Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property - Essay Example

? Legal and Ethical Consideration in Marketing, Product Safety, and Intellectual Property Legal and Ethical Consideration in Marketing, Product Safety, and Intellectual Property Introduction In an increasingly competitive and global environment, companies are struggling just to stay afloat, much earn substantial profits. In an age where ethics are questioned and certain business practices remain skeptical at best, it is no wonder that companies like PharmaCARE are often accused of compromising values for the sake of profit. Not only that, but many industrials, the pharmaceutical field certainly no exception, are responsible for making known any health hazards that may be existent in their products. This is sound ethical behavior, even if such reporting will result in severe financial loss to the company. All of the issues and more are covered in this case study. It is important to consider the reality of direct-to-consumer (DTC) marketing by consumer and its potential impact. This paper will analyze such issues in the context of PharmaCARE, while also exploring intellectual property considerations and U.S. law. The backdrop to this dialogue will be a strong consideration of the ethical obligations that a company like PharmaCARE has to the global community. Direct to Consumer Marketing and Drug Companies Simply put, direct to consumer marketing involves the promotion of a product in mainstream media. The intent is to promote the product by appealing the potential consumer directly. The term is actually most commonly applied to the pharmaceutical industry, which makes it worthy of discussion in this case. Drug companies that engage in direct to consumer marketing bypass health professionals and attempt to reach the patient directly. The Federal Food and Drug Administration regulate such advertising, yet many professionals claim that the oversight is quite lax and ineffective. There are several concerns with this method of advertising that applies particularly in the case of PharmaCARE. It should be noted that the most common methods of direct to consumer marketing include television advertising, print, radio, and now social media outlets. With the lack of adequate oversight, questions of an ethical nature are frequently asked when considering whether or not drug companies should use such a marketing strategy. Advertising companies are not health professionals. They do not diagnose patients and they cannot adequately determine if the side effects of any given drug may be counterproductive for the consumer. While pharmaceutical companies are required by law to indicate potential side effects of the drug being marketing, and they are only permitted to tout proven benefits of the medicine, such disclaimers are often not clear to the consumer. This can lead individual patients to try and self-diagnose their own illnesses, and then approach their own physician about getting a particular drug prescribed to them. This leads us to yet another ethical dilemma. If an advertising campaign for a new drug floods the airwaves, physicians may become inundated with requests to prescribe the drug to their patients. This puts the physician in an awkward position. They may end up overprescribing the drug, doing so without themselves actually researching the drug and feeling comfortable in its use. This creates the ethical question of whether drug companies should even be permitted to engage this practice at all. The argument is that they should only allowed to promote their products directly to health care professions, who can then decide which drugs best suit their particular patients. The practice of direct to consumer pharmaceutical advertising (DTCPA) has so many ethical implications that most countries have an outright ban on the practice. Only the United States and New Zealand permit its broad use. This is the reason that PharmaCARE has been permitted to engage in the practice. To be fair, not at all pharmaceutical companies market their drugs directly to the consumer. It seems to be relegated to only the large companies, and only for drugs that are used by a relatively large percentage of the population. To make the claim, however, that direct-to-consumer advertising the United States should be banned is a bit of a stretch. Current studies are a bit divided on the issue, alluding to both benefits and detrimental effects of such practices. In other words, claims can be made on both sides of the issue, supported with evidence, about why such advertising should be either allowed or banned. PharmaCARE is a precarious position. On the one hand, direct-to-consumer advertising allows them to get their message out to the public. Without being allowed to openly market to potential patients, they would have to depend solely on healthcare professionals to market their drug. The consumer, then, would never know that the drug exists aside from a physician actually telling them. In this case, PharmaCARE’s actions are both legal and a sound business practice. Because of lax oversight, however, PharmaCARE was permitted to continue advertising openly to the public, even when allegations were made about potentially lethal hazards associated with taking the drug. Again, legally they were permitted to do, but ethically the case could have been made that they should