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National Security protections should be applied to Canada's supply of essential medicines and vaccines.
Defence and security studies, Royal Canadian Military Institute (2021)
  • Vivian C. McAlister
Presentation
Abstract
In April 2020, Primeminister Trudeau arranged a teleconference call with the provincial premiers to review use of the Emergencies Act (1988) in order to divert medical supplies to areas of greatest need in the COVID-19 pandemic. There was a nationwide shortage of personal protective equipment and COVID-19 testing swabs and an anticipated shortage of mechanical ventilators. 
However Canada has been experiencing drug shortages for years. More and more, older but still vital drugs were “on backorder”. Just before the pandemic, Dr. Jacalyn Duffin C.M. of Kingston and a group of concerned doctors wrote an open letter to the prime minister outlining the chronic shortage of 1700 medications that had, until then, been routinely used to provide excellent healthcare in Canada. Instead, we are using expensive alternatives that did not have the track record, often over 50 years of common usage, of the cheaper drugs that they replaced. Many drugs have been "on backorder" for so long now, that new doctors no longer know how to use them. The group pointed out that Canada had become vulnerable because less and less of the medications that we need are made in Canada and those that are made here often used critical components from abroad. It would seem that greater forces are at play, which are beyond the power of a single hospital, or indeed a province, to counter. Canada’s healthcare supply has become a matter of national security. 
Bill C-59, which deals with national security, received royal assent in 2019. The bill was the culmination of 2 years of consultation and it was modified during its passage. The focus, which had been to deal with the threat of physical terrorism, was widened to include cyber security. A broader definition of national security is that it is the security “including its citizens, economy, and institutions, which is regarded as a duty of government” (Wikipedia). Even if you take a restricted view of national security, you have to admit that healthcare is a target. Cyber criminals have already used denial of service attacks on hospitals and information systems in order to extort ransoms. These gangs have links to governments such as North Korea, China and Russia. The Russian cyber-op group, known for its disinformation in US political campaigns, has turned its attention to supporting anti-vaccine, anti-mask and anti-lockdown groups. In an overt conflict, we can expect cyberattacks on our healthcare system, designed to distract and demoralize us. When I served with the Canadian Forces in Afghanistan, assasination of doctors and attacks on hospitals were common. It is worse in Syria where state powers are directed at defenceless hospitals. Over a 12 hour period in March 2017, Russia aided the Syrian government in aerial bombing of 4 hospitals in areas occupied by their opponents. They know that healthcare is vital to the security of society. However the most pressing threats to Canada’s healthcare system are not external currently. Instead they are structural and supply is our greatest vulnerability. 
How did we deal with drug shortages and demand surges historically? In the 1880’s, Canada’s supply of smallpox vaccine, which we had imported from the US for a century, suddenly dried up because of simultaneous smallpox outbreaks in both countries. Dr. Alexander Stewart, under the guidance of the newly formed Ontario Board of Health, set up the Ontario Vaccine Farm in Palmerston. Here he raised smallpox vaccine in cows and the farm, with similar institutions in Quebec, supplied Canada’s needs for the next 30 years. In the early 1900s, diphtheria antitoxin, which was available from the US, was too expensive and many patients died difficult deaths. Dr. J. G. (Gerry) Fitzgerald gave up his career as a psychiatrist in Toronto and went to the Pasteur Institute in Brussels to learn how to make diphtheria antitoxin. When he returned home, he was determined to provide the medication cheaply so that it would be available to those that needed it. With the help of the University of Toronto and local patrons, he founded Connaught Laboratories. It was a farm on Steeles Avenue which raised the antitoxin in horses. Their antitoxin saved countless lives and ended the diphtheria pandemic. In 1916, the government used the War Measures Act to transfer the Ontario Vaccine Farm to Connaught Laboratories. By then Connaught had ramped up production to meet the needs of the First World War, providing a range of vaccines and medicines. Connaught first tried to make a ‘Flu vaccine in 1918 and continued through each outbreak such as the Asian ‘Flu pandemic of 1957. Connaught played major roles in the development and rollout of insulin, penicillin, and polio vaccine. In the 1960s, Connaught became the reference laboratory for the successful WHO smallpox eradication program. The last patient treated for smallpox in Canada used Toronto vaccine in 1967. So we dealt with shortages and surges of the past by manufacturing medicines in Canada. We were also able to make real contributions in global campaigns to eradicate disease. 
