TPP IP chapter “a disaster for global health”

By Leith van Onselen

Wikileaks leaked the final draft of the Intellectual Property chapter of the Trans-Pacific Partnership (TPP) over the weekend, which has been panned by various “experts”.

Most notable of these is La Trobe Universtity lecturer in Public Health, Dr Deborah Gleeson, who has analysed the chapter and concluded that it “represents nothing less than a disaster for global health”:

Many harmful provisions still remain in the final chapter, bearing out the concerns of public health advocates. These include:

  • Patents for new uses and new methods of using existing products (Article QQ.E.1.2, p. 17);
  • A low inventiveness threshold – potentially preventing countries from tightening the criteria for granting patents (Footnote 33, p. 17);
  • Patent term extensions to compensate for delays in granting patents (Article QQ.E.12, p. 20) and delays in marketing approval (Article QQ.E.14, p. 22);
  • Data protection for small molecule drugs – at least 5 years for new pharmaceutical products plus 3 years for new indications, formulations or methods of administration (Article QQ.E.16, p. 23-24);
  • Patent linkage provisions likely to result in delays in marketing approval for generic drugs (Article QQ.E.17); and
  • Market exclusivity for biologics, provided through one of two options: at least 8 years of data protection, or at least 5 years of data protection and other measures to “deliver a comparable outcome in the market” (Article QQ.E.20, p. 25-26).

This is the first time a provision for market exclusivity for biologic products has ever appeared in a trade agreement – and this is a new obligation for many TPP countries.

The outcome of this suite of obligations will be delayed competition from follow-on generics and biosimilars – which means delayed access to affordable medicines, placing them out of reach altogether for many people in developing countries. Even countries like Australia, the TPP obligations will lock in current intellectual property standards, making it difficult or impossible to reform our system to improve access to affordable medicines in future…

If the TPP countries ratify the deal, Big Pharma will have succeeded in cementing intellectual property standards that will stymie access to medicines for up to 800 million people in the short term, and more if additional countries sign up in future. Furthermore, the TPP’s intellectual property chapter sets a new norm that is likely to become the template for future trade agreements: its implications are global as well as regional.

The governments of TPP countries have been complicit in a global health disaster of unimaginable proportions – a deal that will prevent untold numbers of people from obtaining medicines that those in many developed countries take for granted…

The Australian Government’s brief about the TPP outcomes for biologics says:

“In the TPP, Australia has negotiated protections that are consistent with Australian law and practice. Australia is not required to change any part of its current law, including data protection for biologics, or our patent regime. There will be no adverse impact on the Pharmaceutical Benefits Scheme and no price increase for medicines. But the final text of the TPP’s IP chapter contains some problematic language and troubling ambiguities”.

Article QQ.E.20.1 (p. 25-26) outlines two options that countries can implement to protect new biologics:

1) At least 8 years’ protection of clinical trial data (QQ.E.20.1(a)); or

2) At least 5 years’ protection of clinical trial data along with other measures to “provide effective market protection” and “deliver a comparable outcome in the market”.

Whatever the understanding reached between parties in the negotiating room, according to the agreed legal text, it appears that the TPP parties are obliged to ensure the same market exclusivity outcomes regardless of which option they choose.

The legal language provides room for the United States to continue to pressure the other TPP countries to ensure that they keep biosimilars (more affordable follow-on products) off the market for eight years, in order to provide equivalent “effective market protection” and a “comparable outcome” to eight years of data protection…

Conclusions…

The provisions relating to biologics are problematic and ambiguous. They appear to commit countries to providing either eight years of clinical trial data protection, or five years of clinical trial data protection along with other measures to deliver comparable outcomes. While the Australian Government has said that the regime for biologics in Australia will not change, the language leaves room for continued pressure by the United States to ensure that TPP countries prevent biosimilars from entering the market for eight years. The definition of biologics is very broad and likely to limit countries’ flexibility in determining the scope of the obligation. A review by the TPP Commission of both the length and scope of protection after ten years provides a further mechanism for US pressure to expand and extend monopolies on expensive biologics.

Dr Gleeson’s full critique is well worth reading and can be viewed here.

Meanwhile, the Electronic Frontier Foundation (EFF), the leading nonprofit organisation defending civil liberties in the digital world, has criticised the final TPP text for extending copyright protections.

