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					    FINAL VERSION APPROVED BY IPMG MEMBERS



                        IPMG CODE
       OF PHARMACEUTICAL
    MARKETING PRACTICES
                    2007 Revision




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                                                                                                         FINAL VERSION APPROVED BY IPMG MEMBERS


                                    IPMG Code of Pharmaceutical Marketing Practices
                                                                 2007 Revision


                                                                   PREAMBLE


(i) The ethical promotion of prescription medicines is vital to the pharmaceutical industry’s mission of helping patients by discovering, developing
    and marketing new medicines. Ethical promotion helps to ensure that healthcare professionals have access to information they need, that
    patients have access to the medicines they need and that medicines are prescribed and used in a manner that provides the maximum
    healthcare benefit to patients.


(ii) IPMG and its members are committed to educational and promotional efforts that benefit patients and promotional programs and collaborations
    that enhance the practice of medicine. IPMG also seeks to preserve the independence of the decisions taken by healthcare professionals in
    prescribing medicines to patients. The pharmaceutical industry has an obligation and responsibility to provide accurate information and
    education about its products to healthcare professionals in order to establish a clear understanding of the appropriate use of prescription
    medicines. Industry relationships with healthcare professionals must support, and be consistent with, the professional responsibilities healthcare
    professionals have towards their patients. Pharmaceutical companies must maintain high ethical standards when conducting promotional
    activities and comply with applicable legal, regulatory and professional requirements. Through the promotion of this Code, IPMG seeks to ensure
    that ethical promotional practices are established nationwide.


(iii) The IPMG Code of Pharmaceutical Marketing Practices (the “IPMG Code”) sets forth standards for the ethical promotion of pharmaceutical
    products to healthcare professionals, and for member companies’ interactions with them. Effective January 1st, 2007, this Code will be applied to
    all members of IPMG.
(iv) IPMG acknowledges the role of relevant codes of ethics developed by all other health care associations. IPMG also commits to adhere to the
    prevailing laws and regulations related to health care in Indonesia.
(v) The IPMG Code contains provisions relating to scope, applicability and guiding principles (Articles 1-2), the content of promotional material
    (Articles 3-6); interactions with healthcare professionals (Articles 7-8); company procedures and responsibilities (Article 9); and operation and
    enforcement (Article 10). It also includes a Q&A section to assist in interpretation of the IPMG Code and details the operating procedures for
    Code complaints (Appendix 1).


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(vi) It is a requirement of IPMG membership to accept the conditions of the IPMG Code


(vii) IPMG member companies are accountable for addressing and correcting infringements under relevant codes. They should also ensure that
    internal structures and procedures (including adequate training of employees) are created to ensure responsible and ethical promotional
    activities.


(viii) The IPMG is open to receive genuine complaints from any source on any aspect of the IPMG Code, in accordance with its operating procedures.
    Where it is determined that there has been a breach of the IPMG Code, the objective is to correct the matter as rapidly as possible.


(ix) The IPMG is a non-profit, non-governmental organization representing multinational research-based pharmaceutical companies in Indonesia.
    Companies are committed to the ethical standards set out in this Code.


                                                                       *****




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                                                                        THE IPMG CODE

                                   CODE OF CONDUCT OF PHARMACEUTICAL MARKETING PRACTICES IN INDONESIA
                                                              2007 REVISION
                                                           (18th October, 2006)



Code of Conduct 2007 Revision                                                          Q&A

CHAPTER I
THE OBJECTIVE
The objective of this Code is to define the high standards that must be abode Q&A 1
by the industry in the ethical promotion of pharmaceutical products to Q: Does the Code regulate communications with the public?
healthcare professionals as well as to establish the process of self-discipline to
                                                                                   A: No. The Code covers interactions with healthcare professionals and the promotion
ensure that member companies’ interactions with healthcare professionals are          of pharmaceutical products. Where direct promotion to the public is allowed, this is
appropriate and perceived as such to serve best the public interests toward an        covered by other laws, regulations and/or relevant codes of practice. All IPMG
improved health level of the society and promotes the rational use of drugs.          member companies should of course, comply with these laws, regulations and/or
Q&A 1                                                                                    codes.




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Proposed CoC 2007 Revision                                                             Q&A

CHAPTER II
THE CODE OF CONDUCT

Article 1
IMPLEMENTATION OF THE CODE

II.1.1. Scope                                                                       Q&A 2
For the purposes of this Code:                                                      Q: To whom does the Code apply?"
- “Pharmaceutical product” means any pharmaceutical or biological product A: The Code applies to IPMG member companies. Pharmaceutical companies that
    (irrespective of patent status and/or whether it is branded or not) which is       are members of neither IPMG nor its affiliated member associations fall outside the
    intended to be used on the prescription of, or under the supervision of, a         reach of the Code. IPMG encourages such companies -- and other organizations
    healthcare professional, and which is intended for use in the diagnosis,           marketing healthcare products or services to healthcare professionals -- to follow
    treatment or prevention of disease in humans, or to affect the structure or any    ethical promotion standards similar to those set forth in the Code.
    function of the human body.
   Q&A 2
- “promotion” means any activity undertaken, organized or sponsored by a
   member company which is directed at healthcare professionals to promote
   the prescription, recommendation, supply, administration or consumption of
   its pharmaceutical product(s) through all media, including the internet.
- “healthcare professional” means any member of the medical, dental,
   pharmacy or nursing professions or any other person who in the course of his
   or her professional activities may prescribe, recommend, purchase, supply,
   or administer a pharmaceutical product.
- “member company” means any company that is a member of IPMG




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Proposed CoC 2007 Revision                                                          Q&A

II.1.1.Scope (continue ……)                                                          Q&A 3
Exclusions: This Code does not seek to regulate the following activities:           Q: Why does the Code not cover public disease awareness campaigns?

• Promotion of prescription only pharmaceutical products directly to the general A: The Code covers interactions with healthcare professionals and the promotion of
                                                                                    pharmaceutical products. A public disease awareness campaign targeted at the
  public (i.e. direct to consumer advertising).
                                                                                       public must not promote specific pharmaceutical products. Whilst not covered by
   Q&A 1, Q&A 3                                                                        the Code, disease awareness campaigns must of course comply with other laws,
                                                                                       regulations, and/or codes.
• Promotion of self-medication products that are provided “over the counter”
  without prescription.
                                                                                    Q&A 4
   Q&A 4                                                                            Q: Does the Code apply to the promotion and marketing of OTC products that may
                                                                                       also be prescribed by healthcare professionals?
• Pricing or other trade terms for the supply of pharmaceutical products.
                                                                                    A: Yes. The Code applies to the promotion of OTC products directed towards
   Q&A 5                                                                               healthcare professionals. However, the promotion of OTC products to consumers
                                                                                       falls outside the scope of this Code.
• The engagement of a healthcare professional to provide genuine consultancy
  or other genuine services to a member company.
                                                                                    Q&A 5
   Q&A 6                                                                            Q: Does the Code prohibit member companies from giving its customers discounts or
                                                                                       other favorable trade terms for the supply of pharmaceutical products?
• The conduct of clinical trials.
                                                                                    A: No. The Code does not restrain or regulate commercial trade terms for the supply
• The provision of non-promotional information by member companies.                    of pharmaceutical products. IPMG encourages competition among companies.
   Q&A 7                                                                            Q: Does the Code apply to the promotion and marketing of pharmaceutical products
                                                                                       to commercial customers who are also practicing healthcare professionals, such
                                                                                       as a pharmacist who operates his/her own practice.
                                                                                    A: The Code does apply to the promotion and marketing of pharmaceutical products
                                                                                       to such a customer. However, the Code does not restrain or regulate commercial
                                                                                       trade terms for the supply of pharmaceutical products, to customers. In any
                                                                                       dealings with such a customer, companies should respect the customer’s role as a
                                                                                       healthcare professional and, if applicable, comply with the requirements of the
                                                                                       Code.

                                                                                    Q: Does the Code apply to the promotion and marketing of pharmaceutical products
                                                                                       to commercial customers who are not healthcare professionals? What if the
                                                                                       customer is a healthcare professional by qualification but is not practicing?



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    A: No. The Code only applies to interactions with practicing healthcare professionals.
       Promotion and marketing to commercial customers (whether or not they are
       healthcare professionals) may of course be governed by other laws and
       regulations, such as those that restrict or prohibit inaccurate, misleading or
       deceptive advertising and promotion or restrict or prohibit the giving of
       inducements to public officials or employees.

    Q: Does the Code cover price lists or other documents describing terms of trade?
    A: No.

