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Clinical tests in developing countries and pharmaceutical ethics issues

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  1. Summary.
  2. Introduction.
  3. The juridical structure: rights and duty of the main actors for clinical trials.
    1. Historic and decision making organization.
    2. The rights and duties from the patient point of view.
    3. Rights and duties from the industry point of view.
    4. Rights and duties from the governments point of view.
  4. Ethical issues of the clinical trials in developing countries.
    1. Type of medicine uses in the clinical trials.
    2. Vulnerability of the patients in the study.
    3. The use of the placebo.
    4. The safety of the trial.
    5. The role of the developing country's government.
  5. Various initiatives to regulate trials in developing countries.
    1. Pharmaceutical industry.
    2. Local organizations.
    3. Government.
  6. Conclusion.
  7. Bibliography.

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. [...]

[...] Second the main ethical issues of clinical trials in developing countries are developed. Finally, the paper focuses on the future evolutions and way of improvement the situation The juridical structure: rights and duty of the main actors for clinical trials The law and the juridical structure is the starting point of the paper because law and ethics are two intersecting domains. Indeed, law covers institutionalisation or codification of ethics into specific social rules, regulations and proscriptions[1]?, according to Crane and Matten book. [...]

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