In addition to extending copyright terms to creator’s life plus 70 years, the TPP would ban the circumvention of Digital Rights Management (DRM), as well as permit disproportionate penalties on users that are deemed to have breached copyright:

The provisions in QQ.G.10 that prohibit the circumvention of DRM or the supply of devices for doing so are little changed from earlier drafts…

The odd effect of this is that someone tinkering with a file or device that contains a copyrighted work can be made liable (criminally so, if wilfullness and a commercial motive can be shown), for doing so even when no copyright infringement is committed. Although the TPP text does allow countries to pass exceptions that allow DRM circumvention for non-infringing uses, such exceptions are not mandatory, as they ought to be.

The parties’ flexibility to allow DRM circumvention also requires them to consider whether rightsholders have already taken measures to allow those non-infringing uses to be made…

Alongside the prohibition on circumvention of DRM is a similar prohibition (QQ.G.13) on the removal of rights management information, with equivalent civil and criminal penalties. Since this offense is, once again, independent of the infringement of copyright, it could implicate a user who crops out an identifying watermark from an image, even if they are using that image for fair use purposes and even if they otherwise provide attribution of the original author by some other means…

On damages, the text (QQ.H.4) remains as bad as ever: rightsholders can submit “any legitimate measure of value” to a judicial authority for determination of damages, including the suggested retail price of infringing goods. Additionally, judges must have the power to order pre-established damages (at the rightsholder’s election), or additional damages, each of which may go beyond compensating the rightsholder for its actual loss, and thereby create a disproportionate chilling effect for users and innovators…

One of the scariest parts of the TPP is that not only can you be made liable to fines and criminal penalties, but that any materials and implements used in the creation of infringing copies can also be destroyed (QQ.H.4(12)). The same applies to devices and products used for circumventing DRM or removing rights management information (QQ.H.4(17)). Because multi-use devices such as computers are used for a diverse range of purposes, this is once again a disproportionate penalty. This could lead to a family’s home computer becoming seized simply because of its use in sharing files online, or for ripping Blu-Ray movies to a media center.

The Intellectual Property Chapter also requires signatories to hand over details of people that are alleged to have breached copyright:

Without prejudice to its law governing privilege, the protection of confidentiality of information sources, or the processing of personal data, each Party shall provide that, in civil judicial proceedings concerning the enforcement of intellectual property rights, its judicial authorities have the authority, upon a justified request of the right holder, to order the infringer or, in the alternative, the alleged infringer, to provide to the right holder or to the judicial authorities, at least for the purpose of collecting evidence, relevant information as provided for in its applicable laws and regulations that the infringer or alleged infringer possesses or controls. Such information may include information regarding any person involved in any aspect of the infringement or alleged infringement and regarding the means of production or the channels of distribution of the infringing or allegedly infringing goods or services, including the identification of third persons alleged to be involved in the production and distribution of such goods or services and of their channels of distribution.

Overall, there’s no joy in Intellectual Property chapter of the TPP, which shifts power away from users/consumers towards the owners of IP, most of whom reside in the US.

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Comments

  1. House Pushing Back on Trade Deal; More Detail on How Secret Arbitration Panels Undermine Laws and Regulations

    Posted on November 13, 2013 by Yves Smith

    Wow, this is amazing. Word has apparently gotten out even to Congressmen who can normally be lulled to sleep with the invocation of the magic phrase “free trade” that the pending Trans Pacific Partnership is toxic. This proposed deal among 13 Pacific Rim countries (essentially, an “everybody but China” pact), is only peripherally about trade, since trade is already substantially liberalized. Its main aim is to strengthen the rights of intellectual property holders and investors, undermining US sovereignity, allowing drug companies to raise drug prices, interfering with basic operation of the Internet, and gutting labor, banking, and environmental regulations.

    http://www.nakedcapitalism.com/2013/11/house-pushing-back-on-trade-deal-more-detail-on-how-secretive-arbitration-panels-undermine-laws-and-regulations.html

    For a good time see the chart – 15 arbitrators alone have captured the decision-making in 55% of the total investor-state cases know today

    Skippy… one would think the anti sovereign mob – pro freedom and liberty tm posse would wise up…

    • O’Bomber’s finest hour. What a waste of time he’s been, just warming the seat. Yes we can’t.

