The Senate of the Kazakh Parliament has adopted the new draft law of the Ministry of Healthcare suggesting clinical research on vulnerable groups, Minister of Healthcare Yelzhan Birtanov informed on the sidelines of the Kazakh Government.
Earlier, the Ministry of Healthcare presented a new draft law on health care in the Mazhilis. The Minister has noted that clinical research, by law, will be on a voluntary basis.
The Senate has passed the draft law. The detailing and regulation of clinical research on certain vulnerable groups are proposed. Earlier such a category did not exist, there were only minors, and the solution of guardians or parents was in earlier legislation. Now we have expanded this group to vulnerable groups, followed by more strict requirements for monitoring clinical research on these groups. The principal new requirement is that these persons are allowed to be involved in such research only if they request. And in such cases, this is the research into drugs or technologies used by these groups. For instance, if it is children's medicine, then they should have parents' permission to participate in the research only into drugs for children. This is how this approach works," said Yelzhan Birtanov.
He also noted the introduction of obligatory medical insurance in case of undesirable consequences, such a move was not suggested in the earlier draft law.
In addition, according to the Minister, such research will be undertaken on a paying basis.
Such research is carried out at the expense of the state, or drug companies, or universities on a voluntary basis. Now clinical research on children is conducted yearly, in various states, but mostly, of course, in developed ones. They include antineoplastic drugs, medicines for cancer, rare diseases. And that's how it works. As a rule, drug companies cover all costs of treatment options. For instance, Kazakhstan carries out international clinical research to implant an artificial heart. Each device is very expensive, and all the costs are covered at the expense of producers and grants issued by universities or science foundations," said Birtanov.
He also has noted that the participants of such research should not pay for it, and receive free medicine.
Responding to the question of whether people participating in clinical research will be paid, Birtanov said that the type of research will be taken into account.
Let's say the company and a rural group have agreed. There are various stages of clinical research by international standards. For instance, there are types of research carried out on healthy volunteers. As a rule, the research is always paid as it involves healthy people, and its aim is to study the level of toxicity. All medicine we intake have been tested on volunteers, on ill people, and only then they are allowed, including Kazakhstan," said the Healthcare Minister.
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