Feds fumbled ball on opioids
Achieving anything in Canadian politics is the art of the possible — and experience suggests not much is possible.
Rona Ambrose, the health minister, was undoubtedly sincere when she identified prescription drug abuse as a growing problem where government action was required.
The research suggested 410,000 Canadians were abusing prescription drugs in 2012, with the result the death toll from drug poisoning rivals car accidents. In Ontario, oxycodone prescriptions rose 850 per cent between 1991 and 2007, with opioid-related mortality doubling.
Ambrose made it a priority to do something about this grim picture.
She said the goal is to make opioids tamper-proof, so they could no longer be crushed and snorted or injected.
The government planned to introduce legislation that would have the effect of “basically reversing the decision” made by her predecessor, Leona Aglukkaq, to allow generic manufacturers to flood the market with their own versions of OxyContin, which could be easily abused.
But the long-awaited new regulations fell far short of those lofty ambitions. In fact, what was published in the Canada Gazette Saturday did not even amount to draft regulations — rather, what emerged was yet another consultation with industry about the possibility of, at some undefined point in the future, bringing in new rules.
In effect, it punted the issue until after the election and into the next parliament.
Even if this government is returned in October, it looks like its ambitions for any new regulations are limited.
The Canada Gazette notice said they will apply only to “solid oral dosage” products, which critics contend will not substantively address the public health issue. The Canadian Medical Association has said that the only way to have an impact on prescription drug abuse is to extend regulations to cover all opioids.
What’s more, the government envisages a three-year, coming into force period “to promote sufficient time for product reformulation and the necessary supply chain adjustments.”
It looks very much like the minister has been swayed by the powerful pharma industry into bringing in watered-down and long-delayed regulations.
The background information released in the Canada Gazette suggests as much. Feedback from “stakeholders” in the initial round of consultations said tamper-proof technology is “new and emerging and it may therefore be challenging to project its long-term impact.”
Some expressed concerns that regulations could affect the availability and affordability of existing medications, while still others highlighted concerns that the adoption of tamper-resistant drugs could encourage those who abuse them to shift to other illicit substances, like heroin.
The pharma i ndustr y pointed out the complexity of the pharmaceutical supply chain, with manufacturers estimating it would take years to move to new formulations and receive marketing approvals.
Over time, the dynamic idea of taking action to mitigate an escalating public health crisis has been reduced to a bureaucracy simply going through the motions.
Supporters of action say there are 15 global companies already pursuing tamperresistant technologies, covering more than 30 products; they point out that the U.S. Food & Drug Administration has already approved four of those, with another three under review.
No one is suggesting that broadening the scope of the regulations will solve the problem of prescription drug abuse — everyone agrees that any regulatory changes have to move in step with public awareness and prevention programs, labelling changes and new guidelines for doctors.
Determined addicts will always find a way round tamper-proofing — either by chewing the drug, or substituting other opioids.
But most addictions start with abuse of easily accessed prescription drugs. It stands to reason that the harder they are to misuse, the less prevalent the problem may become.
It should not take another three years to announce tough new regulations and bring them into force — something the U.S. did virtually overnight.
This is policy lethargy in action — or inaction. Partisan politics, industry cost concerns and a natural tendency in the bureaucracy not to do anything or the first time have acted as a drag on any momentum. Voters should bear that in mind the next time the Conservatives trot out their “proven leadership” line.