COVID-19

Bolivia wants to import COVID-19 vaccines from Canada | Coronavirus

We begin [cette demande] firmly convinced of the right to life– chanted Rogelio Maita. Less than 13% of the population received the first dose, and despite the supply of Sputnik V and Sinopharm vaccines, Bolivia needs millions of additional doses.

So, while wealthy countries are debating the abolition of patents for COVID-19 vaccines, Bolivia has signed an agreement with Ontario’s pharmaceutical company, Biolyse Pharma, which makes injectable cancer drugs.

The Niagara region company says it can produce 20 million doses a year of Johnson & Johnson’s generic vaccine in a matter of months. The American giant refuses to transfer its patent rights, but Biolyse argues that Canada has the right to intervene using an already existing mechanism, albeit a little used.

A Compulsory Licensing Agreement signed in 2003 by member countries of the World Trade Organization (WTO) allows governments to manufacture generic generics in the country in an emergency, subject to royalty payments.

Canadian Medicines Access Regime (CAMR), created one year after the agreementWTO, allows Canadian companies to manufacture pharmaceutical products on behalf of foreign countries under the same conditions. But, according to Biolyse Pharma, Ottawa is refusing to add COVID-19 vaccines to the list of eligible drugs.

If we had help from the government at the beginning of the pandemic, we could have been producing vaccines for 6 or 7 months.

Quote from:Claude Mercure, COO Biolyse Pharma

Bureaucratic monster

IN JSIS was used only once: in Rwanda in 2007 to order AIDS drugs from the Canadian manufacturer Apotex.

It was a disaster because JSISBureaucratic ugliness. This is due to bureaucracy, so much so that large pharmaceutical companies are very happy that this regime does not work.– explains the specialist in pharmaceutical policy at Carleton University Marc-André Gagnon.

Thus, Biolyse Pharma’s request is a trial one. Dr. Gagnon said he was surprised but encouraged by the approach. He sends a very clear symbolic message: there are vaccines that are not being used.

Claude Mercure, who founded Biolyse Pharma in 1979 with his wife Bridget Kicken, however, above all gives the impression of playing David against Goliath.

Claude Mercure in front of the Biolyse Pharma plant in St. Catharines, Ontario.

Photo: Radio-Canada / Natasha MacDonald-Dupuis

Before the pandemic, the company planned to implement a long-term project for the production of biotechnological drugs. Huge unused bioreactors occupy the entire third floor. The same equipment, says Kiken, is also used in the production of viral vector vaccines, for example from Johnson & Johnson.

We have probably one of the largest bioreactors in the country. 2500 liters is huge. We have high speed filling lines, whole water filtration and sterilization system for vaccine production. We are truly prepared for this.

Quote from:Claude Mercure, COO Biolyse Pharma

In April 2020, Deloitte contacted the company on behalf of Ottawa, who wanted to identify a national manufacturing facility. Biolyse would then have requested a multi-million dollar envelope to adapt its production chain, but would not have received a positive response to either this request or access to JSIS

Claude Mercure says he waited a year before he could meet with federal government officials. The exchanges have not yet yielded results. They are asking for a $ 10 million investment and proof that we can get approval from the Ministry of Health before adding a vaccine to the approved drug list. There are not many companies that would get there

The Federal Ministry of Innovation did not provide details of these discussions, but confirmed that it has met with Biolyse Pharma to discuss its production capacity. Vaccine manufacturing is complex, writes her spokeswoman Hans Parmar. It is necessary to acquire specialized equipment and production resources, as well as the necessary technical knowledge and know-how. To these

Bioreactor for 2500 liters.

A 2500 liter bioreactor owned by Biolyse Pharma.

Photo: Biolyse Pharma

Confront the pharmaceutical giants

The World Trade Organization, for its part, is supporting Bolivia in this process. Its head of intellectual property, Anthony Taubman, said other countries could follow suit. According to him, compulsory licenses are important alternative as the ongoing negotiations on global patent abolition are likely to drag on for months.

Same story from Médecins Sans Frontières humanitarian advisor Jason Nickerson. In exchanges withWTOCanada has used compulsory licenses as an excuse to oppose unilateral revocation of patents. If Canada uses this argument, it must be consistent and add COVID-19 vaccines to the list of eligible drugs. [au RCAM], he said.

But there are risks of legal action. Bolivia is the first country in the world to apply for a compulsory license for the COVID-19 vaccine, but Russia began a similar process earlier this year to produce generic Remdesivir, an antiviral drug used to treat COVID-19. Laboratory Gilead tried to appeal the decision to the Supreme Court of the Russian Federation.

A healthcare professional monitors patients who have just received the Sputnik V vaccine at the University of the Mayor of San Andres in La Paz, Bolivia on May 31, 2021.

A healthcare professional monitors patients who have just received the Sputnik V vaccine at the University of the Mayor of San Andres in La Paz, Bolivia on May 31, 2021.

Photo: Associated Press / Juan Carita.

Canada does not want to alienate the pharmaceutical giants’ lobby, said health lawyer Matthew Herder. Ottawa certainly fears that the supply of the next dose will decrease if it attacks patents.

Claude Mercure is more cynical. He pointed out that members of the working group that advises the government are in conflict of interest with companies that have signed supply contracts with Canada. He also claims that Biolyse Pharma is exploring other possibilities and has recently been approached by more foreign countries, especially India.

Biolyse Pharma is not the only company. Toronto pharmaceutical Providence Therapeutics developed an RNA messenger vaccine candidate but did not receive financial support from Ottawa and recently decided to leave Canada.

Meanwhile, COVID-19 continues to kill thousands of people every day in Latin America and around the world. Everyone who lives on this land has the right to proper treatment, and the Canadian government is now putting a lot aside., says Claude Mercure.

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