ePrivacy and GPDR Cookie Consent by TermsFeed Generator

Use of unauthorised Advanced Therapy Medicinal Products

Pursuant to Section 8 (3) (b) (2)  

1) How is quality of the product ensured in cases where a medicinal doctor decides on the use of a unauthorised advanced therapy medicinal product for a given patient?

The possibility to use an unauthorised somatic cell or tissue engineering medicinal product is conditioned by the manufacturer’s obligation to have a GMP (good manufacturing practice) approved by the State Institute for Drug Control for the respective pharmaceutical form, however, the GMP does not guarantee the quality of the given product. The quality of the product is not considered when issuing the GMP authorisation. Where the medicinal doctor who is to administer the medicinal product and is responsible for its administration together with the healthcare facility wishes to be certain about the ensuring of quality, he or she may enquire at the Clinical Trials Department of the State Institute for Drug Control whether the quality of the product was assessed in the extent corresponding to the requirements for assessed medicinal products and was found to be sufficient. This is not an obligation, only an option. Otherwise they must rely on the manufacturer’s declaration; the healthcare service provider at whose premises the medicinal product was administered shall be liable for any bodily harm or death of the patient.

2) Are there any other requirements arising from legal regulations that must be complied with?

  • The use of medicinal products whose starting material is blood or its components must comply with the principles and requirements laid down by Regulation No. 143/2008 Sb., stipulating the requirements for ensuring of the quality and safety of human blood and its components, as amended.
  • The use of medicinal products whose starting materials are human tissues and cells must comply with the principles and requirements laid down by the Regulation 296/2008 Coll., on the ensuring of quality and safety of human tissues and cells designated for use in humans and on amendments to other acts, as amended.

3) How can such product be obtained?

Only by contacting the product manufacturer directly.

4) How do I learn about such product?

Given the fact that this is an administration of an unauthorised medicinal product whose safety, tolerability and efficacy has not been verified and whose quality is not guaranteed, this option should only be used in exceptional cases of life-threatening conditions where there is no possibility of another treatment. Information on the development of such products is available in the media (particularly specialized journals) or from the experts. Advertising of unauthorised medicinal products is not permitted.

5) Does the attending doctor who decides to apply Section 8 of the Act on Pharmaceuticals when administering an unauthorised advanced therapy medicinal product have any obligations?

  • The doctor should inform of his or her intention the management of the healthcare service provider (healthcare facility), who is fully responsible for any bodily harm or death that might occur as a consequence of the use of such medicinal product.
  • The doctor must inform the patient that he or she will be administered an unauthorised medicinal product whose safety, tolerability and efficacy has not been proved so far and the quality of the product cannot be guaranteed (informed consent). The fact that the patient has received this information must be recorded in the medical record.
  • The attending doctor shall report the prescription or use of a non-authorised product to the State Institute for Drug Control (SÚKL) by means of an electronic report via the Institute’s website www.sukl.cz – reports to SÚKL – report of use of a non-authorised medicinal product, no later than within 7 days following the prescription or administration of the medicinal product.

6) How is such medicinal product reimbursed?

The Act on Pharmaceuticals does not address the issue of reimbursement of such medicinal products. The amount of reimbursement from public health insurance cannot be stipulated for these products as they have not gone through the basic investigation in order to verify their safety, tolerability,efficacy and cost effectiveness.