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Gilead wants to restrict access to low cost generic versions of sofosbuvir

Médecins Sans Frontières/Doctors Without Borders (MSF) released a fact sheet and press release elaborating on the agreement between Gilead and Indian companies to produce generic versions of sofosbuvir, calling out Gilead for a program "which places multiple restrictions and demands on people receiving treatment"

Through discussions with Gilead and generic companies over accessing the drug sofosbuvir, MSF has learned about the anti-diversion programme Gilead wants in place to prevent people in developed and some middle-income countries - where the drug is exorbitantly priced - from accessing low-cost versions not available in their own countries.

http://hepatitiscnewdrugs.blogspot.com/2015/03/fact-sheet-gileads-chronic-hepatitis-c.html

excerpts - go to the link above for the details
The programme may require all patients receiving treatment to present national identification and residency papers, which could immediately disqualify migrants, refugees or marginalized people who may not have such papers, but are often those most affected by hepatitis C.

It also requires people receiving treatment to submit to a highly-controlled dispensing procedure that could undermine patient confidentiality, and does not allow people to continue treatment if they do not return their previous empty pill bottle. This could result in treatment interruptions and even treatment failure.
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Avatar universal
Thanks for posting this Jimmy.

I am just speechless!  

dointime

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Avatar universal
Greedy.  
What a shame.
......Kim
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Avatar universal
OK, I have now been for a walk in order to digest this news.  There's no point in my going into a moralistic rant about it because I am sure that most people are there already.  

What does puzzle me though is that this move by Gilead makes no business sense to me.  I think that they have got their calculations wrong.  They seem to think that if they cut off foreign nationals from the drugs priced cheaply for the 91 low-income countries then the home countries of those foreign nationals will be forced to pay their tiered (extortionate) prices to treat their citizens.  Well, I don't think that is going to happen any time soon.

If you take Europe as an example, no European country that I have heard of can afford to treat anybody at current Gilead prices except the most sick, ie. F4 on the Metavir scale, maybe F3 in some places.  The F1's and F2's are out of luck and have to wait indefinitely.  If you take the stats for any country and consider the numbers infected and the rate of people treated there per year then you quickly see that the wait is going to be a long one.  There is a recession on in Europe.  They can't afford to treat more people per year.

So what is going to happen to all those F1's and F2's?  Well, Gilead doesn't care, but it should care because there are a lot of them and many could probably scrape up the $900 for the drugs in India plus travel expenses.  The real world choice for Gilead is not between their percentage on the $900 for drugs in India and their hefty price for people to treat at home.  It is between their percentage on the $900 or a big fat nothing for all from the people to whom they have restricted access at this price.  

Maybe Gilead thinks that when all those F1's and F2's become F4's then their home countries will have to cough up the money and treat them.  Wrong!  Listen.  There is a recession on in Europe and a lot of other countries.  No government has a bottomless purse  They can't afford to treat more people at these prices.  Gilead, you can't get blood out of a stone.  End of.  

dointime
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Avatar universal
I agree with all above.  Such usuristic (is that even a word?  Derived from usury) behavior attains TWO purposes:  It keeps people in need from getting early Tx and it breaks Ins Cos/Gvt Asst programs.  Neither of those is good.

What I can't understand, is why they believe they have to recoup their costs AND make an exobitant profit within the first 1-3 years, and then continue getting the exorbitant profits.  I understand they are trying to do this before the generics get into the act, but come on, folks!  Instead of building customer loyalty, which still does mean somehing, even these days, they are driving people to alternatives as soon as they can get there.

What ever happened to recouping the fees and then a reasonable profit for years and years as everyone can afford, either on their own, through Ins or with Other assistance, to be treated?

This is not to say that I am not totally grateful that they are there!  I am, and always will be.  Just wanting a little reasonable behavior here.

And that is not even talking about other countries - see above posts, it is all covered there.

This may not be to the point.  I hope it is, but if not, then please excuse my rant.  (I can't even blame it on Riba any more!). [See smiley face here]

Pat
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Avatar universal
J:   Read the article - have to be proud of MSF!  P
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Avatar universal
Dear all , I have grown up in India and am fully aware of how things work in this country .

Gilead can do whatever they want , but knowing how things function here , in a years time with the 7 ( licensed ) generic manufacturers  and other Indian companies making Sofa and for all u know they may be making Ledipasvir too .. these meds will be easy to get . .

We all must remember that the companies that are putting in time and money into these meds need them to Sell for them to make more money , lol .

