Roche releases Covid-19 test recipe, after EC considers intervention(ftm.nl)
ftm.nl
Roche releases Covid-19 test recipe, after EC considers intervention
https://www.ftm.nl/artikelen/roche-releases-recipe-after-public-pressure-while-european-commission-considers-intervention-due-to-coronavirus-test
10 comments
It's great that finally EU is doing something. It's better late then never.
Companies are doing their best to be profitable, but it can mean trillions of dollars of damage to economies, and many people dying. Governments are meant to step up in these situations.
Companies are doing their best to be profitable, but it can mean trillions of dollars of damage to economies, and many people dying. Governments are meant to step up in these situations.
This is not the EU doing something. It's the tiny country of the Netherlands being a desperate cowboy and Roche being aware of Brazil once having survived a WTO dispute regarding the access to a certain anti AIDS medicament.
Well yeah people dying does put a bit of pressure on things. Roche hasn't been forced though. Perhaps they decided their strategic relationship with Dutch governments wasn't worth compromising over this.
The fact that Roche was not forced, meaning they where able to offer the dutch government something better, should greatly worry everyone not living in the Netherlands.
No opinion on this exact story, but in general there's a bit of a balance to be struck here.
Early on in this thing, there were lots of stories about companies reluctant to fully commit (e.g. to manufacturing masks, or to dropping everything else to work on a vaccine) because they did that for SARS, and then when it fizzled out felt they weren't sufficiently compensated. Had they worked on their usual business, they would have had their usual profits instead. But this year... it would have been nice if they had worked hard in February!
Early on in this thing, there were lots of stories about companies reluctant to fully commit (e.g. to manufacturing masks, or to dropping everything else to work on a vaccine) because they did that for SARS, and then when it fizzled out felt they weren't sufficiently compensated. Had they worked on their usual business, they would have had their usual profits instead. But this year... it would have been nice if they had worked hard in February!
Well here the issue is that Roche has been compensated as the orders are in. Roche just does not seek to fulfill them in a timely manner. Which is also a strategic decision of production and inventory. Given that any production ramp up would have been a risky decision in January, the point explicitly is not that Roche can not supply the material right this instance.
What's not okay is that Roche uses vendor locking in or legal lock ins (Denmark) to keep countries from running any tests.
This is not a matter of ramping up production in January ex-ante. It's a thing that happened and was discussed just last week, when many EU countries literally were in a state of emergency since more than a week. In an effort to protect future, not current, profits, Roche has more or less directly contributed to the death of people. And if you think this is a strategic decisions that firms should be able to make in such a volatile situation, then you should probably not be allowed to gain these kinds of market shares in the EU.
Because let's be clear. If there were a legal institution to solve this problem last week or two weeks ago, it would have been used. The only reason Roche responds now is because the EC would invoke its discretionary power, slow as it is.
The only ethical decision for Roche would have been to release either the recipe or release legal lock-ins as soon as it was apparent that they could not fulfill orders in time. Roche, which is not a EU company, should be held accountable to whatever degree the law allows. And to the degree it doesn't, such laws should be created.
From a EU perspective, it is doubtful whether a company that acts in this way should be allowed to do business here in this manner - in my personal opinion. And that's not just empty talk - in several countries the constitutions actually do norm that lives and welfare of people take precedence over pecuniary interests. For example, Roche would have simply have been disowned of their intellectual property by a court here in Germany if we would have had the same lock-in issue. There's ample legal precedent for that, and there are high legal boundaries for such actions. But given the setup of our constitution, these requirements are clearly met in this case.
What's not okay is that Roche uses vendor locking in or legal lock ins (Denmark) to keep countries from running any tests.
This is not a matter of ramping up production in January ex-ante. It's a thing that happened and was discussed just last week, when many EU countries literally were in a state of emergency since more than a week. In an effort to protect future, not current, profits, Roche has more or less directly contributed to the death of people. And if you think this is a strategic decisions that firms should be able to make in such a volatile situation, then you should probably not be allowed to gain these kinds of market shares in the EU.
