6 ms·

Roche releases Covid-19 test recipe, after EC considers intervention

148 points by itcrowd 7y ago

HarryHirsch 7y ago
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?
- pergadad 7y ago
  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.
  - the-dude 7y ago
    Your parent claims it is a generic solution. I am confused what the problem actually is.
    - kokx 7y ago
      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.
      - the-dude 7y ago
        Thanks so much for the clarification. Couldn't you just put the solution through a gas chromatography machine?
        HarryHirsch 7y ago
        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.
        the-dude 7y ago
        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.
        prostheticvamp 7y ago
        If I am not mistaken, gas chromatography gives you composition, not proportions. That’s not a minor hurdle in this discussion.
        deleted 7y ago
        [deleted]
        rubidium 7y ago
        No. Manufacturing is about process engineering. Knowing the physical components is only 20% of the work.
xiphias2 7y ago
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.
- iguy 7y ago
  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!
  - tomohawk 7y ago
    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.
    - ClumsyPilot 7y ago
      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.
      - tomohawk 7y ago
        > every hour of delay So, the government should hurry up and make a deal.
willvarfar 7y ago
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 https://news.ycombinator.com/item?id=22706874
- jagger27 7y ago
  A commenter in that thread indicates it’s just the swabs being used, which makes much more sense to me.
chli 7y ago
Also this news that reagent is no longer required: https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-mangelproblem-ved-test-for-covid19-27032020 https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-...
coretx 7y ago
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.
- tomohawk 7y ago
  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.
anonsubmit2671 7y ago
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?
- the-dude 7y ago
  https://openpcr.org/ https://openpcr.org/
- jdc 7y ago
  https://forum.openhardware.science/t/pocketpcr-low-cost-usb-powered-open-source-pcr/2187 https://forum.openhardware.science/t/pocketpcr-low-cost-usb-...
- hcknwscommenter 7y ago
  Not the lysis buffer.
Vinnl 7y ago
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.
prostheticvamp 7y ago
“ Pharmaceutical company Roche announced Friday afternoon that it will release the recipe for its lysis buffer if Dutch laboratories ask for it. ” 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.
Proven 7y ago
I don't care about their recipe, I care about my own right to free speech and property. The EU busybodies violate both of them while the masses cheer.
woadwarrior01 7y ago
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 https://en.wikipedia.org/wiki/Oseltamivir

148 points by itcrowd 7y ago

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?

pergadad 7y ago
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.
- the-dude 7y ago
  Your parent claims it is a generic solution. I am confused what the problem actually is.
  - kokx 7y ago
    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.
    - the-dude 7y ago
      Thanks so much for the clarification. Couldn't you just put the solution through a gas chromatography machine?
      - HarryHirsch 7y ago
        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.
        the-dude 7y ago
        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.
        prostheticvamp 7y ago
        If I am not mistaken, gas chromatography gives you composition, not proportions. That’s not a minor hurdle in this discussion.
      - deleted 7y ago
        [deleted]
      - rubidium 7y ago
        No. Manufacturing is about process engineering. Knowing the physical components is only 20% of the work.

xiphias2 7y ago

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.

iguy 7y ago
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!
- tomohawk 7y ago
  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.
  - ClumsyPilot 7y ago
    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.
    - tomohawk 7y ago
      > every hour of delay So, the government should hurry up and make a deal.

willvarfar 7y ago

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 https://news.ycombinator.com/item?id=22706874

jagger27 7y ago
A commenter in that thread indicates it’s just the swabs being used, which makes much more sense to me.

chli 7y ago

Also this news that reagent is no longer required: https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-mangelproblem-ved-test-for-covid19-27032020 https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-...

coretx 7y ago

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.

tomohawk 7y ago
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.

anonsubmit2671 7y ago

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?

the-dude 7y ago
https://openpcr.org/ https://openpcr.org/
jdc 7y ago
https://forum.openhardware.science/t/pocketpcr-low-cost-usb-powered-open-source-pcr/2187 https://forum.openhardware.science/t/pocketpcr-low-cost-usb-...
hcknwscommenter 7y ago
Not the lysis buffer.

Vinnl 7y ago

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.

prostheticvamp 7y ago

“ Pharmaceutical company Roche announced Friday afternoon that it will release the recipe for its lysis buffer if Dutch laboratories ask for it. ” 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.

Proven 7y ago

I don't care about their recipe, I care about my own right to free speech and property. The EU busybodies violate both of them while the masses cheer.

woadwarrior01 7y ago

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 https://en.wikipedia.org/wiki/Oseltamivir