PharmaCARE: Ethical and Legal Issues | Free Essay Example

PharmaCARE: Ethical and Legal Issues

Words: 2557
Topic: Business & Economics
Updated:

Ethical Issues

Just like other products, marketing of pharmaceutical products requires adherence to ethical principles, as indeed, it directly influences human health (George & Stephen, 2008). The case of PharmaCARE entails improper and unethical drug marketing and advertising techniques that predispose patients to critical health complications. PharmaCARE implemented poor packaging and substandard recycling to introduce the green medical initiatives and the development and sale of AD23.

According to George and Stephen (2008), code of ethics for pharmaceutical marketing requires that pharmacists and drug manufacturers must ensure comprehensive testing of quality and safety of drugs, as well as the impact of promoting and marketing drugs. PharmaCARE also abused the laws governing intellectual property rights pertinent to the autonomy of company in protecting its patents.

The case of PharmaCARE entails a scenario of manipulating the intellectual property rights responsible for safeguarding the production rights of PharmaCARE and producing a fully-owned subsidiary company, CompCARE, as a compounding pharmacy to sell illegally produced drugs. The company abused the exclusive intellectual rights bestowed to them in the production of new drugs through internal manipulation by integrating a substandard subsidiary company that hampered the health of individuals.

The company also abused its legal obligations of maintaining product safety as required in the field of pharmaceutical care through providing unchecked drug, which skipped compliance standards of efficiency, quality, and safety (George & Stephen, 2008). PharmaCARE promoted reformulated drug and labeled it as a safe and effective medicine, which is an unethical pharmaceutical practice.

Direct-to-Consumer (DTC) marketing

The practice of Direct-to-Consumer (DTC) marketing entails marketing and selling of pharmaceutical products directly to patients without going through the Food and Drug Administration approvals (Russell, 2009). The DTCPA commonly referred to as Direct-to-consumer pharmaceutical advertising is completely an improper pharmaceutical marketing approach as it promotes unethical distribution and marketing of drugs (Liang, 2006).

Legal firms in the United States have continued to lobby arguments against the rules and proposed legislations that would allow limited access to healthcare information on several allegations. Liang (2006) postulates that with the increasing demand for medications, especially in private health centers and pharmaceutical companies find it as an opportunity to exploit naïve consumers by using DTCPA, a strategy that pose health dangers to millions of patients.

The use of DTCPA and subsequent sale of drugs would pose healthcare implications since the power and opportunity bestowed to pharmaceutical companies may override the importance of protecting life and promoting good health (Liang, 2006). The global communities are full of illiterate consumers and patients, who require the intervention of regulatory bodies such as the FDA and PhRMA to verify the safety of health care products (George & Stephen, 2008). Through DTCPA where needy patients access medicine without proper pharmaceutical regulations, patients would remain vulnerable to receive and consume wrongly prescribed drug. Liang (2006) asserts that the drugs are likely to contain wrong branding information, improperly packaged drugs, substandard drug elements, and poorly checked medicine. The FDA might have played an important role in averting extreme issues in PharmaCARE.

Food and Drug Administration (FDA) on Pharmacies

The FDA is the ultimate organization in the United States that oversees the production of pharmaceutical drugs, provides pharmaceutical companies with drug production authority, and makes public health and drug production policies that pharmaceutical companies must comply (Liang, 2006). In the scenario such as the one of PharmaCARE, the FDA should have compounded the organization and paralyzed its operations within Colberia, as the company had infringed the legal stipulations of producing and distributing pharmaceutical drugs.

According to George and Stephen (2008), the FDA has the mandate to access potential risk associated with a produced drug and regulatory powers over the manufacturing, advertising, labeling, and marketing of prescription drug. Using published standards required for the pharmaceutical companies, the FDA should have ceased PharmaCARE operations.

The emergence of CompCARE means that the FDA regulations are operating under certain limitations that give pharmaceutical organizations the power to manipulate the market in the production of prescription drugs. The FDA and regulations analysts hold that the FDA policies have numerous limitations that are putting the lives of Americans into healthcare dilemmas (Russell, 2009).

The current allegations regarding the incompetence of the FDA include problems related to ineffective drug approval process and incompetent regulations on food and drug labeling. The power over regulating and analyzing firms covered by intellectual property rights is becoming a constant problem for the FDA, as pharmaceutical companies continue to challenge the roles of the FDA using patent rights (Liang, 2006). The scope and mandate of the FDA on pharmaceutical should increase to compounding pharmaceutical companies.

PharmaCARE: Deontology Theory

From a closer assessment of the case of PharmaCARE, the ethical dilemma is arising from the inability of pharmaceutical members to follow set rules and regulations governing the production and marketing of prescription drugs. According to Russell (2009), major ethical concepts of healthcare ethics arise from the deontological theory that connects the responsibility of individuals with the occurrence of a positive or a negative action. Deontology or duty-based ethics have their greatest concern on the actions of individuals and the theory presumes that people should act ethically to avoid bad outcomes of irrational actions (George & Stephen, 2008). Deontological philosophy believes that right actions result in positive actions and reduces chances of people in engaging in irrational actions that cause harm.

