Health Canada Regulatory Transparency and Openness Framework Action Plan 2014-2015

Annual Report : April 2015

Table of Content

• About this Report
• Building on Our Strong Foundation
• Our Plan for 2014-15
• Delivering on Our Commitment to Canadians
  • Early progress made in 2014-15
  • Sustaining Momentum
• Going Above and Beyond
  • Health and Safety Information and Engagement
  • Enabling Guidance and Science Information
  • Enforcement Information
• What’s Next?
• Our Ongoing Commitment
• Be informed
• Get Involved
• Summary: Planned and Delivered Activities Regulatory Transparency and Openness Framework Action Plan, 2014-15

About this Report

Launched in April 2014, Health Canada's Regulatory Transparency and Openness Framework (RTOF) commits Health Canada to concrete initiatives that have made regulatory health and safety information more available to Canadians this year, and will continue to do so in the years to come.

Building on early achievements described in the Interim Report published by Health Canada earlier this year, this Annual Report summarizes additional steps we have taken to provide Canadians with new tools and information to assist them to maintain or improve their health and safety.

Building on Our Strong Foundation

A lot of information about how we regulate products and businesses – from pesticides to food, drugs and consumer products – is already publicly available on our website, such as:

• Information on our inspection, compliance and enforcement activities so Canadians can see Health Canada's direct role in ensuring industry is following the rules that are in place to protect their health and safety.
• Information on drugs, health and consumer products, and pesticides so that Canadians have the latest information on important health and safety issues to support their decision-making.
• Scientific research and data to support scientists and other experts to conduct independent research that can benefit Canadians.
• Guidance for industry to stay up to date with Health Canada's activities and so that it has useful information to help fulfill its responsibility to provide safe and effective products.
• Information about our departmental plans, operations and priorities.

There are also 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 learn more about additional information that Health Canada makes available, visit our Regulatory Transparency and Openness website.

Our Plan for 2014-15

The Action Plan for 2014-15 committed Health Canada to 15 activities where we identified specific, concrete opportunities to increase transparency on topics of interest to Canadians under three themes: Making Information Easier to Understand, Making More Information Available, and Making Decision-Making Processes More Open.

This Report will highlight the activities we committed to under the 2014-15 Action Plan. However, we've done even more – including adding three additional activities that were noted in our Interim Report. This Report also identifies several other initiatives that have been completed in 2014-15 and that contribute 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

Early progress made in 2014-15

In the first six months of the Action Plan (from April – September 2014), we consulted on initiatives such as the development of a Consumer Product Safety Risk Assessment Framework and new plain-language labelling regulations to improve the safe use of drugs. We also published Annual Inspection Summary Reports for health products such as drugs and medical devices, new Chemicals Management Plan progress reports and added new nutrition information to the Canada.ca website.

During this time, we also expanded several information resources which will be continuously updated with the most recent information as it becomes available:

• Clinical Trials Database – Each year, Health Canada authorizes approximately 900 clinical trials, which are added to the database as they are authorized. In 2014-15, we added information on hundreds of new trials – approximately 70 each month.

• Summary Basis of Decision (SBD) documents on drugs and medical devices outline scientific and other information Health Canada considers when deciding whether to approve a new drug or medical device. This year, we posted over 20 new SBD documents and made over 80 updates to existing information on more than 50 new drugs and medical devices.

• Drug Safety Reviews – More than 20 new safety reviews were posted to our website this year. Copies of the full-length safety reviews can be requested.

Sustaining Momentum

In the second half of 2014-15, we continued to implement the Action Plan, as described below. A listing of all 18 activities that were completed in 2014-15 can be found at the end of this report.

Theme: Making information easier to understand

• As part of the plain language labelling initiative, Health Canada is consulting with stakeholders on a draft of the Good Label and Package Practices Guide. Once finalized, this guide will further enable industry to design labels and packaging that are simple to read and reduce the risk of medication errors.

• Health Canada's Consumer Product Safety Risk Assessment Framework  explains how we assess potential dangers associated with consumer products. A plain language summary is available on the Health Canada website, and the complete document can be requested.

Theme: Making more information available

• Launched in February 2015, the Drug and Health Product Register is an easy-to-use, mobile-friendly search tool that provides information on a wide variety of prescription drugs and biologics. The Register will be updated regularly.

• Through lists of Good Manufacturing Practices Inspections posted on our website, Canadians can now find information online about drug companies we regulate and inspect.

