BRAUN: Bureaucrats will stop game-changing meds from coming here

If the Patent Medicine Prices Review Board (PMPRB) has its way, innovative new drugs and vaccines won’t come to Canada in future.

The final guidelines from PMPRB — a federal agency — were released a few days ago. They will ensure Canada gets left behind for many new drugs, especially those for rare diseases.

Rare diseases aren’t so rare, since 2.9 million Canadians are affected. There are about 7000, including cystic fibrosis, ALS, some types of childhood leukemia, sickle cell anemia, many cancers, PKU, multiple sclerosis and hemophilia among them.

Half are diagnosed in children.

The Patent Medicine Prices Review Board (PMPRB) began life as a way to prevent price gouging by drug companies. Now they want to dictate automatic price reductions that will create a roadblock for many new drugs.

And yes, that would include a new vaccine for COVID-19 — except that therapies for COVID are exempt from the PMPRB rules.

Why? Because with PMPRB as gatekeepers, we wouldn’t be getting a COVID vaccine. It could be deemed too expensive. Their decisions are economic, not medical. And so an exception was made for COVID therapies.

The Canadian Cystic Fibrosis Treatment Society (CCFTS) and CanPKU are but two of the many health groups that have spoken up on what a disaster these new regulations will be for Canadians.

The system is so Kafkaesque that it’s almost impossible to understand.

What’s involved are Health Canada, the PMPRB, which dictates the maximum price for a drug, the Canadian Agency for Drugs and Technologies in Health (CADTH), which decides public reimbursement, and the pan-Canadian Pharmaceutical Alliance (pCPA) which oversees federal and provincial drug-price negotiations. That’s for starters.

The process is so convoluted that hundreds of consulting firms exist solely to help the drug companies navigate Canada’s network of bureaucracy.

It all counts now more than ever because the federal government would like to create a national pharmacare program — to make drugs available to everyone “free” which sounds great, just as OHIP+ seemed like a good idea at the time.

Currently, about half of all Canadians have a drug program through work, and many have an excellent plan that gives them access to all 13,000 drugs approved by Health Canada.

But not everyone has adequate drug insurance, and some people have none.

The feds would solve that with one plan for all, ensuring lousy coverage for everyone. Forget the 13,000 drugs — you might access to 5,000 generics.

Chris MacLeod, head of CCFTS, uses the example of the new CF gene-altering drug Trikafta (from Vertex pharma), a miracle drug that may never come to Canada.

It’s expensive, there are only 4,000 cystic fibrosis patients here, so the PMPRB won’t do the math. Bureaucratic dithering has kept other Vertex drugs in limbo (except for those with private drug plans, of course); while haggling continues, patients die.

(Vertex is giving Trikafta to 140 very sick Canadians on a compassionate basis.)

MacLeod said if PMPRB dictates rock bottom prices for everything, drug companies will just give up on Canada. They won’t bother to try to enter the marketplace here. Say goodbye to innovation and research and development.

It won’t matter what drug plan you have. You’ll have to travel to other countries to get the medications you need.

“Negotiate, don’t regulate,” said MacLeod.

“Don’t preclude the drug from entering our market.”

John Adams, president and CEO of CanPKU, had to figure out this labyrinth on behalf of one of his adult children who needs a specific drug. It’s available here if you have a private drug plan, but if not, you’re out of luck. The drug has been in price negotiation limbo for 10 years for those with government drug plans.

That’s our two-tiered medical system at work.

National pharma care, said Adams, “does not deliver therapies to patients. It does not deliver good outcomes to patients.It serves job security for bureaucrats, running process upon process upon process.

“And you suffer needlessly and die prematurely.”

Rare disease drugs merited two sentences in the 2019 budget, noting $500 million had been set aside for use starting in 2022. That’s about it.

Meanwhile, said Adams, the feds already have the perfect model of decent pharma care right in front of them — the drug insurance every federal employee has.

“It covers all 13,000 drugs approved by Health Canada … we’re talking about 250,000 Canadians and their dependents in every province and territory.  It’s something Prime Minister Trudeau and his wife and children have.

“And guess who’s paying for it? Every federal taxpayer is contributing.

“It will be great when we can have that for every Canadian.”