AmCham Position on the Amendments and Supplements Act of the Medical Products for Human Medicine Law

AmCham Bulgaria addressed today its concerns with regard the Draft Act of Amendments and Supplements of the Law on Medical Products in Human Medicine. The position says that the project contains amendments (Appendix 1 in the letter) that it will cause strong negative effect on the supply of medicine, as well as on the Healthcare system of Bulgaria.

AmCham concerns are on the following changes:

  • The proposed 10% decrease of the price of the medical products (Single Source Products) at the Ministry of Health e-tender is pure administrative precedent. This decrease sets a ceiling price for products which price is formed without considering the price of other products (with the exception of the generics) from the centralized e-tender of MoH (Appending 2 and Appending 3) of the Positive Drugs List (PDL). The PDL includes products for treatment of oncology treatment, HIV therapies, as well as vaccines.
  • Imperativeness of the change – the proposed text says that the price can not be higher than 90% of the price of the same medical product in the PDL that is being paid with public funds. The provision does not concern multiple source products and will apply as the law comes into force including for contracts already signed.
  • Negative effect with regard the budget predictability and the sustainable medical products supply.
  • Impact and effect on the international drugs reference – this administrative decrease will be visible to other countries since the ceiling price of 90% will be part of the law. Thus, those countries that have Bulgaria as a reference country will start to apply it. Hence, those countries which Bulgaria uses as reference countries, will create a spill-over effect and either referent prices will erode. These phenomena will be visible each six months. As a result, we will have a negative domino effect that will lead to dramatic decrease of many medical products, even below cost price in many EU countries. A negative consequence could be the withdrawal of sets of medical products out of those markets. This will jeopardize the quality therapy and medical treatment of thousands European citizens. A potential result could be a strong reaction by the European Commission.
  • Another risk that we identified is with regard the price that the NHIF reimburses to hospitals and pharmacies. If such a product is delivered at a price lower than the one at the PDL or at the e-tender of MoH, then NHIF reimburses this lower price.

Even more, the described changes increase additionally the price restrictions and mechanisms that are already in place: Lowest price in EU; Obligatory discount in reimbursement; Obligatory discount for a minimum 10% of the price that NHIF pays; Mechanism for guaranteeing predictability and sustainability of the NHIF Budget under which the pharmaceutical companies cover the NHIF deficit with direct payments to the NHIF.

As an organization that represents the interests of companies that operate for years in the Healthcare sector of Bulgaria, we have as guiding principles the rules of the market economy and the sustainable development. Our priorities a focused on the development of sustainable business climate, rule of law incl. the EU legislation, as well as we work towards for encouraging of innovation and investments. They are the foundations of the well-being of an active and healthy population either in Bulgaria or in Europe.

Therefore we express our concern that with the Amendments and Supplements Act of the MPHM Law the access to innovative therapies for Bulgarian citizens is being limited. Even more, the proposed changes are introduced in the middle of the year. This jeopardizes the sustainability and predictability of the business environment and touches a very sensitive for every human being topic such as the life and health of a person. Those changes put at risk the supply with medicine and the access to many patients. Such amendments also hurdle or even stop innovation.


Read the AmCham Position in Bulgarian


AmCham Position published on the Strategy.bg Portal