Introduction
Law and Ethics are not necessarily connected. Not all laws are ethical, although a law may be considered ethical on the surface, unethical results may emerge from it. Ethics also moral philosophy is a concept in philosophy that defines, recommends and defends ideologies of what is wrong or right that prescribe that humans should embrace in their daily lives. The pharmaceutical industry faces a number of dilemmas with each passing day. These dilemmas are all linked to making money or if they should or should not sacrifice now for greater benefits either in terms of human life or money.
Pharmaceutical companies are not honest in their operations and tend to use shortcuts which inevitably result in ethical issues. Most pharmaceutical companies spend millions of dollars in research and development that don't result in any resourceful or new drug. The paper starts by highlighting the state of the pharmaceutical industry in the USA, pinpoints the main ethical issues arising from the case study, identifies the stakeholders and their interests, courses of action available for the business and finally the objection.
Overview of the USA Pharmaceutical Industry
Prescription drugs in the United States are sold at costly prices compared to its neighbor Canada and other European countries. The pharmaceutical sector has become the most profitable in the American sector generating nearly 50% in profits annually. I am certain that most American citizens are not happy with the number of profits this companies make and yet the prices are very high and most of the drugs don't fully cure diseases.
Furthermore, from the case study, pharmaceutical companies only use merely 15% of the total revenue in research and development of new drugs (Shaw & Barry, 2016). In recent years, the companies have only produced countable new drugs. What's more upsetting is that research of new drugs is funded by the taxpayer money. The federal government, national health institutes, DoD (Department of defense), private industries e.g. biotech companies, foundations, private hospitals e.tc. or department of veteran affairs provides funding for clinical research. These companies are not innovative at all, most of the drugs they claim are not new at all, they are simply replicas of old drugs with a slight twist in variation.
Essentially, this is more of a "me too" marketing strategy. According to FDA regulations, it is not a requirement for each new/improved drug to be re-tested the same way as the old one. Over the past years, the FDA approved only 78 drugs and just 17 of them had new active ingredients. From the 17, only 7 had a considerable improvement over the older one (Shaw & Barry, 2016).
Ethical Issues Arising From the Pharmaceutical Industry
An Ethical issue arising, in this case, is the fact that pharmaceutical companies, conduct cheap clinical trials in overseas and developing countries and offering them to American citizens at a very high price, selling drugs at high costs is not morally correct, especially if the cost of production is low. Viewing the situation broadly, its clear that if every business overcharged their products compared to production costs, the global economy would inevitably collapse (Shaw & Barry, 2016).
Seeking huge profit margins from overpricing is not justifiable mostly because most of the current society lies within or between the middle class and low middle class, therefore, only a tiny percentage of rich individuals in the society will survive if prices are super high. Pharmaceutical companies can be viewed as greedy self-centered companies. Over the past several years, only a handful of drugs have been availed to the market (Shaw & Barry, 2016). So the question arising from this is "why should they overprice drugs if they are not spending that much on R&D?" I will argue that the "ruthless" pursuit of profit for shareholders won't always lead to the best consequences for everyone. The moral principles are: don't make a profit at the expense of the public interests and don't engage in deception or manipulative business practices.
Also, a question arising from this case is "Do pharmaceutical companies have an ethical obligation to use test subjects from overseas countries without informing them of possible outcomes/side effects? Also, do they have a moral responsibility to provide the drugs to them once they are developed?". pharmaceutical companies use test subjects from developing/ poor countries (Shaw & Barry, 2016).
More so, I think the subjects are tricked into applying for the test believing they will be cured for free or receive medical care for free. Apparently, in the end, these companies simply exploit the test subjects and merely use them as rats or guinea pigs while their local leaders/officiating personnel are awarded, rather bribed to mislead their people. What's more, once the drug is developed, some companies don't sell their drugs in the poor countries. And if they do, only a few patients can afford them few. Test subjects who made a contribution to the experiments did not gain corresponding rewards after the experiments (Shaw & Barry, 2016). It seems to exploit the human subjects.
Obviously, it is only logical that the drugs be availed to their test subjects because without them the drug would not exist in the first place. It is not right that the test subjects are not provided with detailed information regarding the nature of the study as it might have adverse effects on the research.pharmaceutical companies are using dishonest methods to carry out research by conducting them in overseas countries where the FDA cannot regulate the methodology used.
