A new Pricing & Reimbursement Regulation came into force in the beginning of May in Bulgaria. It continues the line of amendments in the national legal framework started at the end of 2012. The amendments came as a result of the heavy pressure to lower the prices of the medicinal products.
Following the extreme tension in Bulgarian society concerning the pricing of medicinal products, in May 2012 the Bulgarian Parliament took a decision and appointed the Bulgarian National Audit Office to audit the performance of the price regulation system for reimbursed medicinal products in the period January 2008 – December 2011. The report was published in November 2012 and one of the key conclusions was that the administration responsible for pricing and reimbursement was unreasonably slow and prevented the quick market entry of new products; the administration was also found to be ineffective in their efforts to systematically update the approved prices in case the concerned referent prices were decreased.
In order to cope with the administrative and technical issues affecting the price regulation system in Bulgaria the setup of the responsible administration was changed several times.
For the period 2008-2011 there were two separate commissions: the Commission on pricing was responsible for the price approval and price registration process for all medicinal products and a second Commission was responsible for the positive drug list (PDL) for medicinal products which are subject to reimbursement. In this way there were two separate and consecutive administrative procedures which had to be completed one after another before reimbursed products reach the market. This resulted in significant delays. For the period 2008-2011 the Commission on pricing managed to complete only 19% of the price approval procedures for reimbursed products within the required 45-day term. 34% of the procedures were delayed up to 6 months and the majority of 47% between 6 months and one year (some of them were delayed even for more than one year)*. Then the second procedure had to be completed for the product listing in the PDL: the procedure was governed by the Commission on PDL again with delays exceeding the required 90-day term. The work of the two commissions logically affected the pharma sector in Bulgaria and changes became more than necessary.
The next step was to close down the two commissions. Instead, a new single Commission on Pricing & Reimbursement was created and it operated in the period 2012-2013. This was a step forward: a single pricing and reimbursement administrative procedure cutting down the overall procedural timeline. However, some of the main issues remained: the lack of administrative and technical capacity to handle the workload. This single Commission on Pricing & Reimbursement continued to delay the majority of the files.
Now, coming into effect in May 2013 we have a new administrative body in Bulgaria replacing the former commission: the National Council on Pricing and Reimbursement.
The panel of the Council is set by a decision of the Council of Ministers following the proposal of the Minister of Health and includes a chairman and six members. The major difference here is that the Council has its own administration managed by the Council’s Secretary General, while all former commissions relied on the administrative support of the Ministry of Health. It is believed that along with the adopted technical measures this could make it possible for the new Council to complete the majority of the procedures within the terms provided by the national regulation:
– 60 days for price approval and listing in the PDL for RX medicinal products subject to reimbursement (30 days for generics);
– 30 days for price approval for RX medicinal products which are not subject to reimbursement;
– 30 for price registration for OTC medicinal products.
Whether this new administrative body will be successful, only time will tell.
* Source: Report 112/2012 of the National Audit Office