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Transition = abdicationA Citizens’ Guide to the Health Protection Branch (HPB)
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Reality Check | What it really means
Reality Check | What it really means
Reality Check | What it really means
Reality Check | What it really means
Reality Check | What it really means
Canadian Health Coalition Recommendation
Note:
This guide provides an analysis of the Health Canada’s discussion paper entitled Shared Responsibilities, Shared Vision: Renewing the Federal Health Protection Legislation. Health Canada’s document and information on the public consultation process is available from:
Health Protection Branch Transition
1-888-288-2098
E-mail: Transition_Dialogue@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/hpb/transitn/index.html
Health Canada is conducting a consultation in September and October on the future of the Health Protection Branch. This guide has been prepared by the Canadian Health Coalition to alert the public to the real issues and to urge organizations and individuals to speak out in defense of the public interest.
Phase 1 of the consultation is the opportunity for the public to make its views known. This will be followed by a White Paper, possibly next spring and a Phase 2 consultation. Make sure your concerns are represented at the workshop nearest you. (See attached invitation and schedule). Send in your request to participate ASAP. Written briefs can also be submitted from anyone unable to attend a workshop.
The health protection system is what guards the safety of the food you eat and the safety of drugs and medical devices. Last summer, Health Canada began to quietly dismantle the structures at the Health Protection Branch which enable the Minister of Health to enforce laws dealing with the safety of food, drugs and health products. Now Health Canada wants to gut Canada’s health protection legislation. Food and drug industries will, in effect, self regulate the safety of their products. This will be sold to the public by the pharmaceutical industry and other corporate interests as "freedom of choice".
The Health Protection Branch consultation, called ‘HPB Transition’, is a smoke screen designed to deceive the public. HPB Transition is really about abdication of the duty to protect the public from hazardous food and health products. The move to abdicate the health protection duty is the most dangerous privatization ever attempted in Canada. If the federal government gets away with destroying the health protection system, no health care system will be able to cope with the fall-out in rising disease rates, premature deaths, and billions of dollars wasted on dangerous or useless drugs. If we lose our health protection system, we lose a key component of Medicare.
The HPB Transition is part of a profound change in policy direction for the Canadian public sector. ‘Old’ values like guarding the public interest and the common good are replaced with ‘new’ values like satisfying industrial clients and serving private interests. The ‘old’ value of health as a public good is replaced by the ‘new’ value of health as an industrial commodity.
The Chrétien cabinet wants the federal government run like a business and for business. Specific policies to achieve this goal include: privatization, de-regulation, harmonization, cost-recovery, voluntary compliance, commercialization, strategic partnerships, and special operating agencies. When "business needs" drive a government agency like the Health Protection Branch, the results are deadly.
This abdication of responsibility can only succeed if the public lets the federal Liberal government get away with it. The Chrétien government is motivated by an ideology from the Thatcher-Reagan era that views government regulation of health and safety as a burden on business to be eliminated. However, the Blair and Clinton governments have reversed a number of these polices after disastrous experiments with privatization of health protection and de-regulation. A focused and tough public campaign by health activists can force a real change in direction in Canada as well.
1. The first objective of HPB Transition is" to update and integrate the federal health protection legislation to ensure that the proper tools are available to protect Canadians".
In existing health protection legislation, if the Minister of Health and or Departmental managers abdicate their duty to protect the public from hazardous products and fraud, they could face criminal prosecution. Health Canada managers, facing the possibility of prosecution, destroyed all audio tapes and verbatim transcripts of every meeting of the Canadian Blood Committee from 1982 to 1989. The RCMP, investigating since February 1997, have still not laid a charge for these crimes.
There are presently $8 billion in lawsuits against Health Canada from victims of contaminated blood and breast implants alone. Many more lawsuits are expected.
The structures that provide the Minister of Health and his managers with the legal means to carry out their responsibility for food and health product safety are being dismantled. The investigative laboratory facilities, food and drug safety research and surveillance capacity have all been gutted.
Canadians are being killed because health protection Acts are not being enforced, not because laws are "outdated". In fact, regulations to the Food & Drugs Act are updated constantly. Laws against poisoning however, don’t go out of date. HPB Transition is a smoke screen for an abdication of responsibility that will contribute to the preventable death of thousands more Canadians.
