Regulatory, Pricing and Reimbursement
Key legal info on regulatory, pricing and reimbursement in Bulgaria. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The following authorities are responsible for applying and enforcing the regulatory framework pertaining to drugs (including biologicals) and medical devices in Bulgaria:
- The Bulgarian Drug Agency (BDA) is a specialized State regulatory authority established by the Minister of Health, which exercises supervision over the quality, safety and efficacy of drugs (including biologicals), and of medical devices. The BDA is responsible for authorizing and registering drugs and medical devices to be placed on the market, as well as for issuing of permits, authorisations and certificates for various activities, including without limitation import/export, wholesale distribution and retail trading, manufacturing and brokering activities. It assesses and confirms the conformity with the law of manufacturers, marketing authorisation holders, wholesalers, retailers, of both drugs and medical devices. It has a role in initiation and carrying out of clinical trials and supervises the trial procedures. The BDA has also control functions related to pharmacovigilance. In addition, the BDA performs supervision over promotional activities pertaining to drugs. In its activities, the BDA correlates with the State customs authorities, revenue authorities, the National Health Insurance Fund (NHIF), the National Council for Prices and Reimbursement of Medicinal Products (NCPRMP), as well as with the Ministry of Health (MoH).
- The NCPRMP is a specialized administrative body established to the Minister of Health and responsible for inclusion and exclusion of drugs from the Bulgarian Positive Drug List (PDL), as well as for determining, registering and controlling the prices of drugs, including reimbursed products, and of maintaining their reimbursement status. The NCPRMP performs health technology assessment of drugs and issues pharmaco-therapeutic guidelines.
- The NHIF is a State authority responsible for the reimbursement of drugs and medical devices and is one of the payers with public funds.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The main local statutory act pertaining to the authorization, pricing, and reimbursement of drugs (including biologicals) is the Law on Medicinal Products in Human Medicine (LMPHM), and the secondary legislation on its implementation. The main local statutory act pertaining to the registration, pricing, and reimbursement of medical devices is the Law on Medical Devices (LMD), and the secondary legislation on its implementation.
Depending on the type of the statutory act, secondary legislation is issued by the Council of Ministers or by the Minister of Health. Relevant guidelines and authority practice are also deemed of relevance. In addition, Bulgarian pharmaceutical legislation is, for the most part, harmonized with the EU Directives and Regulations (the latter, being directly applicable in Bulgaria), e.g. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended.
3. What are the steps to obtain authorization to develop, test, and market a product?
A) Medicinal Products
In order to develop and test medicinal products (drugs) in Bulgaria, it is necessary to obtain an authorization for manufacturing of medicinal products. This is so, insofar as both the development and the testing activities would qualify as “manufacturing of medicinal products”, as such term is defined in the LMPHM. The manufacturing authorization is issued by the Director of the BDA. Applicants must comply with certain requirements set forth in the law. Manufacturing sites are subject to inspections by the competent authorities for compliance with the applicable Good Manufacturing Practices. The manufacturing authorization is issued only for the manufacturing activities, the pharmaceutical forms and the premises, which have been applied for by the applicant. Changes to the circumstances subject to authorization (including – with respect to manufacturing activities, manufacturing sites/premises, pharmaceutical forms, the qualified person, and other significant personnel, etc.) are subject to additional manufacturing authorization for the change.
A medicinal product may be placed on the market in Bulgaria based on a marketing authorisation, issued under one of the following procedures: (i) National Procedure; (ii) Mutual Recognition Procedure; (iii) Decentralised procedure or (iv) Centralized Procedure at the European Medicines Agency.
Homeopathic and traditional herbal medicinal products may be placed on the market in Bulgaria based on their registration certificate.
B) Medical Devices
No specific authorization for the manufacture of medical devices is required; however, the manufacture of medical devices may, depending on the circumstances, include activities for which authorization is required (e.g. handling of chemicals, usage of radiation, etc.).
There is no marketing authorisation for medical devices. However, depending on the medical device class, certain requirements have to be met. Medical devices shall bear CE marking indicating that they have been the subject of an assessment of their conformity (there are certain exceptions, e.g. for custom-made devices not bearing CE marking).
In case the manufacturer or its EU-based authorised representative are established in Bulgaria, there is a special registration procedure at the BDA depending on the medical device type and class.
For certain types of medical devices there is a notification procedure at the BDA.
