BioNiagara/ St. Catharines, ON, Canada / Sept. 21, 2021

Allow Biolyse to Produce COVID-19 Vaccines Under Canadian Law

Canada’s re-elected Liberal Government can help vaccinate millions of people in the Global South by supporting Biolyse Pharma’s application to produce COVID-19 vaccines under a compulsory license.

This is the urgent message from Muhammed Zaheer Abbas PhD, an Australian health law expert, who is presenting online Sept. 23, at the non-profit Creative Commons Global Summit, tasked to help overcome legal obstacles in sharing knowledge to assist world problems.

Abbas is Chief Investigator with the Australian Centre for Health Law Research and a Postdoctoral Research Fellow at the Faculty of Business and Law, Queensland University of Technology in Brisbane. In Abbas’ presentation, The Bolivia-Biolyse Case, his message to Prime Minister Justin Trudeau is straightforward:

Canada has distributed tens of millions of COVID-19 doses domestically, helping its citizens to cope with an international public health disaster.

The country has been adept in its vaccination strategy, but the federal government has largely ignored pleas from poorer nations like Bolivia, who could be helped through Canadian-produced exports of COVID-19 vaccines.
This is a conundrum for Canadian drug companies like Biolyse Pharma of St. Catharines, Ontario, a manufacturer of sterile injectable medicines. Earlier this year, an agreement was reached with Bolivia to produce and export COVID-19 vaccines, should the company be allowed to make and export the vaccine through a Canadian federal compulsory, or voluntary license or intellectual property waiver. It will also be able to produce these vaccines for other low-income countries in need.

Unfortunately, Canada has been non-committal in allowing the domestic production of COVID-19 vaccines, with contradictions and inconsistencies frustrating this effort.

Most developing countries will wait for years to have widespread access to COVID-19 vaccines, since a business-as-usual approach has been adopted in enforcing intellectual property protection. Patent protection blocks reverse-engineering and manufacturing of pharmaceutical drugs and vaccines, if it’s done without the patent-holder’s consent.

There has been an international reaction to this issue, which culminated in a proposal by India and South Africa in October last year to temporarily waive certain provisions of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights. Canada is also a party to the TRIPS Agreement.

Canada has argued at the WTO, that a TRIPS Waiver isn’t required because the existing mechanisms, like Canada’s Access to Medicines Regime (CAMR), are sufficient to address supply problems faced by lower-income countries. On one hand, Canada insists existing mechanisms are working as intended, while on the other, the government is
stonewalling Biolyse’s legitimate attempt to use CAMR to produce COVID-19 vaccines for export.

In February 2021, Bolivia said it intended to purchase up-to 15-million doses of COVID19 vaccines from Biolyse. This would be subject to the granting of a voluntary licence by Johnson & Johnson, the patentee company, or the granting of an export-oriented compulsory licence under the CAMR system.

Johnson & Johnson refused to negotiate with Biolyse — a fully certified GMP/GLP sterile manufacturing facility eager to help bridge the COVID-19 vaccines supply gap. Since March 2021, Biolyse continues to be hamstrung by the first step in CAMR. The preliminary requirement is that the COVID-19 vaccine must be added to Schedule 1 of the Canadian federal Patent Act before applying for an export-oriented compulsory licence under CAMR.

Biolyse is fully qualified to use CAMR. The World’s South needs these vaccines to save lives. The company is willing to follow all regulatory guidelines, but the Canadian government is not moving. The COVID-19 pandemic has already claimed more than 4.6 million lives and caused significant economic harm.

We must act now. The Trudeau government has the opportunity to utilize existing legislation to allow the domestic production and export of COVID-19 vaccines.

Resource-poor countries, scrambling for access to more doses, cannot be left at the mercy of the optional goodwill of major vaccine developers.

For more information, or interviews please contact: John Fulton, President
BioNiagara at Tel/WhatsApp: 905-932-7873

About BioNiagara: A Niagara-based pharmaceutical industry consultancy specializing
in project development, government relations and communications.

Yours very truly,

John R. Fulton
14 James St.
Unit 2

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