The goal of the HPB Transition is to off-load Health Canada’s responsibility for the safety of food and health products onto manufacturers and consumers. The Food & Drugs Act will be broken apart into separate acts for food and drugs to satisfy Health Canada’s clients, the food and drug industries. The "renewal" plan will absolve Health Canada managers of their responsibilities for safe food and drugs products. The next step is to remove the prohibition on direct-to-consumer drug advertising.
Health Canada wants industry alone to be responsible for the safety of food and health products. Consumers will be responsible for the safe use of these products. It is not possible however, to trace the exact source of a contaminated bag of blood or identify which food product caused harm. Manufacturers know they alone can’t be held to account for the safety of their products. This is why the Minister, his managers, and the manufacturer are all currently accountable under the Food & Drugs Act for the safety of products.
The "update" Health Canada is drafting will bring health protection legislation in line with overall objectives of the Chrétien government: trade and the market agenda comes before health and safety. This is known as getting government right and involves running government like a business and for business. HPB language reflects these policy objectives: "regulatory competitiveness", "flexibility in managing health risks" and "cost-effective health protection".
2. The second objective of HPB Transition is: "to strengthen the science that underlies decision making, ensuring its capacity to meet current and emerging public health risks".
Early in 1997, the entire Bureau of Drug Research was quietly dismantled and facilities for independent lab investigations of pharmaceutical products destroyed. These scientists were recognized internationally for independent research on drug quality, toxicity, bioequivalence, and clinical application of drugs. Industry scientists say that with the public labs gone, they don’t bother sending their top scientists to drug review meetings at HPB because nobody there can ask the tough science questions anymore.
In July 1997, food safety research was terminated and labs were secretly dismantled. Generations of scientific know-how was lost and scientific morale shattered. Projects cut included: investigations into detection of deadly microorganisms and harmful bacteria, toxic chemicals, preservatives, pesticides, residues of volatile contaminants, additives, herbicides, insecticides, fungicides, glass particles and insect parts, and genetically modified organisms in food. As a result of the cut, several internationally recognized Canadian food scientists went to work in the U.S. where their scientific skill is rewarded.
The internationally recognized work of Canadian scientific and regulatory personnel in food and drugs took thirty years to build. Senior managers at Health Canada have destroyed it in months. They claim this work can be done elsewhere. The fact is that no private labs in Canada have the multi-disciplinary teams and the legal authority to undertake investigative laboratory research and surveillance of non-standard problems. It is also virtually impossible to find NGO or university researchers who do not have conflicts of interest by virtue of funding from industry.
Without in-house investigative lab capacity, the Food & Drugs Act cannot be enforced. Without these labs Canadians will increasingly play a guinea pig role in the testing of new drugs. Manipulation of data by pharmaceutical companies will no longer be detected or challenged. The investigative laboratory system and staff of research scientists is replaced by "an office of science" which will consist of a small library and Internet connection with pharmaceutical companies and industry funded research institutes. This is science?
Some food research cuts were ordered reversed by the Minister in October 1997, after public outcry. But a year later, no positions have been filled beyond a 2 year term and no scientist given a research budget. The Minister of Health appointed a ‘panel of experts’ to look into this and report in a couple of years, after the regulatory structures no longer exist. If the Minister was committed to performing his health protection duty, wouldn’t he already know that an independent capacity for food and drug safety research and surveillance is essential?
3. The third objective of HPB Transition is "to improve the management of health risks, while explicitly recognizing the roles and responsibilities of all partners and participants in the process, especially the general public".
Senior Health Canada managers are aggressively applying Treasury Board management guidelines to the health protection system. According to a Treasury Board Report on Risk Management, the problem facing government managers is three-fold: "how to reduce the cost of risk management and manage public expectations without jeopardizing global competitiveness".
Treasury Board recommendations on risk management include the following:
The language of risk management, risk assessment, and risk communication has become a weapon of multinational pharmaceutical, pesticide and food corporations and their political supporters. Government regulation of health and safety are seen as barriers to trade, competitiveness and profits.
"Shared responsibility" really means abdicating federal responsibilities, making manufacturers responsible for product safety and consumers responsible for using the products safely. That leaves Health Canada with no safety responsibility, except counting Canadians who get sick and die.
The risk management framework manages uncertainty in the interests of big business at the expense of individuals’ health and safety. Many risks induce systemic and irreversible harm but evade human perceptive abilities (e.g. radioactivity, toxins and pollutants in water, food and drugs).
