Yoshiki NagaseKevin Yamaga-Karns

Miho Mizuguchi

The Second Asia Pacific Pharmaceutical Compliance Congress and

Best Practices ForumJapan Compliance Update

12 September 2012

Japan Compliance Update

Law and code overviewCounterfeit drug situationRecent change on hospitality rulesQ&As

12 September 2012Japan Compliance Update 2

Law and Code Overview

Miho Mizuguchi

12 September 2012Japan Compliance Update 3

Act against Unjustifiable Premiums and Misleading Representations

The Prime Minister may, when it finds it necessary to prevent unjust inducement of customer, restrict the maximum value of a premium or the total amount of premiums, the kind of premiums or method of offering of a premium or any other matter relating thereto, or may prohibit the offering of a premium. (Article 3)

A company or a trade association may, upon obtaining authorisation from the Fair Trade Commission pursuant to the Rules of the FairTrade Commission, with respect to the matters relevant to premiums or representations, conclude or establish an agreement or a ruleaiming at prevention unjust inducement of customers and securingfair competition. (Article 12)

Cease and desist order

12 September 2012 4Japan Compliance Update

Notice and Fair Competition Rules under the Act

Notice of the Japan Fair Trade Commission (No 54 of 1997)

Any company engaged in the business of manufacture or sale of ethical drugs or medical device shall not offer premiums, as a mean to unjustly induce transactions, beyond the level that is considered appropriate in the light of normal commercial custom.

Fair Competition RulesSelf regulations adopted by the Fair Trade Council of Ethical Drug/Medical Device Manufacturing IndustryBlessed by the Consumer Affairs Agency and the Fair Trade CommissionExemption from the law

12 September 2012 5Japan Compliance Update

Fair Competition Rules - Structure

Three layersMain rules – authorised by CAA and FTC Enforcement regulations – approved by CAA and FTCGuidelines – filed with CAA and FTC

Guidelines on restriction on offering premiums• Offering of Premiums• Donation

Guidelines on examples of prohibited premiums

12 September 2012 6Japan Compliance Update

Fair Competition Rules - Structure

Guidelines on examples of permitted premiums• Necessary or Useful Goods and Services• Medical or Pharmaceutical Information• Samples• Survey and Research• Seminars for Own Products

Guidelines on premiums with small value• Premiums with Small Value• Friendship Meetings• Ceremonial Events

Hospitality rules tightened April 2012

12 September 2012 7Japan Compliance Update

Industrial Code

JPMA/JFMDA Promotion Code Self regulations adopted by the Japan Pharmaceutical Manufacturers Association (JPMA) / Japan Federation of Medical Device Association (JFMDA) Based on IFPMA codeMR code of conductUse of printed materials and advertisingVigilance, post-marketing surveillance Offering of samplesOffering of goods and moneySeminarsPromotion outside JapanUpdate envisaged during FY 2012 to follow IFPMA code update

12 September 2012 8Japan Compliance Update

Industrial Code

IFPMA Code of Practice Self regulations adopted by International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)JPMA is a memberUpdated as of 1 August 2012 (renamed to Code of Practice from Marketing Code)Information and materials for promotionEvents, gifts, hospitalityOffering of samplesClinical trialsInternal trainings and education

12 September 2012 9Japan Compliance Update

Pharmaceutical Affairs Law on Advertising

Prohibition of false or exaggerated advertisement

Prohibition of advertisement inferring doctors’ guarantee on effect

Restriction on advertising of certain drugs for designated disease

Prohibition of advertising of unapproved drugs

Criminal offence

12 September 2012 10Japan Compliance Update

MHWL Notice on Advertising under PAL

MHLW General Notice on Advertising (No. 1339 of 1980)Names of drugsPermitted / prohibited expressions in respect of effect and safety Permitted targets – ethical drugs and drugs for general consumersReferring to competitors’ productsProhibition of advertising inducing use of medical drugs for cosmetic purposes or health enhancement purposes

