EU의 제약산업에 대한 경쟁법 집행 및 경쟁정책과 그 시사점

Review of EU Competition Law Enforcement, Competition Policy on the Pharmaceutical Industry and Implications

Europe, together with United States, has led the growth of the pharmaceutical industry around the world. However, some criticized that principle of competition did not work well due to the structural and regulatory characteristics of the pharmaceutical industry. In 2009, the EU Commission conducted sector inquiry on the pharmaceutical industry and reviewed various legal issues in the perspective of the EU competition rules. After the sector inquiry, EU competition authorities have actively enforced their competition rules on the pharmaceutical industry and have actively prepared and implemented competition policies for the industry. Finally, at the request of the EU Parliament and the EU Council, the EU Commission recently submitted a report which includes representative cases and relevant statistics of EU competition authorities on the pharmaceutical industry. Because the industry size is very large and lots of dominant companies have been existed, violations of competition rules have been occurred in various forms and ways. In the perspective of comparative law and comparative administration, it is highly valuable to research about how the EU competition rules, which has played a major role in the global competition law with the United States, has addressed the behaviors. However, since the KFTC published the competition policy report on pharmaceutical industry in 2009, there have been few studies in Korea which reviewed competition law enforcement of EU competition authorities on the pharmaceutical industry. Therefore, this article reviews the recent report of the EU Commission and tries to find implications on the enforcement of MRFTA and relevant competition policy. First, regarding the antitrust enforcement, it seems that the KFTC have mainly focused on rebate issue in the pharmaceutical industry. It is time for the KFTC to review other type of violations which the EU competition authorities have regulated, such as misuse of patent system and other regulatory frameworks for preventing generic companies from entering the market, disparagement the quality or safety of generic drugs for preventing generic companies from entering the market, and the excessive pricing by the original companies. Also, regarding the merger regulation, it is necessary for the KFTC to carefully review the concerns about innovation competition in merger cases involving the industry and find the best remedies through sufficient consultation with the merging entities. For this, experiences of the EU competition authorities on the innovation competition in merger cases of pharmaceutical companies would be great helpful. Additionally, regarding the competition policy, market monitoring about the pharmaceutical industry should be carried out more regularly by the KFTC with reference to the experience of EU competition authorities. Finally, it is necessary for the KFTC to check loopholes in other regulations related to the pharmaceutical industry from the perspective of competition law through competition advocacy activities.