Technologies to improve prevention, tracking and detection of counterfeit medicines

Mar 13 2007

More than twenty technology companies are responding to a call to support the fight against counterfeit medicines spearheaded by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) set up by the World Health Organization (WHO) and partners.

They will join the IMPACT Working Group on Technology today for a one-day meeting in Prague to assess technologies which could improve the global prevention, tracking and detection of counterfeit medicines.

"Technologies can speed up health results in all sorts of ways," said Dr Howard Zucker, Assistant Director-General for Health Technology and Pharmaceuticals at WHO and Chair of IMPACT. "In the case of anti-counterfeiting, the challenges we face are finding technologies that cannot themselves be counterfeited and transferring them to resource poor settings at an affordable cost. While technology alone cannot solve the problem, some of these solutions could greatly enhance the ability to detect and deter the distribution of counterfeit medicines."

"Technology can help to contain counterfeiting, but it is not a magic bullet that will stop this problem on its own," said Dr. Harvey Bale, Director General of the International Federation of Pharmaceutical Manufacturers & Associations and Chair of the IMPACT Technology Working Group. "In looking at these technologies, we will need to assess carefully their applicability in developing countries and their potential synergy with other approaches to stop this criminal activity which can and does result in the deaths of patients."

Counterfeit medicines are on the rise in most countries but are particularly widespread and dangerous in developing regions. IMPACT's most recent figures estimate counterfeits at around 1% of sales in developed countries to more than 10% in developing countries. However, in parts of Africa, Asia and Latin America, more that 30% of the medicines on sale can be counterfeit, while in some former Soviet republics, counterfeits make up more than 20% of the market.

Different technological approaches, ranging from the simple to the more complex, are available or in development. Overt verification tools, including holograms or colour-shift inks, are cheap but relatively easily copied. Covert tools, such as invisible printing and digital watermarks, are more expensive and require special devices to check.

Forensic technology, essentially chemical or biological tags built into medicines packaging, are even more secure against copying but significantly more costly and provide no visible reassurance to customers. Serialization or track/trace systems, using technologies such as bar codes and radio frequency identification (RFID), help provide authentication by allowing a medicine to be tracked through the supply chain. These require an expensive technical infrastructure and are not completely immune to “hacking”.

However, these technologies cannot by themselves stop counterfeiting. Computer and technological illiteracy, lack of infrastructure and cost may limit the ability of technology to deliver solutions, especially in the poorer parts of the world where the threat posed by counterfeiting is greatest.

"Technology needs to be combined with other measures including tough legislation and regulations against counterfeiting, rigorous enforcement, stiffer penalties, and diligent surveillance on the part of the authorities and healthcare providers," said Dr Valerio Reggi, coordinator of the IMPACT secretariat at WHO. "IMPACT recognizes this and has complementary working groups looking at how each of these areas can be strengthened and made to work together in harmony."

In assessing existing and emerging technologies, the Prague meeting will examine a) cost; b) scalability; c) specific country needs and situations; d) feasibility; and e) regulatory implications. The meeting will also look at mechanisms to facilitate exchange of information on technologies and their implementation; disseminate information and recommendations on the merits and limitations of technologies; and demonstrate the benefit of chosen technological approaches to the end user - the patient.