What if he didn’t pay for the clinical trials but got another small country to approve? He could sell the medicine there and start a medical tourism business.
[quote=FlyerInHi]What if he didn’t pay for the clinical trials but got another small country to approve? He could sell the medicine there and start a medical tourism business.[/quote]
You are getting mixed up about whether you can sell something vs. whether you can sell it with a label indication. The premise was that this was worth “billions”. What you are describing will never generate “billions”.
For example, lets say I have data that I consider compelling that Vitamin C applied to my big toe cures melanoma. Assuming that I complete minimal regulatory requirements, I can (of course) sell vitamin C. I cannot sell it with a label indication telling people to rub it on their big toe to cure melanoma *unless* I do a clinical trial to prove that it is effective in the manner described for curing melanoma. If I were to do that clinical trial – I could include that label indication. Unfortunately it would cost all kinds of money that I would never get back because people could buy my Vitamin C or anyone else’s. That is why pharma companies (1) don’t develop anything they can’t patent, because it’s the only way to recoup the cost of development and the necessary clinical trials; and (2) charge a lot for medicines (though nothing close to what Walgreen’s charges) because they have to pay for many drugs that never make it successfully through the regulatory process.
People can hate pharma all they want, and there are valid criticisms to be made, but most of the stuff I hear on boards like this is pretty uninformed.
Right, and all of this process exists for a reason. Science is hard, and life sciences are especially so. You want there to be scientific basis behind something that is offered as a remedy. As opposed to say, homeopathy, which is utter bullshit.
Unfortunately this does mean that non-patentable remedies fall through the cracks. I mean, we have lots of off-patent remedies like aspirin and so on, but there isn’t a viable path forward for new, non-patentable medications. That’s just the economic reality. If it turned out that rubbing Vitamin C on your big toe did in fact cure melanoma, it would be nice if NIH or some other public health entity could fund the clinical trials for the benefit of mankind. I would like to think that ‘benefit to mankind’ falls within NIH’s charter. It would be a nice second path to clinical trials for promising nonpatentable medicine that could run in parallel with the existing clinical trial path for patented medicines.
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