Watch: Health Minister Rona Ambrose announces new rules on what drugs the Special Access Program can provide.

Ottawa could face a legal showdown with some of Vancouver’s hardest-core addicts as they’re cut off from government-supplied heroin doctors say is their only viable treatment option.

New regulations announced last week will ensure Health Canada’s Special Access Program, designed for unapproved medications in serious cases where other treatments have failed, doesn’t allow any more requests for illegal drugs such as heroin or cocaine.

The 20 patients whose requests Health Canada has already approved will get heroin for about three months before they have to re-apply. Under the new rules, they’ll get rejected.

After that, they could be on their own.

The 300-odd addicts involved in Providence Health Care’s SALOME study have all tried other kinds of treatment – some upwards of a dozen times. SALOME studies whether hydromorphone – a potent opioid present in prescription drugs such as dilaudid and Hydromorph Contin – is as effective at treating heroin addiction as clinically administered doses of heroin itself.

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The study isn’t finished. Hydromorpone hasn’t yet been found safe and effective as an addiction treatment. But many of the patients involved have cycled through the program and are left hanging.

In a letter to Health Canada, Vancouver Coastal Health Chief Medical Officer Patricia Daly wrote:

Ambrose says the doctors behind this request for permission to prescribe heroin – Vancouver Coastal Health’s Chief Medical Officer among them – were trying to skirt the rules.

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“I have a feeling the doctors that asked for this authorization through the Special Access Program came this route because they knew they’d be denied another route. But that’s not what it’s there for,” she said. (Her office declined to clarify what she meant)

"it’s not even our jurisdiction to make these kinds of decisions," she told reporters. Ambrose suggested any physicians who really feel their patients need this treatment should approach their provincial College of Physicians and Surgeons –

But the College can’t give a doctor permission to import and prescribe an illegal drug. Only Health Canada can.

Meantime, “there’s all kinds of concerns” about what happens to people who leave this study, still addicted, with no viable treatment, said Scott Bernstein, a Pivot Legal lawyer representing several of the patients.

Overdose is an obvious one. So is crime as addicts break the law – through theft or prostitution or otherwise – to feed their addictions.

But Public Safety Minister Steve Blaney doesn’t think this will be a problem.

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“We want to take heroin out of the hands of addicts, not to put it into their arms. That is why we support treating addiction using real science and real medicine,” spokesperson Jean-Christophe de le Rue wrote in an email.

Treating heroin addiction with prescription heroin has worked before. Even if you discount more than a decade of use in multiple European countries, a 2009 study in the New England Journal of Medicine found it worked in Canada, too.

“It’s not experimental at all,” Bernstein said. (Some people, Toronto-based addiction specialist Mel Kahan among them, have argued the methadone doses used in the NAOMI study were simply too small to be effective)

It also isn’t a financial burden – certainly not on Health Canada, whose permission to prescribe doesn’t mean it’ll foot the bill. A dose of prescription heroin’s actually several times cheaper than methadone, Bernstein said.

Ambrose’s office didn’t respond to questions about the possibility of legal action or how much evidence might be considered enough to justify the prescription of heroin in special circumstances.

“The SAP considers a number of factors when making a decision to authorise a drug under the programme. These include the seriousness of the patient’s condition, other therapies that have been tried or considered and evidence regarding the safe and effective use of the requested drug,” a spokesperson wrote in an email this week.

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Providence is still trying to figure out what its options are. “It’s too early to understand what this means for us,” Byres said.

And lawyers for these addicts are girding for a fight.

“My sense is it’s going to be kind of a very similar case to Insite,” Bernstein said – advocates for Vancouver’s supervised injection site argued the federal government would deny people lifesaving medical care by shutting the facility down, thus infringing on the patients’ Charter rights. They won a Supreme Court victory in 2011.

the current situation, it puts the lives of my clients and other people in SALOME at real risk." “It’s a bit early to say what we’re going to do but I can say we are going to do something, because

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Read: Vancouver Coastal Health Chief Medical Officer Patricia Daly’s letter calling on Health Canada to approve prescription heroin for certain addicts

Read: Health Canada’s new Special Access Program regulations