Meat, antibiotics, and a regulatory wasteland

Posted By William Stephenson – Nov. 25, 2013

Antibiotics administered to humans in the US total about 3.3 million kilogrammes annually. Antibiotics administered to livestock, by contrast, exceed 13 million kilogrammes. Amid growing concerns about antibiotic resistant superbugs, should we worry about the amount of antibiotic use in livestock?

Antibiotic resistance in livestock: risk to humans?

The US Centers for Disease Control and Prevention explains that producers should use antibiotics in livestock judiciously, since they contribute to the “emergence, persistence, and spread of resistant bacteria.” Resistant pathogens in livestock are of particular concern, since they can “directly or indirectly” lead to resistant infections in humans, through meat consumption, for example.

Today, many farmers rely on antibiotics to prevent disease in confined animal feeding operations (CAFOs). This allows them to raise large numbers of animals in close quarters, thus decreasing overhead costs. The animals receive antibiotics through their feed, injections, or topically. Critics especially decry the use of antibiotics in feed, since there is no way to control the dose if the animals are allowed to eat as much as they want.

While the causal link between antibiotic resistant pathogens in livestock and humans remains unclear, some studies have documented a correlation. Notably, a 2010 study of the use of the antibiotic Ceftiofur in chicken production in Québec found evidence that it led to “extended-spectrum cephalosporin resistance in bacteria from chicken and humans.” The researchers concluded that Canada should “scrutinize and, where appropriate, limit use of ceftiofur in chicken production” to preserve the effectiveness of extended-spectrum cephalosporins.

“Own use” regulatory gap in Canada

The most glaring regulatory gap in Canada is the “own use” loophole, which allows farmers to import about $100 million of antibiotics yearly – including unapproved and untested antibiotics – to use on their own animals. Since no one oversees the use of these antibiotics, this represents an enormous void in Canada’s antibiotics resistance strategy.

Toward sounder antibiotic use

In Canada, the most pressing issue in this domain is to close the “own use” loophole and ensure better oversight of the use of antibiotics in livestock. In a 2013 policy paper, the Ontario Medical Association also called for banning the prophylactic and growth-promoting use of antibiotics to preserve the effectiveness of antibiotics. These measures are essential to correcting our approach to antibiotic resistance.

Canada could also incentivize producers to move away from CAFOs, which require a volume of antibiotics, and instead encourage a move toward more natural production. This can, in fact, lead to significant savings. Russ Kremer, for example, found that in the first year he transitioned from his confined hog operation to a natural, antibiotic-free operation, he saved between $16,000-18,000 on veterinary bills and antibiotics.

Consumers can also have an impact on the use of antibiotics in livestock by demanding antibiotic-free meat, poultry and dairy. The market may be the most effective way to reduce – and eventually eliminate – our dependence on antibiotics in livestock production.

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Further reading:

Task Force on “Own Use” Importation of Antibiotics

For a contrasting view on the use of antibiotics in livestock

Drawing the line between Naturopathy and Medicine in Ontario

Posted By Jessica Walsh – Nov. 18, 2013
Naturopathy will soon become a self-governing profession in Ontario bound by new rules. Upon its entry into force, the Naturopathy Act, 2007 will regulate the profession and establish a professional self-regulatory body, the College of Naturopaths of Ontario (the College), to manage accreditation, complaints and disciplinary procedures. It will also bring naturopaths under the Regulated Health Professions Act (RHPA), the umbrella legislation applicable to all other regulated health professions.

The transition toward the new governing structure has been slowed by fierce debate. Proponents of naturopathic medicine worry the new legislation will limit the scope of the profession by outlining a schedule of permissible practices. On the other hand, opponents argue the new structure increases the role of naturopaths to the point of crossing into the practice area of physicians and registered nurses, posing serious risks to public safety.

Background

More than 1200 naturopaths are currently registered in Ontario. They blend science with traditional and natural therapies to stimulate natural healing processes. To be registered, naturopaths must graduate from a recognized naturopathic education program and pass provincial and North American standardized exams. Since 1925, they have been regulated under the Drugless Practitioners Act. Under this scheme, they cannot perform surgery, midwifery or prescribe or administer drugs or anesthetics. However, this structure has allowed naturopaths to operate in a legal grey zone.

