- Keywords > counterfeit drugs
- Keywords > counterfeiting - measures to combat
- Keywords > Intellectual Property Rights (IPR)
- Keywords > pharmaceutical industry
- Keywords > pharmaceutical market
- Keywords > piracy of pharmaceuticals
- Keywords > quality assurance
- Keywords > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
(2008; 399 pages)
Chapter 12. Pharmaceuticals
The purpose of this chapter is to provide an overview of counterfeiting activities in the pharmaceuticals sector, assess the magnitude and trends of these activities, examine the effects on patients/consumers, companies and governments, as well as analyse the measures for combating counterfeiting and piracy activities.
The counterfeiting and piracy of pharmaceutical products involves the deliberate deception of patients, healthcare providers and suppliers of genuine products, such that they unknowingly acquire products of unverified quality, safety and efficacy. Thus, counterfeit pharmaceuticals very often infringe intellectual property rights, violate health and safety legislation and regulation, and create the potential for serious public health consequences.
Pharmaceuticals are understandably amongst the most heavily regulated products due to their direct impact on human health. Consequently, the counterfeiting and piracy of pharmaceutical products is, in most jurisdictions, subject to a myriad of laws and regulations, including those applicable to the regulation of pharmaceutical products, to intellectual property rights, in the criminal and penal field, to customs and border control, etc. In addition to the applicable national legislation, from an international intellectual property perspective, the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement) is also applicable. While this chapter will examine the issue of counterfeit and pirated pharmaceuticals primarily from an intellectual property perspective, it is important to highlight that the most harmful consequences of counterfeit pharmaceuticals are their nefarious implications for and impact on human health...