KRIB's opinion on generic substitution during the emergency is solely for the benefit of patients and with deep respect for the noble profession of doctors and all healthcare professionals. Guided by this respect and for the profession of pharmacists, we supported the proposal of the Bulgarian Pharmaceutical Union for the temporary introduction of generic substitution of medicinal products.
The proposal to introduce a temporary measure during the state of emergency is with the express consent of the patient in case of a missing product in the pharmacy, the master pharmacist to replace a medicinal product prescribed by a doctor with another medicinal product with the same international non-proprietary name, without changing the prescribed dosage form and dosage unit amount. The generic replacement is for all medicinal products that are not paid for by the NHIF.
In the complicated conditions of an emergency situation, pharmacies cannot have an influence on the availability of all medicinal products. The entire drug supply chain – wholesalers and manufacturers – faces various challenges with the supply of medicinal products at national, European and global level. Including due to lack of certain raw materials for production, difficult passage through border control and other restrictive measures imposed by all countries against the spread of COVID19.
In addition, patients' access to medical specialists is extremely difficult due to the measures to limit the spread of COVID-19. The proposed generic substitution avoids additional patient visits to pharmacies or to the prescriber. Thus, the risk of infection is limited, both for doctors and pharmacists, and for patients.
Across Europe, generic medicinal products are recognized as a means of more effectively spending public budgets for drug therapy. Generic medicines have proven therapeutic effectiveness, are available at affordable prices and are a popular measure in Member States to generate savings, both for healthcare budgets and patient out-of-pocket costs.
Bulgaria, together with Malta and Austria, is one of the three member states in which there is no possibility of generic substitution of medicinal products prescribed by trade name. The remaining Member States have introduced legislation accepting various forms of generic prescribing and/or substitution when dispensing medicinal products.
The Healthcare sector is highly regulated, with strict state control and with very intense competition, which does not allow a separate economic structure to exercise non-competitive influence. The evidence is a number of analyzes carried out by the anti-monopoly body in our country, which take into account the good level of competition in the sector, as well as the absence of negative effects on competition from the integrated, vertical structures.
The Confederation of Industrialists and Employers in Bulgaria is recognized through its mission, which protects the free competitive environment in our country. In the extraordinary conditions, in which the pressure on the entire economy, as well as on the health system in Bulgaria is extremely high, we should not forget the most important resource of the state - the people, the employees, the patients. All companies generating GDP today in conditions of increasing economic challenges should take care of their employees, including by facilitating their access to health services and quality therapy. Therefore, we call on everyone in this situation to think first of all about the people, about the patients.
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