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TPP set to potentially block generics 6 years 8 months ago #15588

Congress is the only U.S. body that can ratify treaties.
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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TPP set to potentially block generics 6 years 8 months ago #15605

Yes, that is why it is soooo important Donald gets in. It would sail right through Congress.......
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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 8 months ago #15610

  • Joy
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Hmmmm. :unsure:

Perhaps Japan will save the day.
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.

TPP set to potentially block generics 6 years 8 months ago #15623

The TPP has been signed by everyone. Obama signed it already, so it may be difficult for anyone to stop it. It has not been ratified by the US congress, they are holding it up. But the reason is they are trying to get a longer (12 years) protection for generics instead of the 7 years other countries agreed to.
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
The following user(s) said Thank You: mgalbrai

TPP set to potentially block generics 6 years 8 months ago #15837

I just found some fine print in the article from MSF I posted

In regards to USA:

"The deal would raise our medicine prices, giving big pharmaceutical corporations new monopoly rights to keep lower cost generics drugs off the market. The TPP would roll back the modest reforms of the “May 2007” standards with respect to trade pact patent terms."

The 2007 agreement allowed for access to foreign generic medications in developed countries. This could mean that the "3 month" supply rule has only been around since 2007, and is about to end :ohmy: :-1:
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
The following user(s) said Thank You: mgalbrai

TPP set to potentially block generics 6 years 8 months ago #15840

Well...Shit...
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
The following user(s) said Thank You: Greedfighter

TPP set to potentially block generics 6 years 8 months ago #15897

The smoking gun:

Note the specific reference to Hepatitc C medications.


Mr. Narendra Modi
Honourable Prime Minister of India
Government of India

Smt. Nirmala Sitharaman
Honourable Minister of State for Commerce & Industry (Independent Charge)

3rd February 2016

Dear Mr. Modi and Smt. Sitharaman, Médecins Sans Frontières/Doctors Without Borders (MSF) is an independent international medical humanitarian organization that delivers medical care to people affected by armed conflict, epidemics, natural disasters and exclusion from healthcare in nearly 70 countries. Our medical humanitarian work to provide health care to these populations requires constant access to affordable, quality generic medicines and vaccines, and patient-focused innovation. At the height of the AIDS crisis, MSF set up treatment projects and worked in close cooperation with several countries around the world – particularly India - on overcoming intellectual property barriers - to increase access to affordable HIV medicines. We are writing to you on the occasion of the signing of the Trans-Pacific Partnership Agreement (TPP) in New Zealand to draw the attention of the Indian government to our concerns regarding the potential negative consequences of this agreement on trade in affordable generic medicines among developing countries and particularly between India and ASEAN countries. The TPP is a regional trade agreement recently concluded by the United States and 11 other Pacific Rim countries (Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam). After years of negotiations without appropriate public input, TPP countries reached an agreement in October 2015, and the official text is only now publically available. The signing of the TPP is scheduled for February 4, 2016 in New Zealand, but the potential ratification and national implementation process is just starting. The TPP text confirms that if implemented, the agreement will be the most harmful trade pact ever for access to medicines. Intellectual Property Chapter in the TPP MSF’s analysis of the provisions in the TPP related to intellectual property (IP) reveal that they threaten to restrict access to affordable medicines for millions of people, treatment providers like MSF and Ministries of Health, and undermine the historic World Trade Organization (WTO) Ministerial Declaration on the TRIPS Agreement and Public Health (Doha Declaration).

The TPP contains stringent intellectual property (IP) provisions that will lengthen, strengthen and broaden pharmaceutical company monopolies beyond what is required under the WTO TRIPS Agreement. We have communicated our concerns about the IP Chapter of the TPP on numerous occasions to negotiating countries over the past four years. To reiterate, please find attached an analysis of the most harmful provisions.

The TPP will undermine and act as a permanent obstacle against reform The promise of the Doha Declaration is that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. TRIPS-plus provisions in the TPP threaten to make it impossible for countries who sign the agreement to exercise the rights confirmed in Doha.