    Q: Could a false price claim or a misleading price comparison in promotional material
       be processed under the Code?
    A: Yes, this is possible when a company is inappropriately using pricing information in
       its promotional materials or activities.

    Q&A 6
    Q: In the absence of any formal industry guidelines or local laws, how should
       companies interact with healthcare professionals who are offering legitimate
       consultancy services?
    A: It is appropriate for consultants who provide services to be offered reasonable
       compensation for those services and to be offered reimbursement for reasonable
       travel, lodging, and meal expenses incurred as part of providing those services.
       Compensation and reimbursement that would be inappropriate in other contexts
       can be acceptable for genuine consulting arrangements. Token consulting or
       advisory arrangements should not be used to justify compensating healthcare
       professionals. The following factors support the existence of a genuine consulting
       arrangement (not all factors may be relevant to any particular arrangement):
      • a written confirmation which specifies the nature of the services to be provided
        and the basis for payment of those services;
      • a legitimate need for the services has been clearly identified in advance of
        requesting the services and entering into arrangements with the prospective
        consultants;
      • the criteria for selecting consultants are directly related to the identified purpose
        and the persons responsible for selecting the consultants have the expertise
        necessary to evaluate whether the particular healthcare professionals meet
        those criteria;
      • the number of healthcare professionals retained is not greater than the number
        reasonably necessary to achieve the identified purpose;


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      • the retaining company maintains records concerning and makes appropriate
        use of the services provided by consultants; and
      • the hiring of the healthcare professional to provide the relevant service is not an
        inducement to prescribe a particular product.

    Q&A 7
    Q: What are the examples of non-promotional information that is not covered by the
       Code?
    A: Correspondence, possibly accompanied by material of a non-promotional nature,
       needed to answer a specific question about a particular medicinal product is not
       covered by the Code.
       Non-promotional, general information about companies (such as information
       directed to investors or to current/prospective employees), including financial data,
       descriptions of research and development programs, and discussion of regulatory
       developments affecting the company and its products is also not covered by the
       Code.




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Proposed CoC 2007 Revision                                                            Q&A

II.1.2. Application and Execution
In all matters related to the application, interpretation and execution of any part
of this Code, it is to be understood that adherence to the prevailing laws and
regulation should come first.
II.1.3. Responsibility
Full adherence to this Code is a pre-requisite for a membership in the IPMG.

The President Director and other Board members are responsible for the best
compliance with this Code.

Companies with licensing or agency agreement in Indonesia are expected to
require their licensees and agents to respect this Code.




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Proposed CoC 2007 Revision                                                          Q&A

II.1.4. General Principles:
II.1.4.1. Basis of Interaction: Member companies’ relationships with healthcare
professionals are intended to benefit patients and to enhance the practice of
medicine. Interactions should be focused on informing healthcare professionals
about products, providing scientific and educational information and supporting
medical research and education.

II.1.4.2. Independence of Healthcare Professionals: No financial benefit or
benefit-in-kind (including grants, scholarships, subsidies, support, consulting
contracts or educational or practice related items) may be provided or offered to
a healthcare professional in exchange for prescribing, recommending,
purchasing, supplying or administering products or for a commitment to continue
to do so. Nothing may be offered or provided in a manner or on conditions that
would have an inappropriate influence on a healthcare professional’s prescribing
practices (No quid pro quo).




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Proposed CoC 2007 Revision                                                         Q&A

II.1.4.3. Appropriate Use: Promotion should encourage the appropriate use of Q&A 8
pharmaceutical products by presenting them objectively and without Q: Is it ever appropriate for a company to publish promotional materials that appear to
exaggerating their properties.                                                 be independent editorial content?

II.1.4.4. Transparency of Promotion: Promotion should not be disguised. A: No. Where a company finances or otherwise secures or arranges the publication
                                                                                 of promotional material in journals, such promotional material must not resemble
Clinical assessments, post-marketing surveillance and experience programs and
                                                                                 independent editorial matter.
post-authorization studies must not be disguised promotion. Such assessments,                                           **
programs and studies must be conducted with a primarily scientific or Q: How does the prohibition of pre-approval promotion affect compassionate use
educational purpose. Material relating to pharmaceutical products and their      programmes?
uses, whether promotional in nature or not, which is sponsored by a company
should clearly indicate by whom it has been sponsored.                        A: The clause does not prevent compassionate use programmes which must of
                                                                                      course comply with all applicable laws, regulations and codes. Care should be
Q&A 8                                                                                 taken to ensure that communications for a compassionate use programme are not,
                                                                                      in effect, advertisements for an unlicensed medicine or use.




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Proposed CoC 2007 Revision                                                        Q&A

Article 2
INFORMATION AND CLAIMS

II.2.1. General Criteria
Information and claims for pharmaceutical products should be fair, objective,
accurate and represent a balance of the evidence.
Information and claims should also be presented to a high ethical standard, in
compliance with the latest BPOM authorized product information and in such a
way as not to be misleading or ambiguous

II.2.2. Scientific Evidence
Information provided should be based on the latest evaluation data which are
supported by scientifically valid evidence, accurate, clear and presented in a Q&A 9
way that is not misleading. The scientific data should be referenced and Q: Does the Code allow for quotations to be included in promotional
traceable. In-vitro and animal test data should be clearly marked as such, in    materials?
order not to give an incorrect or misleading impression. These criteria are
applicable for product(s) being promoted as well as for other products being A: Yes. Quotations from medical and scientific literature or from personal
quoted for reference or comparative purpose                                      communications should be faithfully reproduced (except where adaptation
                                                                                 or modification is required in order to comply with any applicable codes, in
Q&A 9                                                                            which case it must be clearly stated that the quotation has been adapted
                                                                                 and/or modified) and the precise sources identified. Quotations should not
                                                                                 change or distort the intended meaning of the author or clinical investigator
                                                                                 or the significance of the underlying work or study.




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Proposed CoC 2007 Revision                                                            Q&A

II.2.3. Requests for information
Companies should handle requests for information from healthcare
professionals with objectivity and good intention by providing accurate and
relevant data. Reponses to requests for data to support promotional claims
should be completed within a maximum of 3 months from the date of the
request.

II.2.4. Safety Data
II.2.4.1. Information on the product safety, as well as contraindications, warnings
and side effects should conform with those currently approved by Badan POM

II.2.4.2. The word “safe” and “no side effects” should generally be avoided and
should not be used without adequate qualification or explanatory notes.

II.2.4.3. All companies are obliged to report adverse drug reactions associated
with their products in accordance with related regulation of competent authority.

All companies should have appropriate system and procedure to collect, monitor
and report on ADR to comply with internationally accepted requirement.




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Proposed CoC 2007 Revision                                                                         Q&A

II.2.5. Incorrect of Misleading Claims
Information, promotional claims, supporting data and audio, graphic or other visual
presentations shall not be directly or indirectly misleading by omission of certain part or
by distortion of evidence or expert opinion.
Information should be based on scientifically valid evidence and in conformity with
product information as approved by Badan POM
Some examples of what is not permissible and therefore considered as violations of this
Code:
II.2.5.1. Quoting vague inferences from clinical evidence or experience that cannot be
validated. Therefore, it is recommended to quote results of specific, published studies.
II.2.5.2. Using or quotating data from a study, which is not relevant to the claim(s) being
made. Presenting data to support a claim without a reference to the published study.
II.2.5.3. Claims based on data that are no longer applicable, e.g. that have been proven
invalid or replaced by the results of more recent research.
II.2.5.4. Dosage recommendations or claims for an indication that do not comply with the
Badan POM approved product information.
II.2.5.5. Using In-Vitro data or data from animal studies which are not clearly identified
as such or which is presented in a way that is misleading or implying that it is In-Vivo
and/or human data.
II.2.5.6. Presentations or layouts that lead to an incorrect or misleading interpretation
e.g.: important and relevant data but actually not supporting the promotional claims,
relegated to fine print; manipulating scales on graphs/charts etc to distort comparisons
with competitor’s product.
II.2.5.7. Negative statements concerning competitive products that bearing no scientific
basis or are refutable based on current evidence or having no relevance to the product
being promoted.
II.2.5.8. Claims implying a product’s efficay for a certain indication but ignoring the
warning or caution applicable to its use in such circumstances.
II.2.5.9. Claims utilizing evidence or quotations :
     - Which have been selectively presented to misleadingly highlight advantages
     - Which are presented or quoted beyond or out of context



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     - Which are quoted or presented in such a way as to distort the meaning or
       objective of the author.
II.2.5.10. Non-medical or non-scientific claims with no evidence.
II.2.5.11. Unqualified superlative claims or hanging comparatives - (see Paragraph
II.2.6. below)
II.2.5.12. Comparisons with competitive products that are not based on scientifically
valid evidence or which distort the evidence or which are not objective and reasonable
(see Paragraph II.2.7 below)


II.2.6.   Unqualified Superlative Claims and Hanging Comparative claim
II.2.6.1. Making unqualified superlative claims are not allowed, e.g.:
     “Product X is the best treatment for condition Y. ”
     “Product X is the fastest treatment for condition Y.”
     “Product X is the strongest / most powerful treatment for condition Y”
     “Product X is the safest treatment for condition Y.”
     If these or other superlatives are used, then the claims must be provable supported
     by scientifically valid evidence.

