National pharmacopoeia for available, affordable meds

The solution to a widespread shortage of certain antibiotics, painkillers and anesthetics is to declare a 'national pharmacopoeia' an issue of national security, says the editor-in-chief of the Canadian Journal of Surgery.

While former Ontario Health Minister Eric Hoskins is chairing a federal committee looking to implement a national pharmacare program, in a recent editorial in the Canadian Journal of Surgery, one Schulich School of Medicine & Dentistry professor has argued that approach isn't enough to ensure essential medications are both available and affordable.

"What is security? We often think of it in terms of the military and securing our borders, but securing your health is an element of security. If your borders are intact but everyone is sick inside, that's not satisfactory," said Dr. Vivian McAlister, Angus D. McLachlin Professor of Surgery at Schulich and editor-in-chief of the Canadian Journal of Surgery.

"There are lots of people who think this (drug shortage) is critical to many patients. If your life is at risk, it's a matter of personal security, but because it affects all Canadians, I think it's a matter of national security."

It's not that certain medications – such as gentamicin, an effective and affordable antibiotic on the market for more than six decades – have no alternatives if unavailable, McAlister explained.

The problem is drugs in short supply are often replaced by much more expensive medications which can be inaccessible to patients who have no health insurance.

"(The shortage) affects all aspects of medicine, and we find ways around it at the moment, but it is expensive. What I've suggested for the federal government is that they should make having access to medication an issue of national security," he stressed.

As McAlister sees it, a national pharmacare program just won't be enough. And getting to the point where the federal government administers a pharmacare program is a challenge in and of itself; health care is a matter of provincial jurisdiction first.

But because the federal government is responsible for regulating drugs in Canada, McAlister sees an entry point to addressing both pharmacare and establishing a national pharmacopoeia – Canada's own version of the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.

Medications in Canada have come to us by way of the free market for two centuries, McAlister said. The government has never been involved directly in the production or supply of medicine and this has limited Canadians' access to care.

"The free market system has let us down in many ways. One is that there are now shortages of important drugs that we've used for many years, some for 50 years, and now we can't get them anymore.

"One of the reasons is drug companies don't make enough money making them. In the hospitals, we say they're on 'back order' but it's just a euphemism for not being available. I've had drugs on back order now for five years. It's not just that they missed this month's delivery. They're not available – at all," McAlister explained.

"Then, there are drugs that are so expensive, you could say you pay a king's ransom for access. Some are hundreds of times the average Canadian's annual income. This is an extraordinary amount to request to pay for medical care. These drugs are probably innovative but the profits made from them are so high that somebody's got to say something about it."

McAlister's suggestion to solve this complex issue of equal access is for the federal government to develop its own supply instead of regulating the drugs sold in the country. That supply would not necessarily mean drugs stored in a warehouse; the supply is itself the access, he explained.

"First, the government would have to set up an expert advisory committee to say what drugs we need to have in our national pharmacopeia. That would require experts to work together and come up with the reason for each drug involved; it would be a huge process. With the free market we don't care; we just regulate them," McAlister noted.

But establishing a list of medications all Canadians should have access to – and then finding the means to provide that access – is important.

"There are companies making generics in Toronto. Or we could make a deal with a company overseas that makes certain drugs and sells them to Canada. We would have the power of purchasing and the government could make the drugs available to provinces to administer their own pharmacare program. I think that would get us out of this legal bind between the federal and provincial government," he explained.

What's more, the government's involvement would interfere with pharmaceutical companies' ability to hold a patient ransom and make an exorbitant profit off of critical drugs, something McAlister sees as, essentially, 'war profiteering.'

"If we make (access) an issue of national security, the government has the authority to do certain things. We have to find ways to get the drugs – either by having contracts abroad for a supply or making them – but it would also be in legislation to prevent people from profiteering from medication. If it's a matter of security, it's not like selling gold where it's an elective or a choice. If you make it a matter of national security, you can't make a profit off that," McAlister said.

"It definitely takes a national approach. It's provocative to suggest this but it makes people think. This would be government involvement that would have to be done very carefully, but as soon as you start this process for a pharmacare program, all of these questions arise and need to be answered. Processes have to be developed."