Maychai Brown

On May 9th, 2005, BCAM members attended a roundtable in Ottawa, convened by the Canadian Health Coalition (CHC), to alert health advocates to the government's new approach to regulation. We were unable to include this report of the meeting in the Fall Bulletin due to lack of space. We include it now, slightly revised to bring you an update.

A government initiative under way since 2003 and dubbed 'Smart' (specific, measurable, attainable, realistic, timely) is causing great concern among scientists, trade unionists, and sociologists. The fear is that a tsunami of deregulation is about to engulf Canadian society, over-riding the health and safety of individual citizens.

This initiative is an attempt to make Canada's regulatory apparatus modern, coherent, and transparent. The vast undertaking, affecting 85 Acts and 250 regulations administered by 14 different ministries and various boards and commissions, is being overseen by the Privy Council. At the May 9th CHC roundtable advertised as "The Precautionary Principle and Canada's Approach to Risk," Ken Moore, a Privy Council Office representative, explained that a principle motivation for changing regulation in Canada is to facilitate the development of business and to keep Canadian industry competitive in world markets.

The purpose of the roundtable was to examine the role that precaution will play in Smart Regulation. Alarmed about the proliferation of carcinogens, Breast Cancer Action Montreal has for the past few years been concerned about regulation. What can be done when a substance seems likely to be harmful yet there is no conclusive proof? BCAM is a proponent of the Precautionary Principle, i.e., "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity rather than the public, should bear the burden of proof."¹

Although he avoided using the term 'Precautionary Principle', Mr. Moore asserted that Smart Regulation makes allowance for certain precautions. The regulation "recognizes that absence of full scientific certainty shall not be used as a reason for postponing decisions where there is a risk of serious or irreversible harm."²

While the wording suggests that Canadian regulators would be justified in banning a likely seriously harmful substance where there is no scientific proof of causality, it also allows for the approval of such substances. What is being prohibited is using the lack of proof as justification for postponing a decision. Smart Regulation makes precaution a possibility, not an imperative.

According to the Canadian Environmental Law Association, and sixteen other national environmental organizations, this does not offer adequate protection. In a letter to members of the External Advisory Committee on Smart Regulation the coalition of environmental groups urged a broader application. They wrote, "Rather than applying precautionary measures in exceptional circumstances as your consultation document proposes, precautionary approaches must be integrated much more fully into conventional risk-based practices."³

Panelist Dr. Barbara Mintzes, of the B.C. Centre for Health Services and Policy Research, echoed the concerns of many participants that the new blueprint will be slanted toward expedition of drug approvals, to satisfy industry, rather than protecting the public. Dr. Mintzes pointed out that, in the 24-year period prior to 1999, faster drug approval in the UK was associated with a higher rate of drugs withdrawn from the market. This was in comparison to the USA where the average time for approval was prolonged. With potentially shorter, industry-friendly approval times, regulatory bodies such as Health Canada will have to manage risk and deal with controlling damage after the fact.

For example, a risk management strategy was used in approving the acne drug Diane-35 (cyproterone-estradiol). This medication can cause liver damage but was approved by Health Canada with the recommendation that it be prescribed only to women with a particular kind of severe acne. Dr. Mintzes questions this attempt to contain risk: How could Health Canada be sure the strategy had worked? There was no attempt to inform patients of potential side effects and no follow-up to verify that the drug's use had indeed been limited to its intended specific market. Dr. Mintzes warned that many more drug approvals, with similar outcomes, will follow if the new regulatory framework is adopted.

Such attempts to manage risk are liable to failure, opening a Pandora's box of medications, products and procedures that will irreversibly harm both individuals and the environment.

Dr. Mary O'Brien, a botanist with many years' experience evaluating risks to the environment in the Northwest US, spoke of successes in implementing the precautionary principle, citing the Precautionary Approach Ordinance in force in San Francisco. Author of Making Better Environmental Decisions: An Alternative to Risk Assessment, Dr. O'Brien suggested several practical ways for citizens to influence the process:

• propose standards rather than simply complaining
• don't be afraid to talk to industry
• when urging the use of the precautionary principle, speak in specific terms explaining how you wish to see it implemented
• tackle one thing at a time.

The opportunity to use Dr. O'Brien's tactics became available in late Fall when the first of a series of eight cross-Canada consultations were opened to the public. Representatives of the Privy Council Office asked participants for suggestions for improvements to the Directive, based on study of the Draft Government Directive on Regulating which was posted at www.regulation.gc.ca

On November 16th, BCAM was one of eight groups that attended the Montreal consultation. Most of the groups agreed that the purpose of the Directive should be to guarantee citizens' well-being before any commercial interests, and demanded a firm commitment to precaution when regulating substances and potential for evidence of harm. Health and environment groups that participated in the Toronto consultation have echoed the same concerns. Our hope is that the six remaining consultations will follow our lead and result in changes to the document. The new regulations were scheduled to be finalized in February 2006, but the pending federal election will now give us an opportunity to alert voters and candidates about this issue.

Cindy Wiggins, of the Canadian Labour Congress, a participant in the closing panel on May 9th, reminded the audience that Canadians' tolerance for risk is low and their expectations for precaution are high. She urged activists to work with the public, educate the press, and encourage them to do some investigative journalism. "We need to intervene at all levels of government," she said.

(Dr. Mary O'Brien's book Making Better Environmental Decisions: An Alternative to Risk Assessment is in the office and available for BCAM members.)
1. C. Raffensperger, J. Tickner, Protecting Public Health and the Environment (Island 1999)
2. K. Moore, "SMART Regulation and the Application of Precaution", May 9, 2005
3. Letter from the Canadian Environmental Law Association to Members of the External Advisory Committee on Smart Regulation, August 16, 2004