II.2.6.2. Hanging comparative claims should not be made, e.g.:
     “Product X is better/stronger/faster/safer for condition Y”

   A comparative claim must include a statement that indicates against what the product
   is better/stronger/faster/safer etc and that this superiority is supported by current
   scientifically valid evidence. (For more on comparisons see Paragraph II.2.7 below).

II.2.7.   Comparisons
II.2.7.1. Comparisons between products should be honest, based on facts proven by
scientific evidence. In presentating the results there should be no attempt to deceive by
distortion, unreasonable emphasis or other means. Comparisons in bad taste or
insulting to competitors’ or their products should be avoided.
II.2.7.2. Comparisons on efficacy and safety should not be based on data that does not
reflect the current published literature or that are from different database not comparing
the same thing
II.2.7.3. Comparisons on efficacy and safety should consider all the aspects of efficacy
and safety. If a comparison is made based on one parameter only, then this should be
clearly stated.
II.2.74. Data used to support comparative claims should satisfy the requirements of


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statistical significance. If data do not meet this conditions, then they should be clearly
marked as such and should not be used to generalize or to support claims indicating
equality or superiority against another product. The statistical significance indicator (i.e.
the “P” value) should accompany comparative data.
                                                                                                     Q&A 10
Q&A 10                                                                                               Q: Does the Code allow for comparisons between different products to be included in
                                                                                                        promotional materials?
II.2.8.   Imitation or Copying of Other Companies’ materials
A company should not deliberatelhy imitate or copy other company’s                                   A: Yes. Any comparison made between different pharmaceutical products should be
marketing/promotional/advertising materials, which might lead to misleading or                          based on relevant and comparable aspects of the products and be capable of
confusion.                                                                                              substantiation. Comparative advertising should not be misleading.
II.2.9.   Healthcare Professionals in Promotion Materials
Names or photographs of healthcare professionals or institutions should not be used in
promotional/advertising materials in a way that violates the medical code of ethics.

It is, however, acceptable to use the names and photographs in proceedings of scientific
meetings (e.g. where a healthcare professional has made a presentation) but it is not
acceptable to do so in promotional brochures, journal advertisements and the like.
II.2.10. Hidden Promotion/Advertising
II.2.10.1. Promotional materials such as mailings and medical journal advertisements
should be clearly marked as such so that its real nature is not disguised, e.g.
Advertisements in journals which is part of the editorial should be marked
“PROMOTIONAL ADVERTISEMENT” or “ADVERTORIAL” in capital letters of the
largest pitch used in the body text of the advertisement.
II.2.10.2. All Clinical Trials should be conducted in accordance with the Good Clinical
Practice (GCP) guidelines. Post-Marketing studies should not be conducted merely as a
means to promote a product or to influence healthcare professionals with little or no
scientific basis.



II.2.11. Pre-Registration communications and Off-label Use
A product shall not be promoted until the requisite license to market for such use
has been granted by Badan POM.

This provision, however, is not meant to limit the rights of the scientific
community and the general public to have complete information on advances in
the scientific and medical fields, provided that the results of the research have


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been acknowledged internationally. It is also not meant to limit the full and
proper exchange of scientific information on a product, including the
dissemination of research findings in the scientific or general communications
media or through scientific congresses.

Likewise, this provision should not limit public disclosure to shareholders and
other parties concerned with the product as may be required by law or
regulation.

With respect to international or regional conferences being held in Indonesia
research findings on a product not approved for the Indonesian market or which
are registered under different conditions, may be communicated provided that
this is done in a proper and responsible manner and in accordance with Article 2
of this Code. It should also be accompanied by:
- An explanatory statement indicating that the product has not yet been
  approved by Badan POM in Indonesia, or
- An explanatory statement indicating that registration conditions differ
  internationally, and,
- An explanatory statement should identify the countries in which the product is
  registered and make it clear that it is not available locally.




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2007 Revision Proposed CoC                                                        Q&A

II.2.12. Company procedures
II.2.12.1. Companies should establish and maintain appropriate procedures to
ensure full compliance with relevant codes and applicable law and to review and
monitor all of their promotional activities and materials. A designated company
employee, with sufficient knowledge and appropriate scientific or healthcare
qualifications should be responsible for approving all promotional
communications. Also, a senior company employee could be made responsible,
provided that scientific advice is taken.




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Proposed CoC 2007 Revision                                                        Q&A

Article 3
MEDICAL REPRESENTATIVES

II.3.1.The company is fully responsible for the quality and conduct of their Q&A 11
medical representatives
                                                                                  Q: Do all MRs have to be certified?
II.3.2. MR must be adequately trained and possess sufficient medical and A: It applies to all MRs (age below 50) who have been employed within the industry
technical knowledge, evidently by possessing a certificate issued by        for minimum period of 2 years and who have been with their current employer for
acknowledged independent institution.                                       minimum period of 1 year. Non-compliance with this requirement is deemed to be
                                                                                     10% of eligible MRs as not having passed the MR certification test (IPMG
Q&A 11                                                                               Circulation 2004)

II.3.3. MR should be able to give technical explanations on their company’s
products in an accurate, fair, and in an ethical manner to the members of the
healthcare professionals’ organization.

II.3.4. MR should be prohibited to give or offer rewards to the members of
healthcare professions other than as specified in the point 5 below.

II.3.5. MR in doing their duties should show good conducts when visiting the
members of healthcare professions

II.3.6. The ruling on MR should be adjusted from time to time in order to be in
compliance with the prevailing regulations/laws issued by the relevant
government institutions governing the manufacturers and distributors (PBF) or
other similar companies.




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Proposed CoC 2007 Revision                                                             Q&A

Article 4
INTERACTIONS WITH HEALTH CARE PROFESSIONALS
II.4.1. SCIENTIFIC AND EDUCATIONAL MEETINGS (“EVENTS”)
II.4.1.1. Understandings and Objectives
The purpose and focus of all symposia, congresses and other promotional,
scientific or professional meetings (an “Event”) for healthcare professionals
organized or sponsored by a company should be to inform healthcare
professionals about products and/or to provide scientific or educational
information.
II.4.1.2. The participation of a company or an association in a symposium,
congress or the like should be declared clearly during the meeting and in any
printed proceedings from the meeting.
Printed, audio, visual or electronic material from the meeting should accurately
reflect the presentations and discussions of the event.

II.4.1.3. If the meeting program is accredited for post graduate education by a
medical association or other professional organization, the responsibility for the
program content remains with that organization. Any support from the
pharmaceutical industry should be sufficiently stated or disclosed.

II.4.1.4. Companies are prohibited from offering any kind of induction,
appreciation, door prize, incentive, financial reward to the medical profession.
                                                                                 Q&A 12
II.4.1.5. Events Involving Foreign Travel:                                       Q: When is it appropriate and justified for a company to organize or sponsor an event
No company may organize or sponsor an Event for healthcare professionals            for healthcare professionals outside of Indonesia?
(including sponsoring individuals to attend such Event as described in article A: A company can only organize events involving travel if it is justified, i.e.:
4.3) that takes place outside of their home country unless it is appropriate and    (a) A significant proportion of the invited healthcare professionals are from
justified to do so from the logistical or security point of view. International          outside of Indonesia, and it makes greater logistical or security sense to hold
                                                                                         the event in another country; or
scientific congresses and symposia that derive participants from many countries
are therefore justified and permitted                                               (b) The relevant resource or expertise that is the object or subject matter of the
                                                                                              event is located outside of Indonesia.
Q&A 12



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Proposed CoC 2007 Revision                                                         Q&A

II.4.2. SPONSORSHIP
Member companies may sponsor healthcare professionals to attend Events
provided such sponsorship is in accordance with the following requirements:

II.4.2.1. The Event complies with the hospitality requirements in this Code as
described in article 4.5.

