|Pharmacology Healthcare policy Ethical dilemma Drug abuse
Political, legal, and ethical dilemmas are some of the main categories of global biopharmaceutical challenges. Among the listed problems and other unmentioned, the comprehensive pharmaceutical industry experiences varying types of problems or difficulties that are classified in distinct classes. There are legal, political, and ethical dilemmas that all need crucial attention. It is essential to learn about the mentioned levels of dilemmas that surround the global biopharmaceutical industry to analyze the case provided effectively. The understanding of the context and the problem broadly relies on elementary facts regarding political, legal, and ethical dilemmas that face the global biopharmaceutical industry. Political dilemmas in the context of challenges that the biopharmaceutical industry experience, the issue emerges when a government weighs the cost of drugs and the lives of its citizens. Additionally, some governments fail to examine the quality and legibility of drugs imported inside a country; this creates and promotes practices for counterfeit medicines. In the case of legal dilemmas, different regions are governed distinctively; this becomes one of the hardest buttons of regulating biopharmaceutical malpractices across areas. The essay broadly analyzes a case study by discussing political, legal, and ethical dilemmas in the global biopharmaceutical industry and the identification of multiple causes of the problem raised.
High Cost of Research and Development
High cost of research and development of drugs involves a cumbersome process that constitutes a considerable amount of money. It is one of the legal dilemmas that the global biopharmaceutical industry experiences due to a legal issue surrounding patent protection laws. The understanding of the problem becomes an issue when other countries and companies violate drugs manufactured using the right procedures to develop counterfeit products of similar medications. It is crucial to identify multiple causes of the raised problem regarding high-cost research and development. Some of the leading causes of the issue include the production of counterfeit products that lower the actual price of the real drugs and high-cost research and development (Andersen, 2019). High-cost research and development force the global pharmaceutical industries to sell drugs produced at higher prices to manage all costs encountered during the manufacturing processes. Additionally, few verified medicines out of many samples prepared becomes another cause of the problem raised. Companies would want to recover the cost of research and development instigated on all those disapproved medicines.
There are several alternative ways of solving this problem. Some of the leading solutions involve the application of patent protection laws that govern counterfeit industries that produce bogus drugs. Furthermore, the global biopharmaceutical industries may lower the number of samples they introduce on the research and development process to reduce costs incurred. The proposed alternative has its pros and cons. Advantages involve the production of quality drugs that address or treat the disease at hand effectively. It happens when counterfeit biopharmaceutical companies have been managed. Cons involve disadvantages and include limited products or medicines to developing countries and less privileged families that struggle with finances. The implementation plan varies according to the problem raised. Since the cost and development problem is a legal dilemma that the global biopharmaceutical industry experiences, strengthening patent protection laws assuming the law guides all regions. The outcome will increase the accessibility of quality drugs even to the developing countries.
Political Dilemma (Counterfeit Drugs)
Counterfeit drugs cover one of the categories of dilemmas the global biopharmaceutical industry experiences. It is a political issue because it involves failures that emerge from governments. Like mentioned before, several governments have failed to set goals that regulate the quality of drugs imported in their countries. It is due to the fact enforcement of intellectual property law varies (Math et al., 2019). It is crucial to understand the problem and list the multiple potential causes of the problem. Some of the leading causes of the issue include varied enforcement of intellectual property laws and failed governments that do not manage to examine the quality of imported medicines. It leads to a growing counterfeit industry globally, which introduces a couple of challenges in the global biopharmaceutical industry.
Numerous alternative ways of solving the problem raised exist. Some of the central alternative ways include leveled enforcement of intellectual property laws across different governments and equal examination measures of drugs imported in countries. Such actions are basics and will suppress malpractices in the global biopharmaceutical industry. Production of counterfeit drugs will lose markets as the majority of states will stick to quality products alone. The proposed alternatives have pros and cons. The pros of the alternative ways involve advantages that come with the mentioned approaches. Some of the pros include accessibility of quality drugs, management of diseases effectively, and equal distribution of medicines across countries globally that works by improving the lives of people. Alternatively, a law can be created that enforces countries to examine and used approved products such as medicines. Such a way individuals and counterfeit companies will learn of consequences related to the production of counterfeit products. Additionally, the enforcement to deal with typically involves bogus companies, which is a much effective method. Such a designated alternative way will reduce the number of counterfeit drugs produced, thus the control of the raised problem.
