December 2020 – Bulgaria’s Council of Ministers has opened public consultations on proposed amendments to the Ordinance on the conditions, rules and procedure for regulating and registering the prices of medicinal products in Bulgaria.
Deadline for submission of comments and opinions is 13 January 2021.
The main objective of the proposed changes is to bring the Ordinance in line with the revised Medicinal Products in Human Medicine Act (MPHMA), in particular with respect to the introduction of new conditions for the reimbursement of medicinal products. The proposal aims to optimise the pricing and reimbursement regimes for medicinal products as well as to fill the regulatory gap created by past court decisions that revoked several of its key provisions.
- Inclusion in the Positive Drugs List (PDL) will require that products with the respective international non-proprietary name (INN) already be subject to reimbursement in at least five of the following 17 countries: Belgium, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and the Czech Republic. This requirement shall not apply to generic medicinal products and medicinal products containing (an) active substance(s) with well-established therapeutic indications.
- Products intended for the treatment of rare diseases shall be included in the PDL only if they are already reimbursed by a public health insurance fund for the same therapeutic indications in at least five EU Member States.
- Price control procedures for certain products with a unique INN shall be relaxed. This amendment defines a new category for products that contain (an) active substance(s) with well-established medicinal use for the treatment of diseases for which there is no medicinal alternative or whose alternatives have a higher value, where the reference value is calculated by a grouping in which no medicinal products of other marketing authorisation holders (MAHs) participate. Price declarations for these products shall be submitted at the standard frequency instead of every six months.
- The Council on Prices and Reimbursement of Medicinal Products shall keep a public register for the new product category described above and update it on a monthly basis. The first list shall be adopted within three months of the promulgation of the amendments.
- Immunological medicinal products containing vaccines, toxins or serums with the same INN and pharmaceutical form but from different manufacturers shall not be grouped together. Their prices shall be calculated separately in accordance with the rule on lowest reference price.
- The price of medicinal products authorised for parallel import or distribution shall not be higher than the cap set by the Council for identical or similar medicinal products. The Council shall be empowered to reduce, ex officio, the limit price of parallel imports in case a lower price is formed for the same or similar medicinal product. The same rules shall apply for over-the-counter products.
- The PDL shall be supplemented with information about the manufacturer(s), the national identification number and product type, as determined in the marketing authorisation (MA) procedure.
- The procedures for monitoring therapy efficiency shall be optimised by introducing the possibility of an extension for medicinal products for which, due to the small number of patients, the information collected is insufficient to perform a complete analysis.
- A leniency rule for therapy effectiveness assessment is introduced: where the assessment cannot be completed on the basis of the data collected, or if it does not have sufficient statistical reliability, the reimbursement status shall be maintained. The Council may decide to continue monitoring effectiveness for another three-year term.
- Council procedures are amended with the aim to ensure work continuity in the COVID-19 environment.
A copy of the draft and more information can be obtained at: http://www.strategy.bg/PublicConsultations/View.aspx?lang=bg-BG&Id=5717 (Bulgarian language only)
For more information, please contact Anton Petrov, Of Counsel, at or Gabriela Ivanova, Associate, at