LEGAL AND ETHICAL CONSIDERATIONS 4 RUNNING HEAD: LEGAL AND ETHICAL CONSIDERATIONS IN MARKETING, PRODUCT SAFETY AND INTELLECTUAL PROPERTY

LEGAL AND ETHICAL CONSIDERATIONS IN MARKETING, PRODUCT SAFETY AND INTELLECTUAL PROPERTY
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Introduction
This paper is concern with legal and ethical issues in advertising, marketing, regulations and intellectual property of product safety with respect to PharmaCARE which is a pharmaceutical company. The paper includes the information regarding drug companies, Direct to Consumers (DTC) marketing. Next we will determine the role of Food and Drug Administration (FDA) in regulatory schemes of pharmacies and determine that whether FDA empower over compounding pharmacies. In this paper, I have to make decision about PharmaCARE that whether the company use of intellectual property of Colberia. After this, I will analyze PharmaCARE ways to use US laws to protect intellectual property to coop with intellectual property in Colberia. To compensate the people of suffered from damages due to usage of AD23 will be studied and different suggestions will be made to compensate them. In the end, three changes will be recommended to PharmaCARE to go forward ethically. 1-Ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCARE violated any of the issues in question.
Ethical issues vary depending on daily morality and social codes. In business world, most of the ethical issues are based on principles of morality, wrongful actions, rights etc. Ethical issues most usually arise in business world from personal selling, advertisements, suppliers, pricing or contractors. Some example of ethical issues in marketing includes issues arise in marketing research, pricing and market audience. In marketing research, customer’s privacy is a critical factor. Stereotyped based market research is unethical.
While conducting market research for marketing purpose and to get feedback of customers, researcher should give respect to customer’s rights. Selecting market audience is likely to cause unethical dilemmas. To exclude potential customers from the target market is unethical. When company use selective marketing and discourage vulnerable customers like needy or children is unethical (Solomon, 1992). Further, discrimination in pricing is also against pricing ethics of business. It should be avoided. Charging higher price above customers range in monopolistic market will be unethical practice.
Unethical issue in intellectual property includes not paying one who innovate drug by consuming a lot of time and research to develop that drug and it is unfair if any other person take this benefit by market that drug on its own name. Secondly it would be unethical to provide intellectual property rights to the drugs that have not been passed through enough research. PharmaCARE has lack of research on AD23 and had not passed by FDA considerations before marketing the products. It is an unethical issue regarding product safety standards regulated by FDA. 2. Direct-to-Consumer (DTC) marketing by drug companies
Direct to consumer marketing consist of multiple debates especially when it is used in pharmaceutical companies. DTC strategy allows direct marketing of products to consumers by pharmaceutical companies. In this way, the companies will be in better condition to identify patients’ needs and influence their decisions.
The situation might benefit or may harm the patients. E.g. through DTC, companies will be in better condition to discuss about the products with patients, provide them effective information regarding drugs, enable users of drugs to better administer them and assist them to prescribe the correct use of drug. In fact, DTC provide education and assistance to patients regarding their wellbeing and medical care and motivate them to take these prescribed drugs (Stocker, 1976).
Secondly, it reduces the time for patient’s evaluation. Due to DTC, drug companies are rarely encouraged to research and evaluate the effect of drugs on patients. The companies do not research enough to evaluate the side effects of drugs before the drug administration. This will cause crucial damages to patient’s health. Same is the case facing by PharmaCARE who had to face negative consequences of drugs because the company was having lack of research before administrating the drug. Due to direct marketing, patents do not feel the need for taking doctor opinion and take self-treatment which sometime cause risk to patients life. 3. Determine the parties responsible for regulating compounding pharmacies under the current regulatory scheme, the actions that either these parties or the FDA could / should have taken in this scenario, and whether PharmaCARE could face legal exposure surrounding its practices. Support your response.
Compounding pharmacies are the third category of pharmaceuticals. This is concerned with the distribution of specified drugs such as the drugs whose milligrams are not produced. Compounding pharmacies are used in most cases for the production of drugs related to allergies and coloring agents which contain particular amount of substance in tablets. Compounding must be licensed to maintain drug standards. The state board usually does this. In US, FDA is the party assisting the preparation, packaging, mixing and labeling of drugs including compound pharmacies.
In this scenario, PharmaCARE has notices the suffering of consumers of AM23 so the company need to grand power to FDA to administer its control to determine insufficiency in drug. However, due large number of pharmacies in state, there is limited supervision of state board to provide appropriate regulatory services to all (White & Rhodeback, 1992). FDA should assist in close monitoring to the drug companies regarding production and packaging and should assist in inspecting drugs with the support of licensed pharmacist which was not happen this case of PharmaCARE. Due to limited supervision of FDA, PharmaCARE could not face enough legal exposure in practice. FDA should stop the compounding process in the case of production of unsafe drugs in company. 4- Analyze the manner in which PharmaCARE used U.S. law to protect its own intellectual property and if John has any claim to being the true “inventor” of AD23. Suggest at least three (3) ways the company could compensate John for the use of his intellectual property.
PharmaCARE used United Sates Law and Colberian law to protect intellectual property. United States protection provides legal counsel to provide overall protection. It is also important to ensure that the company subcontracts and licensing embrace the detail language of intellectual property (Lindgreen & Swaen, 2010). These legal laws provide a well establish monitoring system and ensures the maintenance of due diligence by analyzing foreign partners. In addition, the company has also secured trademarks, patents and sought border protection from the side of Colerian and United States government.
