Non-Violation Nullification of Benefits:A Looming Crisis for the PBS
29 September, 2004, Canberra Times, By Thomas Faunce & Buddhima Lokuge.
Hidden at the back of the 1000 page Australia-US Free Trade Agreement ("AUSFTA"), is a strange Article, numbered 21.2(c). Usually, in a legal document such as a treaty, dispute proceedings only arise if a party has breached a formal obligation in the text.
This unusual provision changes all that. It is called a "non-violation nullification or impairment of benefits" ("NVNB") clause. It is one of the most contentious and despised provisions in international trade law, symbolizing for many the extent to which the World Trade Organisation ("WTO") disputes process has been captured by corporate multinationals.
The Australian Department of Foreign Affairs and Trade ("DFAT") plain english guide to this NVNB article explains that it permits dispute procedures where the actions of a party, "while complying with the strict letter of the Agreement", go against its "spirit" and the legitimate expectations of the other government.
What this guide to the NVNB article fails to mention, however, is that those chapters of the AUSFTA most fraught with danger for the PBS are specifically included within its scope. Directly mentioned, for example, are Chapter Two (which includes Annex 2C on Pharmaceuticals and a side letter on the PBS) and Chapter Seventeen (which includes the "evergreening" drugs patent clause that spurred recent Australian legislative amendments).
A handful of dispute panel cases exist concerning a similar NVNB provision under the General Agreement on Tariffs and Trade (GATT). These emphasise that NVNB is really a supercharged mechanism of commercially-focused treaty interpretation. The so-called Japan Film Case in 1998, for example, established that for one Party to succeed in an NVNB claim, it had to prove to the relevant dispute resolution panel, that it couldn't have reasonably anticipated the domestic legislation that nullified its "legitimate expectations."
Developing nations, in particular, have resisted the introduction of NVNB articles into the convention on Trade Related Intellectual Property Rights ("TRIPS"). They see such causes of action as make a treaty support chiefly the commercial expectations of dominant US and European corporations, not the rule of law, or principles of social justice. At developing nation behest, a moratorium has been placed on NVNB actions under TRIPS.
The Deputy US Trade Representative has repeatedly identified AUSFTA commitments as a means to pursue the legislated US agenda of "eliminating" the PBS mechanism of establishing the price for a medicine by reference to its overall community value when measured against the cost and efficacy of existing competitors. To this end, the new AUSFTA interpretive principles on pharmaceuticals suggest that the relevant "spirit" of that treaty chiefly emphasises reward of pharmaceutcal "innovation" and "research and development" concepts that conflict with the basic principle of our National Medicines Policy, universal access to affordable, essential medicines.
Dispute resolution proceedings will inevitably arise over the AUSFTA, particularly in relation to those 50 or so references to pharmaceuticals in its text. They might concern the concept of "innovation" in pharmaceuticals. They may well arise under the NVNB Article, over the issue of whether the recent amendments directed against brand name drug patent evergreening, breach the "legitimate expectations" of the US under the AUSFTA. The US has already stated that such amendments may breach article 27.1 of TRIPS that prohibits "discrimination" as to the field of technology (ie: pharmaceuticals).
The latter argument can, with careful advocacy, be quite properly disposed of. The World Trade Organisation ("WTO") Canada-Generic Pharmaceuticals Case established that article 27.1 of TRIPS does not prevent a country from dealing in good faith with problems (such as "evergreening" of brand name medicine patents) that only exist in certain product areas.
In relation to the first argument, however, it should be remembered that the current PBS amendments only cover an important, but very narrow area of problems for the PBS under the AUSFTA. If, prior to ratification of this treaty, Australia also puts on record a unilateral declaration of its already stated interpretations of the many other contentious articles related to the PBS, it will have, without in any way interfering with the legal force of the treaty, have clarified in the national interest what should be the enforceable "legitimate expectations" of the US concerning the PBS. This may have a significant bearing on its capacity to withstand dispute settlement pressure under the AUSFTA and ensure the continuance of low pharmaceutical prices in this country.
Dr Thomas Faunce is a Senior Lecturer Medical School and Lecturer Law Faculty, ANU. Dr Buddhima Lokuge is a Visiting Fellow, Medical School and Regulatory Institutions Network, ANU