Essay on What Has Given Rise to the Need for Bioethics in the Development and Testing of New Products/Drugs/Practice Protocols?

What has given rise to the need for bioethics in the development and testing of new products/drugs/practice protocols? What segments of the population are more vulnerable than others to ethical violations? What protections are in place to serve as safeguards? What changes in policy – either government or corporate or both – legislation, and/or public education are still needed to protect the rights of individuals?

Several issues related to controversies surrounding abortion, stem cell research, euthanasia and unethical drug trials have arisen in recent years, pitting interest groups such as religious institutions and research bodies against each other. Clearly, bioethics is a critical issue that links these disparate controversies, as these issues are all bioethical problems that affect certain population segments, and require adequate protections to ensure that these segments are not harmed. This essay will discuss the need for bioethics in the development and testing of new products, drugs and practice protocols in the light of greater competition, public accountability, technological advances, experimentation and fiduciary duties. This essay will then discuss the segments of the population that are more vulnerable than others to ethical violations, which include minorities, lower income and lower-educated segments, rare disease sufferers and individuals in developing countries. This essay will also cover the protections that are in place to serve as safeguards, in terms of regulation, democratic deliberation, public-private partnerships, non-governmental organisation campaigns and media exposes. Finally, this essay will discuss how further changes in legislation, public education and policy ( in terms of corporate and government policy) are necessary to improve the state of bioethics.

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Reasons for the need for bioethics in the development and testing of new products, drugs and practice protocols

Bioethics is important because it forms the ethical basis for several medical and healthcare treatments, and outlines the principles for which new treatments should be evaluated and administered, bearing in mind their ethical implications and potential benefits or harms to their recipients. There are several reasons for the need for bioethics in the development and testing of new products, drugs and practice protocols. These are linked to greater competition in the healthcare and biopharmaceutical sector, calls for greater public accountability in medical products, technological advances and fiduciary duties.

Foremost, greater competition in the healthcare and biopharmaceutical sector has led to several companies cutting corners in compliance, testing, research and development. In an increasingly crowded healthcare and biopharmaceutical market, several companies have been unable to devote sufficient talent, resources and funding to properly research, pilot and validate their products before entering the drug trial phase.(Carr, 2003) As a result of pressure from competitors to roll out blockbuster drugs, and pressure from investors and shareholders to deliver predictable and steady profit margins, pharmaceutical companies are increasingly relying on unethical procedures to get their drugs on the market. These include the use of unreliable prototype drugs in drug trials.

Another important issue has been the use of counterfeit ingredients as a result of greater competitive pressure in the healthcare and biopharmaceutical sector. For example, in 2007, people from Panama were poisoned by cough syrup made from diethylene glycol, a compound frequently used to manufacture brake fluid and anti-freezing compounds.(Bogdanich and Hooker, 2007) Similar cough syrup contamination was found in Nigeria in 2009.(

Orisakwe, O. E., & Nduka, J. K. (2009). Lead and cadmium levels of commonly administered pediatric syrups in Nigeria: a public health concern?. Science of the total environment, 407(23), 5993-5996.

, 2009) A large part of the issue was fuelled by improper regulation and certification on the part of the pharmaceutical producers, which came about through their attempts to streamline costs in the face of increased competition. (Miller, 2013)

Next, calls for greater public accountability in medical products have led to several biomedical issues. (Moore, 2010) One dimension of this issue relates to the need to ensure that product standards are met, and that these products do not inherently harm consumers. For example, in 1938, the sulfanilamide antibiotic was mixed with diethylene glycol and marketed as an elixir drug, which led to over a hund