Everywhere that I look to try and understand the current worldwide rationing of brand name hepC drugs, I ultimately come upon the patent laws. Look, I understand the need for patent laws. I do. I am not a patent lawyer and my understanding may be seen as childishly simplistic by those who are, but here's what I do understand. The letter of the law may be being upheld by the patent protection afforded to Gilead, but justice is not being served. In fact, what Gilead is doing is a travesty of justice.
Here we have a case of governments around the world falling down on their duties to maintain the Public Health. We have a runaway epidemic of hepC with deaths under reported, in some cases I suspect deliberately so. It's just too easy to record the immediate cause of death, eg liver failure, and omit to mention that hepC was underlying.
In countries that have social healthcare, eg the UK, the social contract is that the citizens pay in as they are able and the medical services are available as needed. Paying in is not voluntary, it is mandatory and it is not an insignificant amount. People generally agree to it because they are thinking that there might come a time when they too will need the medical services and those services will then be there for them. They don't expect to be told "Sorry mate, we can't afford to treat you right now and we don't know when we will be able to. We have to ration these drugs because of the price".
In a country like the US where the medical insurers foot the medical bills of the majority of their citizens it comes to the same thing. People sign legal contracts with these insurers but those insurers don't come up with the goods when needed.
It seems to me that medical insurers and governments of whole nations would rather break their social contracts with their people or their legal contracts with their customers,
than risk a breach of the patent laws as applied to Gilead. What is going on? What do they all talk about behind closed doors at those world HepC conferences? Do they merely agree to allocate still more money to hepc treatment (the money which fills the Gilead coffers which are already bursting)? We have already seen that at current prices, the eradication of hepC from the planet is not within the realms of possibility. Is there a realistic plan anywhere to eradicate hepC from the planet, because if there is then how does it deal with Gilead's patent protection and pricing policies? What is the WHO doing about all this? I saw recently that it granted Bangladesh an extension of its exemption from the patent laws, so clearly the WHO has powers if it wants to use them.
Patent, Legal Definition:
A patent is a right granted to an individual or group (such as a corporation) which permits the grantee the ability to prevent others from making, using, or selling the invention described in the patent. A patent can be sold, or the grantee may give others permission to use the invention (generally in exchange for royalty payments).
A patent simply gives the owner grounds to prevent infringement through legal means. By itself, a patent cannot stop someone from making or using an invention; it simply gives the patent owner the right to take the person to court if they do.
But who is actually saying "We'll see you in court Gilead"?
What is so damn sacrosanct about these patent laws that the world finds it more palatable to have the situation as we have it now rather than change these laws to prevent their misuse? Lawmakers everywhere need to grasp this nettle and urgently.
I think all patent applications should state the price the company is planning to charge before they are granted sole rights to manufacture a drug. If the price, like with Gilead and Sovaldi, is so extraordinarily high-I mean beyond all means of justification-then the company should be told to price it realistically or the drug will hit the open market. This precedent can not stand. Enough is enough. Investment bankers and hedge funds risk their clients money to bring in huge profits. Gilead is mortgaging peoples' lives.
The WHO has said they want to see HCV eradicated by 2030. But that clearly isn't going to happen under current circumstances.
Huon Valley, Tasmania
Hep C+ since 1980s
Started Indian Sof and Riba, BMS Dac (comp access) 28 August 2015
UND at 4 weeks
Finished treatment 19 November 2015
12 February 2016 UND SVR12
I like your thoughts on the means of controlling patent pricing though I'm not sure if stating a price during all patent applications would work or is even desirable given today's worldwide markets.
However, perhaps patents for medicinal items could be corralled into a seperate group where there was a price "break" point of say 10 to 100* times the cost of manufacture above which any generics manufacturer could compete with the patent holder. There would probably need to be some sort of appeals process to allow for items that truly had massive R&D costs but that should be on a case by case basis on application.
So basically, the Pharmacueticals companies et al are allowed to use patents to recoup their costs and make healthy profits to support the ongoing search for new advances but over a certain level they are forced to compete in an open market.
* those price multiples seem high till you realise that Gilead's is at least 1,000 times cost of manufacture on Sovaldi/Harvoni.
Edit: whoops, changed price multiples as just realised I was confusing price multiples with % profit.
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
The thing is, Big Pharma are getting Drs under their power. Just type your consultants name and the words "conflicts of interest" into Google and you whould get any papers written by said consultant where they have to state their conflict of interests.
