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28 March 2024 | Country Update
Reduced co-payments for medicines for home treatment of cardiovascular diseases -
02 February 2023 | Country Update
A National Pharmacy Map to determine the regional access to pharmacies
5.6. Pharmaceutical care
Drug policy is carried out by the Minister of Health. The BDA is a specialized body of the MoH, which assesses and supervises the quality, safety and efficacy of medicinal products, authorizes the production of medicinal products, and registers and licenses the wholesalers, the pharmacies and the parallel export (see section 2.8.4 Regulation and governance of pharmaceuticals).
Regulation of pharmaceutical producers
Currently, there are 39 domestic pharmaceutical manufacturers and nine third-country importers (outside the EU) registered by the BDA (BDA, 2017a). The manufacturers have to fulfil the EU requirements of good manufacturing practice for medicinal products. In 2015, domestic production accounted for €121 million or 13% of the pharmaceutical market value at ex-factory prices (European Federation of Pharmaceutical Industries and Associations, 2017). Foreign manufacturers operate through representative offices, which perform only promotion and marketing activities, or through local subsidiaries which distribute medicinal products to wholesalers, pharmacies or health care establishments. Many foreign companies have established local subsidiaries, licensed as wholesalers.
According to the Law on Medicinal Products in Human Medicine, the wholesale of medicinal products can be carried out by natural persons or legal entities holding a permit issued by a regulatory authority of an EU Member State. If the warehouses are located in Bulgaria, a wholesale authorization from the BDA is needed. They must meet the requirements of Good Distribution Practice. More than 300 wholesalers are currently licensed by the BDA, some of them with divisions in several cities (BDA, 2017b). The law also regulates intermediation in the field of wholesale drug dealing.
Pharmaceutical manufacturers and importers are entitled to distribute their products based on the manufacturing or import licence. They can participate directly in procurement tenders organized by the MoH, the NHIF or by hospitals. Public health care establishments are supplied by wholesalers, manufacturers or importers and purchasing is regulated through the Public Acquisition Act. Commercial relations between wholesalers and retailers are not regulated except with regard to wholesaler mark-up, which is specified in an ordinance of the MoH. In 2015, regulatory provisions for the purchase of medicinal products were created through an electronic auction from the Central Purchasing Authority. The purpose of the assignment through this central body is the supply of medicinal products from the PDL, for which the central body will conclude framework agreements on behalf of the contracting authorities – the public health care establishments. These measures intend to provide greater transparency of this process, time savings and lower prices for medicines.
Sale of medicines
Retail sale of medicinal products is carried out by pharmacies and drugstores. Hospitals and other health care establishments providing inpatient care can operate pharmacies but only for their own needs. According to the BDA register, there are currently 4203 pharmacies in Bulgaria, including pharmacies in health care establishments (BDA, 2017c). Of all pharmacies, 2324 or 55.3% concluded a contract with the NHIF in 2017 (NHIF, 2017d). Each pharmacy has to be managed by a licensed pharmacist (with a Master’s degree). Most pharmacies in Bulgaria are owned by independent entrepreneurs. A person or a legal entity may own up to four pharmacies. In 2015, the Commission for Protection of Competition identified 17 pharmacy chains with more than four pharmacies that operated under the same trademark based on a franchise contract, licence agreement or shared use of a trademark. Four pharmacy chains had vertical integration with a wholesaler (Commission for Protection of Competition, 2015). Bulgaria is one of the countries with the highest density of pharmacies per capita in Europe. In 2015, the country ranked third after Greece and Cyprus (Pharmaceutical Group of the European Union, 2015).
Retail sale of prescription-only pharmaceuticals is allowed only in pharmacies. They can only be sold by a pharmacist with a Master’s degree. Over-the-counter pharmaceuticals for personal use are available both at pharmacies and at drugstores. There are 983 drugstores in Bulgaria, registered by the MoH (MoH, 2017). The manager of a drugstore must be a medical specialist. The Law on Medicinal Products in Human Medicine explicitly forbids the sale of prescription-only pharmaceuticals in other outlets, as well as on the Internet. Direct-to-consumer advertising of prescription medicines is not permitted. Medicines without a prescription can only be sold on the Internet by a pharmacy or a drugstore. The sale of medicinal products through automated machines is prohibited except for the medicinal products listed in an ordinance of the MoH. The law allows some exceptions for settlements without a pharmacy. In this case, physicians or dentists may also sell drugs but only with permission from the MoH. The list of pharmaceuticals that can be dispensed by physicians is determined by an ordinance of the Minister of Health.
The pharmaceutical market
Although the Bulgarian pharmaceutical market is one of the smallest in the EU, it has grown substantially over the last few years and the pharmaceutical industry is one of the fastest growing sectors of the Bulgarian economy (Commission for Protection of Competition, 2015). This increase is attributed mainly to two factors: increased NHIF costs for oncological and other expensive medicines and increased consumer demand for over-the-counter drugs. In 2012, the MoH transferred responsibility for payment for a list of specialty medicines to the NHIF. These are 100% reimbursed and include certain oncology drugs, as well as drugs for post-transplant immunosuppression and various orphan diseases. The MoH is providing medical products for the treatment of AIDS, tuberculosis, and mental and behavioural disorders due to the use of opioids, addiction syndrome and radiopharmaceuticals.
