On December 3, 2024, the Commission for Protection of Competition (CPC) published a Resolution aimed at facilitating the parallel import of medicines. In this Resolution, CPC identifies the key difficulties posed by the current regulatory framework and proposes specific recommendations to overcome them.
Some of the main difficulties are:
- Slow and complicated administrative procedures
Current administrative procedures significantly slow down the start of effective trade. The timeframes provided for by the law for obtaining all the necessary permits and commencing effective sales extend up to 164 days, while the CPC has found that the actual time required to obtain all the necessary permits is significantly longer. In some cases, the time to obtain a marketing authorization alone can reach 390 days. These prolonged deadlines inherently delay access to the Bulgarian medicines market.
- Different drug codes from various regulatory institutions
Each institution responsible for the authorization and marketing of medicinal products generates a different code for the medicinal product concerned. This results in multiple different codes for the same or a similar medicinal product. This, in turn, leads to confusion and ambiguity for patients, hinders importers, doctors and pharmacies and creates legal uncertainty. It also distorts competition at all levels of trade, presenting numerous barriers to the parallel import of medicines.
- Legal uncertainty regarding the pricing of parallel import medicines
The legal regulations governing the pricing of parallel import medicines are open to different interpretations. This creates ambiguity and uncertainty among market participants and may discourage potential parallel importers from operating in the country.
The specific recommendations to address the identified issues are:
- Simplification of procedures and shortening deadlines
The Resolution includes recommendations to reduce certain deadlines and introduce accelerated procedures. This will improve patients’ access to vital medicines, especially in cases of shortages.
- Introduction of the possibility of indefinite marketing authorizations for parallel import medicinal products
Currently, the duration of a parallel import license is 5 years. After its expiry, a new procedure should be followed. The CPC proposes introducing the possibility of extending the term of marketing authorizations for the use of parallel import medicinal products indefinitely. This would reduce the administrative barriers to market entry for new parallel import medicines.
- Integration of all currently existing codes and creation of a single code
A proposal has been made for regulatory amendments to require the integration of all currently existing codes from the various institutions into a single product-specific code. This would establish clear standards and make the process easier for both retailers and patients.
- Refining the regulatory framework for the pricing of parallel import medicines
It is crucial to fine-tune the regulatory framework on pricing in order to prevent different interpretations and provide clarity and certainty for economic operators.
The recommendations reflect the CPC’s efforts to amend the regulatory framework to encourage the prompt registration and entry of parallel import medicines on the Bulgarian market, foster effective competition, and ensure that patients have access to the medicines they need.
You can read the full text of the Bill here.
