Volume Nine, Number Two    April 2004    www.columbiajournal.ca

Health Protection or Deregulation?

Colleen Fuller

The federal government is planning to repeal The Food & Drugs Act, The Quarantine Act and The Hazardous Materials Act and replace them with a new bill called The Canada Health Protection Act.

According to Health Canada and the drug industry, a new law is needed because the 1953 Food & Drugs Act is too old and outdated to handle the modern science and technology involved in today's drug development. But the balloon being floated by Health Canada looks more like health destruction than health protection.

The last five years have seen a number of changes within Health Canada, including a major realignment within the ministry, creating nine branches, six regions and two agencies. Among the new branches was the Health Products and Foods Branch (HPFB) (replacing the Health Protection Branch, or HPB), with a mandate to maximize "the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system".

In time-honoured tradition, it was a series of disasters and crises, which led to these changes, dubbed HPB Transition in 1998, and now renamed Legislative Renewal. By the year 2000, the government was confronting a number of serious scandals, which had, in turn, spawned three separate RCMP investigations, a Commission of Inquiry and several lawsuits. These included the Krever Inquiry into tainted blood; an RCMP investigation spawned by allegations that Health Canada officials had failed to withdraw the Meme breast implant despite warnings from one of its own scientists that they were "unfit for human implantation; and the death of 15-year old Vanessa Young after she had dutifully followed a prescription for cisapride, a drug that six months previously had been pulled from the United States and which was contraindicated for her bulimia.

But there were also other government actions that contributed to a rising sense of doubt in Canada's ability to exercise control over the whole area of pharmaceutical drugs and devices. Among these was Bill C-91, a bill passed in the House of Commons in 1993 extending patents on new pharmaceutical drugs to 20 years. Critics of the legislation predicted that Canada would lose control over drug costs, and by the end of the decade it was obvious that they were right. Not only had they lost control over prices, they also appeared to be losing control over the entire industry.

The "Legislative Renewal" process, however, isn't looking at the underlying problems confronting Canadians in the area of health protection. In 1998, an excellent paper prepared by the Women's Health Clinic in Winnipeg accused the Health Protection Branch of "drifting into the role of protecting [the pharmaceutical] industry and its economic growth and abandoning the role of protecting the health of Canadians". The paper pointed to the real problems facing Health Canada, including:



• funding cuts which "deprived the Branch of its ability to set and enforce standards independent of industry influence";
• a lack of sensitivity to issues of gender, culture, class or power and an increasing inability to see or respond to the Canadian public/consumer (as opposed to industry or professionals) as either the real "client" or "partner" in meeting the HPB mandate; and
• a lack of new criteria for "safety", new methods for evaluating drugs and devices after they reach the market.


Canadians have a right to expect Health Canada to be guided by an overarching public interest, not by the marketing strategies of Big Pharma. But that expectation is not being met. Health Canada isn't going to solve the problems we're facing because it hasn't even acknowledged what the problems are. Department bureaucrats lack the political backing they need to put the public interest first, and that is a problem only the politicians can solve. The problem is that both the Liberal Party and the new Conservative Party are not only ideologically in favour of deregulation, they also are financially linked to the pharmaceutical industry (if you don't believe me, go to Election Canada's website at http://www.elections.ca/scripts/ecfiscals2/Default.asp? L=E&Page=Welcome&bhcd2=1080529722 and see for yourself). If this Pharma-funded crew won't serve the public interest (and they won't), it's up to the public to install people who will do the job.

That's what elections are for! But until then, it's important for Canadians to send a strong message to the health minister, Pierre Pettigrew (with a copy to the BC Health Coalition) to put the breaks on the Canada Health Protection Act. Instead of Legislative Renewal, Health Canada needs to address the funding problems -- especially in post-market monitoring. It needs to enforce the existing laws and develop effective mechanisms to involve the public in health protection.

A more effective recipe for change might include:



• the establishment of public advisory committees that are free of industry conflicts of interest to oversee drug approvals;
• a seriously beefed up post-market monitoring system that includes funding so front line organizations like the Vancouver Women's Health Collective or the BC Coalition of People with Disabilities can help collect adverse drug reaction reports;
• whistleblower protection for Health Canada employees;
• and the reestablishment of publicly-funded and independent laboratories that can undertake some of the clinical investigations on potential new drug therapies for Canadians.


Instead of pulling the Food & Drugs Act, Health Canada should try enforcing it first, beginning with the provisions that ban direct-to-consumer advertising of prescription drugs. Then, at least, we might now whether the legislation is workable or not.