Legislative frameworks to combat illicit trade in medical products in Romania

The Romanian Criminal Code criminalises the acts of preparing, offering and displaying with a view to sell a medicine that is counterfeited or substituted, and harmful to health. The offence is punishable with imprisonment between six months and five years, and a ban on exercising certain rights. 

The preparation of counterfeit medicines refers to making medicines by using ingredients or mixtures that are incorrectly dosed or according to a non-original prescription. Preparing substituted medicines consists in replacing high-quality medicines with inferior ones. 

Offering counterfeit or substituted medicines consists in proposing to certain persons to buy or receive counterfeit or inferior quality medicines, instead of original or superior quality medicines. 

Exposure to the sale of counterfeited or substituted medicines consists in the presentation of inappropriate products in specific places (e.g. stands, showcases, shelves) in order to be known by consumers, so that they are tempted to buy them. 

Another separate act criminalised by the Romanian Criminal Code is that of selling a medicine while being aware that it is counterfeited, deteriorated or that its best-before date has expired, if it is harmful to health or if it has lost its therapeutic value in whole or in part. This offence is punishable with a prison sentance of between one and five years, and a ban on exercising certain rights. 

In addition, Law No. 84/1998 on trademarks generally criminalises the offering, trading, importing or exporting of counterfeited trademark products. 

The above offences criminalised by the Romanian Criminal Code are specific only to medicines for human use. Illicit trading, counterfeiting/falsification and other illegal activities involving other products, such as medical devices, veterinary medicines and cosmetics, are punished under Law No. 84/1998.

In Romania, illicit trading, counterfeiting/falsification and other illegal activities involving medicines for human use are criminalised as a separate group of offences by Arts. 357 and 358 of the Romanian Criminal Code.

No, Romania has not yet ratified the Convention on the counterfeiting of medical products and similar crimes involving threats to public health. Please also see our answer to Question 11 below.

The counterfeiting/falsification of medicines in Romania, including any other products, triggers the criminal liability of the perpetrator, either a legal entity or individual person.

Legal entities (except for state and public authorities) can be held criminally liable for offences committed in the performance of the objective of their activity or in their interest or behalf. The criminal liability of legal entities does not exclude the criminal liability of individuals participating in the commission of the same act.

In the same criminal trial, a legal entity or individual person may also be held liable for the civil side of the matter and may be forced to pay the damages suffered through the offence by the aggrieved party if found guilty.

The falsification/counterfeiting of biologics does not entail any liability other than that mentioned above.

The General Directorate of Pharmaceutical Inspection, part of the National Agency for Medicines and Medical Devices (“ANMDMR”), has specific responsibilities for scientific activities in the field of medicinal products and medical devices for human use, and implemented in this regard a specific working team to combat the counterfeiting of medicines, called the Rapid Alert Service for Counterfeit Medicines (“SARMF”).

Among others, SARMF’s role is to:

• carry out activities to prevent counterfeiting/falsified medicines entering the legal supply chain;
• participate in pan-European counterfeiting programmes to resolve rapid alerts of falsified medicines;
• manage rapid alerts of falsified/stolen medicines and take measures to prevent falsified medicines entering the legal supply chain;
• deal with rapid alerts and information on inadequate, falsified or stolen medicines from the Member States of the European Economic Area, and notify them of the possible presence in the distribution network of falsified/stolen medicines, of those arising from fraud in manufacture, packaging, distribution or promotion of medicines containing falsified raw materials;
• access the National Medicines Verification System to monitor the functioning of directories and investigate potential incidents of counterfeiting;
• notify the Romanian Organisation for Serialising Medicines (“OSMR”) when it suspends/withdraws a manufacturing authorisation or wholesale distribution authorisation;
• perform inspections in the field of anti-counterfeiting/falsified medicines;
• conduct investigations into online websites that sell medicines suspected to be counterfeited;
• participate in joint activities with the inspectorates of the Member States of the European Union for inspection matters;
• participate in the working groups of the European bodies responsible for pharmaceutical inspections;
• participate in the development and revision of guidelines and legislation in the field of anti-counterfeiting/falsified medicines, and
• notify the National Customs Authority and the General Police Inspectorate of frauds or counterfeit/stolen medicines.

The ANMDMR must notify the European Commission of over-the-counter medicines that it considers to be at risk of being falsified, and may provide information to the commission on medicines that, in its opinion, do not presents risks (as per the criteria listed in Art. 775 par. (3) lit. b) of Law 95/2006).

