Legal and Ethical issues in business

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Pharmaceutical industries are a decisive industry in Bangladesh but there has been increasing controversy surrounding pharmaceutical marketing and distribution. This study is based on unethical practices of pharmaceuticals companies in Bangladesh. The purpose of the report is to explore the illegal practices and unethical behaviors of the pharmaceuticals companies with a view to popularizing their brands, boosting their sales and earning huge profit in the perspective of Bangladesh. In this report we have tried to cover all the unprincipled way of behavior of the pharmaceuticals companies in Bangladesh.

Moreover, we have discussed accusations and findings of influence on doctors and other health professionals through drug reps, including the constant provision of marketing ‘gifts’ and biased information to health professionals . Thus study recommends an opportunity to bring to a standstill against the illegal and unethical practices are exercising in a vital industry like pharmaceuticals industry in Bangladesh and also a scope to imply the recommendations of the study if it find useful. Preface The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications.

Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs. With a view to popularizing their brands, most of the pharmaceutical companies in the country allegedly practice unethical drug promotion alluring doctors with free samples and gifts to prescribe their medicines.

The role of pharmaceutical companies in the developing world is a matter of some debate, ranging from those highlighting the aid provided to the developing world, to those critical of the use of the substandard and poisonous elements in manufacturing drugs, often causes deaths, particularly in states lacking a strong rule of law. This study is conducted to explore the legal and ethical situation of pharmaceuticals companies in the perspective of Bangladesh. Objective of the Study The objective of the study is to discover the genuine representation of legal and ethical practices of the pharmaceuticals companies in Bangladesh.

And it is also done to describe, evaluate and recommend how to get rid of unethical practices of the pharmaceutical companies. Moreover, this study is to build consciousness among the people who use the medicine to save their lives but actually these medicines do not cure them. This study is also conduct to: ?Find out the unethical practices occurring in Bangladesh ?Find out the related group of people exercising this evil practices ?Be acquainted with whether the legal rules and regulations of drug are maintaining by the pharmaceuticals companies ?

Classify what are the unethical practices pharmaceutical company exercises to boost their sales ?Identify about the fake medicine in local market Problem Statement Counterfeit Drugs According to the WHO, counterfeit medicine is the one which is deliberately and fraudulently mislabeled with respect to renowned brand/generic products. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, with insufficient active ingredients or with fake packaging.

In 1992, 233 Bangladeshi children died after taking paracetamol-based syrup that was contaminated with antifreeze. The antifreeze component diethylene glycol has been used in place of glycerine in cough medicines, killing hundreds of people in Bangladesh in recent years. Smuggled Drugs A large percentage of patients travel to neighboring India for treatment, returning with prescriptions of Indian drugs. To cater to them, dozens of unauthorized pharmaceutical establishments have mushroomed on the Bangladesh border. These units either smuggle in Indian drugs or manufacture fake ones that threaten the lives of thousands of patients, experts observe.

Recently, the Drug Testing Laboratory found that a popular drug used for strokes and brain hemorrhages – Cavinton – was being marketed minus its main chemical ingredients. Lack of Control Over Drug Prices In Bangladesh the maximum retail price (MRP) of every essential drug is fixed by the Directorate of Drug Administration (DDA); for all other drugs the DDA endorses the companies’ quoted prices. Drug prices are quite high in Bangladesh in comparison to neighboring countries. The drugs control authority is apparently reluctant to negotiate with the companies to fix prices.

The regulatory authorities have virtually no control over drug prices in Bangladesh. Indiscriminate pricing can be observed in all therapeutic classes of drugs. For example, prices of various ciprofloxacin brands range from Tk 5 to 14 per unit. The price of dexamethasone eyedrops extends from Tk 24 to 90 per 5ml, and diclofenac eye drops are available at a price range from Tk 40 to 200 per unit. UNETHICAL DRUG PROMOTION:

With a view to popularizing their brands, most of the pharmaceutical companies in the country allegedly practise unethical drug promotion alluring doctors with free samples and gifts to prescribe their medicines. Pharmaceutical companies practice drug promotion to boost sales and earn more profit, although it is clearly unethical according to the rules of the Drug Administration. According to the industry sources, the pharmaceutical companies allocate huge sums in their annual budget for gifts to be distributed among the medical practitioners.

The medical representatives visit doctors daily from morning to night, including at working hours of upazila health complexes, district hospitals and medical college hospitals. Dhaka Medical College Hospital and Bangabandhu Sheikh Mujib Medical University (BSMMU) Hospital are no exception. A number of representatives of pharmaceutical companies, both local and multinational, they often bribe doctors in order to promote their particular drugs. “Beginning with the new year, companies offer calendars to doctors and also gifts on special occasions like Eid, Puja and Victory Day. ” “The pharmaceutical companies offer doctors many things – from pens to cash money – as part of their promotional activities.

Quality of available drugs Of the 300 pharmaceutical companies in Bangladesh, only the 20 to 25 top ones produce drugs of standard quality. Reports show that numerous small companies market substandard drugs in the country. Fake or substandard medicines, including lifesaving ones, with an estimated worth of US$ 150 million per year, are flooding the domestic market. In its annual testing in 2004, the government laboratory detected 300 counterfeit or very poor quality drugs out of 5,000 drug samples.

A recent assay involving 15 brands of ciprofloxacin showed that 47 per cent of samples contained less than the specified amounts of the active ingredient. Another report noted that 69 per cent of paracetamol tablets and 80 per cent of ampicillin capsules produced by small companies were of substandard quality. Good manufacturing practice (GMP) is a major criterion to maintain standard quality in drugs, and it was one of the principal objectives of the National Drug Policy (NDP) to ensure standard manufacturing practices for drug manufacturers. But there are some 265 pharmaceutical companies in Bangladesh that do not follow or comply with GMP.

