Practical cross-border insights into pharmaceutical advertising

Pharmaceutical Advertising2022
19th Edition
Contributing Editors:

Ian Dodds-Smith & Adela Williams
Arnold & Porter

Table of Contents

Expert Analysis Chapters
1

Advertising of Medical Devices and In Vitro Diagnostic Medical Devices in Europe Following the New EU Legislation
Adela Williams & Jackie Mulryne, Arnold & Porter

6

Global Trends in Regulatory Compliance Challenges in Advertising and Promotion
Dr. Lincoln Tsang, Katherine Wang, Kellie Combs & Daisy Bray, Ropes & Gray LLP

Q&A Chapters
12
25

39

53

63
75

85

106
122

135

152

Australia
Clayton Utz: Colin Loveday & Greg Williams
Austria
Herbst Kinsky Rechtsanwälte GmbH:Dr. Sonja Hebenstreit
BelgiumQuinz: Olivier Van Obberghen, Pieter Wyckmans,
Nele Jonckers & Michiel D’herde
BrazilVeirano Advogados: Renata Fialho de Oliveira,Priscila Sansone, Lívia Gândara & Roberta Medina
CanadaMarks & Clerk: Justin Smith
CyprusHarris Kyriakides: Eleni Neoptolemou,
Munevver Kasif & Maria Constanti
Denmark
Jusmedico Advokatanpartsselskab:
Jan Bjerrum Bach & Lone Hertz

165
180

194

205

215
227

237

Ireland
Arthur Cox LLP: Colin Kavanagh & Bridget Clinton
Italy
Astolfi e Associati Studio Legale: Sonia Selletti &Annalisa Scalia
Japan
Iwata Godo: Shinya Tago, Landry Guesdon &Minako Ikeda
Korea
Lee & Ko: Hyeong Gun Lee, Eileen Jaiyoung Shin &Hyun Ah Song
MexicoOLIVARES: Alejandro Luna F. & Armando Arenas
PolandWardynski & Partners: Natalia Falęcka-Tyszka &Małgorzata Sokołowska
PortugalMorais Leitão, Galvão Teles, Soares da Silva &Associados: Fernanda Matoso & Alessandro Azevedo
SwedenMannheimer Swartling Advokatbyrå:Camilla Appelgren & Emmie Montgomery

England & Wales
Arnold & Porter: Adela Williams & Jackie Mulryne

248

FinlandRoschier, Attorneys Ltd.: Mikael Segercrantz &Johanna Lilja

260

Switzerland
Wenger Vieli Ltd.: Frank Scherrer & Ines Holderegger

272

TurkeySezekkaplan Lawyers: Ufuk Sezekkaplan

Germany
Clifford Chance: Dr. Peter Dieners &Ann-Cathrin Bergstedt
GreeceKyriakides Georgopoulos Law Firm: Irene Kyriakides,
Dr. Victoria Mertikopoulou, Maria-Oraiozili Koutsoupia& Aithra-Valentina Antoniadou

282

USA
Arnold & Porter: Daniel A. Kracov, Mahnu V. Davar &Abeba Habtemariam

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Chapter 16

Japan

Japan
Shinya Tago

Landry Guesdon

Iwata Godo

12

General – Medicinal Products

1.1 What laws and codes of practice govern theadvertising of medicinal products in your jurisdiction?

The Act on Securing Quality, Efficacy and Safety of
Pharmaceuticals, Medical Devices, Regenerative and Cellular
Therapy Products, Gene Therapy Products and Cosmetics(Act No. 145 of 10 August 1960) (“PMD Act”) and other relevant laws and ordinances, including the Order for Enforcementof the PMD Act (“PMD Act Enforcement Order”), regulate drug marketing activities. The PMD Act, supplemented
by administrative notices and guidelines issued by the Ministryof Health Labour and Welfare (“MHLW”), sets basic standards for drug advertising. The guidelines include the Standards
for Fair Advertising Practices concerning Pharmaceuticals, etc.
(PSEHB Notification No. 0929-4 of 29 September 2017) (“FairAdvertising Standards”) and the Commentary on the Guidelines(PSEHBCND Notification No. 0929-5 of 29 September 2017).
These Standards prohibit the advertising of prescription drugs to
the public. They include specific restrictions on advertisements
and limit the use of premiums, prizes and rewards. The Guidelines
regarding the Provision of Marketing Information on Prescription
Drugs (PSEHB Notification No. 0925-1 of 25 September 2018)(“Guidelines on Marketing Information”) cover the provision of
information for sales promotion and apply to marketing authorisation holders and their contractors, partners and wholesalers.
General laws include:■
The Act on the Prohibition of Private Monopolisation and
the Maintenance of Fair Trade (Act No. 54 of 14 April 1947).
■
The Unfair Competition Prevention Act (Act No. 47 of 19
May 1993) (“UCPA”).
■
The Act against Unjustifiable Premiums and Misleading
Representations (Act No. 134 of 15 May 1962) (“AUPMR”).
■
The Criminal Code (Act No. 35 of 24 April 1907).
■
The National Public Service Ethics Act (Act No. 129 of 13
August 1999).
The AUPMR regulates premiums and representations relating
to transactions of goods and services to ensure fair competitionand protect consumers. It prohibits unjustifiable premiums andmisleading representations, including through advertisements.
In addition, various industry self-regulations apply to themarketing of drugs. The Japan Pharmaceutical Manufacturers’

Minako Ikeda

Association (“JPMA”) is a voluntary industry group representing large pharmaceutical companies. Members must comply
with its code of practices for the promotion of prescription
drugs to healthcare professionals (“Promotion Code”). This
code is part of the JPMA Code of Practice (“JPMA Code”)
established in 2013 following amendments to the International
Federation of Pharmaceutical Manufacturers and Associations(“IFPMA”) Code of Practice that provides guidance to pharmaceutical companies on how to interact with healthcare
professionals (“HCPs”), institutions and patient organisations. The Fair Trade Council of the Ethical Pharmaceutical
Drugs Marketing Industry (“FTC-EDMI”) has adopted a codefor fair competition and fair trade that limits the benefits andpremiums that can be offered for the promotion of ethicaldrugs (“FCC”). This Code (along with corresponding guidelines and interpretive commentary) has been approved by theJapan Fair Trade Commission (“JFTC”) and the JFTC can stepin to prevent or put an end to violations. The Japan Generic
Medicines Association has adopted its own code of practicefor the promotion of generics. The Japan Federation of SelfMedication Industries (“JSMI”) has issued Guidelines for theProper Advertising of Over-the-Counter Medicines.
1.2

How is “advertising” defined?

Advertising under the PMD Act is defined in a notice issued by
the Pharmaceutical Safety Bureau of the MHLW (No. 148 of 29
September 1998) as information (i) clearly intended to induce
consumers to buy products, (ii) specifying the name of a medicinal
product, and (iii) capable of being seen and perceived by the public.
1.3 What arrangements are companies required to havein place to ensure compliance with the various laws andcodes of practice on advertising, such as “sign off” ofpromotional copy requirements?

