By Peter Ungphakorn
POSTED MAY 12, 2021 | UPDATED MAY 12, 2021
News broke late yesterday (May 11, 2021) that a Canadian company, Biolyse Pharma, had agreed to supply Bolivia with 15 million doses of Johnson & Johnson’s Janssen vaccine for COVID-19, without the patent-owner’s permission.
But the deal cannot go ahead until the Canadian government issues a “compulsory licence” for Biolyse Pharma to make the vaccine in Canada and export it to Bolivia.
Although the objective is to get a cheaper version of the vaccine to a developing country — Bolivia — a lot of the focus will be on Canada, which now holds the key.
The move pits two different and hotly-debated procedures against each other in the World Trade Organization (WTO).
One is a set of rules on using compulsory licences to export medicines to poor countries. Since the rules were agreed in 2003 and 2005, they have only been used once before. That was in 2007–09 when again it was Canada that exported, in that case, an antiretroviral HIV/AIDS treatment to Rwanda.
The other is a proposed waiver, during the pandemic, on intellectual property protection for products related to COVID-19.
The waiver’s supporters say the requirements for cross-border trade under compulsory licence are too cumbersome to deal with the pandemic. That’s why they want intellectual property protection suspended more broadly for patents, copyright, industrial designs and trade secrets.
Its critics say the existing flexibilities for patents, including compulsory licensing, are already available and should be used.
In any case, voluntary licences agreed with the patent owners is the best route, they argue. It is one solution being pursued by WTO Director-General Ngozi Okonjo-Iweala.
But Biolyse Pharma had already tried and failed to obtain a voluntary licence from Johnson & Johnson in March, and also reportedly from Astra Zeneca. Some analysts suggested the Canadian company is too small to interest large vaccine producers.
The failure over a voluntary licence allows Biolyse Pharma the next step of seeking a compulsory licence. Media reports say Ottawa has not commented on how it will respond.
Under Canada’s Access to Medicines Regime (CAMR), the vaccine first has to be listed as eligible for a compulsory licence for export. This is not a WTO requirement, but needed under Canada’s own law.
That may take some time, which is not good news when the need is urgent. Adding Rwanda’s anti-retroviral HIV/AIDS medicine to the list took several months, partly because of a general election and new parliamentary programme in Ottawa. After that, approving the compulsory licence only took two weeks.
But suspending patent protection under the proposed WTO waiver would also take time. We do not know if or when the WTO waiver will be agreed. The most optimistic hope is at the end of the year. Some are less hopeful. After that Canada would need time to change its law. Whether the new law would have a similar process of adding products to a list is hypothetical.
Approval from the WTO is not needed. But unsurprisingly, a senior member of the WTO Secretariat — Intellectual Property Division director Antony Taubman — has welcomed the latest attempt to secure a compulsory licence to export.
After all, WTO members spent years in sometimes-bitter negotiations to produce rules enabling compulsory licensing for export. Since then, the rules have only been used once.
“This is certainly seen as a very welcome step,” he said, “and one that may, perhaps, pave the way for other [WTO] members to make use of this system, to signal unmet needs, and to help precipitate a response to those urgent medical needs.”
(His revised statement on the WTO website was more cautious in describing this is as one of several option, including the proposed waiver.)
According to the World Health Organization, Bolivia with a population of about 11.5 million has had 320,000 confirmed COVID-19 cases, with 13,000 deaths, a higher mortality rate than in developed countries. About 715,000 people (6%) have been vaccinated with at least one dose — 973,000 doses administered in total. The vaccines available are Sputnik V and Sinopharm, according to the US embassy in Bolivia.
The deal with Biolyse Pharma is said to be for 15 million doses of the Johnson & Johnson vaccines — requiring only a single shot per person — for US$3 to US$4 per dose. Under compulsory licensing rules Biolyse Pharma would pay a royalty to the American firm.
There will be work for Bolivia too. One is to handle its own procedure for procuring medicines. In Rwanda, that added to the time, but it had nothing to do with WTO requirements. What is involved in Bolivia remains to be seen
What the WTO does require is information and transparency, in the form of notifications. Bolivia is not a least-developed country, so it will have to supply more information than Rwanda, but not much.
First, it has to tell the world, through the WTO, that it intends to import under the compulsory licensing scheme. It only has to do that once. Bolivia did it in February 2021.
Then it has to notify which products it intends to import, to justify this by stating it cannot produce them itself, and state whether the products are patented in Bolivia. It did so yesterday (May 11, 2021), in a one-page form, ticking the box to say it cannot make the vaccines.
Holger Hestermeyer, who has written extensively about this subject, noticed that Bolivia said the situation with patents was still to be determined, and that it would issue its own compulsory licences if any patents were found. He said this was “refreshingly realistic and indicative of some of the difficulties.”
The main reason is that COVID-19 vaccines contain several components, each with potentially separate patents. Once Biolyse Pharma has sorted out Canadian compulsory licensing, then the situation in Bolivia could become clearer.
Finally, who moved first? Why?
Biolyse Pharma may have spotted a commercial opportunity. It may want to see poorer countries receive vaccines at reasonable prices. It may want to test the Canadian system. Or possibly it is driven by two or all three of those motives.
Bolivia seems to have been active from about the same time as Biolyse Pharma, back in February shortly before the voluntary licence was rejected.
Whatever was happening behind the scenes, this is definitely a case to watch.
Updates: May 13, 2021 — adding links to the brief story on the WTO website