A Study on Constructing the Cross-Strait Legal System in Protection of Pharmaceutical Test Data under TRIPS Agreement
Date Issued
2010
Date
2010
Author(s)
Hung, Wei-Chen
Abstract
This paper illustrates important issues involed in implementing Pharmaceutical test data protection in Taiwan and China. The protection of pharmaceutical test has been a controversy between the brand-name drug companies and the generic pharmaceutical companies. Under Article 39.3 of the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPs Agreement) annexed to the World Trade Organization (WTO) Agreement, WTO members are obliged to protect undisclosed pharmaceutical test data against unfair commercial use.
On one hand, the protection provides incentive for innovation and rewards the innovator for its investment in generating the required regulatory test data as proof of the safety and effectiveness of a new drug. By imposing non-reliance and non-disclosure obligations on governments, innovation and investment are encouraged.
On the other hand, when it comes to pharmaceutical products, for many illnesses there is only one known active component available, and thus it is in the interest of society that more than one competing product using that same component will be developed. Therefore, the public interest in access to affordable medicines should be taken into account.
The issue arises from three aspects that require balancing: fulling the international obligations, providing incentives for innovation, and ensuring full public access to affordable medicines. To obtain an understanding of Article 39.3 of TRIPs, Chapter II contains an introduction to the WTO’s regime for protection of undisclosed information and the negotiation history thereof. Chpater III goes on to highlight the implementation of Article 39.3 of TRIPs in Taiwan and China, pointing out the defect of Pharmaceutical Affairs Act, the controversial scope of pharmaceutical test data protection in relation to cases under the Copyrights Act. Furthermore, the experimental Use Exception on Patent Law and Pharmaceutical Affairs Act will be dicussed.
After the patent term of a certain drug has expired, the more quickly the generic drug is approved in the market, the sooner the price of this drug drops. However, it is important to note that in the context of Article 39.3 of TRIPs, the TRIPs flexibilities accorded to Members under the unfair competition approach are being rapidly narrowed down through bilateral and regional agreements. Chaper V examines how Taiwan and China responsed in their FTAs.
When this approach intersects with domestic law and domestic market, the issue is whether Article 39.3 of TRIPs Agreement makes access to medicine more costly. In the following, Chpater VI will introduce Free Trade Agreement as a tool for Taiwan and China to deal with the issue.To balance the needs including fulfilling international obligation, providing incentives for innovation and ensuring full public access to affordable medicines, this paper will propose a possible solution concerning pharmaceutical test data protection at the end.
Subjects
TRIPs Agreement
data exclusivity
cross-strait framework
pharmaceutical test data protection
Type
thesis
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