Law No. 214 of 2020 aims to issue a law regulating clinical medical research, to lay the foundations and controls necessary for conducting clinical medical research, and to protect respondents, whether this research is preventive, diagnostic, curative or non-curative, invasive or non-intrusive, but it includes a package of penalties if Non-compliance with the provisions of the legislation.
Wufka Laklanon
Without prejudice to any more severe penalty stipulated in the Penal Code or any other law, committing the crimes stipulated in the following articles shall be punished with the penalties prescribed for them. .
Anyone who conducts a clinical medical research without obtaining the informed consent of the respondent and the legal representative of the groups entitled to additional protection from the respondents and the approvals of the authorities specified in this law shall be punished by imprisonment. .
If this results in a permanent disability, the penalty shall be hard labor, and the penalty shall be hard labor for a period of no less than ten years if the aforementioned act results in the death of one or more persons. .
The penalties are multiplied by the number of victims .
Shall be punished by imprisonment and a fine of no less than fifty thousand pounds and not more than five hundred thousand pounds, each of the principal investigator and the sponsor of the study in the event of non-compliance with any of the provisions of Articles (18 and 20) of this law .
A fine of no less than ten thousand pounds and not more than fifty thousand pounds shall be imposed on both the principal investigator and the research sponsor in the event of non-compliance with providing the necessary medical care to any of the respondents during and following the medical research .
If the occurrence of the crime referred to in the previous paragraph results in side effects on the respondent, the minimum and maximum limits established in the previous paragraph shall be doubled. .
But if this results in serious side effects on the respondent, the penalty shall be imprisonment and a fine of no less than one hundred thousand pounds and not more than five hundred thousand pounds, or either of these two penalties. .
The penalties are multiplied by the number of victims .