Interpretation Policy Improvement Priorities Report on Progress
In 2015, Health Canada assessed its interpretation practices and, with its stakeholders, identified several areas of improvement. The improvements were carried out between March 31, 2015 and March 31, 2017. Performance was measured through a questionnaire undertaken both in 2015 and 2016 where stakeholder associations were asked to assess their level of satisfaction with Health Canada's interpretation practices in the areas of predictability, service, and stakeholder engagement. While there was a relatively low response rate, comments received revealed a range of views among stakeholder associations on areas where Health Canada performed well, and where there is room for improvement. Results are summarized below along with an update on progress for each activity identified in 2015.
1. Improving Predictability
Stakeholder associations who responded to the questionnaire in 2015 and again in 2016 were split when it came to their level of satisfaction with Health Canada's practices related to predictability. Approximately half indicated they felt Health Canada was doing well, and half felt there was room for improvement. Comments received stated that improvements could be made with regard to the delivery of timely guidance on new regulations, accessibility of guidance on the web, timeliness for informing stakeholders of upcoming changes, more regular updating of guidance, and use of plain language in both regulations and guidance materials.
Area of Improvement: Providing Guidance and Building Awareness
Health Canada will
- Improve communication of industrial hemp licensing and license renewal requirements
- Progress: Health Canada issued a Notice to Industry on November 22, 2016 regarding the Section 56 Class Exemption in Relation to the Industrial Hemp Regulations to producers of Industrial Hemp in an effort to simplify the licence application process for persons who want to obtain a licence to import, export, possess, cultivate, produce, process, and distribute (sell/provide) industrial hemp. The Exemption is an interim measure to simplify the licence application process as the Government moves forward with its commitment to legalize, strictly regulate, and restrict access to cannabis.
- Develop information sheets for stakeholders to clarify regulatory requirements related to the different categories of precursor chemicals (in conjunction with the Global Affairs Canada and Natural Resources Canada)
- Progress: In November 2016, Health Canada issued a policy statement to provide clarification on the status of aqueous solutions of hypophosphorous acid to stakeholders. This is a first step as work progresses towards providing more plain language guidance on the regulatory requirements for precursor chemicals.
- Improve transparency for marijuana for medical purposes stakeholders by launching a series of communication products to provide fact-based information on the regime
- Progress: On August 24, 2016, the Medical Use of Marijuana website was replaced with the Accessing Cannabis for Medical Purposes website. As part of this update, webpages were published with content aimed at different groups of stakeholders including: persons who obtain cannabis from licensed producers, persons registered to produce cannabis for their own medical purposes, licensed producers, health care practitioners, law enforcement and municipalities. Information on a variety of topics has been posted including: accessing cannabis for medical purposes, compliance with local laws, import & export by licensed producers, safety and security, and testing of cannabis produced by individuals. The update to this website is ongoing and new pages are being added as needed. Any pages not updated in time for the coming into force of the Access to Cannabis for Medical Purposes Regulations on August 24, 2016, were archived and will be updated in 2017.
- Develop performance standards for the marijuana for medical purposes regime
- Progress: In June 2015, there was a re-organization of Marihuana for Medical Purposes Regulations (MMPR) licensing and compliance functions. As an initial step towards developing and establishing performance standards, processes were reviewed to identify efficiencies, and address the high volume of applications for MMPR licences. As a result, processes were streamlined and enhanced, including the creation of a dedicated security unit within the Office of Medical Cannabis and the centralization of all security related activities, which has improved the processing time of security screening. A risk-based inspection program was implemented to refocus or maximize use of inspection resources and additional reviewers were hired to review applications. On August 24, 2016 the MMPR were repealed following a Federal Court ruling and have been replaced with the Access to Cannabis for Medical Purposes Regulations (ACMPR). The program continues to implement changes to reflect the new regulations.
- Improve communication of the legislative and regulatory requirements regarding advertising of pesticides
- Progress: On 26 March 2015, Health Canada released updated proposed Guidelines for the Advertising of Pest Control Products (PRO2015-01) for a 30-day consultation period. Comments were reviewed and the proposed Guideline was updated to address them. The final version of the Guidelines for the Advertising of Pest Control Products (DIR2016-01) was published on November 18, 2106.
