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

Ograniczenia dotyczące reklamy w prawie farmaceutycznym stanowią jeden z przykładów ograniczeń działalności gospodarczej sektora produkcji i dystrybucji leków. Ustawodawca wprowadzając restrykcje w tym zakresie bierze pod uwagę interesy pacjentów, szczególnie w kontekście ochrony zdrowia publicznego. Z drugiej strony interesy producentów przemawiają za jak najmniejszym zakresem ograniczeń. Zarówno z jednej, jak i drugiej strony mamy do czynienia z interesem prawnym i ekonomicznym.

Tę tematykę poruszyłem w prelekcji na międzynarodowej konferencji naukowej w Rostowie nad Donem (Rosja) 24 kwietnia 2012 r. Tytuł referatu brzmiał: The role of advertising in the pharmaceutical market – Polish and Russian legal and economical perspective”. Poniżej znajduje się fragment (cz. I) tamtego wystąpienia.

1.                 Introduction – economical background (part I)

Pharmaceutical sector is a part of economy of special importance. From business point of view it can be seen as high technology industry, based on costly research and development. On the other hand, public health is one of the main issue in policy agenda. There are some areas where this two points of view collide. One of them is an area of marketing medicines.

The interest of producers of pharmaceutical products is to sell as many as they can. Cost of producing innovative drug is enormous. According to the Delloite’s report “Measuring the Return from Innovation”  the cost of introducing new drug was about 830 million dollars in 2010 and about 1,048 billion dollars in 2011[1]. It’s a 25% increase in only one year. In the same time the average number of medicines in advanced phase of development decreased from 23 to 18 for each major company[2]. These numbers show that inventing new drugs is more and more difficult. The analysts do not think that the trend would be reversed.

Although that, we should keep in mind that inventing is only first step to commercial success. According to the research, pharmaceutical companies spending on marketing far exceeds the expenses on research[3]. In 2011 in Poland, there were around 1 billion USD spent on marketing by pharmaceutical companies while the total sale in that sector was over 10 billion USD[4]. The market in Russia is also a big one – the size of that was 8.6 billion USD in 2010, and it was growing rapidly, because the annual growth rate for the past four years was 14.2 percent

On the other hand, there are interests of patients. They want to buy medicines for as little as it is possible. It is known that sick people basically are the poorer ones. This creates a situation of collision between patient and company interest.

State has also its own interest in this area. By the refund scheme, polish National Health Fund spent around 2,75 billion USD while whole pharmacy market in Poland was worth around 8,87 billions USD[5]. To limit the value of subsidies, Sejm (Polish parliament) passed a law – Statute of Refund Medicines[6]. It changed legal environment of pharmaceutical business i.e. by establishing rigid margins on reimbursable medicines or sharpen the limitations of pharmacy advertisement.

Russia has its own new legislation in that area. New Russian public health laws will has begun coming into effect on Jan. 1, 2012. The scope of change is broad – i.e. drug registration, orphan diseases. Partially it covers an area of promoting in the form of visiting medical practitioners and pharmacists by the representative of pharmaceutical and medical equipment companies. Also other statutes contain provisions concerning discussed area.

The aim of this article would be to compare Polish and Russian legal and economical environment and experience in that area. I will focus on Polish regulations with reference to their Russian equivalent to compare some institutions. However, the main question would be – what is the purpose of legal rules concerning this area?

[2] Ibidem.

[3] M. Brezis, Big pharma and health care: unsolvable conflict of interests between private enterprise and public health,  „Isr J Psychiatry Relat Sci” 45/2008, p. 90.

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


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