II.4.2.2. Any sponsorship provided to individual healthcare professionals must
not be conditional upon any obligation to promote, recommend or prescribe any
pharmaceutical product.
                                                                               Q&A 13
II.4.2.3. Sponsorship to healthcare professionals is limited to the payment of Q: Is partial sponsorship allowed?
transportation to and from the event, meals, accommodation and registration
                                                                               A: Generally, partial sponsorships are allowed; however, these should be properly
fees for the scientific related events.
                                                                                      backed up by good documentation and/or evidences, e.g. copy of third party’s
Q&A 13                                                                                invoices, etc.

II.4.2.4. It is not allowed for companies to pay for any expenses of Q&A 14
accompanying person/s, be it the spouse or family member of invited medical Q: It is not allowed for companies to pay for any expenses of accompanying person/s.
participant.                                                                    What is the definition of any expenses?
Q&A 14                                                                             A: Expenses considered unallowable for accompanying person are extra hotel room
                                                                                      charge, any tour for sight seeing, airfare, etc. The principle should be that
                                                                                      additional expenses which will be incurred due to any accompanying person
II.4.2.5. It is prohibited to give honorarium to compensate a healthcare              presence is not allowed.
professionals for time spent in attending a scientific meetings. (Honorarium is       Exception to this ruling is allowed if the spouse is also a health care professional
however permitted for speakers/ moderators at a meeting – see article 4.3.)           and as participant of scientific event.
                                                                                   Q: Is it allowed to invite the spouse to join an official dinner?
                                                                                   A: No, spouse can’t be invited to join a dinner followed by a scientific event and this
                                                                                       should be clearly mentioned in the invitation (eg this invitation is valid only for
                                                                                       healthcare professional). Despite all effort to prevent Spouse participation in case
                                                                                       it is considered as culturally unacceptable and impolite to turn down spouses from
                                                                                       joining the dinner, reasonable spouse participation may be acceptable. The spirit
                                                                                       behind this is to have dinner for health care professional only to the extent
                                                                                       possible. Company management should make every effort to abide with this spirit.



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                                                                                     Q: Is it allowed to sponsor payment of Room Rental?
                                                                                     A: The Code does not preclude the payment of room rental to postgraduate medical
                                                                                         centres and the like, however, payment of Room Rental to doctors or groups of
                                                                                         doctors is not permissible even if such payment is made to equipment funds or
                                                                                         patients’ comforts funds and the like or to charities of companies (ABPI 2003).

II.4.3. SPEAKER HONORARIUM                                                      Q&A 15
Payment for reasonable honoraria and out-of-pocket expenses, including travel
and accommodation, may be provided to healthcare professionals who are Q: What is the definition of “Official Tariff” of speaker fee?
providing genuine services as speakers, presenters or moderators on the basis A: It is a written announcement issued by an institution. However some tariffs are
of a written confirmation.                                                        printed without a letter head and not signed. It is recommended to check the
The amount of the honorarium for local speakers/moderators at local meetings      authenticity of the tariff with a responsible person of the institution
should not be more than IDR 6,000,000 net unless there is an official tariff in
such institution. Honorarium for local speakers at overseas meetings should be
adjusted to conform with regular practice in the country where the meeting is
held.
The honorarium for foreign speakers at local meetings should be at the level of
normal practice in the speaker’s home country.

Q&A 15




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Proposed CoC 2007 Revision                                                        Q&A

II.4.4. HOSPITALITY
II.4.4.1. Appropriate Venue for Hospitality: All Events should be held in an
appropriate venue that is conducive to the scientific or educational objectives
and the purpose of the Event or meeting. Companies should avoid using
unreasonably renowned or extravagant venues. The additional requirements set
forth in this Article 4 of this Code also apply accordingly.
II.4.4.2.. Limits of Hospitality: Hospitality should be limited to refreshments
and/or meals incidental to the main purpose of the Event and should only be
provided if it is moderate and reasonable as judged by local standards          Q&A 16
                                                                                  Q: What is “unreasonably renowned or extravagant venues”?
II.4.4.3. Stand-alone Entertainment: No stand-alone entertainment or other A: The use of 5 star hotels are acceptable in Indonesia. As a general understanding,
leisure of social activities should be provided or paid by companies. At events, the hotels of which room charge/room/day is less than US$ 150 (weekday rate
entertainment of modest nature which is secondary to refreshments and/or         before tax & services) are acceptable.
meals is allowed.
                                                                                  Q: The Code prohibits stand-alone entertainment, leisure or social activities but allows
Q&A 16
                                                                                     entertainment of modest nature in conjunction with meals, etc., which is secondary
                                                                                     to the main purpose of the event. How should companies interpret this in
                                                                                     practice?
                                                                                  A: When a company organizes a meeting and refreshments are provided, e.g., an
                                                                                     evening meal for a meeting stretching over more than one day, it would be
                                                                                     permitted to provide some background music during the meal or to have an
                                                                                     interlude when some low-key local singers perform. However it would not be
                                                                                     appropriate for a company to fund attendance at a concert by those same
                                                                                     performers as this would be self standing and not incidental to the refreshments
                                                                                     and the Code also prohibits the purchase of entertainment tickets. A self standing
                                                                                     sightseeing tour would not be permitted but this would not prohibit a commentary
                                                                                     about sights of interest en-route to a restaurant. The 'modest nature' of the
                                                                                     entertainment may be interpreted as prohibiting high profile, inappropriate or
                                                                                     expensive entertainers-even if their performance is secondary to a necessary
                                                                                     meal. So an appearance by a well known TV or pop star would not be considered
                                                                                     as modest whereas a folk dance display or performance by a local singer would be
                                                                                     acceptable as entertainment for a meal interlude.

                                                                                  Q: What would be our guideline to members on the sponsorship of Gala Dinner at a
                                                                                     congress where there is no Scientific meeting held during the occasion?



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     A: Gala dinner is prohibited as it is considered to be violating:
        * II.4.4.3. (it is more than modest nature and not secondary to refreshments and/or
            meals.) and/or
        * II.4.2.4. (Normally spouses are invited to Gala dinner. So it is against the code.)

     Q: What about evening dinner cruise held as part of the congress by a member
        company?
     A: Cruise Dinner is not allowed as it is more than modest nature and not secondary to
        refreshments and/or meals.

     Q: Is there any examples of such scientific, educational or promotional meetings
        (“events”) permitted to be sponsored or organized by companies?
     A: Pharmaceutical companies may appropriately sponsor or organize a wide range of
        meetings, such as (ABPI 2003):
        - Lunchtime audio-visual presentations in a group practice
        - Hospital meetings
        - Meetings at postgraduate education centres
        - Launch meetings for new products
        - Related Management training courses
        - Meetings of clinical trialists
        - Patient Support Group Meetings
        - Satellite Symposia
        - International Meetings organized by independent bodies with sponsorship from
           pharmaceutical companies, etc.

     Q: What are any requirements with those meetings/ events with hospitality?
     A: With any meeting, certain basic principles apply (ABPI 2003):
        - Meeting must have a clear educational content.
        - Hospitality must be provided in association with such meetings, its level should
           be secondary to the purpose of the meeting, must be appropriate and not out of
           proportion to that occasion, in time spent and cost. Its cost should not exceed
           that level which the majority of recipients might normally adopt when paying for
           themselves.
        - Hospitality should not extend beyond members of the profession unless that
           person is a member of the health professions or appropriate administrative staff
           and qualifies as a proper delegate or participant at the meeting in their own
           right.

     Q: Any examples where administrative staff may be invited to meetings?



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                                                                                         A: Where appropriate, for example, receptionists might be invited to a meeting in a
                                                                                            general practice when the subject matter related to practice administration (ABPI
                                                                                            2003).
II.4.4.4. Exhibitions Stands:
II.4.4.4.1. Exhibitions or hospitality booths, stalls, counters and the like should be
secondary to – and not detract from – the scientific objectives of the event.

II.4.4.4.2. Exhibitions are to be organized solely for the purpose of healthcare
professionals.
The name of the company/exhibitor should be clearly visible and the exhibitions
itself should comply with the provisions as set by organizing committee.
II.4.4.4.3. Quiz or raffles prizes, e.g. gimmick such as pen, note book, etc should
not be worth more than IDR 200,000/ participant except if the prize is in the form
of scientific/medical materials e.g. medical textbook, medical devices or items of
medical utility (should not be worth more than IDR 5,000,000/participant), and
maximum for 10 participants in each event. (See article 5.2.4.). Please refer to
Q&A 16.