It is widely alleged that adulteration flourishes in the country because of poor government vigilance and supervision over drug manufacturers and sellers. Unfortunately, a section of corrupt physicians and government officials is involved in these underhand dealings. The government states that it has limited manpower and facilities to cope with the country’s fast expanding pharmaceuticals sector. In fact, the regulatory authorizes have given scant attention to quality matters in Bangladesh.

Moral Evaluation Utilitarianism ‘Utilitarianism’ is one of the most important methods of moral reasoning, which holds the moral principle that the morally right course of action in any situation is the one that produces the greatest balance of benefits over harms for everyone affected.

So long as a course of action produces maximum benefits for everyone, utilitarianism does not care whether the benefits are produced by lies, manipulation, or coercion. it is important to evaluate the actions of the Trade-Related Intellectual Property Rights (TRIPS) from the rule of ‘Utilitarian’ point of view, TRIPS agreement of the World Trade Organization (WTO) which says the Least Developed Countries (LDCs) are legally permitted to make andsell patented medicinal products not only at home but also to other LDC countries, and to  others where the innovator has not sought patent protection, are likely to disadvantage most the Bangladesh’s pharmaceutical industry.

If the facilities in relation to patent rights under the TRIPs are withdrawn after January 1, 2016 the access on the part of the poor to some drugs that are locally produced and available at prices lower than the imported ones, will become more difficult than what the situation now is. The required facilities have not still been developed in Bangladesh to produce generic medicines locally. The per capita expenditure on drugs in this country is as low as $4. 0, of which the state provides only $1. 0.

This expenditure pattern indicates how vulnerable the poor and low-income people are to sufferings during their physical sickness. It also suggests how terrible the situation is likely to be if such people are made to buy expensive imported medicine, following the expiry of the period for the exemption facilities granted under the TRIPs. This case WTO should consider the situation from utilitarian point of view and extend the expiry of TRIPs or support our country with knowledge transfer and aids to build up the facilities to meet the standards after 2016.

Otherwise the low income people which cover 70% of the population in Bangladesh will be facing serious health threat. Right Moral rights are the rights that every human being posses to an equal extent simply by the virtue of being human beings. One of the basic moral rights is right to live; the counterfeit and substandard drugs threaten human lives. As stated in the point 3.

1 many citizen including children of the country collided to death because of these contaminated medicines. Another important moral right is violated in our country which is right to be informed. Little do the patients are informed about the side effects of the medicines. Protection of right to life (Article-32) Duties of other agents to provide the holder of the right with whatever he or she needs freely pursue his or her interests. It is the duty of the government to ensure the positive right like right to proper medical care.

The government of Bangladesh fails to ensure proper medical facility as studies says that in four district hospitals and one medical college hospital only eight percent of patients received the prescribed medicines. In another report, two major hospitals in the capital city of Dhaka were operating without essential medicines for eight consecutive weeks. Justice The fundamental rights of Bangladesh ensures the Equality before law (Article-27) which goes with the definition of Justice that guarantees distributing the benefits and burdens fairly among the people. The pharmaceutical industry in Bangladesh practices injustice among the rural and urban people.

Pharmacies in urban areas sell higher quality brands, whereas in more rural areas, pharmacies sell lower quality, lower cost brands. Ethics of Care Ethics of Care is the ethics that emphasizes caring for the concrete well being of those near to us. In our study we can find the lack of Ethics Of Care in the unethical practices by Doctors where they prescribe unnecessary medicines to the poor people who may be a regular customer of the doctor. Doctors also don’t bother to prescribe medicines which are promoted by Medical Representatives, without proper checking.

Recommendation and Conclusion Patterns of drug prescribing, uses, availability, affordability and dispensing in Bangladesh are very crucial at present. The existing systems should be reformed in order to ensure better utilizations of therapeutic drugs in the country. The following recommendations can be suggested based on this report 1) The policy makers, manufacturers and the medical professionals should be committed to uphold the status of public health systems of the country through the implementation of the noble objectives of the NDP.

2) The drug regulating authority should increase drug testing facilities and manpower in order to control the quality of all the medicines available. 3) The primary health care systems of the country need to be aware to improve drug utilizations in the rural areas. The government should be more concern to eliminate substandard drugs from rural areas. 4) Mass media like radio, television and news papers can be used to create awareness and to educate the consumers about dos and don’ts of rational drug uses. 5) Drug sellers should be trained properly to minimize inappropriate drug dispensing and recommendations.

Drug use studies in was never given proper importance. This review pointed out many alarming situations in respect to drug prescribing, uses, quality and availability in Bangladesh. Obviously, these all may pose substantial health hazards to the public health systems of the country. Greater commitments are required from the drug regulating authority, drug manufacturers and health care professionals to ensure effective and sound drugs management and utilization mechanisms.

To stop such unethical promotion of drugs, there was no effective implementation of the Drugs (Control) Ordinance, 1982 that regulates manufacture, import, distribution and sale of drugs in Bangladesh. The Drug Administration, which regulates manufacture, import and quality control of drugs in the country, is also inactive to put a stop to such unethical practices. They also have insufficient manpower to effectively carry out its responsibilities. The pharmaceutical companies of our country produce standard medicines but all companies cannot produce quality products.

The authorities should concerned for taking effective steps to stop unethical practice in the country by formulate a ‘Code of Marketing’ as elsewhere in the world to regulate marketing of drugs in the country. The government to recruit more manpower in the Drug Administration to make it more effective in its designated task of helping to save the lives of people.

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