I did this and was unsurprised to discover that my latest allocated consultants education was funded by the likes of Gilead etc...around 6 big pharma companies, so before these Drs are even practising, they are in debt to them. My first hospital, top hepatologist was given £80,000 to write a research paper. My 2nd consultant (lovely man I might add and a good Dr) is an adviser to Gilead.
This last one had his education funded by them.
Make of that what you will.
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 'In the slow lane'
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
"What do they all talk about behind closed doors at those world HepC conferences?"
Since asking myself this question, I became intrigued about it, and so I had a look on the internet to see what I could find out. My finding is that the WHO and like bodies are not talking about hepC eradication, they are talking about hepC MANAGEMENT.
In this talk, the price and low availability of treatment is mentioned but no solutions are offered. www.who.int/mediacentre/factsheets/fs164/en/
Conclusion: We are not going towards hepC eradication any time soon with the WHO at the helm.
I then took a look at the eradication programs for another 2 of the world's deadliest viral diseases, ie. smallpox and polio.
In those cases it was / is being achieved by large scale, far reaching, vaccination programs. Characteristics of the vaccine required were that it must be very cheap, effective, and preferably oral only so that it can be administered by non-medical volunteers. For hepC, we could widen the solution to any vaccine or cure that does the job cheaply, effectively and with very few doses (eg. 1 - 3).
Well, as you know, we don't have anything like this right now, although there are some hopefuls in development. So for worldwide eradication of hepC, these hopefuls that fit the criteria above are what we need to support and promote. 'Successful' is in the hands of the scientists. 'Cheap' - well who's hands will that be in? What if the company that is successful in coming up with this treatment sells out to Gilead? It's unthinkable - right? Or is it? What's to stop that happening? Well, right now, NOTHING!
So here's the deal. We have to be vigilant this time round. There are humanitarian groups in the world that would hopefully use a hepC vaccine to eradicate hepC from the world. We need to ensure that this medicine gets from the developers into the hands of these groups in such a way that the developers are fairly compensated and at the same time mass inoculation is still affordable. I would hope that that is doable, provided that the Big Greedy Pigs are prevented from ripping hundreds of millions of dollars off the top. That cannot be allowed to happen this time.
Here is a list of some of the big players involved in the polio eradication. I do not vouch for any of them because I don't know enough about them, but some might be helpful for the task at hand:
National governments, WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC), UNICEF, supported by key partners including the Bill and Melinda Gates Foundation. Underpinning the effort is a global network of more than 20 million volunteers worldwide who have collectively immunized nearly 3 billion children over the past 20 years (for polio).
So I am watching drug developments closely. I hope a lot of people are watching and will shout loudly about it if they see the progress of this medicine moving in the wrong direction. The Gilead debacle might be seen by some as a fait accompli. Let's face it, there were many who were asleep at the wheel who let it happen. Next time round nobody can use this as an excuse.
Under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any invention, in all fields of technology, and the term of protection available should be a minimum of twenty years.
That does make changing patents per se hard.
One option governments could consider is the notion of patent re-examination and putting a patent back into pending status.
Such a step would send a powerful message to Big Pharma and reexamination of the Sofosbuvir patent might well be appropriate and given it was deemed non inventive in India there is a good pretext. We suggested exactly this to the Department of Health.
Reexamination has been actioned before, for example:
So that's a maybe but government and insurers have other tools to force pricing issues with that they deploy with variable success.
As the payers they can simply refuse to pay and say "sharpen your pencils and come back next year" - this works but patients suffer delay in access.
As payers they can also say "We need 2 good treatments for this condition, there are 5 of you with products, so who's offering the best price?" New Zealand does exactly this and enjoys drug prices 1/8th as much as Australia despite being only 1/4 the size.
Express scripts for example has dropped Gilead in favour or Abbvie:
Government agencies, ie the TGA and FDA approve drugs for sale after patents have been issued. In Australia our TGA could link pricing to approval. In the USA a 1000 page bill, passed after a brief debate, at 3 am in the morning, included words to the effect "When a drug is approved the company can set any price it likes"
In short calculate a fair price based on some metrics and apply a 100% super profits tax to pricing that exceeds that.
If Big Pharma fails to see the wisdom of pricing reasonably parallel import, just like the South African government did for HIV medications 15 years ago until the drug companies decided that 1000% profit on many sales was preferable to 100,000% profit on 0 sales.
And for the record we have suggested all these strategies to our Minister for Health. To date, deafening silence.