Regulatory developments concerning Off-label and compassionate use of pharmaceutical products in Bulgaria

Some recent regulatory changes related to the procedure for Off-label and compassionate use of medicinal products are expected to enter into force these says. Following a public consultation held between 9 February and 11 March 2022, on 31 May 2022 amendments to Ordinance No. 10 of 17 November 2011 on the conditions and procedure for the treatment with medicinal products not authorised for use in the Republic of Bulgaria, medicinal products administered outside the terms of the authorisation for use and medicinal products for compassionate use, as well as the conditions and procedure for the inclusion, modification, exclusion and supply of medicinal products from the list referred to in Article 266a(2) of the Medicinal Products in Human Use Act (the “Ordinance”) were promulgated in the Official Gazette.

  • The amendments to the Ordinance provide that the prescription of the medicinal product administered outside the terms of the authorisation for use shall be carried out by a protocol of a committee of three doctors and shall be accompanied by the written informed consent of the patient (parent, guardian), obtained in accordance with the Health Act and which may be withdrawn at any time. A written opinion of a master pharmacist concerning the safety and efficacy of the medicinal product shall be attached to the protocol.
  • In order to obtain the patient’s consent and to ensure that the patient is fully informed, the latter will have to be provided with written information containing the reason(s) for prescribing treatment with the medicinal product administered outside the terms of the marketing authorisation, the availability of scientific evidence on which the use of the medicinal product for the indication concerned is based, the issues on which information is lacking in relation to the use of the medicinal product, the expected results and possible risks of the treatment, the use of the product, the duration of treatment and the conditions for its discontinuation, as well as the leaflet of the medicinal product with the information for the consumer.
  • An obligation is created for healthcare professionals carrying out treatment to report all adverse drug reactions received during the use of the medicinal product to the marketing authorisation holder or to the Bulgarian Drug Agency.
  • The committee who approved the patient’s treatment, or a member thereof, should document in the patient’s medical record each stage of the patient’s treatment. The efficacy and safety of treatment with the medicinal product shall be documented in the discharge summary, which shall also be signed by the committee.
  • The duration of programme for medicinal products for compassionate use is now changed to last until (i) the medicinal product is placed on the market; or (ii) the responsible person terminates the programme early, which should be notified to the Bulgarian Drug Agency. By comparison, in the previous edition of the Ordinance, the duration of the programme was limited to the day when the medicinal product is placed on the market, but not later than one year from the beginning of the programme.

For further information contact:
Ilya Komarevski, Partner
ilya.komarevski@kdp-law.com
Stanislava Irikova, Associate
stanislava.irikova@kdp-law.com