Rola reklamy w prawie farmaceutycznym – polskie i rosyjskie doświadczenia (cz. II)


Dziś zamieszczam drugą część mojego referatu nt. reklamy w prawie farmaceutycznym w Polsce i Rosji – The role of advertising in the pharmaceutical market – Polish and Russian legal and economical perspective. Jest ona okrojona o dość obszerne fragmenty z zachowaniem jednakże głównej linii opisu i argumentacji. Poruszona tematyka zawiera rozróżnienie informacji od reklamy, a także porusza tematykę publicznej reklamy, skierowanej do pacjentów.

 

2.                 Marketing and advertisement – legal rules

(…)

2)               Advertisement and information

Polish regulation of the discussed area is contained in Pharmaceutical Law[3]. Article 52 section 1 of this statute says: Advertising of medical products is the business of informing and encouraging the use of a  medical product intended to increase the number of prescriptions, supply, sale or consumption of such products.

(…)

Section 3 of this article try to exclude some kind of actions from the scope of mentioned definition and differentiate information from advertising. Ratio legis of that exclusion is to give some space for advertisement in the area where the risk of confusion of patients or other poorly informed market participant is relatively low. However, this distinction might sometimes be blur.

Similar situation might be seen in Russia. Article 46 of the Law on Circulation of Medicines provides that there are some informational requirements which are not an advertisement i.e. name, dosage, manufacturing date etc. The role of this provision is similar to Polish article 52 section 3. As a result, ratio legis of that might be seen similarly.

(…)

The role of such restrictions is to promote registration of medicines (which is mandatory except rare situations) and as a consequence protect public health. That matter has  constitutional legal basis both in Russia and Poland. Article 7 section 2 of the Constitution of Russian Federation states that: „in the Russian Federation the labour and health of people shall be protected (…)”.

In Poland the most important article of Constitution in that case is article 76: „Public authorities shall protect consumers, customers or lessees against activities threatening their health, privacy and safety, as well as against dishonest market practices. The scope of protection defined by law”. In the present case this law is Pharmaceutical Law, mentioned before.

3)               Addressee of advertising

Provisions of Pharmaceutical Law in Poland, differ two types of advertising on the basis to whom this activity is addressed. First group are professionalls – people who are entitled to issue prescriptions. Regarding this group, the legislator have taken into consideration their broader ability to assess the value of advertised product. People who are authorized to issue prescriptions must have graduated medic school, gain practice and pass an exam to be a physician.

The second group is public opinion. Advertisements aimed to public opinion are more strictly limited. The reason of such regulation is that the average recipient of advertising is a consumer with little knowledge about pharmacy.

Russian law use similar differentiation[4]. Ratio legis of that provision is also similar, so the next to chapters will show these two types of advertising regarding both Polish and Russian law.

4)               Public advertising

As it was said before, public advertising rules are more strict than the advertising towards professionals. Both Polish and Russian law are similar in these area. However, the aim of this paper is not only to compare two systems of regulation but also to indicate the role of legal rules. Because of that, in this chapter, when it would not be said to which law – Polish or Russian, statement should be applied, it should be presumed that it is about both. This will be shown below.

Discussing public advertising of medicines we should indicate that some medicines might not even be advertised at all. For example, Russian Law on Advertising provides that prescription medicines, as well as medicines that contain narcotic or psychotropic substances approved for medical use, cannot be advertised outside specialist printed publications intended for medical and pharmaceutical professionals, and at certain medical or pharmaceutical events.

(…)

Polish law puts more emphasis on drugs which are present in the refund scheme. The reason of this emphasis is probably that there is more developed system of reimbursement and state aid in Poland than in Russia. However, after huge political debate and change of law in 2011 polish government limits the sums on reimbursement. One of the sign of that way was issuing Statute of Refund Medicines mentioned before, which came into force in January 1st 2012.

Such general bans on advertising are only a part of restrictions. Russian Law on Advertising contains general restrictions on advertising that apply to medicines as they do to any other product. There is a general requirement that advertising should be fair and true. However, the Law on Advertising also contains specific provisions applicable to medicines.