• Plain language summaries of Good Manufacturing Practices Inspections carried out on drug companies provide more detailed information on Health Canada's findings during inspections where non-compliance with regulatory requirements was identified.

• We posted new scientific assessments of novel foods to give Canadians more information on how Health Canada reviews 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.

• We have started to post Consumer Product Safety Incident Summary Reports and Consumer Product Enforcement Summary Reports. These give Canadians access to information on incidents related to consumer products that have been reported to Health Canada, as well as information on products that do not meet safety standards and what is being done to correct the problem.

• In partnership with Environment Canada, we published new risk assessment summaries for six substances as well as for micro-organisms that are new to Canada. Risk assessments for several additional micro-organisms that are new to Canada are being finalized. These reports summarize scientific information considered and regulatory decisions made, and identify any risk management measures that should be applied when using them in order to safeguard human and environmental health.

Theme: Making the decision-making process more open

• Health Canada consulted with Canadians to determine how to improve nutritional information on food labels and better understand how they use food labels to make nutritious choices for themselves and for their families. The ‘What We Heard' Report is available on our website.

• To increase the transparency of stakeholder engagement and consultations, we launched the Consultation and Stakeholder Information Management System (CSIMS). This new tool allows stakeholders to identify the health topics they are interested in, as well as whether they want to receive information on them or participate in relevant consultations.

Going Above and Beyond

We are also continually identifying new opportunities to improve regulatory transparency at Health Canada and provide Canadians with information they can use. This section outlines additional actions taken and accomplishments made in 2014-15.

Health and Safety Information and Engagement

• We made significant changes to the Canadian Adverse Reaction Newsletter (CARN) to meet the changing information needs of health care professionals and the public. The newly launched Health Product Infowatch provides credible health product safety information in an easy-to-read format. To receive it, subscribe to Health Canada's MedEffect E-Notice.

• A list of new drug safety reviews initiated has been posted so Canadians can see what drugs and potential health risks are currently being evaluated by Health Canada, before a review is complete. These are complementary to summaries of completed reviews and other information Health Canada provides to help Canadians make informed medication choices.

• We consulted Canadians on plans to make certain drugs tamper-resistant. As part of addressing the serious problem of prescription drug abuse in our communities, we are taking steps to ensure that drugs at high risk for abuse have tamper-resistant properties before they can be sold in Canada.

• Through the Paediatric Product Listing, prescribers and caregivers now have easier access to information on health products that have paediatric information on their labels such as drugs, biologics and vaccines. The initial listing includes nearly 300 products and will be updated as new data becomes available.

• For the first time, we consulted on a safety code – Safety Code 6, Health Canada's guideline for recommended human exposure limits for low-frequency electromagnetic energy given off by devices such as cell phones, Wi-Fi as well as cell phone towers. We also posted a summary of these consultations, including information about how feedback received was used to develop the newly-updated version of Safety Code 6.

• We began to publish plain language summaries of some risk assessments for chemicals of interest to Canadians. The first plain language summary published was for petrolatum, which can be found in everyday consumer products like lip balm.

• Health Canada posted its Interpretation Policy, which outlines the commitments, practices and tools it will use when providing Canadians and businesses with information on regulatory obligations to be met.

• The Protecting Canadians from Unsafe Drugs Act Transparency Needs-based Assessment was launched to seek feedback on how information about therapeutic products is disseminated. This online questionnaire will support the ongoing implementation of Vanessa's Law.

Enabling Guidance and Science Information

• We are sharing data from the Health-Canada-led Canadian Radiological Monitoring Network (CRMN) on the Government of Canada's Open Data Portal. We will make additional datasets available through this portal in coming years.

• We posted a summary of the Wind Turbine Noise and Health Study examining potential health impacts of wind turbine noise, in response to concerns from Canadians. Data gathered by Statistics Canada can be accessed through the Research Data Program Centres (RDC) Program. The Health Canada sound measurement data are available on request.

• We began a consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities. This guidance document sets out the principles, policy and standards that Health Canada will follow when using certain new authorities under the Act.

Enforcement Information

• Through the newly-launched Inspection Tracker, Health Canada is publishing information regarding emerging issues identified through the drug inspection program. The Tracker provides a snapshot of the potential health and safety issues we are tracking with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada.

