Pharmaceutical advertising regulation and medical device advertising in Bosnia and Herzegovina

  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 Bosnia and Herzegovina regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices 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 for medicines and medical devices?
  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 in Bosnia and Herzegovina. 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 Bosnia and Herzegovina?

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

The primary legal source regarding advertising of medicines and medical devices in Bosnia and Herzegovina is the Law on medicines and medical devices, adopted at state level (“Official Gazette of B&H”, No. 58/08) (Zakon o lijekovima i medicinskim sredstvima).

The secondary legal source is the Rulebook on the manner of advertising medicines and medical devices (“Official Gazette of B&H” No. 40/2010) (Pravilnik o načinu oglašavanja lijekova i medicinskih sredstava).

Yes, there is a Code of Conduct of the Association of Innovative Medicine Manufacturers of Bosnia and Herzegovina (Udruženje inovativnih proizvođača lijekova u Bosni i Hercegovini-“UIPL”) which governs the advertising of prescription-only medicines to professional public (stručnoj javnosti) and communication between healthcare professionals and medicine manufacturers (UIPL is a member of the European Federation of Pharmaceutical Industries and Associations).

In addition, the Agency for medicines and medical devices of Bosnia and Herzegovina (Agencija za lijekove i medicinska sredstva BiH-“ALMBIH”), established by the Law on medicines and medical devices is the supervisory body for the field of medicines and medical devices that are manufactured and used in Bosnia and Herzegovina.

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?

In general, medicines and medical devices are only advertised in B&H on the basis of a marketing authorisation license issued in accordance with the Law on medicines and medical devices of B&H.

A legal entity with its seat in B&H, which is a marketing authorization license holder in B&H (or the holder of the certificate of registration in the register of medical devices) must organize its service, or designate a person in charge of advertising and providing information on medicines and medical devices that are placed on the market.

The license holder must:

  • Have at their disposal and at the request of the pharmaceutical inspection, copies of all advertisements, together with an indication to which users they are intended, the method of publication and the date of first publication;
  • Ensure that the persons who advertise the medicine or medical device to the professional public are properly trained;
  • Ensure that the decisions of the pharmaceutical inspection regarding the advertising of medicines / medical devices are fully implemented without delay;
  • Provide the pharmaceutical inspection with all the information necessary to monitor the advertising of medicines and medical devices.

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

Yes.

This distinction plays an important role regarding advertisements that are addressed to the general public in such a manner that, while advertising of non-prescription medicines to the general public is permitted under certain conditions, advertising of prescription-only medicines to the general public is generally prohibited (please see below).

5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

As a general rule, a medicine cannot be advertised to the general public unless it has an authorisation license, while advertising of a medical device to the general public is not allowed if the medical device does not have a certificate of entry in the register of medical devices.

Pursuant to applicable legislation, it is prohibited to advertise the following medicines to the general public:

  • Prescription-only medicines;
  • Medicines issued at the expense of compulsory health insurance;
  • Medicines containing narcotic drugs or psychotropic substances.

In addition, when advertising medicines and medical devices to the general public, it is not allowed to:

  • State that the medicine or the medical device has no adverse effect;
  • State that taking/using the medicine or medical device guarantees success in the treatment of the disease;
  • State that a certain medicine or medical device is undoubtedly better than other medicines or medical devices;
  • State that it is good to take the medicine and the medical device even when there are no signs of illness;
  • State that not taking/using some medicines or medical devices may adversely impact health;
  • State that the medicine or the medical device is safe and effective because of its natural origin;
  • State that medicines and medical device represent dietary, cosmetic or other product of mass use;
  • State that using the medicine or medical device may avoid medical examination, advice or surgery and to determine a diagnosis and offer advices about the treatment by post or e-mail;
  • Indicate that a recommended medicine and medical device may be replaced by other medicine and medical device;
  • Advertise exclusively or mainly to children and where children are shown taking the medicine or medical device, or that a medical device is available to children without the presence of adults;
  • Include recommendations from healthcare professionals or scientists and recommendations from people who could encourage the use of medicines and medical devices because of their popularity;
  • Specify the notice of the inclusion of medicine and medical device in the list of medicines and medical devices that are issued at the expense of the compulsory health insurance;
  • Use the disease history or display diagnostic procedures that could lead to wrong self-diagnosis or self-treatment;
  • Use of inappropriate, disturbing or misleading expressions and images of changes in the human body caused by disease, injury or effect of some medicine or medical device to the human body or parts of the body;
  • Refer to inappropriate, harassing or deceptive evidence of healing.

Other restrictions are also proscribed such as TV advertising, print media etc.

