Canada’s amended Patent Act weakens protections for intellectual property in the life sciences just when rights are vital for mobilizing a rapid response.
First, the good news: Symvivo Corp., a Canadian company, has a SARS-CoV-2 vaccine candidate in phase one trials. The bad news is that the federal 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 large-scale manufacture and distribution.
The result, we hope, will be a vaccine developed in record time.
But the federal government is undermining these efforts. In March, the government amended Canada’s Patent Act, providing for a new compulsory licensing regime. The government caved to calls for new legislation to pre-emptively confiscate the intellectual property (IP) of any yet-to-be-discovered COVID-19 treatment.
Canada is among several countries with national legislation that allows for flexibilities to apply to patent protection. As described by the Organization for Economic Co-operation and Development (OECD), this includes “compulsory licensing, especially in cases where [voluntary licences] are refused or too slow to respond to an urgent situation.” Federal Bill C‑13 facilitates Canada’s grant of government use licences.
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. But 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-19, 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 using 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 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 global pandemic, intellectual property rights are vital for mobilizing a rapid response and drawing on the greatest banks of knowledge. If Canadian policy-makers want to improve access to state-of-the-art drugs in Canada, and ensure that COVID-19 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.
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- Absent a vaccine, COVID-19 will linger with us for a long time. As Chris Gardner notes, the primary task of our leaders is charting a course to and through the new normal.
- COVID-19 has ended – or should end – the era of single-source suppliers, argues Roslyn Kunin.