The Law on Advertising contains a requirement that the advertising of medicines must be accompanied by a warning about contraindications in their use, and the need to read the instructions on their use or the need to consult a specialist.

Similar general restrictions are applicable according to Polish law. Article 7 of Regulation of medical products advertising[6] provide special formula which should be attached to the advertisement. The same provision regulate even percentage of the space of whole advertisement occupied by such formula or the time in which it should be showed on the screen in the TV advertising.

Both Polish and Russian law ban advertising of medicines addressed to minors. Child are more sensitive to advertising and their ability to verify informations derived from the promotion campaign might be impossible. Manipulation of them is so easy that the ban of such actions should be seen as proportionate, when compare pros and cons.

Also advertising which contain statements or assumptions that consumers have certain diseases or impairments of health or include references to specific cases of recovery from disease or improvement of health as a result of the advertised object being used are banned. In these situations even adult might not be able to verify such information.

From that perspective we see that in some way, patients are treated as consumers. However, in my opinion we should distinguish these groups on the basis of source of their needs – patient’s needs are really existing because of their physical condition, while the consumer’s needs might be created by advertisement. For this reason, patient’s protection is stricter than other.

This line of reasoning represent provisions limiting the guaranteeing in advertising of a positive effect of the advertised object, its safety, efficacy and absence of side effects. Moreover, statements that the safety or efficacy of the advertised object are guaranteed by its natural origin are also forbidden[7]. Some advertisement might create an impression that a person does not need to consult a physician, even without guaranteeing positive effect. According to Polish Pharmaceutical law such information is banned[8].

Having in mind that all medicines to be registered should be used in the trials before its state registration, creating an impression of the advantages of the advertised object by reference to that fact should not be contained in advertisement. This is another step of protection of patients. Companies might take advantage over patients of their lack of knowledge of registration process and create an impression that there are medicines on the market which were not tried before selling.

Sometimes, advertising might be aimed towards healthy people. Some special restrictions on such actions apply i.e. it is impossible to facilitate the impression that a healthy person needs to use the advertised object (with the exception to medicines used for prevention of diseases). Also representing the advertised object as being a dietary supplement or other product that is not a medicine is contrary to legal rules.

Russian Law on Advertising contains an important general prohibition on using images of medical and pharmaceutical professionals in any advertisements, except advertisements of medical services and of personal care products, and advertisements exclusively for medical and pharmaceutical professionals.

Polish Pharmaceutical Law goes even further – advertising shall not contain not only images or opinions of medical and pharmaceutical professionals but also other publicly known persons. The reason of that is to increase value of product in the advertisement and not opinions of public figures who could be “bought” on the one hand, and to eliminate impression that only advertised products are the medicines which cure people and are recommended by doctors.

These few examples show the scope of restrictions in that area. However, state has to find a balance between security and public health, and interests of pharmaceutical companies. Provisions above shows the areas where interests of patient’s are more sensitive and protected by State.


[1] Pharmaceutical law from 6 september 2001, Polish Journal of Laws from 2001, number 126, position 1381 with subsequent changes.

[2] Advertising of medicines regulation issued by Polish Ministry of Health from 21 november 2008, number 210, position. 1327.

[3] Pharmaceutical law from 6 september 2001, Polish Journal of Laws from 2001, number 126, position 1381 with subsequent changes.

 

[4] Russian Federal Law No. 38-FZ on Advertising.

[5] Drug, specific food and medical devices reimbursement statute from 12 may 2011, Polish Journal of Laws from 2011, number 122, position 696.

[6] Advertising of medicines regulation issued by Polish Ministry of Health from 21 november 2008, number 210, position. 1327.

[7] Article 55 section 2 of Pharmaceutical law from 6 september 2001, Polish Journal of Laws from 2001, number 126, position 1381 with subsequent changes.

[8] Ibidem.

