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LEGAL ALLIANCE, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries.

OUR CLIENTS represent the following industries: pharmaceuticals, medical devices, consumer goods, medicine, cosmetics, para-pharmaceuticals, chemistry, biotechnology, agriculture and food products.

LEADING ASSOCIATIONS — AIPM Ukraine, APRaD as well as the EBA Healthcare Committee have chosen Legal Alliance as their legal advisor.

Promotion of medicines: legal aspects of interaction with healthcare professionals

Yevgen Prohorenko, Аптека.ua, 3.12.2018

On October 17th, 2018 seminar “Communication with HCPs and Promotion of Medicines: Rules, Requirements and Limitations” was held. The event was organized by Legal Alliance Company. Partner Oleksii Bezhevets and associate Nataliia Abramovych were speakers at the seminar. At the event legislative requirements to sponsor and charity aid, various ways of medicines promotion, in particular with the use of digital promotion, and interaction with healthcare professionals were discussed.

MAIN REGULATORY LIMITATIONS

Nataliia Abramovych emphasized that in accordance with the anticorruption legislation doctors fall under the category of persons subjected to rules on anticorruption violations, namely unlawful benefits, and rules on limitations on gifts, and conflict of interests. Unlawful benefit covers not only money or tangible items, but also any services or privileges.

The main difference between unlawful benefit and gift is that the unlawful benefit is obtained without lawful ground, and a gift is an object, service or privilege obtained for free or at the price lower than minimum market price. The legislation establishes both prohibitions and limitations on gifts. The prohibition on getting gifts applies to persons carrying organization or administrative and managerial duties in public legal entities. Officials of public and communal healthcare facilities can accept personal and business gifts provided that:

  • they are not given due to activities of these persons related to state or local self-government functions fulfilled by them;
  • they are not given by a subordinate;
  • they comply with the common rules of hospitality;
  • they do not exceed cost limits.

Personal gifts:

  • gifted to close persons, old friends, acquaintances, and;
  • for birthday, anniversary or popular holiday (New Year, International Women’s Day, etc.).

Business gifts (in modest scale):

  • souvenirs or hospitality demonstration (invitation for coffee or dinner); and
  • widely used to create good business relationships and strengthen work relations.

Legal entities are not subjected to the prohibition to take gifts, however, it should be remembered that in Ukraine most doctors are employees both of private clinics and state and communal facilities. In such cases the prohibition will apply to them too.

Other employees should obey legislative limits related to the nature and cost of gifts. First, gifts to such employees should be in line with the common vision of hospitality (birthday, New Year, etc.). Secondly, cost of a gift should not exceed minimum living wage for able-bodied citizens. Now it is UAH 1,841, and from December 1st – UAH 1,921. For a year, the total cost of all gifts from one donor should not exceed two minimum living wages as of January 1st of the year in which gifts were accepted.

Cost limits will apply only if it is possible to clearly identify both donor and recipient of gifts. If it cannot be done, accordingly it is impossible to determine the total cost of gifts.

Gifts from close persons and gifts received as publicly available discounts, winnings, prizes, etc. are excepted from limitation rules. For example, it can be placement on a company’s website of an announcement for draw, bonus, etc. The unlimited number of persons can register to participate in such a draw. Accordingly, it becomes publicly available and is an exceptions not covered by gift limitation rules.

Oleksii Bezhevets has summarized that, by default ,from the standpoint of anticorruption legislation all doctors working in state and communal healthcare facilities should be considered responsible subjects to whom rules, limitations and restrictions apply. Also, it is valid for pharmaceutical workers of communal pharmacies.

Two spheres should be distinguished here: 1) state/communal; 2) private, since limitations on requirements are different for them. More stringent for state/communal employees and softer for private ones. The only thing which can happen to private employees according to legislation is commercial bribery. It means that anyhow a private sector employee is bribed and contrary to his company’s interests carries some actions for the benefit of the bribing person.

Also, a doctor’s trip abroad to attend any event if such a trip was financed by a pharmaceutical company can be considered corruption violation, especially in case there is no definite goal why the trip took place. A trip abroad will at least exceed financial limitations on gifts allowed by the legislation. However, if a doctor won the trip or won a publicly available lottery held by a pharmaceutical company, the trip is an exception and is not subjected to legislative limitation requirements.

During the event, O. Bezhevets also recommended the market participants to approve in their internal corporate documents a list of holidays for which gifts can be presented to healthcare professionals, since the legislation does not set such a list clearly.

LIMITATIONS ON PROFESSIONAL ACTIVITIES OF HCPs

N. Abramovych has noted that under Article 781  of the Law of Ukraine “Fundamental Provisions of Healthcare Legislation” there are 3 main prohibitions for healthcare and pharmaceutical professionals in their professional activities. Such persons do not have the right to:

1. Advertise medicines and medical devices, including prescribe such medicines on forms containing advertisement information and indicate manufacturers of medicines. In this case, advertisement refers to dissemination of information of a product to the unlimited number of persons. Therefore, it is unclear whether face-to-face doctor-patient consultation is advertisement. Given this, it can be considered individually aimed information not covered by advertisement definition.

