Promotion of Pharmaceutical Products in Japan and Associated Compliance Issues Marianne Slivkova, J.D., MPH Senior Corporate Counsel Bristol-Myers Squibb
Some Country Facts* Population (2010): 127.5 million GDP (2010): $5.46 trillion Infant mortality rate (per 1,000 live births - 2010): 2.4 Life expectancy (2009) 82.93 years No Direct to Consumer (DTC) advertising of prescription pharmaceutical products permitted Corruption Perception Index: 17/174 countries *Statistics from Transparency International.
Japan Pharmaceutical Market, -The Economist, February 2013
Japan: An increasingly important market
Agenda Regulatory Environment in Japan Relevant Laws and Regulations PAL and associated Regulations JPMA and FCC Voluntary Codes Select Promotional Activities Advertising Materials Samples Speaker Events Interactions with Healthcare Professionals and Institutions Gifts/Payments (JPMA) and Premiums Donations Pharmacovigillance
Regulatory Environment
Laws Governing Marketing and Advertising of Pharmaceutical Products
Relevant Laws/Regulations Pharmaceutical Affairs Law ( PAL ) Lays out general prohibitions against pre-approval promotion, false or exaggerated advertising Regulations on Fair Practices for Advertising of Medicinal Products Ordinance promulgated by Ministry of Health, Labour and Welfare ( MHLW ) Defines acceptable marketing practices Act Against Unjustifiable Premiums and Misleading Representations Excerpts can be found in the back of the English translation of FCC Code Act on Prohibition of Private Monopolization and Maintenance of Fair Trade Japan Pharmaceutical Manufacturers Association Code for Prescription Drugs (JPMA) Voluntary Code; Defines acceptable promotion of prescription pharmaceuticals Breaches of laws, JPMA or other voluntary codes are considered breaches of JPMA code even if such violations are not specifically mentioned in the JPMA Code. Fair Competition Code in Ethical Pharmaceutical Drugs Marketing Industry ( FCC Code) Voluntary Code, but has semi-legal binding aspect Promulgated by the Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry (FTC)
Consequences and Penalties MHLW will handle transgressions of PAL or associated Ordinances Serious breaches of PAL are subject to criminal sanctions and/or monetary penalties FTC may investigate suspected violations Companies shall cooperate If companies fail to cooperate, written warning Failure to comply with written warning, monetary penalties or delisting from enrollment in the code If violation is found, remedial actions to be taken JPMA may also take action against member companies Potential reputational harm cannot be underestimated
Promotional Activities under the JPMA Code
Company Responsibilities Responsibilities of Company and Sales Representatives Trained employees Internal systems necessary to comply with relevant laws, regulations and industry codes No regulatory or industry authority pre-approval req d for promotional materials Companies required to appoint individual responsible for promotional materials and advertising Balanced, accurate, timely information that does not defame competitor s drugs, and that is consistent with rules/regulations
No Pre-Approval Promotion Exceptions for provision of information prior to approval Scientific exchange, e.g. congress, academic society, journal Display of scientific exhibition materials Drugs MUST have been approved in at least one other country No associated literature, etc. exhibited Should be clear that product is not approved in Japan Supply of Reprint or research paper, based on doctor s request Disclosure of information to stock holders in accordance with laws and regulations Risk Areas for Pre-approval Promotion?