      • Huge disappointment. Marketed himself as the “peace” candidate. Turns out he has been more militaristic than Dubya, and by a long way – particularly in the use of drone warfare.

        Also, i will add, it should be no surprise that the peace candidate won the election – they generally will if the electorate is tired of war.

  2. The purpose of a patent is to:
    • Defend markets
    • Outsmart enemies
    • Build sales and
    • Level the playing field for competition with larger corporations, and,
    • Create advantages for the formation of strategic partnerships
    Welcome to the real world guys
    Remember politics is about numbers and business. (LNP)

    • Wrong WW,

      Its to provide incentive, albeit one that does not eventually lend to negative social ramifications.

      Skippy…. its not about in perpetuity, that crowd’s out and entrenches.

      • ResearchtimeMEMBER

        Mate – be real… why spend billion on a new drug if you cannot make money from it – and others rip it off? Five to eight years is more than reasonable.

      • RT,

        Firstly the Pharma industry in the states is heavily subsidized by the government, not to mention, now, w/ ACA they have forced participation on top of it all. Got you coming and going lol…

        Your grumble about 5 – 8 years is miss placed as I was referring to TTP metrics and not conventional standards, tho that Venture philanthropy is scary, another tax loop hole.

        Skippy… to top it off the gov does not negotiate with drug company’s, as ours does…

      • @researchtime

        Is that right ?

        Like buying 50 year old patents on drugs which cost dollars and raising the price by 50000% effectively killing vast swathes of people ?

        You’re so clued in.

  3. This will lead to ever greening of patents, no matter how many years Australia agreed to (5 or 8). And the amount of ISDS charges thrown around any time any government tries to improve the situation for its citizens will be staggering considering the existing history of suing countries for minimum wage increases or environmental regulations.

    We may even go back to the days of people losing their homes and livelihoods for downloading a few songs. The big companies backed off this tactic for fear of a public push-back. But now with laws set in stone, there’s no risk of anything coming out it any more.

    The sad thing is, the news keeps on going on about this or that person being involved in an accident, or theft. THIS should be a national crisis story on a similar level to actually being attacked in an act of war. yet I hardly see any mention of it..

    Only the worst kind of mob or state justice can approach the level of punishment anyone supporting this deserves… Am I crazy to think these are bizarrely evil / corrupt monsters?

    • The USA owns our foreign policy, just like it owns that of NATO members. We will acquiesce to their every demand if it is something they want bad enough.

  4. Absolutely astonishing. Why any country would sign up to this is beyond me. I can only think of enormous US pressure to push US interests and consolidate US power.

    Blatant attack on democracy that should be shot out of the water by all involved parliaments.

    • The USA bullies everyone into signing up. That’s what this TPP is, it is the economic piece of the pivot to Asia, soon to be followed by military provocations in the Spratlys and agitation from NGO’s that operate within Chinese borders. The Silk Road for its part is about doing the same to the USA. It would connect China, to Russia (Russia represents 15% of global land mass), former USSR states all the way to Germany and decrease the dominance of the US system of trade which is supported by their dominant navy. Many many things happening in a geopolitical sense atm.

      • How does this bullying work? Do they threaten sanctions and war? Because this TPP sounds like something that a ‘civilised’ government would threaten someone with, not into. The ISDS is especially bad. Is there no ‘good’ leader out there that can come out and reveal the threats they were subjected to in order to sell out their country?

      • Diplomatic pressure, media pressure. They own the media. Japanese politicians can’t even get US troops out of Okinawa (the ones who want to) even though the vast majority of the island wants them gone.

        How about Germany? The media is totally vetted by the US State Dept. The CIA bribing German journalists is part and parcel of the media in that country.

      • “The Silk Road for its part is about doing the same to the USA. It would connect China (Eastasia), to Russia (…), former USSR states all the way to Germany (Eurasia)

        So Oceania is the odd one out this time?

      • Not if it doesn’t want to be. It includes Europe, and Australia will have a China FTA, and the US and China are already symbiotic.

      • What annoys me is that as Australians, in the last 15 years especially, we have sold our unique idea of what it is to be Australian and our identity in the pursuit of being Americanised and worshiping everything USA. We have become a bunch of flag waving ignorant tools who believe in our own exceptionalism and frown down upon anything that isn’t totally superficial or completely PC. We are becoming the 51st (or 52nd) state of another country. This silly agreement just seals our fate politically and economically.