Illicit-trade and counterfeiting activities in Romania are investigated by the Romanian police and prosecutor’s offices. The criminal investigation bodies gather the evidence needed to establish whether grounds for prosecution exist. If a defendant is sent to trial, a criminal court rules on a conviction if it is proved that, beyond reasonable doubt, the act exists, it is an offence and was committed by the defendant.

Manufacturers, MAHs and IP rights holders can engage in investigations involving their affected products to the extent established by the Romanian Criminal Procedure Code. The code sets out the following rights for victims in criminal proceedings:

• to propose the production of evidence by judicial bodies, to raise objections and to make submissions;
•  to file any other applications related to the settlement of the criminal part of the case;
•  to be informed, within a reasonable period, of the status of the criminal investigation, on explicit request, provided that they indicate an address in Romania, an email address or an electronic messaging address, to which such information can be communicated;
•  to consult the case file, under law;
•  to be heard;
•  to ask questions of the defendant, witnesses and experts;
• to receive an interpreter, free of charge, if they cannot understand, cannot express themselves properly, or cannot communicate in Romanian;
• to be assisted or represented by a counsel, and
•  to use a mediator, in cases permitted by law.

Yes. Persons that suffer damage because of a counterfeited/falsified medicine or other product can initiate a civil action in order to establish the civil liability in tort of the persons liable under civil law for the damages caused by the counterfeiting/falsification. This may be requested either before a civil court or in criminal proceedings if the action of counterfeiting/falsification constitutes an offence. In the latter case, the criminal court will decide both on the criminal action and on the civil action through the same judgment.

Over-the-counter Medicines for human use can only be sold online by pharmacies and drugstores authorised on the basis of the specific mention on the annexes to the operating authorisation, as provided by 2019 Norm regarding the establishment, organisation and operation of pharmaceutical units approved by the Ministry of Health Order No. 444/2019.

The website of the online pharmacy or drugstore is considered a virtual extension of a community pharmacy authorised in accordance with the legal provisions in force.

The online selling of medicines must comply with the following specific rules:

• the space allocated for the operation of the online pharmacy/drugstore must be at least 10 sq. m. and needs to be dedicated to specific activities of the online pharmacy/drugstore;
• the online pharmacy/drugstore must be equipped with furniture corresponding to the operations of packaging and storage of packages, equipment that ensures and monitors the temperature, other means for keeping the medicines under the conditions provided by the manufacturer, computer, internet connection, and any other equipment necessary to carry out the activity;
• the website of the online pharmacy or drugstore must include, in addition to the general provisions for pharmacies:
  • a link to the National Agency for Medicines and Medical Devices of Romania (“ANMDM”) website, “Report an adverse reaction”;
  • the data included in the corresponding mention registered by the Ministry of Health on the annex to the operation authorisation;
  • statement of consent regarding the agreement for the processing of personal data to be completed by each patient; and
  • questionnaire in which the patient indicates date of birth, weight, height, sex, current treatments, allergic history, pregnancy or lactation;
• the language of the website must be Romanian but can be translated into other languages;
• the administration of the website must be carried out only by personnel authorised by the legal representatives of the pharmacy/drugstore authorised to carry out the activity of electronic commerce with medicines;
• the website must have a special page for the sale of over-the-counter medicines in order to ensure a clear distinction from other products that are for sale on the same website. On this page, only hyperlinks to the authorities’ websites will be authorised. It is forbidden to display hyperlinks to the websites of pharmaceutical companies;
• medicines can be sold and dispensed online only to patients over 18 years old;
• each medicine that is offered online without a prescription must have its name, therapeutic indications from the marketing authorisation, patient information leaflet and price displayed;
• online pharmacies and drugstores must ensure compliance with all the legal provisions in force regarding personal data and the confidentiality of the virtual dialogue with each patient; the pharmacist in charge will maintain professional secrecy;
• online pharmaceutical units authorised in Romania may also sell medicines to patients that are established in other Member States of the European Union based on the provisions of the legislation on medicines in the country where the patient is located; and
• medicines that are ordered online can be picked up from the online pharmacy/drugstore or can be delivered by specific means, ensuring their protection against damage, counterfeiting, theft, as well as maintaining the temperature conditions in accordance with the manufacturer’s specifications.

