This article is based on a research paper I wrote for an international law course, you can find it here: Máté Hegedűs-Gáspár, ‘Data Exclusivity for Biological Pharmaceuticals: Is New Zealand in Breach of World Trade Organization Law?’ (2016) 50 Journal of World Trade, Issue 5, pp. 909–934

Summary of the article

The protection of intellectual property rights is riddled with conflicts of interests. The TRIPS Agreement introduced standards in order to harmonize IP law enforcement simplifying the task of finding the appropriate level of protection. In some cases IP protective measures result in severe trade restrictions, which can, nevertheless, be justified by virtue of their compliance to TRIPS. However, some trade restrictive IP rights are not covered by TRIPS. This research explores a way in which the enforcement of intellectual property rights falling outside TRIPS can be reconciled with obligations relating to the elimination of trade barriers under the GATT. The rationale is that TRIPS provides guidance as to the application of Article XX(d) GATT in relation to trade restrictive measures that enforce IP rights. This approach is applied in this paper to determine whether, in granting protection to IP in clinical test data relating to biological pharmaceuticals, New Zealand complies with its obligations under the GATT, given that TRIPS does not recognize this IP right and does not provide for its protection.

Once I explained the concept of PHARMAC to my friend, Christian, a law lecturer, who is an expert in international trade law. As he pointed it out to me, there is a palpable tension between this heavy market control and the principles of free trade. I wrote this essay, partly in response to his concern.

I reviewed the essay a few times, as you do. During the last review, I discovered that the perhaps the most important message that I wanted to communicate is that trade law tends to frown on medicine regulations, and that is fundamentally wrong. Medicines are no ordinary goods and restrictions on their trade should not be regarded as a borderline accepted exception from free trade rules, rather, it should be the norm.

Summary of the article

Trade in medicines is highly regulated in New Zealand, both directly and indirectly. Nonetheless, our healthcare system is reliant on the importation of pharmaceutical products. Medicines are not ordinary goods and their market often resists the straightforward application of traditional trade rules, particularly, the fundamental non-discrimination rules. In order for New Zealand to be able to maintain its world renowned public funding scheme, it must ensure that its medicine market regulations are acceptable within the WTO framework. International trade rules are traditionally based on economic interests, and designed to promote equal market opportunities for competitive products. In case of medicines, the market is heavily influenced by non-economic factors, which has been largely accepted as justified breach of traditional non-discrimination rules. This article aims to show that market regulations in New Zealand, dominant as they are, are consistent with the WTO framework.

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