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PHAMACEUTICAL

SECTOR_________________(A Business Ethics Project)

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INTRODUCTIONPharmaceuticals mean in simple terms products that are obtained from

pharmaceutical companies. Pharmaceutical companies manufacture drugs that are used to

treat various diseases in both, humans as well as animals. These are basically classified as

drugs that are given with prescription of a medical practitioner and over-the-counter drugs.

Pharmaceutical products help in improving health of people by treating their

particular diseases. An extensive research process is followed before these drugs are let out

into the market. Clinical testing is conducted before these drugs are used for humans. They

are first tried on animals to test their safety and affectivity. Later these drugs reach patients

through the prescriptions of physicians.

FDA or Food and Drug Administration is the authority that decides whether the drug

is fit for administering to humans or not. Pharmaceuticals are continuously under the scrutiny

of the FDA. Any complaints after or during the use of the drugs are reported to the FDA and

they have the authority to revoke license to sale of those drugs. They analyze the whole

process of testing and packaging before issuing license for sale.

Pharmaceutical companies advertise over-the-counter drugs through websites and

other advertising campaigns. Websites contain detailed information regarding the

constituents of the drug, its uses, probable side effects and prices. Classification of the drug

is made on the basis of the disease and convenience of the doctors to prescribe it to their

patients. The FDA, after undergoing an intensive research, also approves pharmaceutical

drugs such as those used for helping people to stop smoking. Insurance companies usually

pass claims for use of medicines that are approved by FDA.

Animal health care is also an integral part of some pharmaceutical companies.Medicines are manufactured on the basis of results of extensive research and keeping in

mind diseases and symptoms of animals. Veterinary doctors prescribe these medicines for

pets and other domestic animals. The safety of these drugs is also checked and clinically

tested before it is launched into the open market.

Relationships involving medical practitioners and the pharmaceutical industry raise serious

concerns and controversy within both the medical profession and the broader community.

Within the profession itself views differ sharply, from the conviction that the risks associated

with such relationships are minimal to a concern that all contact between doctors and

industry involves compromise and should therefore be avoided as far as possible. Therelationship between the pharmaceutical industry and the medical profession includes clearly

desirable aspects (eg, the cooperative efforts of industry, government and prescribers in

trying to achieve quality use of medicines) and less clearly ethically justifiable ones

(eg, acceptance of lavish gifts and money for entertainment expenses by doctors).

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Sources of concern

Doctors and the pharmaceutical industry share a number of common interests. For

example, both are concerned with encouraging effective and responsible use of existing

drugs in treatment and care, monitoring of their use, and innovative research. However, the

parties have different emphases and focus on different stakeholders. Doctors are interestedprimarily in patient care and scientific advance, while industry is interested primarily in

commercial outcomes. The primary stakeholder in patient care is the patient, whereas the

principal stakeholder in industry is the shareholder. The similarities and differences between

participants and their interests create both a need for discourse and the potential for conflict.

The contribution made by industry to medical knowledge and practice has been

considerable. The cost of development of a new drug is between US$300 and $600 million,

most of which is provided by industry. Clinical research is also expensive: last year, in the

United States, about US$6 billion was spent on clinical research, of which 70% came directly

from industry. The total amount spent on research and development is much larger still. In

spite of these clear common interests and benefits of cooperation, concerns of an ethicalnature have been expressed by both the medical profession and the community. There are

three main concerns:

The possibility that associations between doctors and drug companies may serve

commercial objectives of industry and acquisitive interests of clinicians rather than

legitimate care, educational or research goals, thereby compromising the primary

ethical obligation of doctors to patients, dividing the loyalties of doctors and

undermining the basic trust on which clinical relationships depend;

The risk that drug promotion will inappropriately influence doctors decisions

The danger that industry involvement in research will lead to distortions in scientific

evidence and prevent independent assessment of data.

These issues have been considered by professional bodies and other organizations,

which have from time to time developed guidelines and codes of conduct for their members.

