Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property
Business Legal and ethical concerns can be termed as feasible components in regard to intellectual property, products safety as well as marketing yet they are able to make it clear that organizations cannot control this components while handling employees. Immoral working conduct is not a complete issue of character rather it is driven by several factors that surrounds value which includes the surrounding, colleagues, the organization’s system, policies as well as standards and superiors (Halbert, T., & Ingulli, E. (2014).
Ethical Issues
PharmaCare Inc holds a high international reputation based on its dominance and success in the competitive pharmaceutical corporation. It is therefore not a huge surprise that the corporation’s development of the AD23 drug aimed for slowing the diabetic rate was a major success. The success was seen as a major opportunity for acquiring increased profit for the company and the subsidiaries. The corporation made the decision of growing the medicine to cater for diabetes as well as Alzheimer’s patients. The case exposes numerous ethical problems that are associated with advertising, marketing, product safety regulation and intellectual properties.
Advertising and Marketing Ethical Issues
All the features of advertising as well as marketing are generally subjected to regulations as well as restrictions. It is therefore the responsibility of marketing manager to analyze how the involved ethics and regulations should be addressed (Halbert, T., & Ingulli, E. (2014). The corporation was involved in a failure as it never adhered to ethical marketing as it was promoting drugs which were not completely functional. This was additionally a violation of the stated standards which does not permit direct advertisement and sell as bulk drugs to the consumers. Their advertisement method which was directly addressing consumers affected the general drugs perception by consumers which has no qualifications from or prescriptions from physicians.
The advertisement done by the corporation failed in addressing the drug’s effects on the target group as it was aimed maliciously at creating more profit. The advertisement should have been accompanied by the requirements, the involved risks, legal standards observation and not focusing on the advantages solemnly (McQueen & Jones, 2007). The corporation failed to be socially responsible as it was mainly focusing on money rather than how the community should be impacted positively.
Intellectual Property
Property intellectual raises the necessity of providing the right of protecting one’s ideas and invention. However, modernity has worked in establishing challenging in the management of intellectual property (McQueen & Jones, 2007). This is mainly influenced by the fact that the rights to intellectual property is not objected at offering the exclusive protection in regard to trade or property secrets but today it is more objected at protecting monetary benefits that are linked to an individual (McQueen & Jones, 2007). The general products regulation primarily involves the Act of consumers which is more grounded on developing healthy as well as quality goods to consumers. In the case PhrmaCare violated the rights of their consumers because the products failed in healthiness as the intake resulted in heart attacks and later death. In this sector the concern lies on the good utilization of the products without stealing commercially or exploiting the goods. In the case the renovation of the drug to sit the needs of a wider target is the matter associated with intellectual property. The renewal of the drug was not based but the fact that there is no evidence to demonstrate an official registration is a violation of ownership which was lost to the ambitions of CompCare.
Product Safety Regulation
All companies that are involved in the development of fresh products that relates to the medical area are obliged to acquiring development approval from the responsible management in the field (McQueen & Jones, 2007). In this the corporation is exposed to the assessment of the products by a government or independent agency , process tests as well as an examination of the healthiness, safety and quality of the products. With this, it is clear that the AD23 drug marketing that held strong elements capable of triggering heart attack and death was unethical. This is because the drugs was not safe as well as consistent with the necessary ethical guidelines towards consumers which included patients and healthcare facilities. The appropriate product safety regulations should have been accomplished via consumer legislation and quality compliance standards. This case shows that the drug was of poor quality which is a direct violation of the right legislation, standards and ethics code.
Direct-To-Consumer (DTC) Marketing by Drug Companies
In the modern society when businesses competes based on the ability to be innovative corporations are faced with issues in regard to increasing their ability to be succeed through selecting the appropriate methods to market their products (Nill, 2015). The medical system is comprised of different necessitates in regard to drug marketing as direct marketing is not encouraged based on its ability to change the perception of buyers even those that have no prescription. However, this does not hinder corporation from the kind of marketing since they are more driven by profit rather than the community’s wellness. I believe that direct marketing in regard to medical drugs is unethical. This is because they online highlight the associated benefits of consuming the drugs and rarely addresses the involved risks. Consumes are normally exposed to negative choices since acquiring the drugs directly always seems to be more better than visiting the doctors. Drugs advertisement should particularly be information based to educate consumers rather than arguing them to buy (Halbert, T., & Ingulli, E. (2014). The ability of the direct marketing approaches to convince consumers to buy drugs is a mode of encouraging purchases and the preparations are risky as there is no prescription that is engaged.
