Company Pushes Canada to Grant Compulsory License for Johnson & Johnson COVID-19 Vaccine

A Canadian pharmaceutical company, Biolyse, has agreed to provide Bolivia with 15 million doses of the Johnson & Johnson COVID-19 vaccine – as long as the Canadian government gives it a compulsory license to manufacture the vaccine.

In March, Johnson & Johnson rejected an application by Biolyse for a voluntary license to make a generic version of its vaccine. 

Biolyse is now seeking a compulsory license in terms of Canada’s Access to Medicines Regime (CAMR) in order to supply vaccines to Bolivia, which has only managed to vaccinate around 5% of its population.

But for this to succeed, the COVID-19 vaccine will have to be listed in Schedule 1 of the Canadian Patent Act as only medical products listed there are eligible for compulsory licenses in terms of CAMR.

“Although Schedule 1 can be amended to include additional products, Canadian authorities have refused to tell KEI and Biolyse whether COVID-19 vaccines will be added to the list or what the estimated time frame is for that amendment to take place,” said non-profit organisation Knowledge Ecology International (KEI), which has been advising the company on its compulsory license application.

Canada ‘Stonewalls’ Legitimate Attempt

According to KEI, Canada has claimed at the World Trade Organization (WTO) that existing TRIPS flexibilities are working “as intended,” and asked those in favour of a TRIPS waiver for “concrete” evidence of patent-related challenges in procuring COVID-19 goods.

“If Canada fails to expeditiously allow Bolivia to import vaccines manufactured by Biolyse under a compulsory license, they would be directly contradicting their own statements at the WTO,” said KEI.

“Canada cannot continue to claim that article 31bis of the TRIPS agreement and the CAMR function ‘as intended’ while it stonewalls a legitimate attempt to use this mechanism,” it added.

Biolyse has agreed to sell vaccines to Bolivia at an estimated manufacturing cost of $3 to $4 a dose.

Meanwhile, COVID-19 cases are rising in Bolivia, which has a population of almost 12 million people and around 43,000 official cases of COVID-19 and 13,228 deaths.

Bolivia’s daily COVID-19 cases


Image Credits: Johnson & Johnson.

Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.