Because let's be clear. If there were a legal institution to solve this problem last week or two weeks ago, it would have been used. The only reason Roche responds now is because the EC would invoke its discretionary power, slow as it is.
The only ethical decision for Roche would have been to release either the recipe or release legal lock-ins as soon as it was apparent that they could not fulfill orders in time. Roche, which is not a EU company, should be held accountable to whatever degree the law allows. And to the degree it doesn't, such laws should be created.
From a EU perspective, it is doubtful whether a company that acts in this way should be allowed to do business here in this manner - in my personal opinion. And that's not just empty talk - in several countries the constitutions actually do norm that lives and welfare of people take precedence over pecuniary interests. For example, Roche would have simply have been disowned of their intellectual property by a court here in Germany if we would have had the same lock-in issue. There's ample legal precedent for that, and there are high legal boundaries for such actions. But given the setup of our constitution, these requirements are clearly met in this case.
Of course we have a special time at moment and I understand your point. But on the other hand, Roche is a just a company and companys exist to make money. I couldn't find it, but back in january there was a press release from several pharma companys who said, they will not start to work on Covid-19 because the last time with Sars etc. finally nobody paid them.
It makes a strong argument that companies should not be involved with these things
As the saying goes, in times of emergency "we can either do this nicely, or else..."
Also: Trump and GM right now
Also: Trump and GM right now
Like I said, it's not about retroactively deciding they should have ramped up production in hopes of future payoffs.
This is about a constitutional issue: At this moment (or rather last week), Roche was using a "legal" loophole to keep these states from testing. This is unethical, clearly, and leads to deaths.
Now the question is: why is it a loophole? Is it illegal if there is no law against it? On the surface, Roche is just doing what is in its best interests.
But my point was that in the EU, many systems are explicitly not set up solely as "do what you want if there is no law AGAINST it"! I made the case that this behavior (lock-ins of whatever form to keep hospitals from testing patients) is in fact not consistent with the entirety of our laws, and the only issue here is the difficulty of determining this fact in a short timeframe because constitutional / public law does not directly (however indirectly) legislate private parties.
In particular, in our jurisdiction, we norm (for example in the constitution) that commerce has to fall within ethical boundaries. Sometime these norms are made concrete as laws: price gouging, for example, is illegal.
For this case, no such concrete law exists. Nevertheless if this was ever brought in from of a court, the court would decide without fail that this behavior is not in accordance to the basic law of the constitution and it would in fact mandate the legislative to form a new law forbidding this behavior (where the boundaries were to be set by weighting countervailing interests of private commerce against public welfare). This is absolutely standard legal procedure.
Similarly, executive bodies would eventually (see the EC) step in, and their decisions would ex-post be validated by the constitutional courts, without fail. Because one law that does exists in most countries, coming from the above constitutional consideration, is that the executive can expropriate private parties if it is in the overwhelming public interest. This is simply a law that writes down what our constitution proclaims in terms of ethical behavior.
So, the only reason this loophole exist, then, is because executive bodies are slow to react, and court validation is even slower.
Hence, my point was that Roche was using a loophole within our legal system to engage in unethical behavior. Whether or not this alone is illegal, and whether or not there will be sanctions, is doubtful, as public law of this kind does not directly legislate private businesses.
But I would like to see laws enacted now that norm (even if it needs to be specific such as for pandemic cases) that when a private party engages in behavior that is unethical or otherwise obviously not consistent with basic principles, then they can be retroactively punished.
All this is very simple: Most countries in the EU have a legal basis that unethical behavior, such as endangering lives, is not justifiable by business interests. Everyone doing business here has to be aware of this and we have to conclude that Roche was doing this despite this knowledge.
This is about a constitutional issue: At this moment (or rather last week), Roche was using a "legal" loophole to keep these states from testing. This is unethical, clearly, and leads to deaths.
Now the question is: why is it a loophole? Is it illegal if there is no law against it? On the surface, Roche is just doing what is in its best interests.