Rules for Promotional Materials Promotion to be consistent with drug approval No false, exaggerated or misleading expressions re: efficacy and safety Caution: advertising in journals that appears to be editorial content Balanced presentation of efficacy/safety data, including Adverse Events Do not use phrases such as: highly safe, no deleterious effects or safe as placebo No disparaging of competitor s drugs Things to watch out for: Comparative data comparisons must be based on scientific data Misleading price comparisons Non-clinical studies, or MOA that emphasizes inferior points of competitors drugs Competitor cannot be referred to by brand name, in absence of consent
Rules for Promotional Materials Cont d Extraordinary data should not be presented as fact Issues with case studies No Misleading or indecent photographs, illustrations, etc. Reminder Ads No classic Western type reminder ads Must always include name of product, therapeutic category, regulatory classifications, non proprietary name, and status of NHI drug price listing, and contact address Other restrictions
Samples Distribution (FCC)
Guidelines Concerning Drug Samples Presentation samples Smallest size and quantity Labels will indicate Presentation Samples Purpose to confirm outward characteristics of product, e.g size, smell Clinical Testing Samples Only to HCPs for use for clinical testing in medical institutions Smallest package size * Specific dosage forms *Small Quantity Labels will indicate Clinical Testing Samples Not offered to institutions that have already adopted the drug (unless additional indications) Request in writing by HCP No samples to pharmacies; no offers through wholesalers Time period 1 yr after NHI Listing
Interactions with Healthcare Professionals (FCC and JPMA)
Policy Concerns Interactions with HCPs governed by both FCC and JPMA Code Violation of FCC frequently equals violations of JPMA as well Concern with whether transactions unjustifiably induce purchase or prescribing of pharmaceutical products Rules re: permissible maximum amounts of payments and/or costs of meals for different type of events where healthcare professionals are speakers or audience members Maximum amounts generally strictly adhered to Regulations re: gifs or premiums largely echo IFPMA
Meetings/Seminars with HCPs (JPMA) Purpose: meetings held with Healthcare professionals so company to explain its products/explain scientific info [FCC] restricts seminars and study meetings to prevent them from being held to induce unfair transactions, while the [JPMA Code] takes the point up here on the understanding that using [a seminar opportunity] as an excuse to offer entertainment undermines the status of pharmaceutical companies Venue and refreshments not extravagant Spouses/Guests not included Reimbursement of participant travel expenses permissible Payments to speakers also permissible Presentations to be coordinated with lecturers Seminars should not recommend use of unapproved drugs or disparage competitors drugs Look to both JPMA and FCC Code s FCC provides some additional guidelines regarding cost of meals for attendees at internal vs. external venues (Chairman s Memo FTC 2012)
Gifts/Premiums (JPMA and FCC) JPMA Codes includes guidance on gifts to deal with the offering of gifts from the standpoint of what is appropriate for pharmaceutical companies to offer, irrespective of whether or not the offering of gifts is restricted by the [FCC] Member companies shall not offer to HCPs, medical institutions any gift that could potentially affect the appropriate use of drugs or any gift that is not in good taste (JPMA) Violation of FTC = violation of JPMA Code Cultural gifts: companies need to define clear standards for such gifts, and observe them
Gifts (JPMA) No gift that could potentially affect the appropriate use of drugs, and is not in good taste If gift displays name of product, ensure that it does not appear as advertisement to general public Largely echoes IFPMA Code Items for personal benefit such as CDs or DVDs or sporting, entertainment tickets, electronic items) must not be provided or offered Even if gift is permitted under FCC Code, companies encouraged to examine its suitability with an even more rigorous attitude based on the ethical awareness as a pharmaceutical company, even when they are not deemed a violation of the FCC.