The Guidelines on Marketing Information require companies tohave standard operating procedures dealing with the supply of
information when promoting prescription drugs and to set up
a promotion oversight department responsible for monitoringpromotional activities and reviewing materials. It must be separate from the sales and marketing divisions. The JPMA CodePharmaceutical Advertising 2022

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Iwata Godorequires its members to establish internal verification procedures and to appoint a “Promotional Materials Officer” responsible for the management of product information brochures forprescription drugs and a “Practical Operations Supervisor” incharge of practical operations regarding product information
brochures for prescription drugs. In practice, all pharmaceutical companies have their own in-house verification procedures.
1.4 Are there any legal or code requirements forcompanies to have specific standard operatingprocedures (SOPs) governing advertising activities orto employ personnel with a specific role? If so, what
aspects should those SOPs cover and what are therequirements regarding specific personnel?

See question 1.3.
1.5 Must advertising be approved in advance bya regulatory or industry authority before use? If so,
what is the procedure for approval? Even if there is
no requirement for prior approval in all cases, can theauthorities require this in some circumstances?

No such approval is required. Companies can consult withregulatory or industry bodies to confirm that their promotional
materials comply with applicable laws and codes of practice.
1.6 If the authorities consider that an advertisement
which has been issued is in breach of the law and/orcode of practice, do they have powers to stop the further
publication of that advertisement? Can they insist on theissue of a corrective statement? Are there any rights ofappeal?

The PMD Act does not expressly vest powers in the authorities tostop a breach. In practice, the Minister of the MHLW or Prime
Minister will issue a recommendation asking the pharmaceuticalcompany to cease or cure the illegal conduct and if it does notcomply, an administrative disposition may be taken. For example,
the Minister of the MHLW or competent prefectural governor
may: order a violator to comply with a business improvement order(Article 72-4 of the PMD Act), which may include taking measures
to improve advertising oversight procedures; order a company
advertising a product before obtaining a marketing approval to end
the breach and take measures to prevent future violations (Article
72-5 of the PMD Act); or revoke the company’s manufacturing
or marketing licence or suspend all or part of its operations for acertain period (Article 75 of the PMD Act). Following PMD Act
amendments effective on 1 August 2021, violations of the prohibition against false or exaggerated advertising (Article 66-1 of the
PMD Act) can be the basis of an order requiring the suspension of
the violations or the implementation of measures to prevent recurrence of those advertisements and public announcements relating
to the implementation of those measures. See question 1.7.
1.7 What are the penalties for failing to comply withthe rules governing the advertising of medicines? Who
has responsibility for enforcement and how strictly are
the rules enforced? Are there any important examples
where action has been taken against pharmaceuticalcompanies? If there have not been such cases, pleaseconfirm. To what extent may competitors take direct
action through the courts in relation to advertising
infringements?

Penalties. Breaches of the PMD Act and rules governing
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advertising are subject to administrative sanctions by the MLHW.
Serious breaches can trigger criminal sanctions: imprisonment
with work for up to two years; or a fine of up to JPY2 million(or both), for certain offences, including false and exaggerated claims and advertising (Article 66), and advertising before
receiving a marketing approval (Article 68). Amendments to the
PMD Act effective on 1 August 2021 enable: (i) the Minister ofthe MHLW to order the payment of administrative surcharges tosanction false or exaggerated advertising in violation of Article
66(1) at the rate of 4.5% of the product sales during the periodof unlawful advertising subject to a three-year maximum (nosurcharge is imposed for sales below JPY50 million and a 50%
reduction applies if the violator reports violations of the PMD
Act before an investigation); and (ii) the Minister of the MHLWor competent prefectural governor to issue cease-and-desist
orders (renamed “administrative orders concerning unlawful
advertisements”) against pharmaceutical companies to correct
advertising in breach of Articles 66(1) and 68.
A business that has made misleading representations to
consumers on the quality or standard of goods, price and otherbusiness terms and conditions may be liable to pay an administrative fine under the AUPMR (Articles 5 and 8). A cease-anddesist order may also be issued, and non-compliance is punishable by: imprisonment with work for up to two years, and/or afine not exceeding JPY3 million (Article 36(1)); and a fine of up
to JPY300 million for companies (Article 38).
If an entrepreneur violates Article 4 or 5 of the AUPMR, thePrime Minister (or Secretary General of the Consumer Affairs
Agency (“CAA”) by delegation) can:■Order the entrepreneur to stop the violation (Article 7).
■
Order the entrepreneur to pay surcharges (administrativefines) (Article 8).
■
Take measures to prevent the reoccurrence of the violation(such as delegating powers to the JFTC or Minister supervising the entrepreneur’s business) (Article 33).
This is in addition to the right to request compliance reports
from the offender, conduct on-site inspections and interrogate
the staff. The prefectural governor can instruct the entrepreneur to take certain measures. If an entrepreneur is subject to an
administrative sanction for breach and the punishment is illegal
or unreasonably harsh, he can appeal the decision.
In case of breach of voluntary standards set by industry
organisations, corrective measures or disciplinary sanctions canbe taken against members. For example, the Promotion CodeCommittee of the JPMA can take action against breaches of the
JPMA Code. The Fair Trade Council of the FTC-EDMI, the
JFTC and the CAA can take measures to stop or prevent FCC
breaches. The FTC-EDMI can issue warnings and, in case ofnon-compliance, impose penalties of up to JPY1 million, orderthe violator’s expulsion or ask the CAA to take administrative
action against the violator.
Enforcement. The distribution of drugs to consumers is supervised by the Minister of the MHLW and the competent prefectural governor. The Minister of the MHLW, the CAA, prefectural
governors and the Personal Information Protection Commission(data protection watchdog) are responsible for the supervision ofmarketing activities to consumers. Self-regulatory codes typicallyestablish an organ in charge of enforcing the code, e.g., the JPMA
Code Compliance Committee for the Promotion Code and the
FTC-EDMI for the FCC.
1.8 What is the relationship between any selfregulatory process and the supervisory and enforcement
function of the competent authorities? Can and, inpractice, do, the competent authorities investigate
matters drawn to their attention that may constitute a
breach of both the law and any relevant code and are

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already being assessed by any self-regulatory body?
Do the authorities take up matters based on an adverse
finding of any self-regulatory body?

See question 1.7 (Enforcement). The procedures before theself-regulatory authority and courts/competent authorities
are generally conducted separately. However, the regulatory
authorities can still investigate a matter already assessed by aself-regulatory body.
1.9 In addition to any action based specifically upon
the rules relating to advertising, what actions, if any, canbe taken on the basis of unfair competition? Who may
bring such an action?