- Review and revise existing Pest Management Regulatory Agency guidance documents
Progress: Health Canada's project to review and revise existing Pest Management Regulatory Agency guidance documents was folded into a larger Health Canada project to review and optimize all Health Canada guidance documents, which is part of the government-wide Treasury Board of Canada Secretariat-led Web Renewal Initiative.
Under this new framework, Health Canada identified and migrated its guidance documents to the new Canada.ca website in early 2016. Health Canada is currently working to optimize those documents (i.e., ensure they are up to date, are in plain language, comply with Government of Canada Web Content Accessibility Guideline, etc.).
Area of Improvement: Increased use of Plain Language
Health Canada will
- Make health product labels easier to understand by revising a number of guidance documents, which affect the submission process and the post-market change process, and continue to develop the Good Label and Package Practices Guide
- Progress: Significant progress was made since 2015, resulting in the publications of two documents posted in June 2016:
2. Stakeholder Engagement
Stakeholder associations who responded to the questionnaire in 2015 and again in 2016 were split when it came to their level of satisfaction with Health Canada's current practices related to stakeholder engagement. Approximately half indicated they felt Health Canada was doing well, and half felt there was room for improvement. Comments received stated that improvements could be made in stakeholder identification and engagement (e.g. identifying the right stakeholders to engage), in the number of engagement opportunities offered, in early engagement, and in the provision of an appropriate amount of time for stakeholders to develop a meaningful response.
Area of Improvement: Providing opportunities for stakeholder engagement
The Health Portfolio will
- Continue to improve the Consultation and Stakeholder Information Management System, which allows individuals and organizations to identify their areas of interest and manage their own engagement activities.
- Progress: Through the use of various public notices and marketing activities, Health Canada will continue to promote the Consultation and Stakeholder Information Management System as a means to notify Canadian individuals and organizations of ongoing consultation and engagement activities related to their areas of interest.
The majority of stakeholder associations who responded to the questionnaire in 2015 and again in 2016 felt that Health Canada is doing well when it comes to providing professional service. Areas of improvement included shortening timeframes within which Health Canada provides responses to stakeholder inquiries and improving the consistency of responses.
Area of Improvement: Providing clear and consistent information to stakeholders
Health Canada will
- Provide updated training to health products and food regulatory staff enabling consistent application of new and changing regulations
Progress: In 2015, Health Canada delivered comprehensive training to its drug regulatory staff in the review of labels in plain language to enable consistent implementation of the new Plain Language Labelling regulations. Staff received training through speaker sessions, course hand-outs and case studies.
Training sessions on the Good Label and Package Practices Guide for all label reviewers were held in May 2015. This session was co-led by the Institute for Safe Medication Practices Canada.
Area of Improvement: Providing timely service in responding to stakeholder enquiries
The Pest Management Regulatory Agency will
- Develop service standards for responding to stakeholder enquiries regarding regulatory requirements.
- Progress: A performance standard for stakeholder enquires has been developed and will be posted on Health Canada's web-site.
4. Transparency and Openness
Stakeholder associations were not asked for feedback on regulatory transparency and openness; however, transparency and openness continues to be a key factor in the provision of regulatory guidance to stakeholders.
Area of Improvement: Regulatory Transparency and Openness
Health Canada will
- Continue to make regulatory health and safety information more available to Canadians through its 2015-18 Regulatory Openness and Transparency Framework.
- Progress: Canadians have more information about Health Canada's regulatory role and how and why decisions are made, for example, through the Drug and Health Product Inspections and Pest Control Product Registrant Inspections Databases and annual compliance and enforcement reports for drug and health products, marijuana, pesticides, tobacco and consumer products. Canadians also have more information about issues that are important to their well-being such as drug safety and drug shortages. Health Canada is also involving and consulting more transparently with Canadians on important issues such as revisions to Canada's Food Guide and the Healthy Eating Strategy. Health Canada will continue to build on these achievements so that Canadians have access to timely and relevant health and safety information and confidence in our regulatory system.
For More Information
- Guide for Developing and Implementing Interpretation Policies
- Government-Wide Forward Regulatory Plans
- The Cabinet Directive on Regulatory Management
- The Red Tape Reduction Action Plan
- The Canada-United States Regulatory Cooperation Council
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