2. Obtain samples of medicines and medical devices to be used in professional activities.

3. Obtain unlawful benefits from commercial entities which produce or realize medicines and medical devices.

Such prohibitions apply to both medicines and medical devices.

O. Bezhevets underlined that according to the legislation doctors do not have the right to obtain samples particularly to be used in professional activities, which means they are allowed to obtain them for personal use. In such cases, it is important to observe limits on gift cost set by anticorruption legislation.

Furthermore, doctors while carrying their professional activities may take part in implementation of card programs through which they can obtain samples of medicines. An option of charity activities through third persons when a pharmaceutical company makes a contract with a distributor or pharmacy chain on charity arrangement should not be excluded. The most important thing is that the contract not go beyond licensed activities.

Now it is allowed to disseminate information of medicines in the form of:

  • advertisement, when information is disseminated to the unlimited number of persons with a view of forming or maintaining awareness of advertisement consumers and their interest in a medicine. However, it should be remembered that advertisement of prescription medicines is allowed only in specialized periodicals designed for healthcare facilities and doctors, as well as at seminars, conferences and symposia on medical issues;
  • individually directed information, where there is a specific person to whom the information of medicines is provided at his request;
  • own opinion of an individual not related to entrepreneurial activities;
  • information of products under Article 15 of the Law of Ukraine “On Protection of Consumers’ Rights”.

The speaker emphasized that it is also allowed to disseminate information on prescription medicines in the above ways (except advertisement) and it will not be considered violation. In particular, according to Article 15 of the Law of Ukraine “On Protection of Consumers’ Rights”, a consumer may obtain necessary, available, reliable and timely information about products which enables his to make a conscious and competent choice. Such information should be provided to a consumer before purchase of the good and it is not considered advertisement.

This article contains a clear list of what such information must contain. Among other things, data on main characteristics of products, minimum number (weight, volume, etc.), rules and conditions of effective and safe use of the products should be noted. It means that these criteria apply to the instruction for use of a medicine. This information can be placed in the places where the drugs are realized and if the consumer permits, supplied to him through distance communication channels. In case the information is supplied through distance communication channels, it becomes individually aimed, which allows use of various advertisement materials.

SPONSORSHIP AND CHARITY ACTIVITIES

O. Bezhevets noted that the main difference between sponsorship and charity aid is that sponsorship implies compulsory benefit in response from the recipient, namely support exclusively in the form of promotion and popularization of the sponsor’s name and/or its trademark. Otherwise, it will be considered free financial aid or charity if it falls under objectives and subject list of charity.

According to Article 5 of the Law of Ukraine “On Advertisement” persons producing or distributing goods whose advertisement is prohibited by law cannot be sponsors. Hence, this prohibition applies to manufacturers which, among other things, produce prescription drugs. However, under Article 21(13) of the Law of Ukraine “On Advertisement” persons engaged in production and/or sale of medicines, medical equipment, methods of preventions, diagnostic, treatment and rehabilitation can be sponsors of TV and radio programs through supplying advertisement information about name or trademark, except for any reference to prescription medicines. Therefore, according to the Law of Ukraine “On Advertisement” as a whole, sponsors can be also manufacturers of prescription medicines, except for TV and radio programs.

For the time being there are two approaches to document registration of sponsorship:

1) as a single agreement, the essential terms of which will be:

  • subject matter (provision by a company of sponsor support in material, financial, organization or other form in exchange of popularization and promotion of its name and/or trademark by a contractor);
  • price (amount of provided sponsor support and conditions for its transfer/price of material benefits obtained by a person as sponsorship);
  • term (time determined by parties during which sponsorship relations will exist);

2) exchange of letters (essential terms remain the same, however the form of their approval is different).

O. Bezhevets stressed that as a rule to formalize sponsorship exchange of letters is used due to convenience of this method. In order to prove the amount spent on sponsorship, the following documents should be submitted to the accountant office:

  • letter-initiation, i.e. the request to provide sponsor aid;
  • letter-confirmation of such aid;
  • letter specifying that the sponsorship amount was spent on specific purpose. Besides, it must contain a proof confirming promotion of the sponsor’s name and/or trademark.

Regarding funding of HCPs participation in events, O. Bezhevets underlined that the most important thing is to prove why some concrete doctor received sponsorship aid. This doctor must be selected in such a way so that a company could not affect the process directly. A draw or lottery can be held, upon which candidates can be selected based on specific criteria. Alternatively, this function can be transferred to third party outsourcing – fund, association, etc. If such selection is not done, sponsorship aid recipient can be accused of unlawful benefit, in particular with respect to exceeding gift limits.

