Contributed By Jones Day
If providing information on unauthorised medicines or unauthorised indications is considered advertising under the PMD Act, such provision of information is prohibited. Article 68 of the PMD Act expressly prohibits advertising unauthorised medicines or unauthorised indications. The JPMA Promotion Code provides that member companies must provide information such as indications, dosage and administration, which should not deviate from the approved items for the drugs.
However, if providing information on unauthorised medicines or unauthorised indications falls outside the definition of advertising under the PMD Act, such provision of information may be allowed. In this regard, the Commentary of the JPMA Promotion Code lists several cases in which the provision of information is permitted, where the information provision is for the purpose of medical/pharmaceutical experts’, as well as the general public’s, right to know about scientific/medical advancements. These cases include:
Moreover, the Commentary notes that, even if the activity consists of providing information as permitted above, the company must take special care not to be involved in inappropriate promotional activities for its own commercial purposes.
Once they take effect, the new Detailing Guidelines will require pharmaceutical companies to comply with the following conditions for providing information on unauthorised medicines and unauthorised indications:
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