Fifth Global Forum on Pharmaceutical AntiCounterfeiting

Hollywood, Florida

Next event: May 2011 - London
Download the Press Release from the 5th Global Forum on Pharmaceutical AntiCounterfeiting here
 

Pharma Authentication More Reliable

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  from the developed and developing world.

The two introductory workshops provided a useful background to the topic. The workshop on Parallel Trade and Reimportation: European and American Perspectives, examined the differences in policy and experience between the two regions. Attendees were left in little doubt that the energy invested in Europe to tackle the issue of parallel trade exceeded that in America and any thoughts that Canada might supply cheap medicines to the USA were dispelled on the grounds that the capacity was lacking and Canada had no wish to circumvent US pricing policies. Authentication and Traceability: Complementary Procedures for the Most Effective Strategy, the second Workshop, delved into the differences between authentication and traceability and concluded that both were necessary in framing an effective approach to business process planning and strategy.

Underestimated Costs

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 misdiagnosis 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. Other technologies 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.

The Role of DRAs

National authorities have a critical role in protecting their patients from the effects of fake medicines. Delegates heard from the Ministry of Health in Malaysia how it has had great success using Meditag™, 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. The Director General of NAFDAC (Nigeria) described the measures NAFDAC is adopting to detect and seize counterfeits while simultaneously educating the population on how to distinguish good meds from bad. Nigeria is becoming something of a test-bed, with NAFDAC acquiring several portable Raman spectrometers from Ahura for field testing of suspect pharmaceuticals, while Sproxil has also launched a pilot project there which allows consumers to use a mobile phone to check the code on a medicine. The code is only revealed when a scratch-off hologram is removed.

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 recreate 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.

Quicker & Reliable

The accompanying exhibition gave participants the opportunity to see demonstrations of these technologies. Holograms have a proven record as the leading overt authentication feature, but serialisation and coding systems to allow tracking and tracing of product are being trialled (as in the EFPIA pilot project), 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.

What emerged during the Global Forum is a recognition that pharmaceutical security is moving away from the package and towards the product itself. On the one hand, taggants and markers are now being incorporated into genuine products (a move recognised by the US Food and Drug Administration in its draft Guidance Document on the use of physical-chemical identifiers issued in July,2009); on the other, small scale, hand held analytical devices are being deployed to enable rapid differentiation between genuine and doubtful products in the field. The outcome of these new techniques, combined with established technologies, is that pharmaceutical authentication is faster and more reliable than it has been.

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 next Global Forum on Pharmaceutical AntiCounterfeiting will take place in May 2011 in London.

 

 

Contact Details

  • Reconnaissance International

    4 Windmill Business Village
    Brooklands Close
    Sunbury
    TW16 7DY
    United Kingdom

    Phone: +44 (0)1932 269917
    Email: info@reconnaissance-intl.com

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