Compassionate use programs

Dear Beatrice,

Thank you for contacting us!

Yes, we have a paragraph in our legislation:

§ 21.  Authorisation for distribution of unauthorised medicinal product

 (7) In the absence of authorised medicinal products with equivalent effect or where such products are not distributed according to treatment needs, the State Agency of Medicines may, in addition to the provisions of subsection 1 of this section, grant an authorisation for distribution of:

 4) medicinal products offered free of charge by the manufacturer of medicinal products provided that the doctor providing treatment to the patient has confirmed that the medicinal product is necessary for life-saving purposes and there are no other options for the treatment of a chronic or life-threatening illness and also provided that the illness is deemed life-threatening and all other treatment methods for which the payment obligation is assumed by the Estonian Health Insurance Fund and that are medically suitable and financially accessible to the person have been exhausted, and it is likely that the benefits of the medicinal product outweigh possible risks.

https://www.riigiteataja.ee/en/eli/ee/Riigikogu/act/519012024002/consolide

To use a medicinal product via CUP, the program has to match the criteria stated for CUP, however it is named by the company (expanded access, early access, etc).

In European legislation named patient prescription usually refers to using unauthorised medicines but not under CUP circumstances (for example when there are shortages or an authorised medicine is not distributes in a particular country etc) (Article 5 of Directive 2001/83/EC1).

I hope this answered your questions, if not, let me know!

Kind regards,

Ellen Lurje
Specialist

Bureau of Clinical Assessment

Department Marketing Authorisations

State Agency of Medicines
[email protected]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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