But my point was that in the EU, many systems are explicitly not set up solely as "do what you want if there is no law AGAINST it"! I made the case that this behavior (lock-ins of whatever form to keep hospitals from testing patients) is in fact not consistent with the entirety of our laws, and the only issue here is the difficulty of determining this fact in a short timeframe because constitutional / public law does not directly (however indirectly) legislate private parties.
In particular, in our jurisdiction, we norm (for example in the constitution) that commerce has to fall within ethical boundaries. Sometime these norms are made concrete as laws: price gouging, for example, is illegal.
For this case, no such concrete law exists. Nevertheless if this was ever brought in from of a court, the court would decide without fail that this behavior is not in accordance to the basic law of the constitution and it would in fact mandate the legislative to form a new law forbidding this behavior (where the boundaries were to be set by weighting countervailing interests of private commerce against public welfare). This is absolutely standard legal procedure.
Similarly, executive bodies would eventually (see the EC) step in, and their decisions would ex-post be validated by the constitutional courts, without fail. Because one law that does exists in most countries, coming from the above constitutional consideration, is that the executive can expropriate private parties if it is in the overwhelming public interest. This is simply a law that writes down what our constitution proclaims in terms of ethical behavior.
So, the only reason this loophole exist, then, is because executive bodies are slow to react, and court validation is even slower.
Hence, my point was that Roche was using a loophole within our legal system to engage in unethical behavior. Whether or not this alone is illegal, and whether or not there will be sanctions, is doubtful, as public law of this kind does not directly legislate private businesses.
But I would like to see laws enacted now that norm (even if it needs to be specific such as for pandemic cases) that when a private party engages in behavior that is unethical or otherwise obviously not consistent with basic principles, then they can be retroactively punished.
All this is very simple: Most countries in the EU have a legal basis that unethical behavior, such as endangering lives, is not justifiable by business interests. Everyone doing business here has to be aware of this and we have to conclude that Roche was doing this despite this knowledge.
Sure, I agree with the balancing act. There just shouldn't be any monetary problem going on, as testing is so cheap compared to the effects of not putting sick people on quarantine.
I'm just fustrated of the whole western thinking while Asia shows us that fighting the virus is just a logistical problem, we have all the needed technology (masks, testing, quarantine, hygiene, temperature checking everywhere).
I'm just fustrated of the whole western thinking while Asia shows us that fighting the virus is just a logistical problem, we have all the needed technology (masks, testing, quarantine, hygiene, temperature checking everywhere).
Frustrated too, but it's not just a logistical problem, it's a political problem. We have lots of logistical wizards but had to decide to employ them them. Lots of bio-lab wizards too.
Yes, they learned that lesson, and now we are paying for the short sightedness of the politicians at that time hanging them out to dry.
The signal for a company to work hard is to award them a contract. If it's important enough to get done, then it's important enough for whatever government to put a contract in place and get the work going. When those in power require work to be done for free, it is called slavery, not volunteering.
The signal for a company to work hard is to award them a contract. If it's important enough to get done, then it's important enough for whatever government to put a contract in place and get the work going. When those in power require work to be done for free, it is called slavery, not volunteering.
Right now, fast response and supplies are needed, and every hour of delay is someone dead.
Obstructionism will not be tolerated by the public, and you won't sway anyone with discourse on slavery or evils of socialism.
Yes, foresight would be great, but that ship has sailed.
Obstructionism will not be tolerated by the public, and you won't sway anyone with discourse on slavery or evils of socialism.
Yes, foresight would be great, but that ship has sailed.
> every hour of delay
So, the government should hurry up and make a deal.
So, the government should hurry up and make a deal.
Why "early on"? Just yesterday GM tried to price-gouge the US federal government, and restrict the number of ventilators they will produce, prompting Trump to actually use the DPA for the first time in this ordeal, something he's very reluctant to do other than as leverage in negotiations.