Specific restrictions must be taken into consideration, as follows:

• the website must be designed in such a way that it is not possible to sell and deliver medicines without a prior interactive exchange between the patient and the pharmacist (the dialogue can be done either by email or online);
• the sale and delivery activity of the online website cannot be outsourced (except for technical operations);
• it is prohibited to promote the abusive consumption of medicines; and
• the online pharmacy/drugstore cannot operate without a pharmacist responsible for the sale and delivery of over-the-counter medicines.

Veterinary medicines can be sold online through online stores/sellers based on the provisions of Order No. 83/2014 for the approval of Veterinary Sanitary Norms regarding the conditions of the organisation and functioning of veterinary pharmaceutical units, as well as the veterinary sanitary registration procedure/veterinary sanitary authorisation of units and activities in the veterinary pharmaceutical field, and on Law No. 160/1998 on the Organisation and Exercise of the Veterinarian Profession.

Each online store/seller has the obligation to notify the Sanitary-Veterinary and Food Safety Department in whose territorial area its registered office is located of the intention to market online the veterinary medicines permitted by law, specifying the contact details of the veterinary pharmaceutical unit that supplies the products. The storage and transport of veterinary medicines to the beneficiary is performed only by the veterinary pharmaceutical units that are sanitary-veterinary authorised/registered and suppliers of veterinary medicines.

The online retail sale of the following is prohibited: veterinary medicine with a waiting time, veterinary medicine (other than those with a waiting time) issued under a veterinary prescription, without proof of such prescription, biological veterinary medicine and antibiotics, veterinary medicine containing hormonal, thyrostatic and beta-agonist substances, products containing psychotropic substances, and narcotics and veterinary medicine containing substances under national control. If the online retail sale of veterinary medicine is otherwise regulated through European Union legislation, those provisions will prevail.

The packaging of a medicine must contain the specific information provided by Law No. 95/2006 in order to be saleable in Romania. Among the information, the following specifications are required for protection and safety to combat illicit trading and counterfeited/falsified medicines:

1. the name and address of MAH and, where applicable, the name of the representative appointed by the holder to represent it;
2. the marketing authorisation number of the medicine;
3. manufacturing serial number;
4. instructions for use for over-the-counter medicines; and
5. generally, prescription-only medicines (other than the radiopharmaceutical ones) should contain safety features to enable wholesale distributors and persons authorised or entitled to supply medicines to the public to verify the authenticity of the medicine, to identify individual packaging, and a device to verify whether the secondary packaging has been unlawfully modified.

As an exception to point (v) above and based on the provisions of the delegated acts adopted by the European Commission, the ANMDMR adopts and applies the list of prescription-only medicines that does not have to contain those safety measures and the list of over-the-counter medicines that must contain them.

The above-mentioned lists must be drawn up given the risk of falsification based on the following criteria:

• the price and sales volume of the medicine;
• the number and frequency of previous cases of falsified medicines reported in the EU and in third countries, and the evolution of the number and frequency of such cases to date;
• the specific characteristics of the medicinal product;
• the severity of the conditions to be treated; and
• other potential risks to public health.

In addition, the ANMDMR adopts and applies the following safety measures:

• characteristics and technical specifications of the unique identifier code of the safety elements provided in point (v), which allows the verification of the authenticity of the medicine and the identification of the individual packaging;
• ways of checking the safety elements mentioned in point (v) by manufacturers, distributors, pharmacists and persons authorised or entitled to supply medicines to the population and by the competent authorities. The mentioned methods must allow the verification of the authenticity of each supplied medicine package that presents the safety elements mentioned in point (v) and may lead to the extension of such verification; and
• provisions regarding the creation, management and accessibility of the electronic storage system in which the information regarding the safety elements is kept, which allow the verification of the authenticity and identification of the medicines. (The costs of electronic storage systems are borne by the holders of manufacturing authorisations for medicinal products that have safety features.)

The necessity of a unique identifier code may be extended to any prescription-only medicine in order to reimburse the equivalent value or to comply with the provisions regarding pharmacovigilance. It may also be extended to any medicine to protect the safety of patients.

Romania has not yet ratified the Medicrime convention. although doing so does seem to be on the Government’s agenda.  

The latest development in regard to this was on 29 January 2021, when the (then) Minister of Justice, Mr Stelian Ion, stated at an informal meeting of the Ministers of Justice of the EU Member States that: “an important step in the fight against counterfeiting and organised crime is the ratification by EU Member States of Medicrime convention, which can prove to be a very useful tool in judicial cooperation in criminal matters.”