Guidelines for interaction between Pharma

1. Regulatory guidelines for
promotion of Prescription drugs
Based on,
IFPMA Code of Pharmaceutical Marketing Practices

2. Ethical Promotion of
prescription Drugs

3. • It sets out the standards for ethical
promotion of pharmaceutical products to
healthcare professionals.
 Implementation of the code is a matter of
self regulation and self discipline
IFPMA Code of Pharmaceutical Marketing Practices

4. Does NOT seek to regulate -
 Promotion of prescription drugs to consumers
(DTC advertising).
 Promotion of self medication products (OTC
medications).
 Provision of non promotional information.
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5. Preamble
Industry relationships with healthcare
professionals must support, and be consistent
with, the professional responsibilities that
healthcare professionals have towards their
patients.
Pharmaceutical companies must maintain high
ethical standards when conducting promotional
activities and comply with applicable legal and
professional requirements.
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6. Printed Promotional Material
All printed promotional materials other than
reminder advertisements must be legible and
include :
• the name of the product (normally the brand
name),
• the active ingredients,
• the name and address of the pharmaceutical
company or its marketing agent,
• date of production of the advertisement,
• the abbreviated prescribing information.
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7. Abbreviated prescribing information
This should include the following:
 Approved Indications
 Dose
 Method of use
 Succinct statement of contraindications,
precautions and side effects
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8. Misleading claims
 Promotional material should not mislead
by distortion, exaggeration, undue
emphasis or omission, or in any other
way.
 Absolute or all-embracing claims should
be used with caution and only with
adequate qualification and
substantiation.
 Descriptions such as ‘safe’ and ‘no side
effects’ should generally be avoided and
should always be adequately qualified.
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9. Substantiation of claims
Promotion should be capable of
substantiation either by reference to the
approved labeling or by scientific evidence.
Such evidence should be made available, on
request, to healthcare professionals.
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10. Reminder advertisements
It is a short advertisement consisting of
 Name
 Simple statement of indications to
designate therapeutic category
Such reminders may avoid API.
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11. Promotion should not be disguised.
Clinical assessments,
post-marketing
surveillance and
experience programs,
and post-
authorization studies
must not be disguised
promotion.
© D Sharon Pruitt
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12. Transparent sponsorships
Material relating to
pharmaceutical
products and their uses,
whether or not
promotional in nature,
that is sponsored by a
company, should clearly
indicate by whom it has
been sponsored
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13. Medical samples
 In accordance with local laws and regulations,
free samples of a pharmaceutical product may
be supplied to healthcare professionals in order
to enhance patient care.
 Samples should not be resold or otherwise
misused.
 Companies should have adequate systems of
control and accountability for samples provided
to healthcare professionals, including how to
look after such samples while they are in the
possession of medical representatives
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14. Cash
Payments in cash or cash equivalents (such as gift
certificate) must not be offered to healthcare
professionals.
Personal gifts
Gifts for the personal benefit of healthcare
professionals (including, but not limited to, music CDs,
DVDs, sporting or entertainment tickets, electronic
items) must not be provided or offered.
Cultural courtesy gifts
An inexpensive gift not related to the practice of
medicine may be given on an infrequent basis to
healthcare professionals in acknowledgement of
significant national, cultural or religious holidays.

15.  Promotional aids
Promotional aids or reminder items may be
provided or offered to healthcare
professionals and appropriate administrative
staff, provided that the gift is of minimal
value and relevant to the practice of the
healthcare professional.
 Medical Utility items
Items of medical utility may be offered or
provided free of charge, provided that such
items are of modest value and beneficial to
the provision of medical services and for
patient care.
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16. Electronic Media
Including audiovisuals
The same requirements that apply to
printed materials also apply to electronic
promotional materials and websites.
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17. 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.
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18. Sponsorship
Limited to,
 Travel
 Meals
 Accommodation
 Registration fees
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19. Hospitality
 Companies should avoid using
renowned or extravagant
venues.
• Hospitality should be limited to
moderate and reasonable
refreshments and/or meals
incidental to the main purpose of
the event and should be provided
only to participants in the
event and not their guests.
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20.  As a general rule, the hospitality
provided should not exceed what
healthcare professional recipients
would normally be prepared to pay for
themselves.
• No stand-alone entertainment or
other leisure or social activities should
be provided or paid for by member
companies. At events, entertainment
of modest nature, which is
secondary to refreshments
and/or meals, is allowed.
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21. Compensation
Payments of reasonable fees and
reimbursement may be provided to
healthcare professionals who are providing
genuine services as speakers or presenters
on the basis of a written contract with the
company at the event.
Other Healthcare professionals cannot be
compensated for time spent in attending an
event, e.g. a company-sponsored meeting or
scientific congress.
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22. IFPMA Code of Pharmaceutical Marketing Practices
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