New Tricks for Old Drugs? Canada must change how it accesses Essential Medicines
While Canada must make plans for ensuring access to COVID-19 vaccines and cures that have yet to be discovered, the pandemic has highlighted longstanding but overlooked barriers to accessing valuable medicines that already exist.
To address them, Canada must go beyond narrowly targeted emergency measures or moderate reforms focused on the prices of new medicines and undertake systemic changes that prioritize medical utility over commercial interests. Canada’s approval system hinges not on how useful a drug is but whether any company is interested in selling it. The result is that Canada boasts many patented new drugs offering only mild improvements over their cheaper predecessors while insufficiently profitable drugs, regardless of their utility, may not stay on the market.
Health Canada’s list of Tier 3 drug shortages outlines “those that have the greatest potential impact on Canada’s drug supply and healthcare system.” It is unsurprising that of the 30 drugs on this evolving list on June 10, 23 were “used in the treatment of COVID-19 and/or related conditions.” It is also unsurprising, given those criteria, that more than two thirds were also found on the World Health Organization’s (WHO) Model List of Essential Medicines that outlines drugs every functional health system should have.
What would be likely surprising to many Canadians, however, is how far removed these crucial drugs are from cutting-edge innovation. Only two of the drugs in Tier 3 shortage date from the 21st century; the oldest were discovered more than 200 years ago. An even greater surprise would be that in the case of four of the Tier 3 drugs – atracurium, vecuronium, pancuronium and propylthiouracil – they aren’t merely out of stock but not currently marketed in Canada at all. Indeed, in all four cases (all but pancuronium also being WHO Essential Medicines), every company selling the drug in Canada had already decided to discontinue sales before COVID-19 first appeared.
The first three, like the majority of the drugs currently on the Tier 3 list, are employed as part of the process of putting COVID-19 patients on ventilators, a difficult and painful procedure in their absence. Not all of these drugs would necessarily be the first choice under normal circumstances but in the midst of a pandemic, the value of having a fully stocked medicine chest becomes clear.
The pressures of COVID-19 have exacerbated broader Canadian struggles with drug shortages but in the case of these three drugs, Canada entered the pandemic with no formal access at all. While Health Canada could not have predicted the sudden surge in demand resulting from an unprecedented disease, it could certainly have identified the risk inherent in a drug no longer being sold in this country.
In the case of the fourth drug, propylthiouracil, Canada was informed that it was being discontinued in December 2019; as existing stocks were used up, its absence created serious concerns for treating pregnant women with hyperthyroidism. While not directly implicated in the COVID-19 response, the predicament resulting from its disappearance illustrates a similarly inadequate response despite its serious impact on Canadians.
Unfortunately, many old Essential Medicines serve small niche markets, meaning there may only be one or two suppliers at best. Indeed, quite a few are simply never marketed in Canada at all. Of the two Essential Medicines that jointly won their discoverers the Nobel Prize in Medicine in 2015, ivermectin, was only approved in Canada for human use in 2018, decades after the rest of the world; artemisinin remains absent, albeit readily available abroad. Numerous tuberculosis drugs dating back half a century are similarly unavailable.
Or consider the Interagency Emergency Health Kit, compiled by United Nations agencies in collaboration with organizations like Médecins Sans Frontières and the Red Cross, which boils down the WHO’s Essential Medicines list to the most vital handful of drugs in humanitarian emergencies. Of the resulting 14 drugs in the kit, which includes ibuprofen and acetaminophen, only 10 are available in Canada.
It is also worth emphasizing that none of the Essential Medicines referred to in this article is currently under patent; any company could make the drug if it thought it sufficiently lucrative to do so. Thus, it is striking that the boldest step Canada has taken regarding the drug supply in its COVID-19 response is to permit, at least temporarily, compulsory licensing to override patent monopolies in response to public health emergencies.
This shows that the federal government is fully capable of taking action if it desires. Unfortunately, measures targeting the pressing issue of access to old drugs have been more modest. New flexibilities under the Food and Drugs Act are being used to permit importation of Tier 3 drugs from sources that do not otherwise have Health Canada approval. At the same time, the Interim Order on importation is focused explicitly on COVID-19 rather than encompassing all medicines currently found on the Tier 3 list. Only on May 15 was a drug for something other than COVID-19 allowed to be imported – timolol maleate, an Essential Medicine for ophthalmic conditions like glaucoma. Drugs in Tier 3 shortage still not on the import list include ethambutol, which is one of the world’s most important drugs for tuberculosis but has a history of serious shortages in Canada.
If COVID-19 is to herald a new normal, Canadian pharmaceutical regulations must be rebooted to emphasize getting effective drugs to the people who need them rather than relying upon the caprices of those offering existing wares based upon what will make them the most money. A systemic solution will require reassessing existing costs and criteria to make it easier for a sufficient number of new sources of old drugs whose utility (and limitations) are well understood, such as those considered Essential Medicines by the WHO, to fill crucial gaps in the market. This might involve stabilizing supply at a sustainable price, something potentially aided by universal pharmacare. And it may also necessitate enacting stricter measures against companies that take inadequate safeguards against shortages or who leave the market without a contingency plan in place to preserve ongoing access.
The good news is that, in mid-May, a company received approval to begin selling atracurium and pancuronium in Canada again; however, it remains unclear when the drugs will actually hit the market or what the pandemic will look like when they do. In any case, they should serve as a reminder that standing by while drugs disappear from the market entirely, only to recognize months or years later that they make up more than 10 per cent of the drugs with “greatest potential impact” on the healthcare system is not a sustainable strategy for Canada, whether or not it is facing a pandemic.