The 6th Global Forum on Pharmaceutical AntiCounterfeiting - held May 4-6 2011 in London with its theme of Optimizing Capabilities to Combat Counterfeits - again raised the standard for anti-counterfeiting events.

Tom Woods from Woods International summarized the need for better cooperation and optimization of resources to combat the growing international public health threat of counterfeit medicines and set the tone of the event with a call to action. He pointed to the name of the WHO Working Group of Member States on 'Substandard, Spurious, Falsely Labeled, Falsified, Counterfeit (SSFFC) Medical Products' as an indicator of inadequate cooperation. Further to their inability to reach consensus on WHO's relationship with IMPACT, they shoudl be named the The Working Group of Member States on Discrepancy, Disunity,  Contention, Inconsistency, Misunderstanding, Incongruity, Division, Divergence and Discord. He called for a stop to petty bickering and demanded that we unite for action to defeat the scourge of counterfeit medicines.

This issue was further discussed by Charles Clift with Chatham House who raised some insightful questions such as how important are these debates in WHO for what actually happens in the real world to combat dangerous medicines? How important is IMPACT (or a successor)? Is WHO's participation important for IMPACT to achieve its objectives? Apart from enforcement activities, how can we improve medicines regulation in developing countries?

Roger Bate, with the American Enterprise Institute and an international health policy economist focussed on tropical disease and substandard and counterfeit medicines, revealed in his presentation that one major thing that needs to happen to improve international cooperation is to make the falsification of medicines an international public health crime. Without an international law against falsified medicines, there is little chance of extradition, few prosecutions, and almost no attention given to the middle of the counterfeit supply chain.

Until the falsification of medicines is made an international crime, there are some practical and valuable interim steps that can be assisted by the World Bank. Andreas Seiter from the World Bank pointed out his organizations role with developing nations: providing loans subsidized by level of need as part of an agreed development strategy, assisting in strengthening health systems, serving other donors as an intermediary for financing and project management, and maintaining a country present organization for financial management, procurement, and project implementation.

Another program which is a joint effort between USAID and the United States Pharmacopeia is the Promoting the Quality of Medicines Program (PQM). Patrick Lukulay, Director of PQM shared his organizations objectives which include: building capacity and strengthening quality systems, increasing supply of quality medicines, combating counterfeits and substandard medicines, and providing technical leadership. The PQM works to build consensus at the local and government levels to achieve these objectives and advises and assists governments with strengthening quality control/monitoring programs, helping manufacturers understand and achieve GMP compliance, raising awareness, and promoting substandard and counterfeit detection technologies.

As the World Bank and PQM programs provide locally implementable strategies, tactical support, and guidance, Steve Carden from PA Consulting group offered some advice on borrowing models from other industries mostly notably the tobacco industry. The tobacco sector is likely five years ahead of the pharmaceutical industry with the WHO Framework Convention on Tobacco Control (FCTC). If lessons learned could be translated to the pharmaceutical industry it could have the following implications: global track and trace, global information sharing, global pack-level marking, licensing of manufacture of product and manufacturing equipment, control and monitoring of manufacturing equipment, and passing implementation costs on to the industry. The fundamental flaw in the FCTC is that industry was not involved in the development of the solution.

Understanding the nature of counterfeiters, how they think, and how they are sometimes able to defeat anti-counterfeiting programs was presented by Authentix® through the use of case studies. This presentation emphasized the need for a holistic approach to product security, integration of product security into overall company strategy, and making sure the technologies deployed adequately support the objectives of the program.

Very seldom does one technology approach solve or aid a company or nation in fighting counterfeits, and most drug regulatory agencies and companies deploy technology in a multi-faceted approach or in layers. The Global Forum Program presented an inclusive and holistic range of technologies. Effective analytical approaches were presented by the Health Sciences Authority of Singapore, Bristol Myers Squibb, Thermofisher Scientific, and the China National Institutes for Food and Drug Control. Effective package based technologies were presented by AlpVision, Advanced Track and Trace®, PharmaSecure, Sproxil, and Bilcare. Dosage level technologies were presented by InkSure. Internet tools for monitoring, measurement, and detection of counterfeits were presented by Hologram Industries' AdvestiSEARCH® and BlueOcean. Serialization, e-pedigree, and track and trace systems were presented by Oracle®. And because package based technologies must be applied, the Forum included a presentation from ONELITE®, a manufacturer of labeling and packaging machines.

Tools for communication and education especially for customs such as the Drug Validation Portal (DVP) and the Interface Public Members (IPM) were covered by Johnson & Johnson and the World Customs Organization respectively. The DVP is specifically designed for pharmaceuticals. The IPM is available for use for pharmaceutical manufacturers as well as other industries.

Technology and program implementation along consumer education were presented by Pfizer, European Directorate for the Qualtity of Medicines and Healthcare (EPQDM), the Ministry of Health - Malaysia, the National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC), the Belgian Pharmacists Association (APB), and the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK.

When Pfizer developed their strategy, they did not single out counterfeiting as an isolated threat. Any threat along the supply chain that endangers patient safety is included in their holistic safe and secure supply chain strategy, so cargo theft, diversion, counterfeiting, and economically motivated adulteration are targeted by the same strategy. The Pfizer strategy is covered in a Q&A in this issue.

EPQDM also works toward a holistic strategy upstream to API suppliers and downstream to patients. The Ministry of Health of Malaysia demonstrated how a secure technology called the Meditag^TM coupled with a vigilant registration and enforcement process along with patient education could effectively reduce and control counterfeit medicines and keep supply chain participants honest. NAFDAC demonstrated their multilayered technology and enforcement approach which has dramatically decreased counterfeits in Nigeria. The APB has had a track and trace system in place since 2004 which has serve to prevent counterfeits and prevent healthcare insurance fraud. The MHRA shared their strategy for strengthening the legal supply chain and for attacking the illegal supply chain. Their public awareness campaigns have been very effective in educating consumers about the hazards of internet purchases.

Practical, implementable, solutions were presented in all areas cover by the Forum: policy, legislation, regulatory practice, enforcement, and technology. The objective of giving attendees ways to optimize capabilities was met. What remains is the need for broader global action and to expand the programs that are working.

Sponsors of the event included Authentix, Securikett, Sproxil, and Aegate. Thirty-four papers covered developments in policy and strategy, maximizing capabilities through technology, maximizing resources, and regional, national, and corporate policies and experiences.

The 7th Global Forum on Pharmaceutical AntiCounterfeiting will be held in late 2012 in Washington DC.