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  1. #1 by Marcin Snarski on Październik 29, 2012 - 7:51 am

    Witaj, rozumiem że rosyjską ustawę czytałeś po angielsku, skąd brałeś tekst? Rosyjskie bazy są łatwo dostępne, a angielskie tłumaczenia rozrzucone po sieci niekoniecznie muszą być aktualne, ale byłem kiedyś na jakimś serwisie który publikuje je w zorganizowany sposób… może z niego właśnie korzystałeś?
    PS W Rostowie byłeś wraz z kołem prawa WNP?
    Pozdrawiam

    • #2 by adrianbielecki on Październik 29, 2012 - 9:15 am

      Zgadza się, korzystałem z wersji angielskiej z racji, że nie znam języka rosyjskiego. Nie korzystałem z serwisu, o którym wspominasz – nawet nie miałem świadomości o jego istnieniu. Co do rosyjskich baz – problem bariery językowej nie był łatwy do przeskoczenia. Korzystałem z różnych źródeł biorąc nawet fragmenty ustaw po angielsku, bo tak jak napisałeś ciężko jest znaleźć aktualne wersje w j. angielskim. Jeśli znasz adres bazy, która jakoś ogarnia temat anglojęzycznych tłumaczeń – byłbym wdzięczny za adres.

      Co do drugiego pytania – tak, byłem na wyjeździe z UW, w którym brało udział obok koła WNP także koło myśli politycznej i prawnej, z ramienia którego byłem w Rostowie🙂

      Pozdrawiam,
      Adrian Bielecki

      • #3 by Marcin Snarski on Październik 29, 2012 - 9:34 am

        Niestety nie jestem w stanie wspomóc linkiem, widziałem to dość dawno (z rok) temu. To był bardziej jakiś periodyk internetowy z tłumaczeniami, niż baza. Tytuł brzmiał jakoś w stylu: współczesne prawo Rosji i WNP czy „ex-Soviet states”. Nie wiem, czy jeszcze istnieje, bo potem nie mogłem go namierzyć.
        Poradziłeś sobie w najrozsądniejszy sposób🙂 W doraźnych sprawach, gdy nie jest to bardzo ważne, ale jest potrzeba się zapoznać z rosyjskim tekstem to ten translator jest lepszy od googlowego http://pl.pons.eu/ Przynajmniej portugalski nieźle obsługuje, może przy słowianskim języku bardziej wariuje… Ewentualnie możesz uderzyć do mnie, kontakt zaraz dodam na swoim blogu🙂
        Dobrze, że ta współpraca naukowa się rozkręca, brakowało trochę symetrii wschód-zachód jeśli chodzi o partnerów UW.
        Pozdrawiam

  2. #4 by Marcin Snarski on Listopad 6, 2012 - 10:36 am

    A jednak udało mi się coś znaleźć, oczywiście jak szukałem czegoś innego. Dzięki temu zbiorowi http://www.nyulawglobal.org/globalex/russia.htm wychodzi, że musiałem natrafić na Russia and the Republics: Basic Legal Texts albo Statutes and Decisions: the Law of the USSR and its Successor States. Ponieważ darmowy dostęp jak widzę do obu jest mocno ograniczony, to musiałem trafić na jakąś stronę, którą zamknięto, bo zbyt hojnie się nim dzieliła. Za to na pewno inne linki będą użyteczne.
    My mamy LexPolonicę, Lexa i Legalisa. Rosjanie korzystają z Garanta, ConsultantPlus i Kodeks. Okazuje się, że ten pierwszy na bieżąco zamieszcza tłumaczenia części aktów (te istotne dla działalności gospodarczej) http://english.garant.ru/online/ tutaj można wypróbować ich bazę z tłumaczonymi tekstami. Sądze, że cięzko o bardziej aktualne i systematyczne źródło tłumaczeń. Nie wiem jak dokładnie jest z dostępem do tej wersji ogólnie. Sprawdziłem tylko czy działa. Do rosyjskiej w dzień jest darmowy dostęp do podstawowych aktów, a wieczorami i w nocy do rozszerzonej (np. dochodzi orzecznictwo)
    Pozdrawiam

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