ST. CATHARINES, ON, March 11, 2021 /CNW/ - Thanks to transformative vaccine rollouts, the world is turning a COVID-19 corner — but not every country is on that path.
Recent weeks have been encouraging on the vaccine front for Canadians and others in developed countries. Earlier this month, Canada announced that a COVID-19 vaccine made by Johnson & Johnson (J&J) is the first single-dose vaccine to receive approval for use in Canada. It is the fourth to be approved, as needles in arms continue.
Despite the optimism, there remains a missing space for people in low-income nations who desperately need these vaccines and who may wait too long. As the World Health Organization (WHO) noted in a recent media conference, the global vaccine stocks remain critically short of supply at this time.
Biolyse Pharma an Ontario based manufacturer of sterile injectable medicine hopes to be part of a solution. Biolyse has the potential of producing up to twenty million doses per year. In order to do so, the company will need access to the drug master file of an already approved vaccine which is generally patent protected. The Canadian Access to Medicines Regime (CAMR) relating to emergency-patent transfer may permit the company to achieve its objective.
CAMR is the Canadian enabling legislation that reflects the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a protocol between all the member nations of the World Trade Organisation. Under CAMR, there is an emergency provision for the federal government to waive patent rights, allowing other generic-producing companies to start expedited production of critical preventative or curative drugs. Canada therefore has a mechanism in place to allow drug companies to a compulsory license from a patent holder.
In a media update, the Director-General of the WHO, Tedros Adhanom explained; "Urgent action is needed to ramp-up production to cover eligible countries with a significant approach involving patent-transfer licensing from major vaccine-producing pharmaceutical companies."
As of March 5th, 2021, Biolyse Pharma formally notified J&J for a license request to manufacture the Ad26.COV2.S vaccine. Biolyse is eager to work alongside J&J in order to domestically manufacture the vaccine and distribute it globally. On the other hand, if J&J is unwilling, Biolyse may use the CAMR to apply to the Canadian Commissioner of Patents for authorisation to manufacture and export the vaccine to a developing country that is unable to manufacture sufficiently on its own. Biolyse is hoping to work with J&J alongside the Canadian government to swiftly allow for this license transfer.
Biolyse is continuing with the development of its biotechnology department to accommodate vaccine production. The company has been in discussions with Federal Innovation, Science and Economic Development of Canada since the spring of 2020 to find the means that would expedite its progression.
"Biolyse has made an offer to J&J that should not be rejected," said James Love, Executive Director of U.S.- based Knowledge Ecology International, a non-governmental organization that deals with issues related to the effects of intellectual property on public health, cyber law, e-commerce, and competition policy. "We are in the middle of a pandemic that has impacted everyone everywhere. Governments have funded the development of vaccines, such as the one that J&J is manufacturing, but access remains a challenge, particularly in developing countries," he said. Love further commented that "Biolyse has unused capacity to manufacture vaccines at a time when it will take years to vaccinate everyone at risk. The longer the global population is vulnerable to the COVID-19 virus, the more it will mutate, to present new and unknown risks."
SOURCE Biolyse Pharma
For further information: Biolyse Pharma Corporation, 59 Welland Vale, St.Catharines, Ontario, L2S-3Y2, 905.687.8008, [email protected]