II.4.4.4.4. Distribution of product samples should refer to the applicable
regulation as stipulated by BPOM.

II.4.4.4.5.Other activities such as games, raffles, karaoke, dancing and the like
should not be held at times when the scientific sessions are in progress so as to
avoid disturbing or distracting participants from the prime objectives of the
meeting




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Proposed CoC 2007 Revision                                                               Q&A

II.4.4.5 Sponsorship which is not related with scientific activities such as Pre-
and Post Congress tours, or sports activities are not allowed.

II.4.4.6. Companies should not deliberately interfere or attempt to undermine a
single company sponsored scientific event (e.g. a meeting which is not at or part
of national, regional or international congress).




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Proposed CoC 2007 Revision                                                             Q&A

Article 5
GIFTS AND ITEMS OF MEDICAL UTILITY                                                     Q&A 17
                                                                                       Q: Can we provide healthcare professionals with member company’s own
II.5.1. General Principles                                                             pharmaceutical products if they ask for their personal use?
No gift/rewards, incentives, donations, financial, and the like shall be offered or
given to healthcare professionals in return for prescriptions or                       A: No, you cannot. It is considered as a violation against II. 5.2.2. (Personal
recommendations for a company’s medicines(s)/product(s).                               Gifts).

II.5.2. GIFTS                                                                     Ref: Donation for disaster or poor patients, please refer to II.5.3. (Donation)
II.5.2.1.Cash: Payments in cash or cash equivalents (such as gift certificate) and Q&A related.
must never be offered to healthcare professionals.
                                                                                  Q: What kinds of items are permissible as promotional aids (Promotional
II.5.2.2. Personal Gifts:                                                            Give-Away)?
Gifts for the personal benefit of health care professionals (including, but not
limited to, music CDs, DVDs, sporting or entertainment tickets, electronic items) A: Promotional aids should be of minimal value (max Rp. 200.000,- per item)
must not be provided or offered.                                                     and should be related to the work of the recipient healthcare professional.
                                                                                     Possible examples include:
II.5.2.3. Promotional Give-Away (Gimmick):         Promotional aids or reminder      - pens, notepads, diaries
items may be provided or offered to healthcare professionals and appropriate         - surgical gloves, nail brushes
administrative staff, provided the gift is of minimal value and relevant to the      - a pick flow whistle
practice of the healthcare professional, (maximum of IDR 200,000).                   - walking sticks
                                                                                     - desk trays, desk clocks, calendar, etc (ABPI 2003)
Q&A 17                                                                               Promotional items intended for the personal benefit of the healthcare
                                                                                  professional, such as music CDs, paintings or food baskets would not be
                                                                                  acceptable.-Brand or company name / logo has to appear on the
                                                                                     item




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Proposed CoC 2007 Revision                                                        Q&A

II. 5.2.4. Items of Medical Utility: Items of medical utility may be offered or Q&A 18
provided free of charge provided that such items are of modest value and are Q: What kinds of items are envisaged as being items of medical utility?
beneficial to the provision of medical services and for patient care.
                                                                                A: Items might include items which primarily involve a patient benefit such as:
Q&A 18                                                                             - anatomical model for use in an examination room,
                                                                                   - medical educational CDs, DVDs, VCDs or the like
                                                                                   - selected medical devices (such as stethoscope, sphygmomanometer,
                                                                                      otoscope, ophthal-moscope, laryngoscope, reflex hammer, head mirror,
                                                                                      rhinoscope, medical thermometer, glucometer, tongue refractor,
                                                                                      magnifier lens for medical use, weight and height scales)
                                                                                   - medical textbooks
                                                                                   - medical journals

                                                                                     Requirements:
                                                                                     - They should be of modest value and primarily involve a patient benefit (a
                                                                                        maximum value of IDR. 5,000,000), except for medical textbooks or
                                                                                        medical journals.
                                                                                     - Items should not be offered on more than an occasional basis, even if
                                                                                        each individual item is appropriate
                                                                                     - Items must not bear product name, but should bear a company logo or
                                                                                        name (ABPI 2003).
                                                                                                            **

                                                                                  Q: What kinds of items would not be permissible to offer to a health care
                                                                                     professional?
                                                                                  A: Items which generally would not be permissible to be offered to a health
                                                                                     care professional, such as:

                                                                                     -   Video, VCR or DVD or CD players (IFPMA 2006)
                                                                                     -   TV sets
                                                                                     -   Computer equipment (ABPI 2003)
                                                                                     -   Substantial travel award (ABPI 2003)
                                                                                     -   Subscription of general magazines (IFPMA 2006).
                                                                                     -   Tennis ball (IFPMA 2006)


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                                                                                    -   Sport centre membership (IFPMA 2006)
                                                                                    -   Sport games tickets (IFPMA 2006)
                                                                                    -   Hair dryers (ABPI 2003)
                                                                                    -   Car accessories (ABPI 2003)

II.5.2.5 Cultural Courtesy Gifts:                                                   Q&A 19
Exceptionally, if it is allowed by local law and in accordance with local practice, Q: Payments related to speaker fees, investigator fees, sponsorships, etc
an inexpensive gift not related to the practice of medicine may be given               must not be offered in cash to healthcare professionals. What is the
occasionally to health care professional in acknowledgement of significant             definition of cash payment?
national, cultural or religious events, such as birthday cakes, and other gifts on
                                                                                    A: Any transaction with Cash (physical bank note) is prohibited. Here cash
the occasion of a healthcare professional’s birthday, Lebaran etc. with max Rp.
                                                                                       means physical cash and does not include bank cheque or bank transfer.
500.000,- per gift, Except for wedding gift in the form of a bank cheque or shop
vouchers is permitted with max Rp.2.000.000,- per company per event.

Q&A 19




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Proposed CoC 2007 Revision                                                               Q&A

II.5.3. DONATIONS                                                                        Q&A 20
II.5.3.1. Donations are permissible only if granted to institutions, and are strictly    Q: In case of emergency or disaster or for poor patients, is it allowed to
prohibited to be given directly to healthcare professional.                              provide donation including our own products for individual healthcare
                                                                                         professionals?
II.5.3.2. The donations should entail a benefit for patients and/or benefit the
work or education of the healthcare profession of the institutions.                      A: No, it is not allowed but as stipulated in 5.3, it must be provided for
                                                                                         institutions only.
II.5.3.3. No donations shall be given in return for products purchased or
products standardization, prescriptions or use of a company’s product(s) at the
institutions.

Donations for products standardization permitted only if there is official letter
form the institution
Q&A 20




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Proposed CoC 2007 Revision                                                        Q&A

Article 6
PRINTED PROMOTIONAL OR ADVERTISING MATERIALS

II.6.1. General
This section takes care of printed promotional or advertising material of each
ethical product directed to healthcare professional. Printed promotional or
advertising material should be presented in a legible manner.
The scientific basis and presentation of the information on a product should
conform with the principles as described in Article 2 of this Code and should
conform with the product information approved by BPOM.

II.6.1.1. Full/complete printed promotional material or Advertisements.
Where the objective is to supply the healthcare profession with adequate
information to make a rational decision on the prescription or use of product, the Q&A 21
information provided must include, clearly and concisely, the following:           Q: Are reprints considered as promotional material under the Code?

- Product name (Brand/Trade Name)                                                A: No. Reprints of scientific and medical articles, when used as stand-alone
- Generic name of active ingredient(s) or INN (International Non-proprietary        documents, are not developed by pharmaceutical companies and as such
  Name)                                                                             cannot be considered as promotional materials. If, however, they are
- Name and address of the marketing company                                         presented to a healthcare professional together with other, company-
- Code of production date of the printed material                                   originated documents, they then become promotional materials. In all
- Approved indications for use of the product (Minimum of 1 indication)             cases, where promotion refers to, includes, or is presented together with
- Dosage, method of use/recommended application                                     scientific or medical articles or studies, clear references should be
- A brief statement on side effects, clinically important cautions and warnings,    provided.     Any reprint of artwork (including graphs, illustrations,
  contra-indications and major interactions at the recommended dosage.              photographs or tables) taken from articles or studies and included or
- A statement that further information is available upon request.                   presented with promotional materials should clearly indicate the source of
Q&A 21                                                                              the artwork and be faithfully reproduced.

