Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Drug Safety and Counterfeit Medicines

N´djamawè Bah-Traore (Abschlußjahr: 2008)

The counterfeit medicines have been identified as a growing problem constituting serious health risk to the user for more than two decade, the being a lucrative criminal activity, counterfeit medicines and medical devices pose a major public health threat and evidence shows that in a rapidly globalizing world, it is not isolated to a handful of countries; it is present everywhere and no a single country or region is immune to this devastating criminal activity; it is a problem of all nations. The real fact is that today everywhere in the world, we come across medicines seemingly packaged in the right way, in form of tablets or capsules that look right, but do not contain the correct ingredients and in the worst case may be filled with highly toxic substances. It is an everyday reality in many developing countries and occurs also in developed countries.

The growth of online drug sales, counterfeiters' increasing technologic skill, trade globalisation, illegal trading by legal wholesalers and pharmacies, and a false sense of security in countries with stringent regulatory measures are among the factors that are enabling the spread of this criminal activity. Developing countries are disproportionately affected by the problem of counterfeit medicines; here, the main reasons are ignorance about the quality of fake medicines, poverty and extremely high prices in these countries where there are no adequate reimbursement schemes. The absence of strong laws and regulations from rulers and law makers leads people to seek cheaper alternatives.

Counterfeiters operate where there is high demand or high profits to be made. We have then situation where commonly used lifesaving medicines such as antibiotics or antivirals may be counterfeited, expensive products such as lifestyle medicines, and cancer therapies medicines too. At present even the definition of a counterfeit medicine varies from country to country; if international monitoring and solutions are to have any impact, legal and administrative processes related need a common approach; also coordinated action at the local level between health authorities, police customs, judiciary institutions to unsure proper regulation investigation and prosecution.

A secure drug supply must address supply chain vulnerabilities in the following areas: the packaging and product technology the movement of drugs and providing appropriate regulatory issues.
The WHO has launched an International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which shall develop concrete and pragmatic proposal on how to improve national, regional and international strategies to combat counterfeits. Through the US Radio frequency identification (RFID), the Food and Drugs Administration (FDA) continues to play an active role in supporting public and private sector efforts toward developing an “electronic safety net”.

The EU has launched an inter-service group that involves all services concerned for better understanding of the system and developing a comprehensive toolbox against counterfeiting with aim to present results of the EU project at the major conference that the WHO, through IMPACT organises at the beginning of 2008 in Singapore. Among others perspectives, WHO has instituted May 28Th, as “action day against counterfeiting” in developing countries.

This Master thesis seeks to address the international dimensions of the problem and the need for normative guidelines on national, regional, and international standards to combat counterfeit drugs and to instaure a global safety for medicines and medical devices management.