement Activities (Tobacco Control) 2015-16 were posted for the first time and include summaries of inspections of tobacco manufacturers, importers and retailers.
- The Annual Compliance and Enforcement Report, Fiscal Year: 2015-2016 for consumer products, including inspection activities and findings, was also posted for the first time.
Going Above and Beyond
Health Canada is continually identifying new opportunities to improve regulatory transparency and provide Canadians with useful information. This section outlines additional 2016-17 actions and accomplishments which exceeded the planned activities.
Informing and Engagement
- An experimental eRegulations pilot project was launched to enable stakeholders to comment directly on regulatory amendments using an online open source platform. This pilot was delivered in close collaboration with the Community of Federal Regulators, Treasury Board Secretariat, Privy Council Office, the Department of Justice, and the Canada Gazette, and was a preliminary step towards developing an electronic platform to provide Canadians with easier access to regulatory consultations.
- All Regulatory Decision Summaries and Summary Basis of Decision documents were migrated to the Drug and Health Product Register to support a single Health Canada source of information related to drugs and medical devices. This provides users with the ability to search the information, thereby increasing access.
Enabling - Guidance / Science Information
- The Guide to Recall of Medical Devices (GUI-0054) and factsheet on Medical Batteries were written in plain language, restructured and posted to provide clearer information to our stakeholders.
- Under the continuing efforts of the Plain Language Labelling Initiative, Health Canada revised Part I: Health Professional Information, and Part II: Scientific Information of the Guidance Document: Product Monograph and the five associated templates for prescription products. These revisions will make health professional information easier to read and critical safety information easier to find in the Canadian Product Monograph.
- Medical marijuana inspection reporting (under the Access to Cannabis for Medical Purposes Regulations - Quarterly Compliance and Enforcement Report - Inspection Data Summary) was updated to reflect the implementation of the new Inspection Risk Rating System, under which all licensed producers are now evaluated.
- The 2015 reporting on compliance monitoring: natural health products was posted to inform Canadians about Health Canada actions to assess compliance with legislative and regulatory requirements and act on non-compliance.
Health Canada's planned regulatory transparency and openness - 2017-2018 activities are publicly available on the website. These activities build on the 2016-17 RTOF themes of Inform and Engage, Enable and Enforce. We will report on achievements in 2018.
Health Canada regularly conducts consultations with the public and other interested stakeholders, which provide the department with an opportunity to hear what Canadians are thinking on a particular issue. To keep up to date on, and participate in, Health Canada’s public consultations on various topics, you can sign-up to receive information on topics of interest through the stakeholder registry (CSIMS), also known as the Consultation and Stakeholder Information Management System. The input obtained during these consultations helps inform policies and legislation that reflect the concerns of Canadians. We encourage you to visit the public engagement website, which lists numerous consultation opportunities on different topics, and to participate.
To learn more about Health Canada’s transparency, visit the webpage.
To stay on top of breaking news, including transparency initiatives, visit Health Canada.
Let us know what you think
Health Canada values your comments. We welcome your thoughts on this report and efforts to ensure that the public and stakeholders have access to important and timely health and safety information. You can comment by sending an email to: transparency_transparence/GEN/HC-SC/GC/CA.
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