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Measures of the patients’ legal protection in course of clinical tests of medicines

Measures of the patients’ legal protection in course of clinical tests of medicines

A total anonymity and strict protection of patients’ data are measures of patient’s legal protection while taking part in clinical tests of medicines. Participation in such test is completely free for the patient, what is more he is entitled to reimbursement of the additional costs borne connected to the participation in test. In course of tests he may obtain information from his doctor with respect to state of his health, report changes in his condition observed during tests, the patient is also entitled to the access to the medical documentation of his case. The doctors’ responsibility to inform patient of all new data, which may influence patients decision on further participation in tests is correlated with patients’ rights. Patient may in any moment resign from further participation in tests without any consequences.

In order to guarantee the safety of patients participating in tests, the researcher is obliged to ensure medical care for the patients and to monitor the accuracy of the tests with the rules of Good Clinical Practice. The sponsor is obliged to observe the course of the tests in all research plants both during and after conducting clinical tests. The protection of interest and rights of tests’ participants, the proper course and documentation of tests are subjected to the sponsors supervision. In the event of justified suspicion that the conditions stipulated in the permitted for conducting clinical tests are no longer observed or if achieved information raise concerns about the safety or scientific reason of conducted tests, the Ministry of Health, depending on situation may issue a decision on suspension of clinical tests, withdrawn the permit or indicate actions essential for further conducting of tests. The fulfillment of sponsor and researcher obligations with respect to the requirements of Good Clinical Practice as well ass the correctness of conducted tests are subjected to the supervision of Clinical Tests Inspection.

Agata Skrabucha
postgraduate student of the Law and Administration Faculty atWarsawUniversity
International Law Institute
Chair of Private and Commercial International Law

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