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Legal and Ethical Considerations in the Pharmacare Case

Autor:   •  February 28, 2018  •  2,387 Words (10 Pages)  •  536 Views

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Question 3: Parties Responsible for Regulating Compounding Pharmacies

Overall, compounding denotes the practice wherein licensed pharmaceutical corporations combine or alter ingredients of any drug to create medications that are tailored to the requirements of certain patients. Compounding pharmacies are crucial in the complex environment that is responsible for manufacturing, distributing and consumption of prescription drugs because they are vital in the mixing of chemical constituents into finished pharmaceuticals. In USA, the centralized Food and Drug Administration regulates all commercial manufacturing of pharmaceuticals (Gad, 2008). However, the primary supervisory body responsible for regulating compounding pharmacies under the current regulatory scheme is the state. This is because compounded medications are not FDA-sanctioned, which entails that the FDA cannot authenticate their effectiveness or safety. Therefore, consumers as well as health professionals depend on the compounder’s approval process to guarantee that medicines are effective, safe and manufactured in line with Federal quality criteria.

In our case, the state board of pharmacy in the state that PharmaCARE is established is responsible for regulating the compounding conducted by its pharmacies. The state has laws that guide pharmacy standards, which address matters such as mandatory licenses for all facilities, certified pharmacists as well as other staffs who work for the corporation. Also, the state has prerequisites for recordkeeping, secure storage, labeling, in addition to safety protocols linked to authenticity, origins, chain of custody, purity, expiry dates, sterility, and storage. This consists of the additional, explicit right granted to mix pharmaceutical components into patient-ready products. These state rules are restructured periodically, frequently under the influence of the State Board of Pharmacy (O’Donnell & Ahuja, 2005).

The actions that these parties or the FDA could have taken in this scenario are as follows.

The State Board of Pharmacy ought to have regulated the compounding of PharmaCARE pharmaceuticals. The Board should have should have inspected the corporation’s manufacturing standards, drug safety, facility requirements as well as ongoing research. Since the board is responsible for enforcing penalties on corporation that breach the Pharmacy Act, the manufacture of AD23 should have been discontinued (Gad, 2008). The creation of the drug should have been terminated because the law not only prohibits misbranding of compounded medications but also their advertising as well as distribution. The drugs that were already in the market should have been recalled by the company under the supervision of the board because they were unsafe for human consumption. In addition, the State Board of Pharmacy should have imposed a hefty fine on the corporation for violating multiple laws that govern the manufacture as well as distribution of pharmaceuticals.

Question 4: How PharmaCARE Applied U.S. Law

PharmaCARE utilized the U.S. law to defend its intellectual property by launching CompCARE as an exclusively-owned subsidiary. As a result, the PharmaCARE owned all the patents that protect the manufacture of AD23. By doing so, PharmaCARE was also operating in accordance with the law because as an existing corporation it is allowed to form a new corporation to act as an autonomous subsidiary. The startup procedure is similar to the one used to create the parent corporation (O’Donnell & Ahuja, 2005). PharmaCARE could control CompCARE by being its exclusive shareholder thus retaining the sole right to hire the board of directors. CompCARE was formed as sovereign legal entity, which means that through this separation, PharmaCARE can protect its properties from both corporations in the event of lawsuits, financial loss, or settlements.

Regarding John, he used to be part of the research team that was employed by PharmaCARE. Intrinsically, he has no legal right to claim to be the inventor of the product because he worked for PharmaCARE. Thus, the company has claim over all intellectual property because he signed an employment contract. Despite having designed the drug, his invention belonged to the corporation (O’Donnell & Ahuja, 2005).

Three ways in which John could be recompensed for the usage of his intellectual property are as follows. (a) PharmaCARE could award John a fraction of the profits generated from the marketing of the drug. This would also act as reparation for the death of his wife due to the drug to cater for all the expenses he incurred to treat her. (b) PharmaCARE could afford him the privileges to sell the product. As the researcher who created the medicine, John would bear the rights to reformulate the product for sale. This would allow him to earn money from the distribution of the final medication. (c) PharmaCARE could send John a monthly check to guarantee his financial security (Bohlman & Dundas, 1999).

Question 5: Intellectual Property Theft

In September 2016, SolarCity, which is an energy corporation that deals with the manufacture of solar appliances, was sued by Cogenra Solar, a subsidiary of SunPower for intellectual property theft. In the lawsuit that was filed in San Francisco, Cogenra Solar accused SolarCity of acquiring undue advantage of Shingling technology owned by Cogenra to manufacture commercial solar panels. Along with its subsidiary called Silevo, SolarCity stole Cogenra’s trade secrets, engineering processes, as well as other copyrighted property to gain competitive advantage in the development of shingled-cell solar components. In its defense, SolarCity claimed that it discovered a former SolarCity worker had illegally downloaded confidential information from Cogenra, transferred the data to a private hard drive, and enrolled in SunPower as a high-ranking sales manager. This case has destroyed the reputation of SolarCity. As a result, Tesla Motors, Inc., which was on the process of acquiring it, stopped its efforts due to the ongoing lawsuit. Tesla claimed that SolarCity had breached its fiduciary responsibility (Abbasi, 2016).

Question 6: The Potential Matter Surrounding the Demise of John’s Wife

The potential matter surrounding the demise of John’s wife is product liability. Product liability denotes the scenario wherein manufacturers, suppliers, and retailers who make goods available to the consumers are held accountable for the damages those products generate. Product liability laws, which are responsible for the compensation of victims of lethal products differ

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