Thread by @CoppetainPU

One to watch with (some) implications for the controversial WTO #Covid19Waiver on intellectual property protection.

Bolivia wants to import a generic version of the J&J COVID-19 #vaccine made under “compulsory” licence By @BiolysePharma in Canada

1/17

globalnews.ca/news/7851500/b…

This may test the claim by #Covid19Waiver supporters that this route is too cumbersome

Under WTO rules, @BiolysePharma first had to try to get a voluntary licence from J&J to produce the vaccine. It tried in March and was rejected.

2/17

healthpolicy-watch.news/company-pushes…

Although the objective is to get a cheaper generic version of the vaccine to a developing country—Bolivia—a lot the focus will be on Canada.

Ottawa has to issue a compulsory licence to export, which has special rules. So far, no news on that

3/17

globalnews.ca/news/7851500/b…

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

4/17

healthpolicy-watch.news/company-pushes…

Note that if Canada is to waive patent protection under the proposed #Covid19Waiver, rather than use compulsory licensing, its law would have to be changed too.

Depending on Canada's legislation that might or might not require individual products to be listed.

5/17

Nor do we know if/when the WTO #Covid19Waiver would be agreed. The most optimistic hope is at the end of the year. After that Canada would need time to change its law. Some are less hopeful.

6/17 tradebetablog.wordpress.com/2021/05/07/tri…

It's not surprising a senior member of the WTO Secretariat—the IP Division director—has welcomed the attempt.

WTO members spent years negotiating rules to allow compulsory licensing for export, and it’s only been used once.

7/17 tradebetablog.wordpress.com/note-par6-used…

Last time it took Ottawa several months to add the product to the list eligible for compulsory licences to export. Once the product was listed it only took two weeks for the compulsory licence to be approved in Canada.

8/17

tradebetablog.wordpress.com/note-par6-used…

What does Bolivia have to do? Rwanda is a least-developed country. Bolivia is not, so it will have to supply more info in its notifications.

One difference is information to show that Bolivia (not “least-developed”) cannot make the vaccine itself.

9/17

wto.org/english/tratop…

Bolivia can apply the 2005 amendment on cross-border compulsory licensing to the WTO’s intellectual property agreement, which it accepted (or ratified) in 2018

In February 2021 Bolivia made its one-off notification that it intends to use the system

10/17 docs.wto.org/dol2fe/Pages/S…

On May 11, 2021, it notified the WTO that it would import COVID-19 vaccines and ticked the box to say it could not make them itself (not in English yet)

11/17

docs.wto.org/dol2fe/Pages/S…

Here are some tweets from @hhesterm on what Bolivia said: that it has yet to determine if relevant patents have been registered in Bolivia.

“What Bolivia wrote is refreshingly realistic and indicative of some of the difficulties.”

12/17

https://twitter.com/hhesterm/status/1392221810796679181?s=20

WTO approval is not needed, only information shared through notifications.

Supporters of the #Covid19Waiver say these obligations are “onerous”. If this compulsory licence goes ahead, it will also test that claim.

More details on the waiver

13/17 tradebetablog.wordpress.com/2020/12/17/wto…

Here’s @geoffreyyork in the Globe and Mail

14/17 theglobeandmail.com/world/article-…

Here's a thread by @hhesterm of @KCL_Law who has written extensively about this subject

15/17

https://twitter.com/hhesterm/status/1392218813979152391?s=20

And here’s @DebraPS, a leading Canadian trade lawyer and former head of the WTO Appellate Body Secretariat

16/17

https://twitter.com/DebraPS/status/1392221588842377219?s=20

Finally, who moved first? Why?

@BiolysePharma may see a commercial chance, or want to help poorer countries get vaccines, or to test the Canadian system, or all 3

Bolivia’s general notification was in February shortly before the voluntary licence was rejected

Maybe both

17/17

Now blogged

The move pits two different and hotly-debated procedures against each other in the WTO:

● the proposed #Covid19Waiver

versus

● flexibilities such as compulsory licensing for export, which have their own rules.

tradebetablog.wordpress.com/2021/05/12/bol…