Data Exclusivity for Biological Pharmaceuticals: Is New Zealand in Breach of WTO Law?

Mate Hegedus-Gaspar International Trade

dataprotect

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.

Drug Abuse Prevention vs Health Information Privacy – Part II – A Practical Analysis

Mate Hegedus-Gaspar Pharmacy Practice

control-427512_1280You may have taken law and ethics courses in the past and probably heard lots about our obligations under the Health Information Privacy Code 1994 (HIPC). If you are like me, you will have wondered just how we are meant to even remember, let alone apply all these rules in our day-to-day practice. In the second part of the series I’m going give you a practical, straight-forward overview with respect to collecting, using and disclosing information about sales of codeine containing pharmacist-only products. As I have mentioned it in Part I of the series, many of us are worried about selling codeine-containing products and all the issues around their misuse. The case of codeine containing products is a great example of the difficulty we often see when having to apply the same set of rules to a diverse class of medicines. It also highlights a more general problem that medicines are not amenable to being put into classes, because they are so diverse, they almost need product-specific rules in our practice.

Read Part I here

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Drug Abuse Prevention vs Health Information Privacy – Part I – The Codeine Problem

Mate Hegedus-Gaspar Pharmacy Practice

This is the first in a series of articles focusing on the tension between drug abuse prevention and health information privacy. In our day-to-day practice we encounter this problem way too often and we are expected to get the balance right between protecting the patient (and the public) and respecting their rights under the Health Information Privacy Code. The series offers insight and guidance for pharmacists to better understand the legal issues, what’s expected of them and enabling them to make better calls in curly situations.

Codeine addiction

A number of codeine containing products are available in New Zealand as pharmacist-only medicines. As with all pharmacist-only products, the pharmacist is required to record information related to the sale under Regulation 54A of the Medicines Regulations. There is a range of reasons why these records must be kept. From the patient’s perspective perhaps the most significant reason is to have a complete medicine history for future reference. From the pharmacist’s perspective the record ensures accountability as well. In case of OTC codeine, however, the records are often used to track usage with a view to identify and prevent misuse. This sets OTC codeine products apart from other pharmacist only medicines as far as health information privacy is concerned.

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Pharmacists, here are three reasons why you should learn more about the Pharmacy Action Plan

Mate Hegedus-Gaspar Pharmacy Action Plan

Opportunity

You have probably heard about the recently published Pharmacy Action Plan 2016-2020, by now. If you are as busy as I am, this announcement will have ended up in the “may look at it later, or not at all” basket. You may also think that, like many other top-down initiatives, this too is just another gig that’s just going to happen to us regardless. So, why should we care, right? Aren’t we busy enough as it is? Well, let me give you three compelling reasons why you should learn more about the Plan and get involved one way or another.

Although, one could come up with a whole bunch of reasons, I picked the ones I think will give you an incentive to think about the Plan and get involved. And, since I like to look at all things pharmacy with my law-glasses on, I’ll give you some insight on the legal aspects of the issues as well.

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Trade in Medicines: Resolving the Tension Between Market Regulation and Non-Discrimination Rules

Mate Hegedus-Gaspar International Trade

intltradeOnce 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.

Download full article here (pdf)