Ethical Dilemma (Neglected Therapeutic)
Neglection of therapeutic areas is one of the raised dilemmas covered in the text. Before exploring the issue at hand, it is crucial to define the term to understand the problem entirely. An ethical dilemma involves a situation in which a difficult choice has to be made between to available options. A large portion of biopharmaceutical industries and research has neglected several critical therapeutic areas that focuses on addressing illness available in the developing countries (Sariola et al., 2019). Some of the central neglected therapeutic areas include categories of diseases such as tuberculosis. They prefer focusing on cardiovascular diseases found abundantly in developed countries. It is crucial to learn the multiple causes of the problems raised. Before identifying the leading causes of the problem, it is essential to understand the possible reasons behind such issues. A large portion of the biopharmaceutical industry has diverted on diseases that affect individuals in developed countries because of the increased cost of research and development. The leading cause of the raised problem is increased or costly research and development processes in the industry.
Several alternative ways of solving the raised problem exist. These methods or alternatives lie in cost management and research development. Governments from the developed countries should provide resources to cut down costs, and research development involves the drug processing phase. The management of cost is the biggest problem, where the solution to raised or mentioned issue lies. Pros and cons exist in the mentioned methods or alternative patterns of solving the problem. In the context, reducing or addressing neglected therapeutic areas comes with numerous advantages such as increased availability of given diseases. There is also a strengthened market in the less developed countries and economic strength across the globe. This will result from diverted attention to the biopharmaceutical industry to address neglected therapeutic areas that affect the majority of developing countries. Cons will involve differences in sales and a change in the market that may require new adoption. Alternatively, governments from developing countries can strengthen their market and embrace or address neglected therapeutic areas by the biopharmaceutical industry.
Explanation of the Implementation Plan
The implementation plan is crucial in addressing issues at hand, especially issues presented in the case, such as counterfeit drugs and limited protection for intellectual. It involves prioritized areas, including performance measures, objectives, background, activity, and expected difficulties as well as schedules. Before exploring the implementation procedure, it is essential to learn the goals that need to be addressed in the implementation plan aimed. The objectives focus on addressing issues at hand, those problems raised in the case analysis. They include high cost of research and development, limited protection for intellectual property, a challenge from generic brands, and counterfeit drugs, among others. Since the problem or objectives have been identified, there would be a project name, goals, actions aligned alongside hours, people or organizations, targeted time, and completion date.
The objectives, as earlier mentioned, will involve managing problems around the global biopharmaceutical industry. Actions will include identifying the costs of research and development of drugs. How much do each drug costs and cost per sample of a drug? Another action will involve identifying counterfeit drugs and companies that manufacture those products and strengthen patent protection laws. Strengthening of patent law will enhance the market and minimize any case of counterfeit drugs. Identification of costs will help manage expenses used and equate to the actual production process to find solutions.
In conclusion, the global biopharmaceutical industry experiences several classes of dilemmas, including political, ethical, and legal dilemmas. The political dilemma involves failure from governments that do not examine the qualities of medicines their import. An ethical dilemma is an issue that involves an option between people and the cost of drugs. Some of the main challenges global biopharmaceutical experiences include the high cost of research and development and counterfeit drugs and many more.
Andersen, H. (2019). WTO Law and Prices of Pharmaceutical Products and the Unclear Balance between Trade Protection, Human Rights, and IP Protection. Human Rights and IP Protection (September 24, 2019). University of the Pacific Law Review, 51, 19-32. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3458835
Math, S. B., Manjunatha, N., Kumar, C. N., Gowda, G. S., Philip, S., Enara, A., & Gowda, M. (2019). Sale of medicines by Registered Medical Practitioners at their clinics: Legal and ethical issues. Indian Journal of Psychiatry, 61(Suppl 4), S786. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6482706/
Sariola, S., Jeffery, R., Jesani, A., & Porter, G. (2019). How civil society organizations changed the regulation of clinical trials in India. Science as Culture, 28(2), 200-222. https://www.tandfonline.com/doi/full/10.1080/09505431.2018.1493449?af=R
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