The unethical practice of gift giving to doctors by pharma companies

The Unethical Practice Of Gift-giving
to Doctors By Pharma Companies
Support For Advocacy And Training To Health
Initiatives (SATHI) Report

The Unethical Practice Of Gift-giving By
Pharma Companies

Introduction
• Profit and ethics are both important for the
sustainability of a business.
• But if we take the case of pharmaceutical
companies, it has been observed in some cases
that a few of these companies take undue
advantage of doctors prescribing and
promoting drugs which have no brand and
time tested reputation.
• Here, we see profits being prioritized over
ethics.

Few of pharma companies take undue advantage of doctors
prescribing and promoting drugs which have no brand and
time tested reputation

Introduction
• The basic role of a medical representative is to
apprise the doctor about his or her company's
new drugs.
• There is nothing wrong in that as long as the
ultimate beneficiary of this information is the
patient.
• Unfortunately, there is often a conflict of
interest between the patient and the doctor as
far as the drug promotion of a less reputed
company is concerned.

Basic role of a medical representative is to apprise
the doctor about his or her company's new drugs

Introduction
• The interaction of drug companies with
doctors in order to promote their medical
products through seminars is an acceptable
practice in other countries.
• But interacting with each doctor
individually in public hospitals during their
duty time cannot be acceptable. Patients
come first, and thus duty time should be
reserved for patients.

Medical representative interacting with each doctor
individually in public hospitals during their duty time cannot
be acceptable

Introduction
• Drug companies give gifts and other
incentives to doctors and other professionals
which is a serious breach of code of conduct.
• But it is also true that there are ethical
doctors who continue to prescribe medicines
that are most beneficial and economical to
their patients despite being under pressure
from medical representatives of drug
companies.

Drug companies give gifts and other incentives to
doctors which is a serious breach of code of conduct

Introduction
• There have been news reports that medical
representatives give gifts such as pens and
writing pads with drug names inscribed.
• Some physicians don't consider it unethical
to accept gifts like pen stands, calendars,
drug samples, company funded lunches or
dinners, etc., where a company's products are
visibly mentioned, to influence prescribing
behavior that is morally wrong.

medical representatives give gifts such as pens
and writing pads with drug names inscribed

Some physicians don't consider it unethical to accept
gifts like pen stands, calendars, drug samples

Introduction
• This 'culture of gifts' is forbidden almost
everywhere around the world.
• In Bangladesh, Secretaries to the Government
or officers of equivalent status may accept gifts
offered abroad or within Bangladesh by
institutions or official dignitaries of foreign
government of comparable or higher levels,
provided that the value of the gift in each case
does not exceed Tk 500 (USD 6.5) (Rule 5 of
Government Servants (Conduct) Rules, 1979).

In Bangladesh, Secretaries to the Government or officers of
equivalent status may accept gifts provided that the value of the
gift in each case does not exceed Tk 500 (USD 6.5)

Introduction
• In Australia, any gift or gratuity may be
considered a bribe under the law.
• The prohibition against bribing public officials
can therefore extend to the provision of gifts,
travel expenses, meals and entertainment

In Australia, any gift or gratuity may be
considered a bribe under the law.

Introduction
• In China, no specific types of gifts or
gratuities are considered permissible under
the PRC Criminal Law and, theoretically,
gifts which may create conflict of interest
constitute a crime.

In China, no specific types of gifts or gratuities are
considered permissible under the PRC Criminal
Law

Introduction
• In India, as a general rule, public servants
are prohibited from accepting lavish
hospitality or frequent hospitality from any
individual, industrial or commercial firms,
organizations, etc., having or likely to have
official dealings with such a public servant.

In India, as a general rule, public servants are prohibited
from accepting lavish hospitality or frequent hospitality from
any individual, industrial or commercial firms

Introduction
• In Indonesia, any gift to a public official
must first be approved by the government.
Any undisclosed gift is deemed as an
offence.
• In Japan, the Ethics Act has established
gifts register and requires middle and senior
level public officials to disclose gifts in
excess of 5,000 yen (under USD 50)

In Indonesia, any gift to a public official must first
be approved by the government. Any undisclosed
gift is deemed as an offence

Introduction
• Japanese statutes do not provide a
minimum threshold for a gift.
• The Ethics Act and the Ethics Code serve as a
reference for the gifts and the public service
officials cannot receive any kind of
entertainment.
• In Malaysia, any limit in relation to
gratification, given or received, is an offence
of corruption

Japanese statutes do not provide a minimum threshold for a gift.
The Ethics Act and the Ethics Code serve as a reference for the gifts
and the public service officials

Introduction
• In the Philippines, Presidential Decree No.
46 makes it punishable for any public
officer to receive, directly or indirectly, and
for private persons to give, or offer to give,
gifts, presents or other valuables to a public
officer during any occasion.