The move toward self-regulation of naturopaths in Ontario has paralleled the growing popularity of alternative medicine in Canada, as well as the self-regulation of naturopaths in other provinces. Naturopaths are currently regulated in BC, Alberta, Saskatchewan, Manitoba and Nova Scotia.

What’s new?

Under the Naturopathy Act, naturopaths will only be able to perform controlled acts listed in the RHPA. This includes taking blood samples, giving injections and giving naturopathic diagnoses. However, draft regulations created by the College have suggested authorized acts could include high-risk practices that opponents deem exceed the scope of naturopathy. The new structure does not change the fact that visits to naturopaths are not covered by provincial health insurance.

Reaction

For the College, the new regulations restrict how naturopaths have traditionally exercised their role. The regulations in Ontario are also stricter than those in other jurisdictions, such as BC and California. In those places, naturopaths can use X-ray machines, provide high blood pressure diagnoses and perform minor surgery. These activities would be prohibited under Ontario’s new regime.

Yet opponents would like the new regime to significantly narrow the scope of naturopathy. Registered Nurses and the Ontario Medical Association have voiced safety concerns over allowing naturopaths to order lab testing for conditions like HIV/AIDS and hepatitis. In addition, they warn of the risks of allowing naturopaths to administer substances for which they lack training, such as potassium chloride, lithium, and epinephrine. In a public submission, The Ontario Medical Association has also stated that the proposed regulations problematically grant naturopaths the ability to practice medicine in some circumstances instead of naturopathic medicine. For instance, naturopaths may order lab testing for serious medical conditions or organ failure.

Some opponents even challenge the regulation of naturopaths entirely. They argue that bringing naturopaths under the RHPA will assign credibility to a profession whose practices are not underpinned by evidence-based medicine. These critics point out that naturopathy follows a pre-scientific static belief system that fails to evolve alongside changes in modern science.

At a time when a rising numbers of Canadians are seeking alternative health therapies and Canada is facing new health challenges related to its diverse ageing population, this debate is worthy of attention.

MJLH Online Editor Weighs in on Carter v Canada for JURIST

Posted By Rosel Kim – Nov. 13, 2013
MJLH Senior Online Editor Laura Crestohl recently wrote an article for JURIST, the University of Pittsburgh School of Law’s legal news and research service. The article looks at the state of physician-assisted suicide in Canada, focusing on the case of Carter v Canada, where the BC Court of Appeal overturned the BC Supreme Court’s decision declaring the criminal law prohibiting physician-assisted suicide unconstitutional. The article is available here.

Finding just solutions for the world’s poor within an unjust system: Thomas Pogge’s lecture, “Paying for Health Impact”

Posted By Silvia Neagu – Nov. 10, 2013
Professor Thomas Pogge, world-renowned philosopher, head of the Yale Global Justice Program and Leitner Professor Philosophy and International Affairs at Yale University, gave a lecture at McGill on October 11th, 2013 entitled “Paying for Health Impact.” The event was sponsored by the McGill Research Group on Health and Law and the Institute for Health and Social Policy.

The problem

As Pogge explained, the world’s poor are afflicted with health problems for which medicines are either too costly or unavailable. This stems from the fact that pharmaceutical companies’ patents create monopolies that keep costs high. The current framework is such that pharmaceutical companies’ profits are maximized when they mark-up the prices and make drugs accessible only to the richest portion of the world’s population, rather than keeping costs low and reaching a more substantial portion of the population. Moreover, pharmaceutical companies have little financial incentive to solve health problems affecting the world’s poor, such as tuberculosis and sleeping sickness.

Despite these problems, many experts often predict that changing patent policies and regulations would have the negative effect of decreasing pharmaceutical companies’ incentive for innovation.

The legal framework at play

Further, Pogge explained that the World Trade Organization’s TRIPS agreement requires that its member states (ie, all the developed countries and most developing countries) grant 20-year patents for pharmaceutical innovations. Hence, there is little wiggle-room for governments or other bodies wishing to decrease the cost of new medicines.

The solution: Paying for performance

Pogge’s plan consists of the Health Impact Fund (HIF), an alternative reward program that financially incentivizes pharmaceutical innovators to help the greatest number of people possible, and creates an optional, parallel system to TRIPS. This way, the plan would create an incentive to innovate medicines that the poor do not have access to now. The HIF would pay innovators based on their share of the health impact on the population whose health was improved. By being optional, the plan would not violate TRIPS. Further, since companies’ profits would depend on health impact, the HIF would also incentivize proper drug delivery to patients.

