Legal and Ethical Considerations

Introduction

Legal and ethical considerations, intellectual property, and product safety remain the three most important issues regarding ethics as applicable to marketing, advertising, and intellectual property. The following paper will study the significance of the association that drug companies have with the ‘Direct to Consumer.’ It will proceed to check on the scheme that the FDA has as well as the compounding functioning of pharmacies in line with it together with the issues of usage of intellectual property regarding the PharmaCARE. Various laws describe the necessity of protecting intellectual property and three ways in which the United States can provide compensation to the firm. The pharmaceutical company under discussion serves to exemplify the explanation of both legal and ethical issues that need consideration in the real world. Moreover, the association of WellCo shareholders with PharmaCARE will be discussed, as it remains equally important as the others. The paper will conclude by emphasizing the PharmaCARE brand and give recommendations to the changes in ethical and legal aspects the company must incorporate for it to become successful. 

The legal and ethical issues that relate to advertising and marketing, regulation of product and intellectual property

It is imperative to consider all legal and moral angles that affect a society during the process of product marketing. Indeed, this is so because consideration of how safe the product is should be taken into account. Moreover, consideration should be given to the intellectual property involved with that particular product. The legal and ethical issues have a close relation because they all deal with issues that affect the society as a whole (Carpenter, 2014). It remains of utmost importance to emphasize on ethics in marketing and more precisely regarding the production of drugs and technological incorporation that may demand the protection of intellectual property. The usage of false claims with the aim of obtaining or maximizing profits rather has fast become an issue of concern with regards to the lethal and ethical scope. It is an emerging issue and one full of contention requiring immense outlook and precision when handling (Carpenter, 2014). The policy of the company must capture all intellectual property aspects as well as the advertising and marketing and safety regulation of the commodities. 

Ethical issues experienced in Marketing

The current society experiences numerous marketing issues that are related to the sensitivity and studies of sales, especially in marketing ethics. The business aspect thus needs to concentrate on issuing out the necessity of marketing ethics from a social perspective considering the arising issues that the same sector is always facing (Carpenter, 2012). Various moral issues arise in line with personal selling, marketing internationally, advertising, and market research because of the great impression that results from all the marketing activities that a community conducts. Recent times have been on the social radar due to numerous scandals that relate to the coercion of the rules and regulations instituted by FDA in the pharmaceutical industry. Many companies remain focused on the profits that come from the sales of their commodities rather than the effect and benefit the products have in the community (Carpenter, 2012). They lack the concern of how safe these products are to the society as long as they are making lots of money. In the end, these products harm the users in the community culminating to problems that may take a serious legal action against the involved pharmaceutical companies. 

PharmaCARE is unethical because it partook measures and various channels to circumvent the laws of the FDA instead of striving to make sure that their products satisfy the standards and measures instituted by the FDA. In addition to the above case, PharmaCARE proceeded to market the AD23 product directly to its consumers using a subsidiary company. The marketing of the drug using the subsidiary company amounts to an unethical act and one subjected to the stringent sides of the law. As if that was not enough, PharmaCARE hid the results showing the failures of the drug and its serious side effects on the users. As a result of such withholding of truth and research data, many persons suffered heart attacks as well as other very critical problems. Despite all these happening, the company remained on a course not bothering to either change or advance the drug in a bid to make it safer for consumption by humans. It remains utterly unethical because the company knew exactly what was going on but chose to withhold this information from the relevant bodies just so that they could continue to enjoy the profits from the sales of the drug. Many people complained of heartaches and other pertinent problems after using the drug but still the company did not act accordingly to either stop the supply of the drug to allow for modifications or issue out a public warning. It further failed to share the failures to the FDA and hence put the lives of many people in jeopardy and high risks. 

Ethical Issues that relate to Intellectual Property

It is well to examine intellectual property with relation to the ownership and copyrights of goods. Therefore, in line with the above, the copying of another person’s property, and using it to make profits and any other gains is likened to shoplifting. The property is considered copyrighted and solely belonging to the creator if the person responsible for its development does so as an original and based on a given physical medium. The property is copyrighted legally and ethically if the above holds true for the involved property (Carpenter, 2014). All operations involved in a copyrighted commodity together with the ownership of the copyright remain exclusive to the owner of the product, and it would take some form of legal action to handle any cases of its breach. 