In the Philippines, Presidential Decree No. 46 makes
it punishable for any public officer to gifts, presents
or other valuables to a public officer

Introduction
• In Singapore, all gifts need to be approved
by a permanent secretary and only gifts
under SGD 50 (USD 40) can be accepted.

In Singapore, all gifts need to be approved by a
permanent secretary and only gifts under SGD 50
(USD 40) can be accepted

Introduction
• In Vietnam, generally the giving or
receiving of gifts and hospitality will be
deemed a bribe under Vietnamese law if it
satisfies all elements of a bribe.

Introduction
• The real challenge for the medical
profession, drug companies and the
government is to formulate mutually
acceptable guidelines to avoid unethical
practices of giving and receiving gifts.

Government challenge is to formulate mutually
acceptable guidelines to avoid unethical practices of
giving and receiving gifts

Introduction
• Mushrooming of drug companies is also
responsible for this unethical gift practice.
Competition between drug companies often
compromises the quality of the drug.
• If the retail price, quality, and genetic and
generic names of drugs are regulated and
standardized by the government, this
unethical gift practice of some drug
companies can be put in check.

Mushrooming of drug companies is also
responsible for this unethical gift practice

If the retail price, quality, and genetic and generic names of
drugs are regulated and standardized by the government, this
unethical gift practice of some drug companies can be put in
check

Introduction
• Medical Representatives have revealed
widespread uses of bribes, including foreign
trips, microwave ovens, expensive smart
phones, jewellery and even women, by
pharmaceutical companies even as
government drags its feet on a 2016 proposal
to bring in a uniform Code of
Pharmaceutical Marketing Practices
(UNPMP) in the form of penal provisions.

Medical Representatives have revealed widespread uses of
bribes, including foreign trips, microwave ovens, expensive
smart phones, jewellery and even women, by pharmaceutical
companies

Medical Representatives have revealed
widespread uses of bribes pharmaceutical
companies

Uniform Code of Pharmaceutical
Marketing Practices (UNPMP)

Introduction
• In a report on pharmaceutical marketing
practices compiled by a public health group
support for Advocacy and training to
Health Initiatives (Sathi) medical
representatives (MRs) talked of tremendous
pressure exerted by companies on them
through high sales targets.

Support For Advocacy And Training To
Health Initiatives (Sathi)

Introduction
• Though the code of ethics of the Medical Council of
India bars doctors from accepting any gifts, cash,
travel facilities or hospitality from pharma
companies, there are no law to deal with such corrupt
marketing practices.
• According to MRs, hardly 10- 20 % doctors follow
the MCI code of ethics, while the rest accept or even
demand ‘incentives’ to prescribe products of a
company.
• In many high value deals, such as installments of
cars, the company even threatens the doctors if
targeted business is not achieved, revealed MRs.

Introduction
• The report, published by NGO Support for
Advocacy and Training to Health (SATHI),
suggested that medical representatives bribe
doctors with foreign trips, expensive smart phones
and even women.
• Medical representatives have paid for
“purchase of cars, international conferences,
online shopping vouchers and even female
companionship for doctors”, it stated.

Introduction
• At a review meeting with three drug maker
associations — Indian Drug Manufacturers’
Association (IDMA), Indian Pharmaceutical
Alliances (IPA) and Organization of
Pharmaceutical Producers of India (OPPI)
— the government pulled them up for not
complying with the Uniform Code of
Pharmaceuticals Marketing Practices
(UCPMP).

The report, published by NGO Support for Advocacy and
Training to Health (SATHI), suggested that medical
representatives bribe doctors

Introduction
• “Drug makers have been warned to follow
(Uniform Code of Pharmaceuticals Marketing
Practices) UCPMP voluntarily or else the
government will be forced to make it a
statutory provision under the law.
• This will restrict marketing practices of drug
makers and affect sales,” said a senior official
in the Department of Pharmaceuticals
(DoP).

Drug makers have been warned to follow UCPMP
voluntarily or else the government will be forced to
make it a statutory provision under the law

New Rules For Medical Devices Industry
• While IDMA, IPA and OPPI are responsible
for reporting complaints to the National
Pharmaceuticals Pricing Authority (NPPA)
every quarter about marketing practices and
deviations from UCPMP, not a single
compliance report has been received since
2014, officials said.

