US and Japan Lead Attack on Affordable Cancer Treatments

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Despite claims from the Trans-Pacific Partnership (TPP) states that a final agreement would be reached by the start of this year, the publication of the draft IP Chapter led to a backlash – no agreement was realised, country alignments have altered and negotiations continue. However, US negotiators have made a counter-attack. The latest leaked version of the draft text shows the United States pushing for measures that would significantly constrain affordable access to vital generic drugs, such as cancer drugs and treatments for communicable diseases such as Ebola.

The new US-tabled Article QQ.E.20 will force Parties to enact an automatic monopoly period (marketing exclusivity) for life-saving drugs, with a choice for the groups to decide for definitive inclusion within the treaty of 0, 5, 8 or 12 years. Experts state that the United States is pushing for the maximum 12 years, with the countries' Ministers to decide as the IP negotiators cannot agree on this controversial issue.

If the US is successful in their bid, or even the alternative 8-year period comes into place, the Obama Administration will have gone back on its promise to make cancer drugs affordable, having previously pledged to reduce the monopoly period on biotech drugs from 12 to 7 years. This will mean patients needing these drugs will remain with hugely expensive medical bills for years to come. These costs are also generally unattainable for citizens in the developing countries in the TPP.

Also new in the May 2014 text is a "drug company-friendly" version of the TRIPS agreement for compulsory licensing of vital drugs patents. This is a diminished version of the TRIPS agreement that was present in the 2013 text. In theory, by issuing a compulsory licence, a government can authorise cost-cutting generic competition with patented drugs, in exchange for royalty payments to the patent holder. It is a key tool to promote affordable access to medicines. The new exceptions are set out here and here, having deleted the option for "Other Use Without Authorisation of the Right Holder" in the August 2013 text. The current global norms for justifying exceptions to patents are set out in the TRIPS agreement under either Article 30 or 31. Article 30 is a 3-step test that is restrictive in what it grants exceptions for, and is open to interpretation with regards to procedures for doing these tests. Article 31 (referred to in the August 2013 text and now gone) is the one generally used on all compulsory licensing for HIV and cancer drugs. Whilst it is more restrictive, it is limited to cases where patent holders are paid, so as long as a drug qualifies (as most HIV and cancer drugs do) it is possible to get an exception to the patent held by big pharmaceutical companies, breaking big pharma's monopoly on life-saving drugs.

However, the new version of the text of the TPP IP Chapter has deleted the option to use this assessment procedure, requiring many judgement calls on aspects such as how this might "prejudice" the patent holder. This will mean that the procedure is more restrictive and open to interpretation, and therefore lobbying and manipulation. In short, the TPP will greatly reduce the ability for creating more affordable drugs to save more lives, and increase the pharmaceutical industry's ability to retain monopolies.

Country alignments have also shifted hugely since the WikiLeaks publication last year, where the TPP IP Chapter bracketed text showed Australia closely aligning with the United States throughout the text, joining with the US proposing and opposing statuses 64 times, considerably higher than the next highest. In the May 2014 text the United States has gotten a different closest ally: Japan – with whom it jointly proposes and opposes 32 times. Australia's new closest ally is New Zealand, and this trend to align within regions is now predominant in the Chapter. Links between Latin American countries are now strong, with close links to the poorer Asian countries Malaysia and Brunei.

Brunei Malaysia Chile New Zealand Vietnam Singapore Mexico Peru Canada Australia Japan United States

On hover: *1 The percentage is the relative times that Party cosponsored with other countries, compared with its other cosponsoring.

*2 The figure is the number of times the two countries cosponsored.

Overall, the US is trying to solidify its gains and work through proxies, proposing and opposing far fewer times than anyone else in the Chapter – only 189 times, far less than the next lowest country Japan (226) and Australia (339). Whilst often the US has gotten its way, and in some cases is purposefully reigning back to try to achieve agreements and get the TPP passed, there is a definite move of force from Latin American and Asian countries (excluding Japan) to push back against the US proposals. This trend is most pronounced in the Enforcement Section, particularly around border measures that deal with procedures and enforcements to do with the exporting and importing of trademarked or pirated coyrighted goods.

It should be noted that the border measures section is a resuscitation of the defeated Anti-Counterfeiting Trade Agreement, or ACTA, whose draft was also first published by WikiLeaks. ACTA clauses were also snuck into the EU-India trade agreement and, if successful in the TPP, it seems likely that they will be introduced to the US-EU sister agreement to the TPP, the TTIP.

Canada Malaysia Vietnam Chile Mexico Brunei Australia New Zealand Singapore Peru Japan United States On hover: The figure shows the number of times a country opposed throughout the text Download the graphic showing opposing levels of countries in the TPP IP

Whilst other countries are now pushing back, and the US is feeling the pressure to close the negotiations, it is clear from its positions that US negotiators still act on behalf of key industrial lobbyists. Now that the updated IP Chapter is within the public domain citizens around the globe are able to assess if it has their interests at heart, or not.

By Julian Assange and Sarah Harrison