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Dutch join backlash at expensive drugs by making their own
- wjnc 8y agoThe killer detail (in the article) is that 1/3 of the (small) development cost of 40 million were borne by the Dutch tax payer. How did that patent end up in a big pharma portfolio? Who funds this and what kind of shit lawyers and economists draw up the funding schemes that give away full intellectual property, only with a (historic) backstop for individual preparation? We need risked based co-funding, co-profiting (irregardless of wether it's governments or, say, insurers investing), a backstop on prices via qualy-s, relatively short patents, no gaming of patents via arbitrarily small changes, governments creating generics, ... And now I wake up.
- rocqua 8y ago> relatively short patents, no gaming of patents via arbitrarily small changes This, so much. I'd add no gaming of orphan drug patents. It's through the patent system that pharmaceuticals get their pricing power. http://sourceonhealthcare.org/orphan-drug-act-fostering-innovation-or-abuse/ http://sourceonhealthcare.org/orphan-drug-act-fostering-inno...
- yread 8y agoThat's also not a silver bullet see CF where foundation funded research and sold the IP to pharma company for 3.3B$ and the patients were then charged 300k a year for it. https://philanthropynewsdigest.org/news/cystic-fibrosis-foundation-receives-3.3-billion-royalty-pay-out https://philanthropynewsdigest.org/news/cystic-fibrosis-foun...
- zaroth 8y agoI think you have cause and effect reversed. They helped fund the development of the new CF drug by Vertex, which Vertex sells for $300k. Because of the success of the drug, they were able to resell their royalty rights to another investor for $3.3 billion. Funds which they will use to drive massive amounts of additional R&D to make even better treatments at lower costs. In the process they have created therapies which did not previously exist, saving and improving people’s lives. You can debate the profit motive (as your link mentions) but the Foundation considers this a massive win for their ability to fight CF and make CF sufferers lives better.
- wjnc 8y agoThe important question is... why is it ethical for a foundation to deliver a product at $300k/yr where the cost are borne by other people? [1] In my world that price would never be paid, since about €100k/yr would max out the qaly. They would still have their medicine albeit at a perhaps $1 billion profit / return on risk. I'll bet my ethical balls here that none of the small contributors to a CF foundation expect a billion dollar windfall to come out if there contribution, regardless the merits that billion goes to afterwards. [1] Some economic reductionism here: if you know the cash flow, you can project the value and the other way around. So if someone offers you 3 billion and you know the effect of the medicine and the number of patients, you can infer the price of the medicine. This to establish the (moral) link between the selling of the IP and the price.
- zaroth 8y agoThe pharmaceutical company Vertex sells the drug for $300k. Because CF Foundation helped fund the development, they get royalties, just like universities sometimes do when they help develop a drug. This is great for CF because it’s mostly the insurance companies (and therefore healthy people) who are bearing the costs of the treatment. So the CF Foundation is “forcing donatations” from the healthy populace through increased insurance premiums to bankroll their continued investments in treatments and such. I don’t know if that makes it any more or less ethical, but certainly if it were mostly individual CF patients on the hook for the $300k (in aggregate that is — I’m not saying that never happens) then it would make less sense for the CF Foundation as a strategy.
- JKCalhoun 8y ago> This is great for CF because it’s mostly the insurance companies (and therefore healthy people) who are bearing the costs of the treatment. Don't we all bear the cost of treatment in the form of higher insurance costs because insurance companies are paying exorbitant prices on drugs (among other things)?
- dodobirdlord 8y ago
- lordnacho 8y agoThe pharma will likely also be employing people who were trained on the public bankroll. Not sure what's reasonable there though, it's not like society owns your output because you had your education paid for.
- benj111 8y agoI'm not sure if we are thinking of different things, but in the UK I believe Drs and Nurses have to stay with the NHS (or at least not work for the private sector) for a certain period of time, if they got bursaries. That seems reasonable? Society benefits from their output, in return for paying for their education.
- xorcist 8y ago> How did that patent end up in a big pharma portfolio? While it may sound strange put that way, most universities spend a lot of time thinking about how spin off profitable companies from their research. It's a huge deal and public spending on research is often motivated like this. Universities and R&D companies have a codependent relationship and this is generally regarded as a good thing. The morally dubious outcome of this is that a lot of research ends up locked away as intellectual property of some private entity, but it's not easy to question.
- username223 8y ago> Universities and R&D companies have a codependent relationship and this is generally regarded as a good thing. Is it? At best, I'd say it's seen as a "necessary evil," where "evil" is much more certain than "necessary."
