REGULATORY FRAMEWORK FOR ADVERTISING OF MEDICINAL PRODUCTS IN THE REPUBLIC OF NORTH MACEDONIA AND THE EUROPEAN UNION

Abstract

Pharmaceutical companies frequently engage in drug advertising to connect with potential buyers. In the competitive pharmaceutical market, where patients are highly sensitive to various forms of advertising, manufacturers aim to reach a broad audience. This rapid dissemination of information in the advertising of medicinal products leads to some details being unverified and inaccurate, which emphasizes the critical importance of establishing and enforcing legislation. This paper aims to evaluate the current legislation for advertising of medicinal products in Republic of North Macedonia, as well as the regulations in European Union member states, namely Germany, Slovenia and Spain. The basic legal act that regulates the advertising of medicinal products in the European Union is Directive 2001/83/EC of the European Parliament and of the Council of Europe of 6 November 2001 on the Community code relating to medicinal products for human use such as amended by Directive 2004/27/EC of 31 March 2004. By reviewing relevant literature and conducting a comparative analysis of regulations in the Republic of North Macedonia and European Union, it can be concluded that the European Directive serves as a foundational framework. Each country has transposed the European Directive in domestic laws and regulatory guidelines with local adaptations and all Member States have therefore adopted further specific measures concerning the advertising of medicinal products. Depending on the member state, pharmaceutical promotion can be monitored and controlled by the government, by a national competent authority or not, this approach is called “self regulation.Upon examining the regulatory structures in each specific country, there are five key components that must be implemented: development and adoption of national laws and regulations; implementation of the regulation, codes and other standards; monitoring the pharmaceutical promotion to ensure compliance with legal regulations; enforcement of the law through suitable sanctions to prevent violations; and evaluation of regulatory efficiency. Drawing parallels between the practices of established European member states and the regulatory framework of the Republic of North Macedonia, it becomes evident that there is an opportunity for the Republic of North Macedonia to leverage positive experiences from the European countries. By incorporating successful elements of European member states' regulations, the Republic of North Macedonia could enhance its own pharmaceutical regulatory environment. Based on this evaluation of established practices and experiences in European countries, direction will be provided for harmonizing and improving the regulatory framework for advertising od medicinal products in the Republic of North Macedonia.