Minister Ambrose announces a Transparency and Openness Framework

Health Canada posts Diane-35 Safety Review Summary and works with partners on a prescriber checklist as first step

OTTAWA, April 8, 2014 /CNW/ - The Honourable Rona Ambrose, Minister of Health, today delivered on a commitment to begin transparently publishing drug safety reviews.  The Minister committed to providing Canadians with access to Health Canada drug safety reviews with the posting of a summary of the safety review of the acne treatment Diane-35. This is the first summary safety review to be made public.

Once a drug is on the Canadian market, Health Canada continues to monitor the safety of health products to identify and assess potential harms. As a result, departmental safety reviews are conducted when a safety issue is identified for a product on the Canadian market. The posting of summary safety reviews will provide Canadians with plain-language descriptions of Health Canada's findings and decisions, so patients can make informed decisions and continue to have confidence in the health products they use.  The full reports will be made available through a link on Health Canada's website; however they are subject to redactions of personal and confidential information.

The posting of summary safety reviews is the first in a series of measures that Health Canada is taking to be more transparent and open with Canadians about regulatory decisions. As part of Health Canada's Regulatory Transparency and Openness Framework, the department has committed to providing Canadians with credible and timely information. This easy to understand information will allow them to make well-informed decisions concerning their health and that of their families.  Canadians will also have the chance to provide Health Canada with feedback on the Framework.

Health Canada has also made available today a practical new tool to assist in the safe prescribing of Diane-35 and to better inform healthcare professionals and patients of its risks.  In consultation with the Canadian Pharmacists Association, the Canadian Dermatology Association, and the Institute for Safe Medication Practices, Health Canada has developed a checklist to guide healthcare professionals through the decision to prescribe Diane-35. The checklist will reinforce existing warnings and precautions for this drug.

Today's announcements build on the Government's Patient Safety agenda, including Legislation that was introduced in December 2013, known as the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).

Quick Facts

  • Health Canada's safety review of Diane-35 concluded that the drug's benefits continue to outweigh the risks when the product is used according to the conditions on the label. The results of the review were communicated to Canadians on May 17, 2013.

  • With the posting of summary safety reviews, Health Canada is a leader in making post-market drug safety information publicly available. Canadians will now have access to more drug safety information than ever before. The Diane-35 safety review is just the first summary to be made public. Health Canada will be posting additional summary safety reviews, beginning with those of highest interest to Canadians.

  • The Regulatory Transparency and Openness Framework lays out solid principles and commits Health Canada to a set of concrete initiatives that will make regulatory health and safety information more available to Canadians this year and in the years to come.

  • Vanessa's Law aims to protect Canadians and children from unsafe medicine and will give the Government new tools to recall unsafe products, require mandatory reporting of adverse reaction, impose tough new penalties for unsafe products, including jail time and compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.


"Patient safety is a priority to our Government. Greater access to easy to understand and credible information about the potential risks and appropriate use of health products is one of the most valuable safety tools we can provide Canadians and healthcare professionals."
Rona Ambrose
Minister of Health

"With the posting of summary safety reviews, Health Canada is going beyond what other regulatory agencies are doing in terms of sharing this type of post-market drug safety information. This positive step is the first of many measures the Department is taking to improve the openness and transparency of its work."
Terence Young
Member of Parliament for Oakville

"We were pleased to partner with Health Canada on the prescriber checklist for Diane-35, which will promote safe use of the drug. We commend the Government of Canada's efforts to increase transparency by making the findings of Health Canada's drug safety reviews publicly available. This information will help front-line healthcare professionals educate patients and ultimately protect the health of Canadians."
Perry Eisenschmid, CEO
Canadian Pharmacists Association

"We are supportive of measures that increase safety for patients and promote safe practices. The checklist for Diane-35 and its generics is a good first step to assisting healthcare professionals in responsible prescribing and highlighting important safety information for patients and it is our hope this entire class of OCPs will be examined."
Dr Richard Langley, President
Canadian Dermatology Association

"Health Canada's release of the drug safety review summary for Diane-35 demonstrates commitment to transparency. The checklist developed for Diane-35 can provide an aid when prescribing this medication and communicating its risks to patients."
David U, CEO and President
Institute for Safe Medication Practices

Related Products

Prescriber checklist
Diane-35 Summary Safety Review
Regulatory Transparency and Openness Framework
Vanessa's Law - Information

Associated Links

Diane-35 Information Update (May 2013)

SOURCE: Health Canada

For further information:

Michael Bolkenius
Office of the Honourable Rona Ambrose
Federal Minister of Health
(613) 957-0200

Health Canada
Media Relations
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709

Health Canada news releases are available on the Internet at:

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