MHLW Various Individual Notice on Advertising

12 September 2012 11Japan Compliance Update

Counterfeit Drug Situation

Kevin Yamaga-Karns

12 September 2012Japan Compliance Update 12

Counterfeit Drug Situation

12 September 2012Japan Compliance Update 13

Customs Seizure Cases <Total of Cialis/Viagra/Levitra>Year 2007 2008 2009 2010 2011 2012

(as of June 30)Seizure Cases* 149 683 652 626 536 339

Tablets Seized 113,708 92,376 82,742 50,427 78,029 389,285

*Total of cases which were notified by the Customs to each of Lilly/Pfizer/Bayer

Police Cases2011:

Japan Police participated ICPO (Interpol) sponsored “Operation Pangea” for the 1st time.14 criminals were arrested in only one week of September.More than 100 illegal websites were either closed-down or rectified.

2012:As of June 30, 14 inquiries from Police regarding counterfeit

cases were made to Lilly/Pfizer/Bayer.

Recent MovementsOn July 23, 2012, IFPMA, EFPIA, PhRMA and JPMA issued joint statement calling for broad-based cooperation to fight online sales of counterfeit medicines around the world(http://www.phrma.org/media/releases/global-pharmaceutical-industry-calls-broad-based-cooperation-fight-online-sales- count)

(http://www.phrma.org/media/releases/joint-industry-statement-internet-sales-access-safe-medicines)

MHLW has budgeted 120 million yen in 2012 to:Improve MHLW’s website to attract more attention in order to raise public awareness of counterfeit drug issueEstablish hotline (call center) to collect information/data of counterfeit drug incidentsEstablish Coordination Committee among MHLW, Customs, pharma industry associations, and pharma companies to coordinate anti-counterfeit efforts.

12 September 2012Japan Compliance Update 14

55% of ED drugs purchased on the Internet were counterfeit55% of ED drugs purchased on the Internet were counterfeit

Consumer Behavior SurveyConsumer Behavior Survey97% of people know that counterfeit drugs are sold on the internet.75% of people think that it is difficult to distinguish counterfeit drugs from

genuine drugs.Yet, 88% of people think that what they purchased online are genuine drugs.

45%

95% of Online Pharmacies were rogue.95% of Online Pharmacies were rogue.

15Japan Compliance Update

Recent Change on

Hospitality Rules

Yoshiki Nagase

12 September 2012Japan Compliance Update 16

Recent ChangesOn April 1, 2012, the changes to the Fair Trade Council rules on hospitality took effectBackground:

Shift of emphasis from the concept of fair trade to consumer protectionAround 80% of the total incidents reported to the FTC were pertaining to excessive entertainmentsThe definitions of allowable entertainment and excessive entertainment were too vagueLack of clear guidance as to the treatment of certain types of entertainments, such as “Nijikai”, where you take out HCPs in 2 or more different venues in one day

12 September 2012Japan Compliance Update 17

MeasuresForgo the concepts of allowable entertainment and excessive entertainmentCreate a positive list with clear upper limit amountsExplicitly prohibit “Nijikai” and “Goraku” (amusement / recreation)

12 September 2012Japan Compliance Update 18

New RulesReceptions after the promo/educ events：

Upper limit of JPY20,000 (USD257) per personMeals provided to the presenters/speakers at the promo/educ events：

Upper limit of JPY20,000 (USD257) per personLunch boxes/beverages provided at the promo/educ events:

Upper limit of JPY3,000 (USD38) per personMeals provided to the participants of advisory board, etc：

Upper limit of JPY20,000 (USD257) per personMeals provided to the presenters/speakers at the internal educational events：

Upper limit of JPY20,000 (USD257) per personMeals provided in conjunction with MR activities：

Upper limit of JPY 5,000 (USD63) per person12 September 2012Japan Compliance Update 19

Q&As

12 September 2012Japan Compliance Update 20

Yoshiki NagaseKevin Yamaga-Karns

Miho Mizuguchi

The Second Asia Pacific Pharmaceutical Compliance Congress

and Best Practices ForumJapan Compliance Update

12 September 2012

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