Economic and Legal Frameworks for Non-Prescription Medicines 2004 studied by AESGP 4. ADVERTISING TO THE GENERAL PUBLIC All classes of OTC medicines (none of which are ever reimbursed) can be "freely" advertised in Japan as any other consumer goods because OTC medicine advertising is regarded as an important vehicle of information to the general public. On the other hand, the advertising of prescription medicines aimed to general public other than health professionals is prohibited. In other words, the advertising of prescription medicines through the mass media such as newspapers and TV is not allowed. This "freedom" for OTC medicine advertising is, of course, subject to strict compliance with the regulatory and voluntary controls described below. OTC medicine advertising control in Japan can be characterised by two aspects. Firstly, in the legal framework, all control is post-publication or post-broadcast. Secondly, it is characterised by a voluntary code well established and strictly observed by the industry and other parties involved. Legal Framework for Advertising Control The legal framework to prevent medicines from posing a risk to public health and hygiene is so controlled and regulated that the contents of medicine advertisements must not be false or exaggerated, and conform to both the regulations in PAL and the "Standards for Appropriate Advertisements of Pharmaceuticals" (SAAP). The PAL regulations concerning medicine advertising are spelled out in the following three articles:   Article 66 1. No person shall, explicitly or implicitly, advertise, describe or circulate false or exaggerated statements regarding the name, manufacturing process, indications or effects, or properties of medicines, quasi-drugs, cosmetics or medical devices. 2. It shall be construed as falling under the preceding paragraph to advertise, describe or circulate such statements as lead to the false impression that a physician or other person has certified the indications or effects, or properties of medicines, quasi-drugs, cosmetics or medical devices. 3. Statements or diagrams suggesting criminal abortion or any obscene statements or diagrams shall not be used in connection with medicines, quasi-drugs, cosmetics or medical devices.   Article 67   With regard to the advertisements of medicines specified by cabinet order which are intended for use in the cure of cancer or other designated diseases laid down by cabinet order and for which use not under the direction of physicians or dentists is likely to be extremely dangerous, appropriate measures (such as restriction of the advertising means to ordinary people other than those involved in medical and pharmaceutical affairs) for maintaining the appropriate use of such medicines may be provided by cabinet order.   Article 68   No person shall advertise the name, manufacturing process, indications or effects, or properties of either medicines or medical devices, which have not yet been approved.   SAAP   In order to facilitate compliance with the three PAL articles above, MHLW compiled a booklet entitled "Standards for Appropriate Advertisements of Pharmaceuticals" or SAAP. Since its first publication in 1964, this guidebook has been revised and updated seven times, fully reflecting the ever-changing pharmaceutical environment. The guidebook is indeed the bible for those engaged in the pharmaceutical business and keeping this book at hand, there should be no reason to make serious mistakes in medicine advertising. Implementation of Advertising Control   Voluntary Code for OTC Medicine Advertising   In line with the spirits of both PAL and SAAP, the Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ) and the Japan Self-Medication Industry (JSMI) jointly issued the "Voluntary Code for OTC Medicine Advertising." Although voluntary, the Code has been accepted by MHLW as the most appropriate advertising standard for the industry to observe; therefore, the code is regarded as the basic advertising policy of the competent authorities. It has been in operation for over 45 years as FPMAJ and JSMI voluntarily agreed upon implementation of the Code for the first time in 1955.   Advertising Review Board (ARB)   As far back as 1974, the OTC medicine industry established a self-regulatory control body called the "Advertising Review Board" (ARB). This body, being functionally placed within the Japan Self-Medication Industry, consists of four independent experts representing consumers and professionals, and several JSMI representatives in order to ensure fair and unbiased review of the medicine advertisements. ARB holds meetings every two months to thoroughly post-review all the OTC medicine advertisements carried in the five major media channels; television, radio, newspapers and magazines. At each meeting, judgements based on PAL, SAAP and the Voluntary Code for OTC Medicine Advertising are issued and reported to MHLW as well as to all JSMI members and non-members alike. Depending upon the judgements each manufacturer or each sponsor receives, he/she has to take necessary actions such as immediate suspension or modifications, or to file a report if he/she wants to contest the judgement by giving reasons together with supporting data or materials. Judgements range from "violation" to "minor modification" to mere "guidance." The "Post-Review Committee," consisting of officials from both the MHLW and the MHLW-designated prefectural governments, meets three times per year. Besides the sanctions applied by the Advertising Review Board (ARB), in extremely serious cases of clear violation of the PAL, the competent authorities may order suspension of business operation for a certain period of time. There is no mandatory text to be specifically included in advertising depending on the kind of media channel. In other words, all the media channels are subject to compliance with exactly the same regulations and requirements. However, the Voluntary Code from time to time stipulates the specific addition of "Read carefully the ÔPrecautions for use' before you take this medicine" in the cases of, among others, H2 blockers and ibuprofen preparations. There are no special rules for OTC advertising to health professionals. All the OTC medicine advertisements are subject to exactly the same regulations and requirements as specified in PAL, SAAP and Voluntary Code regardless of the targeted audience. Comparative advertising for pharmaceuticals is not allowed. The comparison with a company's own pharmaceuticals is however permissible.   "So-called Health Foods"   In the area of "so-called health foods," "Maintenance of health" may be claimed but "Promotion of health" may not be claimed. The marketing of foods claiming the maintenance or promotion of health has been increasing in recent years. Many of these claims, however, have not been scientifically or medically proven and the situation needed to be improved for the protection of the public health. With this in mind, MHLW introduced a new legal category of foods, "Specified Health Foods," under the framework of "Special Nutritional Foods" defined in the Nutrition Improvement Act. A licence system was introduced for this purpose in 1991. In the system, the definition given is "Specified Health Foods are foods for particular use which are allowed to state in the label that those who consume these foods for particular health purposes can expect to achieve specified results by taking the foods regularly". The Japan Health Food and Nutrition Food Association, headquartered in Tokyo, a juridical foundation accredited by the MHLW, has established a guideline covering Specified Health Foods.   Advertising Expenditure   Total expenditure for OTC advertising in 2004 was JPY 176.9 billion (euro 1.38 billion). The expenditure can be broken down over the media, as follows: TV - JPY 126.0 billion (71.2%); Radio - JPY10.1 billion (5.7%); Newspapers - JPY 29.5 billion (16.7%); Magazines - JPY 11.3 billion (6.4%).