Lower ceiling prices for new medicines will make Canada less attractive as a country for new drugs and vaccines, making access to new drugs for Canadians with rare disorders even more challenging, writes Nigel Rawson and John Adams. 

By Nigel Rawson and John Adams, April 6, 2020

Given the impact of the COVID-19 pandemic on all aspects of Canadian life for the past several weeks, most Canadians would likely be very surprised if you told them that as of April 6, COVID-19 still qualified as a rare disease in Canada. Health Canada defines a rare disorder as one with a prevalence of not more than 5 in 10,000 persons that is life-threatening or seriously debilitating. So, COVID-19 becomes a common disease when 19,000 Canadians have it. It will finally cross that threshold this week.

COVID-19 causes fear because it is highly contagious, transmissible before symptoms appear, and from the data we have so far seems to kill about 1 percent of victims. Federal and provincial governments are coming up with vast sums of borrowed money to counter the health and economic effects of the disease and responses. This contrasts with the usual reaction from governments when asked to pay for new high-cost drugs for cystic fibrosis and other genetic rare disorders, including the new era of cures by gene therapies.

The Canadian Organization for Rare Disorders estimates that 1 in 12 Canadians, two-thirds of whom are children, are impacted by a rare disorder. That’s more than 3 million individuals. Many of these disorders cause early death (e.g. the median survival age of cystic fibrosis sufferers in Canada is 52 which means many die at young ages), mental and physical development issues, severe disability, and pain.

Why do Canadian governments’ reactions to COVID-19 differ from their responses to pleas for access to new drugs that can alleviate the suffering and premature deaths caused by genetic and other rare disorders? First, unlike COVID-19, almost all are not infectious. Second, while more than 3 million Canadians have a rare disorder, few have a particular one and, consequently, can create little political influence.

In contrast, although relatively few have COVID-19 so far, the disease’s wider impact of fear and life disruption is felt by all Canadians. Governments are working diligently to build capacities to rescue patients needing intensive hospital care, including respirators. That is the rescue principle in action. As a compassionate society, most of us support extraordinary efforts to save these lives. Any mismanagement of the situation could not only overwhelm the health system and result in many preventable deaths but also swing elections.

COVID-19 is making all Canadians poorer due to loss of employment and business income, depressed property values, depleted pensions and investments, and the inevitable increased taxation as governments try to reduce the huge debts incurred. The situation is more likely to entrench the federal government in its objective to drastically reduce the cost of new medications for rare disorders, cancer and other life-threatening and debilitating conditions.

In July, new Canadian regulations are to take effect to lower ceiling prices for new medicines. The changes will significantly reduce prices, making Canada less attractive as a country for new drugs and vaccines. Two new drugs for breast cancer have already been withdrawn due to uncertainties created by these changes. Applications for new drugs and new clinical trials have fallen significantly.

Canadians with unmet needs face many barriers to accessing new drugs that could extend their lives and improve their quality of life, or even cure them permanently. Access to essential new medicines can be interrupted and delayed for months, years, or forever by the tortuous processes of regulatory approval, health technology assessment, national price negotiation, and provinces’ reluctance to increase their drug plan budgets by including new medicines in their formularies. The increased indebtedness of federal and provincial governments can only exacerbate the situation.

When a drug developer, using private funding, produces a medicine or vaccine against COVID-19, it will undoubtedly be made available to Canadians. The company will be either generous or shamed into making it available at a low price. Governments can’t embarrass manufacturers of drugs for other rare disorders into lowering prices, so they are trying to force them by regulation, not negotiation, to make harsh price reductions. The methods being applied are heavy-handed and more likely to deter companies from bringing new products to Canada.

The federal government’s failures to act quickly to control borders to reduce COVID-19 carriers entering Canada, to ensure tracking or supervision for 14 days of incubation and to establish comprehensive and rapid testing for the virus will sadly lead to COVID-19 becoming a common disease in Canada very soon. When life eventually returns to some state of normality, Canadians with genetic and other rare disorders who face premature death and disability every day must be provided with access to new medicines that can improve their lives. They need to be rescued too. They must not be left even further out in the cold than they are now.

Nigel Rawson is president of Eastlake Research Group and affiliate scholar with the Canadian Health Policy Institute. John Adams is cofounder and CEO of Canadian PKU and Allied Disorders Inc. and volunteer board chair of Best Medicines Coalition.


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