Regulatory Transparency and Openness Framework and Action Plan - Annual Report for 2017-2018

Overview of Report

In June 2015, Health Canada launched the Regulatory Transparency and Openness Framework and Action Plan 2015-2018. 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 numerous initiatives to increase regulatory transparency and reports on those achievements. This report highlights how Health Canada delivered on the 2017-2018 planned commitments.

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.

While Health Canada's RTOF Action Plan ended in March 2018, the department will maintain its commitment to openness, transparency and accountability by introducing a new three year action plan. This renewed effort will ensure that Health Canada continues to make important health and safety information public and engage Canadians and stakeholders on health and safety issues, while contributing to the Government of Canada's Action Plan on Open Government.

Our Plan for 2017-2018

Health Canada identified 11 specific opportunities in 2017-2018 to increase regulatory transparency and openness on topics of interest to Canadians under the three RTOF themes: Inform and Engage, Enable, and Enforce. Only one public commitment, to publish the complete Structured Product Monograph through the Drug and Health Product Register (DHPR) for researchers and healthcare providers, is expected to be delayed until Q1 2020-2021. The DHPR currently publishes information for all marketed drugs for human use, such as what it is used for, side effects and ingredients. The DHPR also includes summary documents and other information for all Canadians, particularly patients, consumers and health care providers.

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 2017-2018, Health Canada undertook the following activities:

Provided more information about the regulation of generic drugs

To better inform Canadians about the generic drugs we regulate, the information available online was expanded. A fact sheet was published describing how generic drugs are brought to market once a drug submission is received, and what factors affect market access in Canada.

Engaged stakeholders on a proposed transparency initiative related to generic drug products

Health Canada consulted with stakeholders on a proposal to better explain how decisions are made about certain prescription generic drug products. The feedback received from the consultation is published in the What We Heard Report - Proposals for Prescription Drug Transparency posted on the What's New - Drug Products page. Interested parties and stakeholders will be informed via a posting to the Government of Canada website as to the next steps for the proposals.

Provided more information about the department's stakeholder engagement activities on key policy files

As part of our commitment to be more transparent about the work we do, information was shared with Canadians about departmental stakeholder correspondence and meetings related to healthy eating initiatives. Information on 136 meetings held by Department officials was made publicly available. This included correspondence in which views, opinions and information were shared, with the intent to inform the development of policies, guidance or regulations related to healthy eating initiatives.

The department also published information about public consultations and stakeholder engagement with regards to the public release of clinical information. Information posted online included a list of submissions received in response to the public consultation on the white paper entitled "Public Release of Clinical Information in Drug Submissions and Medical Device Applications"; a What We Heard report from the white paper consultation; and records of all meetings and correspondence with stakeholders on this initiative.

Engaged Canadians in modernizing the regulation of self-care products

Health Canada hosted a series of in-person and online consultations with Canadians throughout 2017-2018 to inform the development of a modernized approach to the regulation of self-care products.

Engaged stakeholders on the development of the structured product monograph

Drug product monographs are factual documents that contain scientific data about drug products and information for safe use of the drug. Product monographs are made available to the public as part of Health Canada's commitment to openness and transparency.

Product monographs are being transitioned to a new structured format that will allow information to be more easily found online by the public and healthcare stakeholders. Initial testing with stakeholders has taken place and was successful. The next step is to test the final structured product monograph.

Provided stakeholders with up-to-date information about the activities of Health Products and Food Branch scientific advisory bodies

Health Canada provided updated online information about the meeting activities of its Scientific Advisory Panels and Scientific Advisory Committees. This included information about the topics these bodies discussed, when they met, and recommendations that were made at these meetings. For the latest information, please refer to the Scientific Advisory Panels and Scientific Advisory Committees pages of the departmental website.

Theme: Enable

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:

Shared more information about the drugs and medical devices we regulate

Health Canada introduced draft regulations and draft guidance for publicly releasing clinical information relating to safety and effectiveness of drugs and medical devices, once decisions have been made on industry submissions. The department consulted with the public and stakeholders on the implementation of proposed regulations.

Health Canada expects that public access to clinical information will allow independent analysis that will increase an understanding of the safety and efficacy of health products. This can improve patient care in Canada by: helping patients and healthcare providers make better decisions about using drugs or medical devices; reducing research participant exposure to harm during duplicative studies; and using analysis of existing data to advance new research.

Continued to make more scientific data and information publicly accessible

Health Canada continues to contribute to the federal government's Open Data initiative by meeting the Directive on Open Government requirement that an inventory of the department's data be captured and maintained on a regular basis. Health Canada published six new datasets during 2017-2018 and has a total of 50 datasets available to the public via the Open Data Portal. Health Canada has also established an Open Data Working Group with the Public Health Agency of Canada to advance this work.

Developed and implemented policies and procedures for sharing Confidential Business Information related to therapeutic products

The department has published guidance and maintains a process for eligible requesters to obtain confidential business information related to therapeutic products. The guidance and information on the process underwent public consultation before being implemented and are available online.