4. What are the approximate fees for each authorization?
A) Medicinal Products – Marketing Authorisation
|National Procedure||Amounts in BGN|
|Referent medicinal product||15,000|
|Medicinal product with well-established use||15,000|
|Medicinal product with active substances with well-established use, but not known in that combination||15,000|
|Generic medicinal product||7,500|
|Medicinal product according to Art. 32 of the LMPHM with informed consent, regarding the preclinical and clinical parts||7,500|
|Medicinal product according to Art. 29 (1) of the LMPHM||15,000|
|Medicinal product according to Art. 29 (2) of the LMPHM||15,000|
|Decentralized Procedure||Fees in BGN (RMS)*
||Fees in BGN (CMS)**|
|Referent medicinal product||20,000||10,000|
|Medicinal product with well-established use||20,000||10,000|
|Medicinal product with active substances with well-established use, but not known in that combination||20,000||10,000|
|Generic medicinal product||14,000||7,000|
|Medicinal product with informed consent regarding the preclinical and clinical parts||14,000||7,000|
|Medicinal product according to Art. 29 (1) of the LMPHM||20,000||10,000|
|Medicinal product according to Art. 29 (2) of the LMPHM||20,000||10,000|
|Mutual Recognition Procedure||Fees in BGN (RMS)
||Fees in BGN (CMS)|
|Referent medicinal product||16,000||8,000|
|Medicinal product with well-established use||16,000||8,000|
|Medicinal product with active substances with well-established use, but not known in that combination||16,000||8,000|
|Generic medicinal product according to Art. 28 of the Drug Law||12,000||6,000|
|Medicinal Product with informed consent regarding the preclinical and clinical parts||12,000||6,000|
|Medicinal product according to Art. 29 (1) of the LMPHM||16,000||8,000|
|Medicinal product according to Art. 29 (2) of the LMPHM||16,000||8,000|
* Reference member
** Concerned member state
B) Medicinal Products – Manufacturing authorisation: between 5 000 and 20 000 BGN depending on the types of products. Good Manufacturing Practice on-site inspections are subject to separate fees.
Note: 1 EUR = app. 1.95 BGN
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
Marketing authorizations are valid for 5 (five) years. Renewals must be applied for not later than 9 (nine) months prior to the expiration date, after an assessment of the benefit-risk ratio is made. For the renewal of the marketing authorization, a marketing authorization holder must submit an application together with supplementary documentation to the BDA. After the first renewal, marketing authorizations are valid for an indefinite term. In the event of duly justified reasons related to pharmacovigilance, the BDA may require an additional 5 (five) year renewal.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
Further to the LMPHM, marketing authorization for generic products is subject to the same procedures, as those applicable to brand-name products. However, for generic products, the process may be shorter, as the presentation of pre-clinical and clinical study results is not required, if the so-called “data exclusivity” period has expired. This rule applies equally for both local and foreign-owned manufacturers. However, only marketing authorizations holders whose place of residence or seat is located in a Member State of the European Economic Area can apply for the marketing authorization.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
There are no specific rules regulating combination products (except for some rules in the reimbursement process). As far as biologics are classified as medicinal products, combinations of medicinal products and biologics are subject to the regulations under the LMPHM.
When combination products of medical devices and medicinal products is concerned, these would require considering the regulatory framework for both types of products individually – for the medicinal products and for the devices:
- where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in LMPHM and which is liable to act upon the body with action ancillary to that of the device – the LMD shall apply, however the quality, safety and efficacy of the substance must meet the LMPHM requirements;
- if the devices are intended to administer medicinal products they are governed by the LMD but must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing medicinal products (LMPHM); if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by LMPHM – the relevant essential requirements of the LMD shall apply as far as safety and performance-related device features are concerned.
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
Compliance with regulations pertaining to medicinal products is monitored by the MoH via the NCPRMP, the BDA and the Regional Health Inspections, i.e. the supervisory authorities with respect to the healthcare policy in Bulgaria. Compliance with medical devices regulations is monitored by the BDA. The BDA ensures supervision and enforcement of the law through (i) periodical inspections (both sudden ad-hoc on-site inspections, as well as planned inspections) and (ii) audit and reporting requirements, including for pharmacovigilance compliance. Within its competencies, the BDA follows European Commission guidelines. The regulatory regime set forth in Bulgarian law, as well as the relevant authority practice of the competent authorities, is compliant with EU directives, regulations and guidelines, pertaining to medicinal products and to medical devices. It is in line with the European Medicines Agency expectations and requirements.
The EU and the U.S. regulatory authorities are parties to a sectoral mutual recognition agreement on GMP inspections. In performance thereof, as a result of an audit conducted by the FDA on the BDA, on 29 April 2019 Bulgaria was confirmed by the FDA as a capable State, having an equivalent to the U.S. GMP-requirements, including conflict of interest avoidance rules.
9. What is the potential range of penalties for noncompliance?
Penalties for noncompliance vary depending on the infringement, and whether it is a one-time violation, or a repetitive one (in which case, the double amount of the penalty is usually levied). Penalties represent monetary sanctions, levied at the discretion of the penalizing bodies, within a certain range, whereas minimum and maximum amounts are set forth in the LMPHM. For different infringements, penalties may range between BGN 750 (appr. EUR 380) and BGN 150 000 (appr. EUR 76 000). In case the infringer is a legal entity, sanctions are triple the amount envisaged for the respective infringement. Additional ancillary sanctions in the form of pecuniary measures are also levied in cases of serious violations, whereas these include (possible) suspension of an authorization, a license or a permit, deprivation in favour of the State of products and equipment used by the infringer, or such subject of the infringement, prohibition to exercise professional activities for up to 2 years, etc. For the purposes of the administrative penal procedures, the regulatory authorities partner with the customs, the revenue and internal affairs authorities.