Cash or equivalent payments (JPMA) Generally cash payments prohibited Exceptions: e.g., Condolence payments Payment for Consulting Services Legitimate need for services has been identified Criteria for selecting consultants directly related to identified purpose Payment is appropriate for services provided Written contract Hiring is not inducement to prescribe
Premiums (FCC) Definition of Premium defined as goods, money or other kinds of economic benefits Premiums should not be offered to induce transactions of drugs Small amount/reasonable The FCC sets out specific amounts that may be paid for food/refreshments during outside speaking events, in-house seminars and other activities In keeping with social common sense
Premiums (FCC) Restricted Premiums money, goods, invitation to tours, lavish entertainment and the like Non restricted Premiums Goods/services necessary to use the drugs Medical or pharmaceutical information Drug samples Payment for post-marketing surveillance, clinical trials or other medical or pharmaceutical research Goods/services that are not excessive, in connection with a meeting, or assumption of attendance costs
Overseas Promotional Activities (JPMA) Overseas Promotional Activities Must be consistent with codes of relevant nation Applies when info is provided by distributors Safety related information such as information on serious and previously unknown ADRs, must be reported to the regulatory authorities of the relevant nation Activities Overseas for Japanese HCPs When member companies undertake activities aimed at Japanese healthcare professionals overseas by holding seminars or scientific meetings or at academic conferences overseas, they shall comply with the JPMA Promotion Code
DONATIONS (FCC)
Donations ( Kifukin ) Catch all term Donation system has been in place for decades, but does it provide for sufficient clarity and transparency? Term may encompass research or educational grants, charitable donations, etc. Under FCC Code donations will be restricted if (a) it is in return for advantageous treatment or to avoid threat of unfavorable treatment (b) excessive (c) involves target amounts No restriction for donations for disaster relief
Restricted Donations Restricted donations Assumption of institutions expenses Donation to fund normal operating business quid pro quo donations Other donations, not permitted, or not executed according to the FCC Code
Unrestricted Donations Donations for study and research activities Must be for concrete Academic Study and Reserach Provided in accordance with university s accounting rules Donator to receive brief report of research results No donations to individuals or doctor s offices must be to universities Under above point, donations are permitted to: Donations to Hospitals with Research Functions Research Departments Research money provided in response to request for assistance from pharmaceutical company Analogous to RFP? Must fulfill specified criteria Donations to Lecture Meetings for HCPs General public invited, or wide audience of HCPs Provision of Free Drug for Research Purposes Certain Other Categories of Donations
PAYMENTS FOR POST MARKETING SURVEILLANCE (FCC)
Post Marketing Surveillance Payment for case reports requested by pharmaceutical company (form) in writing where physician has used the drug Money shall not be offered as pretext for case report, nor as inducement or reward for prescribing/purchase Reasonable number of surveys Request made to medical institutions selection of institutions to be unbiased Payment to be made upon receipt of form, except in certain cases
Post Marketing Surveillance Types Early Post Marketing Phase Surveillance For six months after launch No remuneration Drug Use Results Survey Detect/Confirm Side Effects Approx 10,000 Yen per case; not more than 30,000 If long term survey, can be paid per form Can be survey of all cases if req d by authorities Special Drug Use Results Survey Detect/Confirm Side Effects in Special populations (e.g. pregnant women, hepatic dysfunction) an amount not judged excessive Side Effects and Infectious Diseases Report Diseases and Infections suspected to be related to the use of the drug
RESOURCES
Resources:www.jpma.or.jp/english/ http://www.jpma.or.jp/english/isuues/practice.html for JPMA and Transparency Codes in English
Sexual and Power Harassment Issues in Japan Marianne Slivkova, J.D., MPH Senior Corporate Counsel Bristol-Myers Squibb
Sexual Harassment Article 5, Labor Contract Act 2007; also Industrial Health and Safety Law Duty to provide safe and appropriate working environment Equal Employment Opportunity Law (EEOL) Freedom from sexual discrimination; right to have children Duty of care by employers to prevent harassment Administrative complaint procedure
Types of Sexual Harassment EEOL includes two types of harassment largely mirrors divisions in the U.S. quid pro quo Hostile work environment Applies to both men and women Most complaints are hostile work environment
What employers should do Clear internal policies Set out what consequences for harassment may be Helpline/Hotline Ensure appropriate employees are trained to deal with inquiries/help seekers Take appropriate action against harasser and also take appropriate corrective actions Privacy issues No retaliation
Liability Potential criminal and civil liability Legal claims usually brought as civil tort Reasonable employee standard Civil claims monetary recovery by plaintiffs largely insignificant
Power Harassment Relatively new protections against power harassment No statutory definition, but MHLW provided definition for first time in 2012 Any behavior in which a person in a superior position takes advantage of his or her position in the workplace, and causes physical pain or emotional pain or distress, or [a detrimental working environment] MHLW responding to sharp increase in power harassment complains in the last decade
Examples of Power Harassment Examples of Power Harassment identified by MHLW Physical violence or attacks Psychological abuse Isolation Excessive demands Demeaning demands Intrusion upon the individual (e.g. intrusion into an employee's personal life)
Notables Superior position not meant to refer only to rank within workplace Excessive Demands Difficult to define precisely may depend on what employee s scope of duties was expected to be Liability under Power Harassment similar to Sexual Harassment