Pharmaceutical Regulation and Control Across Nations: A Comparative Analysis Example

Introduction

The United States The Federal Drug Manufacturing Law and the Food and Drug Administration (FDA) The agency is responsible for protecting and promoting public health by managing and regulating how medications are produced and distributed across the country (Davis & Patel, 2019). As such, it is the role of the agency to ensure all pharmaceutical companies in the country follow and adhere to drug laws. In collaboration with other organization, the FDA follows and supervise all project that deals with the production of drugs (Davis & Patel, 2019). Through participation in project management, the FDA ensures pharmaceutical companies conduct all the tests in accordance with the law (Davis & Patel, 2019). Additionally, the FDA reviews and controls prescription drug advertisements and promotions. The approach ensures that pharmaceutical companies comply with the Federal Trade Commission. Due to the complexity associated with the advertisement and promotion of over-the-counter drugs, the FDA ensures that a drug is only for a particular indication (Davis & Patel, 2019). The approach helps in embracing a ‘fair balance’ between the advantages and threats associated with the drug. Furthermore, the FDA conducts post-market safety surveillance, which assists in determining the implications associated with a particular drug (Davis & Patel, 2019). Through this approach, the FDA helps in determining drugs that lead to major health implications after use. The approach is crucial as it impacts the implementation of drug-related laws. The FDA is mandated to ensure all drug products are safe and effective for human applications. As such, the agency certifies that drugs abide by religious, social, and cultural requirements (Davis & Patel, 2019). The approach promotes drug acceptance, which is a critical aspect of promoting quality health. As such, the FDA is mandated to promote safe and effective drugs, which have little or no side effects (Davis & Patel, 2019).

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France Pharmaceutical antitrust law in France (The French Public Health Code)

Agence Nationale de Sécurité du Médicament et des Produits de Santé (AFSSAPS) AFSSAPS is a France agency that is mandated to assess health threats that are triggered by the application of pharmaceutical products. AFSSAPS is mandated to regulate the marketing and sale of pharmaceutical products. As such, pharmaceutical companies are supposed to obtain the selling authority from AFSSAPS (Bocquet et al., 2017). Additionally, AFSSAPS is responsible for exercising the marketing authorization, which controls the selling rate (Bocquet et al., 2017). Before entering any market, drug firms are required to comply with the French Public Health Code, which determines whether AFSSAPS should allow the company to market its products (Bocquet et al., 2017). Additionally, the agency is mandated to regulate the price of drugs, thus preventing people from being exploited (Bocquet et al., 2017). In this case, the agency is mandated to review the risk-benefit balance, which helps in determining the sale price of products (Bocquet et al., 2017). In case there is a need, AFSSAPS collaborate with other medical organization to adjust the price of a drug. The agency is supposed to control any form of conflict of interest, which has been a critical aspect affecting the production and sale of drugs in France (Bocquet et al., 2017). As such, the agency is supposed to embrace transparency in all levels that drugs pass. The approach helps in respecting human rights, thus avoiding implications that impact dignity (Bocquet et al., 2017). Monitoring helps the agency in pharmaceutical companies observe and maintain ethical requirements.

India The Drug Price Control Order (Essential Commodities Act) The Central Drugs Standard Control Organization (CDSCO) CDSCO is an agency that controls pharmaceutical products across India. Among the key role, CDSCO is mandated to reduce the sale of pharmaceutical products, by regulating the selling price (Nishandar et al., 2019). In collaboration with other organizations such as the Drug Controller General of India, CDSCO regulates the marketing of drugs (Nishandar et al., 2019). As such, the agency participates in market authorization and post-market surveillance, which monitors drug performance, thus ensuring companies comply with the law (Nishandar et al., 2019). Furthermore, the organization is mandated to ensure companies maintain high-quality drugs, which is a critical aspect in determining the price (Nishandar et al., 2019). Normally, standards are crucial aspects that determine the price of a product. Therefore, it is the role of the agency to ensure the manufacturer follows the required practices, thus maintaining quality. As a way of maintaining the environment, CDSCO collaborates with other government agencies to establish the kind of products pharmaceutical companies are supposed to use when parking products (Nishandar et al., 2019). The approach helps the SDSCO in ensuring safety and efficacy when using pharmaceutical products across the country. Ethically, the agency has the mandate to protect and maintain the needs of the people, which is a critical aspect of maintaining the value (Nishandar et al., 2019). Due to a lot of changes that are taking place in the healthcare sector, CDSCO is required to ensure pharmaceutical companies focus on the needs of the people (Nishandar et al., 2019). The approach helps avoid values and social violations. As such, it is easier for people to understand the rights and wrongs related to particular drugs.