Managing public expectations downwards means convincing citizens that some deaths and illness are acceptable even when preventable at minimal cost.
Risk management frameworks encourage regulators to take risks they would not otherwise take. Safety becomes just another trade-off. The health risks of a toxic tar pond are just another economic trade-off in your neighbourhood, defined as "acceptable" by Ottawa.
Risk management in health protection leads to grotesque calculations that put dollar assessments on human lives. For example, Health Canada blood regulators, working with their "client" - the manufacturer of blood products - could decide that the benefits of distributing contaminated blood product (i.e. $100's of millions in revenue for the company) could outweigh the costs (i.e. liability for loss of life and injury which is difficult to prove).
4. The fourth objective of HPB Transition is "to improve and modernize the Canada-wide health surveillance network".
When the Health Protection Branch Transition is completed, it will have dumped its responsibility for product safety and lost most of its regulatory power. Plans are underway to set up a special operating agency closer to industry to regulate drugs and medical devices. Food inspectors have been transferred to a special operating agency, the Canadian Food Inspection Agency; the Bureau of Drug Research has been eliminated; environmental labs transferred; and food safety research discontinued.
All that will be left at HPB will be the disease watchdog, the Laboratory Center for Disease Control. With the health protection system gutted there will be lots more disease to watch. This surviving entity would probably be renamed the Center for Public Health and relocated to Winnipeg, in isolation from the regulatory units.
The proposed Centre for Public Health would do everything but focus on issues that determine the health of the population. Health Canada would no longer have the ability to protect basic determinants of health like safe food.
Health Canada is dismantling its integrated health protection system housed under one roof and disbanding the co-ordinated response teams of food inspectors, food scientists, drug scientists, epidemiologists and environmental scientists needed in times of crisis.
Health Canada food and drug safety scientists will no longer have the means to detect and anticipate dangers in the food system and in drugs and thus prevent hazards from killing people. The "health surveillance network" will focus instead on the analysis of death and disease in the population.
If all Health Canada does is count dead bodies, in isolation from regulatory investigation and action, then health protection is weakened not strengthened. Death and disease rates will rise as a result of Health Canada’s abdication of responsibility for health and food product safety.
5. The fifth objective of HPB Transition is "to review and improve the delivery of health protection programs".
Food and drug scientists are told that they must now serve their ‘client’ (the food and drug manufacturers) who now pay for services through cost-recovery. $24.2 million of the 26.8 million budget for drug safety at HPB in 1997 comes from drug industry revenues. Industry satisfaction is the ‘new’ value. Public interest and the common good is the ‘old’ value. Food and drug scientists who stick to ‘old’ values and refuse to approve multi-million dollar products for safety reasons are removed from the file. They are replaced by reviewers who will satisfy their ‘client’.
In February of 1997, HPB drug reviewers were instructed that their client is the company who pays for the service. "By adopting a client focus and service orientation, regulatory organizations can help those seeking approval to comply with regulations as easy as possible, promote voluntary compliance, earn goodwill from the regulated community...,and improve the working atmosphere". The bulletin also says: "there is no conflict of interest between delivering a service to a client and functioning in a regulatory environment."
Health Canada food inspectors were transferred to a special operating agency, the Canadian Food Inspection Agency (CFIA). The mandate includes the promotion of trade and the food industry. The CFIA has already cut about 300 food inspectors. 80% of the remaining food inspectors will be eliminated in two years. Meat slaughterhouses and food processors will do their own inspections.
Plans are underway to establish additional special operating agencies outside the Department of Health for drug approvals and medical devices. Experiments with these special operating agencies in the U.K. under Thatcher have resulted in a major public health crisis over Mad Cow disease (BSE) and other food safety scares. The Blair government recently reversed the policy and returned responsibility for food safety to the Department of Health.
These "improved" delivery mechanisms involve massive abdication of regulatory authority. It amounts to institutionalized conflict of interest. It also means HPB won’t force manufacturers to spend more to make a product safe. Justice Krever concluded that HPB was a lax regulator and that minimum safety precautions would have averted the entire blood tragedy. HPB Transition violates the spirit if not the letter of the entire Krever Report. Chrétien is putting the fox in charge of the henhouse.
