A marginal phenomenon just a few years ago, counterfeit has now become a global problem affecting every country in the world. According to WHO, 10% of drugs placed on the world market are counterfeits, worth over 40 billion euros. While counterfeiters are better organised and have ever greater means, pharmaceutical companies, players in the distribution chain, authorities and institutions around the world are becoming mobilised and are ramping up the fight. This fight involves technological innovations that use packaging as an essential substrate. Director of Industrial Anti-Counterfeit Strategy at Sanofi-Aventis, Jean-Marc Bobée explains the main principles underpinning action taken by the pharmaceutical industry in this field to increase product and patient safety.
As a specialist in the technological fight against counterfeit, how do you analyse the way this problem has evolved ?
It is a growing phenomenon that is obviously very dangerous for public health. In Europe, where it did not use to exist, figures are on a disquieting, upward trend. According to data provided by European customs, 8.9 million counterfeit drugs were seized in 2008, compared with 4 million in 2007 and 500,000 in 2005. The problem is growing worse in Europe and also in the developing countries. Several reasons explain this development. Counterfeiting drugs is a highly profitable activity that is more lucrative and less risky than drug trafficking. Furthermore, counterfeiters can now access sophisticated technologies to copy the labels and packaging. In addition, there are factors inherent in distribution like the practice of repackaging and the existence of illegal drug marketing circuits/networks that facilitate the development of counterfeit. Counterfeiters are well organised and have considerable means. They can target weaknesses in the system to enter the official distribution chain. Finally, it is worth mentioning the growing offer of drugs sold on the Internet.
When people talk about counterfeit, they turn first to the manufacturers. Are they the only players involved in the protection of drugs ?
Of course, in the event of problem, one usually turns first to the pharmaceutical company. However, the fight against counterfeit calls for joint work among all the players in the distribution chain and the authorities. This fight calls not only for technological means but also a change in legislation and work by customs, police and intelligence. What is important is to succeed in securing and simplifying the distribution chain which involves wholesalers, wholesaler-distributors, traders, re-packers, etc. From a legal stance, all these players must be made to feel responsible. This is the purpose of the draft European directive published in December 2008 and currently discussed in the European Parliament and the Council of Europe.
How can pharmaceutical companies like Sanofi-Aventis work to combat counterfeiters through packaging ?
Packaging, and in particular secondary packaging, is where we must focus efforts to protect drugs because it remains visible throughout the distribution chain. Furthermore, the drug is almost always delivered to the patient in its original packaging, so it should be possible to make it truly safe. Unfortunately, there are two exceptions to this rule : products repackaged in Europe and a lot of the prescription drugs delivered in the US (tablets) where there is repackaging in the pharmacy for each patient. Pharmaceutical packaging can thus be the vector for the three key elements of an effective anti-counterfeit strategy. First, an optimum tamper-proof system that guarantees the integrity of the container and its content. Second, a reliable authenticator comprising visible and/or invisible elements. Finally, an identifier containing traceability information like the product code, the batch number, the expiry date and a serial number (as planned in the pharmaceutical product serialisation project - especially for prescription products). In the long run, all pharmaceutical packaging should be guaranteed tamper-proof either by security labels placed at either end of the carton or by gluing the flaps of the cardboard container in association with pre-cut lines that are damaged when the packaging is opened and constitute proof of tampering. Some products will also comprise visible and invisible means of protection.
Do you think there are further avenues for technological innovation to be explored to expand the range of anti-counterfeit solutions made available to pharmaceutical companies?
The development of very high security visible devices is a field where there is a strong need for innovation. Contrary to invisible features which are only known and controlled by the pharmaceutical company (manufacturer), these visible features enable players in the distribution chain to make far more frequent checks to guarantee patient safety. But strangely enough, the fact these devices are visible increases the risk of copying by the counterfeiters. The pharmaceutical companies are thus faced with a choice: not include visible features to avoid the risk of copying or accept this risk and develop high security systems (that are regularly renewed) to provide for identification of their products by the professionals involved in the distribution chain. Sanofi-Aventis has chosen to use visible features to protect certain products as we believe they enhance product and patient protection. Innovation in high security devices should enable pharmaceutical companies constantly to be a step ahead of counterfeiters by using sufficiently sophisticated, hard to copy technologies to provide optimal security.
