의약품 가격남용의 유형과 규제요건에 관한 연구

A pharmaceutical product is the result of the huge investment of research and development and the innovation which overcame the high probability of failure. Therefore, basically the price of a pharmaceutical product would be lawful. Generally the price of a pharmaceutical product is regulated by health authorities, and so there are very few cases that the competition authorities should intervene in. However, regardless of the regulation by health authorities excessive pharmaceutical price may be an important matter in exceptional cases. such excessive pharmaceutical price can be regulated by excessive price abuses under the competition law. The cases where excessive pharmaceutical price may be the important matter from the perspective of the competition law can be categorized as below. First, a pharmaceutical company sets the excessively high price of the new drug (original drug) under the patent protection. Second, although the patent of the original drug expires a pharmaceutical company sets the excessively high price of such original drug considering the circumstances where any generic product does not enter into the market. Third, a pharmaceutical company discontinues to supply off patent brand drug and then it causes the patients to switch to significantly more expensive brand drug. Fourth, after the patent of the original drug expires a pharmaceutical company intentionally blocks generic entry and then it increases the price of such original drug. Because EU’s and Korea’s competition law accept the concept of excessive price abuses the excessive pharmaceutical price in the first, second, third cases can be regulated by excessive price abuses. However, the US antitrust law does not accept the concept of excessive price abuses and so such cases cannot be regulated by excessive price abuses. The excessive pharmaceutical price in the fourth case can be indirectly regulated by the exclusionary abuses under the US antitrust law and EU’s and Korea’s competition law. The special screens is necessary for the regulation of the excessive price of a pharmaceutical product as excessive pharmaceutical price abuses. On the a pharmaceutical product under the patent protection publicness of a pharmaceutical product and a pandemic like COVID-19 should be considered as the special screens. If the government invests money and human resources significantly for the research and development of such pharmaceutical product the publicness as a screen could be accepted. Also, a pandemic is very rare circumstance and so the patent would not be easily downplayed although a pandemic is considered as the screen. On the off patent pharmaceutical product the level of negotiation power of health authorities and the large gap between the cost excluding the research and development cost and the price of a pharmaceutical product should be considered as the special screens. Meanwhile, although the commitment between the competition authorities and a pharmaceutical company is made in excessive pharmaceutical price abuses case the effort for the determination of the excessiveness of the price would be meaningful because such effort could provide the predictability for the reasonable level of the price of a pharmaceutical product to a pharmaceutical company.