The clinical trials performed on humans by the pharmaceutical companies are essentials for the advancement of the knowledge of human health. After the terrible Nazis experimentation during the Second World War, some actions have been taken to protect the participants of the clinical trials. Many laws have been implemented to regulate those trials, because those researches can injure and even induce death of the patients involve in the studies. The Declaration of Helsinki has been written in 1964 and presents the ethical principles of the conduct of human researches. Since then, the declaration has been modified several times. A new ethical problem has emerged in the last decades. More and more clinical trials are made in the developing countries and that created some ethical problems because the economic and social situations in those countries are different than in the developed countries. The laws can not by themselves regulate all the actions of the pharmaceutical companies in the developing countries. Many actions have been implemented to regulate those ethical issues. The governments, the pharmaceutical companies and some local organizations have all took some actions to overcome the problems of the clinical trials in the developing countries.
[...] In the developed countries it would have been totally unethical to realize that kind of trial because this drug was mainly use as a good therapeutic method and the risk of contracting the virus was high in the study The safety of the trial The safety of the clinical trials leads also to some ethical questioning. In some cases, the urgent need of a medicine in the developing countries has lead to the use of non approved medicine that could harm the patients. [...]
[...] Ethical issues of the clinical trials in developing countries The clinical trials perform in the developing countries by the pharmaceutical companies raise many ethical problems. The social and economic context in those countries differs from the developed countries. The regulations are not as strong as in the developed countries and the healthcare systems are not well structured. The clinical researches which involve humans are made to improve human welfare and the scientific knowledge but those studies need to respect the dignity and the health interest of the patients. [...]
[...] Lurie, P and Wolfe, S M Unethical trials of interventions to reduce perinatal transmission of the humanimmunodeficiency virus in developing countries. New England Journal of Medicine. 337: p.853–856. Stephens, Joe Panel Faults Pfizer in '96 Clinical Trial In Nigeria. Washington Post. Available from: www.washingtonpost.com/wpdyn/content/article/2006/05/06/AR2006050601338 .html [Accessed 2007 April 13]. Roche Website. Available from: http://www.roche-trials.com/ [Accessed 2007 April 12]. Pan-African Bioethics Initiative (PABIN) Third Conference Good Health Research Practices in Africa United Nations Conference Hall. Ethiopia. Available from: http://www.who.int/sidcer/fora/en/pabin3rd.pdf [Accessed 2007 April 12]. [...]
[...] This part presents the guidelines of Roche policy like: Compliance to the WHO Good practices guidelines Roche-sponsored clinical trials using Roche pharmaceutical products are conducted according to these guidelines” The question of respect of privacy of patient “Roche is committed to protecting the privacy of patients participating in Roche-sponsored clinical trials to avoid stigmatisation of such patients and violations of their personal data protection rights and to comply with the law.” The question of trial in developing countries is appears also clearly on this website with three stated principles: The question of marketing “Where the results of a clinical trial in a developing country are used to obtain regulatory approval for a pharmaceutical product in another country, Roche will apply for marketing authorization for the product in the developing country.” The question of clinical trials in developing countries is in particular developed in the guidelines, by specifying the following principles: The implication of local partners for trials in developing countries and respect of local laws and human rights “When conducting clinical studies in developing countries, Roche is committed to working with local investigators, and respecting local laws and customs, provided such laws and customs do not compromise patient safety, human rights and dignity, ethical principles or Good Clinical Practice standards.” The principle of collaborative work with local authorities to ensure efficient healthcare system conducting clinical trials in developing countries, Roche works within local healthcare systems in a manner that does not overburden such systems.” This practical example of pharmaceutical industry communication about clinical trials shows how companies play their roles and can clarify their positions on the subject. [...]
[...] This declaration is not only focused on developing countries or clinical trials but covers more largely all ethical issues and defines well- practices concerning medicine. Signed by United Nations members, the declaration contains 28 articles, divided in 5 parts that are “General Provisions”, “Principles”, “Application of the Principles”, “Promotion of the Declaration”, “Final Provisions”. Concerning the clinical trials and ethical issues specific of the developing countries, the main articles are: Art : The question of inform consent “Scientific research should only be carried out with the prior, free, and express and informed consent of the person concerned. [...]
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