On December 23, 2015, the Korean Constitutional Court, the final arbiter of constitutional disputes in Korea, issued a pair of companion decisions that clarify the bounds of medical advertisement regulation in Korea. In one of the two decisions, the Constitutional Court struck down as unconstitutional the statutory provisions requiring prior review and clearance for all medical advertisements and providing for criminal sanction in case of non-compliance. In the other decision, however, the Court upheld the constitutionality of the statutory provision under which criminal sanction may be imposed for false medical advertising. In both decisions, the statute at issue was the Medical Services Act.
Interestingly, the invalidated provisions of the Medical Services Act subjected medical advertisements to prior review and clearance by a civilian organization delegated with that authority by a government agency. Nevertheless, the Constitutional Court held that where, as in the instant case, the civilian organization at issue is not deemed independent of government (i.e., the executive branch) control, requiring prior review and clearance by that organization amounts to unconstitutional censorship. Whether the organization is independent of government control, the Court found, depends on a totality-of-the-circumstances test, namely whether the delegating government agency may (i) freely revoke the delegation of authority and exercise that authority on its own; (ii) supervise the civilian organization in exercising the delegated authority; (iii) influence the composition of the civilian organization; (iv) establish or amend guidelines and other internal regulations governing the standards and procedure for prior review and clearance; (v) provide financial support to the civilian organization; and (vi) require reports on the results of review and clearance evaluations.
The above holding is particularly noteworthy because in a 2010 decision, the Constitutional Court upheld the constitutionality of subjecting advertisements for the so-called "health foods" to prior review and clearance. In that decision, the Court held that the advertisements are purely commercial in nature and therefore are not protected by the general constitutional doctrine prohibiting prior censorship. There, the statute at issue was the Health Foods Act. Nevertheless, insofar as commercial speech is concerned, the 2010 decision appears to have been overruled in effect by the 2015 decision which struck down portions of the Medical Services Act although the latter decision does not address the issue whether a medical advertisement is purely commercial in nature. In fact, the 2015 decision could have far-ranging implications as it could be interpreted as striking down provisions of the Health Foods Act, the Pharmaceutical Affairs Act, and the Medical Devices Act, all of which currently provide for some degree of prior review and clearance for advertisements, including those for drugs and medical devices.
However, any expectation that the Korean pharmaceutical/medical industry will not need any prior examination of advertisements should be tempered by the holding in the second of the two companion decisions issued by the Constitutional Court. That decision upheld the constitutionality of the Medical Services Act provisions under which criminal sanctions may be imposed on a medical institution or professional for false medical advertising. Thus, medical institutions and professionals are advised to "self-censor" their advertisements to comply with the prohibition on false advertising.
Originally published in Healthcare News Alert 2016.01
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