Academic journal article Health Law Journal

A Study of Laws in Latin America: Is Access to Affordable Medicine Threatened?

Academic journal article Health Law Journal

A Study of Laws in Latin America: Is Access to Affordable Medicine Threatened?

Article excerpt

1. Introduction

During the 1994 Uruguay round of the General Agreement on Tariffs and Trade (GATT), the member states negotiated the Trade Related Aspects of Intellectual Property Agreement (TRIPS). (1) TRIPS, which is administered by the World Trade Organization (WTO), guides and elaborates the minimum standards for worldwide intellectual property regulation. However, over the past several years, countries with the most extensive intellectual property right protection schemes have pursued an increasing number of bilateral free trade agreements (FTAs) in different parts of the world. The FTAs that have been (and are currently being) negotiated are accused of including provisions that go beyond the common requirements of the TRIPS Agreement, and that trespass into a domain commonly known as "TRIPS-plus", where it is thought the provisions might be unjust or too onerous for some countries. The debate is especially topical when it comes to the field of pharmaceutical technology, and whether TRIPS-plus provisions are likely to prejudice public health by making access to medicines substantially more difficult. (2)

However, few studies have attempted to catalogue and empirically analyze countries' laws to discover how intellectual property rights have evolved--and advanced--since the TRIPS Agreement was signed. The present study attempts to do exactly this, while focusing on the particular case of data exclusivity laws for pharmaceuticals to determine if in this field of technology, "TRIPS-plus" protection of intellectual property is coalescing and developing into any sort of global or regional norms.

II. Background

(i) Data Exclusivity Explained

'Data exclusivity' (or 'data protection') refers to the practice whereby for a period of time, national drug regulatory authorities cannot permit the pharmaceutical test data furnished by an originator company and relating to a drug's quality, safety, clinical efficacy, and physical and chemical characteristics to be used by a competing generic drug company for the purpose of registering a therapeutically equivalent, generic version of the drug. (3) Since no drug can be marketed without having test data supporting it, controlling access to the data is nearly tantamount to controlling access to the market, and that is why originator companies care about it so deeply. That said, nothing about data exclusivity prevents a generic drug company, rather than relying on data generated by the originator company, setting out to repeat all the tests and to generate data of its own. Therefore, data exclusivity rules are never an absolute barrier to the entry of generic medicines to a market, but only a qualified barrier, which a thoroughly determined generic company can lawfully circumvent, although likely at a high cost to itself.

Developing a new drug is very expensive. Estimates differ widely and are heatedly debated, but range from about $100 million to $2 billion, depending on the methodology used and the particular drug in question. (4) Importantly, the expense of drug development is only trending up, and dramatically so since TRIPS came into force, which calls into question whether the intellectual property provisions of TRIPS are not already obsolete. (5) A large share of the product development expense arises from research costs incurred in the laboratory, pre-clinical, and clinical phases of drug development. (6) The research data that an originator company amasses at each phase is used to assess and justify the development of the drug to the next phase, and this "dossier" (as it is called in the industry) grows more valuable as the project advances and the would-be drug moves nearer to regulatory approval. Needless to say much of the data in the dossier is proprietary and very carefully guarded, but to gain regulatory approval, ultimately the dossier has to be shared with the national drug regulatory authority. Hence the need for data exclusivity laws--to protect the dossier. …

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