There has been disagreement about whether voluntary codes are sufficient or mandatory

rules are needed, but the self-regulatory model has so far largely prevailed in Australia. Last

year, the Royal Australasian College of Physicians released new guidelines and the

Australian Pharmaceutical Manufacturers Association issued a comprehensive code ofconduct that provides detailed guidance to industry on such matters as drug promotion.

The question of divided loyalties

An interest is a commitment, goal or value that arises out of a particular social

relationship or practice. The possibility that dealings with drug companies might lead to

divided loyalties of doctors, or conflict of interest, has been an abiding concern, but

identifying such conflicts is not entirely straightforward. One definition refers to either

motives that caregivers have and/or situations in which we could reasonably think

caregivers responsibilities to observe, judge, and act according to the moral requirements of

their role are, or will be, compromised

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However, this approach understates the crucial dependence of interests on particular

relationships and the need for public processes by which coexisting interests can be

evaluated. It is common for relationships to be associated with several interests. Interests of

medical practitioners include:

community welfare

pecuniary interests (eg, consultancy fees, share holdings, paid employment)

advancement of career

research grants

hospitality

Participation in research.

patient welfare

When a doctor is engaged in a relationship with a pharmaceutical company, a duality of

interests exists. It cannot be assumed that such a duality will constitute a conflict in each

case this will depend on the particular circumstances, and often not everyone will agree

anyway. Dualities of interest are common; conflicts relatively rare. Further, whereas the

distinction between the two is sometimes clear-cut, at other times it may be subtle and

depend on the nature of the relationship in question and the values of the community within

which it occurs. Dualities of interest constitute conflicts only when they are associated with

competing obligations that are likely to lead directly to a compromise of primary

responsibilities. To establish whether a conflict of interest exists, it is necessary for the

factual details to be declared and for the community to have the opportunity to scrutinize the

issues publicly.

Drug promotion

Promotion and marketing (including advertising, gift giving and support for medicallyrelated activities such as travel to meetings) make up a very large part of the activities of

drug companies (consuming a quarter to a third of their entire budgets, and totalling more

than US$11 billion each year in the United States alone). There are no comprehensive

figures available, but it is estimated that, of this, about US$3 billion is spent on advertising

and US$5 billion on sales representatives, while expenditure per physician is believed to be

over US$8000.

Advertising

Doctors generally perceive the way they practice to be determined by knowledge and

evidence, but it appears that they often fail to recognize commercial influences ontherapeutic decisions and underestimate the subtle and pervasive effects of pharmaceutical

promotion. It is disquieting that some practitioners rely on pharmaceutical company

representatives for much of their drug information. Although physicians often deny it, there is

considerable evidence that advertising affects clinical decision-making behavior. Contact

with drug company representatives leads to prescribing of their drugs; physicians exposed to

advertising are more likely to accept commercial rather than well-established scientific views;

and drug company advertising is associated with an inability of some physicians to identify

wrong claims and a propensity to engage in non-rational prescribing behaviour.

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Gift giving

Gift giving is another widespread drug-promotion strategy. A study from the

University of Toronto showed that, over a period of one year, psychiatry residents and

interns attended up to 35 meetings and 70 drug lunches and received up to 75 promotional

items and US$800 in gifts (although there was considerable variation). In another study,

more than 80% had received at least a book and in some cases much more. Although, aswith advertising, physicians deny that gifts influence their behaviour, here, too, there is clear

evidence to the contrary. A survey of 120 physicians in Cleveland, Ohio, showed that those

who met with pharmaceutical representatives were 13.2 times more likely to request

inclusion of the companys products in their hospital formulary; those who accepted money

to speak at symposia were 21.4 times more likely to do so; and those who accepted money

to perform research were 9.2 times more likely to do so.

