Ban on the same person owning both a medical device warehouse and a pharmacy

A ban is being introduced on a single person owning both a medical device warehouse and a pharmacy. This is stipulated in the Transitional and Final Provisions of the Law on Amending and Supplementing the Medical Devices Act, submitted by the Council of Ministers to the National Assembly, reports zdrave.net.

According to the government, the concentration of these two activities in the same person is in contradiction with the law. Furthermore, this leads to a disruption of the established supply chain for medicinal products and medical devices.

A transitional period is provided during which the affected entities must bring their activities into compliance with the new rules, specifies zdrave.net.

The bill also proposes that meetings of the National Council on Prices and Reimbursement, when considering drugs for health technology assessment, be limited only to representatives of the NHIF and the Ministry of Health, without the participation of the Bulgarian Drug Agency (BDA). The Council of Ministers points out that the BDA is not a body involved in the assessment process. They add that it does not pay for the medicinal products and medical devices that are subject to assessment.

The project also provides that the powers of the Chairman of the Council in their absence shall be exercised by a member of the council. Members will receive a basic monthly salary amounting to 90% of that of the Chairman.

As zdrave.net adds, the new texts provide for the National Council on Prices and Reimbursement of Medicinal Products to become a member of the European Coordination Group on Health Technology Assessment and to be designated as the national body for its implementation. Products with a new international non-proprietary name will be included in the Positive Drug List. They must have passed a health technology assessment and received a positive opinion in countries such as the UK, France, Germany, or Sweden. This requirement will not apply to vaccines.

Significant changes are also being made to the rules for the application of unauthorized medicinal products. The European Directive allows their use not only for treatment but also for prevention and diagnostics in emergency situations. In this sense, the project expands the possibilities by allowing the application of such drugs outside of hospitals as well. Specifically: in medical facilities under the Ministry of Defense, the Ministry of Interior, and the Ministry of Transport, as well as in emergency medical centers and comprehensive oncology centers.

An analogous change is planned for medical facilities that can propose to the Minister of Health the inclusion of new products in the list under the LMPHM. These will be drugs used for diseases with no therapeutic alternative in the country, but which are already authorized in another EU member state.

The full text of the bill can be viewed here.