Carrying clinical trials abroad not only saves money but also bypasses FDA requirement approval for using humans for testing. Drug companies using this method to achieve their objective, have the highest profit margins, however, if all business used this method, the end result would be catastrophic to human nature. Humans have fundamental rights that must be respected. In the long run, Pharmaceutical companies severely impede the basic rights of other people.
Key Stakeholders in the Industry
Stakeholders are individuals or groups holding a stake/interest in a company, people who stand to gain from the operations of a company or anyone who may or may not be affected by company activities. Therefore, key stakeholders, in this case, will be company CEO's & managers, investors/shareholders, employees in R & D, patient & test subjects, supply chain partners and leaders of the communities where the tests are conducted.
Stakeholders related to these companies have varying interests some intentional while others are innocent. The main interest of company CEO's is to build a rapport of excellence, perpetual success, ensure the company gains the most in terms of profit and to ensure that the board and its investors are happy with the outcome. to some extent, most of the CEO's may be considered evil and self-centered because they are aware of possible effects on the subjects and that the means used to cut costs on drug or clinical research is unethical and against the basic human rights.the government key concern is taxes.employees face the biggest dilemma as most of them innocently applied for the jobs to produce drugs and help alleviate human suffering.however, they have to turn a blind eye in order to safeguard their jobs.test subjects mostly believe they are getting free medication which probably they cannot afford.they, therefore, believe it is aid from good wishers.community leaders despite knowing the truth are only interested in filling their pockets with loads of money(greed), suppliers are obviously in for the money and huge profits.the consumer has no alternative but to buy the overpriced drug because they really need it.
Courses of Action
Direct consumer advertising should be banned because it leads to drug overpricing and yet alternatives exist.pharmaceutical companies should not be spending more on marketing instead of R & D and ensuring that the consumer can easily access the drug.
When patent for a new drug expires, competing companies start making generic drugs which are cheaper than the brand-name drug and get a share of the profit.manufactures of the new drug, bribe or pay generic manufacturers to prevent them from producing the drug.this is illegal as it is not right to monopolize and manipulate the market in this manner.therefore strict legal action should be placed to deter such behavior.
Breaking laws to gain profits cannot be part of the sales strategy.fraud in the sector has become a custom.in the past decade alone, over 30 false claim act cases involving drug companies have been settled.infact, the largest fraud settlement in American history amount to a staggering 2.2 billion dollars! For forfeiture and criminal fines.it seems these companies are okay with paying fines, therefore, the more severe punishment should be used e.g jail time. Imprisoning such perpetrators will make executives, managers or employees to think twice before endorsing unethical strategies.it will bring ethical violations to a personal level and employees will not fear to testify against the employer.
Leaders in the sector should take the first step in bolstering their compliance and ethics in order to enhance amoral corporate culture.they should be on the forefront discouraging bad schemes, encourage proper channels and take immediate action if wrongdoing occurs.an ethical culture build trust within the company and its external environment i.e. its customers and partners.therefore, it will bring profits in the long run.
Human subjects used must be informed in detailed of all likely side effects, the purpose of the clinical research and also be provided with the drugs after the trials. they should be allowed to freely exercise their rights to access credible information and make the decision. The regulator should devise a follow-up the program in partnership with these countries to ensure that set regulations are adhered to.
Rather than using commercial bribery to influence researchers and doctors/physicians, pharmaceutical companies should create marketing plans that explain benefits of their products to its. incentives offered to sales representatives should be eliminated and replaced by a team capable of educating its customers (physicians and doctors) with information that will help them make ethical prescriptions and decisions.
Choice of Action
Pharmaceutical companies can continue to carry out their research overseas but must use honest and legal methods. They should apply the FDA regulations used in the states in this countries as well without supervision.they have a moral obligation to exercise what is right whether the regulators are supervising them or not.an ethics committee (more like a jury) must be used to approve such trials.FDA must also provide certain parameters that ensure no violations in any way are committed once the trials are done overseas.it's also, the ethical responsibility of the company to ensure that the drugs are availed to these countries at affordable prices and that the test subjects are able to receive aftercare after the clinical trials. This will mean the company will have to avail some more money in distributing the drugs, cutting the profits and the amount the shareholders will receive. however, it will improve the ethics and corporate look of the company, enhance loyalty and trust among its employees and patients and promote transparency.
Objection
One objection arising from the case is, if the drug industry cannot bring maximum profit to its investors and shareholders, then why should the shareholders invest their money in the industry? According to the shareholder approach, managers don't have moral obligations to engag...
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