- tomcam 8y agoIt stinks, I agree. What economic/social arrangement has done a better job in drug innovation?
- tirrit 8y agoHas there ever been made an effort with any other approach/arrangement, in modern times? Any sources on this, anyone?
- username223 8y agoPublicly-funded research universities, along with the March of Dimes, funded the polio vaccine, which has almost entirely eliminated the disease, and was not patented.
- xorcist 8y agoI think so. Funding research is difficult as it is, and the potential to leverage that spending to create jobs and tax income is important. It certainly helps that it concerns an highly qualified academic workforce. Most universities tend to keep people employed just to expedite the process.
- rayiner 8y ago> The killer detail (in the article) is that 1/3 of the (small) development cost of 40 million were borne by the Dutch tax payer. How did that patent end up in a big pharma portfolio? It says so in the first few paragraphs: Novartis licensed (bought) the right to sell the drug in Europe. The patents remain with the hospital. The hospital that developed the drug is a public hospital associated with a public university. So the government paid for development, and (indirectly) to government is benefitting from the license fees paid by Novartis. That is co-profiting.
- eecc 8y agoThe article reads as follows: “Novartis bought the rights to Lutathera with a $3.9-billion-euro takeover of French company AAA last year.” Where exactly does it say that the patents have remained with the hospital?
- fouc 8y agoBuying the rights means licensing the rights of the patent, otherwise it would've said "Novartis bought the patent to Lutathera"
- sonnyblarney 8y ago"Buying the rights means licensing the rights of the patent" I don't think journalistic language necessarily so accurate. I don't think we can say for sure what changed hands in the transaction, but it should not matter anyhow. If they bought everything, then the total lifetime value of the asset would hopefully have been baked into the price.
- Vinnl 8y agoThere's an interesting Dutch article from January about how the rights ended up with this company [1]. It doesn't say anything about patents, but it does say (my translation): > The producer (AAA, later bought by Novartis) gets exclusive rights to sell the drug, for ten years in the EU, and for seven in the US. The only exception is hospital pharmacies preparing the drug for their own patients. [1] https://nos.nl/artikel/2266712-hoe-nederlands-kankeronderzoek-novartis-aan-miljarden-gaat-helpen.html https://nos.nl/artikel/2266712-hoe-nederlands-kankeronderzoe...
- rocqua 8y agoYes, less payout on rare disease drugs is less of an incentive to research them. But: * Drug companies have profit margins of 15% on average indicating there is room. * many recent 'orphan drugs' were not newly developed, but off-label uses registered with the FDA for a whole new patent. * these drugs rely heavily on research done by universities through public funding. It stands to reason the public should get to benefit. * there is something morally wrong about setting the price of drugs purely based on demand. It is essentially blackmail: pay me or die / suffer.
- Freak_NL 8y agoThe blackmail part is literally by-design. They call it value-based pricing, where the price of the medicine is not related to its cost plus a profit margin plus a margin for research and development of new or improved medicines, but on what each nation (pricing is adjusted per country) is willing and able to bear to keep a small group of people alive (or at least comfortable). It puts quite a dent in public health care resources. People who are in this business to actually help the sick hate this system with a passion, and some national governments are now willing to allow hospitals and pharmacists to experiment with creating their own medicine again as a result.
- pault 8y agoThis model is perfectly fine for most of the economy, but is a perfect example that for-profit medicine is inherently flawed.
- aaavl2821 8y agoDrug companies increasingly fund r&d with their balance sheet, not with internal r&d. So the money they pay for new drugs is not reflected in the profit and loss statement. There are maybe 15 pharma companies that commercialize a large portion of the drugs developed in the world. The vast vast majority of drug companies never make a penny in profit. They sell their products or companies to bigger, commercial companies So the profits in the industry all accrue to a few big players, and the losses largely accrue to companies you've never heard of Something like 65% of FDA approved drugs are developed by small companies that will never generate revenue. Bigger companies buy these drugs and plug them into their established sales forces Virtually (probably literally in the last few years) no drugs emerge fully formed from academia. For profit companies bear the brunt of the r&d costs. 30% of public r&d goes to academic "overhead" and much goes to research that will never come close to informing drug r&d. The NIH spends $30-35B a year, the top 15 pharma companies spend $75B in r&d
- yread 8y agoStrange that the article doesn't mention Oncode institute [1], which has specific goals of repurposing generic and patent-expired drugs in combinations to lower costs and there were some discussions about making the drugs themselves [1] https://www.oncode.nl/research/programs https://www.oncode.nl/research/programs
- stretchwithme 8y agoI think it would be better to have bounties for cures rather than patents for drugs you have to take forever. Pay a fixed price that is easy for innovators to understand and maybe the energy will focus on what we really want.
