This country-specific Q&A provides an overview of the legal framework and key issues surrounding pharmaceutical advertising law in Lithuania.
This Q&A is part of the global guide to Pharmaceutical Advertising.
For a full list of jurisdictional Q&As visit http://www.inhouselawyer.co.uk/index.php/practice-areas/pharmaceutical-advertising
What laws are used to regulate advertising on medicines in your jurisdiction?
The Law on Pharmacy of the Republic of Lithuania (approved by the Seimas), Regulations on Medicinal Products Advertising (approved by the Order of the Minister of Health), Procedure for Qualification Improvement of Healthcare and Pharmaceutical Specialists (approved by the Order of the Minister of Health).
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
Yes, two associations – the Innovative Pharmaceutical Industry Association (representing manufacturers of innovative medicines) and the Pharmaceutical Manufacturers Association (representing manufacturers of generic medicines) – have approved the Code of Ethics for Pharmaceutical Marketing (hereinafter referred to as the Code of Pharmaceutical Ethics).
The Code of Pharmaceutical Ethics applies to pharmaceutical companies that supply medicines to the Lithuanian market. This Code regulates the ethics of marketing of medicines (in more detail than regulated by law). The Code regulates the relationship between pharmaceutical companies and healthcare professionals, and medical institutions, companies and pharmacists, companies and patients, companies and governmental authorities, defines issues of pharmaceutical support, ethics of sales promotion actions, etc.
The Code of Pharmaceutical Ethics does not have a binding legal force as a law or an order of the Minister of Health. It is a self-regulatory document that is binding only on members of associations that have approved the Code of Pharmaceutical Ethics. Public authorities that control the advertising of medicinal products do not follow the provisions of this Code.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
The definition of advertising of medicines is provided in the Law on Pharmacy of the Republic of Lithuania. This advertising includes the spread among the general public, healthcare professionals and pharmaceutical specialists, in any form and by any means, of purposive information about medicinal products, the canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. These activities include:
(i) visits by medical sale representatives to healthcare professionals;
(ii) distribution of free samples of medicinal products;
(iii) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of a benefit or bonus, whether in money or in kind;
(iv) sponsorship of promotional or scientific events, attended by healthcare and pharmaceutical specialists and in particular payment of the travelling and accommodation expenses of the participants of such conferences;
(v) the support of radio, television broadcasts and/or programmes during which information about medicinal products is provided.
In practice, advertising of medicines is considered to be the presentation of branded medicine names, medicine package images, medicine filler images on the slides (whether in scientific reports or promotional messages).
The assessment of advertising is individual in each separate case and depends on an array of circumstances. For example, patient information leaflets are not advertising in themselves, but if excerpts from two patient information leaflets of competing medicines are provided by comparing the contraindications of these products with each other, it will be considered comparative advertising.
Yes, it applies to all groups of interest.
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
In principle, press releases are possible, but their publishing depends on the content and on their target audience.
Press releases on prescription medicines are possible only to healthcare professionals or pharmacists, including clinical information, brand name and generic name, and other information.
If press releases are released to the general public, they may be only about over-the-counter medicines and no brand names may be provided.
In practice, there were cases in which a public authority announced information to the public that a decision had been made to reimburse a particular medicine (and mentioned its brand name), and when the company itself reprinted this information, it was recognized as advertising for that medicine.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
There is no statutory obligation to obtain approval for advertising prior to publication. Some pharmaceutical companies ask external lawyers for conclusions on the compliance of their prospective advertising with the law, while others apply to the State Medicines Control Agency, pay the state fee and request an expert examination of the intended advertising. The conclusion of the SMCA is valid only if the layout of the advertisement is not changed later (colours, texts, wording, etc.).
Do companies have to have material approved by regulatory bodies prior to release?
No, such approval is not mandatory.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
All comparative advertising is governed not by the Law on Pharmacy of the Republic of Lithuania, but by the general Law on Advertising of the Republic of Lithuania.
There is a number of requirements for comparative advertising, arising both from the law and from the practice of various state institutions and case law.
For example, such advertising must not be misleading, the medicines compared must be intended to treat the same disease or have the same therapeutic effect, the advertisement must not cause confusion, must not discredit or disparage the particular medicine, there must be no dishonesty, etc.
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
Advertising of unauthorised medicines to either professionals or patients is prohibited. However, pharmaceutical information – scientifically sound, based on clinical trials and included in the summary of medicine characteristics – can be provided.
Yes, such information can be provided during a scientific conference, specifying that this is the treatment with unauthorised medicines.
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
Prescription medicines other than vaccines may not be advertised to the general public.
When advertising over the counter medicines to the general public, the following shall be provided:
(i) the name of the medicine and the name of the medicinal substance contained;
(ii) the pharmaceutical form and the strength of the medicine;
(iii) therapeutic indications except for homeopathic remedies;
(iv) route of administration of the medicine;
(v) dosage of the medicine;
(vi) special warnings (for example, "Please read the package leaflet carefully and take the medicine as prescribed. An improper use of this medicine may harm your health”);
(vii) contraindications to the medicine.
