On May 11, Biolyse, a St. Catharines-based manufacturer of injectable medicines, announced an agreement with the Bolivian government to produce and export COVID-19 vaccines, if permitted by the Government of Canada.
Currently, there are over 317,000 confirmed cases of COVID-19 in Bolivia, a country that has a total population of 11 million people.
John R. Fulton, spokesperson for Biolyse, said that the St. Catharines facility has been trying for over a two months to get the government to start the process of achieving compulsory or voluntary licensing status, and to obtain the intellectual property waiver to produce the COVID-19 vaccine.
Per Fulton, this collaboration with the government of Bolivia should satisfy the requirements for licensing and acquiring of the property waiver as laid out by the Canadian Access to Medicines Regime (CAMR).
CAMR is the framework which allows Canadian companies to facilitate patent waivers for vaccines. It does so by enacting the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which allows companies to bypass or use patents of other companies, in special circumstances, such as a pandemic.
“This is a path that we are taking with commitment to the right to life,” said Bolivia’s Foreign Affairs Minister, Rogelio Mayta, through an interpreter.
“We need to unite to find ways to overcome the pandemic.”
“If we have to do compulsory licences, let’s do it. If we have to change the rules of the (World Trade Organization) WTO, let’s do it. If we have to free the patents and transfer technology, then let’s do it,” added Mayta.
“This is one small step in the process of granting a compulsory licence for a COVID-19 vaccine, and one giant step toward international co-operation to vaccinate the global south,” said Fulton.
The facility, which normally produces injectable cancer drugs, already has all the required equipment and Fulton said can be fully operational for COVID-19 vaccine production in four to six months.
Alone, Biolyse would produce 20 million doses yearly, but when partnered with Pnuvax and other medicine production companies in Canada, the companies could produce well over 50 million in a year.
Gloria Ghéquière, an adviser of international trade, from the office of European Union member Kathleen Van Brempt, provided insight the announcement.
“It shows how much we need these types of solutions,” she said, when speaking on the collaboration between Biolyse and the Bolivian government. “From a policy point of view, I'm just puzzled at how slow the bureaucratic process goes of allowing generic manufacturing.”
“It also shows that the rules are not fit for purpose when it comes to access to vaccines during a pandemic,” Ghéquière said. She said that she believes that there should be free trade on vaccines, and that it is “unethical” for governments to prevent smaller companies from aiding in production.
She said that collaborations of these sorts should be more commonplace, as the vaccine production supply chain is already an international process, and not sharing vaccines with countries who supply vials, for example, could remove incentive for production and international collaboration in general.
Earlier this year, Fulton said Biolyse contacted Johnson & Johnson for a licence transfer request to produce the vaccine, but the company refused. Now that the company has a importer partnering country, he said the next step would be to contact Johnson & Johnson again, and the Government of Canada, and await patent and licensing approval, respectively.
Moosa Imran, Local Journalism Initiative Reporter, Grimsby Lincoln News