Pharmaceutical companies can initiate proceedings against
competitors before the courts for advertising infringements
under the UCPA. Companies whose business interests havebeen infringed by a competitor’s “act of using a description of
goods or services, in an advertisement, or in trade documents orelectronic correspondence, in a way that is likely to mislead as
to the place of origin, quality, content, manufacturing process,purpose or quantity of the goods, or the quality, content,
purpose or quantity of the services, […]” or a competitor’s “false
allegations that harm business reputation” may seek an injunction against the competitor to stop or prevent the infringement.
They can also claim damages for wilful or negligent infringement with respect to unfair trade practices.
Companies can initiate legal proceedings based on tort, e.g.
for defamation or disparagement. Preventing competitors fromentering, or operating in, a market is another form of unfair
competition that includes conduct like boycotting or offering
unreasonably low prices.

22 Providing Information Prior to
Authorisation of Medicinal Product2.1 To what extent is it possible to make information
available to healthcare professionals about a medicine
before that product is authorised? For example, may
information on such medicines be discussed, or madeavailable, at scientific meetings? Does it make adifference if the meeting is sponsored by the company
responsible for the product? Is the position the samewith regard to the provision of off-label information (i.e.
information relating to indications and/or other productvariants not authorised)?

Article 68 of the PMD Act prohibits advertising the name,manufacturing process, indications or performance of a drug
before the grant of a marketing authorisation.
The Guidelines on Marketing Information allow the provision of information on unapproved drugs or off-label use only
if requested by HCPs or other non-HCP persons, patients ororganisations, and subject to strict conditions:■information on unapproved drugs and off-label indications
is separated from other ethical drug promotion activities;■
information is only provided to those who have requested
it and is limited to what has been requested;■
information must not be provided under the false pretenseof being requested by HCPs, patients, etc.;■
comprehensive and accurate information based on scientific and objective evidence is provided, without exaggerations or misleading statements;■

information relating to clinical trials involving a pharmaceutical company is only provided if the study is conductedin accordance with the Good Clinical Practice Ministerial
Ordinance (MHW Ordinance No. 28 of 1997), theClinical Research Act (Act No. 16 of 2017) or other applicable regulations;■
negative information, such as information on risks ofadverse effects or inconclusive clinical trials results, isprovided in a proper manner;■the fact that the efficacy and indication, dosage or method ofadministration of the ethical drug covered by the information have not been approved must be clearly explained; and■records of information content, background and recipientsshould be kept.
The Promotion Code commentary states that members mustrefrain from starting promotional activities until the marketing
approval is granted; however, this prohibition should not deprive
medical and pharmaceutical experts (or the public) of the rightto know about scientific advancements. For example, the Codedoes not restrict:■
The appropriate exchange of scientific information about
a drug through the presentation of research findings at an
academic society meeting or in a scientific journal.
■
The display of scientific exhibition materials about a drug
yet to be approved in Japan (but approved in anothercountry) in accordance with separate guidelines at an international academic society meeting.
■
The supply of peer-reviewed scientific literature, such as
the reprint of a research paper at a doctor’s request.
■
The lawful disclosure of medical information on products
under development to the pharmaceutical company’s
shareholders. This also applies to off-label information.
However, the Promotion Code does not allow the provisionof information on unapproved drugs at seminars sponsored bypharmaceutical companies.
The supply of information or explanatory materials concerning
medical data or a drug manufactured by a company to HCPs is
not prohibited by the FCC.
2.2 May information on unauthorised medicines and/or off-label information be published? If so, in whatcircumstances?

See question 2.1.
2.3 Is it possible for companies to issue press
releases about unauthorised medicines and/or off-label
information? If so, what limitations apply? If differences
apply depending on the target audience (e.g. specialised
medical or scientific media vs. mainstream public
media), please specify.

Press releases about unapproved pharmaceutical products andoff-label indications for promotional purposes are prohibited
under the PMD Act. However, press releases not intended toadvertise a product or disseminate off-label information may
be permitted (e.g., shareholder information). The JPMA Codeemphasises that “information disseminated through press
releases as well as disease education activities targeting ordinary
citizens and patients and the provision of information to investors” must be scrutinised “so that there will be no suspicion thatsuch communication of information constitute the advertisement of prescription drugs or recommendations of unapproved
drugs or off-label uses”.

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Iwata Godo

2.4 May such information be sent to healthcare
professionals by the company? If so, must thehealthcare professional request the information?

See question 2.1. The Guidelines on Marketing Information
allow the provision of information on unapproved drugs or
off-label use only if requested by HCPs or other non-HCP
persons, patients or organisations and under strict conditions.
2.5 How has the ECJ judgment in the Ludwigs
case, Case C-143/06, permitting manufacturers of
non-approved medicinal products (i.e. products
without a marketing authorisation) to make available topharmacists price lists for such products (for namedpatient/compassionate use purposes pursuant to Article
5 of the Directive), without this being treated as illegal
advertising, been reflected in the legislation or practicalguidance in your jurisdiction?

This is not applicable to our jurisdiction.
2.6 May information on unauthorised medicines orindications be sent to institutions to enable them to planahead in their budgets for products to be authorised in
the future?

Doing so may be in breach of the prohibition against the advertising of unapproved pharmaceuticals.
2.7 Is it possible for companies to involve healthcare
professionals in market research exercises concerning
possible launch materials for medicinal products orindications as yet unauthorised? If so, what limitations
apply? Has any guideline been issued on market
research of medicinal products?

No guideline has been issued on market research of medicinal
products; however, research should not be used to circumvent theprohibition against the advertising of unapproved pharmaceuticals.

32 Advertisements to Healthcare
Professionals
3.1 What information must appear in advertisements
directed to healthcare professionals?

The Fair Advertising Standards do not require specific information to be included in advertising targeting HCPs. However,past MHLW guidelines published in 1980 did list the minimum
information to be provided to HCPs, including:■
The product’s name for distribution.
■
The generic classification name.
■
The product’s indications and effects.
■
The method of administration.
■
Information regarding adverse reactions, precautions andcontraindications, and dosage.
■
A contact address for further information.
■
The date of preparation of the advertisement.
The JPMA’s Guidelines for the Preparation of Product
Information Brochures for Prescription Drugs list informationthat must appear in prescription drug advertisements targeting
HCPs via professional journals (including conference brochures
and publications by pharmaceutical companies):■
Product brand name and generic name.
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■
■
■
■
■
■
■

Therapeutic category.
Indications and usage.
Regulatory classification.
Dosage and administration.
Precautions.
National Health Insurance (“NHI”) price listing.
Marketing authorisation holder’s contact details.
3.2 Are there any restrictions on the information that
may appear in an advertisement? May an advertisement
refer to studies not mentioned in the SmPC?