Charity aid is voluntary personal and/or property aid to attain objectives set by legislation, which does not imply obtaining any benefit by the donor or payment of any award or compensation to the donor on behalf or upon instruction of the beneficiary. For example, personal help can refer to gratuitous help in organization of any event, etc.

Objectives of charitable activities are providing help to promote lawful interests of beneficiaries (recipients of such help) in the areas of charitable activities, including healthcare, as well as development and support of these areas in public interests.

Main types of charitable activities include donation, grant, public collection of money. Main difference between grant and donation is that grant clearly specifies its target and term for achieving it.

Recipients of charity aid can become individuals, non-commercial organizations and territorial communities. Non-commercial organizations should be included in the Register of Non-Profit Organizations and Facilities. Otherwise, provision of such help is doubtful.

Recipients of aid from charity institutions can also be any legal entities which receive help to attain objective set by the legislation.

At provision of charitable aid for the benefit of its recipient transfer of money to a third party’s account, for example, organizer or technical partner of the event (in case of provision of charity grant for participation in the event) is allowed.

AGREEMENTS FOR PROVISION BY HEALTHCARE AND PHARMACEUTICAL PROFESSIONALS OF SERVICES/PERFORMANCE OF WORKS

N. Abramovych stated that conclusion of such agreements with HCPs is not prohibited by legislation of Ukraine. Mainly such agreements are entered into to deliver a speech at specialized events, workshops, etc.

There a limitation established for public officials should be taken into account, namely prohibition of combining of public service with other types of activities. Thus, this restriction applies to civil agreements, including on services. They are allowed to engage only in scientific, teaching and creative activities along with public service.

Anticorruption legislation of Ukraine does not set any limits on moonlighting for HCPs who are not public officials, but perform organization or administrative and managerial duties in a public legal entity, for example, chief doctors of healthcare professionals.

In order for the service agreements on participation of HCPs in the event not to go beyond legislation, it is necessary to clarify the provided service, place of provision, etc. in the subject matter of the agreement. For example, specify subject of the report for presentation at the conference, its venue and date.

BRANDED SOUNVENIR PRODUCTS

N. Abramovych noted that for healthcare professionals prohibition to give patients souvenirs containing brand of medicines as advertisement is the most important. However, they are not prohibited from using for personal purposes in non-working hours souvenirs with both brand of medicines and logo of pharmaceutical company. Placement of souvenirs with brand of pharmaceutical companies is allowed in an office where patients are examined.

Furthermore, there is no direct prohibition to place in the doctor’s office souvenirs with brand of medicines or give a patient souvenirs with brand of medicines or pharmaceutical companies. However, the speaker did not recommend to do it due to the existing risk of recognizing such actions advertisement.

UNUSUAL PROMOTION METHODS

O. Bezhevets among such methods has distinguished webinars, blogs/forums, landings, information on the problem without specification of the drug name, websites of companies manufacturers. Thus, webinars can be held for:

  • promotion of prescription drugs (exclusively on medical subjects; as a rule for healthcare professionals);
  • promotion of OTC drugs (on any subjects for any audience).

On forums or in personal blogs individuals can share their opinion on various subjects, including through their attitude to a medicine. However, it should not be related to entrepreneurial activities. For example, when any public person (sportsman, actor, popular blogger, etc.) publishes photos of medicines with the advertising text seen by millions of subscribers on social network or blog. Such bloggers can be directly accused of advertising only provided that their connection with a pharmaceutical company or distributor can be proven.

Website of a company manufacturer of medicines can contain information on such drugs (both prescription and OTC) on the condition that terms of Article 12 of the consumer’s rights protection law are observed.

In its turn medicine landing must comply with Article 15 of the Law of Ukraine “On Consumers’ Rights Protection” or Article 12 of the Law “On Advertisement”. In particular, when the website is being opened, a consumer sees a window with a question whether he wants to see information on some medicine. If clicked “yes”, the user gets access to landing. Thereby requirements of law for the manufacturer to provide information about a medicine to the user at his request are fulfilled.

Also, pharmaceutical companies may initiate discussion of a problem, for example, treatment of a disease without indication of a medicine’s name or international non-proprietary name. When this subject gets more and more publicity, companies actually widen their niche of prospective buyers at the market.

Medicines can be promoted also with the use of independent information portals. However, it should be remembered that only portals having registered specialized printed periodicals can place information on prescription drugs. However, if an information portal exists only in electronic form and poses itself as a specialized periodical for healthcare professionals, advertisement and placement of information only about OTC medicines is allowed there. If the platform places advertisement of prescription medicines, it can be brought to liability for violation of legislation in the area of medicines’ advertising.

The speaker drew the audience’s attention to the fact that such kinds of promotion of medicines as games, competitions, contests, etc. are actively developing, also placement on websites of pharmaceutical companies and mobile applications (games, health condition control, programs for HCPs). Now there is a practice of use of mobile applications by medical representatives, since what they show to doctors in such applications remains confidential information.

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