April 1, 2019 amendments to Regulation 10 concerning pharmaceutical product reimbursement were introduced. Can the new rules limit competition in the sector?
New rules effective April 1, 2019, allow NHIF to charge pharmaceutical companies if their sales exceed sales (value) from previous periods. The sales numbers will be now monitored every quarter. As introduced, the current rules are expected to bear future revisions.
Pharmaceutical products are grouped in baskets by a molecule. Each INN basket is being monitored every quarter. If the
salesvalue of the group increases, each MAH for the respective product will have to pay back a lump sum to NHIF proportional to the sales increase in the individual INN group.
IMPACT ANALYSIS, Highlights
- NHIF aims to remain budget neutral Direct impact on the introduction of new treatments and new product categoriesAnticompetitive to the pharmaceutical industryIt does not account for the of INN baskets, i.e., product withdrawals, out of stock conditions and other force major.
The new regulation, as framed, may trigger legal actions against texts that can limit competition in the pharmaceutical sector in Bulgaria.
Comments on the Bulgarian Pharmaceutical Market
Bulgaria is a relatively small pharmaceutical market located in Southern Europe. Being, value-wise, a small market, it can only receive moderate attention from pharmaceutical companies in regards to retaining their existing portfolios and launching new products. Regulations introducing additional stringent rules for pharmaceutical products without sentiment and notice to the local specifics can only make this market even more fragile. Based on many factors, currently, Bulgaria is not among the markets in Europe where new products are first launched. The introduction of regulations that do not account sufficiently for market characteristics and specifics, and make the market, even more, unattractive can only harden the current trends.