The War Measures Act (1914) was passed within days of the declaration of the First World War so that orders-in-council could be used to govern during the emergency. It was invoked until January 1920. In addition to control of public order, the act was used to regulate industrial and agricultural production. This included medicines. Canada’s drug manufacturing companies banded together to form the Canadian Association of Manufacturers of Medicinal and Toilet Products. The group changed their name over the years and is known today as Innovative Medicines Canada. From 1965 until 1999 it was called the Pharmaceutical Manufacturers Association of Canada or PMAC. The War Measures Act was invoked again in the Second World War. This time a Wartime Trade and Prices Board was established to prevent profiteering and to control inflation. The War Measures Act was last invoked during the 1970 October Crisis and it was replaced by the Emergencies Act in 1988. 
The situation got dramatically worse for the prime minister just before the teleconference with the premiers, when President Trump sought to invoke the Defence Production Act (1950) in order to divert supplies made by 3M to the US instead of Canada. 3M realized that this extension of the act outside of territorial USA would totally disrupt their operation. They prevailed upon the administration to stand down by promising to meet US requirements from existing global operations. President Trump did invoke the Defence Production Act to fund expansion of Puritan, a small company in Maine that made the special nasopharyngeal swabs used to test for COVID-19. Notwithstanding this escalation, the premiers refused to support the invocation of the Emergencies Act in Canada. 
The wording of Canada’s Emergencies Act is very similar to the US Defence Production Act with two important exceptions. Both acts give the government powers to requisition property, to compel qualified individuals to provide essential services and to control distribution. Canada’s act is designed for emergencies such as the world wars and includes provisions for public order. The US Defence Production Act is designed to ensure the supplies required for national security. It was not an idiosyncrasy of President Trump to invoke the Defence Production Act. It has been used many times, without consulting or offending state governors, since it was passed in 1950. President Biden’s first executive order cited the act when it directed immediate actions to secure supplies to fight the pandemic. He used the Defence Production Act again in March 2021 to compel Merck to manufacture the J & J vaccine at one of its US plants. Primeminister Trudeau considered the Emergencies Act again in November 2020 for the vaccine rollout. President Trump had invoked the Defence Production Act to direct that ‘Americans would have priority for America’s vaccines’. This time feelers to the premiers were rebuffed so quickly that no teleconference was necessary and the Emergencies Act was not used. 
When there is a shortage, those who can provide are in a position of great power. Profiteering is not only the accumulation of undeserved wealth but it may also be the application of undue influence. Pfizer and other companies that make the COVID-19 vaccine will profit by billions and billions of dollars from the pandemic. Pfizer was particularly tone deaf when it chose a time, when vaccine supplies to Canada were interrupted by a planned facility upgrade, to lean on the prime minister to reduce their tax liabilities in the next budget. Pfizer has demanded, from countries less well off than Canada, embassies that are located in desirable locations as collateral for debts that may be incurred by purchasing their vaccine.
Canada has had a fraught relationship with multinational pharmaceutical companies for 50 years and maybe going back to the First World War. From 1969 until 1987, we had an act of parliament that provided for the compulsory license of a patented medicine, under special circumstances, in return for a 4% royalty. PMAC vehemently opposed the act and exerted maximum pressure to rescind it. Offers to extend the patent period or increase the royalty were rebuffed. I believe the reason for this stance was that the multinational companies feared the US might follow our example. California congressman Henry Waxman tried to introduce a bill similar to ours, and many other bills over his career, in a vain effort to reduce drug costs in the US. He did succeed in 1984 in having a law passed which assisted generic drug companies make medicines once the patent had expired. In the late 1980s, governments and universities sought to divest themselves of manufacturing capabilities in order to capitalize on past investments and to appear more business friendly. Connaught Laboratories were sold and resold and are now owned by Sanofi Pasteur. The compulsory license act was repealed in return for a promise from PMAC to innovate and produce medicines in Canada. The pandemic has completely exposed how the poor was the deal that we made. The impact of those decisions had been felt for years by those of us in the field but are now the source of great anxiety to governments at all levels. 