Health Canada’s duty to guard and protect public health and safety is being corrupted with trade and commercial values. This amounts to what Jane Jacobs calls ‘a monstrous hybrid’. A Globe & Mail editorial ("Dust settles at Westray", Dec. 2, 1997) observed that: "Businesses can’t be properly regulated by government - and for environmental and health reasons they must be - if that government is in bed with them."
"We are committed to maintaining a universal health care system in which Canadians are assured equal access to appropriate, high quality care as needed. We must build a public medicare system that will meet the emerging needs of the 21st century."
The protection of the public from food and drug hazards is a key component of the medicare system. Poor performance of this duty leads to lives lost and billions of scarce health care dollars squandered on useless or dangerous drugs.
Overall funding for the Health Protection Branch is being cut in half from $237 million in 1993-94 to $118 million by 1999-2000. Plans are underway to eliminate 60% of the staff at the Health Protection Branch. Health Canada’s spending priorities tell the story.
HEALTH CANADA SPENDING BY ACTIVITY ($ millions) |
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Activity |
1993-94 |
1996-97 |
1997-98 |
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Food Safety, Quality and Nutrition |
63.1 |
42.5 |
22.5 (1) |
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Drug Safety, Quality and Effectiveness |
69.5 |
26.2 |
na |
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Program Management (2) |
96.0 |
153.4 |
na |
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Unspent money returned to Treasury Board |
na |
17.0 |
na |
Major investments in administration and information management, combined with the elimination of food and drug safety research laboratories, indicates that Health Canada is in Transition from a science-based health protection agency to an propaganda agency. Without in-house food and drug investigative lab capacity information supplied by industry for use on the Health and Information Highway cannot be independently verified. The proposed Canadian Health Information System would then be a highway for contaminated evidence and food and drug industry advertising.
To deal with the crisis in health protection and the deception at Health Canada, the CHC is making the following recommendations to the Chrétien government:
Isn’t safe food a major determinant of health for Canadians?
Yes, but corporate greed seems to be the major determinant of federal food policy.
What happens when Ottawa throws its food and drug regulators into bed with industry?
Thousands of Canadian women, children and men die prematurely. Billions of Medicare dollars are wasted on drugs that don’t work or harm people.
With the public food and drug safety research labs closed, who will validate the information supplied to Health Canada for use on the Health and Information Highway?
The food & drug manufacturers and the researchers they fund.
Who will benefit from weaker health protection laws?
The multinational pharmaceutical, food and chemical corporations.
Who will stand with the tens of thousands of Canadians who are dying or ill because of Health Canada’s lax approach to safety and health protection?
The Canadian Health Coalition hopes you will.
John Abraham, Science and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation, London: UCL Press, 1995.
Ulrich Beck, Risk Society: Towards a New Modernity, London: Sage Publications, 1992.
Ursula Frankin, The Real World of Technology, Toronto: General Publishing, 1998.
Jane Jacobs, Systems of Survival: A Dialogue on the Moral Foundations of Commerce and Politics, New York: Vintage, 1994.
Nicholas Regush, Safety Last: The Failure of the Consumer Health Protection System in Canada, Toronto: Key Porter Books, 1993.
Peter L. Bernstein, "The New Religion of Risk Management", in Harvard Business Review, March-April 1996, pp. 47-51.
Mary F. Hawkins, Unshielded: The Human Cost of The Dalkon Shield, Toronto at the University Press, 1997.
Barbara Mintzes, Blurring the Boundaries: New Trends in Drug Promotion, Amsterdam: Health Action International, 1998.
André Picard, The Gift of Death: Confronting Canada’s Tainted Blood Tragedy, Toronto; Harper-Collins, 1997.
Sheldon Rampton and John Stauber, Mad Cow U.S.A.: Could the Nightmare Happen Here?, Monroe, ME:Common Courage Press, 1997.
Sheldon Rampton and John Stauber, Toxic Sludge Is Good for You: Lies, Damn Lies and the Public Relations Industry, Monroe, ME:Common Courage Press, 1995.
Ken Rubin, Towards an Ecological Diet for Canadian Consumers: Some Regulatory Barriers and Citizen Action Strategies, Ottawa, 1995. Available from Ken Rubin, 212 Third Ave. Ottawa K1S 2K3.
Langdon Winner, The Whale and the Reactor: A Search for Limits in an Age of High Technology, Chicago: University of Chicago Press, 1986.