  5. I always suspected that TPP was in fact a proto form of globalised taxation whereby US IP holders are the new breed of tax collectors …that suspicion seems confirmed…sad day for Australia and a sad day for democracy / sovereignty, I’m left wondering what concessions Australia actually won…maybe the concessions are only apparent when one realizes how one sided and absolutely shitty the original TPP was.

    • “I’m left wondering what concessions Australia actually won”.

      400 farmers in QLD get to sell more sugar.

      • token amount, just to help Nationals, otherwise cane growers are screwed like the rest of Australia

  6. To further unpack that a bit more…

    The TPP is an international trade agreement currently being negotiated between the US and 11 other countries, including Japan, Australia, Chile, Singapore and Malaysia. Among other things, it could could strengthen copyright laws, limit efforts at food safety reform and allow domestic policies to be contested by corporations in an international court. Its impact is expected to be sweeping, yet venues for public input hardly exist.

    Industry Trade Advisory Committees, or ITACs, are cousins to Federal Advisory Committees like the National Petroleum Council that I wrote about recently. However, ITACs are functionally exempt from many of the transparency rules that generally govern Federal Advisory Committees, and their communications are largely shielded from FOIA in order to protect “third party commercial and/or financial information from disclosure.” And even if for some reason they wanted to tell someone what they’re doing, members must sign non-disclosure agreements so they can’t “compromise” government negotiating goals. Finally, they also escape requirements to balance their industry members with representatives from public interest groups.

    The result is that the Energy and Energy Services committee includes the National Mining Association and America’s Natural Gas Alliance but only one representative from a company dedicated to less-polluting wind and solar energy.

    The Information and Communications Technologies, Services, and Electronic Commerce committee includes representatives from Verizon and AT&T Services Inc. (a subsidiary of AT&T), which domestically are still pushing hard against new net neutrality rules that stop internet providers from creating more expensive online fast-lanes.

    And the Intellectual Property Rights committee includes the Recording Industry Association of America, the Pharmaceutical Research and Manufacturers of America, Apple, Johnson and Johnson and Yahoo, rather than groups like the Electronic Frontier Foundation, which shares the industry’s expertise in intellectual property policy but has an agenda less aligned with business.

    Maira Sutton, a global policy analyst with the EFF, points to the Recording Industry Association of America as an organization that has been “very much in favor of copyright term extensions and limiting fair use.” The pact could make it difficult for countries to shorten copyright terms that currently extend long past an author’s life, or for artists to repurpose copyrighted material to make art or music. Apple, Sutton notes, is notorious for creating technology that comes riddled with restrictions on what users and programmers can do with them, a practice that could be bolstered in the TPP.

    There does exist a Trade and Environment Policy Advisory Committee and a Labor Advisory Committee, but their members are far outnumbered by those from industry. A Washington Post analysis from February 2014 noted, “Of the 566 committee members [in the 28 committees], 306 come from private industry and an additional 174 hail from trade associations. All told they represent 85% of the voices on the trade committees.”

    https://theintercept.com/2015/05/12/cant-read-tpp-heres-huge-corporations-can/

    Skippy…. smell the corporatist feudalism…. ahhhh….

  7. Obviously the media did not see this but their gushing over the TPP in terms that Robb wanted makes their role more than compromised as they ensure consent.

    • JAke this is one of the strengths of MB. Whilst the discussion may go from boundary to boundary, the outcome is nearly bang on all the time.
      My call is that this site nearly single handed-ly will undo the TPP for Aussie, then the MSM will follow.

  8. Terror Australis

    We can count on the Australian Labor Party to mutter some unhappy things under their breath … then dutifully pass the TPP bill.

    The Opposition you have, when you don’t have an Opposition.

  9. If I saw Robb in the street I’d be tempted to cnt punch that sell out hooker.

    What a piece of sh$t he is.

    Motherfker.

    (Sorry mum for the language)

    He is a treasonous scumbag

    • ceteris paribus

      Steady on Marshie. He is just your normal, selfish Liberal who has no compassion for anyone who has not got two or three spare million to look after himself or his own.