II.6.1.2. Brief (Reminder) Promotion/Advertisement
In short promotional materials and advertisements which provide only a simple
statement on the indications to denote the relevant therapeutic category and
why the product is recommended for that indication, the following minimum
information should be provided:
- Product name (Brand/Trade Name)


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- Generic name of active ingredient(s) or INN (International Non-proprietary
  Name)
- Name and address of marketing company.
- Code of production date of the printed material


II.6.2. Brand Reminders/’Gimmick’
Promotional give-away items/gimmicks given to healthcare professionals should
be related to their work and should be of small value (maximum IDR 200,000).
On small items with little space for printing and where no promotional message
or scientific information is presented, it is acceptable for just the Brand or
Company name/logo to appear.

II.6.3. References                                                                      Q&A 9
II.6.3.1. Promotional materials containing information from published studies           Q: Does the Code allow for quotations to be included in promotional
should include clear and traceable references to those studies.                            materials?
II.6.3.2. The use of reprints, abstracts and quotations should be compliant with        A: Yes. Quotations from medical and scientific literature or from personal
the copyright conditions of such material.                                                 communications should be faithfully reproduced (except where adaptation
                                                                                           or modification is required in order to comply with any applicable codes, in
II.6.3.3. Quotations or opinions from medical literature or from personal
                                                                                           which case it must be clearly stated that the quotation has been adapted
communications must not be modified or distorted so as to mislead or confuse
                                                                                           and/or modified) and the precise sources identified. Quotations should not
or alter the intended meaning of the author.
                                                                                           change or distort the intended meaning of the author or clinical investigator
Q&A 9                                                                                      or the significance of the underlying work or study.



II.6.4. Mailings
II.6.4.1. Promotional materials should only be sent to appropriate individuals
considered to have a professional interest in the information being supplied.
II.6.4.2. The frequency and volume of promotional mailings to healthcare
professionals should be reasonable. Requests from healthcare professionals to
be removed from the mailing lists for promotional materials must be respected.
However, companies must maintain a complete mailing list for other important
information such as contra-indications, adverse reactions, cautions etc.




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Proposed CoC 2007 Revision                                                    Q&A

Article 7
Audio-visual and electronic promotion material

Promotional information for the healthcare professional using these media
should comply with the requirements relevant to printed materials, i.e. as
described in Article 6.
Product information may be omitted provided the full product/prescribing
information is available on request from interested parties.
Specifically, in the case of pharmaceutical product related websites:

 -the identity of the pharmaceutical company and of the intended
audience should be readily apparent;-the content should be appropriate
for the intended audience;

-the presentation (content, links, etc.) should be appropriate and apparent
to the intended audience; and
-country-specific information should comply with local laws and
regulations.




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Proposed CoC 2007 Revision                                                         Q&A

Article 8
Sample

In accordance with Ministry of Health Decree No. 437/MEN.KES/SK/VI/1987 of
11th June 1987, providing free sample of pharmaceutical products to the medical
professional is prohibited.
Hence, companies are prohibited from sending samples to healthcare
professionals, except in the case of specially approved by the respective
authority.


Article 9
Market Research                                                                    Q&A 22
                                                                                   Q: How is the fee for FGD (Focus Group Discussion)?
II.9.1. Market research should not employ method that in any way discredit, or A: FGD may be categorized into two:
reduce public trust in the industry. This requirement applies in any case, whether • One is a market research. Then Article 9 should be applied or the tariff of
the research is being conducted by marketing company or other organizations           an independent agency appointed for market research will be applied.
acting on its behalf.                                                              • The other FGD is an expert meeting like an advisory board meeting. In this
                                                                                      case II.4.3. (Speaker Honorarium) will apply.
II.9.2. Devious or coercive methods to influence respondents are prohibited

II.9.3. Fees for research respondents should be modest and in proportion with
the work involved (for internally conducted market research using questionnaire,
maximum IDR 500,000 per respondent per project).

Q&A 22




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Proposed CoC 2007 Revision                                                         Q&A

Article 10
Communications with the public and mass media

Unless stipulated otherwise by BPOM or related institution, ethical product may
                                                                                .
only be promoted and advertised to the healthcare professional and shall not be
advertised to the general public.

Companies should not place articles or advertorials in the mass media to
promote a prescription medicine or for the purpose of encouraging the general
public to request a certain product through their physician.

Article 11
Infringement and Complaints
Genuine complaints relating to infringements of the IPMG Code are encouraged.
Detailed procedures for complaints and the handling of complaints (including the
respective roles and jurisdiction of IPMG and member associations) are set out
in Appendix 1: Operating Procedures of the IPMG Code.
In the first instance complainants are encouraged to raise any complaints
directly with the allegedly infringing company.




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                                                          APPENDIX 1

                                 OPERATING PROCEDURE OF THE IPMG CODE


1.     THE PROCEDURE FOR CODE COMPLAINTS

 1.1   Submission of Complaints: Complaints must be in writing or by e-mail and include:

       •   Complainant details
           The identity of the complainant, with a full mailing address (including fax number and e-mail, if possible) for correspondence. On
           the request of the complainant, the identity of the complainant can be kept confidential to all parties outside the IPMG MP sub-
           com.

       •   Company
           For each case, the identity of the company which is alleged to be in breach of the IPMG Code, and the name of any product or
           products which are specifically involved.

       •   Reference material
           For each case, a specific reference to the source of the advertisement/activity which is the subject of the complaint, of printed
           material or other evidence. Wherever possible a copy of the material in question should be provided.

       •   Date
           The date, where relevant, of the alleged breach of the IPMG Code.

       •   Summary
           For each case, a brief description of the complaint with, if possible, a specific reference to the part of the IPMG Code under which
           the complaint is being made (section and paragraph number(s)).

       All correspondence should be addressed to:

           Head of IPMG MP Sub-com
           Wisma Pondok Indah 1st floor suite 102


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           Jl. Sultan Iskandar Muda Kav. V-TA....
           Jakarta Selatan 12310

           Telephone: +62 (21) 769 7531
           E-mail:ipmg@ipmg-online.com


1.2.   Acknowledgment of complaints

       MP sub-com will acknowledge the receipt of complaints in written to complainants within 5 working days after receiving the
       complaints.

1.3    Validation: Marketing Practice Sub-com will validate the complaint within 10 working days after sending the acknowledgement to the
       complainants in order to ensure that:
        •     it appears to be a genuine matter, submitted in good faith;
        •     there is sufficient information to enable the complaint to be processed (see 1.1);

       If the complaint cannot be validated, it will not be processed under this operating procedure and, where possible and/or appropriate,
       the complainant will be notified accordingly. In appropriate cases, IPMG may refer the complainant or forward the complaint to an
       appropriate member association.

       A single complaint may cover more than one “case”, e.g. the complaint may refer to several advertisements from different companies
       and/or for different products. Each “case” is handled separately by IPMG under the main complaint reference. The first action in each
       case is to identify the company cited in the case and the head office or parent company, and its location, if different.

1.4    Referral: The complaint, including a copy of any supporting evidence (e.g. a copy of the advertisement alleged to be in breach of the
       IPMG Code), together with an accompanying letter from IPMG (the “Letter”), is sent by the MP sub-com to the senior management of
       the company immediately after validation is completed.

1.5    Non-member Companies:          When a case refers to a company that is not subject to the IPMG Code, the case cannot be processed
       formally.




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1.6    Time Limits: The Letter to the company indicates the time within which a response must be made on the case(s) under investigation.
       This is normally 30 calendar days from the company’s receipt of the documentation. In exceptional circumstances Head of IPMG MP
       sub-com may grant an extension to the time limits.

1.7    Company Response: Where the company acknowledges that it has acted in breach of the IPMG Code, the response should indicate
       what action has been taken or will be taken to remedy the matter. Where the allegations are rejected, the reasons for rejection must be
       clearly stated and, where appropriate, supporting data (e.g. scientific evidence to support claims which have been questioned) must be
       provided.

1.8    Adjudication: Where the company disputes the allegation, IPMG MP sub-com will rule on the case. IPMG MP sub-com normally
       decides cases within 30 days from receipt of the company’s response. If necessary, IPMG MP sub-com can ask the complainant or
       the affected company for additional information or argumentation, in which case the timelines may be extended.

1.9    Appeal: Where the company or complainant disagrees with the decision of the IPMG MP sub-com, they may within 30 days, request
       a second instance ruling. If new facts or arguments are put forward, the other party is invited to provide comments within 30 days. The
       Head of IPMG MP sub-com refers the complaint to the IPMG Ex-com. IPMG Ex-com may appoint a neutral arbitrator based on the
       consent of the accused and/or the defendant. The final decision is proposed by Ex-com in reference to the arbitrator’s
       recommendation and made by General Meeting of IPMG.