I said early on because in Jan/Feb some people thought it might blow over -- it wasn't 100% obvious that you would be able to sell every mask you could make. Had someone signed a contract for 6 months of full production, they would have switched, but without it, they sat. That was a situation with a lot of parallels to SARS.
Now of course things are different, nobody is thinking the way I suggested. They are playing other games, though.
Now of course things are different, nobody is thinking the way I suggested. They are playing other games, though.
But I thought Trump said there wasn't a ventilator shortage, or something along those lines. Didn't he accuse New York of asking for more than they needed?
Now, all of a sudden, ventilators are very important to Trump. Odd.
Now, all of a sudden, ventilators are very important to Trump. Odd.
He doesn't understand exponential function, neither most of the people in the world. It's counterintuitive, as the brain is heavily biased to linear thinking. Also in western world generally math is not cool, people have a strong bias against it.
There isn't a shortage, yet. Cuomo was put on the spot today over thousands of ventilators sitting in a warehouse. He said they don't need them yet, but they "expect to" in the future. Any claims of a current shortage, therefore, are a lie.
The Doha Declaration on the TRIPS Agreement and Public Health;
In Paragraphs 4 to 6 of the Doha Declaration, governments agreed that:
"4. The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.
5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include:
(a) In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.
(b) Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.
(c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. (d) The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4. 6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002." These provisions in the Declaration ensure that governments may issue compulsory licenses on patents for medicines, or take other steps to protect public health.
/!\ All countries of weight signed this already, but not enough countries for the treaty to be in effect and the deadline is in sight. /!\
Pressure this information & save lifes.
In Paragraphs 4 to 6 of the Doha Declaration, governments agreed that:
"4. The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.
5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include:
(a) In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.
(b) Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.
(c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. (d) The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4. 6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002." These provisions in the Declaration ensure that governments may issue compulsory licenses on patents for medicines, or take other steps to protect public health.
/!\ All countries of weight signed this already, but not enough countries for the treaty to be in effect and the deadline is in sight. /!\
Pressure this information & save lifes.
Sure, but there is a cost one way or the other.
TANSTAAFL (there ain't no such thing as a free lunch)
If its really important, then working out a deal that protects all parties is far better than threatening to give the business to someone else by fiat.
Roche has invested a lot into these machines and processes. Ensuring that they are adequately compensated and adequately protected from their competitors is important. Not just for fairness, but for also ensuring that companies don't decide in the future that the risks outweigh the rewards.
What will happen, for example, if some local lab starts putting together tests for these machines and ends up putting the machines out of commission? Who's doing the QA to make sure this is not a problem? Will Roche be on the hook for this? And how will the people who are depending on this machine benefit if it taken off line?
These are very complicated machines, and a lot can go wrong.
TANSTAAFL (there ain't no such thing as a free lunch)
If its really important, then working out a deal that protects all parties is far better than threatening to give the business to someone else by fiat.
Roche has invested a lot into these machines and processes. Ensuring that they are adequately compensated and adequately protected from their competitors is important. Not just for fairness, but for also ensuring that companies don't decide in the future that the risks outweigh the rewards.
What will happen, for example, if some local lab starts putting together tests for these machines and ends up putting the machines out of commission? Who's doing the QA to make sure this is not a problem? Will Roche be on the hook for this? And how will the people who are depending on this machine benefit if it taken off line?
These are very complicated machines, and a lot can go wrong.
Saving the economy which will then be able to afford multiple Roche products is a pretty good payment, methinks.
That logic makes no sense. It's like the government taking your home from you to build a new stadium saying "well, I think the ability to enjoy the new stadium is payment enough!".
I might be misunderstanding the situation, but it feels like Roche has been acting like a printer manufacturer: capture the market with underpriced devices, but having those devices only work with a specific variation of an otherwise not that special input material that only they can produce, and then charging a premium for that.
Swedish healthcare workers have discovered that chlamydia tests they have in stock are also effective at detecting corona. News (in Swedish) https://news.ycombinator.com/item?id=22706874
A commenter in that thread indicates it’s just the swabs being used, which makes much more sense to me.