Meeting sponsorship and continuing medical education activities Sponsorship of

meetings is an important and difficult issue. There are clearly common interests between

professional societies, which are usually responsible for organising conferences, and thepharmaceutical industry: the former stand to gain substantial funding from the

pharmaceutical industry for their meetings and other activities, while, for the latter,

unparalleled opportunities are provided to showcase their wares. On the other hand, choices

of speakers and topics at meetings may have important implications for pharmaceutical

companies, and, if these are subject to influence from outside the professional society, the

kinds of impressions that people go away with may be significantly altered.

Indeed, sponsorship of conferences has been shown to lead to bias in favour of the

sponsoring companies drugs, with increases in prescriptions for sponsors drugs in the six

months after an event. Similarly, pharmaceutical support for continuing medical education

(CME) activities leads to increased prescribing of sponsoring companies products. Thisoccurs even when the course content is controlled by the society or institution and the drugs

are referred to by their generic names only.

Control of publication and research outcomes

The effect of drug company sponsorship on research and publications is a major

issue that will not be discussed in detail here. Briefly, there are many ways in which research

findings can be directed towards producing a desired result, ranging from careful design of a

trial and selection of drug doses to selective reporting of results or actual suppression of

unfavourable outcomes. The prominence of a publication can be enhanced by paying

authors to participate, or publishing non-peer-reviewed material as a supplement in a

respected journal. Delays in the publication of unfavourable results are common, and it is

speculated that the results of many clinical trials are never published at all.

Guidelines for action

Although opinions differ about whether voluntary guidelines or mandatory rules are

the best way to monitor potential conflicts of interest, no professional bodies or institutions

have proposed a ban on interactions between doctors and the pharmaceutical industry.

Indeed, it is accepted that such a policy would not serve the interests of any party. It is

strongly felt that the most desirable approach is to develop an amicable relationship that

allows healthy criticism and is based on clear, but non-coercive, guidelines. This is the view

adopted by the Royal Australasian College of Physicians

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Dualities of interest should be publicly declared and examined for the presence of a

conflict.

Acceptance of gifts should be kept to a minimum.

Non-service-oriented gifts, including items of trivial value, should not be accepted.

Entertainment should not be lavish.

Support for travel should be restricted to those making formal contributions to

meetings/conferences.

Meetings should be organised by an independent committee.

Research and publication should be guided by scientific and ethical rather than

commercial values

Dualities of interest

The central principle that should be adopted is that arrangements between

physicians and pharmaceutical companies should be open and transparent. Dualities ought

to be clarified and clearly declared in the relevant context to patients, research

participants, hospital committees, and so on. Whether they constitute conflicts should not be

left to the individuals concerned to decide, but to a process of informed public debate within

the setting in which the duality arises. Where conflicts appear likely, special procedures

should be devised to avoid unacceptable outcomes.

Drug promotion, including acceptance of gifts

Ideally, drug promotion should be restricted to the dissemination of well-founded data

about specific products. This would ensure reduction of costs of pharmaceuticals to theconsumer as well as reassuring the community about the independence of physicians,

restricting excessive claims about the effectiveness of drugs and ensuring unbiased

assessment of evidence. Benefits received from pharmaceutical companies should leave

physicians and scientists independence of judgement unimpaired. Various levels of advice

have been advanced to medical practitioners about accepting gifts. These range from

blanket rejection, to a gradient of moral acceptability based on cost, to the principles that

gifts should not be excessive and should not influence decision-making, to the test of

whether the recipient would be willing to have the arrangements publicly known.

Sponsorship of meetingsFull disclosure of commercial sponsorship of meetings should be made. Sponsorship

should always be provided through independently organised scientific committees; speakers

should indicate dualities of interest at the time of presentation; and sources of commercial

funding should not influence scientific, educational or public policy decisions of the

professional body.

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GLAXO SMITH KLINE:ACASE STUDY.

Research and innovation

In undertaking their research and in innovating they explore and apply newtechnologies and constructively engage stakeholders on any concerns that may arise. Theywill ensure that their products are subject to rigorous scientific evaluation and testing forsafety, effectiveness and quality.

