Pharmaceutical advertising regulation and medical device advertising in Bulgaria

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in Bulgaria regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising to the general public?
  6. 6. What are the main restrictions applicable to the advertising to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in Bulgaria?

1. Which laws are applicable regarding advertising of medicines and medical devices?

1.1 Medicines

The advertising of medicinal products is mainly regulated under the Medicinal Products in Human Medicine Act, promulgated in State Gazette Issue 31, dated 13 April 2007, as amended (“MPHMA”).

Ordinance No 1 dated 25 January 2012 on the requirements for the advertising of medicinal products, promulgated in State Gazette Issue 10, dated 3 February 2002 (“Ordinance”).

1.2 Medical devices

The Medical Devices Act, promulgated in State Gazette Issue 46, dated 12 June 2007, as amended (“MDA”).

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“Regulation 745”).

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“Regulation 746”).

1.3 Other general pieces of legislation that can also apply

  • The Protection of Consumers Act, promulgated in State Gazette Issue 99, dated 9 December 2005, as amended (“PCA”).
  • The Competition Protection Act, promulgated in State Gazette Issue 102, dated 28 November 2008, as amended (“CPA”).
  • The Radio and Television Act, promulgated in State Gazette Issue 138, dated 24 November 1998, as amended (“RTA”).
  • The Code of Professional Ethics of Healthcare Practitioners in Bulgaria, promulgated in State Gazette Issue 79, dated 29 September 2000, as amended (“Code of Ethics”).
  • The Code of Professional Ethics of Dental Healthcare Practitioners in Bulgaria, promulgated in State Gazette Issue 34, dated 25 April 2006, as amended (“Dental Healthcare Code of Ethics”).

Yes. The main codes of conduct are the following: Code of Conduct 2020 of the Association “Medicines for Europe” that is applied also by the Bulgarian Generic Pharmaceutical Association (BGPharma); and the Consolidated Code of Ethics of the Association of the Research-Based Pharmaceutical Manufacturers in Bulgaria (adopted on 10 June 2020, in force as of 01 January 2021) (“Arpharm Code”). 

Self-regulatory codes that are generally applicable to advertising of medicines and medical devices.

National Ethical Standards for Advertising and Commercial Communication in Bulgaria, adopted by the Association “National Council for Self-Regulation” on 25 September 2009, as amended in 2020.

The Codes of Ethics of the healthcare practitioners and the Dental Healthcare Code of Ethics of the dental healthcare practitioners mentioned above.

3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

3.1 General public

Advertising of a medicinal product shall be authorised in advance by the Executive Director of the Bulgarian Drug Agency (“BDA”). For this purpose, the marketing authorisation holder must submit to the BDA a standard application, enclosed with a set of documents, including, inter alia, a project of the advertising, which should be clear, contain understandable text and allow evaluation of all of elements of the advertising. The application is also accompanied by a PoA (if applicable) and the literary sources of quotations, tables or other material used in the advertising material (if any).  

The project of the advertising is subject to assessment by the Advertising Expert Council with the BDA. If the project is considered not compliant with the requirements of the MPHMA, the BDA would issue to the applicant an instruction to remedy the default within a one-month term. 

The timeline for providing the advertising authorisation or motivated refusal is one month as of the date of filing of the application. The advertising could also be considered tacitly approved, if the BDA has not issued a motivated refusal within the statutory term. 

The advertising authorisation is specific to the medicinal product and will only be valid for the term of validity of the marketing authorisation. 

3.2 Healthcare professionals (“HCPs”)

The advertising to HCPs is not subject to authorisation, but to a notification procedure to the BDA, whereby the applicant submits an advertising project, in accordance with the requirements of the MPHMA and the Ordinance.

No specific licenses/approvals/fees are required for medical devices to be advertised to either the general public or healthcare professionals.

4. Does the law in Bulgaria regulate the advertising of prescription-only and over-the-counter medicines differently?

Yes. POMs cannot be advertised to the general public. 

Vaccination advertising is allowed.

5. What are the main restrictions applicable to the advertising to the general public?

5.1 Medicines

As a general note (applicable to both POMs and OTCs) advertising shall be allowed only for medicinal products for which a marketing authorisation has been issued. The content of the advertisement must correspond to data from the medicinal product summary approved in the course of the marketing authorisation and shall present only indications specified in the course of the marketing authorisation.

There are a number of requirements on the content of the advertisement set forth in the MPHMA and the Ordinance. The advertisement of a medicinal product must suggest its correct use, objectively presenting its therapeutic indications, without exaggerating the effect of the treatment, or on the prevention or diagnosis using the medicinal product. The advertisement must not contain misleading information. The advertisement must not contain offers and/or promises of a gift and/or another material or nonmaterial benefit.

