Pharmaceutics & Novel Drug Delivery Systems

Pharmaceutical industry plays a major role in the country’s economic development. Though, in the European countries there are general regulations (Directives) and the pharmaceutical market of each country is unique because it has its own statutory regulation, economic and demographical factors influencing it. Polish pharmaceutical market has its own features and peculiarities. This is the only market in the European Union, where advertising of pharmacies is prohibited.

 

Statement of the Problem: Since, January 1 2012, by art. 94a of the Pharmaceutical Law Act issued on May 12, 2011, it is forbidden to advertise pharmacies, pharmacy points and their activities in Poland. The ban, which was in force until the end of 2011, applied only to the advertising of pharmacies, which is related to reimbursable drugs or drugs with the same name as covered by a refund. The current Pharmaceutical Law applies to all activities of pharmacies. Nevertheless, Polish pharmaceutical law does not define the term advertising of pharmacy and its activities, however, it is indicated that every action is directed to the public, aiming to boost sales of medicinal products and medical devices offered by a given institution. Such, a definition of advertising is understood very broadly in practice and can be misleading for all participants of the market. The pharmacies are not allowed to issue newsletters about price cuts, participate in loyalty programs and use promotional information in the name (e.g., cheap medicines). The Supreme Administrative Court recognized that encourage using the sphygmomanometer is also a form of pharmacy advertising, although the law allow to provide information regarding the address of the institution and its working hours. The entry into force of the above law violates the legal norms of the European Union. Moreover, at the beginning of the year 2018, the Presidium of the Supreme Medical Council appealed to the Polish Minister of Health with a petition to consider a total ban on advertising of OTC drugs for that reason Polish pharmaceutical market is on the verge of global change. The purpose of this study is to describe the existing situation in the Polish pharmaceutical market to indicate the gaps and to highlight its controversial nature.

 

Methodology & Theoretical Orientation: The framework of study contains legal practice and statutory regulations overview. 

 

Findings: Polish pharmaceutical regulations are not compliant with EU regulations; strict regulation has increased price competition in the Polish pharmaceutical market. 

 

Conclusion & Significance: The applications resulting from the Court of Justice of the EU ruling and the cited Pharmaceutical Law should be taken into account by the country authorities in the course of work on the major amendment to the Pharmaceutical Law. A good solution would be for example, to introduce a pharmacy advertisement definition and its activity as well as a catalog of non-advertising activities. This would protect the role of pharmacies as health care facilities, and at the same time enabling an action aimed at the welfare of patients.