News | May 21, 2008

US Forum Focuses On Tackling Pharmaceutical Anti-Counterfeiting

Experts are gathering next month at a Washington DC conference to discuss the global threat of counterfeit medicines and look at ways of tackling the problem and the inherent dangers.

Organised by publishers and consultants Reconnaissance International, the fourth ‘Global Forum on Pharmaceutical AntiCounterfeiting' takes place for the first time in the US at the Grand Hyatt, Washington DCM (June 4 – 6).

Pharmaceutical executives, drug regulators, healthcare professionals, customs officers and others from around the world will be attending to examine anti-counterfeiting and authentication systems from specification, design and implementation to user training among other issues.

The forum will showcase the different anti-counterfeiting measures countries have adopted as the problem of counterfeit medicines and medical device sectors becomes increasingly global.

The event comes as the US gears up for a potential sea change in attitudes towards counterfeit drugs – and their impact - and a genuine commitment to tackling the problem.

This comes on the back of the tragic death of over 100 people who used contaminated batches of the blood-thinning drug Heparin.

The FDA has just closed a public consultation on the introduction of a serialisation system for prescription medicines, following President Bush's signing of H.R. 3580 Food & Drug Administration Amendments Act last September.

That was sponsored by Rep. John Dingell, who is also sponsor of H.R.3610, The Food and Drug Import Safety Act of 2007. Additionally, Congressman Stephen Buyer has presented a bill 'Safeguarding America's Pharmaceutical Act' to Congress which, if passed, will require all prescription medicines in the US to carry a unique identifying number.

This will have to be recorded using technologies to be recommended following research by the Secretary of Commerce.

If successful, the move, together with other plans to adopt unique numbering systems, could pave the way for far tougher and effective action in tackling the lucrative trade in fake pharmaceuticals.

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry - the World Health Organisation estimates that annual earnings from the global sales of counterfeit and substandard medicines are over $32B.

The two-day programme of debates will also feature a review of some of the latest techniques counterfeiters are using followed by reports on global, regional and national responses to the problem.

The California Board of Pharmacy will explain its stalled progress in moving to establish e-pedigree distribution chain monitoring while the Partnership for Safe Medicines will explain its strategic role as part of a global anti-counterfeiting system.

The latest results from Malaysia's Meditag project and Nigeria's plans for a similar system will also be revealed and whether authentication or traceability - or a combination - offers the best protection against counterfeiters.

Speakers include:

  • Katherine Eban - Author of the award-winning Dangerous Doses
  • Virginia Herold - Executive Officer of the California Board of Pharmacy
  • Dora Akunyili - Renowned and successful leader of the Nigerian effort to combat counterfeits
  • Marv Shepherd - The Partnership for Safe Medicines
  • Jim Thompson - The European Alliance for Access to Safe Medicines
  • Tim Marsh - Pfizer, speaking in his role as Chairman of GS1 Healthcare, which is working on standards for distribution chain control
  • Lew Kontnik - Amgen's Brand Protection Director
  • David Howard - Johnson & Johnson, on corporate responses to deal with counterfeits

Two workshops on 4 June will precede the forum. Michael Eakins, well-known consultant on safe medical packaging, will lead a morning workshop on Making the Internet Work for You, with input from Alina Halloran of OpSec's GenuNet and Andrew Horton of MarkMonitor.

In the afternoon Glenn Wood will lead the workshop on Integrating Authentication & Tracking for Best Effect, supported by a security specialist from Eli Lily and Kamal Mustafa of SecureSymbology.

The Global Forum is supported by an anti-counterfeiting exhibition. Contact Reconnaissance for details, but exhibition bookings close 23 May. Register at www.pharma-anticounterfeiting.info.

SOURCE: The Global Forum