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

During the advertising process to the professional public, main restrictions are that it is not allowed to:

  • Encourage the professional public that one medicine or medical device can be replaced by another medicine or medical device from the same treatment group without a clear medical indication;
  • Make statements or conclusions on the efficiency of the medicine or medical device which are subject of clinical trials in the country or abroad;
  • Advertise a medicine or medicinal device that is in the process of amending the summary of medicine characteristics and the approved patient instruction;
  • Provide a summary of the medicine characteristics, relevant information from the summary of medicine characteristics, or an approved patient instruction using font sizes less than 3mm or other printing methods that make it unable to read and understand;
  • Publish the information intended for professional public through the mass media;
  • Diminish the importance of the warnings on precaution or adverse reactions listed in the approved summary of medicine characteristics;
  • Diminish the therapeutic value of another medicine or medicinal device or to in any other way raise doubt about the value of another medicine and medical device;
  • Use the name of the competent Ministry of Health, Agency, or legal entities participating in the examination procedure, and placing the medicine or medicinal device on the market;
  • Use of material protected by any form of intellectual property protection without the prior consent of the owner;
  • Use of postcards or other forms of written mail whose content may be accessible or readable by persons other than professional public;
  • Use of the telephone, fax, email or other electronic systems of persons belonging to the professional public without their express prior consent of advertisement.

Other restrictions are also proscribed.

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

Each advertisement for medicines or medical devices directed only to professional public must contain essential information on the medicine or medical device, identical to those in the summary of medicine characteristics or patient instructions.

Advertising to professional public must contain at least the following information:

  • The number of the authorisation;
  • The manner of publication;
  • The name and address of the authorisation holder;
  • The name and the international name of the active substance(s);
  • Approved indications, contraindications, precautions and frequent adverse reactions;
  • The dosage, instructions of use and warnings.

All information in the promotional material, that are part of advertising of a medicine / medical device, must be accurate, up-to-date, verifiable and sufficient to enable the professional public to form their own opinion on the therapeutic value of the particular medicine / medical device. In addition, all promotional materials must include a date of production or a date of modification.

8. What information must appear in advertisements directed to the general public for medicines and medical devices?

An advertisement for medicines / medical devices that is directed to the general public must include:

  • The name of the medicine or medical device, or the international name of the medicine;
  • Information necessary for the proper use of the medicine or the medical device;
  • Notification for the patient to carefully read the package instructions or the instructions on the external packaging or container.

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.)?

In general, advertising of medicines and medical devices must provide true and scientifically proven information about medicines and medical devices in compliance with ethical criteria, and in order to ensure their adequate and rational use, without misleading the users. The advertising for the medicine must also be in accordance with the summary of main medicine characteristics and the approved medicine manual.

Statements, tables and other graphic material taken from medical journals or other scientific material which are part of the promotional material must be faithfully reproduced with the indication of the exact sources.

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

As stated above, when advertising medicines or a medical devices to the general public, it is not allowed to:

  • State that a certain medicine or medical device is undoubtedly better than other medicines or medical devices;
  • Indicate that a recommended medicine and medical device may be replaced by other medicine and medical device.

When advertising medicines and medical devices to a healthcare professional, it is not allowed to:

  • Encourage the professional public that one medicine or medical device can be replaced by another medicine or medical device from the same treatment group without a clear medical indication;
  • Diminish the therapeutic value of another medicine or medicinal device or to in any other way raise doubt about the value of another medicine and medical device.

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

In case of internet advertising, the warning ‘‘Read the package leaflet carefully before use. Consult your doctor or pharmacist for information on indications, precautions and adverse reactions to the medicine and the medical device’’ must be an integral part of the main / home page of the advertisement and not its link.

Pharmaceutical-inspectorial supervision over the implementation of the relevant law and regulation derived therefrom is performed by the pharmaceutical inspection, i.e. the inspection formed within the Agency for medicines and medical devices of Bosnia and Herzegovina as the relevant supervisory body.

Duties of the pharmaceutical inspection are performed by pharmaceutical inspectors, i.e. Agency inspectors.

A legal person will be issued a fine in the range of 5.000 BAM to 15.000 BAM (approx. 2.555 EUR to 7.670 EUR) if it does not comply with the relevant provisions related to the advertisement of medicines or medical devices.

13. Any future developments in Bosnia and Herzegovina?

An initiative to prepare and submit a proposal for the new Law on medicines and medical devices of B&H as soon as possible in order to harmonize this regulation with the new EU regulations was recently accepted at the Parliamentary Assembly of B&H.

Picture of Nedzida Salihovic-Whalen
Nedžida Salihović-Whalen
Partner
Sarajevo