Bulgaria: Amendment to the pricing and reimbursements process for pharmaceuticals

It affects the interests of individuals with health insurance and the activities of more than 290 authorisation holders, of the wholesalers of pharmaceuticals, and of pharmacies (as retailers).

The discussed amendment to the Bulgarian Ordinance on the terms and conditions for registration and regulation of pharmaceuticals' prices (the "Ordinance"), was published on January 2, 2017. It restores the legal situation that existed before September 2016, repealing the provisions of art.5, para.5 of the Ordinance. The abolished provision provided that the medicinal products included in the national positive list could not be subject to an additional patient side payment exceeding 60 % of the price calculated on the basis of the reference price of the medicinal product with the lowest price for a defined daily dosage/ therapeutic course.

This limitation of the additional payment of patients was introduced in September 2016. The government's reasoning was that it would have social benefits only. However, the impact assessment showed that the application of this provision may:

• lead to a withdrawal from the local market of a large number of pharmaceuticals that are unable to meet the required limitation; and
   
• create burdens for wholesalers and retailers as they will have to keep statistical records of all products with the lowest prices.

The limitation was challenged before the Supreme Administrative Court, with the argument that it creates inter alia a precondition for price fixing. The case is still pending. The discussed repeal from the government (the Ordinance is a secondary legislation), overtook the final judgment in this case.