PharmaCARE was ethical regarding the intellectual property. The company employed research from their team of researchers in the development of a drug that they then funded fully with their money to achieve its functionality. PharmaCARE did not at any point steal information or technology from another company but rather used their resources to determine and assess the effect the drug had on Alzheimer’s. Therefore, there is no legal that would hold water against the company in light of this issue because PharmaCARE acted well too and independently profited from its product sales as a result of the marketing through their subsidiary company, the CompCARE. However, it is well to appreciate the fact that the drug, AD23, was initially developed to treat diabetes but was used in the treatment of Alzheimer’s. It functioned adequately and efficiently when used to treat diabetes but showed various and burning side effects when utilized in the treatment of Alzheimer’s. 

Ethical Issues that Relate to the Product Safety

Ethically speaking, companies are responsible for ensuring that the goods they produce and sell are suitable for consumption by human beings and appropriate for the environment as a whole. Therefore, the companies must guarantee the society that the products lack harm or pose a threat to the public by compromising their health or adversely affecting the environment (Carpenter, 2012). It is because of such that governments and other relevant institutions develop regulations and rules that mandate companies to follow so that they produce safe products. 

PharmaCARE has failed to function ethically concerning this issue because it has failed to consider the safety of its product. Its researchers discovered that the drug proved harmful to the consumers because of the numerous heart attacks it caused, but the company chose to bury the results and make no changes to the drug to ensure the safety of the customers. Furthermore, the company failed to adhere to the rules of the FDA that serve to ensure all products are fit for the consumption of human beings. Therefore, in light of this, the company was unethical. 

Argument for or against the Direct-to-consumer marketing by the drug companies

It would seem that there are many ethical concerns regarding the ‘Direct to consumer marketing’ and their association with pharmaceutical companies (Kozauer, 2013). First, it is well to appreciate that this marketing stands to incur additional costs to their insurers and the government and consumers as a whole without paying attention to the manner in which the finances are spent. The policymakers are specifically concerned that this marketing motivates the usage of a drug for more than one purpose among the consumers and apart from the fundamental purposes, a situation that may lead to adverse health issues. Another concern is that the marketing leads to commercialization of new drugs in the society and the fear emanates from the aspect of consumers’ willingness to use drugs that have not been analyzed critically to determine whether they have adverse impacts on people (Kozauer, 2013). The above concerns have contributed to the development of the moratorium that applies to the marketing of particular drug prescriptions in the first two years of the approval of these drugs. 

Considering the following situation, PharmaCARE need not have implemented the DTC strategy of marketing on the release of the drug. It remains that the drug was not a treatment for Alzheimer’s despite its long stay in the market. The company thus should have waited the two years before it began to sell or market rather its product to its consumers directly. However, the company was focussed on maximizing profits and assumed this regulation leading to the adverse influences of the drug on many consumers. Moreover, the drug did not undergo critical analysis to determine its dangerous effects on people. It is imperative to identify the responsible parties for regulation of the compounding pharmacies under the existing and operating regulatory scheme and whether their actions or those of the FDA should have taken place. It is also well to determine whether PharmaCARE should face legal action because of its practices. 

The state board of pharmacy is usually the regulatory body for compounding companies together with the Pharmacy Advisory Committee that operates under the Food and Drugs Administration (Lindon, 2012). In regards to PharmaCARE, the company has evidently proven to focus on the maximization of profits at the expense of following stipulated regulations and laws. It has also purposefully evaded the FDA scrutiny. For instance, the company set up a subsidiary company that functioned independently to market the AD23 drug without any legal implications on the PharmaCARE Company. Furthermore, CompCARE does well to market the product directly to their clients by a subscription with the view of a compounding pharmacy. 

The regulations by the FDA appear to have some loose ends that have facilitated the evasion of PharmaCARE in its bid to improve sales of its product. However, the company has proven to be still and forceful of the system, as it has intended to overlook any obstructions that related to the authorities so that they could sell their commodities and gain enormous benefits. Given this situation, the authorities were charged with the task of testing the drug and holding the company in violation of all regulations that relate to the distribution of a newly developed drug in the market before appropriation by the maturity of its evaluation period. Many deaths and causalities would have been avoided had the authorities followed up as narrated above. It would also seem that the authorities played reluctantly and allowed the company to maneuver itself past the regulations set by the FDA. Given this, the authorities also have a significant part to play in the unethical supply and distribution of the drug to the consumers leading to various events of heart attacks and numerous deaths. 