Japan Act on Securing Quality, Efficacy, and Safety of Products

The Pharmaceuticals and Medical Devices Agency (PMDA) Due to the complexity associated with pharmaceutical products, PMDA is mandated to ensure safety and efficacy when using drugs (Saeki et al., 2017). As such, the agency ensures all companies that deal with the production of pharmaceutical drugs produce high-quality products (Saeki et al., 2017). Additionally, PMDA is mandated to conduct drug testing, which helps ensure that the product is safe for human consumption. During testing the agency offer advice to pharmaceutical companies on how to conduct testing and other critical aspects in drug project (Saeki et al., 2017). Therefore, companies can effectively deploy all the required approaches, which ensure quality maintenance. Furthermore, the company conducts post-marketing drug safety, which ensures little effect on people and the environment. In this case, PMDA conducts internal auditing of producers to ensure they all comply with the production laws. During the process, the agency collects analysis and distribution of information on how to enhance of quality and safety of the people (Saeki et al., 2017). Moreover, the agency advises consumers on understanding how to use and avoid poor-quality drugs. The tactic helps in maintaining and promoting the safe application of drugs (Saeki et al., 2017). In case of any effect, the agency is mandated to determine what a victim could be compensated with. In addition, the agency is mandated to take action against companies that violate the safety and efficiency of the drug (Saeki et al., 2017). Throughout the country, safety is a critical aspect that the agency aims at. The approach ensures human needs are a key aspect that impacts the kind of products companies are supposed to produce (Saeki et al., 2017).

Assessment

Among all the agencies, safety and quality is a critical aspect that influences how they perform. As such, the agencies ensure all pharmaceutical companies maintain high-quality standards. Through the approach, the agencies reduce negative impacts that could occur due to poor-quality products. In comparison, the FDA is highly concerned about the distribution and sale of pharmaceutical products. On the other hand, AFSSAPS concentrates on examining the threat associated with the application of pharmaceutical drugs. CDSCO regulates the price to ensure that companies do not exploit consumers. PMDA is mandated to ensure safety and efficacy when using drugs (Saeki et al., 2017).

Recommendation

Due to the complexity associated with pharmaceutical drugs, agencies are to have the power to control how companies operate, thus promoting the safety of the people. The approach may assist in preventing some of the health issues that occur due to improper and low-quality drugs can be prevented. As such, the world could improve the performance of pharmaceutical companies, thus enhancing the capability of dealing with particular health issues. Quality and safety products are perceived as major aspects of the improvement of the healthcare sector.

Conclusion

The regulation and control of pharmaceutical companies have been a critical approach to improving the kind of drugs produced. Through this approach, the government has managed to control low-quality products, which are associated with numerous health complications. Additionally, through the application of agencies, governments have managed to regulate the price of products, thus preventing companies from exploiting consumers. Moreover, the collaboration agencies and drug companies have assisted in the introduction of quality products, which have assisted in combating critical health issues.

References

Bocquet, F., Degrassat-Théas, A., Peigné, J., & Paubel, P. (2017). The new regulatory tools of the 2016 Health Law to fight drug shortages in France. Health Policy, 121(5), 471-476. https://www.sciencedirect.com/science/article/pii/S0168851017300684

Davis, A. A., & Patel, V. G. (2019). The role of PD-L1 expression as a predictive biomarker: an analysis of all US Food and Drug Administration (FDA) approvals of immune checkpoint inhibitors. Journal for Immunotherapy of Cancer, 7(1), 278. https://link.springer.com/article/10.1186/s40425-019-0768-9

Nishandar, T. B., Birajdar, A. R., Gogtay, N. J., & Thatte, U. M. (2019). Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases. Perspectives in Clinical Research, 10(2), 84. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463500/

Saeki, H., Yamada, K., Morikawa, N., Asahina, A., Ochiai, T., & Iijima, M. (2017). Severe drug eruptions due to lamotrigine in Japan based on data from the relief system of the Pharmaceuticals and Medical Devices Agency. Allergology International, 66(1), 156-158. https://www.jstage.jst.go.jp/article/allergolint/66/1/66_156/_pdf