Legislations affecting healthcare


Legislations affecting healthcare receive supports and resistance form different groups depending on their impact. The different groups are impediments or motivators to the success of such legislations depending on the perceived benefits. This paper analysis the 21st Century Cures Act based on external and internal threats to its sustenance. The threats include advocacy, organization culture, economics, and social-political issues. One primary purpose which emerges from the Act is the effort to reduce the cost of healthcare by providing a more efficient system. Such a provision attracts extensive support in the U.S. because of the negative impact on the GDP. The analysis reveals that the 21st Century Cures Act experiences minimal threats due to its appeal on an issue which the whole public and some organizations advocate. Although there are resistance threats, there are minimal to anta extent that they cannot affect the implementation and support of the policy.

Keywords: Healthcare, Resistance, Support, Public, Cost

21st Century Cures Act


The Act negatively and positively affects sensitive areas in which different lobby groups persuade the medical profession to observe, creating high chances of resistance and support at the same time. One such area is informed consent, which is a constitutional provided right. The 21st Century Cures Act of 2016 provides that medical researchers can go-ahead to test a device o drug without patient informed consent where such elements pose minimal risk. However, such researchers should ensure the protection of rights, welfare, and safety of the participants. Although the Act provides that only devices and drugs which poses minimal risk, it is a violation of human right on privacy. Testing of drugs is not one such area where the researcher or government can provide an excuse for going against human rights, which the constitution provides. Informed consent still comes before the need for medical researches and development since it affects overall subject health (Dankar et al., 2019). As a result, human rights activists, including the U.N. and other smaller organizations, will not agree to such a provision that goes against one sensitive subject of privacy. The 21st Century Cures Act, therefore, will face opposition due to its violation of public advocacy for human rights

Despite the chances of resistance from public support on human rights, the Act appeals to lobby groups that advocate for access to healthcare. Most of the provisions in the Act contributes to a more efficient system of improving administering healthcare. For example, there is a change in the meaning of ‘real-world evidence’ to allow the U.S. Food and Drug Administration (FDA)drug approve drugs using any data which developers supply. The system ensures quick approval of new medicines for community use. Another provision which supports efficient healthcare system is the use of data summaries to approve new indication, especially on existing medications. Such an approach also increases the speed of releasing drugs for public use. The two provisions and others not only make the system efficient but also cheap due to reduced time and labor, which brings down the cost of medical care. Advocates of public access to healthcare, for example, the American Medical Association (AMA), will support such an act that meets their goal. There is much quest for a cheap and efficient healthcare system in the U.S. form such lobby groups and the public (Camillo, 2016). The Act has more positive impacts on advocacy groups compared to negative and, therefore, will receive much support on human rights and healthcare lobby groups alongside the public.


The 21st Century Cures Act, on the other hand, affects social-political issues negatively and positively to attract different support and resistance from divergent groups. One such problem is the development of substandard drugs and devices due to freedom given to manufactures. Drug developers and medical device manufacturers are influential people, and most of them are higher in social and political classes. Despite their position, the Act has gone ahead to provide minimal regulations to pass their drugs and devices. One such weak provision is the definition of ‘real-world evidence,’ which now includes other sources of evidence apart from clinical trials. There is also the use of drug developer data summaries without external research to approve their application. The provisions risk exposure of substandard drugs and medical devices to the public since the FDA might incline on assessment with less bureaucracy and demands. Most of the developers furthermore are influential people with the ability to corrupt the department and have their drugs pass (Kingori et al., 2019). Such a practice of influencing the system to have poor-quality medicines and medical devices exposes the public to poor and worse health (Kingori et al., 2019). The public might, therefore, fail to support the Act while it gains approval from the elite class.

Another social-political issue which impacts the Act is drug, especially opioid addiction, although positively. Drug addiction and, in this case, opioid is a social, political issue because socially influential people like doctors, business people, and pharmacists determine spreading and consumption (Dasgupta et al., 2018). Society members are victims of addiction without the ability to control since they trust doctors on the right prescription. However, the 21st Century Cures Act provides a solution to the dependence of opioids, which has much impact from selfish influential society members, including some politicians. Through the Act, there will be funds to implement programs that monitor drug prescription. There is much support from the public since it addresses one of the issues which is beyond their control. The legislation also appeals to many legislatures and lobby groups, which supports a solution to addiction as a social-political problem. The positive impact in helping the community’s social-political issue, therefore, strengthens the legislation with high chances of sustenance due to public influence on the legislature’s decisions.


The policy, on the other hand, appeals to the U.S. economy through the reduced cost of healthcare. The high cost of healthcare to the point of weakening the economy is one of the ongoing concerns for most Americans. According to the United States Department of Health and Human Services (n.d), spending on healthcare is growing at a rate higher than the GDP. Any policy that focuses on reducing the cost of healthcare supports the economy and hence has high chances of experiencing support alongside sustenance. The 21st Century Cures Act has provisions that raise the cost on the healthcare system and others, which lowers the same expenses. There is an allocation of $6.3 billion to fund research on cancer treatment and medication (Gabay, 2017). The money will also help in supporting mental health alongside programs such as the one for monitoring drug prescription. However, other provisions like the use of data summaries to approve drugs, improvement on healthcare record technology, and implementation of systems for telehealth reduces the cost of healthcare. Through the Act, there will be minimal spending on labor following system efficiency, such as telehealth. The various improvements save recurrent expenses while the expenditure provisions in the Act spends on non-recurrent expenses. Favoritisms on the U.S. economy, especially on healthcare, therefore, makes the Act to attract support.