In fact, the TPP blocks countries that sign the agreement from doing precisely what India has done – amending their patent systems to include safeguards that will improve the quality of patent examination - and effectively address abusive patent ‘ever-greening’ practices that prolong patent monopolies. This will lock countries into paying excessive prices to multinational pharmaceutical companies for patented medicines, which undermines the right to health and national efforts to implement universal healthcare. MSF believes reform of the IP system is essential to overcoming the gap in access to medicines for millions of people around the world. Today, whether in response to the Ebola outbreak, the lack of new antibiotics to address TB and other drug-resistant infections, or the unaffordable price of $1000 per pill to treat hepatitis C in the US, there are numerous efforts underway to reform intellectual property rules while also introducing new approaches to incentivize R&D. The TPP will undermine and act as a permanent obstacle to such efforts. TPP in the region and the need to counter its expansion Lobbying efforts are now underway to actively encourage and pressure additional countries in the region — particularly India and ASEAN countries that did not participate in the negotiations—to join the TPP. Currently, Malaysia, Singapore and Vietnam from the ASEAN group are signing the TPP and starting national discussions on whether to ratify and implement the agreement. Indonesia and Thailand—middle-income countries that have championed TRIPS flexibilities and the Doha Declaration—have not participated in the negotiations, but have shown an interest in joining the TPP. It is imperative for countries in the region, including India, to lead an effort to counter the expansion of the TPP in the region and to promote the commitments enshrined in the Doha Declaration. Each of the new IP obligations in the TPP will limit access and trade in generic medicines, which has been one of the most reliable and powerful forces to reduce drug prices systematically, thereby making essential, life-saving medicines such as antiretrovirals (ARVs) for the treatment of HIV/AIDS more affordable for individuals and the health systems that serve them. As a medical humanitarian organization, we cannot accept the subordination of the health needs of our patients and millions of others to US trade interests. The US must not hamper the ability of countries in the region to fully implement the Doha Declaration. In order to ensure the protection of public health and the promotion of access to medicines, the TRIPS Agreement must be the ceiling for regional and bilateral trade agreements.

We thank you for your attention and are available for further discussions and information. Sincerely,

Dr. Manica Balasegaram
Executive Director,

Rohit Malpani
Access Campaign Director Policy & Analysis

China is now the only one not honoring the patent of :evil:

IMO, the availability of these meds through third party channels that exist now may remain unchanged, but the likelihood of policy changes at the national level of TPP countries is now 0%, especially given India's patent reversal.
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
The following user(s) said Thank You: Joy, mgalbrai, Ariel

TPP set to potentially block generics 6 years 8 months ago #15898

Here's more bad news from a 2/16 press release that I feel addresses Dr. Freeman's trial results:

Unless is modified, the TPP will exacerbate the global crisis of high drug prices. For example, the TPP will not allow national regulatory authorities to use existing clinical data demonstrating a pharmaceutical product’s safety and efficacy to authorize the sale of competitor products, even in the absence of patents. The additional monopoly protection provided for biologic drugs and vaccines will keep already very expensive products out of the hands of millions. The TPP would also force governments to extend existing patent monopolies beyond current 20-year terms at the request of pharmaceutical companies, and to redefine what type of medicine deserves a patent, including mandating the granting of new patents for modifications of existing medicines.

The only thing not mentioned was Dr. Freeman's name! :sick:

Perhaps an algorithm suppressed the words FREE MAN

:evil:
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 8 months ago #15905

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Ratification is tied to collective GDP.

As there is significant push back in some signatory countries, it’s reasonable to assume at least one will fail to ratify the agreement. This is the mark everyone will be watching. In that event, the agreement can still come into force if at least six countries, which between them represent at least 85 percent of the total GDP of the original 12, have ratified it within two years.The TPP will truly be decided between the United States and Japan, which together represent just under 80 percent of the total GDP of the signatories. As Ankit Panda noted in October, “Basically, the TPP can’t come into force if either of these states fail to ratify the agreement in their domestic legislatures because there would be no way for the remaining signatories to fulfill the 85 percent of GDP requirement (even if the United States and all states but Japan ratify, the eleven would stand at 83 percent of GDP).”

thediplomat.com/2016/02/tpp-the-ratification-race-is-on/

And what happens if Indonesia and Thailand join in?

Complicated.
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.
The following user(s) said Thank You: Vororo, mgalbrai
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