• Health Canada announced it is moving towards a mandatory reporting system which requires all manufacturers to publicly report drug shortages to allow Canadians to make plans before one happens. A Public Notification Register has been launched on our website that lists all manufacturers that commit to voluntarily post their shortages – once reporting becomes mandatory, companies will face fines and penalties for failing to comply.

• We posted summary reports related to inspections carried out at individual health facilities, such as ID Biomedical Corporation of Quebec (GSK) and Apotex Pharmachem Inc.  These summarize information about inspection planning and observations, manufacturing controls and any next steps including whether corrective actions were required.

What's Next?

The Regulatory Transparency and Openness Framework and Action Plan 2015-18 outlines the key areas of focus over the next three years:

• Informing and Engaging Canadians : We are supporting Canadians to make informed decisions about their health and that of their families by providing more access to plain language health, safety and scientific information; clearly describing Health Canada's job as a regulator; and providing more opportunities to engage in meaningful conversations on issues that impact them.

• Enabling industry and other stakeholders: Industry is responsible for following the regulatory rules designed to provide Canadians with safe health and consumer products. Health Canada will help industry to fulfill this responsibility by updating and expanding our guidance about regulatory requirements. In addition, we will support scientists and experts by providing more data, documents and other information to enable independent research that benefits Canadians.

• Providing Enforcement information: The regulatory rules at Health Canada are designed to protect Canadians.  Inspections are an important way that Health Canada enforces these rules.  By seeing more inspection reports for more products, Canadians can better understand the systems we have in place to keep them safe.

Our Ongoing Commitment

Through the Regulatory Transparency and Openness Framework, we will make more information available in easy-to-access formats to foster increased dialogue with Canadians on issues and decisions that impact their health and safety.

Each year, we will improve access to timely, useful and relevant health and safety information.

Each year, we will report on our accomplishments and welcome comments and suggestions on what we can do better. To find out how to contribute, see the ‘Get Involved' section at the end of this report.

Be informed

To be advised of, and have your voice heard in, public consultations on various topics 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, like the Healthy Canadians Facebook page, and download the Recalls and Safety Alerts Mobile Application to have health and safety recalls and alerts delivered right to your phone.

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

Get Involved

The Regulatory Transparency and Openness Framework is constantly evolving, and new items will continue to be added to our transparency agenda. To stay up to speed on our progress, check the Regulatory Transparency and Openness Framework website.

We value your comments, insights and advice. Let us know what kind of information you would like from Health Canada that would help you to make the best possible health decisions for you, your family, or your business by sending us a note using the feedback form, also available on the RTOF website.

Summary: Planned and Delivered Activities Regulatory Transparency and Openness Framework Action Plan, 2014-15

Making Information Easier to Understand

• Posted the Consumer Product Safety Risk Assessment Framework, including a plain-language summary.
• Consulted on regulatory changes for Plain Language Labelling Regulations and consulted on the Good Label and Package Practices Guide.
• Posted new, consumer-friendly nutrition information on the Canada.ca website.

Making More Information Available

• With Environment Canada, published Chemicals Management Plan Progress Reports.
• Posted Annual Inspection Summary Reports that provide compliance information about health products inspected by Health Canada, such as drugs, medical devices and human tissues.
• Expanded the Health Canada Clinical Trials database with information on hundreds of new clinical trials.
• Posted new Summary Basis of Decision documents on drugs and medical devices.
• Starting with a review of Diane-35, began to publish Drug Safety Reviews.
• Launched the Drug and Health Product Register, a mobile-friendly web portal that provides Canadians with information on approved products in Canada.
• Posted Good Manufacturing Practices (GMP) Inspection Lists about drug establishment licences (DELs), including information about inspection results and compliance outcomes.
• Posted plain-language summaries of Good Manufacturing Practices (GMP) Inspections conducted on non-compliant drug establishments.
• Posted new summaries of scientific assessments completed as part of the approval process for novel foods.
• Posted the first Quarterly Consumer Product Safety Incident Report Summary.
• For the first time, developed and posted Consumer Product Enforcement Summary Reports.
• Informed our stakeholder about our plans to post information about advertising complaints received for health products advertised in Canada, including drugs and natural health products.
• With Environment Canada, published risk assessment summaries for new chemical substances – including micro-organisms – that are evaluated before they can be made available in Canada.

Making the Decision-Making Process More Open

• Launched the Consultation and Stakeholder Information Management System (CSIMS).
• Consulted with Canadians on food labelling to determine how to improve nutritional information on food labels.