The JPMA Code includes basic principles regarding materials(brochures, adverts in medical journals, websites targeting
HCPs, audiovisual materials) and provides that statements
contained therein must be correct, objective and based on scientific data. For example:■
Statements regarding indications, dosage and administration, and any other statements, must not deviate from theapproved items.
■
No false, exaggerated, or misleading labels, layout or
expression can be used regarding efficiency and safety.
■
Fair statements must be made by presenting efficiency andsafety data, including adverse reactions.
■Comparisons with other drugs must be based on scientificdata, in principle, using generic names.
■
Competitors or their drugs must not be slandered or
defamed.
■Extraordinary data must not be presented to give theimpression that the data has universal value.
■
Where an advertisement is aimed mainly at promoting
only the name of a drug, the advertisement must include
the information mentioned in question 3.1.
Advertisements may refer to clinical studies not mentioned in
the SmPC, although such references are limited by general advertising rules under the PMD Act and by self-regulatory codes.
3.3 Are there any restrictions to the inclusionof endorsements by healthcare professionals inpromotional materials?

The PMD Act prohibits advertisements, descriptions or thecirculation of statements giving the false impression that a
medical doctor or other person has endorsed the efficacy or
performance of a drug.
3.4 Is it a requirement that there be data from any, or aparticular number of, “head to head” clinical trials before
comparative claims may be made?

No, there is no such requirement.
3.5 What rules govern comparative advertisements?
Is it possible to use another company’s brand name aspart of that comparison? Would it be possible to refer to
a competitor’s product or indication which had not yet
been authorised in your jurisdiction?

The AUPMR does not prohibit comparative advertising.
However, in accordance with the CAA’s Guidelines for
Comparative Advertising under the AUPMR, the following
forms of advertising are considered misleading and likely toaffect product selection by consumers:

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■

Comparison by indicating matters not demonstrated andincapable of being demonstrated.
■
Comparison based on unfair grounds, e.g., by putting theemphasis on aspects inconsequential to product selection
by consumers, or on an arbitrary selection of products
being compared.
■
Advertising that disparages competitors or products.
The Fair Advertising Standards prohibit a pharmaceuticalcompany from disparaging other companies’ products in relation to quality, potency/effect, safety, or other drug-related
aspects.
The JPMA Code provides that comparisons with other drugs
must be conducted properly and based on scientific data, inprinciple, using generic names. Competitors’ drugs must not beslandered or defamed. Its commentary stresses that comparing
new drugs with existing drugs is important. Drugs should be
introduced based on accurate data with scientific backing, incompliance with the JPMA’s Guidelines for the Preparation of
Product Information Brochure for Prescription Drugs, while
avoiding ambiguous expressions that may lead to misunderstandings. The drug being compared against must be referred
to using its generic name (the use of rival manufacturers’ logos
or brands is prohibited without their consent).
3.6 What rules govern the distribution of scientificpapers and/or proceedings of congresses to healthcare
professionals?

See question 2.1. The JPMA Code commentary allows the
supply of peer-reviewed scientific literature, such as reprints
of a research paper or medical journals at a doctor’s request.
However, the distribution of scientific papers or proceedingsof congresses should not be used to circumvent advertisingprohibitions.
3.7 Are “teaser” advertisements (i.e. advertisementsthat alert a reader to the fact that information on
something new will follow, without specifying the natureof what will follow) permitted?

Teasers are not expressly regulated as such. The JPMA Codeprescribes that where advertisements are aimed mainly at
promoting only the name of a drug, they must include the brand
name, therapeutic category (product title), regulatory classification, non-proprietary name, NHI price listing status and contact
details for further information.
3.8 Where Product A is authorised for a particular
indication to be used in combination with another
Product B, which is separately authorised to a different
company, and whose SmPC does not refer expressly
to use with Product A, so that in terms of the SmPC for
Product B, use of Product B for Product A’s indication
would be off-label, can the holder of the MA for ProductA nevertheless rely upon the approved use of Product
B with Product A in Product A’s SmPC, to promote the
combination use? Can the holder of the MA for ProductB also promote such combination use based on theapproved SmPC for Product A or must the holder of the
MA for Product B first vary the SmPC for Product B?

Combination products are treated as one and this situation should theoretically not arise. Combinations have to bementioned in the company’s SmPC (essentially label information under Article 52 of the PMD Act) to avoid off-label use.

42

Gifts and Financial Incentives

4.1 Is it possible to provide healthcare professionals
with samples of medicinal products? If so, what
restrictions apply?

Samples may be provided to HCPs (with product information),provided the pharmaceutical company has obtained a marketing
authorisation for the product.
The provision of free samples is permitted under the
Promotion Code and the Japan Generic Medicines Association
promotion code. The Promotion Code specifies that only theminimum requisite number of samples should be supplied. The
FCC contains detailed provisions on samples. A company isprohibited from providing free medicinal drugs as a meansof inducing a medical institution to buy drugs. However, theprovision of free “trial-use samples” is permitted for clinical
trial purposes. Free samples can be supplied to medical institutions to allow medical staff to become familiar with the formulation, colour, taste, appearance or other characteristics of the
product before use.
4.2 Is it possible to give gifts or donations of money tohealthcare professionals? If so, what restrictions apply?
If monetary limits apply, please specify.

Gifts. In special circumstances, gifts and promotional items
can be offered to HCPs, provided they comply with good ethicalpractices and remain within the limits of decency. Under the
FCC, inappropriate financial benefits or benefits in kind should
not be offered to medical practitioners to induce them toprescribe drugs, and a marketing authorisation holder cannot
provide premiums to HCPs and healthcare institutions, such as
hospitals or pharmacies, to unjustly induce transactions. The
Promotion Code generally prohibits members from offering any
gift or cash that could potentially affect the appropriate use ofdrugs to HCPs. The impact of the gift or cash offering must
be considered, in particular whether the practice may affect theproper use of drugs or be perceived by the public as interferingwith independent and scientifically based prescription methods
and consequently undermine the social role of drugs.
JPMA members must set clear standards for gifts and cash
offerings in their in-house codes. Seasonal gifts must not be
offered even when they are customary because, depending onvalue and frequency, they can be seen as interfering with theindependence of an HCP’s decision to prescribe, recommend orpurchase drugs. Members should refrain from offering congratulatory money because the intention behind the payment andthe range of congratulatory events are difficult to assess. The
Promotion Code commentary states that reasonable condolence money (about JPY10,000) for funerals is permitted as it isunlikely to influence prescription practices. According to the
FCC Enforcement Rules and Operating Standards, gifts having
a small value not exceeding appropriate levels in light of ordinary commercial customs (about JPY3,000) and modest gifts
offered at seminars organised for one’s own products or memorial events (about JPY5,000) are permissible, as they are notconsidered to unduly affect an HCP’s decision.
Grants and donations. Pharmaceutical companies may
generally provide grants or donations to HCPs or healthcare
institutions, subject to restrictions. The FCC prohibits theoffering of premiums to healthcare institutions, etc., that unjustifiably induce drug transactions. Donations should be made toserve the interests of society as a whole and not for commercial
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Iwata Godo

