Q（Question）

Although the Guidelines state that 'raising awareness of diseases (including activities targeting the general public) is also included,' may disease awareness activities conducted for the general public that do not meet the three advertisement criteria and comply with the proper advertising standards be considered outside the scope of the Guidelines?

A（MHLW answer）

There is a risk that disease awareness activities may be used as a pretext to particularly recommend drug treatment; therefore, as explicitly stated in 2(2), such activities are within the scope of the Guidelines.

So what (meaning): General-public disease awareness activities conducted by marketing authorization holders fall within the Guidelines even if they do not meet the three advertisement criteria. Compliance with proper advertising standards alone does not provide an exemption.

So why (rationale): When pharmaceutical companies conduct disease awareness activities, there is an inherent risk of indirectly promoting drug treatment; therefore, such activities are regulated regardless of formal advertisement classification.

Commentary — background, application, practical notes

Disease awareness campaigns serve a public health purpose by encouraging patients to seek care early and obtain timely diagnoses. However, when a pharmaceutical company conducts disease awareness activity in a therapeutic area where its own product is approved, it is difficult to dismiss the underlying expectation that such activity will increase prescribing opportunities for the company's product. Even when the activity formally complies with the proper advertising standards, this does not eliminate its character as an activity conducted with an expectation of promoting sales, and it therefore falls within the Guidelines.

A typical scenario is a campaign funded and led by a pharmaceutical company that encourages the general public to undergo screening for a particular chronic disease. While the surface purpose is to promote early detection and early treatment, the activity can be understood as one that expects the company's own product to be selected once a diagnosis is established.

The point most easily misunderstood is the assumption that communications targeting the general public are assessed under a different framework from information provided to healthcare professionals. The Guidelines explicitly state that they 'include activities targeting the general public,' making no distinction based on the audience. Materials should be reviewed at the design stage to confirm that content positioned as 'disease awareness' does not cross into particularly recommending drug treatment.