VII COMMISSIONING AND PROCUREMENT
Commissioning is a process where the delivery of certain public services to be provided by the public sector is commissioned to the private sector, whereas procurement is a process where the public sector procures from the private sector goods and services it needs to deliver public services. In Japan, medical services are provided by private entities, which are not subject to commissioning and procurement procedures applicable to governmental entities.
VIII MARKETING AND PROMOTION OF SERVICES
Restrictions on advertisement of medical services
Before the 8th Revision, there were two different sets of restrictions on the advertisement of medical services: (1) one for advertising media such as advertising inserts, TV commercials and signboards under the Guidelines for Advertisements on Medical Services, and (2) another for advertisements on websites under the Guidelines for Home Pages of Medical Institutions.
Before the 8th Revision, generally, no-one may advertise any matter with respect to medical services other than certain limited information (such as the name of a physician or dentist, his or her clinical department name, and medical services to be rendered). False advertising was subject to penalties (so called 'direct penalties'), while comparative advertising, exaggerated advertising, objective-truth-not-proven advertising and advertising with contents in violation of public orders and morality (collectively, 'exaggerated advertising') were subject to orders for suspension or correction from the relevant prefectural governor but only subject to penalties in violation of such orders (so called 'indirect penalties'). In any event, if there was a threat of false or exaggerated advertising, the prefectural governor was entitled to request the submission of a report and to have its officials enter and inspect the sites. Advertising on the websites of medical institutions was not treated as 'advertisement', which was prohibited under the Medical Care Act, and therefore no penalties were imposed on the violation of the Guidelines for Home Pages of Medical Institutions.
However, because numerous consumer problems related to aesthetic medical services arose from advertising on the medical providers' websites, the 8th Revision defined advertising under both items (1) and (2) above as statutory 'advertisement' subject to direct penalties for false advertising, indirect penalties for exaggerated advertising (to which definition the 8th Revision added advertising by use of patients' experiences on a subjective or hearsay basis and advertising by use of misleading pictures before and after medical treatments), and site inspection by the relevant prefectural governor. The 8th Revision also clarified the limited cases that are not subject to the aforementioned limitations on advertisement, taking into account medical treatments that are not covered by the NHIS or other information that patients need to know. The Guidelines for Home Pages of Medical Institutions were integrated into the Guidelines for Advertisements on Medical Services on 1 June 2018.
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Healthcare providers and their commissioned advertising agencies and affiliate marketers may also be subject to other advertisement regulations under other laws of more general application, such as the Act against Unjustifiable Premiums and Misleading Representations, the Pharmaceuticals and Medical Devices Act,9the Health Promotion Act, and the Act on Unfair Competition Prevention.
Restrictions on marketing and promotion activities toward healthcare providers and professionals
Medical institutions and universities (including healthcare professionals) not only buy from pharmaceutical and medical device companies, but also collaborate with these companies for medical and pharmaceutical research, safety measures, and reliefs from adverse drug reactions, and arrangements are often accompanied by monetary payments in return for their contribution.
The MHLW and the Pharmaceuticals and Medical Devices Agency10 are the principal regulatory authorities under the Pharmaceuticals and Medical Devices Act. In addition, the Fair Trade Commission and the Consumer Affairs Agency oversee those relations through the relevant self-regulatory organisations11pursuant to the Fair Competition Code Concerning Restrictions on Premium Offers in the Ethical Pharmaceutical Drugs Marketing Industry and the Fair Competition Code Concerning Restriction on Premium Offers in the Medical Devices Industry, both of which are based on the Act Against Unjustifiable Premiums and Misleading Presentation.12
At an industry self-regulation level, pharmaceutical and medical device companies have made efforts to make such relations more transparent through their industry associations and industry regulations based on high ethical standards. These industry regulations include corporate activity charters, compliance programme guidelines, codes of practice, promotion codes and transparency guidelines. It should be noted, however, that these industry regulations are not legally binding and violations thereof are not penalised.
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Some groups within the MHLW are pushing to partially elevate such industry self-regulations into official MHLW notifications that are subject to 'indirect penalties' if violated.13
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