First, the good news. Symvivo Corporation, a Canadian company, currently has a SARS-CoV-2 vaccine candidate in phase one trials. But the bad news is that the Trudeau government is dismantling the incentives to find a vaccine.
In the battle against the global pandemic, public- and private-sector actors both have essential roles to play. Governments are collecting data, sharing information, removing regulatory roadblocks and identifying where resources are most desperately needed. Meanwhile, the private sector is ramping up research and development of treatments and vaccines, speeding up clinical trials, and arranging for largescale manufacture and distribution. The result, we hope, will be a vaccine developed in record time.
But again, at the same time, Ottawa is undermining these efforts. In March, the federal government amended Canada’s Patent Act, providing for a new compulsory licensing regime. In short, the government caved to calls for new legislation to pre-emptively confiscate the intellectual property (IP) of any yet-to-be-discovered coronavirus treatment.
Canada is among several countries with national legislation that allows for flexibilities to apply to patent protection. As described by the OECD, this includes “compulsory licensing, especially in cases where [voluntary licenses] are refused or too slow to respond to an urgent situation.” Federal Bill C‑13 facilitates Canada’s grant of government use licenses.
While Canada is not the only country to exhibit such short-sightedness—Chile, Ecuador, Germany and Israel have also moved to suspend IP rights including patents for new COVID-19 treatments—Canada’s amended Patent Act additionally weakens protections for intellectual property in the life sciences, which already lag behind other industrialized countries.
A new study by the Fraser Institute describes how Canadian patient access to potentially life-saving biologic medicines is comparatively limited. Although cutting-edge biologic drugs are treating previously untreatable conditions, often with fewer adverse effects, improving the health of patients and saving lives worldwide, Canadian patients are missing out. As of December 2018, the latest month of comparable available data, Canada has approved only 10 biosimilars, which are the biologic drug equivalent of a generic “small molecule” drug, compared to 15 in the United States, 20 in Australia and 62 in the European Union.
Biologic drugs are produced from or contain elements of living organisms. They are therefore more complicated—and more expensive—to develop, produce, distribute and dispense than other medicines. They are also at the forefront of treatment and vaccine technologies for COVID-19. Strong intellectual property rights for biologics are crucial for expediting clinical trials for preventive vaccines and therapeutic biological medicines, for scaling up manufacture and distribution capacity, and investigating the use of convalescent plasma in the treatment of COVID-19.
Clearly, these protections are crucial in the fight against COVID, and in the development of the biologics that will treat a host of other diseases. The ability of drug companies to protect their intellectual property—for example, by using data exclusivity to prevent competing firms from utilizing proprietary testing data to produce generic versions of the drugs—is essential for incentivizing the development of biologics. These protections are particularly critical because biopharmaceutical innovations are easily copied and sold by competitors, eliminating the financial incentives that drive innovation.
Unfortunately, Canada’s current intellectual property laws are weak compared to laws in other jurisdictions including the U.S. and EU. For example, Canada has one of the shortest terms of data exclusivity for pre-clinical and clinical trials.
In the face of the COVID-19 global pandemic, intellectual property rights are vital for mobilizing a rapid response and drawing on the greatest banks of knowledge. If Canadian policymakers want to improve access to state-of-the-art drugs in Canada, and ensure that COVID vaccines are available, they must incentivize it and strengthen protections for intellectual property.
Kristina M.L. Acri is an associate professor of economics at Colorado College and a senior fellow at the Fraser Institute.