Raising the Barriers to Access to Medicines in the Developing World - The Relentless Push for Data Exclusivity

Developing World Bioethics
Lisa DiependaeleSigrid Sterckx

Abstract

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Cont...Continue Reading

Citations

Dec 23, 2017·Frontiers in Medicine·Hilde Stevens, Isabelle Huys
Feb 19, 2020·CA: a Cancer Journal for Clinicians·Javier CortesJoaquín Arribas
Oct 30, 2018·Applied Health Economics and Health Policy·Carlos Vílchez-RománEdward Mezones-Holguín

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