Life Science Bulletin: Upcoming changes to parallel distribution of medicinal products in Bulgaria

In August 2023, the Bulgarian Ministry of Health published a draft bill for amendment of the Law on Medicinal Products in the Human Medicine for public consultations. The proposed changes mark a shift towards greater transparency and regulatory control over the pharmaceutical value chain in Bulgaria. They target practices of parallel distributors which lead to shortages of key medicinal products. 

Parallel distribution has emerged as one of the main factors shaping the pharmaceutical landscape in Bulgaria. The distribution of medicinal products freely across the single EU market offers patients a broader selection of medicines at competitive prices. However, parallel distribution is often identified as one of the reasons for the shortage of medicinal products in Bulgaria and the CEE&SEE region. 

Draft bill for amendment of the Law on Medicinal Products in the Human Medicine includes the following key proposals:

• the introduction of similar obligations for parallel distributor as marketing authorization holders. These include informing the Bulgarian Drug Agency about the marketing date of the medicinal product in Bulgaria and providing a 3-month written notice before any (temporary or permanent) suspension of sales. 

• adjustments to the formula for the calculation of medicine shortages and the introduction of an expedited administrative procedure for authorizing parallel imports during shortage periods.

• The inclusion of medicinal products, for which notifications of suspension of sales have been submitted, in a nation-wide export ban list. Additionally, medicinal products identified in the specific shortages list of the European Medicines Agency may also be subject to export bans if reimbursed locally. 

The draft bill is currently pending submission and discussions before the Bulgarian Parliament.

In addition, the Commission for the Protection of Competition (CPC), the Bulgarian competition watchdog, launched advocacy proceedings over parallel export & import regime in November 2023. The focus of the debate is whether current legislative framework in Bulgaria complies with competition law and adequately deals with shortages issues. It is notable that the CPC will consider both regimes – for parallel exports and for parallel imports. Historically, the CPC has played a crucial role in the dynamics of the medicinal market, safeguarding the observation of the free movement of products in the single market and the efficiency of competition rules.