Anti-Counterfeiting in Global Pharmacovigilance

Abstract

Counterfeit products present a huge problem due to their great number on the market all over the world. In contrast to counterfeit luxury goods, which mainly harm the economy, counterfeit medicinal products pose a serious risk to health and safety. For this reason, the combat against counterfeit medicines should be of particular interest by the stakeholders of the health sector to safeguard patients’ welfare.<br /> Concerning the issue of counterfeit medicinal products existing statutory provisions are presented in this dissertation with a special focus on the obligations of the pharmaceutical industry. The objective of this thesis is to reveal what kind of anti-counterfeiting measures can be and should be adopted by the pharmaceutical industry exceeding the legal provisions. In this context, special focus is laid on the opportunities and limitations of such anti-counterfeiting measures. Thereby, three measures were examined and presented in detail, which are: Monitoring, education and procedural review of anti-counterfeiting activities. <br /> Monitoring: Adverse event data was investigated to ascertain if it could serve as a basis for an extended monitoring with respect to potential counterfeit signals. Based on the assumed correlation between the number of reported adverse events and a counterfeit presence on the respective market, the adverse event data and the counterfeit incident data of 6 example products was analyzed with regard to a potential correlation. The results show that with respect to 3 example products a correlation between particularly defined adverse event data and counterfeit incident data could be identified. Hence, peaks in the number of adverse event reports can hint at a potential counterfeit presence on the market.<br /> Education: An education campaign pilot project with the purpose to raise awareness of the counterfeit issue was initiated within the frame of this thesis. The campaign was planned and carried out in a product-specific way in one country. Thereby, its perception by and effect on the target group and its applicability to serve as an example for further education campaigns were examined. The results of the conducted pilot project show that a product-specific education campaign performed under the name of its marketing authorization holder using different kinds of media is a very effective measure to raise awareness.<br /> Review of anti-counterfeiting activities: A global company-internal survey including all relevant functions of the local affiliates was initiated and carried out within the frame of this thesis to review the current state of implemented anti-counterfeiting activities and procedures and the required topic-specific expertise. Afterwards, the affiliates of 10 countries were selected as interview partners to gain further and more detailed information. The results of the conducted global company-internal affiliate survey and the interviews demonstrate the huge interest of the affiliates in the counterfeit topic as a whole. The results also confirm the necessity of a broad internal collaboration and the net-working between multiple functions of different areas within a global pharmaceutical company and the importance of the collaboration with external stakeholders with respect to the counterfeit topic. Furthermore, the results reveal a need for improvement regarding the counterfeit-specific knowledge and consequently the counterfeit-specific training of the employees of multiple functions. Thus, a respective training and communication concept was developed within the frame of this dissertation.<br /> By means of this thesis pharmaceutical companies shall be encouraged to adopt anti-counterfeiting measures. The detailed description of the examined anti-counterfeiting measures and the outlined points to be considered implementing such measures shall serve as an orientation. It is very unlikely that the problem of counterfeiting medicinal products will ever be solved completely. Thus, it is imperative that the pharmaceutical industry actively contributes to the combat against counterfeit medicines by adopting appropriate anti-counterfeiting measures in order to protect patient safety and to safeguard patients’ welfare.