have ceased all advertising and promotional campaigns until the safety of the drug could be assured. For these reasons, the practice of direct-to-consumer marketing by pharmaceutical companies should be permitted to continue, but there should be more oversight by the Food and Drug Administration. Drug companies should be permitted to openly market approved medications to patients nationwide. To deny them that right would be to deny them the opportunity to grow. At the same time, however, consumers have the right to be duly informed of all uses and potential side effects of any drug. To deny them this right would be to deny them the right to protect themselves. In order to ensure that these rights on both sides are protected, more authority could be granted to the Food and Drug Administration in terms of regulating direct-to-consumer marketing. They could, for example, insist that all marketing cease any time the efficacy of the drug is called into question. They could also insist that all possible uses of the drug be highlighted, along with the side effects being clearly explained in language that the average layperson can understand. The argument can be made that drug companies should be ethically responsible to do this on their own, but companies such as PharmaCARE have demonstrated that some organizations must be forced to comply with ethical behavior that is considered to be common sense. Currently, the FDA does have the power to enforce certain regulations put in place governing direct-to-consumer advertising. Companies that violate these regulations are subject to action being taken against them by the Food and Drug Administration. Ventola (2011) notes, however, that “In recent years, the number of regulatory actions taken by the FDA against DTCPA violations has fallen off dramatically, which could reflect better industry compliance but could also be a result of a decline in FDA oversight” (p. 671). One would hope that the former is the case, but many argue that the latter is unfortunately true. In PharmaCARE’s situation, one can arrive at the conclusion that the company is ethically responsible for their own advertising campaigns. If they refuse to police themselves, then the Food and Drug Administration should certainly step in. PharmaCARE and Colberian Intellectual Property There have been documented cases throughout history of certain medicinal cures and remedies being discovered in the far reaches of the world, such as in the jungles of Colberia. Village doctors in these remote areas have found ways to treat their people that appear to work for them. Occasionally, a Western physician or company may come along such areas and realize that the jungle remedies can work for the global population. This was certainly the case for PharmaCARE, who discovered various uses for medicine long used in the Colberian region. As such, they began to mass develop the remedies with the help of the village doctors, but it appears as though the company retained all rights to the cures being manufactured. Simply put, intellectual property is generally defined as being applied to inventions of the mind (Siwek, 2008). The village doctors of Colberia would certainly seem to apply here, as they are the ones who discovered the medicinal uses of the plants in their native lands. The law here, however, appears slightly muddled. Colberia certainly does not fall under any American jurisdiction. In addition, the people of Colberia apparently willingly gave access to their cures to PharmaCARE, albeit the implication made is that they would receive some kind of compensation. In essence, the legal ramifications of this case apparently favor the pharmaceutical company. They are the ones investing in the infrastructure to harvest the drug on a massive scale. They are also the ones financing the operation and providing compensation to the people of Colberia. Granted, the compensation offered is certainly far lower than would be considered adequate, so that is certainly an ethical consideration to take up in this discussion. Since PhamaCARE retained the rights to the drugs found in Colberia, the company uses intellectual property laws in America to their advantage (Pakes, 2006). They obtained the legal rights to the drug and conduct all of their legal business from their offices in New Jersey. As such, not only do the people of Colberia no longer have any marketing rights to the drug, but other companies cannot gain access to it either. Since this medicine or remedy is only known to be located in Colberia, this in essence gives the PharmaCARE organization a virtual lock on the manufacture and distribution of the drug for the foreseeable future. As mentioned, there are ethical issues at play here. The compensation given to the people of Colberia is currently quite low, and the environmental damage severe. There are some ways that the company could consider compensating the people for the use of its intellectual property and to protect from causing further damage to the environment. First,, the could begin to give a set percentage of profits earned from the sale of the drug directly back to the people of Colberia. Second, for every tree that is cut down, they could plant a new one. This would provide a sustainable future for the jungles of Colberia, while still allowing the powerful remedy to be used and marketed globally. Finally, to