John is one of the key inventors of the AD23 for PharmaCARE. He has researched for the drug and considers an important part of team in the development of new drug. However, the drug is slow in its working and need more research to make effective for users and to avoid its negative consequences however, the intellectual rights of property is still exist as drug selling attain high profit in market. So the company should compensate John by providing him the part of profit through the amount attains from patents and trademarks for the product after selling it to the public.
Secondly, the company can compensate John by providing him additional benefits such as allotting him home with facilities such as water and electricity, convince and other financial benefits. However, it is ethical to provide the benefits of intellectual property rights for some specified period of time so that researcher would be motivated to research for further drugs invention.
Thirdly, the company can compensate John by allotting him a research center and facilitate him to begin advance research on drugs in order to invent more effective and exceptional drugs according to diseases facing by the people. 5. Summarize at least one (1) current example (within the past two [2] years) of intellectual property theft, and examine the effect on that company’s brand.
A recent example of intellectual property is in high tech industry in United States when Oracle sued against Rimini Street. Rimini Street usually provides Oracle with support service. Oracle alleged that Rimini engaged in fraud, copy right infringement, unfair competition, breach of contract and unjust enrichment with Oracle.
The dispute was taken in Las Vegas District Court. The court dismissed Rimini arguments and found that Oracle claims were true. On 12 August, 2014, Court gave decision in the favor of data base giant “Oracle”. Oracle claims about Rimini Street about its involvement in massive theft of intellectual property was proved true. Court agreed that Rimini was engaged in dispute of repeatedly theft intellectual property of Oracle by making Oracle copyrighted software program multiple copies. In addition, Rimini Street also found a part of theft of infringed database copyright of Oracle.
The intellectual property theft of Oracle cause loss of its secrets regarding database system, which effect company profit as the secret programs are copied due to which the company cannot secure its unique product features. On the other hand, it has loosed its important vendor (Rimini Street) due to unethical considerations. 6-Analyze the potential issue surrounding the death of John’s wife and other potential litigants against PharmaCARE as a result of AD23.
There are many potential issues surrounding the death of wife of John. John is also one of a researcher or inventor of drug AD23 for PharmaCARE. He and his partners research to invent AD23. One of a potential issue behind the incidents of death is lack of legal consideration given by FDA to regulate the drug according to FDA standards. PharmaCARE form a compound pharmacy called CompCARE in order to avoid scrutiny of FDA in drug administration. CompCARE was a low cost company and administer very low cost on its renovation and marketing efforts. It use direct marketing to the patients and companies which was unethical because compound companies who sold products in bulk are usually not allowed to use direct to consumer marketing (DTC).
Due to DTC marketing, the company found less chance to evaluate the drug reaction on consumers. CompCARE was sold to WellCo and continuous to surf drugs to people due to which rate of heart attacks in patients also increased. John wife also became the victim of consumption of AD23. Company lack of research on drug, lack of testing and evaluation and greediness for profit cause potential issues for the death of large number of people including John’s wife. 7-Specify both the major arguments that John can make to claim that he is a whistleblower and the type of protections that he should be afforded. Justify your response.
John was one of an inventor of AD23 and he had loosed his wife who had also intake AD23. However, john was a part of team of PharmaCARE who was involved in invention of AD23 but his later action can be assumed as an active predictor for taking company’s consideration on the negative effects of AD23. John was the one who had written an internal company memo to tell about the problems of AD23. He described potential issues with AD23. He informed that company was willing to continue to market the product. John can claim to be a whistle blower through this action. His internal company memo about the clear information about the issue and cause of issue make him able to assume to be whistle blower for this unethical and illegal issue.
An employee who whistle the company wrongdoings face many risks such as retaliation, termination, exclusion from social invitations, giving less desirable assignments etc. however, despite these risks, employee who become a whistle blower are morally justified due to certain conditions. For example, John felt that the firm policies or product is causing serious harm to public, when employee identifies serious threat, or when employee feel that revealing the fact brought any change which is necessary to improve the situation (Dozier & Miceli, 1985). In all such conditions, whistle blowing is justified.
Sarbanes-Oxley Act (SOX) protects John by prohibiting publically traded companies from doing any retaliation against the John who reports the wrong doing of company. But the reporting to employers narrowed the protections under this section. Sarbanes-Oxley Act only covers the reporting of fraud or any other misconduct which impact on company shareholders (Act, 2002). In this case, large number of consumers of AD23 suffered from heart diseases due to consumption of ineffective drug. John act to be a whistle blower against this wrong doing of company should be afforded by the protection of his job supporting by legal law. Conclusion
PharmaCARE was failed to maintain its brand image due to the launch of AD23 because the company fails to conduct ethical testing of drug and retaining FDA standards under consideration by establishing another subsidiary. This unethical practice of company causes the mortality of large number of people. It was clearly killing of people which are simply the breach of ethics and morality. It is important for company to live up with sense of ethical and moral responsibilities in internal organizational culture. Company should also closely consider DA regulations to provide safe and healthy product to consumers. Customer safety should be the first and foremost goal of the company. In this way company can manage good image and igh sales in market.

References
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