Compounding Pharmacies Regulation and the Role of FDA
Compounding pharmacies plays major determining roles in the development and marketing of drugs and therefore regulation is necessary since the lives of consumers are risked (FDA, 2017). From the case compounding can be described as the activity through which the licensed medical providers, pharmacists or an individual who operates under the administration of a pharmacy that is licensed combines put together the needed medicines ingredients customized to the necessities of the patients (FDA, 2017). PharmaCare Management is directly responsible for the negative effects caused by the drug they developed. The corporation ignored pharmaceutical ethical abilities by primarily focusing on the maximization of more profit. The company disregarded its responsibility of enhancing individual’s wellness as required. Compounded pharmaceutical drugs are not normally approved by FDA since it is not directly involved in the verification healthiness or safety of the drugs (FDA, 2017). This is made clear by the fact that the corporation acquired a compounded subsidiary to avoid being scrutinized. However, health institutions and pharmaceutical consumers highly depends on the general approval of drugs to understand their safety as well as the alignment with the effectiveness as stated by the Federal quality standards.
What the FDA Would Have Accomplished In PharmaCare Scenario
PharmaCare is not demonstrated as a legally and socially responsible corporation from the case. It developed the AD23 but was not ready to be scrutinized by FDA which forced it to acquire a full supplementary of its own named as CompCare. The subsidiary was to operate as a compounding pharmacy to stimulate sales to persons under the grounds of prescription. Compounded drugs are not normally characterized by FDA assessments on their quality prior to their marketing. The pharmacy state board is thus responsible primarily for the regulation of compounded pharmacies in regard to FDCA’s statement despite the fact that FDA is entitled to a certain degree of authority in regard to the matter (FDA, 2017). This in most cases involves provision of misguiding message, misbranding or the engagement in drugs advertisements that can be considered to be inappropriate as the violate the rights of consumers (FDA, 2017). Organizations that are registered by FDA acquire their assessments, supervision and inspection by the agency to examine the risks. Since PharmaCare was directly registered under FDA it avoided the analysis through using a subsidiary approach.
FDA necessitates more authority over the regulation of pharmacies operating under compounding. The authority that FDA holds is too minimal which supports the ability of the compounding pharmacies to escape inspections at ease (FDA, 2017). In order for such cases to be avoided where corporations subsidizes their operations to avoid assessment more authority should be passed to FDA. PharmaCare is obviously exposed to several legal issues based on its conduct. To begin with quality as well as the safety of the product was not enhanced since it avoided the analysis from FDA. This therefore shows that the corporation is not committed to the objective of generating wellness to the consumers and it offers no support to accomplishing the healthcare industry’s objection of wellness. it practice exposed consumers to negative consequences of triggering deadliness health issues without any action. The undesired results should have been be eliminated if the corporation committed to the safety standards.
PharmaCare utilized the American intellectual law by acquiring its fully owned subsidiary. This means that CompCare was only involved in the marketing as well as the AD23 sales while the product ownership rights were retained by PharmaCare. John cannot make the claim of being the real inventor of the drug since he did not make the creation on his own. This means that making a claim of an intellectual theft is wrong since the company was entitled to it. however if for instance John made the general attempt of selling ownership of the invention without the corporation an intellectual theft can be filed against him since the ownership registration belongs to the corporation that he works for. In real sense an intellectual theft occurred in the case since the company took the whole invention for its personal benefit without considering John’s efforts and rights as a creator.
The corporation can compensate john by sharing a certain percentage of the acquired profit from AD23 sales with John. The sale of the drug is characterized by high profit based on the marketing and its associated benefits and John’s effort can be paid by getting a particular share. In addition, the corporation may offer him compensation my raising his monthly earning either temporary or constantly . This would help him ease the pain caused by the company’s betrayal that caused the loss of many which included his wife. Ensuring the employees financial stability is just the little that the company can help since the loss of his Wife cannot be paid. Finally the company can decide to sell half of the possession rights to John. This does not fall under the desires of the corporation because the product was able to generate much profit which supported its ability to grow but this may recompense him since he never acquired any form of benefits from the prior sales.
Intellectual Property Theft Current Example
In 2015, a property intellectual theft occurred which incorporated several organization where the Microsoft, Valve Inc and Epic Games (Walker, 2015). Several men confirmed that they were highly involve d in stealing a sum that exceeded one hundred million dollars intellectual property worth from the companies through hacking(Walker, 2015). The investigation was performed and supervised by the FBI agency which established several hacking and scheme leads. The assessment established that the group had access to the unreleased software’s made by the corporation which was generating so much profit. The hacking was particularly aimed at stealing trade secrets, source codes for the unreleased software’s, confidentiality, proprietary data and copy rights. This case therefore shows the violation of ownership that was conducted by the men against the companies which had invented and designed the software’s thus denying them the ability to sell and generate maximized profits (Walker, 2015).