1.10   Communication of the Outcome: When a complaint is upheld and a breach of the IPMG Code is determined, or non disputed by
       the company, information without identifying the companies and products concerned, and providing a summary of the key facts of the
       case will immediately be communicated to the members

1.11   Status Reports: IPMG MP sub-com will issue an Annual Report on the IPMG Marketing Practices, summarizing its activities. The
       report will be distributed to all IPMG members.




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2    Penalties
     First offence
     - A warning letter will be sent by IPMG MP sub-com to the General Manager concerned. Cc. IPMG secretariat
     Second offence-           The IPMG Ex-com will invite the GM to a meeting with the Ex-com to explain his company’s behavior. If the violation is
       proven, an official letter shall be sent to the Senior Management at Global Head Quarter of the violating company by IPMG Ex-com and such
       a decision will have to be endorsed by a General Meeting of IPMG. The rejection to attend the meeting above may result in the same
       consequence of sending an official letter in the same process mentioned above.
     Further offence
     – The offending company’s behavior will be presented to a General Meeting of IPMG, at which time an expulsion of the company from IPMG
       will be recommended by the ExCom and decided by the voting in a General Meeting of IPMG.
    However, even before a second offence, depending on the severity of the case, i.e. ,an official letter might be sent immediately to the Senior Management at
    Global Head Quarter of violating company by IPMG Ex-com and such a decision will have to be endorsed by a General Meeting of IPMG.

                                                                            *****




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                                                     QUESTIONS & ANSWERS
______________________________________________________________________________________________________________________

1.   Communications with the Public
Q:   Does the Code regulate communications with the public?
A:   No. The Code covers interactions with healthcare professionals and the promotion of pharmaceutical products. Where direct promotion to the
     public is allowed, this is covered by other laws, regulations and/or relevant codes of practice. All IPMG member companies should of course,
     comply with these laws, regulations and/or codes.
2.   Code Application
Q:   To whom does the Code apply?"
A:   The Code applies to IPMG member companies. Pharmaceutical companies that are not members of IPMG fall outside the reach of the
     Code. IPMG encourages such companies -- and other organizations marketing healthcare products or services to healthcare professionals --
     to follow ethical promotion standards similar to those set forth in the Code.
3.   Disease Awareness Campaigns
Q:   Why does the Code not cover public disease awareness campaigns?
A:   The Code covers interactions with healthcare professionals and the promotion of pharmaceutical products. A public disease awareness
     campaign targeted at the public must not promote specific pharmaceutical products. Whilst not covered by the Code, disease awareness
     campaigns must of course comply with other laws, regulations, and/or codes.
4.   OTC Products
Q:   Does the Code apply to the promotion and marketing of OTC products that may also be prescribed by healthcare professionals?
A:   Yes. The Code applies to the promotion of OTC products directed towards healthcare professionals. However, the promotion of OTC products
     to consumers falls outside the scope of this Code.
5.   Pricing and Terms of Trade




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Q:   Does the Code prohibit member companies from giving its customers discounts or other favorable trade terms for the supply of pharmaceutical
     products?
A:   No. The Code does not restrain or regulate commercial trade terms for the supply of pharmaceutical products. IPMG encourages competition
     among companies.
                                                                          **
Q:   Does the Code apply to the promotion and marketing of pharmaceutical products to commercial customers who are also practicing healthcare
     professionals, such as a pharmacist who operates his/her own practice.
A:   The Code does apply to the promotion and marketing of pharmaceutical products to such a customer. However, the Code does not restrain or
     regulate commercial trade terms for the supply of pharmaceutical products, to customers. In any dealings with such a customer, companies
     should respect the customer’s role as a healthcare professional and, if applicable, comply with the requirements of the Code.
                                                                           **
Q:   Does the Code apply to the promotion and marketing of pharmaceutical products to commercial customers who are not healthcare
     professionals? What if the customer is a healthcare professional by qualification but is not practicing?
A:   No. The Code only applies to interactions with practicing healthcare professionals. Promotion and marketing to commercial customers (whether
     or not they are healthcare professionals) may of course be governed by other laws and regulations, such as those that restrict or prohibit
     inaccurate, misleading or deceptive advertising and promotion or restrict or prohibit the giving of inducements to public officials or employees.
                                                                           **
Q:   Does the Code cover price lists or other documents describing terms of trade?
A:   No.
                                                                           **
Q:   Could a false price claim or a misleading price comparison in promotional material be processed under the Code?
A:   Yes, this is possible when a company is inappropriately using pricing information in its promotional materials or activities.


6.   Consultancy Agreements




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Q:   In the absence of any formal industry guidelines or local laws, how should companies interact with healthcare professionals who are offering
     legitimate consultancy services?
A:   It is appropriate for consultants who provide services to be offered reasonable compensation for those services and to be offered
     reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services. Compensation and
     reimbursement that would be inappropriate in other contexts can be acceptable for genuine consulting arrangements. Token consulting or
     advisory arrangements should not be used to justify compensating healthcare professionals. The following factors support the existence of a
     genuine consulting arrangement (not all factors may be relevant to any particular arrangement):
         •   a written confirmation which specifies the nature of the services to be provided and the basis for payment of those services;
         •   a legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with
             the prospective consultants;
         •   the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the
             consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
         •   the number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified
             purpose;
         •   the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; and
         •   the hiring of the healthcare professional to provide the relevant service is not an inducement to prescribe a particular product.


7.   Non-Promotional Information
Q:   What are the examples of non-promotional information that is not covered by the Code?
A:   Correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular
     medicinal product is not covered by the Code.
     Non-promotional, general information about companies (such as information directed to investors or to current/prospective employees),
     including financial data, descriptions of research and development program, and discussion of regulatory developments affecting the company
     and its products is also not covered by the Code.




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8.    Disguised Promotion
Q:    Is it ever appropriate for a company to publish promotional materials that appear to be independent editorial content?
A:    No. Where a company finances or otherwise secures or arranges the publication of promotional material in journals, such promotional material
      must not resemble independent editorial matter.
                                                                          **
Q:    How does the prohibition of pre-approval promotion affect compassionate use programmes?
A:    The clause does not prevent compassionate use programmes which must of course comply with all applicable laws, regulations and codes.
      Care should be taken to ensure that communications for a compassionate use programme are not, in effect, advertisements for an unlicensed
      medicine or use.
9.    Use of Quotations
Q:    Does the Code allow for quotations to be included in promotional materials?
A:    Yes. Quotations from medical and scientific literature or from personal communications should be faithfully reproduced (except where
      adaptation or modification is required in order to comply with any applicable codes, in which case it must be clearly stated that the quotation
      has been adapted and/or modified) and the precise sources identified. Quotations should not change or distort the intended meaning of the
      author or clinical investigator or the significance of the underlying work or study.


10.   Use of Comparisons
Q:    Does the Code allow for comparisons between different products to be included in promotional materials?
A:    Yes. Any comparison made between different pharmaceutical products should be based on relevant and comparable aspects of the products
      and be capable of substantiation. Comparative advertising should not be misleading.
11.   Medical Representatives
Q:    Do all MRs have to be certified?
A:    It applies to all MRs (age below 50) who have been employed within the industry for minimum period of 2 years and who have been with their
      current employer for minimum period of 1 year. Non-compliance with this requirement is deemed to be 10% of eligible MRs as not having
      passed the MR certification test (IPMG Circulation2004)



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12.   Events Involving Foreign Travel
Q:    When is it appropriate and justified for a company to organize or sponsor an event for healthcare professionals outside of Indonesia?
A:    A company can only organize events involving travel if it is justified, i.e.:
        a. A significant proportion of the invited healthcare professionals are from outside of Indonesia, and it makes greater logistical or security
        sense to hold the event in another country; or
        b. The relevant resource or expertise that is the object or subject matter of the event is located outside of Indonesia.
13.   Partial Sponsorship

Q:    Is partial sponsorship allowed?
A:    Generally, partial sponsorships are allowed, however, these should be properly backed up by good documentation and/or evidences, e.g. copy
      of third party’s invoices, etc.
14.   Sponsoring Healthcare Professionals

Q:    It is not allowed for companies to pay for any expenses of accompanying person/s. What is the definition of any expenses?