purposes. Whether they have such purpose is decided basedon criteria provided in the FCC Operating Standards. The
Standards on Donations under the FCC provide that even if adonation is “free of charge”, if the manufacturer of prescription drugs is promised to be treated advantageously in returnfor the donation or the manufacturer responds to a donation
request that is excessive compared to what is socially acceptable,
it may improperly induce a transaction and should be restricted.
Examples of prohibited donations include complying withdonation requests where a certain target amount is set for eachmanufacturer or making donations in response to hints that the
manufacturer will be treated disadvantageously if the request is
rejected. Examples of permissible donations not deemed to be
associated with drug prescription include:■
Donations widely accepted by society.
■
Donations by industry organisations widely acknowledged
in society.
■
Donations in response to disasters (e.g. relief money, free
supply of prescription drugs).
■
Donations by medical institutions to other businesses (e.g.
educational or research facilities) managed by the samelegal entity.
■
Other donations where neither the medical institutions nor
HCPs are involved; the supply of prescription drugs not
associated with a transaction (such as overseas support).
With respect to donations to medical institutions or HCPs,
the Standards provide detailed guidelines on what is prohibitedas improperly inducing prescription drug transactions:■
Donations through the assumption of costs that should beborne by the medical institutions/HCPs.
■
Donations for ordinary medical services performed by the
medical institutions/HCPs.
■
When the manufacturer is promised that it will profit frommaking the donation.
■
When the requested donation is compulsory or such thata certain target amount is allocated among manufacturers,
and a manufacturer makes the donation considering theconsequences it may have on its future transactions.
■
Donations deemed excessive compared to what is sociallyacceptable.
Donations acceptable under the FCC include: donations forresearch activities (except for support for clinical research on the
manufacturer’s own medicinal products); donations for lectures
targeting the public or HCPs that do not belong to the medical
institutions receiving the donations; and other donations notdeemed to induce transactions (e.g. donating funds to build a
new hospital, providing prescription drugs for free to educate
students in response to requests from universities, donations foreducational, training or scholarship funding purposes).
4.3 Is it possible to give gifts or donations of money
to healthcare organisations such as hospitals? Is it
possible to donate equipment, or to fund the cost of
medical or technical services (such as the cost of anurse, or the cost of laboratory analyses)? If so, what
restrictions would apply? If monetary limits apply,
please specify.

The principles in questions 4.2 and 4.4 apply. JPMA member
companies can offer or provide items of medical utility if they
are of modest value, do not offset routine business practices andare beneficial to the provision of medical services and patientcare (different rules could apply to clinical trials). The cost of anurse cannot be covered by a donation.

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4.4 Is it possible to provide medical or educational
goods and services to healthcare professionals that
could lead to changes in prescribing patterns? For
example, would there be any objection to the provisionof such goods or services if they could lead either tothe expansion of the market for, or an increased market
share for, the products of the provider of the goods orservices?

Notification No. 124 issued by the Cabinet dated 1 April 2016
on Restrictions on Premium Offers in the Ethical Drugs,
Medical Devices and Hygienic Inspection Laboratory Industries
under the AUPMR prohibits pharmaceutical companies fromoffering goods, services or other premiums to HCPs beyond
what is necessary for the use of ethical drugs and commerciallyreasonable as a means of inducing unjust transactions. Undercertain conditions, the FCC allows the supply of goods orservices required for the proper use of the drugs or services thatmaximise the use of the product or its benefits. A market expansion would likely result from action beyond the pale.
4.5 Do the rules on advertising and inducements
permit the offer of a volume-related discount toinstitutions purchasing medicinal products? If so, whattypes of arrangements are permitted?

Volume-related discounts are permissible, subject to generalcompetition law rules. If a company offers a volume-related
rebate, it may have the effect of restraining the purchaser’s dealings in competing products (exclusionary dealing). The FCC
exempts “premiums that do not include any economic benefit
such as discounts or after-sales services in light of normal business practices” from its premium restrictions.
4.6 Is it possible to offer to provide, or to pay for,additional medical or technical services or equipment
where this is contingent on the purchase of medicinal
products? If so, what conditions would need to beobserved? Are commercial arrangements whereby thepurchase of a particular medicine is linked to provisionof certain associated benefits (such as apparatus foradministration or the provision of training on its use) as
part of the purchase price (“package deals”) acceptable?
If so, what rules apply?

See question 4.4. The FCC does not prohibit package deals, buteach deal should be reviewed on a case-by-case basis.
4.7 Is it possible to offer a refund scheme if the
product does not work? If so, what conditions would
need to be observed? Does it make a difference whether
the product is a prescription-only medicine, or an overthe-counter medicine?

There is no express prohibition against refund schemes, although,in practice, pharmaceutical companies typically go through wholesalers, who in turn sell drugs to medical institutions or pharmacies, and this may limit refund opportunities. These schemes
are sometimes used for over-the-counter (“OTC”) medicine likemoney-back guarantees for other consumer goods. There havebeen instances of pharmaceutical companies paying a refund to
consumers when recalling ethical or OTC drugs.

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4.8 Are more complex patient access schemes ormanaged access agreements, whereby pharmaceuticalcompanies offer special financial terms for supply of
medicinal products (e.g. rebates, dose or cost caps,
risk share arrangements, outcomes-based schemes),
permitted in your country? If so, what rules apply?

No specific rules apply to more complex schemes or agreements,
and certain companies are exploring schemes to move awayfrom volume-based pricing. Potential issues may involve sales
below cost, patient data protection, insurance regulations, etc.
4.9 Is it acceptable for one or more pharmaceuticalcompanies to work together with the National Health
System in your country, pooling skills, experience and/or
resources for the joint development and implementationof specific projects? If so, what rules apply?

No specific rules govern or restrict such cooperation.
4.10 May pharmaceutical companies sponsor
continuing medical education? If so, what rules apply?

Please see question 4.2. This is permissible under the FCC,
provided it does not improperly induce transactions.
4.11 What general anti-bribery rules apply to theinteractions between pharmaceutical companies andhealthcare professionals or healthcare organisations?
Please summarise. What is the relationship between thecompetent authorities for pharmaceutical advertisingand the anti-bribery/anti-corruption supervisory andenforcement functions? Can and, in practice, do the antibribery competent authorities investigate matters that
may constitute both a breach of the advertising rules
and the anti-bribery legislation, in circumstances wherethese are already being assessed by the pharmaceuticalcompetent authorities or the self-regulatory bodies?