Another way through which the Act appeals to economics is through increased innovation on drugs to reduce the burden on patients and the government. Most Americans are paying more on medications due to strict regulations, which minimizes innovation and competition.  The current process of approving such drugs and devices is complex. However, The Cures Act is more lenient to the process, thus attracting more manufacturers who will bring the prices down. There are also few to no drug manufacturing for rare diseases, especially cancer. Most of the patents have to import such drugs from other countries such as India. However, the 21st Century Cures Act aims at facilitating manufacturers in the development of such drugs and their approval. Local manufacturing will reduce imports and the cost of such medications. Another provision in the Act is to have favorable terms for loan repayment on biomedical research, primarily within the national institute of health. Support for researchers and a simplified approach to assess their innovations in drugs and devices will increase medicines and medical devices in the healthcare system. Improved drugs and devices, on the other hand, will reduce the cost of access to the public and the government through Medicare. The 21st Century Cures Act thus appeals to economics by reducing the burden of the US GDP through reduced prices of healthcare products.

Organizational Culture

The 21st Century Cures Act affects different organizations, including drug manufacturing, pharmacies, hospitals, and insurance companies, differently to attract support and resistance. Among the organizations which the Act affects negatively include pharmacies and public hospitals. Through the policy, Medicare will only pick the healthcare providers with three stars in their service to patients. Three stars mean that only hospitals that patients recommend as goodwill receive approval to provide Medicare services. Most public hospitals do not have the motivation to offer quality services due to the absence of external motivation, such as profit maximization (Lepore et al. (2018). The culture focuses on conventional treatment without extra efforts, which can increase patient satisfaction. As a result, the culture does not support the Act, which aims at making access to Medicare services hard where there is underperformance on patient satisfaction. Some pharmacists collaborate with doctors to have specific prescriptions even when such drugs affect patients, for example, an opioid. The organization culture in pharmacies is also profit-oriented. However, the provision for monitoring prescription does not support such a culture. In general, organization cultures in public hospitals and pharmacies do not support the strict regulations which 21st Century Cures Act proposes and might work to bring it down.

Despite the opposing organizational structures, some influential organizations, including the legislature, have a culture that supports the 21st Century Cures Act. The 21st Century Cures Act, in general, aims at making the U.S. healthcare system more efficient and cheap. Some provisions increase transparency, especially those providing for automation. Such requirements align with the U.S. legislature’s culture to reduce the burden on the economy while providing quality healthcare to the public. The organization culture, as a result, appeals to the 21st Century Cures Act leading to more support and sustenance through the allocation of more funds.


The 21st Century Cures Act analysis reveals that it attracts support and resistance at the same time following its positive and negative impact on various internal and external threats. There much appeal on community advocacy for access to affordable and quality healthcare. However, the Act receives some resistance due to the impact on the right to privacy. The Act, on the other hand, had more focus on solving socio-political issues like drug addiction, which reduces the risk of resistance from the public. The economic threat, on the other hand, is very minimal since the policy provides for much savings on healthcare recurrent expenditure such as labor. Nevertheless, the Act affects different organizations’ cultures in divergent ways where some experiences negative and others positive impacts. Organizations such as public hospitals experience a negative effect, which is different from the legislature. In general, the 21st Century Cures Act experiences fewer threats from external and internal factors due to its inherent support to, therefore, attract support.




21st Century Cures Act of 2016

Camillo, C. A. (2016). The U.S. healthcare system: Complex and unequal. Global Social Welfare3(3), 151-160.

Dankar, F. K., Gergely, M., & Dankar, S. (2019). Informed consent in biomedical research. Computational and structural biotechnology journal.

Dasgupta, N., Beletsky, L., & Ciccarone, D. (2018). Opioid crisis: no easy fix to its social and economic determinants. American journal of public health108(2), 182-186.

Gabay, M. (2017). 21st Century Cures Act. Hospital pharmacy52(4), 264–265.

Kingori, P., Grietens, K. P., Abimbola, S., & Ravinetto, R. (2019). Poor-quality medical products: social and ethical issues in accessing ‘quality’ in global health. BMJ, 4(6).

Lepore, L., Metallo, C., Schiavone, F., & Landriani, L. (2018). Cultural orientations and information systems success in public and private hospitals: preliminary evidences from Italy. BMC health services research18(1), 554.

United States Department of Health and Human Services (n.d). The effect of health care cost growth on the U.S. economy. Retrieved from https://aspe.hhs.gov/system/files/pdf/75441/report.pdf


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