By King & Wood Mallesons’ Healthcare Group
Some recent news releases show that the PRC Ministry of Health has proposed to revise (the “Proposed Revision”) the current Measures for Inspection of Medical Advertisement (promulgated on 13 March 2007 and effective as of 1 May 2007) (the “2007 Measures”).
Among all other changes in the Proposed Revision, one hot-button issue is that, except for general information and name of the medicine, any other specific information (e.g. usage) regarding all medicine, including OTC medicines, is no longer allowed in public-oriented media, and only allowed in professional media. Compared with the 2007 Measures, which allowed OTC medicine advertisement to be used in public media, but subject to inspection by the SFDA. However, the Proposed Revision might ban this practice.
A fundamental change might occur in the whole industry due to the new change’s impact on both new players and media advertisement revenue. Based on reports, medical advertisement accounts for 10% to 15% of the annual advertisement revenue of all traditional media, in particular, television advertisement. Furthermore, the Proposed Revision will establish a higher barrier for new players to enter into the OTC medicine market due to the lack of exposure to the public by way of high volume advertisement campaigns.
Most pharmaceutical enterprises, especially those OTC medicine manufacturers, are strongly against the Proposed Revision. SFDA has also said that they would take opinions and comments from the pharmaceutical industry into consideration when formulating the new draft legislation. We will keep an eye on the update of this regulation.
Under the existing applicable laws and regulations, medicine advertisement must be true, valid and in line with the approved instructions. Should any misleading statement, misstatement or inaccuracy in the advertisement exist, the approval regarding such advertisement shall be rescinded and will not be reissued for a certain period.
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