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TPP set to potentially block generics 6 years 9 months ago #15432

  • Hazel
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Vororo wrote: What does "investor-state" arbitration mean with the TPP?

www.theatlantic.com/politics/archive/201...constitution/396389/

Every country who signs up is called an investor state. There is an arbitration and dispute settlement process, between corporations and governments, who those corporations think are infringing their right to do, whatever, to make money in that governments country. It's unacceptable to most legal systems because there is no appeal process, at all. none. The small group of appointed corporate lawyers who run it take turns to prosecute and adjudicate.They can set fines in the tens of millions.
Genotype 3 30 years, 2x treatment interferon/ribavirin non responder. Cirrhosis 17 years. Fibroscan, decompensating, 40 down to 22 by 29/3/16- now down to 6.5, normal, no cirrhosis. Started Buyers Club Sof/Dac 14 Nov 15. SVR 12 29/0716
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TPP set to potentially block generics 6 years 9 months ago #15442

  • Vororo
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Hi Hazel, I completely agree. This is the most insidious part of the TPP. It aims to give "investors" (in practice, that means american corporations) the power to challenge and over-rule policies that have been set constitutionally by the participating state governments (in practice, that means non-american governments). What government in their right mind would ever agree to a deal like that?
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
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TPP set to potentially block generics 6 years 9 months ago #15453

Hillary will. ;)
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
The following user(s) said Thank You: Greedfighter

TPP set to potentially block generics 6 years 9 months ago #15459

It won't take more than a phone call to change access in USA. Approved drugs technically can't be imported, customs just doesn't enforce the rule right now. So all it would take is a change in their internal policy. And it seems to me there is a strong likelihood that could happen, otherwise what is the point of this legislation?

The big changes may come to countries that allow generics to be imported. Perhaps they will do the same as USA; make them technically illegal but allow them anyway.
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs VL UND, AST 27, ALT 20
EOT labs VL UND, AST 23, ALT 19
SVR 16, VL UND, AST 28, ALT 17
SVR 24 , VL UND, 10/8/16
SVR 125, VL UND, 9/22/18
SVR 230, VL UND, 10/3/20

TPP set to potentially block generics 6 years 9 months ago #15466

  • Gaj
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Perhaps they will do the same as USA; make them technically illegal but allow them anyway.


No, from my reading of Vororo's attachment regardless of what the government of a country legislates, a corporation (investor) can "sue" that government (investor state) via the private arbitrators for the actions of anyone (citizen/company/government) who detracts from the ability of the corporation to derive a profit.

So in our case, if one of us imports generics for our own use, the corporation can sue our government presumably for the profits that the corporation missed out on. For Sofosbuvir the government may have to pay the corporation up to the full $84k for every citizen who imports a 12 week course of this drug.

No government could afford to allow that to happen so they will not only legislate to prevent import of generics but will actively enforce that legislation against their own citizens. Being able to prove strict and non exclusionary enforcement is the only way that they will have any hope of a defence against the corporation during arbitration.
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
:cheer: :cheer: :cheer:
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TPP set to potentially block generics 6 years 9 months ago #15467

I completely agree Gaj. I'm just trying to be optimistic; which is against my nature :( .

In USA, I am sure the government would send you a bill for whatever they get charged.

But I would agree that the most likely outcome will be a banning of foreign generics. I read this on wiki leaks about 6 months ago. It's why I have been harping on it.
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs VL UND, AST 27, ALT 20
EOT labs VL UND, AST 23, ALT 19
SVR 16, VL UND, AST 28, ALT 17
SVR 24 , VL UND, 10/8/16
SVR 125, VL UND, 9/22/18
SVR 230, VL UND, 10/3/20

TPP set to potentially block generics 6 years 9 months ago #15469

THIS is why there is a real revolution going on right now in America. We have NEVER been so divided. Mexicans, blacks, trans-whatever. Read the news. It's all coming to a head, and the reason Trump is winning hugely against all odds and predictions. Import life-saving medicine and then get caught and owe the government/corporation $90k? Never gonna happen. Luckily, we still 'cling to our guns and religion', as Obama once said. The irony here is that the Democrat party is supposed to be for the 'common man'. Obama sold that off to the highest bidder.....

Donald Trump just came to my city and had a rally. Costa Mesa, Ca. Have you seen the footage of the 'protesters'? Vile, violent, ungrateful people disrespecting the host country that lets them live a better life. Almost nothing disgusts me more. People often cite Trump's "wall", I reply that we ALL have fences and walls around our property. Why?
So, yeah. The TPP is a horrible idea, and not one to help America be the great leader it once was.
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James

TPP set to potentially block generics 6 years 9 months ago #15470

  • re_roll
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[quote= Import life-saving medicine and then get caught and owe the government/corporation $90k? [/quote]

J...calm down. There are bigger fish to fry than us importing generics. We are <.01%. Think of
the mechanics of implementing the proposed regulations worldwide. There will always be end-
arounds in life.

