6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
It is possible. The restrictions on advertisements of medicinal products under the Pharmaceutical Affairs Act and the Standards for Fair Advertising Practices, which stipulate that a pharmaceutical company must not make a false or exaggerated advertisement in relation to their name, method of manufacturing or indications or effects, also apply to advertisements of non-prescription medicines to the general public. In addition, with respect to the advertisements of non-prescription medicines, the Japan Self-Medication Industry provides the Guidelines for Fair Advertising Practices of OTC drugs as its voluntary standards.
6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?
It is not possible, since the Standards for Fair Advertising Practices clearly prohibit advertisements of prescription-only medicines to the general public.
6.3 If it is not possible to advertise prescription-only medicines to the general public, are disease awareness campaigns permitted encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?
If disease awareness campaigns are recognised as advertisements of prescription-only medicines in view of the particular medical condition targeted by the campaign, the purpose of the campaign, and the extent of involvement of the pharmaceutical company and other circumstances, such disease awareness campaigns could be prohibited as advertisements of the specific prescription-only medicine. We recommend consulting with the relevant regulatory authority in advance if there is doubt as to whether or not the campaign is permissible.
6.4 Is it possible to issue press releases concerning prescription-only medicines to non-scientific journals? If so, what conditions apply?
It is not possible, since the Standards for Fair Advertising Practices prohibit the distribution of product information concerning prescription-only medicines to the general public for advertisement purposes. However, it may be possible for a company to issue press releases in order to announce its business development.
6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?
In accordance with the definition of advertisement in question 1.2, if the description of products and research initiatives is seen as promotion of the particular products and is interpreted as “advertising”, the rules described above will also be applied. In addition, of course, pharmaceutical companies are required to make such materials correct, fair and objective, and to base them on scientific evidence.
6.6 What, if any, rules apply to meetings with, and the funding of, patient organisations?
Although there is no specific requirement in law, the JPMA has established a self-regulatory code for member companies to make information publicly available about donations, grants, benefits in kind or any other support provided by them to patient organisations. These guidelines recommend that member companies make information publicly available about their financial contributions to patient support organisations for the previous fiscal year through their website. The disclosed information includes contributions to patient organisations’ meeting costs, grants for supporting patient organisations, payments for writing articles and payments for information that member companies have provided to patient organisations.