Hang on ... its all going to happen in the near future ..
I hope i make some sense ;) ;)

My best wishes to all

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Avatar universal
Following on from my last post on this thread here I am again because it has continued to bother me why Gilead would want to do this.  Well, maybe I am slow on the uptake but I just figured it out.

Gilead is pricing its drugs to create rationing in all countries.  The price is deliberately tuned to control the rate of those treated, so that the infected people who are cured or who die will be replaced by the newly infected.  Thus the numbers of infected will not go down even if new drugs come out, because a cartel of pharmaceutical companies will corner the market and control the supply of drugs via pricing.  Thus the goal of Gilead and others like them is to NEVER eradicated hepC.  All those F1s and F2s who can't get treatment in their home countries need to be prevented by the anti-diversion system from getting treated cheaper elsewhere because they are needed in their home countries to infect others.  Gilead plans to turn all countries into their very own cash cows, in perpetuity.

Did somebody say 150 million people infected worldwide?  Well who can know.  Just pick a very big number.  This didn't happen with the HIV epidemic because with HIV you are on the drugs for life.  However HCV can be cured, so another way had to be thought up to create an ongoing demand for hepC drugs, and here it is.  Rationing + anti-diversion (restriction).      

The interesting aspect of this is that a government has a public health duty to eradicate an epidemic if the means exist to do so.  Have governments round the world woken up yet to the fact that their country is not on course to eradicate hepC and never will be if Gilead has its way?  I have to wonder how I don't see evidence that health bodies round the world, including governments, don't seem to be joining up the dots on this one.  Isn't there any organization out there powerful enough to stand up and say that hepC must be eradicated from the world and Gilead's strategy is incompatible with that goal.  Thank you MSF for starting the ball rolling.  We lived under the yoke of the OPEC oil cartel for decades until the US flooded the market by fracking for oil.  Isn't it time that countries now being extorted by Gilead come together with innovative solutions to put an end to it and finally eradicate hepC from the planet.  A start could be made right now with all concerned parties refusing to implement Gilead's anti-diversion system.

dointime                  
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Avatar universal
Rationing of hepC drugs can be ended.  Everybody who needs these drugs should have access to them.  I call on health organizations and governments round the world to follow MdM's lead.
dointime

http://www.reuters.com/article/2015/02/10/us-health-gilead-hepc-idUSKBN0LE0WL20150210

Global health charity Medecins du Monde (MdM) launched a legal challenge on Tuesday to a European patent held by U.S. drugmaker Gilead Sciences Inc which it accused of charging "exorbitant" prices for a hepatitis C drug.

Arguing that Gilead is "abusing" its patent on Sovaldi, known generically as sofosbuvir, MdM said its challenge marked the first time in Europe a medical charity has used this method to try and improve patients' access to medicines.

"While using sofosbuvir to treat hepatitis C represents a major therapeutic advance, the molecule itself, which is the result of work by many public and private researchers, is not sufficiently innovative to warrant a patent," MdM said in a statement.

"As Gilead is abusing its patent to impose prices which are unsustainable for healthcare systems, (MdM) has decided to contest it."

A Gilead spokeswoman said the firm had no comment at this time.

According to World Health Organization data, as many as 150 million people worldwide live with chronic hepatitis C infection, most of them in low and middle-income countries. In the European Union, between 7.3 and 8.8 million people are believed to be infected with hepatitis C.

Sovaldi is a so-called nucleotide analog inhibitor which blocks a protein needed by the hepatitis C virus to replicate.

Gilead has previously argued Sovaldi's high price is justified by its near guarantee of a cure, far fewer side effects and its ability to help patients avoid expensive hospital treatment, including potential liver transplants.

But the sheer cost of the drug - which sold $5.8 billion in its first six months, making it the most successful new drug launch ever - has fueled controversy.

MdM said the cost of the medicine in Britain, some 33,000 pounds ($50,160) for a 12-week treatment, was an "exorbitant price" which hinders many people's access to the drug.

It said that if successful, its legal challenge could allow competition from generic versions of the drug which it said could be produced for as little as 66 pounds.

Jean-François Corty, MdM's French programs director said the charity was defending universal access to healthcare.

"The struggle against health inequality involves safeguarding a healthcare system based on solidarity," he said in a statement.

"Even in a 'rich' country such as France, with an annual drugs budget of 27 billion euros, it's hard to meet this cost and already we're seeing an arbitrary rationing approach that excludes patients from care."
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10175413 tn?1427170251
Wow..in a way I'm shocked by the news then again I'm not.
You know it was a sad day when the almighty dollar became more important than a life....watch out for that Karmic wheel!!

Peace & Serenity to the Community
Deb
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