Bolivia seeks to import COVID-19 vaccines from Biolyse, if Canada grants them a compulsory license

Today the government of Bolivia and Biolyse, a company based in Canada, signed an agreement to acquire COVID-19 vaccines manufactured by the company, if Canada grants them a compulsory license. Biolyse is a manufacturer of cancer drugs with the potential to produce up to twenty million doses of COVID-19 vaccines per year, and is currently seeking a compulsory license under the Canadian Access to Medicines Regime (CAMR). Bolivia now has an option to acquire the first fifteen million doses produced by Biolyse, according to the deal reached today.

Rogelio Mayta, the Bolivian Minister of Foreign Affairs, announced the deal today during a press conference held in La Paz. Brigitte Kiecken, President of Biolyse, joined the announcement online. KEI has obtained a copy of the agreement in English and Spanish

With 11.67 million habitants, thus far Bolivia has only been able to vaccinate roughly 5% of their population. During the United Nations Economic and Social Council (ECOSOC) Forum on Financing for Development held on April 12, 2021, Minister Mayta said that “all private or state pharmaceutical companies that have the capacity to produce vaccines should do so, considering that vaccines are, ultimately, public goods.” He also called for the lifting of trade norms preventing companies from manufacturing COVID-19 vaccines. During the Ibero-American Summit held on April 21, 2021, the Bolivian President Luis Arce Catacora called for a “reform of international standards, especially those relating to intellectual property rights” to accelerate the global distribution of COVID-19 vaccines. 

Bolivia is a co-sponsor of the proposal to waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and recently notified the World Trade Organization (WTO) of their desire to use the compulsory license mechanism provided in article 31bis of the TRIPS agreement. This week they will notify the WTO of their intent to import vaccines manufactured by Biolyse, as required by article 31bis.

In previous WTO meetings, Canada has asked TRIPS waiver proponents for “concrete” evidence of patent-related challenges in procuring COVID-19 goods. Canada has argued that existing flexibilities are working “as intended,” citing their own Canada’s Access to Medicines Regime (CAMR) mechanism as an example. TRIPS waiver proponents such as South Africa have pushed back against that argument specifically citing the case of Biolyse. CAMR, like article 31bis of the TRIPS agreement, is a procedural labyrinth that has only been used once since it came into force and includes a number of protectionist provisions impeding the expeditious grant of compulsory licenses. For example, compulsory licenses may only be granted for products listed in Schedule 1 of the Canadian Patent Act and no COVID-19 vaccine is currently on that list. 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.

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. 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. 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. 

Biolyse has agreed to sell vaccines to Bolivia at an estimated manufacturing cost of $3 to $4 U.S. dollars a dose, according to the deal. KEI has been assisting Biolyse in their request for a compulsory license and met with Bolivian officials to discuss this issue. Neither KEI or any of its staff members received compensation in connection to this agreement.