Allow me to tell you a short story of pharma patents in world trade. The story start in the old days of GATT. Where patents were decidedly not part of world trade law (thread)
In those old days, it was a decision of each country whether to grant patents or not. Each country had to think "will this be a good choice for us? an incentive for research? Or actually counterproductive exclusivity?"
But in some developing countries this was perceived as unfair. In the US some thought "we pay higher prices for innovation. You just get it for free". Pharma patents were central to the debate.
In the 1980s the US accused Brazil of not respecting pharma patents. Brazil unsurprisingly argued we do not have to under the GATT. nytimes.com/1989/02/22/bus…
And then along came the Uruguay round. The developed world wanted IP to enter the world trade system. The developing world didn't really. The mandate was a diplomatic compromise.
Industry build a coalition to lobby for IP. The outcome was an agreement that makes patent protection mandatory. Compulsory licenses are allowed - under conditions. What does that mean?
Basically a state can under certain conditions allow others to produce the patented product, one of the conditions is you have to pay for that. The conditions are in Art. 31 TRIPS.
And again pharma patents were at the core of this debate. And US pharma was amongst the main forces in lobbying here.
HIV drugs were one of the major fighting points here, where drug companies charged exorbitant prices. The fights about this fill books.
One of the infamous episodes here is that India made granting patents a bit more stringent - in compliance with TRIPS - and the US made banning clauses like the Indian one an item in their trade negotiations.
So this changed position is both stunning and welcome.
One final clarification: people often get confused about patents and say "Brazil breaks a US patent." That is incorrect. Patents are territorial. A UK patent is valid for the UK. It grants no protection elsewhere. But the same company might hold a similar patent in Brazil.
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Always astonished by human capacity for mental exaggeration. Just take a look at the journey of public opinion on the UK. Starting point "a very competent country". (thread)
During the Brexit campaign, politics became disconnected from the civil service and some... let's say extraordinary things were said and done. At first people thought there must be a secret plan - precisely because of the amount of respect for competency.
But there was no secret plan. Suddenly people started to think "are we fundamentally incompetent? What is wrong with us?".
There’s a lot of muddled thinking on what the problem with export bans is. So... in the form of a Q&A, a quick overview (thread)
1) Is it the rule of law?
Two components to this, arguably. Is there a problem because it interferes with private contracts? Not really. Most regulatory power does. Take Brexit: it interferes with thousands of contracts. Or the UK ban on parallel exports of some medicines. What about international law?
A note on timing of contracts: The first sentence here is wrong. So those who tweeted at me that the EU signed first so it wins or that the UK signed first so it wins (yup, got both of those): both wrong. Interested why?
Suppose A signs a contract with B. Two days later it signed a contract with C. Both contracts are for delivering 100 widges. Result? A has to deliver 100 widges to B AND to C. It is obliged to deliver both according to the terms of the agreement.
Problems only arise if A cannot deliver on both contracts. What then? Well, A still owes the 100 widges to both parties. If there’s no term in the contract giving preference to one or the other or modifying the obligation - A will have to break at least one contract.
Curious fact of contract law: I can sell the same Picasso painting to 15 people. I am contractually obligated to deliver the Picasso to all of them. Each one has the same claim, unless that specific contract stipulates otherwise.
Also true if I don't have a Picasso painting.
And just for @SpinningHugo : if I conclude 15 identical contracts for producing 100 widgets, but actually only can produce 100 on times, the same problem arises: all 15 have a claim against me. Priority is only valid if in the contract.
Now I don’t know what was in these contracts. Let y’all battle it out. But it’s not won on the grand principles of contract law. It’s won on the specifics of the contract.
Includes such great terms as pharmacoviligance risk assessment and observed v expected analysis, even though it's in German. And it explains the timing of the decision of the PEI.
(Just in case: PEI= Paul Ehrlich Institut, the German federal institute for vaccines, sort of the Robert Koch Institut for vaccines)
A quick hypo: assume a glass vial manufacturer has a production issue and a charge of 10.000 of its vials is contaminated. The vial is used for vaccines. The contamination leads to an increased frequency of heart attacks. How does the regulator find out?
Another hypo: assume one of the chemicals used in producing a vaccine is not up to the normal standard of the company. Despite using the adequate standard of diligence they do not detect it, because it wasn't detectable. How does the regulator find out?
The answer is: the regulator gets tons and tons of data on problems. From "I felt like I had to drink alcohol after taking the drug, which is why I had to drive drunk" (well, dubious) to "I could not sleep" to "X died, no idea why".