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/