PHAMACEUTICAL SECTOR _________________

(A Business Ethics Project)

INTRODUCTION
Pharmaceuticals 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. The relationship 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).

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 interested primarily 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 ethical nature 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 of conduct 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

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 medically related 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 on therapeutic 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.

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, as with 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 the pharmaceutical 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. This occurs 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

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 the consumer 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 meetings Full 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.

GLAXO SMITH KLINE: A CASE STUDY.

Research and innovation

In undertaking their research and in innovating they explore and apply new technologies and constructively engage stakeholders on any concerns that may arise. They will ensure that their products are subject to rigorous scientific evaluation and testing for safety, effectiveness and quality.

Products and customers

They promote their products in line with high ethical, medical and scientific standards and comply with all applicable laws and regulations.

Caring for the environment

Glaxo 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 practices
They treat their employees with respect and dignity, encourage diversity and ensure fair treatment through all phases of employment. They provide a safe and healthy working environment

Human rights
They 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 the International Labor Organization. They expect the same standards of ther suppliers, contractors and business partners working on GSKs behalf.

Community investment
They 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 sustainable improvements to under-served people in the developed and developing world.

Positive Action on HIV/AIDS

The programme targets its funds towards community-focused projects that reach those most affected by HIV, particularly in marginalized or vulnerable populations. Positive Action works with these communities to enable them to tackle stigma and discrimination, to test innovations 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 million available over 10 years to help prevent mother-to-child transmission of HIV and to support orphans and vulnerable children. At the end of 2010, the latest call for proposals was made broadening the reach and scope of its response for babies and children affected by HIV.

The GlaxoSmithKline African Malaria Partnership

The African Malaria Partnership is our programme to alleviate the mortality and suffering malaria brings to affected communities in Africa. They help provide health education to affected populations and to train community health workers.

Humanitarian product donations

Working with non-profit partners, AmeriCares, Direct Relief International, MAP International, Interchurch Medical Assistance and Project HOPE, they supported humanitarian relief efforts and community healthcare in over 90 countries. They responded to the healthcare needs of the many communities affected by disasters, including the devastating earthquake that struck Haiti in January 2010, GSK donated supplies of medicines valued at over 1 million. Included in these shipments theyre significant volumes of antibiotics as theyll as respiratory and diabetes treatments. Their consumer division provided a range of products, including toothpastes, antacids, pain relievers and vitamins. During the cholera outbreak they responded to a further specific request for antibiotics and donated 250,000 to the British Red Cross to support the deployment of a mass sanitation unit serving more than 50,000 people living in temporary relief camps. Following the earthquake in Chile, in response to an urgent request they supplied 95,000 doses of Hepatitis A vaccine, antibiotics and more than 6,000 dental hygiene kits.

Environmental sustainability
Glaxo is committed to integrating environmental sustainability into our business, especially conserving resources and addressing climate change. They see this as an opportunity.

Climate change and energy

The 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 from manufacturing, distributing, using and disposing of our products, including sourcing raw materials.

Environmental stewardship
They 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 use materials is a priority. The long-term aspiration is to achieve 5% mass efficiency by 2020 for new pharmaceutical products transferred from R&D to manufacturing. This is about five times the typical level in the pharmaceutical industry and will reduce input materials and waste by 80%. The average mass efficiency for new products during the 2006-2010 period has reached 3.3%

Animal cruelty
They 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 theyre recovered. Further investigations followed and the revelations shocked medical and pharmaceutical circles in the country. The scrap dealer confessed to selling rejected medicines to an enterprising Gujarati businessman operating from a cubby hole in Ahmedabad. On February 14, 1994, the Mumbai High Court upheld the closure orders of Glaxo India Limited given to it by the state FDA. The company opined "they feel they theyre being singled out although there are other pharmaceutical companies which are found to be violating the rules". Glaxo was referring to violation of rules done by Boots and German Remedies Limited.(These are all multinational drug companies.)

2. Between January 21 and February 7, 1986, 14 patients died in J.J. Hospitals in Mumbai from a cause totally unrelated to the diseases that brought them there. They died of poisoning by the adulterated glycerol given to them. The toxic adulterant was diethyl glycol which was present in a concentration of 18.5% - over three times the lethal dose. Rapid necrosis of the kidneys took place and the unfortunate victims succumbed to acute renal failure. Kailash Company sold this adulterated glycerol, meant for industrial consumption, to Alpana Pharmacy with Glaxo India Limited as the supposed middle man, with Glaxo knowing that it was not to be used for medicinal purpose. This was not a mistake, nor an act of carelessness. It was an extremely conscious act motivated by greed for more profits. What about ethics? The licensing authority, the drug testing laboratory, the tender committee, the pharmacology department and the highest authorities in J.J. Hospitals, and the 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 a farce. 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.

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 principles should 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.

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.

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-trained detailers. 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 science and 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.

BIBLIOGRAPHY: 1. 2. 3. 4. 5. Annual report of Glaxo Smith Kline 2009-2010. The Medical Journal of Australia Working draft for field testing and revision by World Health Organization. Good Health and You Wikipedia

Project by: 1. 2. 3. 4. 5. 6.

Harsh Thariani Ritviza Agraval Yash Sejpal Pranoti Puro Nishit Vaswani Jai Karani