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On March 11 2011, Medwatcher Japan submitted a “statement concerning direct-to-consumer (DTC) advertising of prescription drugs” to the Prime Minister, the Minister of Health, Labor and Welfare (MHLW), the Minister of State for Government Revitalization, Consumer Affairs and Food Safety, and the Chairman of the Consumer Commission.

The MHLW administrative guidance prohibits companies from advertising “prescription drugs” directly to consumers in Japan. Advertising prescription drugs directly to consumers is called DTC (direct-to-consumer) advertising.

The “Disease awareness ad” is a type of DTC advertising, which is used by companies to make consumers aware of a certain symptom as a disease, encourage them to consult a doctor, and turn their attention toward a useful drug in order to cure that disease.

However, disease awareness ads are exempt from regulations by the current administrative guidance in Japan. This is because the MHLW narrowly defines advertising as information which indicates a specific drug name, but the disease awareness ad does not include any specific drug names. Therefore, it has been a popular form of virtual DTC ad among many pharmaceutical companies in Japan since 2000.

Pharmaceutical companies tend to pursue profit through DTC advertising, and consumers are exposed to a high risk of being given biased information. Such advertising may also impede the proper use of drugs and consumers may request that a doctor prescribe a specific drug after seeing a disease awareness ad. For these reasons, DTC advertising of prescription drugs is allowed only in the US and New Zealand.

However, despite world trends, the Government Revitalization Unit of Japan is currently trying to abolish restrictions concerning the advertising of prescription drugs in accordance with the Standard for Adequate Advertisement of Pharmaceutical Products, as part of its regulation and system reform.

Medwatcher Japan opposes the easing of regulations. We also suggest that the definition of advertisement be amended, DTC advertising be regulated not only by administrative guidance as it is today but also by the law (the Pharmaceutical Affairs Act) , and that the government establish a framework to fairly provide drug information to consumers through a public institution, instead of doing so through business advertising.

＜Outlines of the submitted statement＞

1. Medwatcher Japan opposes the easing of regulations concerning the advertising of prescription drugs proposed　by the Government Revitalization Unit.

2. The Pharmaceutical Affairs Act should be amended in order to regulate DTC advertising of prescription drugs.

3. A public institution of healthcare professionals and patients should be established to fairly provide drug　nformation to consumers.

4. A research group should be established so that the ｃurrent status of DTC advertising in Japan is clearly understood.

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