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August
29, 2011
Product
promotions - Pharma companies under restrictions
Introduction:
In
view of the recent uproar regarding incentives being given to the doctors
by various pharmaceutical companies to make sure they prescribe their
medicines, the Department of Pharmaceuticals in India (“DOP”) released a
Code of Marketing Practice for the Indian Pharmaceutical Industry (“DOP
Code”) in June, 2011. The DOP Code has put various restrictions on the
practices adopted by companies while marketing medicines to doctors
including banning all kinds of gifts to doctors.
At
present, the DOP Code is voluntary. However, the Government will review the
implementation by companies after a period of six months and then the
Government may consider making it a statutory code if not implemented
effectively.
Specific provisions relating to restrictions on benefits
to be procured by doctors have also been incorporated in the Indian Medical
Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI
Code). Registered medical practitioners in India are required to adhere to
the MCI Code, issued by the Medical Council of India, under the provisions
of section 20A read with section 33(m) of the Indian Medical Council Act,
1956. In a recent amendment, the MCI Code has put restrictions on doctors
in their dealings with the pharmaceutical and allied health sector
industry.
Moreover,
the Organization of Pharmaceutical Producers of India had issued a Code of
Pharmaceutical Marketing Practices 2010 (the “OPPI Code”). The OPPI Code
has set out specific standards for the promotion of pharmaceutical products
ethically to the doctors. It is based on the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) Code that has been in practice for
the last two decades. However, the OPPI Code is a matter of self regulation
and self discipline on part of the member companies.
In
this update, we have examined the combined effect of the DOP Code and the
amendments to the MCI Code.
In
India, advertisements of prescription drugs is not permitted. Hence,
pharmaceutical companies promote medicines to doctors to convince them to
prescribe their medicines with a view to increase the companies’ sales. The
sales representative of a pharmaceutical company, popularly known as a
medical representative (MR) plays a vital role in this process. MRs hold
meetings with doctors and explain the benefits of the drug along with the
safety and the side effects of the drugs.
Important
features of the DOP Code:
1.
Timing
of promotion
The
promotion can be carried out only after product authorization by the office
of the Drug Controller General of India
(DCGI). The promotion should be consistent with the terms of product
authorization. E.g. if the product authorization is only for one
indication, the drug cannot be promoted for any other indication.
2.
Information
supplied
The
information supplied must be accurate, fair, objective, verifiable and must
not be misleading. In case of a request for additional substantiation by
medical or pharmacy professionals, the same has to be provided without
delay.
3.
Claims
The
DOP has expressed concern over the use of the words “safe” and “new” by the
companies or their MRs. The DOP Code mentions that “safe” should not be
used without qualification and it must not be stated categorically that a
medicine has no side effects, toxic hazards or risk of addiction. If
medicines is are generally available in India for more than 12
months, then the term “new” should not be used.
4.
Product
comparisons
As
far as product comparisons are concerned, the DOP Code prescribes as
follows:
·
The
comparisons of medicinal products must be factual, fair and capable of
substantiation;
·
Due
care must be taken to ensure that comparison does not mislead by
distortion, by undue emphasis, omission or in any other way;
·
Brand
names of the products of other companies should not be used without
obtaining prior consent;
·
Companies,
their products, services or promotions as well as clinical and/or
scientific opinions of members of healthcare professionals should not be
disparaged, either directly or by implication.
5.
Product
promotional material
The
DOP Code prescribes certain do’s and don’ts in relation to promotional
material (“PM”) and also prescribes the contents to be incorporated in such
material. An illustrative list of the do’s and don’ts is provided below:
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Do’s
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Don’ts
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·
PM
to be consistent with the DOP Code
·
Date
of printing or of the last review of PM to be mentioned
·
Audio-visual
material to be accompanied by printed material in compliance with the DOP
Code
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·
The
paid or secured PM in journals not to resemble the editorial matter
·
Photographs
or names of healthcare professionals should not be used
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6.
Gifts
Companies
should not give any kind of gifts or promise, offer or supply any kind of
pecuniary advantage or benefits to doctors including gifts for personal
benefits such as tickets to entertainment events etc.
7.
Samples
The
free samples that are provided by the companies must be supplied only to
the qualified professionals and that too in response to a signed and dated
request from the recipient. Detailed records of samples provided are
required to be maintained. Such samples can be supplied only on an
exceptional basis and for the purpose of acquiring experience in dealing
with such a product. The sample pack should be limited to prescribed dosage
for 3 patients and each sample pack shall not be larger than the smallest
pack presented in the market. The DOP Code prohibits supply of samples of
an antidepressant, hypnotic, sedative or tranquillizer.
8.
Hospitality,
Sponsorships and meetings
As
per the DOP Code, the companies are permitted to provide assistance to
doctors for continuing education facilitating doctors’ genuine attendance
in such events. This assistance could cover actual travel expenses, meals,
refreshments, accommodation and registration fees to attend such an event.
The DOP Code has, however, laid down certain conditions: (i) events for
which assistance will be provided must be held in India at an appropriate
venue that is conducive to the main purpose of the event; and (ii) such
events should not coincide with sporting, entertainment or other leisure
events or activities or organized at venues that are renowned for their
entertainment or leisure facilities or are extravagant. This assistance
cannot be provided to a doctor’s spouse unless the spouse is a doctor too
and qualifies to attend such an event. The hospitality offered should be reasonable
and strictly limited to the main purpose of the event. The funding provided
should not be for the time spent in attending the event.