The Criminal Code prohibits bribing Japanese public officials.
Medical practitioners of a state-owned hospital are quasi-public
officials and regarded as public officials under the Criminal
Code. Offering bribes is punishable by imprisonment with workfor up to three years or a fine of up to JPY2.5 million.
The National Public Service Ethics Act covers anti-corruption
measures with respect to national public servants. The National
Public Service Ethics Code (Cabinet Ordinance No. 101 of
2002) provides standards of conduct. For example, personnel
must not receive cash, goods or real estate, cash loans, freeservices from interested parties (i.e., counterparties in theirduties), accept entertainment from them or play games or golfor travel with them. Exceptions include accepting refreshmentsin the form of a buffet at a party attended by many people oraccepting tea and cake at meetings or other gatherings attended
by personnel in the performance of their duties.
The UCPA ensures fair competition among business operators and the bribery of foreign public officials is punishable byimprisonment with work for up to five years and/or a fine of up
to JPY5 million. Companies may also be punished by a fine of
up to JPY300 million.
The National Police Agency and Public Prosecutors’ Office
are responsible for the supervision and enforcement of antibribery rules. They can investigate matters that may constituteboth a breach of advertising rules and anti-bribery legislation,in circumstances where these are already being assessed by thecompetent pharmaceutical authorities or self-regulatory bodies.

52

Hospitality and Related Payments

5.1 What rules govern the offering of hospitality tohealthcare professionals? Does it make a difference if
the hospitality offered to those healthcare professionals
will take place in another country and, in thosecircumstances, should the arrangements be approvedby the company affiliate in the country where thehealthcare professionals reside or the affiliate where thehospitality takes place? Is there a threshold applicable tothe costs of hospitality or meals provided to a healthcare
professional?

The Promotion Code requires that seminars for members’
products be held at appropriate venues and, if food and drinks or
any social event or gift is offered in conjunction with a seminar,
they must not be lavish and extravagant. The FTC-EDMI has
wining and dining rules serving as guidance for its members.
For instance (for each HCP) the maximum value is:■for buffets following information-sharing lectures or
meetings concerning the company’s products, food anddrinks: JPY20,000;■
for food and drinks provided to participants of meetings
related to conference management: JPY20,000;■
for food and drinks offered to guest speakers at in-house
workshops and seminars or guest speakers at symposia orother promotional events in recognition of their services:
JPY20,000;■
for food and drinks in connection with the activities of
medical representatives: JPY5,000; and■for “bento”-lunch boxes and snacks and a cup of tea
offered at in-house briefing meetings or drug explanatory
meetings held by medical representatives: JPY3,000.
The code rules also apply to hospitality offered overseas andthe JPMA Code commentary explains that even for activities
taking place overseas, members must abide by the JPMA Codewhile at the same time conforming to local laws and regulations,in addition to whatever pharmaceutical organisation codes exist,
or to the IFPMA Code in the absence of a code. There is norequirement regarding company affiliate consent.
5.2 Is it possible to pay for a healthcare professionalin connection with attending a scientific meeting? If
so, what may be paid for? Is it possible to pay for his
expenses (travel, accommodation, enrolment fees)? Is it
possible to pay him for his time?

HCPs can be paid in connection with attending scientific meetings, subject to restrictions under the FCC and Promotion Code.
The Promotion Code provides that members should hold seminars in appropriate locations and venues (i.e., avoiding resorts)
and, in principle, in Japan. It authorises the reimbursement of
nominal expenses, including travel expenses and accommodation and the payment of lecture fees to HCPs providing genuine
services as guest speakers or presenters. Should a seminar takeplace abroad, the payment of travel expenses is limited to thoseof HCPs providing information on the company’s drugs. Wherea company hosts a seminar unrelated to its own drugs, only
meeting expenses may be paid.
5.3 To what extent will a pharmaceutical company
be held responsible by the regulatory authorities forthe contents of, and the hospitality arrangements for,scientific meetings, either meetings directly sponsoredor organised by the company or independent meetings inPharmaceutical Advertising 2022
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Iwata Godo

respect of which a pharmaceutical company may provide
sponsorship to individual healthcare professionals toattend?

6.2 Is it possible to advertise prescription-only
medicines to the general public? If so, what restrictions
apply?

A company is responsible for the contents and hospitality
arrangements at meetings it directly sponsors or organises. For
independent meetings, responsibility will be assessed on a caseby-case basis.

The PMD Act and its Enforcement Order only prohibit advertising of drugs for specially designated diseases (treating cancer,
sarcoma and leukemia) but the Fair Advertising Standards
prohibit the advertising of prescription drugs to the public. Suchadvertising may only target HCPs. In addition, they prohibit
misleading representations in advertisements targeting consumers
to the effect that the use of a particular drug, without a diagnosis
or treatment by medical practitioners, will cure cancer, diabetes,
hyperlipidaemia, heart diseases, hepatitis or other diseases thatgenerally require a medical practitioner’s diagnosis and treatment.

5.4 Is it possible to pay healthcare professionals toprovide expert services (e.g. participating in advisoryboards)? If so, what restrictions apply?

The FCC provides for the payment of compensation andcosts and expenses for medical or pharmaceutical studies/
research that are entrusted to a medical institution (for example,
post-marketing surveillance studies, clinical trials, other medicalor pharmaceutical research). Pharmaceutical companies mustcomply with the FCC guidelines (in particular, the Standards
for Premiums) issued by the JFTC and CAA. It is possible topay reasonable honoraria, reimburse out-of-pocket expenses(e.g., travelling and accommodation) for conference speakers
and presenters. These payments must be kept at a modest level.
The Promotion Code and commentary clarify that JPMA
members may engage HCPs for services such as lectures, writing
papers, conducting surveys or research, taking part in meetings held by members, or providing training, etc., where suchparticipation involves fees such as honoraria. Fees should not
be excessive in light of the services. A written contract must be
agreed, which specifies the purpose of the services and basis forpayment. A legitimate need for the services must be identified,
and the HCP must have the relevant expertise.
5.5 Is it possible to pay healthcare professionals totake part in post-marketing surveillance studies? Whatrules govern such studies?

See question 5.4.
5.6 Is it possible to pay healthcare professionals totake part in market research involving promotional
materials?

See question 5.4.

62

Advertising to the General Public

6.1 Is it possible to advertise non-prescription
medicines to the general public? If so, what restrictions
apply?

They can be freely advertised like other consumer goods. OTC
drug advertising is regarded as an important means of conveying
useful health-related information to the public. Advertisements
for non-prescription drugs must comply with the PMD Act
and the Fair Advertising Standards (e.g., no misleading or false
information on efficacy and safety, no unproved claim, nouse of expressions guaranteeing effectiveness, no encouragement leading to abuse or overdose, no reference to endorsements by HCPs, compliance with special restrictive rules applicable to e-detailing, sponsored TV and radio programmes andprogrammes targeting children).
JSMI’s Guidelines for the Proper Advertising of Over-theCounter Medicines deal with OTC drug distribution (see question 1.1).
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6.3 If it is not possible to advertise prescription-only
medicines to the general public, are disease awarenesscampaigns permitted encouraging those with aparticular medical condition to consult their doctor, but
mentioning no medicines? What restrictions apply?