Don't the reagents for similar commercial lab rtPCR tests typically have to be kept hard frozen too?
CMIIAW: this doesn't seem like a readily DIY biohacking-possible project without some significant infrastructure, procedural knowledge, and expenses.
Also is there a low-volume, open source rtPCR procedure with cheaper equipment and consumables?
CMIIAW: this doesn't seem like a readily DIY biohacking-possible project without some significant infrastructure, procedural knowledge, and expenses.
Also is there a low-volume, open source rtPCR procedure with cheaper equipment and consumables?
Also this news that reagent is no longer required:
https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-...
https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-...
This is reminiscent of what happened in 2008, when Roche was the only manufacturer of Tamiflu (Oseltamivir)[1] and the Indian drug company Cipla managed to get legal approval to release a generic clone of it called Antiflu in India. And the rest of the world followed soon enough.
Governments can and do lift up patent protections in times of emergencies.
[1]: https://en.wikipedia.org/wiki/Oseltamivir
Governments can and do lift up patent protections in times of emergencies.
[1]: https://en.wikipedia.org/wiki/Oseltamivir
Roche have a legal problem. Their lysis buffer is completely unpatentable, it's a standard reagent whose composition has been published many times over and is obvious to any biochemist. And once you disclose the makeup you can't claim trade secret either.
The sanest way for Roche would be to price accordingly, buying your own kit saves technician labour, but we can't have than, can we?
The sanest way for Roche would be to price accordingly, buying your own kit saves technician labour, but we can't have than, can we?
Seems the key issue is that they can't supply enough which creates a shortage for the Netherlands as the machines (?) rely on this specific product. It's called lock-in and is every company's dream. But the situation is severe enough that a strong government like NL and the EU won't let them get away with it. If you're a big company one the things you really want to avoid is the European Commission coming after you for antitrust rules, that's where for once legislation has teeth and the price tag for abuse can be steep.
Your parent claims it is a generic solution.
I am confused what the problem actually is.
I am confused what the problem actually is.
Even though it is a generic solution, they apparently use a slight modification in the recipe (not which components, but the amounts) on which the machines are calibrated. You could reproduce this, but it costs time and you need specialized equipment that only a few labs have. With this disclosure, labs can produce their own without that research.
Thanks so much for the clarification.
Couldn't you just put the solution through a gas chromatography machine?
Couldn't you just put the solution through a gas chromatography machine?
There is an epidemic going on, and personnel have better things to do than optimizing a buffer to play nice with your thermocycler.
Any time there is a monopoly, prices have nothing to do with the cost of production and everything with what the market is going to bear, and no one but the monopolist benefits. And then the monopolist comes and wants to suborn the power monopoly of the government to sustain its profits. Come again, why should the European Union put the financial wellbeing of Roche above the health of Dutch citizens? We used to have antitrust, but nowadays even right-to-repair is controversial.
Any time there is a monopoly, prices have nothing to do with the cost of production and everything with what the market is going to bear, and no one but the monopolist benefits. And then the monopolist comes and wants to suborn the power monopoly of the government to sustain its profits. Come again, why should the European Union put the financial wellbeing of Roche above the health of Dutch citizens? We used to have antitrust, but nowadays even right-to-repair is controversial.
I wasn't saying that at all. I was just wondering about 'how hard can it be?'.
It just needs to be analysed once. And there is a ton of researchers available who are not medical personnel.
But if you want to argue : this whole Roche saga conveniently diverts the attention away from the lack of action of our government.
It just needs to be analysed once. And there is a ton of researchers available who are not medical personnel.
But if you want to argue : this whole Roche saga conveniently diverts the attention away from the lack of action of our government.
If I am not mistaken, gas chromatography gives you composition, not proportions. That’s not a minor hurdle in this discussion.
No. Manufacturing is about process engineering. Knowing the physical components is only 20% of the work.
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Is what the article says. What it doesn’t say is whether Roche will actually do so, or use stalling tactics. One shouldn’t count their chickens before they hatch.