Pricing and reimbursement
The NCPRMP to the Minister of Health compiles the PDL determining which pharmaceuticals are covered by SHI and through the state budget. The PDL comprises four annexes:
- the Reimbursement List, which lists those medicines paid for by the NHIF according to the Health Insurance Act and the level of subsidy they receive;
- medicines funded from the budgets of the public health care establishment for inpatient care;
- medicines for the treatment of HIV/AIDS and certain communicable diseases outside the scope of the Health Insurance Act, as well as vaccines; and
- maximum retail prices for medicines included in the PDL.
The PDL is organized in pharmacological groups with relevant International Nonproprietary Names and includes the defined daily dose, the reference value for the defined daily dose and the reference price. The PDL is published by the NCPRMP, and for existing drugs is updated twice a month. New products are only added on the 1 January each year, and the Council may only change the level of reimbursement of a medicine in PDL once a year, although price changes can occur more frequently.
Insured persons have access to medicinal products covered totally or partially by SHI. According to the Health Insurance Act (1998), the NHIF pays for only the medicinal products included in the PDL intended for the treatment of diseases covered by the compulsory health insurance, set out in an ordinance of the Minister of Health. Reimbursement levels of pharmaceuticals covered by the SHI are determined according to the NHIF budget for the respective year (capped for outpatient drugs) and are specified in the Reimbursement List. Reimbursement may also be provided by the private health insurance. Subsidies vary between 25% and 100%. For products with the same International Nonproprietary Names in the same pharmaceutical form, the benchmark price is set with reference to the cheapest version of the product as determined by cost per defined daily dose.
In 2014, pharmaceutical expenditure in Bulgaria was €438 PPP per capita, and was among the highest in the EU – Bulgaria took seventh place in this ranking (OECD/EU, 2016). The prices of drugs remain high: patients often cannot afford prescribed medicines. Moreover, co-payments for pharmaceuticals covered partially by SHI are also considerably high. During the economic crisis from 2010 to 2012, about 20% of households stopped buying regular medicine (World Bank, 2012). According to a study conducted in 2014, approximately 20% of the respondents indicated that they did not always buy the prescribed drugs because of insufficient funds (Rohova, 2015a).
HTA
In 2015, HTA for pharmaceuticals was introduced in Bulgaria. It is obligatory for the inclusion of new medicines (with new International Nonproprietary Names) in the PDL. Pharmaceuticals included in the PDL are selected on the basis of several criteria such as efficacy, therapeutic effectiveness and safety, as well as on the basis of pharmacoeconomic analysis. The HTA is conducted by the NCPHA (see subsection 2.7.2 Health technology assessment and Chapter 6 Principal health reforms).
The National Health Insurance Fund (NHIF) has proposed to increase the reimbursement level for more than 400 medicinal products, grouped into 52 INN groups, indicated for the home treatment of chronic cardiovascular diseases. The proposal is supported by the Ministry of Health and the Ministry of Finance and will be implemented from April 2024, following ratification by the National Council on Prices and Reimbursement of Medicinal Products.
The NHIF estimates that more than 600,000 patients suffering from cardiovascular diseases will receive medicines from these groups free of charge or at reduced co-payments. The necessary funding for the amendment will be provided through the NHIF budget.
The decision to increase the reimbursement level for medicines for chronic cardiovascular diseases is in line with the NHIF’s long-term strategy to fully reimburse pharmaceuticals for socially important chronic diseases and to expand the group of medicinal products for which patients pay no or low co-payments.
Authors
References
National Health Insurance Fund: https://www.nhif.bg/bg/news/475
OECD/European Observatory on Health Systems and Policies (2023), Bulgaria: Country Health Profile 2023, State of Health in the EU, OECD Publishing, Paris/European Observatory on Health Systems and Policies, Brussels
In 2020, the Parliament of Bulgaria passed amendments to the Law on Medicinal Products, regulating the development of a National Pharmacy Map, which is intended as a planning tool to guarantee the accessibility of pharmaceutical care. The map will identify the regions, municipalities, and settlements across Bulgaria that have gaps in the provision of pharmaceutical services.
In June 2022, the Minister of Health approved the methodology for elaborating district pharmacy maps. The methodology describes the assessment procedure, taking into account some regional features (such as the remoteness of the settlements and infrastructure), districts’ demographic and health profiles, the provision of pharmaceutical care, and the availability of community pharmacies and pharmacists. However, the National Pharmacy Map’s purpose beyond need evaluation is unclear.
While the availability of community pharmacies per 100 000 population in Bulgaria is high compared to the EU average, most pharmacies are situated in large cities and rural areas have limited access.
Authors
References
Bulgarian National Assembly (2020). News. https://parliament.bg/bg/news/ID/5107
Ministry of Health (2022). Methodology for the elaboration of the district pharmacy map (in Bulgarian) https://www.mh.government.bg/media/filer_public/2022/06/28/zapoved__rd-01-274-28062022_g.pdf