The role of intellectual property rights and packagе safety features in the prevention of counterfeit medicines

  • Katerina Ančevska Netkovska Institute of Pharmaceutical Chemistry, Faculty of Pharmacy, University “Ss. Cyril and Methodius”
  • Katerina Brezovska Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, University “Ss. Cyril and Methodius”
  • Nikola Geškovski Institute of Pharmaceutical Technology, Faculty of Pharmacy, University “Ss. Cyril and Methodius”
  • Jasmina Tonić Ribarska Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, University “Ss. Cyril and Methodius”
  • Biljana Petrovska Jakimovska Institute of Pharmaceutical Technology, Faculty of Pharmacy, University “Ss. Cyril and Methodius”, Alkaloid AD
  • Blagoj Achevski Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, University “Ss. Cyril and Methodius”
  • Katerina Goračinova Institute of Pharmaceutical technology, Faculty of Pharmacy, University ” Ss. Cyril and Methodius”
Keywords: intellectual property rights, counterfeiting, medicines, drug packaging


The fast growth of counterfeiting medicines in the last two decades has created one of the biggest problems facing the pharmaceutical industry on the global level, resulting in loss of income, product withdrawal, loss of brand value, etc. But this is not only the problem of the intellectual property rights of the pharmaceutical industry, it is also the problem of the healthcare regulatory authorities, whose most significant concern is the risk to the public health. Pharmaceutical manufacturers, together with the wholesalers and retailers, have an essential role in the fight against counterfeit medicines by the implementation of different anti-counterfeit technologies for securing the supply-chain of medicines. The protection of drug packaging has a specific role in the drug development process, as well as in the fight against counterfeit medicine. The authenticity of the medicine and the forensic elements for protection on the packaging may be confirmed using different technologies. Tracking and tracing of pharmaceutical products in the supply chain, keeping electronic records for all stages of the distribution, and verification of the authenticity of a medicinal product is a key element and an effective solution for timely detection of counterfeit medicines and protection of intellectual property rights.


OECD. Trade in Counterfeit Pharmaceutical Products. Paris: OECD Publishing; 2020. (Illicit Trade).

Clark F. Rise in online pharmacies sees counterfeit drugs go global. Vol. 386, The Lancet. Lancet Publishing Group; 2015. p. 1327–8.

Council of Europe. Ad hoc group on counterfeit medicines (P-SP-PH/CMED) national and international co-operation to combat counterfeiting of medicines and pharmaceutical crimes: a model for a network and single points of contact (spocs). Brussels; 2013.

World Health Organization (WHO). Counterfeit Drugs: Guidelines for the Development of Measures to Combat Counterfeit Drugs. Geneva; 1999.

World Health Organization (WHO). Conclusions and recommendations of the who international conference on combating countefeit medicines, Declaration of Rome. Rome; 2006 Feb.

Medicines and Healthcare Products Regulatory Agency (MHRA). Falsified Medical Products Strategy 2012-2015. London; 2012.

Wijnberg B. Counterfeiting of medical products and similar crimes (‘medicrime’). Strasbourg: Council Of Europe; 2013.

Council of Europe. DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsi. Brussels; 2011.

European Commision. Falsified medicines | Public Health [Internet].

European Commision. COMMISSION DELEGATED REGULATION (EU) 2016/ 161 - of 2 October 2015 - supplementing Directive 2001/ 83/ EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. Brussels; 2016.

Nath Saha C, Bhattacharya S. Intellectual property rights: An overview and implications in pharmaceutical industry. Vol. 2, Journal of Advanced Pharmaceutical Technology and Research. Wolters Kluwer Medknow Publications; 2011. p. 88–93.

Cockburn I, Long G. The importance of patents to innovation: updated cross-industry comparisons with biopharmaceuticals. Expert Opin Ther Pat. 2015;25:739–42.

Wouters OJ, Kanavos PG, Mckee MARTIN. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending. Milbank Q. 2017;95:554–601.

Kortum P, Edwards C, Richards-Kortum R. The impact of inaccurate Internet health information in a secondary school learning environment. J Med Internet Res. 2008;10.

Bauer EJ. Pharmaceutical packaging handbook. Boca Raton, FL: CRC Press; 2016. 1–585 p.

World Health Organization (WHO). Annex 9 Guidelines on packaging for pharmaceutical products. Geneva; 2002.

Agrawal Y, Shah R, Prajapati P. Anticounterfeit packaging technologies. J Adv Pharm Technol Res. 2010;1:368.

Davison M. Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs. Hoboken, NJ: John Wiley and Sons; 2011.

Zadbuke N, Shahi S, Gulecha B, Padalkar A, Thube M. Recent trends and future of pharmaceutical packaging technology. Vol. 5, Journal of Pharmacy and Bioallied Sciences. Wolters Kluwer -- Medknow Publications; 2013. p. 98–110.

Imlau M, Fally M, Coufal† H, Burr G, Sincerbox G. Holography and Optical Storage. Springer Handbook of Lasers and Optics. Springer New York; 2007. p. 1205–49.

Thermochromic Ink Ensures Safety of Pharmaceutical Products [Internet].

Jallouli Y, Paillard A, Chang J, Sevin E, Betbeder D. Influence of surface charge and inner composition of porous nanoparticles to cross blood–brain barrier in vitro. Int J Pharm. 2007;344:103–9.

Therapeutic Goods Administration. Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods Published on behalf of the Industry Government Crisis Management Committee (IGCMC) About the Therapeutic Goods Administration (TGA). Woden; 2003.

Kovacs S, Hawes SE, Maley SN, Mosites E, Wong L, Stergachis A. Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries. Sullivan DJ, editor. PLoS One. 2014;9:e90601.

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