In principle, disease awareness campaigns do not qualify as
advertising unless they satisfy the definition of advertising(see question 1.2). They should not promote a particular drug.
The Guidelines on Marketing Information apply to campaigns
focusing on diseases treated with prescription-only medicines.
Extra caution is needed where there is only one treatment option
or medicine available.
6.4 Is it possible to issue press releases concerningprescription-only medicines to non-scientific journals?
If so, what conditions apply? Is it possible for the press
release to refer to developments in relation to as yet
unauthorised medicines or unauthorised indications?

Press releases concerning medicines are not prohibited, but if apress release falls under the definition of advertising (see question 1.2), advertising restrictions under the PMD Act and the
Fair Advertising Standards will apply.
6.5 What restrictions apply to describing products
and research initiatives as background information incorporate brochures/Annual Reports?

Should the product information and pipeline fall within thedefinition of advertising, the advertising regulations will apply.
Under the JPMA Code, if the information disclosed to shareholders concerns a product under development, members mustensure it is not used for promotional activities and that it will not
be perceived as information for investors.
6.6 What, if any, rules apply to meetings with, and thefunding of, patient organisations?

There is no specific regulation. The JPMA Code provides thatmembers must act ethically and respect the independence of
patient groups. Those collaborating with patient organisations
must establish internal guidelines based on the JPMA’s Guidelines
on Collaboration with Patient Organisations and the Guidelines
for Transparency of Relationship between Corporate Activities
and Patient Organisations (“Transparency Guidelines”).
Members are advised to include in their internal guidelines theneed to clarify their involvement with patient organisations and,

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Japan

when providing financial support, to secure written consent forthe objectives and keep records. The Transparency Guidelines
include spend disclosure obligations. Members must publicly
release data on donations, grants and benefits in kind or othersupport provided to patient organisations. The Guidelines
recommend that members’ financial contributions for the pastfiscal year be disclosed on their website.
6.7 May companies provide items to or for the benefitof patients? If so, are there any restrictions in relation to
the type of items or the circumstances in which they may
be supplied?

The advertising of prescription drugs to consumers is prohibited (see question 6.2); however, the restrictions do not apply to
non-prescription drugs, and gifts and benefits can be provided
to patients and consumers as part of a marketing strategy, subject
to the rules on premiums under the AUPMR. The benefits
should be reasonable and should not lead to overconsumption.
6.8 What are the rules governing company funding ofpatient support programmes?

See question 6.6.

72

Transparency and Disclosure

7.1 Is there an obligation for companies to disclosedetails of ongoing and/or completed clinical trials? If so,is this obligation set out in the legislation or in a selfregulatory code of practice? What information should be
disclosed, and when and how?

There is no such obligation in the legislation. To ensure transparency of information on clinical studies, JPMA members must
publicly disclose clinical study information in conformity with
the Joint Position on the Disclosure of Clinical Trial Information
via Clinical Trial Registries and Databases adopted by majorinternational industry associations. A publicly accessible clinical trial registry contains basic information on ongoing clinical
trials, other than exploratory, sponsored by members, including
brief title, description, trial phase, type, status and purpose (e.g.,treatment, diagnosis, prevention), intervention type (e.g., drug,
vaccine), condition or disease and eligibility criteria. A publicly
accessible clinical trial results database summarises the results ofcompleted clinical trials, other than exploratory trials, conducted
on a drug approved for marketing and commercially available in
at least one country, regardless of outcome. Trial results from
exploratory trials of a significant importance should be disclosed.
7.2 Is there a requirement in the legislation forcompanies to make publicly available information
about transfers of value provided by them to healthcare
professionals, healthcare organisations or patientorganisations? If so, what companies are affected (i.e.
do these requirements apply to companies that have
not yet been granted a marketing authorisation and/or to foreign companies), what information should be
disclosed, from what date and how?

Disclosure obligations regarding the details of transfers ofvalue to HCPs or healthcare institutions are basically left toself-regulation by the pharmaceutical companies except in relation to clinical trials.

The Clinical Research Act requires pharmaceutical companies and their subsidiaries to disclose certain transfers of value
to HCPs and institutions in connection with specified clinicalresearch (as defined in the Act). The Act requires a manufacturer with marketing approval for pharmaceuticals providing
a person who conducts specified clinical trials with researchfunds or other benefits for specified clinical trials to enter into
an agreement specifying the amount and details of such researchfunds or other benefits, etc. The manufacturer must, in addition
to information on the provision of research funds or other benefits for specified clinical trials, make information public on theprovision of money or other profits (excluding research funds orother benefits) to a person who conducts specified clinical trials
and other organisations that are in special relationships withsuch person, such as medical or research institutions to whichsuch person belongs, using the Internet. This information must
be made public within one year after the end of each fiscal year
and must be kept public for five years. The disclosure obligation under the Clinical Research Act applies to pharmaceuticalcompanies that are licensed to market under the PMD Act.
7.3 Is there a requirement in your self-regulatory codefor companies to make publicly available information
about transfers of value provided by them to healthcare
professionals, healthcare organisations or patientorganisations? If so, what companies are affected (i.e.
do these requirements apply to companies that have
not yet been granted a marketing authorisation and/or to foreign companies), what information should be
disclosed, from what date and how? Are companies
obliged to disclose via a central platform?

The JPMA Guidelines for Transparency of Relationshipbetween Pharmaceutical Companies and Medical Institutions,etc. require members to disclose information regarding transfers of value made to HCPs or healthcare institutions. Members
must prepare their own in-house transparency policy as a codeof practice referring to the Guidelines. Transfers of value aredisclosed on each company’s website within one year of eachfiscal year end. Fees and expenses to be disclosed are broken
down into five categories:■
Research and development expenses, etc.: expenses
required for research/surveillance, etc. conducted underpublic regulations and various policies such as the Clinical
Trials Act and the PMD Act’s Good Clinical Practice,Good Pharmacovigilance Practice and Good Postmarketing Study Practice ministerial ordinances.
■
Academic research support expenses: scholarship donations and general donations for promotion of academic
research or research support, etc., and donations toacademic societies, etc., and expenses of co-sponsoredconferences, etc., as expenses to academic societies, etc.,
for supporting conferences.
■
Manuscript/writing fees: for instance, fees for the provision of scientific information on the company’s pharmaceutical products or fees, etc., for lectures and writing or
supervision of a manuscript that are related to researchand development, or commissioning of services including
consulting contracts (such as fees for writing manuscripts
containing scientific information regarding the companies’
own drugs).
■
Expenses related to the provision of information including
spend for lecture meetings and explanation meetings, etc.,
for providing information, etc., related to the company’s
pharmaceutical products to medical professionals (such as
expenses for lectures and seminars).
■
Other expenses (such as for hospitality as a matter of social
courtesy).
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7.4 What should a company do if an individual
healthcare professional who has received transfersof value from that company, refuses to agree to thedisclosure of one or more of such transfers?