Analysis of how PharmaCARE used the laws of the United States to Protect its Intellectual Property and whether John has a claim on being the true inventor of the AD23 drug

PharmaCARE effectively applied the law by establishing a subsidiary company that saw the production of the AD23 drug, which also patented it before it began distribution to the society. By doing so, the company ensured it had the full support of the law and hence no legal action can stand against them. John belonged to a team that PharmaCARE sponsored and employed. Therefore, he lacks a legal claim whatsoever over the intellectual property relating to the drug as he worked as the company employee. His work and everything that refers to the drug belongs to the enterprise regardless of whether it was his idea or not. 

Three ways that the company can compensate John

The company can compensate John by meeting the medical and psychological requirements of his wife. The other way to compensate him is by paying him a lump sum of money that would cater for his innovation in the company (Kozauer, 2013). Lastly, the company can view and treat John as the other affected persons and proceed to compensate him as the other affected individuals. 

Summary of one current example within the past two years of a case of theft of intellectual property and examine the effect it had on the brand of the company

Ford Automobile was accused of theft of intellectual property in the year 2015 on the month of June. Versata, a software developing company, made the accusation. Versata argued that Ford used its technology to manage effectively warranty costs that were incurred by the corporation. The case arose when Ford decided to patent the software that had a code, which was developed by the software company, Versata (Kozauer, 2013). The eventuality was that Ford made significant investments to compensate the Versata Company as well as employ a fit legal team to help it win the case. The image of the company brand was gravely affected as the consumers chose to remain and preferred businesses that operated ethically. 

Analysis of the potential issue that surrounds the demise of John’s wife as well as other possible litigants against the company due to the AD23

The potential problem that beholds PharmaCARE is the idea that the firm stands to face a lawsuit for wrongful death. Joh’s wife had the potential to live longer had she not taken the drug. However, her health began to deteriorate when she took the drug and eventually led to her demise. Other Litigants can stand to demand legal action against PharmaCARE because of its harmful effects. 

Specification of the two main arguments John can make in a bid to claim he is a whistle-blower and the protections that he should be awarded

John can be viewed a whistle-blower considering that he was an employee of the company and had full knowledge of the illegal activities that the company was undertaking. Also, John remains an employee that is legally covered by the common law, which necessitates fulfillment against the enterprise (Fink, 2015). John has shown his intentions as a whistle-blower by his visit to a law firm and hence the intention of taking the company before a court. The activities described above protect John as a whistle-blower and ensure that he receives legal protection from the actions taken against the company by law. Therefore, John has protection against any retaliatory act against him by the corporation. He is further protected against any discrimination at his place of work or industry in case he decides to leave the business (Fink, 2015). In light of this, John can get employment in any other firm without being discriminated as a whistle-blower. 

Conclusion

Legal and ethical considerations, intellectual property and product safety remain the three most important issues regarding ethics as applicable to marketing, advertising, and intellectual property. It is imperative to consider all legal and ethical angles that affect a society during the process of product marketing. Indeed, this is so because consideration of how safe the product is should be taken into account. Moreover, consideration should be given to the intellectual property involved with that particular product. The current society experiences numerous marketing issues that are related to the sensitivity and studies of sales, especially in marketing ethics. The business aspect thus needs to concentrate on issuing out the necessity of marketing ethics from a social perspective considering the arising problems that the same sector is always facing. Ethically speaking, companies are responsible for ensuring that the products they produce and sell are suitable for consumption by human beings and appropriate for the environment as a whole. Therefore, the companies must guarantee the society that the products lack harm or pose a threat to the public by compromising their health or adversely affecting the environment.

References

Carpenter, D. (2014). Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton: Princeton University Press.

Carpenter, D., Chattopadhyay, J., Moffitt, S., & Nall, C. (2012). The complications of controlling agency time discretion: FDA review deadlines and post-market drug safety. American journal of political science , 56 (1), 98-114.

Fink, J. L. (2015). An Overview of the IRS’s Whistleblower Program. The CPA Journal , 85 (5), 40.

Kozauer, N., & Katz, R. (2013). Regulatory innovation plus the drug development for early-stage Alzheimer’s disease. New England Journal of Medicine , 368 (13), 1169-1171.

Lindon, J. (2012). Who Regulates Compounding Pharmacies? Medscape . Retrieved 21 November 2016, from http://www.medscape.com/viewarticle/774501