While IDMA, IPA and OPPI are responsible for reporting
complaints to the National Pharmaceuticals Pricing Authority
(NPPA) not a single compliance report has been received since
2014, officials said.

New Rules For Medical Devices Industry
• “The associations told us that they haven’t found
any non-compliance in the industry whereas several
media reports have highlighted misuse of marketing
strategies to lure doctors,” the official quoted earlier
said.
• The government has also warned drug makers to come
up with a rule to revoke manufacturing licenses if any
instance of unethical practice is reported.
• “The associations have been asked to not force the
ministry to take strict action otherwise we will come
up with a new law and revoke manufacturing
licenses,” the official added.

What is Uniform Code of Pharmaceuticals
Marketing Practices ?
• The UCPMP, released in 2014, is a
voluntary code issued by the DoP and
related to marketing practices for
pharmaceutical companies and the medical
devices industry.

• The UCPMP also says “no gifts, pecuniary
advantages or benefits in kind may be
supplied, offered or promised to persons
qualified to prescribe or supply drugs, by a
pharmaceutical company or any of its
agents i.e. distributors, wholesalers,
retailers etc”.

Uniform Code of Pharmaceuticals
Marketing Practices

• Not only healthcare professionals, but no gifts
should also be extended to a doctor’s family
members (both immediate and extended).
• It also says “companies or their associations
shall not extend any travel facility inside the
country or outside including rail, air, ship,
cruise tickets, paid vacations, etc. to healthcare
professionals and their family members for
vacation or for attending press conferences”.

What the SATHI report said
• The report by SATHI found that “the ethics and
values which were followed in the past are
getting bypassed” and “often these codes are
not adhered to achieve business”.
• It said tactics like an inducement, emotional
appeals, persuasions, serving family members,
sponsorships for national and promotional and
marketing practices of the international
conferences, pampering pharma industry and the
implementation doctors, etc are used as a norm.

What the SATHI report said
• “Some doctors who give huge business
demand women for entertainment and these
demands are met,” the study based on the
responses of medical representatives (MRs)
found.
• “Such arrangements are done by a senior
level management, and MRs are not directly
involved, and is reserved only for the
doctors who give enormous business.”

Doctors Prescribe More of a Drug If They Receive
Money from a Pharma Company Tied to It
• Pharmaceutical companies have paid
doctors billions of dollars for consulting,
promotional talks, meals and more.
• A new Pro Publica analysis finds doctors
who received payments linked to specific
drugs prescribed more of those drugs.

A new Pro Publica analysis finds doctors who
received payments linked to specific drugs
prescribed more of those drugs

Marketing Practices
• Doctors who receive money from drug makers
related to a specific drug prescribe that drug
more heavily than doctors without such
financial ties, a new ProPublica analysis found.
The pattern is consistent for almost all of the most
widely prescribed brand-name drugs in Medicare,
including drugs that treat diabetes, asthma and
more.
• The financial interactions include payments for
delivering promotional talks, consulting and
receiving sponsored meals and travel.

Doctors who receive money from drug makers related to a
specific drug prescribe that drug more heavily than doctors
without such financial ties

Marketing Practices
• ProPublica’s analysis found that doctors
who received payments wrote 45% more
prescriptions for the drug, on average, than
doctors who received no payments.

ProPublica’s analysis found that doctors who received
payments wrote 45% more prescriptions for the drug, on
average, than doctors who received no payments

Marketing Practices
• Other research, has found a correlation
between payments and overall prescribing.
• This new analysis expands upon past work by
looking individually at a variety of popular
drugs.

Other research, has found a correlation
between payments and overall prescribing

Marketing Practices
• Our analysis looked at the relationship in two
ways: whether those who received payments
prescribed more of a drug, as well as whether
those who prescribed a drug received higher
payments than those who did not.
• We found that, on average, physicians who
prescribed a drug received higher payments
related to the drug that same year than those
who didn’t prescribe it

On Average, Physicians Who Prescribed A Drug Received
Higher Payments Related To The Drug That Same Year Than
Those Who Didn’t Prescribe It

There's an unhealthy alliance between
doctors and pharma firms
• The government has shown little interest to
penalize pharma companies that offer sops
to doctors to push their drugs
• It’s a clear case of self-regulation gone wrong.
• That some pharmaceutical companies give
expensive gifts, distribute cash and pay for
extravagant pleasure trips of doctors willing
to push their products, is no news.

