How the battle over biologics helped stall the Trans Pacific Partnership

Deborah Gleeson and Ruth Lopert write: Talks that were meant to finalise the Trans Pacific Partnership wound up in Hawaii late last week

Deborah Gleeson and Ruth Lopert write: Talks that were meant to finalise the Trans Pacific Partnership wound up in Hawaii late last week without reaching a final deal. Over the last five years, 12 countries – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam – have been involved in negotiating the […]  final text of the deal.

=Despite the setback, there will be a strong push to sort out the remaining issues in August. After that the Canadian and US election cycles will make further progress in negotiating the trade deal next to impossible. And one of the most highly charged matters negotiators will be trying to resolve is intellectual property protections for medicines.

Over the next few weeks, Australia’s trade minister, Andrew Robb, will be under intense pressure to renege on the government’s oft-repeated commitment to reject anything in the deal that could undermine the Pharmaceutical Benefits Scheme (PBS) or increase the cost of medicines for Australians.

Data exclusivity

A key issue affecting drugs is the length of the data-exclusivity period for a class of medicines called biologics, which are produced from living organisms. Biologics include many new and very expensive cancer medicines, such as Keytruda, a melanoma drug recently listed on the PBS. Without the PBS subsidy, it would cost over A$150,000 to treat a patient for a year.

Data exclusivity refers to the protection of clinical trial data submitted to regulatory agencies from use by competitors. It’s a different type of monopoly protection to patents. While a product is covered by data exclusivity, manufacturers of cheaper follow-on versions of the product can’t rely on the clinical trial data produced by the originator of the drug to support the marketing approval of their product.

Section 25a of Australia’s Therapeutic Goods Act provides for five years of data exclusivity for all medicines. It makes no distinction between biologics and other drugs. Data exclusivity provides an absolute monopoly that, unlike a patent, can’t be revoked or challenged in court.

The powerful biopharmaceutical industry lobby in the United States has been seeking 12 years of market exclusivity for biologics.

Facing intense opposition from all other countries, the US trade representative fell back this week to eight years. While this was heralded as a new level of “flexibility” in the US position, in reality it remains a significant extension of intellectual property rights in most of the TPP countries.

Thus far, the Australian delegation has apparently maintained the position that it will not go beyond existing domestic law. Days before the talks broke up, the trade minister indicated in an interview on ABC Radio National that he didn’t see the sense in accepting a longer monopoly for biologics.

Good reasons to not budge

Three factors are likely to be contributing to this resolve. The first is the costs of extending monopolies. These are likely to be hundreds of millions of dollars a year in the short term and could rise exponentially in the longer term as patents gradually expire on biologics already listed on the PBS.

Without a PBS subsidy, some new medications could cost patients thousands of dollars for a course of treatment.
Toni Fish/flickr, CC BY-NC-ND

Another pressing consideration is the degree of political opposition to longer medicine monopolies in Australia. Extending the period of data exclusivity would require an amendment to the Therapeutic Goods Act – a move Labor, the Greens and many independents would strongly oppose. And the failure to get implementing legislation through the Senate could compromise the whole deal.

The third factor is the lack of progress in bargaining for access to US markets; the US reportedly made only a token offer on sugar and withdrew an earlier offer on dairy products.

Eight years of data exclusivity won’t be an appealing option for any of the other TPP countries, with the exception of Japan and Canada, which already allow for eight years. New Zealand’s trade minister recently faced outrage at home over admissions that the cost of medicines may be expected to increase after the agreement. The country’s opposition, also Labor, has declared it won’t support a deal that raises the costs of medicines.

The US stance itself is contradictory as the Obama administration has been trying to reduce the exclusivity period for biologics to seven years, to speed up the availability of cheaper alternatives and save an estimated US$16 billion in the next decade.

It seems clear to everyone except US negotiators – and biopharmaceutical industry lobbyists – that the demand for extending data exclusivity for biologics needs to be dropped if the TPP is to be finalised.