The morality of human actions is what defines individuals within their stipulated duties. In the healthcare sector, the deontological theory postulates that characters of individuals in the healthcare professional field determine the goodness or badness of actions (George & Stephen, 2008). The officials of PharmaCARE act with irrational reasoning and malice to produce substandard prescription drugs that finally result into lost corporate reputation, and health complications among people of Colberia and its own esteemed workers. The actions of PharmaCARE officials are against the principles and righteous practices advocated by the deontological theory. Liang (2006) postulates that deontological theory of duty-based ethics requires people to avoid doing the wrong things and embrace a culture of doing only what deontological theory considers as ethically right actions.

Protection of Intellectual Rights

The American environmental laws and acts have some stipulations that gave PharmaCARE the power to protect its own intellectual property and demean environmental protection and intellectual property policies of Colberia. The case of PharmaCARE entails massive destruction of the environment, which causes major environmental problems. One of the major legislations is the American Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which has provisions that protect environment from contamination by industries. Under the CERCLA, the 1990 Pollution Prevention Act of the United States that is currently active requires corporate organizations to take corporate responsibility through ensuring voluntary prevention activities. Voluntary prevention activities include activities meant to reduce or prevent waste through recycling, reusing, reduction, treatment or transformation and disposal.

The Pollution Prevention Act (1990) allows corporate organizations to use response actions for short and long-term removal of waste, including imposing prompt actions that contaminate the environment, but are less hazardous than the initial waste (Elfring & Gordon, 2003).

Additionally, the American environmental law contains the National Contingency Plan (NCP) that provides procedures and guidelines required for responding of hazardous substances. According to Elfring and Gordon (2003), the NCP is subject to changes and revisions that appear in the CERCLA and such incidences give PharmaCARE a chance to manipulate the environment in Colberia. During their operations in the African land of Colberia are not under the jurisdiction of the American regulations. PharmaCARE used its ‘we care about your world’ campaign to instigate its commitment to environmental protection through packaging changes and recycling techniques.

Compensating the People of Colberia

Major corporate ethical implications that have arisen from the actions of PharmaCARE included 19 cases of people suffering heart attacks, 200 cardiac deaths of the Colberian innocent people, and degraded environment through air pollution. Regarding compensation of people suffering from heart attacks due to the AD23 drug, PharmaCARE should have promoted free community diagnosis to identify the extent of heart attacks and other infections and sponsor treatment to the infected persons. Community health and diagnosis is one way of promoting good health among members of the society. Such approaches would avert the pain and treatment cost that patients would have incurred. Regarding deaths, PharmaCARE should make considerable financial compensations to the affected or bereaved families.

Secondly, the company should have considered restoring the state of environment through implementing processes of rehabilitating the land through varied land rehabilitation programs. The destroyed forests due to efforts of PharmaCARE to provide green initiatives to medical care through indigenous treatments must receive considerable attention. PharmaCARE should have promoted forest protection campaign for members to understand the accrued significance of forests. It would also deem significant for PharmaCARE to introduce industrial policies that would support a reduction in air emissions that act as atmospheric pollutants. PharmaCARE should have promoted means of controlling air pollutants by passing air through filtering techniques and technologies essential in preventing or reducing air pollution, just like other companies.

PharmaCARE Actions Replicated in Real-world Companies

Apart from the scenario explained in the case of PharmaCARE, America has a record of cases involving real-world pharmaceutical companies breaking legal and ethical norms necessary in the pharmaceutical companies (Liang, 2006). Pfizer is one of the American and global leading pharmaceutical companies that have recently hit the American public discourse regarding drug safety and protection of human health. On November 2004, Pfizer was caught after infringing the legal stipulations for production, branding, promoting and marketing drugs (Liang, 2006). The case on January 2004 revealed that Pfizer illegally bribed and pushed doctors to prescribe and recommend an unapproved epilepsy drug against the regulations and policies placed by the FDA agency. Pfizer marketed the epilepsy drug and made billions of profit.

After deceptively marketing unapproved drugs to millions of American patients, subsequent reports of 2005 by the U.S Department of Justice indicated that millions of people were at risk of suffering chest infections, suicidal impulses and heart attacks (Liang, 2006).

The approach of Pfizer that entailed dodging of legal technicalities in producing and marketing unapproved and untested medicine contributed to 10 million false prescriptions in hospitals and clinic centers that most pharmaceutical companies stimulated in the United States (Liang, 2006). The drugs that Pfizer produced were either ineffective, had low treatment outcomes, or simply caused health complications among patients. Eventually, Pfizer lost the case and the criminal system fined it $1.19 billion, which became the highest fine ever imposed on a pharmaceutical company.

