Legislative frameworks to combat illicit trade in medical products in Bulgaria

The following legislative frameworks are available in Bulgaria to combat the illicit trading and other illegal activities in counterfeited/falsified/diverted medicines:

1. General administrative and civil law regulations based primarily on breaches of competition law (in particular the prohibition of unfair competition), consumer protection law, intellectual property law that could result in both administrative pecuniary sanctions and civil claims for damages.
2. Specific administrative law based on breaches of provisions set down in the Medicinal Products in Human Medicine Act (“MPHMA”).
3. Criminal law that applies to the most severe cases.

As a general note, all types of counterfeited/falsified/diverted products, including medical devices, veterinary medicines and cosmetics, can be challenged based on general administrative, civil law and criminal law. There are particular regulations for medical devices set down in the Medical Devices Act (the “MDA”). Specific provisions regarding veterinary medicines are included in the Veterinary-Medicinal Activity Act (the “VMA”).  

Illicit trading, counterfeiting/falsification and other illegal activities involving medicines are prosecuted as crimes in general categories, such as intellectual property crimes and crimes against the customs regime. There is no separate group of crimes specifically dedicated to illicit trading, the counterfeiting/falsification of medicines in the Bulgarian Criminal Code.

The Medicrime convention has not been ratified in Bulgaria.

Three types of liability exist in Bulgaria, which are differentiated based on the severity of the illegal activity regarding medicines and other products:

1. Civil law liability: liability for the infringement of legal obligations imposed by statutes or by contracts. Tortious (non-contractual) liability is established by the competent civil court in a legal dispute and the court determines fair compensation based on the assessment of the facts.
2. Administrative-penal liability: liability for a breach of legal statutory obligations. In such instances, the competent administrative body must commence administrative-penal proceedings and establish the liability of the offender. The proceedings can be commenced either ex-officio or based on a complaint. The statutory provisions establish a range for the amount of the fine or the pecuniary sanction which can be imposed on the offender.
3. Criminal law liability: liability provided in the Bulgarian Criminal Code for breaches of statutory obligations. The competent prosecutor or investigative bodies commence criminal proceedings (pre-trial proceedings and investigation) in the case of a statutory event (such as a complaint filed by a third party, media publications, ex-officio on the discovery by the pre-trial authorities of signs of a perpetrated crime) and sufficient information about the perpetration of a crime. The Bulgarian Criminal Code recognises the liability only of individual persons; legal entities cannot be criminally prosecuted.

Civil liability can cumulate with either administrative-penal liability or criminal liability, and the remedies can be requested separately. Administrative-penal liability cannot cumulate with penal liability, as an act cannot qualify both as an administrative offence and a crime.

There is no separate liability for the falsification/counterfeiting of biologics (e.g. vaccines) and the above-mentioned regime would apply.

The Bulgarian Drug Agency (the “BDA”) is the primarily regulatory authority regarding medicines and medical devices. Regarding medicines, the BDA exercises control over the production and import; wholesale and retail trade; conducting clinical trials; advertising, as well as the system for monitoring the safety of medicinal products placed on the market. The BDA also takes measures to prevent the import and placing on the market of counterfeited medicines. Regarding medical devices, the BDA exercises control over their placement on the market, putting into service, and trade; evaluates the conformity of the medical devices with regulatory requirements, and issues permits for conducting clinical trials and wholesale trade with medical devices. The Executive Director of the BDA is entitled to issue an order suspending or prohibiting the placing on the market or putting into service and for the withdrawal from the market of medical devices that do not conform with the regulatory requirements and which may endanger the health and safety of patients, medical professionals or third parties.

The Bulgarian Food and Safety Agency (the “BFSA”) is the primary regulatory authority for veterinary medicinal products. The BFSA supervises the production, import, storage, trade and use of veterinary medicinal products.

The Bulgarian Ministry of Health and the State Health Control authorities are the regulatory authorities regarding cosmetics.

Depending on the nature of the activities and products, other state bodies might be involved in anti-counterfeiting activities. These bodies include customs officials, regional health inspectorates, regional veterinary authorities, police officials, financial inspectors, etc.