See question 7.2 on Clinical Research Act obligations. Transfersof value are typically made on the condition that disclosure isauthorised by the HCP.

82

Digital Advertising and Social Media

8.1 How is Internet advertising regulated? What rules
apply? How successfully has this been controlled?

Advertising drugs on the Internet is governed by the samelaws, regulations and self-regulatory codes as those applicable to other media, in particular the PMD Act and the Fair
Advertising Standards. Advertising prescription-only medicines
to the general public is prohibited. When an unapproved drug
is advertised on the Internet, the MHLW or competent prefectural governor may request Internet Service Providers to block
the prohibited advertising pursuant to MHLW’s guidelines onmonitoring and guidance concerning Internet advertisements inbreach of the PMD Act (PSFSBCND Notification No. 1217-1 of
17 December 2014). Due to the advertising of unapproved drugs
by importers on the Internet, a notification was issued to provide
guidance to individual importers, including in relation to drug
advertising (PSFB Notification No. 0828014 of 28 August 2002).
The activities of pharmaceutical companies in relation to thepromotion of prescription products to HCPs are self-regulated
through industry associations. The Promotion Code commentarylays down specific rules concerning access restrictions to information on prescription-only medicines available on the Internet.
Companies providing HCPs with product-related information
concerning prescription-only medicines through the Internet
must restrict access to the relevant website and ensure that only
HCPs can access the information. Although there is no need to
set a password, the restricted nature of the information should beapparent and users should first confirm their HCP status before
accessing the site. The Promotion Code also contains detailed
guidance on the use of social media (sponsor identification andresponsibility for contents, extra care in the review and validationof the information and materials given the nature of social media).
Non-prescription drugs may be marketed on the Internet but
only if these drugs are also marketed at a real store with the relevant marketing business licence.
8.2 What, if any, level of website security is required toensure that members of the general public do not haveaccess to sites intended for healthcare professionals?

See question 8.1.
8.3 What rules apply to the content of independentwebsites that may be accessed by a link from acompany-sponsored site? What rules apply to thereverse linking of independent websites to a company’s
website? Will the company be held responsible for thecontent of the independent site in either case?

Responsibility should be considered on a case-by-case basis.
Companies may be held responsible for the advertising content
of an independent website accessed from a company-sponsoredsite or in case of reverse linking arranged by them.
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8.4 What information may a pharmaceutical company
place on its website that may be accessed by membersof the public?

See question 8.1.
8.5 Are there specific rules, laws or guidance,
controlling the use of social media by companies?

The rules in question 8.1 would also apply.
8.6 Are there any restrictions on social media activity
by company employees using their personal accounts,
including interactions with third parties through “likes”,“applauds”, etc.?

There are no express restrictions. Clearly, responsible employees
should show some restraint depending on the circumstances,and in-house rules and policies can be adopted.
8.7 Are there specific rules governing advertisingand promotional activity conducted virtually, including
online interactions with healthcare professionals, virtual
meetings and participation in virtual congresses andsymposia?

No, there are no specific rules.

92 Developments in Pharmaceutical
Advertising
9.1 What have been the significant developments
in relation to the rules relating to pharmaceutical
advertising in the last year?

There have not been any significant developments in the lastyear.
9.2 Are any significant developments in the field ofpharmaceutical advertising expected in the next year?

No significant developments are expected in the next year.
9.3 Are there any general practice or enforcement
trends that have become apparent in your jurisdiction
over the last year or so?

Japan is following international trends. The advertising of
medicines is subject to tighter controls for a variety of reasons(e.g., the fact that the advertising of OTC products via social
media and the Internet has skyrocketed, thereby increasing risksof abuse, fraud, or overmedication, the need to protect a more
vulnerable aging population and rising healthcare costs). Overthe last few years, the MHLW has been stepping up its enforcement activities in relation to drug advertising.

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Shinya Tago is a Japanese attorney-at-law, admitted to the New York State Bar Association, and is the Managing Partner of Iwata Godo. His
practice focuses on: general corporate and general commercial litigation; arbitration (domestic and international), conciliation and mediation;and tort claims (including product liability disputes). Shinya Tago’s practice also includes Healthcare and Life Sciences and he handles anarray of commercial, legal and regulatory matters related to pharmaceuticals and medical devices for domestic and international industry
players. Shinya Tago has an LL.B. from Hitotsubashi University and an LL.M. from Cornell Law School. He is also a professor at Hitotsubashi
University School of Law.
Iwata Godo
Marunouchi Bldg., 15th Floor
2-4-1 Marunouchi, Chiyoda-ku
Tokyo 100-6315
Japan

Tel:
Email:
URL:+81 3 3214 6205
stago@iwatagodo.com
www.iwatagodo.com

Landry Guesdon is a Registered Foreign Attorney (Tokyo Bar) and Avocat (Paris Bar) and a member of the International Practice Committeeof Iwata Godo. With more than 20 years’ service in a Magic Circle firm, Landry Guesdon has extensive experience in mergers & acquisitions,joint ventures and general corporate and commercial matters and antitrust spanning numerous industries, including Healthcare and Life
Sciences. Landry Guesdon has a B.A. in Law from the University of Kent in Canterbury and an LL.M. from the University of Paris.
Iwata Godo
Marunouchi Bldg., 15th Floor
2-4-1 Marunouchi, Chiyoda-ku
Tokyo 100-6315
Japan

Tel:
Email:
URL:+81 3 3214 6205
lguesdon@iwatagodo@com
www.iwatagodo.com

Minako Ikeda is a Japanese attorney-at-law and a Counsel at Iwata Godo specialising in general corporate and dispute resolution. Her practice also includes Healthcare and Life Sciences and she handles an array of commercial, legal and regulatory matters related to biologicals,
drugs and medical devices for domestic and international industry players. Minako Ikeda has an LL.B. from the University of Tokyo, an LL.M.
from the University of Michigan Law School and a J.D. from Waseda Law School.
Iwata Godo
Marunouchi Bldg., 15th Floor
2-4-1 Marunouchi, Chiyoda-ku
Tokyo 100-6315
Japan

Tel:
Email:
URL:+81 3 3214 6205
minako.ikeda@iwatagodo.com
www.iwatagodo.com

Iwata Godo was established in 1902 and is one of Japan’s premier law firms.
It is a full-service firm numbering around 80 attorneys. The firm’s Healthcare& Life Sciences team assists the full range of industry players, including
hospitals, pharmacy chains, pharmaceutical and medical device manufacturers, distributors and suppliers, in all aspects of their operations. Our
team advises on the areas of law impacting our healthcare clients, including
regulatory law and compliance, litigation and dispute resolution, and generaltransactional issues.
www.iwatagodo.com

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