That some pharmaceutical companies give expensive gifts,
distribute cash and pay for extravagant pleasure trips of
doctors willing to push their products

• What’s alarming is that there is no law to
punish those guilty of the unethical practice;
and the government refuses to blink. Result:
patients are forced to buy costly medicines.

patients are forced to buy costly
medicines

There's an unhealthy alliance
between doctors and pharma firms
• Companies ramp up drug prices to recover
the amount spent on promotion.
• It was, therefore, no surprise when on January
8, 2019, KC Ramamurthy, Congress MP
from Karnataka, demanded in the Rajya
Sabha a list of firms accused of bribing
doctors and the action taken against them.
The government’s response was ambiguous.

Companies ramp up drug prices to recover
the amount spent on promotion

KC Ramamurthy, Congress MP from Karnataka, demanded
in the Rajya Sabha a list of firms accused of bribing doctors
and the action taken against them

• To seek clear-cut answers, Down To Earth (DTE)
filed a Right to Information (RTI) application
demanded from DoP, the nodal agency responsible
for curbing such malpractices, names of the
companies against whom complaints were filed since
2015 and the action taken against them.
• In 2015, the government had notified the Uniform Code
for Pharmaceutical Marketing Practices (UCPMP),
crucial for an industry that until now had nothing to
regulate it—neither a law nor any guidelines.

To seek clear-cut answers, Down To Earth (DTE) filed a Right
to Information (RTI) application demanded from DoP, the
nodal agency responsible for curbing such malpractices

• Reply to the RTI, dated February 14, revealed
names of 20 firms charged with “bribing
doctors, medical shopkeepers and
unauthorized medical practitioners to sell
their pharmaceutical products” in 2016.

20 firms charged with “bribing doctors, medical
shopkeepers and unauthorized medical practitioners
The firms are:
• Eris Life sciences Pvt Ltd,
• Merck Ltd,
• Glenmark Pharmaceuticals Ltd,
• Bayer Healthcare,
• Lupin Ltd,
• M S D Pharmaceuticals Pvt Ltd,
• Cryobanks International India Pvt Ltd,
• Sanofi India Ltd,
• Sun Pharmaceuticals Industries,
• Life Cell International Private Ltd,
• U S V Private Ltd,

• Torrent Pharma,
• Cordline Sciences India Pvt Ltd,
• Intas Pharmaceuticals Ltd,
• Abbot Healthcare Pvt Ltd,
• E-Meditek (TPA) Services Limited,
• U S V Private Ltd,
• Bristol-Mayers Squibb India Pvt Ltd,
• C M R Life sciences Pvt Ltd,
• Boehringer Ingelheim and
• Mcleods Pharmaceuticals Ltd.
• The complaints were made by Jan Swasthya Abhiyan (JSA) and
Punjab Medical Council. In 2018, DoP received complaints against
Acinta Pharmaceuticals Private Limited

20 firms charged with “bribing doctors,
medical shopkeepers and unauthorized
medical practitioners
• The RTI reply did not reveal the erring
doctors’ names.
• Asked what action was taken against the firms,
DoP, which comes under the Ministry of
Chemicals and Fertilizers, steered clear of owning
up all responsibility and said it had forwarded the
complaints to the Ministry of Health and Family
Welfare (MoHFW), the Medical Council of India
(MCI) and a pharma association.

20 firms charged with “bribing doctors,
medical shopkeepers and unauthorized
medical practitioners

There's an unhealthy alliance between doctors
and pharma firms
• “Ethical practice can be enforced only through peer
pressure.
• Legislation is no solution to the malady,”
• MCI, however, does have the authority to cancel the
license of corrupt doctors.
• But it has only doctors in its ethics committee. “MCI
has been completely passive on the ethics dimension,”
acknowledges the Parliamentary Standing Committee
in a report presented in March 2016.
• “All over the world, it has been realized that the
medical profession tends to protect its own flock.”

Ethical practice can be enforced only
through peer pressure.

• In the absence of a law, those who feel unprotected
are the medical representatives. They get everyday
targets to give pre-planned packages to doctors.
• “If a doctor avails privileges from a pharma firm, but
does not prescribe its drug, the firm catches hold of us,”
says Santanu Chatterjee, secretary, Federation of
Medical and Sales Representatives’ Associations of
India (FRMRAI).
• “We are forced to go to the doctor again so that the
commitment is fulfilled. If we don’t meet targets and
assure profits, our salaries can be withheld. We can
be even sacked.”

