Canadian drug maker’s deal with Bolivia opens potential path for more vaccines into arms of world’s poorest

A top official of the World Trade Organization says he welcomes a landmark decision by the Bolivian government to seek a compulsory licence for a Canadian company to produce and export COVID-19 vaccines without the permission of the patent holder.

The agreement, if approved by the Canadian government, would be a rare step to open up avenues for expanded vaccine production with fewer patent restrictions at a time of severe shortages in lower-income countries.

It also offers an alternative to a full waiver of vaccine patents – an issue that has been debated at the WTO for the past seven months without resolution, partly because of a lack of support from governments such as Canada.

Two federal officials, asked whether Ottawa will support the application for a compulsory licence, declined to answer the question.

The Bolivian government decision to seek a compulsory licence for the Canadian company Biolyse Pharma is “a very welcome step and one that may perhaps pave the way for other [WTO] members to make use of the system,” said Antony Taubman, director of the WTO’s intellectual property division, at the signing ceremony on Tuesday. The move could make it easier for countries to “signal unmet needs and to help precipitate a response to those urgent medical needs,” he said.

With supplies dwindling, Bolivia has managed to give a first dose to less than 6 per cent of its population so far.

Under the new agreement, it has an option to purchase 15 million doses of Johnson & Johnson vaccines from Biolyse for a price of US$3 to US$4 per one-shot dose – a significant supply for Bolivia’s population of about 11.5 million.

The Canadian producer would pay a fixed royalty fee to Johnson & Johnson, despite the lack of an agreement between the two companies.

Bolivian Foreign Minister Rogelio Mayta said he expects a “complicated bureaucratic process” as his government and the Canadian company seek the vaccine licence. But “life is what matters,” he said.

“The economy should be in the service of life, and not the other way around,” he told the signing ceremony in La Paz.

“We need to unite to find ways of overcoming the pandemic. We can’t be blind or silent in the face of what is happening. We are sure that this marks the beginning of an important path.”

Federal government officials have said that companies such as Biolyse are too small to be of interest to the main manufacturers of COVID-19 vaccines.

“Vaccine production is a complex process dependent on securing access to needed equipment, production inputs, technical expertise and know-how, as well as a range of other considerations,” said John Power, a spokesperson for François-Philippe Champagne, the federal Minister of Innovation, Science and Industry, in response to questions from The Globe and Mail on Tuesday.

Michel Cimpaye, a spokesperson for Global Affairs Canada, said the government is “closely following” the Bolivian request for a compulsory licence and the Bolivian agreement with Biolyse, but he did not say how the government would respond.

The World Health Organization warned this week that high-income and upper-middle-income countries have received 83 per cent of the world’s COVID-19 vaccines so far, despite representing only 53 per cent of the world’s population. Low-income and lower-middle-income countries have received just 17 per cent of the world’s vaccines, it said.

Biolyse, based in St. Catharines, Ont., normally produces cancer drugs. It believes it has the capacity to produce COVID-19 vaccines within six months if it wins approval. But when it approached Johnson & Johnson, the company said it was not interested because it already has manufacturing partners in North America.

Biolyse says it has been trying to catch the attention of the federal government and the vaccine manufacturers for the past year without success, although it finally won a meeting with officials from four federal departments last month.

Compulsory licensing in Canada has been permitted only once before, in 2007, when Canadian company Apotex won the right to manufacture HIV medicines for export to Rwanda under the Canadian Access to Medicines Regime (CAMR). It took Apotex four years to achieve its first shipment, and it said the process was too cumbersome and bureaucratic for the company to use again.

Biolyse says it won’t be deterred by the obstacles. “We want to help end the pandemic and save lives in Bolivia,” company president Brigitte Kiecken said on Tuesday.

“Governments need to take all measures to allow companies like ours to manufacture,” she told the signing ceremony.

During the WTO debates on a proposed COVID-19 patent waiver, Canada has argued that existing laws such as CAMR should be sufficient to resolve any supply problems in lower-income countries.

“If Canada fails to expeditiously allow Bolivia to import vaccines manufactured by Biolyse under a compulsory licence, they would be directly contradicting their own statements at the WTO,” said a non-profit group, Knowledge Ecology International, which has been helping Biolyse in its licensing efforts.

“Biolyse wants to participate in the global efforts to end the pandemic, but their ability to help save lives in Bolivia depends on the actions of the Canadian government,” the group said in a statement.

The CAMR process and the WTO’s own compulsory licensing rules are a “procedural labyrinth” with “a number of protectionist provisions,” it said.

If Canada fails to expeditiously allow Bolivia to import vaccines manufactured by Biolyse under a compulsory licence, they would be directly contradicting their own statements at the WTO. KNOWLEDGE ECOLOGY INTERNATIONAL NON-PROFIT GROUP