be ethically responsible, the company could begin to provide more adequate compensation to any persons from Colberia actively involved in work for PharmaCARE. In so doing, they could also consider giving back to the community by providing educational and vocational training options to the people. By taking these simple measures, the bottom line of PharmaCARE would not be adversely affected, they would be giving back to the very people that have contributed greatly to their success, and they would be seen as an ethically responsible company that is truly living up to its vision. Speaking of their vision as being a company that cares, it certainly does not appear that they own up to that reality. We have learned from the case study that they are known as a company that treats its employees unfairly and provides low compensation. They also engage in questionable marketing practices, even after a certain drug is seen as causing potential death in many patients. They continue this unethical behavior by destroying the environment of Colberia without having any plan for a sustainable future, and by violating the ethical foundation of intellectual property rights. In other words, at nearly ever turn and seen in ever action, the company is showing that it is actually a company that does not care. They are only interested in increasing profits and solid shareholder statements. While they are technically legal in many of the business operations covered under the scope of this case study, they are certainly not to be considered a business that is conducting itself in an ethical manner. Conclusion and Recommendations In summary, PharmaCARE is a company with great potential. Somewhere along the line, however, they have lost sight of their vision. In our capitalistic society, there is nothing wrong with a company desiring to sustain large profits. Drug companies, however, have a larger obligation to the public. Individuals need to be assured that the medicine they are taking is safe and effective at treating the ailments as advertised. PharmaCARE’s direct-to-consumer marketing campaign, while certainly legal, fails on this account. Even when their drug was called into question, they continued to mislead the public into purchasing the medicine. Physicians were in limbo over the efficacy of the drug due to misleading advertising as well. Moving forward, the company should consider tapering back their advertising campaign to include more accurate and detailed information, along with clearly described potential side effects. In addition, moving forward, marketing should be mostly directed at the physicians who are more adequately equipped to determine which of their patients would benefit from the drug most. Capitalizing on the inventions and ingenuity of others is nothing new. Individuals often come up with great ideas, but are unable to really act on them due to a lack of resources. This certainly applies in the case of Colberia. While the cure was there in the jungle, the village doctors had no intention or desire of sharing it with others. We can also assume that they probably thought the rest of the world had access to similar remedies as well. Whatever the case, they accepted the offer that PharmaCARE presented to them to take the cure globally. Colberia could never have done this on their own, so PharmaCARE provided the financial resources to make it happen. Ethically, however, a company should have the foresight to properly compensation people or countries for their own intellectual property. PharmaCARE failed in this area and should take the steps outline in this paper to rectify that. In addition, companies need to be environmentally responsible. Any damage done to the environment should be minimized as much as possible, and steps taken to create a sustainable future. Instead of doing, this, we get the picture of a company in this case that simply chose to ravage the jungles until nothing was left. Not only is that irresponsible, but it destroys the very ecosystem that made PharmaCARE one of the largest pharmaceutical companies in the world in the first place. Again, the steps outlined in this paper should be considered and immediate implementation should take place. Ethics are a gray area to be sure. This is why there are entire course of programs at the University level and corporate trainings and workshops galore. Ethical responsibility must be considered. Any company truly desiring to make a positive impact on the world must not stop at ensuring they are operating in a legal manner. An individual or company can perform a legal action, yet still be unethical. Unethical business practices can hurt a company in the long run, and even cost the entire business as customers flee the organization and the media pounces on an opportunity to expose the situation. In this particular case, PharmaCARE had a lot to learn, and the lessons learned were not heeded quickly enough. Their entire organization was compromised, resulting in their eventual downfall. References Pakes, B. (2006). Public health ethics and intellectual property policy. Bulletin of the World Health Organization, 84(5), 341. Siwek, S. (2008). Information ethics: Privacy and intellectual property. Business Communication Quarterly, 71(2), 267. Ventola, C. (2011). Direct-to-consumer pharmaceutical advertising. Pharmacy and Therapeutics, 36(1), 669-674. Read More