A healthcare professional or a person claiming to be a healthcare professionals may not engage in direct or indirect advertising of medicinal products in the printor electronic media, as well as on the internet.

The MPHMA specifies that only non- prescription drugs (OTCs) may be subject to promotion and advertising to the general public.

The Ordinance provides further details with respect to the content of over- the-counter advertising to the general public. 

As a general statement, the advertising of medicinal products intended for the general public including also the advertising or on the windows display of pharmacies and drug stores, must be clearly identifiable as advertising of a medicinal product. 

The Ordinance provides a list of forbidden content when advertising to the general public, including advertising creating the impression that the use of the medicinal product excludes the necessity of medical consultation or surgical intervention; or implies that the effects of the medicinal product are guaranteed without side effects, or that human health can be improved upon using the medicinal product. This list is not exhaustive. 

The Ordinance also prohibits advertising of narcotics and the provision of samples of medicinal products to the general public.

According to National Ethical Standards for Advertising and Commercial Communication in Bulgaria, adopted by the Association “National Council for Self-Regulation”, medicines, must not be shown as accessible for children without parental supervision. According to the Ethical Standards commercial communications must not show children using such materials.

5.2 Medical devices

According to Regulations 745 and 746, in the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:

  • Ascribing functions and properties to the device which the device does not have;
  • Creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
  • Failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
  • Suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Only CE marked medical devices may be promoted and placed on the market. Non-CE marked medical devices may be exhibited at trade fair and exhibitions provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.

No national specific restrictions applicable to the advertising of medical devices exist apart from the general rules applicable to advertising in general. 

In addition to that, according to the Code of Ethics of the healthcare practitioners, any signs or symbols on the plates in front of doctors’ offices, on letterheads and prescriptions, in phonebooks and other materials must not have the characteristics of an advertising.

6. What are the main restrictions applicable to the advertising to healthcare professionals?

6.1 Medicines

The general requirements as set forth in the MPHMA and the Ordinance for advertising of medicinal products (as stated in the previous section 5) shall apply. 

In addition, the Ordinance provides detailed requirements on the content of advertising to healthcare professionals. 

It is forbidden to indicate in advertising materials any data from unpublished trials or research or with unverified clinical importance, as well as to exclude or “downplay” contra indications or adverse events. 

The information contained in the advertising shall be accurate, updated, exhaustive and verifiable and shall allow healthcare professionals to develop their own opinion on the therapeutic importance of the medicinal product.

Tables, quotations or other information taken from published medicinal literature shall be accurately reproduced and the source must be correctly provided.

6.2 Medical devices

The general requirements for advertising of medicinal products (as stated in the previous section 5) shall apply.

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

7.1 Medicines

The Regulation enumerates the content of advertising to healthcare professionals:

  • Information complying with the data of the Summary Patient Notice, where the date of its last approval is indicated;
  • Means of prescribing of the medicinal product;
  • Quality and quantity composition, INN of the active and additional substance if necessary for the proper use of the medicinal product;
  • Name and address of the marketing authorisation holder, or its authorised representative, where healthcare professionals may receive full information on the advertised medicinal product.

The advertising may include the price and conditions for entire or partial reimbursement by the National Health Insurance Fund.

7.2 Medical devices

According to Regulations 745 and 746, in the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:

  • Ascribing functions and properties to the device which the device does not have;
  • Creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
  • Failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
  • Suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

There are no national specific requirements applicable to the information that must appear in advertisements directed to the general public for medical devices except the requirement that the purpose of use of the medical device has to be indicated in, among others, advertising materials.

8. What information must appear in advertisements directed to the general public?

8.1 Medicines

The advertising of medicines to the general public shall contain:

  • The trade name of the medicinal product and its INN;
  • Express information that this advertising is for a medicinal product;
  • Information necessary for the correct use of the medicinal product;
  • Age limit above which the medicinal product can be used;
  • The statement: “Read the patient notice before use”;
  • The statement: “Homeopathic product” if it is one;
  • Reminder of the necessity of renewal of the vaccination, (where applicable) in vaccination advertising; and
  • The number and date of the authorisation for advertising or of the application in case of tacit authorisation.

Further requirements may be applicable depending on the type of product and advertising used.

8.2 Medical devices

Advertisement for medical devices directed to the general public must include at least the following information:

  • Name of the medical device;
  • Purpose of the medical device;
  • Information essential for the correct use of the medical device;
  • Clearly visible indication of possible adverse effects; and

If applicable, clearly visible indication that adverse effects may also be caused and that the instructions for use must therefore be strictly observed or the advice of a doctor, pharmacist or dentist sought; in acoustic or audiovisual media the indication must be in acoustic form.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

As noted above, tables, citations or other information taken from published medicinal literature shall be accurately reproduced and the source correctly provided in the advertisement to HCPs. 