When advertising over-the-counter medicines to the general public, the following is prohibited:
(i) to claim that the medicine is advised by scientists, doctors or other celebrities (e.g. politicians, public figures, actors, artists, sportsmen, etc.);
(ii) to provide a specific medical case history that could lead the general public to wrong self-diagnosing;
(iii) to misleadingly assure that the patient will recover using the medicine;
(iv) to use misleading definitions and graphic material depicting changes in the human or animal body caused by disease, injury or the medicine being promoted;
(v) to provide children-centric material;
(vi) to presume that no consultation by a physician or surgery is required, in particular to specify a diagnosis;
(vii) to indicate that the therapeutic effect of the medicine is guaranteed and it has no adverse reactions;
(viii) to state that the medicine is a food, cosmetic or other commonly used product;
(ix) to indicate that the medicine is safe or effective because it is natural;
(x) to specify reduced prices of medicines (discount rates can be displayed);
(xi) to advertise medicines and food supplements in the same advertisement insert during a radio or television program or between them.
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
There are basically no restrictions. The cooperation must be transparent and legally substantiated.
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
Yes, information about clinical trials, scientific publications can be sent as it is considered pharmaceutical information. However, if these publications are accompanied by a message that “New clinical trials show the advantage of YYY in its product group. It has been proven to be more effective and safer for patients. Please be advised that starting with the next month, there will be a better medicine availability in pharmacies and higher budget reimbursement, so you can confidently prescribe it to your patients,” this message, although supported by scientific evidence, will be considered as advertising for the medicine.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
Gifts from pharmaceutical companies to healthcare professionals are prohibited. This is considered as advertising for medicines that is prohibited.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
Samples can only be demonstrated but cannot be left. The demonstration, according to a special order of the Minister of Health, shall not take place in private communication between the company representative and the healthcare professional, but in an internal event of a medical institution, the date and time of which must be approved by the administration of the medical institution. The visits of representatives of pharmaceutical companies are governed by the order of the minister and separate regulations of medical institutions.
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
Yes, sponsorship is allowed. Sponsorship must be transparent, documented. Sponsorship is only possible under a sponsorship agreement when a health professional submits a reasoned request for sponsorship. The sponsoring pharmaceutical company must report this to the Supervisory Committee for the Code of Pharmaceutical Ethics, specifying their sponsored events, healthcare professionals, and the amounts sponsored. Sponsorship reports (without detailing names) are also submitted to the State Tax Inspectorate. There is no difference between sponsored events in Lithuania and abroad.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
None. It is an established practice that a pharmaceutical company is a sponsor of a sports event (running marathon), cultural event (exhibition, etc.).
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
Yes, it is possible. In the case of services provided by a healthcare professional or pharmacist to a pharmaceutical company, a service contract must be concluded and the scope of the services clearly defined. Typically, such services include the collection and systematisation of clinical practice, the preparation of slides and reading reports, the preparation of advice and recommendations on the use of the product should there be a need to adapt the available material, to summarize clinical trial results, etc.
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
In Lithuania, grants are awarded to societies, unions or associations of patients or healthcare professionals. Supporting specific healthcare professionals or patients is possible only in exceptional cases.
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
Yes, there is such a requirement. It is applicable to all pharmaceutical companies operating in the market, irrespective of whether it is a national (Lithuanian) or foreign pharmaceutical company that has an agency, branch or subsidiary in Lithuania.
Requirements for disclosure of values are set out in the Code of Pharmaceutical Ethics, but in the practice of SMCA it is also positive regarded that the company declares events, discloses values and adheres to other relevant requirements.
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
Existing legislation regulates all advertising, regardless of where and how it is disseminated – through live communication with the general public or healthcare professionals, in scientific publications, conferences, press, internet, social networks, e-mails, closed websites (where pre-registration is required). The requirements for advertising depend on the mode of supply of the drug (authorised/unauthorised) and prescription type (prescription / over-the-counter), but this is not related to the place where the advertising is disseminated.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
There are many such requirements. General requirements are listed in Code of Pharmaceutical Ethics, the Law on Prevention of Corruption, and the Law on Pharmacy. If a healthcare professional works in a public (budget) medical institution, the requirements of declaring public and private interests are additionally applied to him/her.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
The Law on Pharmacy of the Republic of Lithuania (approved by the Seimas), Regulations on Medicinal Products Advertising (approved by the Order of the Minister of Health), Procedure for Qualification Improvement of Healthcare and Pharmaceutical Specialists (approved by the Order of the Minister of Health), Code of Pharmaceutical Ethics (a self-regulatory document).
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
Supervision is carried out as follows:
(i) In the case of violations of the requirements for the advertising of medicines – by the State Medicines Control Agency;
(ii) In the case of comparative advertising of medicines – by the Competition Council;
(iii) In the case of the Code of Pharmaceutical Ethics – by the Supervisory Committee for the Code of Pharmaceutical Ethics.
Usually, a pharmaceutical company that disagrees with the decisions of the relevant supervisory authority, applies to the court. However, litigations in the area of advertising of medicines are not frequent.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
See the response to the question 22.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
The sanctions are as follows:
(i) For violations relating to the advertising of medicines – from EUR 560 to EUR 3000 (depending on the nature of the infringement);
(ii) For violations relating to comparative advertising of medicines – up to 3% of the annual financial turnover for the year in which the violation was committed;
(iii) For violations of the Code of Pharmaceutical Ethics – making a public statement on the website of the Supervisory Committee for the Code of Pharmaceutical Ethics that a penalized pharmaceutical company is unethical.
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
These procedures are unrelated. Self-regulatory authorities, as well as SMCA, can appeal against the decisions to the courts. In practice, the SMCA takes into account the decision of self-regulatory authorities regarding the ethics of the company when addressing the issue of violation of the laws on medicine advertising.
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
Advertising of medicines is not an infringement which is the subject of a public press release or other publicity by the authorities. Typically, these are minor technical violations that in rare cases lead to administrative fines.