Products and customersThey promote their products in line with high ethical, medical and scientific standards

and comply with all applicable laws and regulations.

Caring for the environmentGlaxo operates in an environmentally responsible manner through systematic

management of environmental impacts, measurement of performance and setting

challenging performance targets and minimize all the unwanted waste

Employment practicesThey treat their employees with respect and dignity, encourage diversity and ensure

fair treatment through all phases of employment. They provide a safe and healthy workingenvironment

Human rightsThey are committed to upholding the UN Universal Declaration of Human Rights, the

OECD guidelines for Multi-National Enterprises and the core labor standards set out by theInternational Labor Organization. They expect the same standards of ther suppliers,

contractors and business partners working on GSKs behalf.

Community investmentThey make a positive contribution to the communities in which they operate, and will

invest in health and education programmes and partnerships that aim to bring sustainableimprovements to under-served people in the developed and developing world.

Positive Action on HIV/AIDSThe programme targets its funds towards community-focused projects that reach those

most affected by HIV, particularly in marginalized or vulnerable populations. Positive Actionworks with these communities to enable them to tackle stigma and discrimination, to testinnovations in education, care and treatment and to deliver greater involvement of those

living with HIV. Our Positive Action for Children Fund launched in 2009 to make 50 millionavailable over 10 years to help prevent mother-to-child transmission of HIV and to supportorphans and vulnerable children. At the end of 2010, the latest call for proposals was madebroadening the reach and scope of its response for babies and children affected by HIV.

The GlaxoSmithKline African Malaria PartnershipThe African Malaria Partnership is our programme to alleviate the mortality and

suffering malaria brings to affected communities in Africa. They help provide healtheducation to affected populations and to train community health workers.

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Humanitarian product donationsWorking with non-profit partners, AmeriCares, Direct Relief International, MAP

International, Interchurch Medical Assistance and Project HOPE, they supportedhumanitarian relief efforts and community healthcare in over 90 countries. They respondedto the healthcare needs of the many communities affected by disasters, including the

devastating earthquake that struck Haiti in January 2010, GSK donated supplies ofmedicines valued at over 1 million. Included in these shipments theyre significant volumesof antibiotics as theyll as respiratory and diabetes treatments. Their consumer divisionprovided a range of products, including toothpastes, antacids, pain relievers and vitamins.During the cholera outbreak they responded to a further specific request for antibiotics anddonated 250,000 to the British Red Cross to support the deployment of a mass sanitationunit serving more than 50,000 people living in temporary relief camps. Following theearthquake in Chile, in response to an urgent request they supplied 95,000 doses ofHepatitis A vaccine, antibiotics and more than 6,000 dental hygiene kits.

Environmental sustainabilityGlaxo is committed to integrating environmental sustainability into our business,

especially conserving resources and addressing climate change. They see this as anopportunity.

Climate change and energyThe long-term vision is for entire value chain to be carbon neutral by 2050. This is a

very ambitious target and means that there will be no net greenhouse gas emissions frommanufacturing, distributing, using and disposing of our products, including sourcing rawmaterials.

Environmental stewardshipThey aim to use materials efficiently and safely, minimizing waste and pollution and

avoiding harm to people and the environment. Increasing the efficiency with which they usematerials is a priority. The long-term aspiration is to achieve 5% mass efficiency by 2020 fornew pharmaceutical products transferred from R&D to manufacturing. This is about fivetimes the typical level in the pharmaceutical industry and will reduce input materials andwaste by 80%. The average mass efficiency for new products during the 2006-2010 periodhas reached 3.3%

Animal crueltyThey do not do medical tests on animals or harm them in any way possible. They are

an active donor of PETA . And no animal body parts are used in the medicine. GSK donated$3 million to PETA last year