Why is Canada so far behind the US and the UK in the vaccine rollout? Would it have been different if our healthcare supply was protected by national security provisions? In contrast to our history, Canada brought nothing to the table regarding vaccine development. The co-founder of Moderna, Derrick Rossi, is from Toronto. We have expertise in mRNA technology and experience in SARS vaccine development. None of it was coordinated the way that we coordinated production during the Second World War. We did not take part, in a meaningful way, in clinical trials. Healthcare providers like me were itching to be included as subjects in clinical trials a year ago. We might have systematically tested different vaccines in parallel so we could compare their efficacy and in different populations. COVID-19 vaccines have received emergency licenses, based on foreign company information, but we have not put in place emergency-grade surveillance. Instead we rely on the informal reporting system that we use for fully licensed products. We have made no effort to understand when someone is immune - we know this for hepatitis B virus but we may never know it for SARS-CoV-2 virus. These are all actions that we would have expected from a coordinated response under the national security umbrella. I believe they would have put us at the front of the vaccine race which we could have shared with the less developed world.
Canada’s Emergencies Act is defunct. Primeminister Trudeau chose to consult the premiers for sound political reasons. The act is invoked by the cabinet, with subsequent parliamentary approval. It is designed to provide the supplies so that the provinces and municipalities can meet their responsibilities and not to override those responsibilities. The act is viewed with considerable suspicion by the provinces, possibly as a legacy of the 1970 invocation of the War Measures Act, and probably because of its public order provisions. We need an act that will allow us to prepare for emergencies rather than respond to them. The US Defence Production Act is a good start. Canada's healthcare system is threatened by chronic shortage of medicines. If we brought healthcare supply under the protection of national security, we would either direct manufacture or use compulsory license to manufacture essential medicines, devices and equipment whose regular supply was threatened. There would be significant knock-on demands including the need for expert panels to determine the efficacy and value of medicines. The goal of protecting the healthcare supply would be to provide the provinces with access to the materials and information needed to provide best quality healthcare. It is the only way provinces will be able to establish universal pharmacare.
Keywords
  • pharmacare,
  • national security
Publication Date
March 25, 2021
Location
Toronto, Ontario, Canada
Comments
In April 2020, Primeminister Trudeau arranged a teleconference call with the provincial premiers to review use of the Emergencies Act (1988) in order to divert medical supplies to areas of greatest need in the COVID-19 pandemic. There was a nationwide shortage of personal protective equipment and COVID-19 testing swabs and an anticipated shortage of mechanical ventilators. 
However Canada has been experiencing drug shortages for years. More and more, older but still vital drugs were “on backorder”. Just before the pandemic, Dr. Jacalyn Duffin C.M. of Kingston and a group of concerned doctors wrote an open letter to the prime minister outlining the chronic shortage of 1700 medications that had, until then, been routinely used to provide excellent healthcare in Canada. Instead, we are using expensive alternatives that did not have the track record, often over 50 years of common usage, of the cheaper drugs that they replaced. Many drugs have been "on backorder" for so long now, that new doctors no longer know how to use them. The group pointed out that Canada had become vulnerable because less and less of the medications that we need are made in Canada and those that are made here often used critical components from abroad. It would seem that greater forces are at play, which are beyond the power of a single hospital, or indeed a province, to counter. Canada’s healthcare supply has become a matter of national security. 
Bill C-59, which deals with national security, received royal assent in 2019. The bill was the culmination of 2 years of consultation and it was modified during its passage. The focus, which had been to deal with the threat of physical terrorism, was widened to include cyber security. A broader definition of national security is that it is the security “including its citizens, economy, and institutions, which is regarded as a duty of government” (Wikipedia). Even if you take a restricted view of national security, you have to admit that healthcare is a target. Cyber criminals have already used denial of service attacks on hospitals and information systems in order to extort ransoms. These gangs have links to governments such as North Korea, China and Russia. The Russian cyber-op group, known for its disinformation in US political campaigns, has turned its attention to supporting anti-vaccine, anti-mask and anti-lockdown groups. In an overt conflict, we can expect cyberattacks on our healthcare system, designed to distract and demoralize us. When I served with the Canadian Forces in Afghanistan, assasination of doctors and attacks on hospitals were common. It is worse in Syria where state powers are directed at defenceless hospitals. Over a 12 hour period in March 2017, Russia aided the Syrian government in aerial bombing of 4 hospitals in areas occupied by their opponents. They know that healthcare is vital to the security of society. However the most pressing threats to Canada’s healthcare system are not external currently. Instead they are structural and supply is our greatest vulnerability. 