- suddenstutter 8y agoPatents shouldn't exist. Its a violation of capitalism and the free market. The only reason why this happens in the first place is because of these violations.
- matthewmcg 8y agoThe situation described in the article doesn’t seem to be related to patents. Rather this appears to be a generic drug with a very small market. There is only one producer of an approved formulation and they are charging too much. The article mentions that the compound (lutetium octreotate) has been in use for a long time, suggesting that any patent term on the compound has lapsed. Novartis’ specific preparation has been approved for this use by the EMA. Compounding pharmacies have the right to prepare the drug without this approval, which they could not do if the compound was subject to a patent. Theoretically another company could make a generic version of this but the market is probably too small to justify the approval costs.
- vilifiedtwin 8y agoGovernments are corrupt and so the law enforcement so I think the only hope is that army will look into how big pharma shapes the national policy and makes sure the broken system keeps going on.
- radicalbyte 8y agoIt's worth noting that pharmacists in The Netherlands have a doctorate and the same training requirements as MDs (the study last until 24/25 with no skip years). The requirements are considerably lower in other countries (in the UK for example they just need a BSc). Source: my wife is a pharmacist and could have worked in the UK after only completing 1/3rd of her study.
- Luc 8y agoIt's a 6 year study, but like the study for Medical Doctor, at the end you have a Masters diploma, not a Phd/Doctorate. Source: apotheek.nl e.a.
- radicalbyte 8y agoThat's what I said :) A doctorate* (nl: doctorandus) which takes 6 years to earn (3-4 years BSc then 1-2 years MSc to use the English terms) followed by a 1 year specialization for public pharmacist. Exactly the same as the MDs (also doctorandus) have to do. It's not a PhD; although I assume that you'd want to go that route if you're more interested in the research (I'm assuming that a PhD in Pharmacology is a thing). I tried convincing my wife to do it but she feels that she helps others more by being more hands on. I think the confusion comes because a doctorate and a PhD are different things and different countries and disciplines use different terminology. I just about understand the Dutch system now but I'll never understand the German system.
- Luc 8y agoHere's the correct usage of the terminology: https://en.wikipedia.org/wiki/Doctorate#Netherlands_and_Flanders https://en.wikipedia.org/wiki/Doctorate#Netherlands_and_Flan...
- pard68 8y agoIn the US it takes: * 4 years undergrad, of which 90 credit hours must be a specific series of courses * 4 years PharmD, doctorate program * 1800 hours of internship At this point a student has met all requirements to sit for the two license exams (NAPLEX and MPJE[^1]):). Many students will elect for an additional period of education due to the competitive nature of pharmacist jobs in the USA. Those two extra opportunities are: * 2 years of residency; followed by, * 2-3 years of fellowship Most pharmacists at a common drug store will not have the last 4 or 5 years of study. However most pharmacists in research or synthesis (including at both manufacturers and pharmacies) will have these two final steps of education due to just how competitive these jobs are. Briefly there was also a 6 year accelerated pharmacy track (BS+) however this is no longer allowed and any practicing pharmacists with these credentials have to take a non-degree PharmD program to meet the new requirements. At this point in time I don't know if any practicing pharmacists still only hold the accelerated credentials. [^1]: AK, CA, and VA have their own jurisprudence exams and do not accept the Multistate Pharmacy Jurisprudence Exam
- chicob 8y agoThis is exactly the kind of excellent initiative that can save lives and benefit lots of patients, that could also, in principle, be completely obliterated by ISDS rulings.[1] [1] https://en.wikipedia.org/wiki/ISDS https://en.wikipedia.org/wiki/ISDS
- simonsaidit 8y agoIn Denmark I recently saw a discussion between politicians and the just resigned head doctor of a major hospital where he said he no longer could bear the responsibility of “optimizing” and that there was not enough money in the coming years no mattter how much money the politicians were promising in their soon to be election campaigning.. and his belief was we had to decide what we can afford as a country in regard to medicine. Meaning we had to choose who should live or die or die sooner as medicine treatment prices were too high and new treatments are coming all the time.
- jknz 8y agoI am wondering if any cost-analysis studies have been done to assess the trade-off between lengthy end-of-life terminal care and the corresponding cost. Doctors seem to make such decisions all the time; but we may have at some point to discuss collectively how much of the public money involved in end-of-life terminal care (last two months, say) for elderly should be used instead for better care earlier in life. In countries where such care is provided by private insurance and not the state, I am wondering why this trade-off is not given as a choice to the consumer. Many people might be OK to get smaller premiums and better coverage throughout their life by explicitly rejecting coverage of end-of-life care.
