At the fifth Global Forum on Pharmaceutical AntiCounterfeiting, held in Hollywood, Florida, February 24-16 2010, the cost to healthcare budgets of fake medicines was shown to be tens of billions of euros/dollars, which, with the acknowledged threat to patient health, led the Forum attendees to seek more urgent action from governments and inter-government agencies.

The theme for this fifth Global Forum was End-to-End Protection: from API to Patient (API = active pharmaceutical ingredient), reflecting both current concerns and the Forum's uniquely wide range of stakeholders involved in combating counterfeit medicines, pharmaceuticals and medical products. The 180 attendees included national drug regulators, pharmaceutical companies, patients' and safe medicines advocates, and anti-counterfeiting product and service providers from 20 countries in continents, a good spread from the developed and developing world.

Delegates heard Jim Thomson of the European Alliance for Safe Medicines kick off the meeting by "doing the arithmetic" on the cost of counterfeits to the healthcare systems in the European Union. Factoring in the cost of lost sales to pharmaceutical companies, the daily cost of in-hospital patients, and the health cost of mis-diagnosis caused by fake medicines camouflaging genuine symptoms (all of which the European Commission estimates at €633 per medicine), he surprised delegates by showing that in the EU alone this cost was at least €50bn in 2007. Nonetheless, he reminded delegates that it's not about the numbers, it's about the individual patients put at risk.

Delegates also heard of several successes in the fight against counterfeit medicines. Merck and AstraZeneca presented papers showing how they are using the latest in Raman spectroscopy systems to help detect fakes, and the Nigerian drug regulatory agency NAFDAC revealed that it is also testing this relatively new technology. Other systems developments are also being successfully deployed, including the use of mobile (cell) phones to capture a serial number or code and check it against a central database. Similarly, the European Federation of Pharmaceutical Associations (EFPIA) reported on the success of its pilot project in Sweden to assess the use of data matrix codes to track medicines and check that they are legitimate at the point of dispensing.

From several papers given at the Forum it is clear that national authorities have a critical role in protecting their patients from the effects of fake medicines. In addition to the NAFDAC paper, delegates heard from the Ministry of Health in Malaysia how it has had great success using Meditag^TM, a serialised hologram label; they heard about the new legislation and enforcement system being introduced in Brazil, and how in Colombia INVIMA, the drug regulator, is taking a holistic approach to control pharmaceutical products and prevent counterfeits reaching patients.

One way to combat counterfeits is to provide low-cost medicines to areas of the world where malaria, HIV/AIDS and other sicknesses are reaching epidemic proportions, and one way to do that is to make generic medicines available, according to Dilip G. Shah, of the Indian Pharmaceutical Alliance. He pointed out to delegates that one factor that is holding back the fight against fakes is the difficulty in agreeing a definition of counterfeits that does not refer to intellectual property rights. Indian patent law means that Indian companies are free to re-create medicines patented by non-Indian companies, but some countries are enacting rules that include generic medicines as fakes because they infringe patents in other countries.

Delegates also heard about new developments in technologies to identify genuine products and the successes in detecting fakes. And in the accompanying exhibition, they had the opportunity to see demonstrations of these technologies. Holograms have a proven record as the leading overt (naked-eye visible) authentication feature, but serialisation and coding systems to allow tracking and tracing of product are being trialled (as in the EFPIA pilot project and in Nigeria), with developments that allow the consumer or patient to check the provenance of a medicine online or using a mobile phone. Covectra - which was the Forum's Platinum sponsor - and Sproxil gave papers explaining their systems for involving the patient in this way.

Paper authors and delegates broadly agreed that the most effective future system for control of medicines will be a combination of serialisation or track and trace technologies with overt and covert authentication technologies. Tracking a product helps to control the supply chain to spot infiltration of counterfeits, but this still needs authentication systems that can be examined by people without the need to connect to a telecoms network. Authentication also works on product distributed through the black market, outside the official supply chain, which tracking and serialisation does not cover.

All this led delegates to observe that, as authentication technologies are now easy to use and give reliable results, and given that the urgent priority is to protect patients from the dangers of counterfeit pharmaceuticals, national and international authorities should as soon as possible implement inspection programmes, regardless of agreement on the nuance of definition of what constitutes a counterfeit pharmaceutical.

 

The Global Forum on Pharmaceutical AntiCounterfeiting is organised by Reconnaissance International. It was the fifth in the series which began in Geneva, Switzerland, in 2002 - on the WHO's doorstep and with its active participation. The Global Forum has the widest coverage of the issue, involving representatives from all stakeholder groups. The 2010 Forum was attended by representatives from 76 organisations, of which 26 were pharmaceutical companies or associations, 8 were patient or healthcare representative organisations, 8 were government agencies, 6 were academic organisations and 28 were anti-counterfeit product or service suppliers.

The fifth Global Forum was supported by the Partnership for Safe Medicines, the European Alliance for Access to Safe Medicines (EAASM), the Coalition Against Counterfeiting & Piracy (CACP), Business Alliance to Stop Counterfeiting & Piracy (BASCAP) and the Canadian Intellectual Property Council. Media Partners were SecuringPharma, Pharmaceutical Commerce and Pharmaceutical Manufacturing and Packing Sourcer.