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Some bioethics problems in the drug discovery and development process

With the development of new techniques and technologies in the fields of molecular biology and biomedicine over the last 20 years, the drug discovery and development process has become more complex, expensive, prolonged and burdened with risks, as well as bioethical challenges. The pharmaceutical industry is under the big pressure, because of use of laboratory animals in testing of the new drugs, prior clinical trials in human beings. Definitely, some work in whole animals must be performed as an essential step before exposure to humans, in order to make a valid prediction of drug behaviour in the human organism. At the same time, some bioethical rules should be respected. Despite all regulatory recommendations, unfortunate incidents have arisen during drug development, and have alerted the media significantly. With each incident, regulatory rules have proliferated and become more rigid, reducing the number of new drugs developed to the market. To be sure that a new drug is worth all that risk, time and money, the pharmaceutical industry utilizes human biological material early in the drug discovery process. This has raised many bioethical problems. First problem is the increasing creation and use of biobanks that store different human biological sample material (body fluids, cells, tissues, DNA), but also related patient information data. These have scientific value, but also could present legal problems, because of the sensitivity of private medical information. The pharmaceutical industry may work on targets that will never provide a return on investment. This target selection and the chosen therapeutic area are also considered as a bioethical problem. Another issue is raised by intellectual property on human tissue, especially on human genes, because those patent restrictions does not lead to (and may even discourage) further drug development and growth, which is again bioethical problem. Pharmacogenetics and pharmacogenomics are new disciplines important for present and future clinical studies, but are also bioethical issues, due to the possibilities of population selection with a more “appropriate“ drug response. Taking into account all these problems, it is very important for the pharmaceutical industry to know when and how to introduce human biological material into research, to be aware of the problems involved in introducing bioethical rules and policies into companies, and to know precisely the roles of bioethics in drug discovery research companies.

drug discovery and development, new drugs, bioethical problems in R&D process

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