"A Bad Precedent"? You Betcha!

Some follow-up to my post yesterday about the bungling around the approval of Mifegymiso (abortion pill) for inclusion in taxpayer-funded provincial healthcare plans.

The Globe and Mail is still on the story.

It seems that when Mifegymiso's manufacturer, Celopharma, began the long and winding (and politically stymied? remember, there were CONservatives in charge then) process, there were no costs associated with the Common Drug Review.

[Paula Tenenbaum, president of Celopharma] said that when the company began the Health Canada application process in late 2011, the Common Drug Review – which is a separate process, not run by Health Canada – was offered at no cost to pharmaceutical companies. “As a result, we did not budget for the $72,000,” she said. The company asked for a fee reduction or a two-year payment plan, but that proposal was rebuffed.

The Canadian Agency for Drugs and Technologies in Health (CADTH), which oversees the Common Drug Review, confirmed the fees only came into effect in September of 2014. (Ms. Tenenbaum said the full process would actually cost between $100,000 and $150,000; CADTH disagreed and reiterated the $72,000 figure.)

Brent Fraser, the vice-president of pharmaceutical reviews for CADTH, said on Tuesday that giving Celopharma a break on the fees could set a bad precedent.

Here's the short version of drug approval works in Canada.

First, a new drug has to go through Health Canada's Health Products and Food Branch (HPFB), where it is assessed for safety, quality, and effectiveness.

How long does this take? Well, it's hard to say from the website's blah-blah.

HPFB has set internationally competitive performance targets for its conduct of reviews. The length of time for review depends on the product being submitted and the size and quality of the submission, and is influenced by HPFB's workload and human resources.

This part of the ordeal was finally completed and the good news reported in July 2015.

Then Health Canada issues a monograph detailing who may prescribe it, with what training, and other restrictions. That link is from April this year, when abortion providers were getting worried about the folderol being proposed.

But getting provincial healthcare plans to pay for it is a whole other regulatory nightmare.

And of course, Quebec is slightly different.

Here's how it works in Quebec.

Authorization from Health Canada is the first step common to both Quebec and the rest of Canada.

In the rest of Canada, new non-cancer drugs go to Canadian Agency for Drugs and Technologies in Health (CADTH) for what is called a Common Drug Review (CDR). Cancer drugs go to the pan-Canadian Oncology Drug Review.

In Quebec, both cancer and non-cancer drugs go to the Institut national d’excellence en santé et en services sociaux (INESSS).

Expert committees evaluate the new drugs.

If the drug’s therapeutic value has been established, INESSS then evaluates the drug based on four criteria: reasonableness of price charged; cost-effectiveness ratio; impact on the health of the population; effect on the basic prescription drug insurance plan.

Then provincial health departments decide whether to include it. In Quebec, the article notes, sometimes politicians have over-ridden recommendations to include very expensive drugs.

So. Celopharma entered the labyrinth in 2011 and budgeted based on the rules at the time. Health Canada took its sweet time to approve a drug that has been in use in France for 30 years and in the US for over 15 years.

Meanwhile, the independent agency, CADTH, that must review it before provincial healthcare plans will pay for it, slaps on some whopping big fees.

And CADTH can't give the company a break because it would "set a bad precedent."

The rules were changed in the middle of the game -- a game that Celopharma had zero control over -- and there's no relief offered?

This seems unfair to say the least.

There's got to be a way around this. In Australia, a Real Feminist PM, Julia Gillard simply ordered that the drug be listed on its taxpayer funded Pharmaceutical Benefits Scheme.

I realize that things are done differently here, but surely our globally touted FeministPM™, with his gender-balanced cabinet and other meaningless fripperies of respect for women and their rights, could bloody well do something.

Unless of course this whole schmozzle has been engineered as a sleight-of-hand slap in the face to Canadian women, while keeping the Blue Liberals onside.

Whaaaat? I hear you say. Liberals saying one thing and doing another?????????