In the absence of a law, those who feel unprotected are the
medical representatives. They get everyday targets to give
pre-planned packages to doctors

• McKinsey & Company, a US management
consulting firm, states the Indian
pharmaceuticals market is set to grow from
$33 billion, according to India Brand Equity
Foundation, to $55 billion by 2020 and become
comparable with all developed markets other than
the US, Japan and China.
• Small wonder, pharma firms completely ignore
UCPMP and promote their products as a
business. “The drug promoted the most becomes
costliest,” says Chatterjee.

Indian pharmaceuticals market is set to grow from
$33 billion, according to India Brand Equity
Foundation, to $55 billion by 2020

• The gifts, however small, influence the
physician, states a study conducted in 2013 by
Roshni Narendran of the University of
Wollongong, Australia, and M Narendranathan of
the Kerala Institute of Medical Sciences,
Thiruvananthapuram.
• When a physician listens to a drug salesperson
and accepts gifts from the company, the doctor
is under obligation to prescribe that drug, the
study states.

The gifts, however small, influence the physician, states a
study conducted in 2013 by Roshni Narendran of the
University of Wollongong, Australia, and M Narendranathan of
the Kerala Institute of Medical Sciences.

• An analysis by the Economic Times Intelligence Group
shows 10 largest pharma firms had spent six per cent of
their total sales between April 2003 and March 2004 on
research and development. In contrast, these firms spent
290 per cent more on marketing.
• Clearly, self-regulation has failed to police the interactions
between the physician and the pharma firms. “We had given
an alternate law which made regulatory obligations
mandatory and not voluntary.
• It clearly gave penal provisions, from a fine of Rs 50,000
to Rs 20 lakhs and imprisonment depending upon the
violation. If such measures are not adopted, this sector
will never be regulated”.

10 largest pharma firms had spent six per cent of their total
sales between April 2003 and March 2004 on research and
development. In contrast, these firms spent 290 per cent more
on marketing

• Gifts to doctors influence their prescribing
patterns. Research has shown, quite
unequivocally, that even a small gift, like a pen,
can have an influence.
• The evidence on this is catalogued in detail on
the website www.nofreelunch.org.
• The move of the Medical Council of India (MCI)
to amend the code of ethics for doctors and
incorporate a specific ban on gifts must,
therefore, be welcomed.

• It must be noted that the rule in India is far more
stringent than that in other countries such as the
United States.
• The new rule in India bans all gifts above Rs
1,000 in value.
• The recommended minimum punishment for
accepting a gift up to a value of Rs 5,000 is
censure, and above this value, suspension from
the medical register for various periods is
prescribed.

The new rule in India bans all gifts
above Rs 1,000 in value

There's an unhealthy alliance
between doctors and pharma firms
• The laudable aim of such bans is to prevent the
drug and medical device industry from
influencing doctors to use inappropriate or
expensive (or both) drugs and devices because
of the benefits the doctor can receive for such use.
• As many commentators have pointed out, in
medicine, the doctor decides and the patient
pays; hence there is a special need to ensure
that decisions are made solely in the interest of
the patient.

The laudable aim of such bans is to prevent the drug and
medical device industry from influencing doctors to use
inappropriate or expensive (or both) drugs and devices

In Medicine, The Doctor Decides And The Patient Pays;
Hence There Is A Special Need To Ensure That Decisions Are
Made Solely In The Interest Of The Patient.

Drug information in India
• Drug Information In India
• Good prescribing habits imply the availability of good
information about drugs and medical devices. This
means that the doctor must be aware, not only of the
appropriate usage of drugs but also of the quality of the
different suppliers and the prices.
• Unfortunately, in India such information is not easy to
come by. In the United Kingdom, for example the Joint
Formulary Committee publishes the British National
Formulary which lists all medicines available in Britain,
the indications for their use and their side effects and prices.
• Similar publications exist in most of Europe. The
European Union has established the European
pharmacopoeia and is moving towards harmonization.

Drug information in India
• In India, on the contrary, no official and reliable
channel of information exists. Except for checking in
the Monthly Index of Medical Specialties or the
Current Index of Medical Specialties, there is no way
for a doctor to know the relative prices of various
brands of the same or similar drugs.
• Looking at hundreds of formulations from hundreds
of companies is no easy task. The initiative of setting
up drug information centres in several states has not
taken off in a big way.