1. In 1992, during a raid on the premises of one scrap dealer Barkat Ali, rejected

materials and labels in bulk, both coded and uncoded, of Glaxo India Limited theyrerecovered. Further investigations followed and the revelations shocked medical andpharmaceutical circles in the country. The scrap dealer confessed to selling rejectedmedicines to an enterprising Gujarati businessman operating from a cubby hole inAhmedabad. On February 14, 1994, the Mumbai High Court upheld the closureorders of Glaxo India Limited given to it by the state FDA. The company opined "theyfeel they theyre being singled out although there are other pharmaceutical

companies which are found to be violating the rules". Glaxo was referring to violationof rules done by Boots and German Remedies Limited. (These are all multinational drug companies.)

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2. Between January 21 and February 7, 1986, 14 patients died in J.J. Hospitals inMumbai from a cause totally unrelated to the diseases that brought them there. Theydied of poisoning by the adulterated glycerol given to them. The toxic adulterant wasdiethyl glycol which was present in a concentration of 18.5% - over three times thelethal dose. Rapid necrosis of the kidneys took place and the unfortunate victimssuccumbed to acute renal failure. Kailash Company sold this adulterated glycerol,meant for industrial consumption, to Alpana Pharmacy with Glaxo India Limited asthe supposed middle man, with Glaxo knowing that it was not to be used formedicinal purpose. This was not a mistake, nor an act of carelessness. It was anextremely conscious act motivated by greed for more profits.

What about ethics? The licensing authority, the drug testing laboratory, the tendercommittee, the pharmacology department and the highest authorities in J.J. Hospitals, andthe Health minister are indicted.What has been the track record of action taken against the guilty?The non-implementation of the judgments makes statutes like the Drugs & Cosmetics Act afarce.

Good governance has 8 major characteristics. It is participatory, consensus oriented,

accountable, transparent, responsive, effective and efficient, equitable and inclusive and

follows the rule of law. It assures that corruption is minimized, the views of minorities are

taken into account and that the voices of the most vulnerable in society are heard in

decisionmaking. It is also responsive to the present and future needs of society.

Components of a Framework for Good Governance in the Public Pharmaceutical

Sector:

Moral values and ethical principles:

Moral values relate to what is believed to be good and of primary importance to

human civilization, and are often articulated as ideals. Moral values inform judgment by

defining right from wrong, and good behaviour from bad.

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Ethical principles are the operational expression of moral values and provide guidance to

decisionmaking and action. Along this same line of reasoning, Carol W. Lewis relates these

concepts to public service: ethical principles are guides to action; they operationalize values

and cue behaviour befitting public service.

The following conditions are considered to be basic requirements that ethical principlesshould fulfill in order to effectively guide decisionmaking.

Principles should be general.

They should be stated in a general manner that does not limit their application with

reference to specific individuals or associations. Principles must be capable of

serving a public charter of a wellordered society in perpetuity and the knowledge of

them must be open to individuals of any generation. Thus to understand these

principles should not require a knowledge of contingent particulars, and surely not a

reference to individuals or associations.

Principles should be universal in application.They must hold for everyone in virtue of their being moral persons. In this context,

the term moral persons refers to individuals who are committed to the application of

principles based on moral values in making decisions and implementing them.

Principles should be publicly known and accepted.

They should be accessible to public knowledge and subject to public scrutiny and

debate. The difference between this condition and that of universality is that the

latter leads one to assess principles on the basis of their being intelligently and

regularly followed by everyone. But it is possible that all should understand and

follow a principle and yet this fact not to be widely known or explicitly recognized.

Principles should impose an ordering on conflicting demands.

This requirement springs directly from the role of principles in adjusting competing

demands. The ordering of competing demands requires the judicious prioritizing of

values and the application of principles.

Principles should have a condition of finality.

The parties are to assess the system of principles as the final court of appeal in

practical reasoning. There is no higher standard to which arguments in support of

claims can be addressed; reasoning successfully from these principles is conclusive.