The logistics

Registration and reward pools: Pharmaceutical innovators would register a drug with the HIF and enter a reward pool comprised of all the drugs targeting the particular health issue. If Drug A saved 10% of the total Qualify-adjusted life years (QALY) in a given year, drug A would receive 10% of the reward pool. Its impact would be re-evaluated every year for 10 years. Afterwards, drug innovators would allow the generic version of their products to go on the market.

Prices: Innovators would agree to sell the medicine at the lowest feasible cost of manufacture and distribution, as determined by a tender process. This would also be favorable to developing countries who are most likely to be the lowest bidders.

Funding: Countries would have to register with the plan at an initial 6 billion dollars, which Pogge argues will be worth it in terms of the health care costs. Also, richer countries could pay the registration costs for poorer countries as part of their foreign aid package. If countries with a high rate of poverty did register, the medicines would still be distributed at the HIF rate, but this would not be the case for richer countries, such as Canada.

Final thoughts: how refreshing!

My classmates and I were both struck by the novelty of being presented with a solution to a problem, along with a concrete implementation plan. Pogge’s plan seems very plausible because it is grounded in reality – it finds a way to work without disrupting WTO’s TRIPS agreement and without upsetting “Big Pharma’s” interests. However, one might wonder whether governments might see supporting the HIF as being too radical a step, in light of conservative economic trends.

Should the HIF gain ground in Canada, where health care is a provincial prerogative but is still reliant on transfer funds from the federal government, what would happen if there were tensions between provincial and federal actors? For better or for worse, the fate of the HIF seems to be closely tied to the capriciousness of state support.


Also check out: MJLH’s live tweets from the Pogge lecture.

Physician-Assisted Suicide: Where is Canada going?

Posted By Stephanie Hewson – Nov. 1, 2013

Part I: The B.C. Court of Appeal Ruling in Carter v Canada (Attorney General)

On October 10, 2013 the British Columbia Court of Appeal (BCCA) overturned a trial court decision that found the criminal ban on physician-assisted suicide to be unconstitutional. The BCCA upheld the ban, basing its decision on a previous Supreme Court of Canada case, Rodriguez v. British Columbia (Attorney General), decided in 1993.

Legal history of assisted suicide in Canada

Section 241(b) of the Criminal Code states that “Every one who…aids or abets a person to commit suicide, whether suicide ensues or not, is guilty of an indictable offence and liable to imprisonment.” In Rodriguez, the Court upheld this law, stating that though it might infringe a person’s right to liberty and security of the person under section 7 of the Charter, it reflected fundamental values at play in our society. Specifically, the law reflected the state’s interest in protecting vulnerable people from being coerced or pressured into an unwanted end-of-life.

BCCA decision: Majority

The majority found that they had to respect Rodriguez and uphold the ban. Justices Newbury and Saunders found that s. 7 jurisprudence had not changed enough since 1993 to set aside the Supreme Court decision. The majority held that they were bound by the decision in Rodriguez. They further held that a total ban was an appropriate measure to protect vulnerable populations, such as people with chronic illnesses and disabilities, from being coerced into an unwanted end-of-life.

The majority also wrote that there was no clear societal consensus either way on assisted suicide, and suggested “the value-laden question” was one better decided “by our elected representatives after an informed public debate.”

BCCA decision: Dissent

The dissenting judge at the BCCA, Chief Justice Finch, would have struck down the criminal ban. He found that a total ban on assisted suicide infringes the s. 7 “right to life,” which was not specifically addressed by the Supreme Court in Rodriguez. He cited evidence of the premature deaths of people with degenerative illnesses. These people commit suicide earlier than they otherwise would, because they know they will not have access to doctors’ assistance to end their lives when they are no longer autonomous. Justice Finch also found that the law was too restrictive, and that safeguards seen in other countries where physician-assisted suicide is legal could effectively protect vulnerable populations.

What’s next?

The plaintiffs have stated that they will appeal the decision, and hope that their case will proceed to the Supreme Court. The Supreme Court will have to decide whether s. 241(b) is still constitutional in light of the new evidence about premature deaths, and whether there have been substantial changes in how s. 7 Charter claims are decided. The case has generated a surge in public interest on the issue, which is also the topic of new legislation in Quebec.

Part II of the series will discuss the newly proposed legislation on the right to die in Quebec.