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Unpatented Pharmaceuticals for American Public

Introduction

The pharmaceutical industry is greatly influenced by the registration of intellectual property rights for a product that has been manufactured. The U.S. Patent and Trademark Office grants a patent for a drug after receiving a complete set of documents proving the ownership and exclusivity of the production, which has a twenty-year validity period from the filing of the application for approval (Bultman; Nuijten 34). Hence, the actual duration of the patent right for a drug that has already been put into mass production is lower, depending on the complexity of the approval (Nidel). After twenty years, the production of such a drug ceases to have the exclusive right for that company, which means that other companies are allowed to produce the same drugs — with a different name — without a patent. As a rule, such drugs are much cheaper, but their quality is often questioned by treating physicians: hence, the dualistic effect of generic drugs on the public in the United States cannot be denied. This research paper aims to qualitatively assess the extent of this effect on society, politics, and the pharmacy industry.

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Impact on the Health Care Industry

Generally, bias and prejudice are created around generics, especially by qualified medical professionals, that they are of low quality or even ineffective. This is not surprising when considering the fact that all generics do not have the exact composition but are different; only the main active ingredient is retained, and the list of excipients changes depending on the will of the manufacturer. It turns out that doctors may be unaware of exactly how a generic will behave and what side effects it may lead to, while the quality and composition of the branded drug are time-tested.

The impact of generics on the health care industry is hard to overestimate, as they help to achieve the ultimate goal of the industry. For example, the manufacturing of drugs aims to treat, vaccinate, or symptomatically alleviate disease. Generics are more affordable drugs, which means maximizing the number of patients who can be cured increases dramatically (Karamehic et al. 286). In turn, this contributes eventually to the development of personalized medicine (FIFARMA). In addition, drugs released on the mass market have undergone multistage quality reviews, which means that the drug being sold must not pose a threat to patient safety. This requirement, in turn, catalyzes the development of pharmaceutical knowledge, as numerous laboratories use technology to test drugs (Grayling; Faust 425; TMF). Notably, the emergence of generics can be beneficial to the original drug companies. In particular, the lower price tends to encourage consumers to invest in generics, which means the brand manufacturer must fight the competition (Mire). One such method is to research and produce new drugs that can be patented for the next twenty years. Thus, the use of generics, in general, is a positive factor for the health care industry, which provokes its development.

Impact on Society

One of the public’s main expectations of the pharmaceutical industry is that the drugs it sells should be inexpensive yet of high quality. In an attempt to meet this expectation, manufacturers of generic drugs produce generics, which can be significantly more expensive. Meanwhile, the reduced price has a positive impact on consumers’ desire to take care of their health, which generally increases the culture of drug consumption. On the other hand, a generic can never exactly replicate the effects of a branded drug, which means that if a patient had a positive experience with the original drug before, there is no guarantee that the generic will have precisely the same effect. This also poses the threat of generic-type counterfeit drugs being sold, which can lead to serious consequences (Acri and Née 13). As a result, generic use can, but does not always, lead to disappointing patient outcomes and regret wasted money if the drug did not work.

The health effects are compounded because Medicare health insurance plans cover not only the purchase of patented drugs but also generics. Wanting to save money on a drug, consumers may ignore quality issues and invest in cheaper drugs (Rankin 637). An additional problem that patients may be oblivious to is the possibility of allergic reactions to individual drug components. As mentioned earlier, generics may contain a different composition of excipients than the original, and some of them are used purely for marketing purposes. For example, if the tablet is bitter, the manufacturer may add flavorings to its composition, and the patient may be allergic to these substances. The presence of additional components not present in the original drug can lead not only to unwanted reactions but also to unexpected behavior of the drug in the patient’s body. Only branded drugs have the stated effect, so neither the public nor pharmacists can ever be assured of the end result from using generics.

One cannot help but discuss the societal effect of generics in creating a culture of choice in the perception of consumers. Generics significantly combat monopoly in the pharmaceutical market because the public can always choose between different drugs. This creates an environment in which consumers are not inclined to take the first drug they see but may want to study it further, which in turn increases the education of the population. Thus, an individual’s stay in a pharmacy may be accompanied by learning information — either from the pharmacist or through the Internet — about specific generics and brands.

