전문의약품 대중광고 규제완화 논의에 대한 소고 - 미국, 캐나다 및 유럽연합의 사례를 중심으로 -

The current enforcement decree of the Pharmaceutical Affairs Act completely prohibits ethical drugs advertising through mass media except for very exceptional cases and in case of violation, imposes criminal punishment as well as administrative sanction on a breaching pharmaceutical company. However, there are questions of legitimacy of such blanket prohibition and necessities for loosening tight regulations raised not only by pharmaceutical associations and media outlets, but also by several governmental entities including the Ministry of Strategy and Finance. From a comparative legal study perspective, the United States has admitted direct-to-consumer advertising of prescription drugs without limitation and Canada has adopted conditional admission system based on the contents of such advertising. However, the European Union has generally prohibited direct-to-consumer advertising of prescription drugs. To put together lessons of such comparative legal study, in the United States, any regulation on commercial advertising has been discussed in connection with freedom of speech under the 1st Amendment of the Constitution and the balancing test of relevant interests has been conducted mainly based on empirical studies such as statistical survey materials. It is also notable that Canada and the European Union has adopted a gradual and middle-way approaches such as admitting limited scope of direct-to-consumer advertising of prescription drugs which seems to impose relatively small negative impact on consumers even in case of potential adverse effects, misuse and overuse. And all 3 nations have recognized the assurance of consumers' rights to know through freedom of speech as the most significant ground for admitting direct-to-consumer advertising of prescription drugs. The above-mentioned points seem to be important factors which should be considered in discussing deregulation of direct-to-consumer advertising of prescription drugs in Korea.