9.
Medical
Representatives
MRs
employed by the company or on contract with third parties are required to
maintain a high standard of ethical conduct in the discharge of their
duties and comply with all relevant requirements of the DOP Code. They are
restricted from employing any inducement or subterfuge to gain an interview
and paying, under any guise, for access to the doctor. It is important to
note that the companies are made responsible for activities of its
employees including MRs to ensure that the DOP Code has been complied with.
10.
Complaint
Handling
The
DOP Code has stipulated that each association of pharmaceutical companies
shall form a “committee for pharma marketing practices” that will handle
all the complaints received by them. The associations will also be required
to form a review committee that will review the complaints, in case the
review of the decision is sought. The DOP Code has also included the
methodology for lodging and handling of complaints. The associations will
be required to submit a copy of the proceedings and the decisions once the
proceedings in a complaint are completed, to the DOP.
MCI
Code:
The
Medical Council of India has amended the MCI Code to include specific
restrictive provisions for doctors and professional associations of doctors
in their relationship with the pharmaceutical and the allied health sector
industry. The MCI Code has imposed the following restrictions on the
doctors:
a) A medical
practitioner shall not receive any gift from any pharmaceutical or allied
health care industry and their sales people or representatives;
b) A medical
practitioner shall not accept any travel facility inside the country or
outside, including rail, air, ship, cruise tickets, paid vacations etc.
from any pharmaceutical or allied healthcare industry or their
representatives for self and family members for vacation or for attending
conferences, seminars, workshops, CME programme etc as a delegate;
c) A medical
practitioner shall not accept individually any hospitality like hotel
accommodation for self and family members under any pretext;
d) A medical
practitioner shall not receive any cash or monetary grants from any
pharmaceutical and allied healthcare industry for individual purposes in
individual capacity under any pretext. Funding for medical research, study
etc. can only be received through approved institutions by modalities laid
down by law / rules / guidelines adopted by such approved institutions, in
a transparent manner. It shall always be fully disclosed;
e) A medical
practitioner may carry out, participate in or work on research projects
funded by pharmaceutical and allied healthcare industries, after taking
necessary clearances and fulfilling certain conditions;
f) A medical
practitioner shall not endorse any drug or product of the industry
publicly.
In
case of violation of these provisions by the medical practitioners, the MCI
Code provides for disciplinary action.
In
the recent past, in view of the restrictions imposed, a practice of
entering into consultancy arrangements with pharmaceutical companies has
developed. Under the MCI Code, a medical practitioner may work for
pharmaceutical and allied healthcare industries in advisory capacities, as
consultants, as researchers, as treating doctors or in any other
professional capacity.
Global
Practices:
European
Federation of Pharmaceutical Industries and Associations (“EFPIA”):
The
EFPIA has prescribed a code of practice that covers the promotion of
medicine to doctors. The said code has put restrictions on activities like
events and hospitality organized by companies. However, the code does not
specifically prohibit offering gifts to doctors, but it does state that the
companies may offer inexpensive gifts that provide value to the practice of
medicine or pharmacy.
Pharmaceutical
Research and Manufacturers of America (“PhRMA”) USA:
PhRMA
has issued a set of voluntary guidelines for the members of the group
regarding promotion of medicines to the doctors since 2002 and updated them
in January 2009. The PhRMA code prohibits providing entertainment and
recreation facilities including gifts that are non-educational to the
doctors. However, it permits conducting CME and consulting arrangement with
the doctors.
The
office of the Inspector General for the U.S. Department of Health and Human
Services has also issued guidelines similar to PhRMA code but with stricter
penalties.
Singapore
Association of Pharmaceutical Industries (“SAPI”) code of marketing
practices:
The
SAPI Code has stipulated that no inappropriate financial or material
benefits, including inappropriate hospitality, should be offered to
doctors. It permits items of insignificant value of no more than $20
provided free of charge but prohibits offering gifts and funds or cash that
are inappropriate.
Implications:
The
pharmaceutical companies will certainly be required to change their
strategy to market the medicines to doctors and be more creative and
innovative. Since MRs are actively involved in the promotion of
prescription drugs, companies will be required to conduct intensive
training so that even inadvertently the code is not violated.
At
present, the DOP Code is voluntary, but the MCI Code is mandatory. After
six months, if the DOP Code is incorporated as a statutory code, then
pharma companies are likely to face prosecution or penalties in case of
violation.
A
review of the global practices seems to indicate that in some respects, the
DOP Code and the MCI Code may be more restrictive than the codes /
regulations in other jurisdictions. However, there are certain other
aspects that are covered in other jurisdictions that are still not covered
in the Indian codes. Further, some of the provisions under the MCI
Code are more onerous than that of the DOP Code. E.g., while the DOP
Code permits companies to provide assistance for travel and events within
India, the MCI Code prohibits doctors from accepting the same. Hence, the
government should, once again, take a look at both the codes, and re-align
the same for more cohesive implementation.
- Dr. Milind
Antani & Gowree Gokhale
You can direct
your queries or comments to the authors
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