10. Is there a national healthcare system? If so, how is it administered and funded?
Yes, there is a national healthcare system in Bulgaria. It is (in the most part) funded by the NHIF budget, which is formed from compulsory health security contributions made by the population, collected by the National Revenue Agency and administered by the NHIF. Certain products and services are subject to financing from the State budget. Healthcare services may also be funded by private health insurers, based on voluntary insurance contributions. As a matter of practice, due to the underfinancing of the public healthcare system, healthcare services are often co-financed by the patients themselves, or co-reimbursed by pharmaceutical companies by means of participation of pharmaceutical companies in co-reimbursement schemes under agreements with the NHIF.
11. How does the government (or public) healthcare system function with private sector healthcare?
The healthcare system financed with public funds covers a specific, exhaustive set of products and services, which is subject to update on an annual basis, and is conditional on the meeting of numerous criteria and requirements of all stakeholders – marketing authorization holders, medical services providers, healthcare establishments, pharmacies. It is dramatically underfinanced, resulting in the necessity for active co-funding by companies and by patients. Bulgaria recognizes both public and private healthcare organizations (both for inpatient and for outpatient medical care), all of which are entitled by law to participate in the reimbursement model subject to meeting certain criteria set down by the NHIF towards its contractual partners. With respect to the provision of healthcare services funded with public funds, the NHIF contracts with both public (i.e. State or municipal) and private healthcare establishments.
12. Are prices of drugs and devices regulated and, if so, how?
Price regulation is applicable to all drugs, regardless of whether they are prescription (Rx drugs) or over-the-counter (OTC) products, subject to reimbursement or not. The reimbursed Rx drugs are listed in the PDL that contains a list of the maximum prices subject to regulation by the NCPRMP. For reimbursed products included in the PDL there is an internal price reference system (reference is made to the lowest price within the concerned group). For all Rx drugs (reimbursed or not), there is an external reference pricing system in place. The following ten EU member states are considered reference states: Belgium, Greece, Spain, Italy, Latvia, Lithuania, Romania, Slovakia, Slovenia and France. Depending on the price level of the specific medicine, the markup for a wholesaler could be up to 7%, 6%, or 4% and the markup for a retailer could be up to 20%, 18%, or 16%. For OTC drugs the maximum retail prices are subject only to registration by the NCPRMP and there is no external price reference system.
For medical devices there is a separate registration procedure for products subject to payment with public funds. There is an e-register managed by the BDA for that purpose. The prices of the medical devices reimbursed by the NHIF are subject to an annual negotiation procedure. The maximal value reimbursed by the NHIF is subject to an internal reference system applied to the concerned groups of medical devices. Apart from that, the prices of medical devices not paid by public funds are not regulated.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
There is a relevantly complex reimbursement system depending on the type of product and the public payer. The main payers are the MoH and NHIF. Some medical devices are paid by the budget of the Ministry of Labour and Social Policy. Reimbursement can be channelled in different ways. For example, payments by the NHIF to contracted hospitals (both public and private) on the basis of clinical pathways and then public tender procedures initiated by the concerned hospitals; or direct reimbursement of outpatient drugs by the NHIF to the dispensing pharmacies – based on contractual arrangements negotiated and concluded year-by-year. In some cases, there are centralised tender procedures by the MoH.
Payments may also be covered by private health insurers or paid by the patients themselves. A possibility exists in Bulgarian drug legislation for patients’ co-payment to be covered by pharmaceutical companies based on an individual agreement concluded by the MAH with the NHIF for specific discounts distributed in favour of the patients.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Medicinal products prescribed by healthcare professionals are dispensed in pharmacies. In addition to pharmacies, OTC products, as well as medical devices, may also be sold by drugstores or on the Internet.
Retailers are entitled to their commercial discounts and margins which, in the case of medicinal products, may be administratively regulated. For medicinal products intended for outpatient treatment and 100% reimbursed by the NHIF, the pharmacies are entitled to a fixed fee per prescription.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
Prescription medicinal products are prescribed by healthcare professionals and are dispensed by pharmacies – either hospital pharmacies or retail pharmacies. OTC drugs are dispensed in pharmacies and drugstores. In some cases, dentists and medical doctors are also able to dispense medicinal products to patients. For medical devices the scope of dispensing places/entities is wider.
Pharmacists are responsible to provide all necessary information to the patients concerning the use and safety of the products and they may also consult the patients in relation to medicinal products. The organisation and operation of the pharmacies is regulated by the legislation. Pharmacists who are entitled to exercise their profession on the territory of Bulgaria are members of the Bulgarian Pharmaceutical Union (BPhU) established according to the national Law on the Professional Organization of Master Pharmacists. BPhU adopted a Code of Ethics and rules of Good Pharmacy Practice which further regulates the pharmaceutical care provided to patients/consumers.