How did we deal with drug shortages and demand surges historically? In the 1880’s, Canada’s supply of smallpox vaccine, which we had imported from the US for a century, suddenly dried up because of simultaneous smallpox outbreaks in both countries. Dr. Alexander Stewart, under the guidance of the newly formed Ontario Board of Health, set up the Ontario Vaccine Farm in Palmerston. Here he raised smallpox vaccine in cows and the farm, with similar institutions in Quebec, supplied Canada’s needs for the next 30 years. In the early 1900s, diphtheria antitoxin, which was available from the US, was too expensive and many patients died difficult deaths. Dr. J. G. (Gerry) Fitzgerald gave up his career as a psychiatrist in Toronto and went to the Pasteur Institute in Brussels to learn how to make diphtheria antitoxin. When he returned home, he was determined to provide the medication cheaply so that it would be available to those that needed it. With the help of the University of Toronto and local patrons, he founded Connaught Laboratories. It was a farm on Steeles Avenue which raised the antitoxin in horses. Their antitoxin saved countless lives and ended the diphtheria pandemic. In 1916, the government used the War Measures Act to transfer the Ontario Vaccine Farm to Connaught Laboratories. By then Connaught had ramped up production to meet the needs of the First World War, providing a range of vaccines and medicines. Connaught first tried to make a ‘Flu vaccine in 1918 and continued through each outbreak such as the Asian ‘Flu pandemic of 1957. Connaught played major roles in the development and rollout of insulin, penicillin, and polio vaccine. In the 1960s, Connaught became the reference laboratory for the successful WHO smallpox eradication program. The last patient treated for smallpox in Canada used Toronto vaccine in 1967. So we dealt with shortages and surges of the past by manufacturing medicines in Canada. We were also able to make real contributions in global campaigns to eradicate disease. 
The War Measures Act (1914) was passed within days of the declaration of the First World War so that orders-in-council could be used to govern during the emergency. It was invoked until January 1920. In addition to control of public order, the act was used to regulate industrial and agricultural production. This included medicines. Canada’s drug manufacturing companies banded together to form the Canadian Association of Manufacturers of Medicinal and Toilet Products. The group changed their name over the years and is known today as Innovative Medicines Canada. From 1965 until 1999 it was called the Pharmaceutical Manufacturers Association of Canada or PMAC. The War Measures Act was invoked again in the Second World War. This time a Wartime Trade and Prices Board was established to prevent profiteering and to control inflation. The War Measures Act was last invoked during the 1970 October Crisis and it was replaced by the Emergencies Act in 1988. 
The situation got dramatically worse for the prime minister just before the teleconference with the premiers, when President Trump sought to invoke the Defence Production Act (1950) in order to divert supplies made by 3M to the US instead of Canada. 3M realized that this extension of the act outside of territorial USA would totally disrupt their operation. They prevailed upon the administration to stand down by promising to meet US requirements from existing global operations. President Trump did invoke the Defence Production Act to fund expansion of Puritan, a small company in Maine that made the special nasopharyngeal swabs used to test for COVID-19. Notwithstanding this escalation, the premiers refused to support the invocation of the Emergencies Act in Canada. 
The wording of Canada’s Emergencies Act is very similar to the US Defence Production Act with two important exceptions. Both acts give the government powers to requisition property, to compel qualified individuals to provide essential services and to control distribution. Canada’s act is designed for emergencies such as the world wars and includes provisions for public order. The US Defence Production Act is designed to ensure the supplies required for national security. It was not an idiosyncrasy of President Trump to invoke the Defence Production Act. It has been used many times, without consulting or offending state governors, since it was passed in 1950. President Biden’s first executive order cited the act when it directed immediate actions to secure supplies to fight the pandemic. He used the Defence Production Act again in March 2021 to compel Merck to manufacture the J & J vaccine at one of its US plants. Primeminister Trudeau considered the Emergencies Act again in November 2020 for the vaccine rollout. President Trump had invoked the Defence Production Act to direct that ‘Americans would have priority for America’s vaccines’. This time feelers to the premiers were rebuffed so quickly that no teleconference was necessary and the Emergencies Act was not used. 