A:    Expenses considered unallowable for accompanying person are extra hotel room charge, any tour for sight seeing, airfare, etc. The principle
      should be that additional expenses which will be incurred due to any accompanying person presence shall not be covered.
      Exception to this ruling is allowed if the spouse is also a health care professional and as participant of scientific event.
                                                                              **
Q: Is it allowed to invite the spouse to join an official dinner?
A: No, spouse can’t be invited to join a dinner followed by a scientific event and this should be clearly mentioned in the invitation (eg this invitation
    is valid only for healthcare professional). Despite all effort to prevent Spouse participation in case it is considered as culturally unacceptable
    and impolite to turn down spouses from joining the dinner a reasonable spouse participation may be acceptable. The spirit behind this is to
    have dinner for health care professional only to the extent possible. Company management should make every effort to abide with this spirit.
                                                                               **
Q: Is it allowed to sponsor payment of Room Rental ?
A: The Code does not preclude the payment of room rental to postgraduate medical centres and the like,
However, payment of Room Rental to doctors or groups of doctors is not permissible even such payment is made to equipment funds or patients’
      comforts funds and the like or to charities of companies (ABPI 2003).


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15.    Speaker Honorarium
Q: What is the definition of “Official Tariff” of speaker fee?
A: It is a written announcement issued by an institution. However some tariffs are printed without a letter head and not signed. It is recommended to
     check the authenticity of the tariff with a responsible person of the institution
16.    Events and Entertainment/ Hospitality
Q:     The Code prohibits stand-alone entertainment, leisure or social activities but allows entertainment of modest nature in conjunction with meals,
       etc., which is secondary to the main purpose of the event. How should companies interpret this in practice?
A:     When a company organizes a meeting and refreshments are provided, e.g., an evening meal for a meeting stretching over more than one day,
       it would be permitted to provide some background music during the meal or to have an interlude when some low-key local singers
       perform. However it would not be appropriate for a company to fund attendance at a concert by those same performers as this would be self
       standing and not incidental to the refreshments and the Code also prohibits the purchase of entertainment tickets. A self standing sightseeing
       tour would not be permitted but this would not prohibit a commentary about sights of interest en-route to a restaurant. The 'modest nature' of
       the entertainment may be interpreted as prohibiting high profile, inappropriate or expensive entertainers - even if their performance is
       secondary to a necessary meal. So an appearance by a well known TV or pop star would not be considered as modest whereas a folk dance
       display or performance by a local singer would be acceptable as entertainment for a meal interlude.
                                                                              **
Q: What would be our guideline to members on the sponsorship of Gala Dinner at a congress where there is no Scientific meeting held during the
     occasion?
A: Gala dinner is prohibited as it is considered to be violating:
       * II.4.4.3. (it is more than modest nature and not secondary to refreshments and/or meals.) and/or
       * II.4.2.4. (Normally spouses are invited to Gala dinner. So it is against the code.)
                                                                              **
Q: What about evening dinner cruise held as part of the congress by a member company?
A: Cruise Dinner is not allowed as it is more than modest nature and not secondary to refreshments and/or meals.
                                                                              **
Q:     Are there any examples of such scientific, educational or promotional meetings (“events”) permitted to be sponsored or organized by
       companies ?


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A:       Pharmaceutical companies may appropriately sponsor or organize a wide range of meetings, such as (ABPI 2003):
     -    Lunchtime audio-visual presentations in a group practice
     -    Hospital meetings
     -    Meetings at postgraduate education centres
     -    Launch meetings for new products
     -    Related Management training courses
     -    Meetings of clinical trialists
     -    Patient Support Group Meetings
     -    Satelite Symposia
     -    International Meetings organized by independent bodies with sponsorship from pharmaceutical companies, ect.
                                                                          **
Q: What are the conditions for providing hospitality in conjunction with those meetings/events?
A: With any meeting, certain basic principles apply (ABPI 2003):
    - Meeting must have a clear educational content.
    - Hospitalitly must be provided in association with such meetings, its level should be secondary to the purpose of the meeting, must be
        appropriate and not out of proportion to that occasion, in time spent and cost. Its cost should not exceed that level which the majority of
        recipients might normally adopt when paying for themselves.
    - Hospitaliity should not extend beyond members of the profession unless that person is a member of the health professions or appropriate
        administrative staff and qualifies as a proper delegate or participant at the meeting in their own right.
                                                                          **
Q: Any examples where administrative staff may be invited to meetings ?
A: Where appropriate, for example, receptionists might be invited to a meeting in a general practice when the subject matter related to practice
administration (ABPI 2003).
                                                                          **
Q: What is “unreasonably renowned or extravagant venues”?
A:       The use of 5 star hotels are acceptable in Indonesia. As a general understanding, the hotels of which room charge/room/day is less than
         US$ 150 (Weekday rate before tax & services) are acceptable.




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17.       Gifts ,Promotional Aids & Donation

Q:        Can we provide healthcare professionals with member company’s pharmaceutical products for their personal use?
A:        No, you cannot. It is considered as a violation against II. 5.2.2. (Personal Gifts).
                                                                                   **
Q:        What kinds of items are permissible as promotional aids?
A:     Promotional aids should be of minimal value (max Rp.200.000,- per item) and should be related to the work of the recipient healthcare
      professional. Possible examples include:
      -     pens, notepads, diaries
      -     surgical gloves, nail brushes
      -     a pick flow wistle
      -     walking sticks
      -     desk trays, desk clocks, calendars, etc (ABPI 2003)
      -     Promotional items intended for the personal benefit of the healthcare professional, such as music CDs, paintings or food baskets would be not be
            acceptable.
      -     Brand or company name / logo has to appear on the item
                                                                                   **
18.       Items of Medical Utility

Q:        What kinds of items are envisaged as being items of medical utility?
A:      Items might include items which primarily involve a patient benefit such as:
      - anatomical model for use in an examination room,
      - medical educational CDs, DVDs, VCDs or the like
      - selected medical devices (such as stethoscope, sphygmomanometer, otoscope, opthalmoscope, laryngoscope, reflex hammer, head mirror,
           rhinoscope, medical thermometer, glucometer, tonge refractor, magnifier lens for medical use, weight and height scales)
      - medical textbooks,
      - medical journals,

      Conditions:



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      - They should be of modest value and primarily involve a patient benefit (a maximum value of IDR. 5,000,000), except for medical textbooks or
        medical journals.
        -Items should not be offered on more than an occasional basis, even if each individual item is appropriate
      - Items must not bear product name, but should bear a company logo or name (ABPI 2003).

                                                                                **
Q: What kinds of items would not be permissible to offer to a health care professional ?
A: Items which generally would not be permissible to be offered to a health care professional, are for example:
    - Video, VCR or DVD or CD players (IFPMA 2006)
    - TV sets
    - Computer equipment (ABPI 2003)
    - Substantial travel award (ABPI 2003)
    - Subscription of general magazines (IFPMA 2006).
    - Tennis ball (IFPMA 2006)
    - Sport centre membership (IFPMA 2006)
    - Sport games tickets (IFPMA 2006)
    - Hair dryers (ABPI 2003)
    - Car accessories (ABPI 2003)
19. Cash Payment to Healthcare Professionals

Q:      Payments related to speaker fees, investigator fees, sponsorships, etc. must not be offered in cash to healthcare professionals. What is the
        definition of cash payment?
A:      Any transaction with Cash (physical bank note) is prohibited. Here cash means physical cash and does not include bank cheque or bank
        transfer.


20.     Donation
Q:    In case of emergency or disaster or for poor patients, is it allowed to provide donation including our own products for individual healthcare
      professionals?
A:     No, it is not allowed but as stipulated in 5.3, it must be provided for institutions only.




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21.     Reprints
Q:      Are reprints considered as promotional material under the Code?
A:      No. Reprints of scientific and medical articles, when used as stand-alone documents, are not developed by pharmaceutical companies and as
        such cannot be considered as promotional materials. If, however, they are presented to a healthcare professional together with other,
        company-originated documents, they then become promotional materials. In all cases, where promotion refers to, includes, or is presented
        together with scientific or medical articles or studies, clear references should be provided. Any reprint of artwork (including graphs, illustrations,
        photographs or tables) taken from articles or studies and included or presented with promotional materials should clearly indicate the source of
        the artwork and be faithfully reproduced.

22.     Market Research
Q: How is the fee for FGD (Focus Group Discussion)?
A: FGD may be categorized into two:
      • One is a market research. Then Article 9 should be applied or the tariff of an independent agency appointed for market research will be applied.
      • The other FGD is an expert meeting like an advisory board meeting. In this case II.4.3. (Speaker Honorarium) will apply.


                                                                                *****




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Description: Pharmaceutical marketing practice 2007 at Indonesia