The Surrounding Of Potential Issues against PharmaCare In Regard To AD23
The consumption of AD23 that was developed by the corporation led to the triggering of heart attacks and deaths which included John’s wife. The death of many people from the consumption was not a reason enough to stop the corporation from selling the product since it made the compensation and continued with its sales. The consequences that were developed by the drug would have been indicated by an assessment and adequate knowledge in regard to the functionality which never occurred. PharmaCare was wrongly objected for targeting to generate profit rather than providing global and healthier products. With the assessment this would not imply that success would be a hard thing to achieve rather it would work on enhancing its ability to acquire success in the market for the long-term period through responding effectively to the patients issues (Schweitzer, 2007). Too many lives would have been spared if the corporation had focused of effectiveness rather than sales. The corporation understood the incapability of the drug as it resulted in heart attacks to the consumers but never acted. This should have been responded through withholding the drug from the market for further expansion and understanding of what it lacked or how the damages would be eliminated.
The company was unethically involved in avoiding scrutiny despite the fact that it understood that its product was aimed at handling a serious issue. The marketing which directly addressed consumers was also unethical. The corporation makes the advertisement to increase awareness and the capability to beg and convince consumer’s perception that they needs would be solved by the drug. This strategy was wrong since it attracted consumers who held no prescription from the Doctor resulting in self treatment. This is unaccepted medically since the corporation exposed lives of many thus affecting families (Nill, 2015). The company was not socially responsible mainly because it was only focused on its individual interests rather than focusing on healing the community. The desperate nature of acquiring speedy treatment to chronic illnesses motivates consumers to highly demand the product with questioning its safeties. In addition the company did not release the functioning and the associated risks to the product. This was because the acquired knowledge in regard was inadequate.
John’s Claims as a Whistleblower
The protection of a whistleblower establishes the general treatment of an individual either by the government or a corporation for an individual who make a report of an illegal or dishonest practice against a party that is engaged in a socioeconomic issue. This opens grounds for the conduction of investigation in order to develop certain proves that the accused person is at fault. This implies that John can make the claims that he is the whistleblower after an application for legal protection establishment to stir an investigation and guard him from negative treatment. This will help to ensure his confidentiality as the accuser. The protection offers privacy as well as confidentiality of his identity and ideas towards the company which was engaged in a faulty activity that risked and took the lives of several consumers. This is a sensitive case since he is making accusations of a powerful corporation and protection is highly required. John as the inventor clearly understood the negative consequences that were associated with the drug but he was not given the opportunity to give opinions whether the marketing of the drug without adequate assessment was right. He holds a rough experience as his rights were violated by the corporation by acting as the sole owner of the product with him receiving zero benefits as well as the loss of his wife. He is therefore not responsible for the caused effects since the marketing idea belonged to the corporation which believed more on profit rather than wellness.
Conclusion
The case demonstrates several legal as well as ethical issues which are related to the practice adopted by PharmaCare and the undesirable consequences generated. It is clear that corporations are highly required to adhere to safety, legal and ethical issues for long term success. The necessity to develop should be aligned with the consumers wellness which can best be obtained through ethical and legal corporation. The case has shown Phramacare to be legally, socially and ethically irresponsible. In that their social irresponsibility has caused deaths while it continuously runs after fulfilling its monetary interest. The initiatives that the corporation states to be upholding in response to social responsiveness has not been done. The integrity of the drug is not their concern since after learning of the effects the company does not participate in developing and withholding sales to prevent additional damages. Its legal irresponsibility is demonstrated by the fact that it schemes FDA’s regulations by acquiring a compounding pharmacy as a supplementary. This form of conduct is unacceptable since legal standards must be followed particularly when creating, marketing and selling sensitive goods to consumers characterized by no knowledge of functionality.
References
FDA. (2017). Human Drug Compounding. Retrieved from https://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/
Halbert, T., & Ingulli, E. (2014). Law and ethics in the business environment. Cengage Learning.
McQueen, D. V., Jones, C. M., & International Union for Health Promotion and Education. (2007). Global perspectives on health promotion effectiveness. New York, NY: Springer.
Nill, A. (2015). Handbook on ethics and marketing. Edward Elgar Publishing.
Schweitzer, S. O. (2007). Pharmaceutical economics and policy. New York [u.a.: Oxford Univ. Press.
Walker, D. (2015). Man Pleads Guilty To Intellectual Property Theft Conspiracy Impacting Microsoft And Other Firms. Retrieved from https://www.scmagazine.com/hacking-ring-member-pleads-guilty-to-stealing-intellectual-property-data-of-microsoft-others/article/535941/