The Conversation

Deborah Gleeson is Lecturer in Public Health at La Trobe University.
Ruth Lopert is Adjunct professor, Department of Health Policy & Management at George Washington University.

This article was originally published on The Conversation.
Read the original article.

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One thought on “How the battle over biologics helped stall the Trans Pacific Partnership

  1. David E.H. Smith

    TPP, TTIP, CETA & other Global Treaties/”Arrangements’; ‘The Three Card Monte’.
    How long have Global Corporate Associates been ‘Passing’ Legislation in Anticipation of Suing Once Ratified? ‘Trickle’ Up & Out Economics.

    TPP & Global Corporate Treaties/’Arrangements Not about How Much Trade & more about Preferred Trading Partners & more about Tort ‘Abolishment’ than Tort ‘Reform’?

    TPP nations, et al, need ‘good corporate citizens’ that respect our legislation & need to ‘out’ bad corporate voters via shareholder meetings?

    Americans, Japanese, et al, look forward to working with Savvy Slave Trading Malaysians & Slick Cultural ‘Genociding’ Canadians. ‘But, we didn’t know’.
    Traditional Canadian Parties Demanding Supplicance to Corporate Canada & its Global Corporate Assocs. is an unholy sin?

    Will Pope Francis & other leaders Intercede with Prayer against PM Harper, Corporate Canada, The Canadian Establishment, et al, for Continuing to Blame & Punish those who are continuing to be Deprived of the Due Diligence Info and Continuing its Cultural Genocide? Protecting the Human Rights of Unborn Native Canadians, et al.
    Making the leaders of TPP, Shareholders, et al, ‘Persona non Grata’; Shareholders’ Meetings I.D. Toxic Neighbors, In-laws, et al?

    But, will the lil’ guy get 10 years to read, consider, discuss & improve upon (with lawyers paid by Global Corporate Assocs.)?

    The Big 3 vs. Green Party & Quebec
    ANTI-Globalists (GREENs) PROHIBITED from ‘Corp.Can.’s Election’ DEBATE…

    For NO to Global Treaties/”Arrangements’ just VOTE for the GREEN Party’ Canada’s Big 3 Traditional Parties tell Voters.

    Can the Canadian, TPP nations, et al, voters even debate the Pros & Cons of the TPP & other Global Treaties/’Arrangements’ when the CBC & Corporate Canada’s media have Decided that the TPP is NOT a CHOICE, but, merely a matter of ‘Choosing the best negotiator..’ of their ’Arrangements’? by David E.H. Smith, ‘Qui tam…’

    • After New Zealand’s PM admitted that medicines will cost more, have the citizens of New Zealand & other TPP nations also noticed similar moves like Canadian Prime Minister Harper below? ‘To help pay for the harmless taxpayers ‘guilty transgressions’ against Global Corporations in Canada, Prime Minister Harper has recently cut the funding for health care by $36 billion dollars’. (please article below)

    There is absolutely no ethical reason for hyping a mountain of corporate ‘arrangements’ to screw the harmless, lil’ guy by espousing the legitimate benefits of reducing tariffs & referring to the arrangements as ‘trade’ treaties?

    The fact of the matter is the TPP, TTIP, CETA & other Global Treaties/”Arrangements’ are not about how much trade, but, who the signatory corporations prefer to trade with & how to ‘Vichy’ their profits while ‘undermining’ the AIIB, et al. And, if one understands the basic economic law that
    there is only a finite amount of global value & that it does not grow, or, shrink, it just moves around, then, one might be able to understand that the TTIP, CETA & the other Global Treaties/’Arrangements’ are the means for just such moves; they are just attempts to move the value of the signatory nations to the (‘global’) corporations that are presently located in these nations. These ‘moves’ only make economic sense if the value that is moved to the global corporations is at the expense of the non-shareholders (via ‘their’ governments), whether the non-shareholders are citizens of the signatory nations, or, not.