Theme: Enforce

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 inspection reports public for more products, Canadians can better understand the systems in place to keep them safe. In 2017-2018, Health Canada undertook the following:

Reported quarterly on illicit drug analysis statistics and trends

Health Canada's Drug Analysis Service continues to provide Canadians with easy to understand quarterly information and statistics on illicit drugs, including opioids, found in samples seized by law enforcement agencies. Detailed information can be found on the Drug Analysis Service website.

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 2017-2018 actions and accomplishments that exceeded the planned activities.

Engaged stakeholders on the development of the Cannabis Regulations

To inform the development of its regulatory framework that will support the Cannabis Act, Health Canada held a 60-day public consultation on the Proposed Approach to the Regulation of Cannabis, which ended on January 20, 2018. The department heard from thousands of Canadians as well as provincial and territorial governments, Indigenous organizations, current and prospective cannabis licensed producers, and other stakeholders, including public health experts. In March 2018, Health Canada published a Summary of Comments Received During the Public Consultation, which summarized the feedback received. The Cannabis Regulations and other regulations supporting the Cannabis Act were published in Canada Gazette, Part II:

Regulatory Review of Drugs and Devices

Health Canada has launched the Regulatory Review of Drugs and Devices initiative, which aims to support improved access to needed medicines for Canadians through activities such as working more closely with health system partners and improving our internal processes. The department has developed a webpage that describes all of the activities under this initiative and is posting reports and notices on that page to show the progress being made. There is also an associated consultations webpage, which is updated on a monthly basis, that will inform Canadians about their opportunities to provide input into this work as it goes forward.

Special Access Program

The Special Access Program (SAP) provides access to non-authorized, non-marketed drugs to individual practitioners treating a patient with a serious or life-threatening condition where conventional therapies have failed, are unsuitable or are unavailable. In order to update the SAP processes and improve stakeholder relations, a reconsideration process has been developed to ensure a transparent, fair and independent review stage for those who may have differing positions from a SAP recommendation. The main objective of the reconsideration process is to provide an applicant with an opportunity to discuss his/her request when the SAP is considering issuing a denial and, if needed, an opportunity to get an independent review of the request.

"Tweeting out" project

Health Canada is issuing notices via Twitter for each new drug market authorization for new active substances and biosimilars, and each market authorization of a new class IV medical device. Tweets may also be issued following the market authorization of other submissions of interest. The tweets are linked to the product information within the Drug Product Database for drugs, and the Regulatory Decision Summaries within the Drug and Health Product Register for medical devices.

Mandatory reporting regulations for drug shortages

Health Canada has been actively engaged with stakeholders, informing them of the mandatory reporting regulations for drug shortages and discontinuations, and providing them with updates on enhancements to the Drug Shortages Canada website. Several webinars took place throughout 2017-2018 on how to report shortages and discontinuations on the website and how to sign up for notifications to stay informed.

Personal use import exemptions for pest control products

Health Canada conducted outreach activities throughout the year to provide stakeholders and the public with information about changes to the personal use import exemption provisions under the Pest Control Products Regulations. The changes increase health and environmental protection by clarifying and strengthening the criteria required for the personal importation of unregistered pest control products into Canada by travellers. Outreach activities included letters to customs brokers and associations, training of CBSA officers and outreach to general public through posting on the departmental website and Twitter.

Guidance/Science Information

Health Canada developed a suite of tools and process documents to support the publishing of datasets and information resources on the Open Government Portal. The department also posted five modernized guidance documents related to good manufacturing practices on the departmental website, which enables industry to comply with requirements related to the safety and quality of drugs.

Enforcement Information

The 2017 Report on Compliance Monitoring: Natural Health Products was posted online to inform Canadians about Health Canada's proactive monitoring of natural health product good manufacturing practices and actions taken when non-compliance with regulatory requirements was identified.

What's Next?

The RTOF and 2015-2018 Action Plan successfully launched Health Canada's efforts to make more data and information available to Canadians and stakeholders than ever before. It has provided more opportunities to participate in discussions on government policies and priorities.

While Health Canada's RTOF Action Plan ended in March 2018, the department will continue its commitment to openness, transparency and accountability by introducing a new three year action plan. This will ensure that Health Canada maintains its momentum in advancing regulatory transparency and openness in ways that meet the needs of Canadians and stakeholders.

Be Informed

Health Canada values opportunities to hear from Canadians on important issues, and regularly consults with the public and interested stakeholders on a variety of health-related topics. You can keep up to date and participate in Health Canada's public consultations by signing up to receive information on topics of interest through the Consultation and Stakeholder Information Management System (CSIMS). The input received during these consultations helps to inform departmental policies and legislation that reflect the concerns of Canadians. We also encourage you to visit the public engagement website, which lists numerous consultation opportunities on different topics and offers opportunities to participate.

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 transparency at Health Canada, visit the website.

To stay on top of Health Canada news, including transparency initiatives, visit Health Canada's website.

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: HC.transparency-transparence.SC@canada.ca.