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TPPA: Trouble with Pharmaceutical Product Access?

Mon 12 Oct 2015 In: Health and HIV View at Wayback View at NDHA

Several months ago, I wrote a brief article on the Trans-Pacific Trade Partnership, wondering how it would particularly affect HIV+ people, given that New Zealand has no domestic pharmaceuticals industry. The treaty was signed on October 6, and debate is still occurring about its extent and implications. To recap; there are two chief pharmaceutical and medical device regulatory agencies in New Zealand. One is MedSafe, which assesses the clinical safety or risk of particular pharmaceuticals and medical devices, and the other is Pharmac, which makes decisions about which pharmaceuticals to fund-including protease inhibitors and other medications for HIV+ people, as well as other medications- which also affects lesbians and bisexual women with ovarian, breast, cervical and other women's cancers. Transwomen may also be liable for prostate cancer, just as transmen may also be at risk of cervical cancer if they don't have medical checkups and there is a history of such medical conditions within their families.  As for the Trans-Pacific Partnership Agreement, it has been the subject of discussions among various Asia-Pacific Trade Ministers and within national legislatures since it was first canvassed at the Asian-Pacific Economic Council (APEC) forum in 2002. Originally, it consisted of New Zealand, Chile, Singapore and the anti-gay Sultanate of Brunei, which has just drafted repressive shariah law-based legislation that may lead to capital punishment for gay male sexuality. Malaysia, Australia, Canada, Peru, Japan and the United States all joined in later, but not without controversy within Canada, New Zealand, the United States and Australia over its implications. Both leftist opponents of hypermarket economics and rightist economic protectionists (such as elements of the US Tea Party movement) oppose it. Pharmac is resented by pharmaceutical companies overseas because it is a national monopoly purchaser and because it contains costs within the New Zealand healthcare system when it comes to imported pharmaceuticals, enabling New Zealand healthcare dollars to be spent elsewhere within its institutions.  The approval process usually means that if particular pharmaceuticals are greenlighted, they can take from ten to fifteen months to arrive here. This is not as bad as it sounds, given that this leaves time for adverse or supportive clinical data about the new medications to become available.  The Global Commission on HIV and the Law has warned that national pharmaceutical purchasing policies may not be easily compatible with intellectual property clauses within the TPPA. Modern healthcare economics means that medical practitioners, healthcare managers, regulatory agencies and Health Ministers all need to make decisions about particular costs within healthcare provision. As well as pharmaceuticals, these include medical equipment wear and tear and replacement costs, medical practitioner wages and the effects of their professional associations, hospital bed occupancy and other incidental costs. Greens Health spokesperson Kevin Hague expressed concern earlier this year about the possibility that some new HIV treatment drug options may have increased patent costs and duration, as well as new TPPA opportunities for pharmaceutical companies to challenge its processes, erode its negotiating position and resulting in higher drug prices, which may adversely affect the introduction of new treatment options in terms of scope and scale.  The Wikileaks saga also exposed unreleased official documents about possible restrictions on Pharmac's independence of action as pharmaceutical purchaser, according to Green Co-Leader James Shaw. Labour Health spokesperson Annette King has expressed frustration at the absence of transparency and relevant detail, noting that the TPPA is being debated in the Canadian and US national legislatures more openly than it is within New Zealand.  How might Pharmac be affected? In 2012, Pharmac released a paper on what it called "pharmacoeconomic analysis", a guide to what criteria it uses in deciding which drugs to either fund or not fund. These background factors include the scale of the target population (ie HIV+ people), available clinical data sources and their quality, advice from New Zealand medical specialists, extrapolation of existing data, pharmaceutical costs, hospital inpatient and other healthcare costs. Calculating the interaction of these variables results in what Pharmac calls a "cost-utility" analysis. However, it remains to be seen whether the TPPA will result in inflation of one variable- pharmaceutical costs- and distort the usefulness of the cost-utility analysis in the allocation of new treatment options for HIV+ people and other potentially vulnerable groups. Are the Greens right to suggest caution and more careful analysis? Pharmac's own documents seem to suggest so.  Just as predictably, David Farrar at Kiwiblog was supportive of the deal, noting that the TPPA was better than nothing at all. It would create new markets for New Zealand agricultural products, insure competitor parity with nations already in free trade agreements with other major signatories, and gradually eliminate tariff and other costs to New Zealand products. It would also enhance harmonised technical standards and benefit the reputation and status of New Zealand products through closer economic co-operation, according to a cited ANZ opinion on the deal.  Predictably, opinion is still divided about the effects of the TPPA. On the left, Rob Salmond is blunt about what New Zealand has or has not gained as a result of the agreement. There is increased beef access to Japan, but that has to be shared with New Zealand's economic competitors and tariff removal will be glacially slow. Only a fraction of the Canadian and US dairy markets will be open to international competition, so no wonder Fonterra and other dairy companies are angry at the government over minimal progress on access. The United States has not removed tariffs against New Zealand milk powder, and New Zealand cheese access to North American markets will increase only minimally. The tobacco industry has been shut out of the TPPA's new intellectual property regime, which serves it right given its mercenary and predatory behaviour, threatening Australia with litigation over its plain packaging policies. Canada won protection for its dairy and poultry industries, and has gained better access to US beef markets. Australia got new access for wheat, beef and other horticultural products.  Is the TPPA worth it? The jury still seems to be out. Recommended: Jane Kelsey (ed) No Ordinary Deal: Unmasking the Trans-Pacific Partnership and Free Trade Agreement: Wellington: Bridget Williams Books: 2012. "Don't Weaken Pharmac for US Drug Lobby say Labour, Greens" New Zealand Herald: 26.08.2011: http://www. nzherald.co.n z/business/news/article.cfm?c_ id=3Speaker: Public Address: 06.10.2015: http://www. publicaddress.net/ speaker/tpp-eh/ "TPP Impact on HIV meds likely substantial" Gaynz.Com: 30.07.2015: http://www.gaynz. com/articles/publish /2/article_17129.php "Leaked TPPA papers back HIV meds concerns" Gaynz.Com: 11.06.2015:  http://www.gaynz.com/ articles/publish/2/article_ 16943.php David Farrar: "ANZ on the TPP" Kiwiblog: 07.10.2015: http://www. kiwiblog.co.nz/2015/10/anz_ on_the_tpp.html Pharmac: Prescription for Pharmacoeconomic Analysis: Version 2.1: 2012: https://www.pharmac. health.nz/assets/pfpa- final.pdf [Graphic: Pharmaceuticals] Craig Young - 12th October 2015    

Credit: Craig Young

First published: Monday, 12th October 2015 - 8:33am

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