When there is a shortage, those who can provide are in a position of great power. Profiteering is not only the accumulation of undeserved wealth but it may also be the application of undue influence. Pfizer and other companies that make the COVID-19 vaccine will profit by billions and billions of dollars from the pandemic. Pfizer was particularly tone deaf when it chose a time, when vaccine supplies to Canada were interrupted by a planned facility upgrade, to lean on the prime minister to reduce their tax liabilities in the next budget. Pfizer has demanded, from countries less well off than Canada, embassies that are located in desirable locations as collateral for debts that may be incurred by purchasing their vaccine.
Canada has had a fraught relationship with multinational pharmaceutical companies for 50 years and maybe going back to the First World War. From 1969 until 1987, we had an act of parliament that provided for the compulsory license of a patented medicine, under special circumstances, in return for a 4% royalty. PMAC vehemently opposed the act and exerted maximum pressure to rescind it. Offers to extend the patent period or increase the royalty were rebuffed. I believe the reason for this stance was that the multinational companies feared the US might follow our example. California congressman Henry Waxman tried to introduce a bill similar to ours, and many other bills over his career, in a vain effort to reduce drug costs in the US. He did succeed in 1984 in having a law passed which assisted generic drug companies make medicines once the patent had expired. In the late 1980s, governments and universities sought to divest themselves of manufacturing capabilities in order to capitalize on past investments and to appear more business friendly. Connaught Laboratories were sold and resold and are now owned by Sanofi Pasteur. The compulsory license act was repealed in return for a promise from PMAC to innovate and produce medicines in Canada. The pandemic has completely exposed how the poor was the deal that we made. The impact of those decisions had been felt for years by those of us in the field but are now the source of great anxiety to governments at all levels. 
Why is Canada so far behind the US and the UK in the vaccine rollout? Would it have been different if our healthcare supply was protected by national security provisions? In contrast to our history, Canada brought nothing to the table regarding vaccine development. The co-founder of Moderna, Derrick Rossi, is from Toronto. We have expertise in mRNA technology and experience in SARS vaccine development. None of it was coordinated the way that we coordinated production during the Second World War. We did not take part, in a meaningful way, in clinical trials. Healthcare providers like me were itching to be included as subjects in clinical trials a year ago. We might have systematically tested different vaccines in parallel so we could compare their efficacy and in different populations. COVID-19 vaccines have received emergency licenses, based on foreign company information, but we have not put in place emergency-grade surveillance. Instead we rely on the informal reporting system that we use for fully licensed products. We have made no effort to understand when someone is immune - we know this for hepatitis B virus but we may never know it for SARS-CoV-2 virus. These are all actions that we would have expected from a coordinated response under the national security umbrella. I believe they would have put us at the front of the vaccine race which we could have shared with the less developed world.
Canada’s Emergencies Act is defunct. Primeminister Trudeau chose to consult the premiers for sound political reasons. The act is invoked by the cabinet, with subsequent parliamentary approval. It is designed to provide the supplies so that the provinces and municipalities can meet their responsibilities and not to override those responsibilities. The act is viewed with considerable suspicion by the provinces, possibly as a legacy of the 1970 invocation of the War Measures Act, and probably because of its public order provisions. We need an act that will allow us to prepare for emergencies rather than respond to them. The US Defence Production Act is a good start. Canada's healthcare system is threatened by chronic shortage of medicines. If we brought healthcare supply under the protection of national security, we would either direct manufacture or use compulsory license to manufacture essential medicines, devices and equipment whose regular supply was threatened. There would be significant knock-on demands including the need for expert panels to determine the efficacy and value of medicines. The goal of protecting the healthcare supply would be to provide the provinces with access to the materials and information needed to provide best quality healthcare. It is the only way provinces will be able to establish universal pharmacare.
Citation Information
Vivian C. McAlister. "National Security protections should be applied to Canada's supply of essential medicines and vaccines." Defence and security studies, Royal Canadian Military Institute (2021)
Available at: http://works.bepress.com/vivianmcalister/297/