- AndrewGaspar 8y agoFor better or worse, people don't apply purely rational thinking about trade-offs to healthcare. I think it would make a lot of people squeamish to hear this argument about why somebody, where somebody might be mom or dad, isn't going to receive certain care because they didn't pay for it earlier in their life. Unfortunately the trade-offs don't go away, and we haven't figured out a way of making these trade offs that doesn't feel horribly statist (so called "death panels") or callous (private insurance denying care).
- dodobirdlord 8y ago> Unfortunately the trade-offs don't go away, and we haven't figured out a way of making these trade offs that doesn't feel horribly statist (so called "death panels") These already exist. Donor organs are a scarce resource and there aren't enough to go around, so some person(s) has to decide who lives and who dies. People already regularly die in the United States because it is uneconomical to have Level I/II trauma centers within emergency response distance of the entire country. People have very different ethical standards for how people should act in advance planning scenarios versus in the moment. I think most people agree with the unreasonableness of arranging to have an on call neurosurgeon in a small town in the middle of nowhere. But I think people would have a very different reaction if the same neurosurgeon refused to skip a day of teaching medical students to instead walk across the hospital and carry out a 12 hour brain surgery on a 90 year old patient with dementia who will be dead from lung cancer in two months anyway. I think people will just have to get over it. There aren't alternatives.
- forinti 8y agoThis reminded me of an incident in which the Netherlands intercepted generic drugs en route to Brazil from India. https://www.kff.org/news-summary/india-brazil-launch-trade-dispute-against-eu-netherlands-over-seizures-of-generic-drugs/ https://www.kff.org/news-summary/india-brazil-launch-trade-d...
- hermitdev 8y agoThat's strange. Reading your comment, my first thought was WTF is the Dutch Navy doing intercepting shipments from India to Brazil. Then, I read your link and had another WTF moment: why is a shipment from India to Brazil travelling through the Netherlands and thus subject to their customs? India->Netherlands->Brazil seems like an incredibly inefficient trade route.
- forinti 8y agoCentral economies gain a lot from simply being in the centre. That's why there has been an effort to promote South-South relations.
- cedex12 8y agoAre there countries where drug research and production isn't privatized? I would naively consider it ideal if research and “recipes” were made in the open, shared between countries and the production wouldn't be the job of for-profits… what am I missing?
- tanzbaer 8y agoCuba maybe?
- pault 8y agoIt's really depressing knowing that no matter what policies other countries adopt to bring drug prices down it will never happen here in the US because there's too much money to be made from bribes^H^H^H^H^H^H donations from the pharmaceutical companies.
- pard68 8y agoI agree, but it should be added that most other countries can have cheaper drugs because most drug R&D costs are eaten up by US drug makers and the US and state governments. Even if we cut out all the bad eggs rebranding old drugs at huge markup and/or selling generics are ridiculous prices, the US prices will always be higher because the US market is paying for 90%+ of all drug research.
- Thriptic 8y agoOne thing that is typically not mentioned in these debates is the fundamental structure of the industry. Let's say someone finds a research compound which looks to be promising, and they start a new company to try to commercialize it. Often, they are looking at at least 1-2 decades to get that product to market. Assuming they don't sell out to a big company, they almost certainly have to go public before starting trials in order to amass the required funds. Normally, a public company is expected to show regular profits and growth. This is impossible for a new pharma company because they don't have a product yet, so they are expecting investors to foot the bill for years and years of development and trials. During this time, if the compound fails a major trial, the entire company can go under because it may be prohibitively expensive to start over again if there is a problem. Therefore, not only is there a massively delayed ROI but a lot of risk. As such, when a company gets something to market, investors expect massive profits for shouldering that risk and delay. It is simply not feasible for companies to charge small amounts of money because no investor could justify locking up capital / taking those risks for something other than a huge return.
- Ericson2314 8y agoThat's why drug bounties, or even "promising compound bounties", can be good for researchers too.
- JKCalhoun 8y agoMaybe drug "companies" should be government entities then and not for-profit at all.
- deleted 8y ago[deleted]
- PrimalDual 8y agoI think the government can definitely fund certian types of research but in most developed countries the private sector commands so much more wealth that it would be a waste not to allow companies to develop drugs for profit. I would rather have expensive drugs than no drug at all. This isn’t even an argument about government efficiency but rather about the relative size of what can be done when the private sector is much larger than the government.
- qaq 8y agoMajority of Big Pharma expanses are not R&D but sales and marketing.