Impact on Policy

The central goal of government organizations is to invest in the well-being of the population through whatever tools are available. As long as generics bring more advantages than disadvantages to society, policymakers should actively support their production and expand their practices. The U.S. pharmaceutical system is renowned for its abundance of drugs that are strictly prescribed by a physician, meaning a barrier to purchase is created for the individual who does not have such a prescription. With at least 10% of the U.S. population living below the poverty line by 2020, this sets an important precedent for public health (PU). Policymakers in the country are creating reforms that aim to lower the average price of drugs in the country.

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Notably, originator drug makers can use political lobbying to influence critical congressional decisions. Such lobbying decisions are aimed at supporting consumer spending initiatives and inhibiting bills that force pharmaceutical companies to lower the cost of drugs they sell (Greenberg). In addition, generics create a competitive environment for drug manufacturers, which is beneficial not only to the national economy but also to the quality of the products produced. It follows that the government can develop a culture of consumption of generics, which will lead to their saturation in the market (Fisher and Paul 2). Interestingly, generics can catalyze the current trend of shifting production to cheaper countries, which will additionally affect the final cost of the product (Badwy). Consequently, Americans’ quality of life with generics production should improve overall.

Conclusion

To summarize, generics as inaccurate copies of the original drugs have a dualistic effect on the United States. With regard to the health care industry, it is proper to emphasize that their release develops the industry and encourages manufacturing companies to invest in innovation. From the public perspective, more patients have access to low-cost drugs, but the quality and safety of such drugs are questioned, especially if the patient has underlying allergies. Finally, for politics, generics do not have a particularly pronounced effect, but, among other things, they indirectly affect the national economy and are implemented through the lobbying of brand companies.

Works Cited

Acri, Kristina M.L., and Née Lybecker. Pharmaceutical Counterfeiting: Endangering Public Health, Society and the Economy. Fraser Institute, 2018.

Badwy, Ammar. “The Future of Pharma: 5 Things That Will Change the Pharmaceutical Industry.” PharmaOffer, 2021, Web.

Bultman, Matthew. “PTAB Sees Fewer Drug Patent Fights as Generics’ Strategy Shifts.” Bloomberg Law, 2021, Web.

Grayling. “Emerging from Covid-19: What next for the Pharmaceutical Industry?” 2021, Web.

Greenberg, Jon. “The Money And Politics Of Prescription Drugs: What You Need To Know.” KHN, 2019, Web.

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Faust, Richard E. “The Future of Domestic Pharmaceutical Research: The Role of the Multinational Corporation.” Food, Drug, Cosmetic Law Journal, vol. 34, no. 8, 1979, pp. 404-425.

FIFARMA. “This Is How the Pharmaceutical Industry Will Look like in 2030.” FIFARMA, 2020, Web.

Fisher, Dale, and Paul Wicks. ” Medicine and the Future of Health: Reflecting on the past to Forge Ahead.” BMC Medicine, vol. 14, no. 1, 2016, pp. 1-4.

Karamehic, Jasenko, et al. ” Financial Aspects and the Future of the Pharmaceutical Industry in The United States of America.” Materia Socio-Medica, vol. 25, no. 4, 2013, pp. 286-290.

Mire, Sam. “What is the Future of Pharma? 12 Experts Share Their Insights.” Disruptor, 2019, Web.

Nidel, Christopher T. “Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment.” Food & Drug LJ, vol. 58, 2003, pp. 81-101.

Nuijten, Mark. “The Potential Impact of Current and Future Pharmaceutical Policy Changes on Cash Flows for Innovative Medicines.” The Journal of Private Equity, vol. 18, no. 1, 2014, pp. 34-45.

PU. “The Population of Poverty USA.” Poverty USA, 2018, Web.

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Rankin, W. B. “The Future Relationships of FDA and the Pharmaceutical Industry.” Food, Drug, Cosmetic Law Journal, vol. 20, no. 11, 1965, pp. 632-637.

TMF. “Future of Pharma & the Pharmaceutical Industry.” The Medical Futurist, Web.

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