Quality concerns
• Quality concerns
• In a situation of poor regulation, the
proportion of spurious to authentic drug
formulations in India is estimated to range
between 10% and 20%, the figure provided
by the legitimate pharmaceutical industry
in India and quoted by the World Health
Organization task force on spurious drugs

Quality concerns
• The medical devices market is no different with a
large number of small players many of whom are
not compliant with good manufacturing practices.
• In 2005, 10 categories of medical devices were
declared to be drugs and their manufacture needs
approval from the Central License Approval
Authority under the Central Drugs Standardization
and Control Organization.
• In private conversations, manufacturers of these
products allege that the licensing authority demands
bribes of about Rs 15 lakh to certify the
manufacturing unit as quality compliant. It
therefore remains uncertain if the company makes
quality goods.

Quality concerns
• In critical areas like stents for the heart, and orthopedic
implants, it is unclear if these products have been put
through the rigorous testing required.
• The Central Drugs Standardization and Control
Organization is understaffed and poorly run and it is
difficult to repose confidence in this institution
• They are: poor enforcement of laws, understaffing,
failure to establish a National Drug Authority,
inadequate testing facilities, lack of drug inspectors,
non-existence of a data bank, and non-availability of
accurate information.

The Central Drugs Standardization and
Control Organization

Quality concerns
• It is alleged that bribes are a way of life here.
Certification by the CDSCO is therefore no
guarantee of quality, and doctors must seek other
means to be assured of the quality of the drugs that
they prescribe.
• One of the common tactics that doctors use is to
prescribe only the products of multinational companies
or large local companies in the belief that these
companies need to protect their brand image and
therefore will maintain quality. But the products of
these companies are rarely the cheapest in the
market.

Credibility gap in the Medical Council of
India
• There is also the problem of the huge
credibility gap in the MCI.
• In recent years this statutory body of the
government of India has been in the news for
its poor regulation of medical education, its
failure to play a leadership role in the
governance of medical education and practice
and several unsavoury allegations against its
members.

India

India
• The situation has reached such a sorry pass that the
government has expressed an intention to abolish it and
replace it with another body.
• The way the Council is constituted lays it open to the
shenanigans of people of little integrity. It is difficult
to escape the conclusion that the present amendment to
the ethical code is a feeble attempt to lay claim to
ethical behavior.
• If the Medical Council of India is really serious
about setting right the numerous infractions of its
ethical code, it needs to do much more than add
another rule to a code which is seldom enforced

Medical Council of India
(Code of Conduct)
• 6.8.1 In dealing with Pharmaceutical and allied
health sector industry, a medical practitioner shall
follow and adhere to the stipulations given below:-
• a) Gifts: A medical practitioner shall not receive any
gift from any pharmaceutical or allied health care
industry and their sales people or representatives.
• b) Travel facilities: 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.

(Code of Conduct)

(Code of Conduct)
• c) Hospitality: A medical practitioner shall not
accept individually any hospitality like hotel
accommodation for self and family members
under any pretext.
• d) Cash or monetary grants: A medical
practitioner shall not receive any cash or
monetary grants from any pharmaceutical and
allied healthcare industry for individual purpose
in individual capacity under any pretext.

AMA Code of Medical Ethics
• Gifts to Physicians from Industry
• Any gifts accepted by physicians individually
should primarily entail a benefit to patients and
should not be of substantial value.
• Accordingly, textbooks, modest meals, and other
gifts are appropriate if they serve a genuine
educational function.
• Cash payments should not be accepted. The
use of drug samples for personal or family use
is permissible as long as these practices do not
interfere with patient access to drug samples.

• Individual gifts of minimal value are
permissible as long as the gifts are related to
the physician’s work (e.g., pens and
notepads).

• Subsidies from industry should not be
accepted directly or indirectly to pay for the
costs of travel, lodging, or other personal
expenses of physicians attending
conferences or meetings, nor should
subsidies be accepted to compensate for the
physicians’ time.

• Subsidies for hospitality should not be
accepted outside of modest meals or social
events held as a part of a conference or
meeting.
• It is appropriate for faculty at conferences or
meetings to accept reasonable honoraria and to
accept reimbursement for reasonable travel,
lodging, and meal expenses.

• No gifts should be accepted if there are
strings attached. For example, physicians
should not accept gifts given in relation to the
physician’s prescribing practices.