Might the patient, using traceability features and a widespread tool like the mobile phone, question a database to check whether a drug is genuine or fake?
It would not be a totally reliable solution for the patient to check a serial number to verify whether a product is authentic because the serial number is an identifier (that can be copied) and not an authenticator. It would therefore be difficult for a pharmaceutical company to guarantee the authenticity of a drug based solely on that type of check. To work properly, the traceability data check (serial number) must be systematically carried out by the pharmacists at the point of dispensation (the pharmacy). Only such systematic checks at the point of dispensation via a database can identify copies and thus prevent counterfeit (by doing away with any potential source of profit for the counterfeiters). This concept proposed at a European level by the European Federation of Pharmaceutical Industries and Associations (efpia) is currently the subject of a pilot study in Sweden conducted by EFPIA in conjunction with pharmacists, wholesalers and the Swedish government. We fully support this concept based on the use of serialised Data Matrix with systematic checks at the point of dispensation and we have played a very active part in this approach.
Who are the players involved in this project and what is its goal ?
This project is designed to set up a system to check the product identifier at the time of dispensation. The pilot project was conducted in Sweden over a four-month period, with 14 pharmaceutical companies, 200 pharmacists (25 pharmacies in the Stockholm region). 25 products were marked with a serialised Data Matrix, that is about 110 000 packs. From mid September 2009 to end January 2010, pharmacists used a 2D bar code reader to check the Data Matrix code of each product delivered (via a centralised database). Reading the code makes it possible automatically to check the product expiry date, receive a systematic warning in the event of batch recall and check for fakes (by checking that the serial number has not already been sold in another pharmacy). By registering the transaction in the database, the system can detect and block subsequent deliveries of any product with the same serial number. And in the event of a fake, it facilitates investigations at the two points of delivery to identify the problem. In the end, this system will make it possible (in the developed countries) to do away with any economic incentive to indulge in counterfeit or copies.
Setting up this system involved two major challenges : securing the database and response time in the pharmacy, which proved to be less than 0.5 seconds in most cases. For the concept to be effective, it is essential systematically to check the products at all the points of dispensation. A global, harmonised approach at state level is therefore necessary.
What is the next stage in the EFPIA project?
The pilot project finished end January 2010 but the project itself is still being discussed with the European Commission, the different players in the distribution chain and the governments. The approach here is different from California which is moving towards product monitoring throughout the distribution chain (Full track and trace) with no final, systematic unit check in the pharmacy. Within EFPIA, we would like an end to end checking process, that is between the manufacturer (who knows what he placed on the market) and the point of drug dispensation (the pharmacist), that is the place where the product is given to the patient. This is a concept that will require important investment by the pharmaceutical companies as we shall have to equip all our packaging lines to be able to add a Data Matrix on the cartons. For Sanofi-Aventis, this means between two hundred and four hundred lines depending on the scope envisaged. But thanks to this technology, it is becoming possible to fight counterfeit, health insurance reimbursement fraud, errors in dispensation (combined with e-prescription systems) and also to facilitate batch recalls. All by means of a single, harmonised, standardised technology. The pharmacists will obviously have to be equipped to read the Data Matrix codes at the point of dispensation and it will be necessary to envisage governance systems for the setting up and management of the databases.
Do you have a message for visitors to Pharmapack 2010?
Yes. Packaging is an essential component and it is of paramount importance for packaging and security device suppliers to continue efforts to innovate in order to propose ever more effective, economically viable systems that can be implemented on a large scale. Packaging is the visible component for the distribution chain and it contains the traceability and authentication features. Patients in the vast majority of countries are given the drugs in their packaging.
The introduction of a serialised Data Matrix that makes it possible automatically to read the traceability data of each drug (product code, batch number, expiry date and serial number) is a considerable step forward in increasing product and patient safety. It is now possible to envisage a harmonised identification system at a European level. However, such a system requires major investment by the pharmaceutical companies in an increasingly difficult economic context. Efforts will have to be made to harmonise and simplify the current, different systems in order to reduce complexity and associated costs.
Finally, I would express the hope that all the governments, players in the supply chain and professional associations pool their efforts in the various countries to combat the scourge of counterfeit. In Europe, let us hope that the final version of the European directive to combat drug counterfeiting will provide for European harmonisation in the field of drug traceability.