By King & Wood Mallesons’s Healthcare Group

Although the existing laws and regulations already establish certain rules and general principles for product promotional activities by pharmaceutical enterprises, the RDPAC Code of Practice 2012 (“RDPAC Code”) has further refined and defined the relevant requirements and standards for medical promotion and seeks to establish a bright line industrial practice.

The RDPAC Code only applies to RDPAC members. However, according to the comment made by RDPAC, the RDPAC Code will also regulate the behavior between its members and their subcontractor (such as consultants, contracted sales representatives or PR agents). RDPAC requires its members’ counterparties to be in compliance with RDPAC when acting on its behalf. Therefore, non-RDPAC entities are also required to pay attention to the RDPAC Code when dealing with RDPAC members.

The definition of promotion is expanded explicitly, which includes promotion via internet. According to the RDPAC Code, any communications with healthcare professionals shall be in a proper manner (i.e. proper purpose, proper place and proper costs.) RDPAC members are required to establish internal compliance rules to ensure that promotional materials are in the proper manner. Furthermore, RDPAC also sets out specific requirements regarding the accuracy of information and the standard of printing for the promotion process.

Compared with the 2010 version, the 2012 version has narrowed the scope of membership, but expanded the coverage of its rules. On the other hand, RDPAC will no longer apply its rules to medical equipment promotion but will apply to clinical trials. Furthermore, certain prerequisites for medical promotion have been set in the 2012 version.

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