US Pharmaceutical Industry
I do believe that US pharmaceutical companies take too long to produce new medications, drugs, and vaccines. According to Hemphill (2019), brand-name pharmaceutical enters into pay-for-delay agreements with generic pharmaceutical manufacturers to eliminate competition. They, therefore, negotiate specific entry dates, which may take months or years longer than they would without the agreements. They tend to obtain and list additional patents on the drugs with the FDA. These additional patents may be put on secondary aspects of the drug, such as coating or methods of administration. This strategy made the number of patent patents listed triple between 1985 and 2005. Alternatively, they use restrictions on distribution on competing manufacturers’ access to drug samples to prevent them from completing FDA-required bioequivalent testing. As of 2016, the FDA had received more than 150 inquiries from pharmaceutical companies. These companies have also used reverse litigation to delay the introduction of new drugs for Americans. For instance, the introduction of biosimilars is being delayed due to ongoing patent litigation. They have made agreements to defer entry due to settling patent disputes.
Once the new medication, drugs, and vaccines enter the market, their prices are unbearable making, limiting access. The main idea behind the strategies to delay entry into the market is to keep prices higher and limit affordability to patients and payers. The availability of generic drugs drives costs by 80 percent less, saving the US healthcare system trillions of dollars. However, pharmaceutical companies are doing everything to also delay the generic drugs. After the delay, the companies are allowed to set their prices since the country lacks government regulation and single-payer negotiation. The patents and exclusivity limit competition allowing the manufacturers to control the prices. The price control of soforsbuvir, a breakthrough new drug that Gilead introduced after it bought it from a smaller company and delayed introduction while buying patent right, suits the case of how pharmaceutical companies in the US overprice new medication (“When Big Pharma Plays for Keeps,” 2018). A drug that cost $42 retailed for $1000 per bill since Gilead had bought the patents delaying its introduction to the market.
The best way to go about pay-for-delay and the exorbitant prices is to work towards patent-free drugs. According to Baker (2021), it would do more good to the prices of medication if brand names in the industry had difficulty charging high patent-protected prices for their drugs. Due to limited resources among generic manufacturers, the federal government should source funding and implement a system of direct funding for buying drug patents and placing them in the public domain for the new drugs to be sold as generics. The federal government should also implement policies that regulate the pricing of prescription drugs.
The US pharmaceutical industry has some aspects that make it different from other countries. According to Wagner (2021, p. 370), the US dedicates less healthcare spending on pharmaceuticals than other countries. In 2017, pharmaceutical spending in the US was 11.96 percent of the total healthcare spending, while other countries like Russia accounted for 28.99 percent. Similarly, Americans pay the highest pharmaceutical costs in the world due to the monopoly power of manufacturers, rebates, and direct-to-consumer marketing.
US Long-term Care (LTC) Industry
Although there is a history of government reforms in the US long-term care, I do not believe that the government is doing enough to help the geriatric, disabled, and aging populations with services in home settings. There may be attempts from several government agencies, including the Joint Commission (n.d.), which has helped home care organizations transform their practices by meeting and exceeding rigorous performance standards. However, such attempts are just the bare minimum as these populations continue to grow. According to the Institute of Health Improvement (2018), despite the potential benefits of home care, the safety of the aging population is not guaranteed as the government does not give much attention to safety, like in hospitals and other clinical settings. Aside from care provided under Medicare and Joint Commission accreditation, home setting in US LTC continue to experience limited regulation of the education, training, and licensure of the professionals, further endangering the health of the populations.
I believe that it is the same case for the geriatric, disabled, and aging populations when they can no longer take care of themselves at home and have to move to long-term care settings. Although the government has put measures in place, there is little follow-up on better care protocols and resident monitoring. According to (McSweeney-Feld et al., 2017), 22 percent of Medicare beneficiaries in skilled nursing facilities experienced adverse events and temporary harm during their stays. The Covid-19 pandemic further revealed the fact that the US government is not doing enough, given the significant staff shortages in nursing homes. The nursing homes also rely on Medicaid as the only federal program for LTCs, and the reimbursements are too low to get the residents adequate care.
Following the issues faced by the long-term care population, it is essential for the US government to take a comprehensive approach to address the concerns in the different settings. LTC is not a one-size-fits-all setting. The government should therefore encourage home-based care but at the same time reimagine nursing homes and other settings’ care. This way, long-term care will be delivered at the preference of the individual and their family. It should follow up by funding both settings for an adequate supply of licensed professionals to provide quality care.
In the US, long-term care is primarily paid for by the government through Medicare and Medicaid. Past national spending showed that Medicaid covered 51 percent of total expenditure. However, although the US government pays for a large part of LTC, it does not come close to other countries where the same is covered by universal health care. The LTC payments are broken down such that the remaining part is covered by other public programs and consumers’ out-of-pocket funds McSweeney-Feld et al. (2017, p. 17). Other countries like Japan, Korea, Germany, and Netherlands have everything under LTC covered by UHC.
Reference
Baker, D. (2021). The Future of the Pharmaceutical Industry: Beyond Government-Granted Monopolies. Journal of Law, Medicine & Ethics, 49(1), 25–29. https://doi.org/10.1017/jme.2021.5
Hemphill, T. A. (2019). Generic drug competition: The pharmaceutical industry “gaming” controversy. Business and Society Review, 124(4), 467–477. https://doi.org/10.1111/basr.12186
Institute of Health Improvement. (2018). No Place Like Home: Advancing the Safety of Care in the Home | IHI – Institute for Healthcare Improvement. Www.ihi.org. https://www.ihi.org/resources/Pages/Publications/No-Place-Like-Home-Advancing-Safety-of-Care-in-the-Home.aspx
Joint Commission. (n.d.). Home Care Accreditation | the Joint Commission. Www.jointcommission.org. Retrieved January 31, 2023, from https://www.jointcommission.org/what-we-offer/accreditation/health-care-settings/home-care/
McSweeney-Feld, M. H., Molinari, C., & Oetjen, R. (2017). Dimensions of Long-Term Care Management: An introduction. Health Administration Press.
Wagner, S. L. (2021). The United States Healthcare System: Overview, Driving Forces, and Outlook for the Future. Health Administration Press; Washington, Dc.
When Big Pharma Plays for Keeps. (2018). When Big Pharma plays for keeps, who wins and who loses? Médecins sans Frontières Access Campaign. https://msfaccess.org/when-big-pharma-plays-keeps-who-wins-and-who-loses
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