한-미FTA 의약품 분야 협상의 쟁점 및 전망

Abstract

In KORUS FTA negotiations, the following issues may be raised, among others: <Drug Expenditure Rationalization Plan> -whether to encourage, and how to encourage, research and development of innovation and IPR protection of pharmaceuticals -whether to apply pharmacoeconomic evaluation to generic drugs -how to recognize the value of the innovative pharmaceuticals in the amount of reimbursement -whether to permit manufacturers to apply for an increased amount of reimbursement after a decision on a reimbursement amount is made -whether to ensure that the reimbursement amounts are inflation-adjusted -how to guarantee transparency of DERP: publish in advance any measures provide interested persons opportunities to comment complete consideration of approvals within a specified time disclose procedural rules, methodologies, principles, and criteria make available an independent review body to review determinations -whether to permit a pharmaceutical manufacturer to disseminate to health professionals and consumers through the manufacturer’s Internet site and on other linked sites information regarding its products -How to encourage ethical business practices <MRA> -Mutual Recognition Agreement on the Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) inspection of pharmaceuticals within specified period of time -Mutual Recognition of Marketing approval of generic drugs <Biogenerics> -Development of regulations related to the approval of biogenerics within specified period of time <Committee> -Whether to establish a technical committee or working group and its scope of authority <IPR Protection> -scope of guaranteeing data exclusivity -whether to permit linkage between patent and marketing approval -whether to permit use of patented product to generate information necessary to support an application for marketing approval (Bolar provision) -whether to allow adjustment of patent term to compensate unreasonable delay in marketing approval procedure -scope of compulsory licensing For a successful conclusion of negotiations, a package deal among the above core issues is necessary. Given the political sensitivity and high priority of DERP to Korea and its national interest, Korea must make certain concessions in IPR issues and Committee issues in order to accomplish its policy aims regarding DERP. Also, it must be considered that enhance protection of IPR may give certain incentives of R&D for Korean drug manufacturers who need a long-term business strategy of development. Although MRA and Biogenerics are ambitious proposals by Korea, they are susceptible to an unbalance-of-benefit claim by the United States because those proposals are focused on trade in generic (not original) drugs. In order to avoid a situation where drug issues are compelled to be traded with other unsolved controversial issues in other sectors at the last phase of negotiations, both sides must make sincere efforts to reach an early agreement through practical gives-and-takes.