CEE Expert Guide on the reimbursement of orphan drugs in Bulgaria

Bulgaria has adopted the legal definition of orphan drugs of the European regulation. Under the Medicinal Products in Human Medicine Act (“MPHMA”), orphan drugs are medicinal products intended for treatment, prevention, and diagnosis of rare diseases. These are medicinal products which: 

1. are intended for the diagnosis, prevention or treatment of life-threatening or progressive chronic diseases that affect up to five in 10,000 people in the country; or
2. are intended for the diagnosis, prevention or treatment of life-threatening diseases and of chronic conditions seriously damaging health (diseases with a high proportion of disease-related incapacity to work and disability) and it is evidenced that the sale of the product does not provide a satisfactory level of return to justify the necessary investment in research and development, without incentives to the product developer; and
3. where there is no satisfactory method for diagnosis, prevention or treatment of the respective condition, or, if there is, the proposed medicinal product has significantly more advantages than, and benefit to, those affected by that condition.

Orphan drugs can be reimbursed in Bulgaria. There is no specific reimbursement procedure. The general reimbursement rules for medicinal products apply.

For an Orphan Drug to be reimbursed, it must be included in the Positive Drug List (“PDL”) maintained by the National Council on Prices and Reimbursement of Medicinal Products (“NCPRMP”). The PDL includes medicinal products with market authorisation only. For the authorisation of orphan drugs, the MPHMA refers to Regulation (EC) No. 141/2000 of the European Parliament and of the Council and Regulation (EC) No. 726/2004 of the European Parliament and of the Council.

The pricing of the medicinal products included in the PDL and paid for with public funds is regulated by the Ordinance on the conditions, rules and procedure for regulating and registering the prices of medicinal products, adopted in Resolution No. 97 of the Council of Ministers of 19.04.2013. The price is decided based on the lowest manufacturer prices in the following reference countries: Belgium, Greece, Spain, Italy, Latvia, Lithuania, Romania, Slovakia, Slovenia and France, and also includes an additional wholesaler and retailer surcharge defined as a percentage of the so determined manufacturer price.

Furthermore, the Bulgarian National Health Insurance Fund (“NHIF”) pays for such orphan drugs only if the medicine is used for treatment, prevention and diagnosis of a rare disease included in the list of rare diseases for which the NHIF pays. This is a separate procedure that should be fulfilled for orphan drug manufacturers to apply and the medicine to be included on the PDL. Under the MPHMA, a “rare disease” is defined as a disease characterised by a frequency of prevalence up to five per 10,000 population. Orphan drugs may also be reimbursed from other public funds.

Additionally, for the reimbursement of orphan drugs another requirement is that those with an international off-patent name are only paid for by a public health insurance fund or with public funds if the same therapeutic indication is reimbursed in at least five other Member States.

The general rules apply. The medicinal products included in the Positive Drug List undergo a reimbursement status maintenance procedure every three years from the date of inclusion in the list. The NCPRMP performs an assessment based on the evidence for efficacy, therapeutic effectiveness, safety and pharmacoeconomic analyses.

No. The criteria for designating an orphan drug as such are governed by Regulation (EC) No. 141/2000 of the European Parliament and of the Council.

No such public information is available in Bulgaria.

The general rules apply. In the most general case, when initially included in the PDL, the procedure could take more than four months. In the case of reimbursement renewal, the procedure can take up to 90 days. Following a decision to include a medicinal product on the Positive Drug List, there is an additional 14-day period to appeal the decision. Notwithstanding the above, in exceptional cases where the medicine is immediately necessary or there are epidemiological circumstances, the medicinal product may be included on the reimbursement list under a simplified procedure.

There are no planned future legal/judicial developments in Bulgaria regarding Orphan Drugs.