    And, while the aforementioned reorganization will cause an increase in employment in some sectors of the signatory Global Corporations it will be off-set by:
    1) the devaluation of the operational costs as jobs move to the signatory nations with the lowest cost of employment,
    2) the decrease of jobs in other sectors which will be lost entirely to non-signatory nations which have un competitively low wages.

    Other ‘secret’ cost shifts from the corporations to the harmless, individual tax payers include:
    1) the systematic move from one corporation suing another corporation, to both corporations suing the harmless taxpayers in secret (‘Death-Star’) Tribunals; but, with no defense, nor, appeals for the harmless taxpayers (see; ‘The MERKEL Letter’*),
    2) the prohibition of governments to sue the signatory corporations; ie. what was previously (prior to the treaties) illegal, &/or, unethical is now ‘legal’ in the new jurisdiction of the cyber Tribunals (the U.S., et al, Corporations that have craved for Tort Reform are getting Tort Abolishment),
    3) the provisions to make more secret add-ons at later dates with no public consultations,
    4) et al.

    To help pay for the harmless taxpayers ‘guilty transgressions’ against Global Corporations in Canada, Prime Minister Harper has recently cut the funding for health care by $36 billion dollars. Not only do these funds reward the Global Corporations (to pay for present-future punitive developmental costs, penalties, etc.), but, it gives the Corporations the funds to purchase national health care systems of Canada & the other signatory corporate states whose health care functions are being deliberately exacerbated in anticipation of the secret intent of the Treaties/’Arrangements’; acquisition of national health care & pharmaceutical systems. Other public services are similarly being made vulnerable in preparation for corporate take-overs. Surprisingly, the Canadian province of Saskatchewan seems to be particularly resilient to the pressures from Corporate Canada & its Global Corporate Associates, at least for now.

    However, where the real money is to be made in the secret
    Treaties/’Arrangements’ is not in the ‘three card Monte’ (ie. Zero net effect) trade area of the treaties, but, in the moves in finance. Perhaps the most significant move here is from a system that is barely accountable in open courts, such as:
    1) the money laundering of HSBC, et al, on behalf of drug & terrorist groups,
    2) Enron’s unregulated (fraud, insider trading**, etc.) manipulation of electrical power-services,
    3) the unregulated & fraud induced (Chase bank; ‘fine before no crime, nor, time’, et al) melt-down of Wall St. in the 2008 (the ‘tactical probe’ before the ‘invasion’ of the Global Treaties/’Arrangements’)
    4) et al,
    to a system of secret tribunal ‘arrangements’. In other words, the illegal practices that were barely detectable due to the deliberate underfunding of the regulators
    the political interference of the investigations by the Dept. of Justice (U.S.),
    will enable the practices of HSBC, Enron, Chase, et al, to not only live on but, expand exponentially & internationally.

    The advocates of the Global corporate economy can warmly point out that the lil’ guy will no longer have to pay for the costs of the governments regulating, policing, investigating, prosecuting & incarcerating (?) financial felonies & misdemeanors as these duties will fall under the new cyber-jurisdiction.

    This ‘cost savings’ begs the questions:
    1) what are the various different ways that these costs savings can be made contractually binding in an agreed upon reduction of taxes of the harmless taxpayers,
    2) what constitutes a ’good corporate citizen’ in the post treaty ratification world
    3) how many pieces of legislation have Corporate Canada & its Global Associates encouraged, sponsored, &/or, paid a consideration to have passed in anticipation of suing the harmless individual taxpayers for windfall profits after the Treaties/’Arrangements’ have been ratified
    4) et al?

    And, finally, it may be regrettable that nowhere in the discussion of the flurry of Global Treaties/’Arrangements’ has there been any mention about what will be the destabilizing consequences for the signatories due to;
    1) the deliberate deprivation of information (particularly, Canada, re; The W.A.D. Accord & its Compensation) that is increasing the unrealistic expectations of the other signatories, potential signatories, et al,
    2) the signatories making geopolitical side deals with non-members which have the appearance of being at the expense of the other corporations of the treaty signatories & 3) et al?

    FULL Article, see;

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