Submission from WHP to Health Canada in response to Blueprint for Renewal: Transforming Canada 's Approach to Regulating Health Products and Food

November 2006

Since its inception in 1997, WHP has submitted many briefs, attended numerous consultations and public fora, and prepared discussion papers and public information pamphlets on a range of issues relating to the process of legislative renewal at Health Canada. We have followed closely the department's reaction to public input on matters of drug and product regulation for the past 9 years, with a particular focus on the implications for women's health. We have written to every Minister of Health since '97 expressing concern about violations to the Food and Drugs Act, particularly in the form of direct-to-consumer advertising.

Given this history, we awaited the release of this latest document in the legislative renewal process with great interest. We are disappointed to see that many of the concerns that we and others have been raising for almost a decade continue to go unanswered. We come away from reading this document with a sense that the essence of the precautionary principle for drug and device regulation has been lost, only to be replaced by notions of "managing risk". With a legacy of problems that have arisen because precaution was not exercised (DES, HRT, Vioxx,. etc.), it is distressing to see this ethic not being more wholeheartedly embraced by our regulators. Instead we read that ".science and management capacities are defined by the business processes that support the gathering of evidence, generation of new knowledge and a rigorous approach to decision-making."

In general terms, we worry that the authors of the Blueprint simply have not told the whole story. For example:

1) The authors speak of promoting a culture of openness and transparency. While some strides forward have been made, the department is seriously hampered by the fact that all safety and efficacy data submitted as part of the regulatory approval process are still considered commercially confidential and will not be released without permission of the company. There is nothing in the Blueprint that commits Health Canada to releasing this type of information even if the Food and Drugs Act is rewritten.

3) The authors refer to "two ground-breaking forums that enabled public input on regulatory decisions and product submissions" (i.e. COX-2 and silicone gel breast implants). While the efforts to receive public input were laudable, Health Canada authorities repeatedly suppressed or ignored legitimate concerns raised by participants and the press that some experts chosen for one of the advisory panels had serious conflicts of interest, thereby basically silencing much of the public input allegedly sought.

4) Frequent reference is made to "meeting internationally-benchmarked performance targets", and "adopting internationally recognized regulatory best practices". However, much of this is done without public consultation or Parliamentary debate.

Another of our over-riding concerns with the document is its complete inattention to one of the most contentious issues in legislative renewal: i.e. legislation respecting direct-to-consumer advertising (DTCA). We understand that this omission is likely conscious and strategic in light of the impending Charter Challenge case by CanWest. Nonetheless, the public has a right to know in what general direction the government is moving on this file.

Finally, the inclusion of a glossary, clearly-presented appendices, and sidebars with additional information all serve to make this rendition of the legislative renewal process a more appealing package. However, the real change needed lies not in packaging but in a substantive commitment to putting public health concerns before industry interests, and in a return to the precautionary principle over a risk-management approach.

The Health Canada document, "Blueprint for Renewal: Transforming Canada 's Approach to Regulating Health Products and Food", is available online at http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/blueprint-plan/index_e.html . The website includes a section for responses by the general public to the document.

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