April 11, 2020
COVID-19 is commonly compared to the 1918 Spanish flu, which killed 50 million people around the globe. At that time, there were no vaccines, no test kits, no antiviral drugs and no antibiotics. Social distancing and hand-washing were the only tools in the arsenal.
A century later, the resources of a mature biopharmaceutical industry are now being directed toward combating COVID-19. Promising candidates have already been reported, including a vaccine that has entered human trials and an experimental antiviral drug, remdesivir, originally developed by Gilead Sciences to treat Ebola but which has been shown to be effective against SARS and MERS, two other deadly coronaviruses.
Industry is not alone in its quest for a panacea. Public health agencies around the world are consolidating resources, sponsoring academic research, and partnering with industry to identify safe existing treatments to combat COVID-19. A multicountry clinical trial testing four separate interventions, aptly called SOLIDARITY, is underway.
With the development of a vaccine or effective treatment for COVID-19 comes the inevitable questions: how will we get our hands on it? And what will it cost?
Domestic manufacturing capacity matters a lot, and Canada may no longer have it. In this sense, although Canada is immeasurably better equipped to address COVID-19 than it was in 1918 when facing the Spanish flu, the country will still face major obstacles in getting essential medicines to those who need them.
The polio vaccine was an early success in prioritizing access for all. In the first half of the 20th century, the disease presented a public health dilemma afflicting young children. A vaccine then became available in 1955. Jonas Salk, who developed the vaccine, famously declined to patent it, saying, “There is no patent. Could you patent the sun?” Less known is the fact that the vaccine was developed using significant public-sector funding and charitable donations, and Dr. Salk is said to have believed his approach was not patent-eligible anyway.
During the era of polio’s eradication, pharmaceutical patenting was weak. In Canada, patents were not available for pharmaceuticals per se, and the government had the right to compel a licence from the patent owner to permit its chosen manufacturer to make the drug.
Since then, pharmaceutical patent monopoly power in Canada has strengthened. As part of NAFTA negotiations in the early 1990s, the Canadian government agreed to a U.S. demand to abandon its compulsory licensing scheme. Compulsory licences could then only be granted in circumstances of patent abuse, and government agencies could also avail themselves of government-use licences. These provisions have since gathered dust.
The U.S. then took to the World Trade Organization and, working with the European Union and Japan, established a global standard for pharmaceutical patent protection in the multilateral TRIPS agreement. Developing countries reserved their rights to take emergency measures to protect public health and security.
In principle, these measures ought to have been effective. However, Africa’s experience during the HIV/AIDS epidemic demonstrated that the provisions were cold comfort for countries that could not domestically manufacture essential medicines.
Recognizing deficiencies in TRIPS, the WTO adopted measures permitting countries with manufacturing capacity to export drugs to countries lacking such resources to address national emergencies. Canada amended its Patent Act to accommodate this flexibility, but these provisions too have gathered dust for being too restrictive and as a result of the migration of drug manufacturing overseas. The consequence has been that domestic manufacturing capacity is a critical determinant of a country’s ability to access drugs in times of emergency. Canada is not immune to this dynamic.
Where commercially feasible, the pharmaceutical industry has found ways to provide access to essential medicines to the world’s poor. As HIV/AIDS treatments improved, manufacturers such as Gilead licensed lower-cost manufacturers to produce generic versions of expensive medicines for poorer countries, while taking a royalty. Prices fell and access expanded. Learning from this experience, Gilead pursued the same strategy with its Hepatitis C blockbusters. However, crucially, Gilead continued to charge richer countries based on their ability and willingness to pay, with these drugs costing tens of thousands of dollars in North America.
Will this approach work for COVID-19? Early signs suggest not, due to an extreme urgency of need experienced everywhere at the same time. Gilead is arguably best positioned to roll out an international access strategy for its candidate drug remdesivir, having now done so for HIV/AIDS and Hepatitis C. Yet, due to a spike in demand, Gilead has had to stop making the drug available as an emergency treatment. If the drug is effective and Gilead is able to make more of it, it will be approved quickly. However, without government intervention, its price will almost certainly be high in developed countries, with delayed access during price negotiations.
That is, unless we have the power to make the drug ourselves.
The Canadian government is not naïve to the strategic imperative of domestic manufacturing. After 9/11, there was heightened concern about anthrax being used as a biological weapon. The Canadian government attempted to stockpile ciprofloxacin as a precaution. They acquired the product from domestic manufacturer Apotex, despite the fact that the patent holder, Bayer, was in active patent litigation to prevent the Canadian company from selling the drug. Bayer threatened to sue the Canadian government as no emergency had been declared, nor had the limited flexibility in the Patent Act been used. In the end, the government agreed to purchase the product from Bayer after it made significant commercial concessions.
Canada’s emergency bill to address COVID-19 (Bill C-13) provides a new pathway for the Canadian government to authorize any manufacturer to make patented medicines during a public health emergency. However, will there be such a company waiting for the call, and if so, will they be able to meet Canadian demand?
The medicines needed to prevent and treat COVID-19 will include a vaccine and possibly other large-molecule treatments made using biological rather than chemical manufacturing methods. Canadian capacity for manufacturing these in an emergency is doubtful.
Back in 2001, when the Canadian government sought a long-term domestic vaccine partner, only one company showed interest in establishing sufficient capacity to manufacture enough vaccine to inoculate the entire population in the event of an influenza pandemic. Quebec-based ID Biomedical manufactured the flu vaccine, including the H1N1 vaccine in 2009. In a report on lessons learned following the H1N1 pandemic, Health Canada reported that production capacity was limited, and the vaccine had to be rationed based on perceived health risk.
More recently, Canada faced an acute shortage of vaccine for the 2019 flu season. Although Health Canada purported to make arrangements with alternate vaccine suppliers, these arrangements did not prevent shortages as recently as November, 2019.
A vaccine or other biologic medicine, or even a new chemical drug, will inevitably be developed to prevent or treat COVID-19. Undoubtedly, all Canadians will want instant access. But recent experience suggests the country may not have the domestic manufacturing capacity to make use of the myriad access pathways created under the Patent Act and international access frameworks.
Over the last 20 years, most of Canada’s pharmaceutical industry has shut down in favour of offshore manufacturers in India and China or – as happened with ID Biomedical – been acquired by foreign multinationals. Today, there appears to be no Canadian biomanufacturing facility capable of producing a vaccine at regulatory standard to provide national coverage. Even if the necessary treatment does not require biomanufacturing, lack of public knowledge about production and formulation of any new chemical drug may practically prevent domestic manufacture of a generic version within the time needed.
As a result, at our time of truly greatest need, we may be beholden to a foreign manufacturer facing unprecedented demand from around the world. If so, our ability to access the medicine will be slower, far more costly, and far less controlled than if we have adequate domestic supply capability.
Today, Canadians are understandably frightened about what COVID-19 means for them. In so many ways, we are far more fortunate than our great-grandparents who lived through Spanish flu with nowhere to turn. But when it comes to access to pandemic medicines, Canada has a long way to go – and must get there faster than it ever imagined.
This article was originally published by The Globe and Mail.