Clinical tests in developing countries and pharmaceutical ethics issues

Résumé du document

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.

Extraits

[...] This overview of the juridical situation and the presentation of rights and duties of patients, firms and governments concerning trials show the importance of this procedure for the medical research and for the population. The clinical trials are not blamed. But the questioning point is limited to how they are conducted, especially in developing countries. Even if legislators have tried to set rules and solve the conflict with ethical issues, the trend of increasing clinical trials in developing countries proves the limit of law. What are the main ethical issues related to clinical trials in developing countries? 2. [...]

[...] Clinical trials can not be proceeding as in developed countries and they have to take care of the cultural dimension to be ethical. People have the right to well adapted information. As mentioned in the first part, the key role of the consumer for clinical trial is the informed consent. This concept contains both the right to safety and to adapted information so that consumer can decide perfectly his implication or not Rights and duties from the industry point of view The clinical trials form a part of the medical research. [...]

[...] This point lacks largely in developing countries, which should imply, for clinical trials, to reinforce education and to adapt information for a population with only a weak responsibility regarding health. A second role of government is to reduce the risk. The government has to fix an acceptable level of risk for the population and consequently to implement the needed programs like vaccination or testing programs. This point also differs largely in developing countries from western ones. Because of education lacking and financial reasons, programs are often insufficient and do no fit with the population. [...]

[...] Many developing countries do not have any research ethics committee. Sometimes when they have that kind of committee, the workers are not well trained and are not able to do a complete analysis of the studies Various initiatives to regulate trials in developing countries 1. Pharmaceutical industry The pharmaceutical industry's actions to guarantee ethical trials on human being, in developing or developed countries, are not limited to sign international declarations and respect international laws. Most of the firms have also worked on communication with the patients to explain how trials are processed and have elaborated global policy or code of conducts. [...]

[...] 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. [...]