Doctors who take gifts from pharma
firms to be punished: MCI guidelines
• For the first time, these guidelines will define
punishment for errant doctors based on the value of
favours or freebies received from pharma companies
• Doctors accepting freebies such as gifts and foreign
jaunts from pharmaceutical companies will now be
punished, based on the value of gifts received.
• The punishment will range from a censure for gifts
of up to Rs 5,000 to deletion of the errant doctor’s
name from the state or national medical register for
a period of one year or more for freebies valued
more than Rs 1 lakh.

Doctors who take gifts from pharma firms to
be punished: MCI guidelines

• The Medical Council of India (MCI) is set to notify the
new ethical guidelines under the Indian Medical
Council (Professional Conduct, Etiquette and Ethics)
(Amendment) Regulations, 2015.
• For the first time, these guidelines will define
punishment for errant doctors based on the value of
favours or freebies received from pharma
companies.
• While the Indian Medical Council Regulations, 2009
bar doctors from receiving freebies, the punishment, if
caught, is now subject to the discretion of either the
central or the state councils’ ethics committee

• As per the new ethics guidelines any doctor
accepting gifts, travel facilities, hospitality, cash or
monetary grants worth Rs 5,000 to Rs 10,000 from a
pharma company would see his/her name removed
from the national or state medical register for three
months.
• Nobody can practice medicine without registration
with either the state medical council or the central
council. If the value of the freebies is between Rs
10,000 and Rs 50,000 the penalty would go up to six
months, and for those priced Rs 50,000 to Rs 1 lakh,
the errant doctor’s name would remain struck off
the register for a year.

• For free gifts amounting to more than Rs 1
lakh the period would be more than a year,
subject to the discretion of the ethics
committee. Repeat offenders under all slabs
would be punished on a case to case basis,
depending on the gravity of the offence.

• An alleged nexus between some pharmaceutical
companies and unscrupulous doctors is widely
recognized as one of the key reasons behind rising
drug prices, although companies maintain that the
margins are to account for research and
development work.
• In reality, cost of the freebies to doctors are
usually worked into the marketing cost of
drugs. As a result, drugs priced higher
containing the same molecules often tend to be
the market leaders.

Doctors who take gifts from pharma firms to
be punished: MCI guidelines
• The new guidelines lay down that medical
practitioners may carry out research work funded
by pharma companies, provided they ensure that
the research proposals have all the necessary
clearances, it fulfills the legal requirements.
• Any contravention for the first time will merit
a censure but repeat for offenders names
would be struck off the medical registers for a
period depending on the gravity of the
violation.

• According to norms, a doctor cannot also
endorse any medical product unless it is to
present the results of an efficacy or other
study done in an appropriate scientific body
or journal.
• Not doing so for the first time would result in a
censure; a second offence would mean deletion
of his/her name from the medical register.

According to norms, a doctor cannot also endorse
any medical product unless it is to present the results
of an efficacy

Doctors Prescribe Too Many
Medications
• Medications save lives and make life more
bearable for millions of people. No doubt
about it. But medications can also cause
harm.
• Logically, the more medications a patient
takes, the higher the risk of side effects and
dangerous interactions between medications.

What are the dangers associated with
over medications?
• Although medications are designed to help patients, they
can also cause health issues. All medications have side
effects. Some are potentially serious, while others are
minor. But it’s important to understand that all
medications carry some degree of risk. There are two
major issues of concern – side effects and adverse drug
reactions.
• Adverse drug reactions (ADR) involve an unexpected or
dangerous reaction to a medication. You can develop an
ADR after one dose of medication, from prolonged use
of a drug, or from a negative interaction between 2 or
more medications.
• The more medications you take, the higher your risk of
problems, an issue called medication overload.

What are the dangers associated with
over medications?

What is Medication Overload?
• What is Medication Overload?
• Medication overload is “the use of multiple
medications for which the harm to the patient
outweighs the benefit.
• There is no strict cutoff for when the number of
medications becomes harmful, but the greater
number of medications a person is taking, the
greater their likelihood of experiencing harm,
including serious adverse drug events.”

What is the impact of medication
overload?
• Health issues from medication overload can
range from mild to life threatening. And the
economic ramifications are staggering.

What is the impact of medication
overload?
• Over the last decade:
• There were over 35 million cases of older
people seeking medical treatment for adverse
drug events.
• Medication issues led to 2 million hospital
admissions.

