Gilead's 100+ country Licensing agreements

This topic has 6 replies, 4 voices, and was last updated 9 years ago by zhuk.

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28 November 2015 at 4:32 am #4766
2b
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- Guardian Angel
@2b
When I look at the list that Gilead puts out, they have what looks like over a hundred countries they say they have made deals with, countries like viet nam, nicaragua, Cuba, Honduras, India of course, and lots of other places that would be really convenient for people in various locations to get to.

So, although these countries supposedly have gilead permission to manufacture and sell these drugs cheaply, is the problem just that they do not have the technical capability and facilities to do so? I’m guessing that’s the case, but I don’t know, so I was just wondering if that’s the problem, or, if I’m just misinterpreting what I read..anybody know?

GT 2b; since 80’s, no prior tx, sofosbuvir and daclatasvir compounded from API’s at Kingswood Pharmacy in Sydney, started tx nov 6,2015, undetected at 4 wks, UND at 8 weeks, UND at 1 week after EOT, UND at 4 weeks after EOT and UND at 8 weeks after EOT. I feel GOOD!! I knew that I WOULD!””
28 November 2015 at 5:12 am #4769
Gaj
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- Guardian Angel
@gaj
Hi 2b,

I suspect the list you are looking at covers a couple of different things:

First is a list of about a dozen (Indian) companies that are licensed to manufacture Sofosbuvir containing products by Gilead. Then there will be a list of about 100 countries where these dozen or so manufacturers are allowed to sell their products. There are also “in country” licences issued to manufacturers in Egypt and Pakistan which as I understand only allow those companies to manufacture and sell in their own country.

So Vietnam, Cuba, etc don’t have licenses to manufacture. They are just the countries where the license holders can sell their products.

Hope this helps.

G

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
28 November 2015 at 7:05 am #4770
klhilde
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- Guardian Angel
@klhilde
Never take anything Gilead says at face value. The compassionate access programs are only to get good press, and seem to have been pretty much shut down. They appear to be hindering other entities from providing good information as we’ve seen on online forums and news story comment threads, and they buy the top entries for all relevant search terms which link to their various marketing sites.

They sold the idea that the deals with the Indian companies was about compassion, but in reality they had a good inkling that their patents for sofosbuvir would be rejected and the contracts were really meant to tie the hands of these companies as to where they could market while forcing them to pay royalties for the sales. Companies that didn’t sign on aren’t paying the royalties because the patents were, in fact, rejected in India … as well as in China, with the decision still on hold in Brazil, Russia, and a few others if I understand correctly.

As for access to these drugs in the countries listed, I think I read somewhere that they are available in Honduras now … could be wrong … but remember that each country also has to approve the drugs and then distribution must be worked out before they start actually shipping/stocking the drugs.

It would be helpful if someone who has some time on their hands could research the issue and find out where the drugs are currently available and at what cost.

Here are a couple articles that discuss the issue, but I think both are from before the point that India had made the decision to reject the patents for sofosbuvir.

Gilead’s Hepatitis C Medicines License – Troubling Territorial Exclusions, Illusory Exceptions, and Tiered Pricing Policy Fracture Global Access

(click through to the PDF to read the full article, including the country lists)

http://www.hepcoalition.org/advocate/advocacy-tools/article/gilead-s-license-on-hepatitis-c
28 November 2015 at 8:40 am #4771
Gaj
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- Guardian Angel
@gaj
Hi klhilde,

Thanks for adding the additional information.

You are correct, it is important to understand why Gilead went down this licensing path to maintain some control when they realised that their patents wouldn’t be granted in India and that inclusion of a country in the list doesn’t necessarily mean that country has access.
It is also interesting to note the comment in one of the articles about the inclusion of tiny micro-nations to make the list look bigger than it really is in terms of coverage.

G

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
28 November 2015 at 10:04 am #4775
2b
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- Guardian Angel
@2b
would have made for more clarity for me to have posted what I was referencing (doh), this is the thing I saw, reading it more closely it looks like its referencing their licensing agreements to the Indian companies to manufacture, and then the big list of developing countries is where the Indian manufactured drugs are permitted to be sold? here’s the thing I read:

http://www.gilead.com/~/media/files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%2072815.pdf

GT 2b; since 80’s, no prior tx, sofosbuvir and daclatasvir compounded from API’s at Kingswood Pharmacy in Sydney, started tx nov 6,2015, undetected at 4 wks, UND at 8 weeks, UND at 1 week after EOT, UND at 4 weeks after EOT and UND at 8 weeks after EOT. I feel GOOD!! I knew that I WOULD!””
28 November 2015 at 10:10 am #4776
2b
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- Guardian Angel
@2b
your article’s cited make it clear, should have read that first, as you guys noted, its just another gilead price scheme to keep control and keep prices obscenely high for the most part. Thankfully we have the access from China and India now or we’d still be begging for medicine.

GT 2b; since 80’s, no prior tx, sofosbuvir and daclatasvir compounded from API’s at Kingswood Pharmacy in Sydney, started tx nov 6,2015, undetected at 4 wks, UND at 8 weeks, UND at 1 week after EOT, UND at 4 weeks after EOT and UND at 8 weeks after EOT. I feel GOOD!! I knew that I WOULD!””
29 November 2015 at 9:54 am #4807
zhuk
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- Guardian Angel
@zhuk
Compare and contrast with Bristol-Myers Squibb and daclatasvir:

Bristol-Myers Squibb Co. has signed a broad agreement with Medicines Patent Pool, allowing the United Nations-backed organization to distribute licenses for generic- drug companies to copy its hepatitis C treatment in more than 100 developing and middle-income nations.

The agreement allows the generics makers to produce copies of the drug Daklinza, known chemically as daclatasvir, without paying any royalties, Medicines Patent Pool said in a statement Monday. The liver ailment is a new treatment area for the organization, which has helped developing nations gain access to HIV medicines.

http://www.swissinfo.ch/eng/bloomberg/bristol-myers-lets-low-income-countries-copy-hepatitis-c-pills/41795652

GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 – 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 – 6 weeks UNDETECTED
AST 26
ALT 26
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