Hillary will be the first Ms President. If you would like a wager (no limit), let me know....e.
contracted Gen 1a in the 70's, dx in 2007...ast 27 to 35...alt 43 to 96...vl 1.2 mil to 8.6 mil.
biopsy F-2 (2012)..pre tx results 1/23/16 ast 32, alt 46, vl 3.1 mil
tx started 2/11/16.... lab results 2/24/16 ast 18, alt 18, vl <15 IU/ml
28 days later.............lab results 3/9/16 ast 21, alt 21, vl UND
56 days later.............lab results 4/6/16 ast 20, alt 22, vl UND
139 days later...........lab results 6/29/16 ast 28, alt 30, vl UND...EOT
SVR24

TPP set to potentially block generics 6 years 9 months ago #15471

I know. I absolutely shudder at the thought of hearing her voice for the next ?? years........ :sick:
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James

TPP set to potentially block generics 6 years 9 months ago #15472

  • Gaj
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There are bigger fish to fry than us importing generics.


Hi guys,

I realise that it is election year (my country too) but on this international site dedicated to the affordable cure of HCV the above and its impact on us is the point of discussion.

Perhaps partisan party politics relating to our individual countries would be better served on any number of other sites dedicated to it?

TIA :)
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
:cheer: :cheer: :cheer:
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TPP set to potentially block generics 6 years 9 months ago #15473

  • re_roll
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G...sorry for the derail, but people need to know generics will probably still
be available notwithstanding any treaty which is not a slam dunk. Research
is one's friend...e.
contracted Gen 1a in the 70's, dx in 2007...ast 27 to 35...alt 43 to 96...vl 1.2 mil to 8.6 mil.
biopsy F-2 (2012)..pre tx results 1/23/16 ast 32, alt 46, vl 3.1 mil
tx started 2/11/16.... lab results 2/24/16 ast 18, alt 18, vl <15 IU/ml
28 days later.............lab results 3/9/16 ast 21, alt 21, vl UND
56 days later.............lab results 4/6/16 ast 20, alt 22, vl UND
139 days later...........lab results 6/29/16 ast 28, alt 30, vl UND...EOT
SVR24

TPP set to potentially block generics 6 years 9 months ago #15475

  • Gaj
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Hi e,

I have no problem with the discussion of whether/how the TPP will be applied but I do believe we need to be discussing its implications here at a wider level than who is going to win in US domestic politics. Given the sway multinational big business holds over all political parties these days, who wins is only likely to change the spin rather than the substance of the agreement.

Actually I suspect that the TPP probably won't make a huge difference to the importing of generics into the US. I'm quite sure that Big Pharma has enough influence at the moment to ensure that the US customs and FDA would strictly apply the available rules if they thought doing so was worthwhile against the current trickle. The potential bad publicity of them moving against sick US citizens just isn't worth their while. And anyway, as you point out there are usually ways and means for individuals to get around those sort of problems.

The real issue is probably the use of the TPP by Big Pharma to restrict generics access into other countries or possibly out of the countries where they are currently manufactured. What happens if at some point in the future India or Bangladesh* becomes a member country and Gilead sues their government for allowing export of generics to countries where patents apply.

And while we are basically talking about HCV DAAs here, there are many other life saving medications that are or could become available in generic format but be restricted by the TPP at some point in the future.

* (Don't laugh, stranger alliances have occurred)
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
:cheer: :cheer: :cheer:
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TPP set to potentially block generics 6 years 9 months ago #15477

  • MtGoat
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Thanks Gaj for addressing the inappropriate injection of partisan politics into this topic. This is definitely not the place for it.
Cheers
3a for 35 years
Dx 1996, tx naive, ALT 46 AST 38 VL 140K
Started Sof/Dac 1/23/16
Kingswood generics AUS
2/19/16 4wk lab HCV Undetected ALT 14 AST 19
EOT 6/1/2016
TX was 18 wks (w/some 1/2 doses & 1 skip dose after 11 wks
while waiting for +6 wks to arrive)
SVR4 6/30/16
SVR12
SVR24 Redeemed
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TPP set to potentially block generics 6 years 9 months ago #15548

Actually, it did have to do with Hep C. The TPP will affect all people wanting alternative sourced medications. It should be stopped at all frontiers. So I feel Trump is the strongest of Americans to do that. You can thank him when he wins in November.
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James

TPP set to potentially block generics 6 years 9 months ago #15587

  • Joy
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Médecins Sans Frontières are strongly opposed to the TPP, particularly concerning generics. From a letter addressed to US Congress and co-signed by 50 other organisations concerned with public health:

Generic competition has consistently proven the most effective means of reducing prices and ensuring prices continue to fall over time. In the U.S., generic medicines have saved $1.5 trillion in health care costs in the past decade. Internationally, generics have played a critical role in responding to the AIDS epidemic, saving millions of lives and enabling people living with HIV to still realize their potential. By expanding the monopoly power of pharmaceutical companies, TPP provisions would restrict generic competition and thereby enable medicine prices to keep spiraling out of reach – locking in a broken system here at home and exporting that system to the eleven other TPP countries and those that may join later, including lower-income developing countries where public resources are limited and most people pay for medicines out-of-pocket.

www.msfaccess.org/content/letter-msf-and...-congress-reject-tpp

TPP - signed but not ratified, and let's hope it never is. It's companion TPIP (between US & EU) is also in trouble after being leaked to Greenpeace this week: www.theguardian.com/business/2016/may/01...-on-eu-us-trade-deal
NSW Australia. Genotype 1b 30+ years, F0-F1, VL 91,000 Feb 2015 (740,000 in 2010), Tx naive.
Ordered Sof/Dac from Buyers Club 21 Sept, received 14 Oct.
Virus UNDETECTED at 3 weeks AND 12 weeks (EOT) AND SVR4 AND SVR12 AND SVR24. :-)
A thousand thankyous to Dr James and the amazing FixHepC team.
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