Manufacturers, MAHs or IP rights holders for products affected by illegal activities may refer the matter to the competent state authority. The competent authority will initiate administrative-penal or criminal proceedings. Manufacturers, MAHs and IP rights holders can submit statements, evidence, and assist the authority in gathering evidence.

In pre-trial criminal investigations, manufacturers, MAHs and IP rights holders that suffered damages, have the right: to be present in person or through their authorised representative when investigative actions are carried out, if this will not hinder the investigation; to receive information on the progress of the investigation; to acquaint themselves with the materials on the case after the completion of the investigation; to make requests, remarks and objections, including objections during the investigation; and to appeal termination or suspension of the proceedings. Manufacturers, MAHs or IP rights holders that suffered damages have the right to take part in the court proceedings before the penal court as private prosecutors and to submit civil claim for the damages caused by the crime.

In civil law proceedings before a court, it is possible to receive compensation for the counterfeiting/falsification of a medicine and other products if they have caused material/pecuniary/damages to the manufacturer, MAHs or IP rights holder, or the offender has been unjustly enriched due to the counterfeiting/falsification of the products. In claims under the common rules of the Obligations and Contracts Act (the case of general tort), the guilt of the offender is presumed by law. The claimant will have to prove that the damage is caused directly by an act by the offender contrary to the general legal obligation not to cause damage to third parties and possibly contrary to other legal obligations (if other particular provisions are also violated). The amount of the compensation for pecuniary damages is determined through individual assessment according to the evidence.

Specific provisions regarding compensation for damages are available in trademark infringements. Under the Marks and Geographical Indications Act (the “MGIA”), if it is difficult to prove the amount of the damages, the claimant can request either: (i) compensation of ca. EUR 250–50,000, the exact amount to be determined by the court; or (ii) the equivalent at retail prices of legally manufactured goods, identical with or similar to the infringing goods. The claimant may also request that the infringer terminates the infringing activity; the seizure and destruction of the infringing goods, as well as the means for their production; and the publication/public announcement of the court’s final decision. An action can be brought against an intermediary whose activity facilitated the infringement. It is also possible to request interim measures, such as interim cease-and-desist measures and measures for gathering evidence.

In criminal law proceedings, the injured party can submit a civil claim for the damages caused by the crime.

It is possible to sell non-prescription medicinal products online. Only a pharmacy or a drugstore that has been granted authorisation under the terms and conditions of the Medicinal Products in Human Medicine Act can sell non-prescription medicinal products online. The BDA publishes on its website a list of all the pharmacies/drugstores that provide non-prescription medicinal products online and of their websites.

Under the MPHMA, the advertising of medicinal products, which are available on prescription, is prohibited, except for advertising campaigns for vaccinations. The content of each particular advertisement is subject to the BDA’s approval. Advertising is allowed only for medicinal products for which a marketing authorisation has been issued.

The Bulgarian Medicines Verification Organisation (the “BgMVO”) was established on 14 March 2016 as a non-profit organisation to support the implementation in Bulgaria of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, regarding preventing the entry into the legal supply chain of falsified medicinal products (the “Falsified Medicines Directive”). The main purpose of the BgMVO is to ensure that patients are supplied with authentic medicinal products by building, operating and maintaining an effective medicinal products verification system in Bulgaria. The BgMVO works in close collaboration with healthcare authorities in Bulgaria.

Marketing authorisation holders and parallel distributors that market products in Bulgaria must ensure that prescription only medicines packages carry unique identifiers and anti-tampering devices according to the requirements of the Falsified Medicines Directive. The data for the products must be uploaded in the national medicinal products verification system. 
The packaging of all prescription medicines must have a unique identifier code that is placed by the manufacturer and which contains four elements: product code, batch number, expiration date and unique serial number. At the pharmacy, the pharmacist checks the integrity of the package and scans the unique identifier code of the medicine with a barcode reader. This verifies that the medicinal product is of proven origin. When the medicine is dispensed, the code is deactivated so that the same package cannot be used again.

We are not aware of any new legislative developments in Bulgaria relating specifically to combatting illicit trading and other illegal activities involving counterfeited/falsified medicines and other products.