Burcu Killic: Standing up to drugs industry the best medicine

New Zealand could see its drug patent and data laws altered dramatically. Photo / APN

Opinion

How the Trans Pacific Partnership (TPP) will treat access to affordable medicines is the most controversial issue confronting trade ministers from the 12 countries when they meet in Singapore tomorrow. The US proposals on patents and medical test data have been roundly criticised for limiting the availability of cheaper generic versions of medicines and thereby restricting access to medicines.

The United States Trade Representative (USTR) recently announced a new two-tier proposal on patents and medicines, which it says balances the interests of the pharmaceutical companies and incentives for them to innovate, and access to medicines. Countries would not have to apply the full set of tougher patent and data rules on medicines and medical devices until their per capita GNI was higher than US$12,500 ($15,200). Only Vietnam is likely to have many years before it must make that transition.

The World Bank classifies New Zealand as a high-income country. This means it will not benefit from any transition period and will be subject to same treatment as the other high-income TPP countries. But Chile, Australia, Singapore and Canada already have free trade agreements with the US, so the changes in New Zealand would be the most far-reaching of any of the TPP countries.

New Zealand's current patent regime complies with the requirements of the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips), which sets the standards for intellectual property protection in the world today and binds all members of the WTO. However, Trips includes flexibilities for countries to implement the rules in a way that supports their rights to protect public health and access to medicines. It is far from perfect, but provides some policy space for the members to address public health challenges.

Standard US free trade agreements require "Trips-plus" patent provisions and limit what governments can do to protect public health. The US aims to go further in the TPPA. US proposals would take away some Trips flexibilities, introduce Trips-plus provisions, and transform New Zealand's laws on patents and clinical trial test data. They would not only limit generic competition and raise pharmaceutical prices for Pharmac, but also hinder pharmaceutical production and innovation in New Zealand. These provisions would have a number of serious impacts.

First, they would expand the scope of protection for patents, and require granting of patents on new uses and minor variation of older, known medicines even in the absence of improved therapeutic value. This 'evergreening' of patents would extend the term for which a company can earn monopoly profits and keep the drug prices artificially high.

They would also introduce patent protection for surgical techniques and other methods of treating patients. This could create a greater cost burden on the New Zealand health system, as hospitals and medical professionals could be required to pay royalties if they use patented methods for treating, diagnosing, or operating on patients.

Third, the term for some patents would be extended beyond the Trips standard of 20 years. Pharmaceutical companies could request patent term extensions if the time IPONZ or Medsafe took to examine applications exceeds a certain period of time. A recent review of pharmaceutical drug patents in Australia found that patent term extensions, introduced as a result of the Australia US FTA, had been exceedingly expensive.

The provisions also risk facilitating patent abuse. Medsafe would be required to make approvals to market medicines conditional on their patent status (patent linkage). Under this system, even spurious patents would function as barriers to the registration of generic medicines.

Finally, commercial control over regulatory information and medical test data would intensify. Medsafe would be unable to use test data and other information necessary for registration of generic medicines for at least five years in the case of new pharmaceutical products, and for at least three years in cases of new uses of old medicines - even when that information is already in public domain. Applicants wanting approval to market generic medicines would have to wait until the exclusivity period expired or duplicate tests on humans or vertebrate animals to demonstrate safety and efficacy. In the case of cancer drugs (biologics), these periods would extend to 12 years, which means New Zealanders would have to wait 12 more years for generic affordable cancer medicines.

It is obvious New Zealand will not benefit from this proposal and will be the TPP country that sees its patent and data laws most dramatically transformed.

New Zealand is one of many countries in the TPP negotiations that have supported a superior vision for intellectual property - one rooted in economics, but which accounts for the importance of public health, competition and safeguards against abuse. The US vision, by comparison, is driven by pharmaceutical industry lobbyists.

The US has been isolated in the negotiation, while New Zealand is in good company, sharing many positions with Canada, Australia, Malaysia, Chile and Singapore. New Zealand should not trade away its better rules for the monopolistic rules dictated by the pharmaceutical industry.

• Dr Burcu Kilic is the legal counsel at Public Citizen Global Access to Medicine Programme, Washington DC