The Success PharmaCARE and WellCo’s Suit

It is very hard for PharmaCARE to succeed in suit against it because it made outrageous violations in the formulation of AD23. PharmaCARE bears full responsibility for the cardiac deaths that occurs due to the use of AD23 because it hatched the plan to reformulate the drug. Although PharmaCARE is a noble pharmaceutical company with a matchless reputation in the manufacture and sale of drugs, it deliberately decided to violate laws and regulations that govern drug discovery. In this view, it implies that the suit against PharmaCARE has compelling evidence, which can definitely incriminate the company. Hence, the company will be liable for the cardiac deaths that happened because of its violations and negligence in the sale of AD23, a drug that has no safety and efficacy data to warrant its sale as a pharmaceutical product.

In contrast to PharmaCARE, WellCo will win the suit against it because it bought CompCARE innocently. From the case study, WellCo bought CompCARE just before the release of the report, which found out that AD23 has caused over 200 cardiac deaths. Fundamentally, WellCo acquired CompCARE when it was not public knowledge that AD23 had caused cardiac deaths among patients with Alzheimer’s’ disease. Therefore, WellCo is not liable for the cardiac deaths that CompCARE caused because they happened when it was still under the management of PharmaCARE.

PharmaCARE and Its Presumed Brand

Pharmaceutical companies have become highly technical and suave in their marketing approaches that make consumers use their products. According to Liang (2006), “due to the high financial stakes, brand name pharmaceutical companies lobby and advertise heavily to ensure prices may be set independently and that consumers consider their particular drugs for use” (p.318). From the initial reputation, PharmaCARE brands itself as a reputable company that observes corporate social responsibility through recognizing the need to provide good care to consumers. Consumers have known PharmaCARE as a successful, caring and an ethical pharmaceutical organization that promotes good healthcare through producing high quality products that help millions of patients across America.

The acts of skirting legal technicalities and penetrating the consumer market with unapproved and substandard healthcare products makes one have a perception that PharmaCARE is not living up to the public expectations regarding its market brand. Following the assertions of Liang (2006), the actions of manipulating the foreign market with unethical business practices and fake marketing of unapproved commodities makes PharmaCARE seem like an organization that has risen merely from its commercialized advertisements and counterfeit programs that help to promote its brand in the market. Being a common practice that most pharmaceutical companies use to gain consumer confidence and build reputable market profiles, PharmaCARE stands as one of the companies that use illegal marketing strategies.

Recommendations

The first recommendation is that CompCARE enhance safety and efficacy of its drugs. Since the health of the people is paramount, PharmaCARE should follow appropriate guidelines that the FDA and PhRMA have established because they ensure safety and efficacy of drugs. In essence, PharmaCARE should adhere to rigorous guidelines and procedures of drug discovery and avoid shortcuts such as reformulation of AD23 and establishment of fake pharmaceutical companies like CompCARE, which aim at selling the reformulated drug.

In this view, PharmaCARE should file a New Drug Application with the FDA, obtain permit to reformulate the diabetes drug into AD23, conduct clinical trials among patients with Alzheimer’s disease, perform post-surveillance assessment, and then establish the safety and efficacy of AD23. By adhering to this procedure, CompCARE will regain its reputation as pharmaceutical company that follows ethical principles, which protect patients and dignity of human life.

The second recommendation is that CompCARE should undertake corporate social responsibility in Colberia. From the case study, it is evident that CompCARE derives immense benefits from Colberian community, yet it does nothing to uplift the lives of people. Corporate social responsibility is an ethical practice that companies should exercise in improving living standards of communities within their jurisdiction (Hurst, 2004).

CompCARE should reward traditional healers because it derives indigenous knowledge about diverse forms of cures. Moreover, CompCARE should avoid exploiting Colberians, but instead, it should employ and pay them according to the stipulations of the Equal Employment Opportunity Commission (EEOC). For the benefit of all members of the community, CompCARE need to supply water and electricity to improve living conditions of the Colberians.

The third recommendation is that CompCARE must comply with the stipulations of EEOC instead violating the rights of employees haphazardly. CompCARE should understand that employees have their inalienable rights, which it has responsibility to guard and promote among its employees. When employees sustain injuries or acquire health complications owing to the negligence of the company, CompCARE should compensate them well. Moreover, CompCARE should encourage employees to develop their careers by rewarding their contributions through promotions or presents.

References

Elfring, C., & Gordon, I. (2003). Superfund Strategy. New York: DIANE Publisher. Web.

George, P., & Stephen J. (2008). Ethical issues in the pharmaceutical industry: An analysis of US newspapers. International Journal of Pharmaceutical and Healthcare Marketing, 2(3), 163-180. Web.

Hurst, N. (2004). Corporate Ethics, Governance and Social Responsibility and Social Responsibility: Comparing European Business Ethics and those in the United States. Web.

Liang, B. (2006). Fade to Black: Importation and Counterfeit Drugs. American Journal of Law & Medicine, 26(1), 279-323. Web.

Russell, B. (2009). Pharmacists, the Pharmaceutical Industry, and Ethics. Journal of Ethics in Mental Health, 4(1), 1-5. Web.