It is forbidden to indicate in advertising materials any data from unpublished trials or research or with unverified clinical importance. 

The purpose of use of a medical device shall be the purpose of use indicated on the label provided by the manufacturer, in the instructions for use and/or advertising materials.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

There are no specific rules in the MPHMA or Ordinance regarding comparative advertising. However, the competition law rules will apply.

Comparative advertising is allowed in cases expressly provided for under the CPA, specifically if:

  • It is not misleading and does not constitute unfair commercial practice;
  • It compares goods or services meeting the same needs or intended for the same use;
  • It compares objectively one or more characteristic features of the goods and services which are essential, comparable and representative of such goods and services, including their prices;
  • Does not lead to confusion between the advertiser and its competitors, or between its trademarks, brand names, other distinctive features, goods and services and those of its competitors;
  • Does not discredit or defame competitors’ trademarks, brand names, other characteristic features, goods, services, activities or positions;
  • Does not take unfair advantage of the popularity of the competitors’ trademark, brand name or other distinctive features of the competitors or the designation of origin of competing goods;
  • Does not present the goods or services as an imitation or copy of goods or services with a registered trademark or brand name.

The Arpharm Code contains specific requirements with respect to the self-regulation of comparative advertising. Any promotion and advertising, which points out directly or indirectly to a competitor or to a product of a competitor, is considered comparative promotion and advertising.

The information and statements contained in comparative promotion and advertising must comply with the Arpharm Code, be factually correct and be proved through reference to the respective source. When comparative advertising refers to studies that were not intended to directly compare the properties and characteristics of the advertised medicinal products and the medicinal products used for comparison, this must be explicitly stated in the advertisements.

Comparative advertising is forbidden if it:

  • Specifies medicinal products that have different therapeutic indications in comparison with the medicinal product that is the subject of the promotion or advertising;
  • Does not objectively clarify one or several of the main, relevant properties and peculiarities of the medicinal products concerned;
  • Creates confusion in respect to the company conducting the promotion and advertising and its competitors, or with respect to the medicinal products subject of the promotion and advertising, as well as to the medicinal products used as comparison, or regarding the trademarks of the medicinal products specified;
  • Contains statements defining the medicinal products used for comparison as an “imitation or copy” of the medicinal product, which is the subject of the promotion or advertising;
  • Contains disparaging or disgraceful statements concerning the products, activity, personal or business standing of a competitor or its employees; or if
  • Contains the trade mark of the competitor’s medicinal product or the name of the company of the competitor.

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

Internet advertising is regulated under the general provisions of the MPHMA and the Ordinance. The advertising on the internet of the prescription-only medicines is expressly prohibited.

The Arpharm Code expressly provides that it covers the cases of advertising on the Internet, including via websites and social media.

The competent authority to monitor compliance of advertising with the MPHMA and the Ordinance is the Executive Director of the BDA.

The compliance with observance of the ARPharM Code is controlled by the Arpharm Ethics Committee.

Other competent authorities are the Competition Protection Commission (“CPC”) and the Consumer Protection Commission.

Penalties under the MPHMA

The MPHMA provides for monetary sanctions of different levels depending on the type of breach and the person in breach. The sanctions for violations of the provisions in relation to advertising of medicinal products is in the range of approx. EUR 5,000 to 10,000. Broadcasters, publishers and distributors of the advertising are also subject to sanctions if they are found to be in breach of the MPHMA provisions.

Penalties under the Arpharm Code

The monetary sanctions range between 1,000 EUR to 3,500 EUR, depending on the nature and seriousness of the offence.

Competition law sanctions

The CPA expressly forbids certain types of misleading and comparative advertising. The sanctions imposed by the CPC in cases of a breach of the CPA provisions are very severe. They can be up to 10% of the aggregate annual turnover of the infringer for the previous financial year. Affected competitors may bring damages claims before the regular civil courts in case they have suffered damages in result of such breach.

Consumer law sanctions

Sanctions for violation of the prohibition for offering or selling POMs through distant means of communication can be up to EUR 7,500. Other violations (concerning certain provisions as regards unfair commercial practices within the territory of Bulgaria).

13. Any future developments in Bulgaria?

With respect to the advertisement of medicinal products, there are no future developments envisaged in the short-term.

Portrait ofAssen Georgiev
Assen Georgiev
Partner
Sofia
Portrait ofNevena Radlova
Nevena Radlova
Partner
Sofia
Iveta Manolova
Portrait ofAnna Tanova
Anna Tanova
Counsel
Sofia