What factors lead to medication
overload?
• Culture of Prescribing
• The culture of prescribing is shifting.
• Doctors and patients feel the need to “do something”
to improve patient health. Ads for prescription
medications encourage patients to seek medications
for improved happiness and health. The practice of
medicine is fast paced, with doctors often seeing
patients in time-limited slots. Additionally, we have
adopted a medical approach to normal aging. All these
factors have led to a shared expectation among
doctors and patients that there is a “pill for every
ill.”

overload?
• Information & Knowledge Gaps
• Doctors and other clinicians, as well as
patients, don’t always have the critical
information and skills they need to evaluate
the circumstances and make informed
decisions regarding medications.

overload?
• Fragmented Care
• There is a widespread lack of communication
among a patient’s various doctors and other
healthcare providers. As a result, patients can
suffer. One common scenario: one doctor
writes prescriptions for what seems like a new
health condition but is actually a side effect
from another medication prescribed by
another doctor. This practice, referred to as
“prescribing cascade”, can lead to a cycle of
debilitating health and even death.

Terminology
• No Free Lunch was a US-based advocacy organization
holding that marketing methods employed by drug
companies influence the way doctors and other
healthcare providers prescribe medications.
• The group did outreach to convince physicians to
refuse to accept gifts, money, or hospitality from
pharmaceutical companies because it claims that
these gifts create a conflict of interest for providers.
The group also advocated for less involvement of drug
companies in medical education and practice in a
variety of other ways.

The Sunshine Act For Indian Pharma
Companies
• The report published by the end of 2015 by
Comptroller and Auditor General of India (CAG)
titled “Assessment of Assesses in Pharmaceutical
Sector” pointed a massive figure of projected tax
foregone. In a further investigation, CAG stated that
Income Tax Department (ITD) allowed Rs. 16443
Crores as a tax foregone, which comprised a massive
component made up by freebies and payments to the
doctors. CAG and ITD subsequently made a tax
demand for almost all the cases. Going one step
beyond, CAG also pointed out that most of the
payments by the companies were an infringement of
Medical Council Regulation- 2002.

Income Tax Department (ITD) allowed Rs. 16443 Crores as a
tax foregone, which comprised a massive component made up
by freebies and payments to the doctor

The Sunshine Act For Indian Pharma
Companies
• The issue was also brought on the radar when a
member of Rajya-Sabha wrote to the Minister of
Chemicals and Fertilizers (who oversees
pharmaceuticals portfolio) accusing 4 major Pharma
companies for their payment to doctors.
• The member also claimed to have a list of companies
and doctors who received these payments and freebies.
The headlines are making quite a noise in the national
capital as patient advocacy groups, public
representatives are pushing for India’s own Sunshine
Act.

The Sunshine Act For Indian
Pharma Companies
• Originally introduced in the USA as Physicians
Payments Sunshine Act has been found
effective in bringing transparency and curb
unethical practices from both pharma
companies and doctors alike

Sunshine Act
• The Sunshine Act requires manufacturers of
drugs, medical devices, biological and
medical supplies covered by the three
federal health care programs Medicare,
Medicaid, and State Children's Health
Insurance Program (SCHIP) to collect and
track all financial relationships with physicians
and teaching hospitals and to report these data
to the Centers for Medicare and Medicaid
Services (CMS).

Sales growth of therapy drugs due to the corona-virus
(COVID-19) across India in March 2020, by type

References
• AMA Code of Medical Ethics’
• https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-physicians-relationships-
drug-companies-and-duty-assist-containing/2014-04
• A physician’s guide to acceptable pharma swag
• https://www.mdlinx.com/article/a-physician-s-guide-to-acceptable-pharma-swag/lfc-3715
• Doctors, drug companies, and gifts
• https://pubmed.ncbi.nlm.nih.gov/2585690/
• Doctors who take gifts from pharma firms to be punished: MCI guidelines
• https://indianexpress.com/article/india/india-news-india/doctors-who-take-gifts-from-pharma-firms-to-
be-punished-mci-guidelines/
• Ethical considerations in doctors & pharmaceutical industries relationship: a narrative
review
• https://ijmdc.com/fulltext/51-1572794591.pdf?1613022855
• Indian Medical Council(Professional Conduct, Etiquette and Ethics) Regulations, 2002
• https://wbconsumers.gov.in/writereaddata/ACT%20&%20RULES/Relevant%20Act%20&%20Rules/Cod
e%20of%20Medical%20Ethics%20Regulations.pdf
• Support For Advocacy And Training To Health Initiatives (SATHI) Report
• https://sathicehat.org/wp-Content/uploads/2019/12/Pharma-study-report_by-SATHI.pdf

The unethical practice of gift giving to doctors by pharma companies

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