This requires the development of the capability of moral reasoning, which is the

capability to reason from abstract general ethical principles to resolve conflicts that

arise from moral dilemmas and ethical problems.

Justice/fairness:

Justice relates to the exercise of impartial judgment in determining the truth of facts and

principles in making decisions that guide action. Fairness is the operational expression of

justice on the individual level.

Truth:

This framework does not attempt to define truth, but rather emphasizes the vital importance

of fulfilling the basic moral responsibility to search for truth, to recognize it once found and to

faithfully abide by it in all human affairs.

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Ethical principles of truth:

Truthfulness in reporting the facts.

Honesty in managing resources.

Evidencebased decisionmaking.

Transparency of decisionmaking and resource management for public scrutiny.

Safeguards for whistleblowers.

Trusteeship:

Good governance is based on public trust.

Ethical principles of trusteeship

Legal contract between government and public servant

Responsible stewardship

Efficient and effective service of the public interest

Transparency regarding possible and apparent conflict of interest

Recognition of merit and adequate remuneration

Safeguards for whistleblowers

A code of conduct:

The code of conduct attempts to articulate in concrete terms the application of ethical

principles.

A public service is a trust that requires a public servant to place faithfulness to his/her

moral contract with society and obedience to the laws and ethical principles above

private gain.

A public servant shall fulfill his/her lawful obligations to the government and the public

with professionalism and integrity.

A public servant shall perform his/her official duties with justice, truthfulness and with

a spirit of service to the common good (public interest).

A public servant shall perform his/her official duties with honesty, transparency and

accountability.

A public servant shall respect the rights of the public and of his/her colleagues.

A public servant shall disclose unethical practice and corruption to appropriate

authorities. A public servant shall avoid any actions that may create the appearance of violating the

law or ethical principles promoted by this code of conduct.

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CONCLUSION:

Evidence indicates that doctors rely heavily on drug companies for their drug information.

The ayurvedic, homeopathic, unani and other doctors practicing in indigenous or traditional

systems of medicine have no access to independent information on drugs they prescribe

and for them education in clinical pharmacology is the unchallenged province of ill-traineddetailers. It is no wonder if maximum unethical practices are employed by the

pharmaceutical industry to win over the support of these doctors. Introduction of a

pharmaceutical product to a person not trained or educated in pharmacology, is in itself, an

unethical practice.

Unethical, uncontrolled pharmaceutical promotion is obviously one of the many problems in

health care in the Third World. It is not a trivial problem as the pharmaceutical industry tries

to suggest. When physicians rely on information provided by drug companies, they tend to

prescribe expensive branded products. It thus become the moral responsibility of the drug

manufacturer to give nothing but the correct information. Is this responsibility being ethically

discharged?The current pattern of relationships between doctors and the pharmaceutical industry is the

outcome of a long established culture in which gratuities, gifts and the like are both expected

and provided. As a result, change will require a substantial shift in attitudes and values and

thus is likely to be slow. Research into the expectations of stakeholders and the impact of

the various practices discussed may contribute fruitfully to community debate. In reviewing a

number of the issues concerning the relationships between medical practitioners and the

pharmaceutical industry, we have tried to emphasise that benefits received from

pharmaceutical companies must leave the independent judgement of physicians unimpaired

and that arrangements between physicians and pharmaceutical companies ought to be open

and transparent. The overriding principle should be a firm belief that the values of scienceand clinical medicine must prevail over commercial imperatives. If these simple guidelines

are followed, we feel that much progress will be made towards allaying the concerns of both

the community and the medical profession.

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BIBLIOGRAPHY:

1. Annual report of Glaxo Smith Kline 2009-2010.2. The Medical Journal of Australia3. Working draft for field testing and revision by World Health Organization.

4. Good Health and You5. Wikipedia

Project by:

1. Harsh Thariani

2. Ritviza Agraval

3. Yash Sejpal

4. Pranoti Puro

5. Nishit Vaswani

6. Jai Karani