Tracing Pharmaceutical Products

France Leads the Way with a New Regulation

10.08.2010 -

On the Jan. 1, the new regulation on the traceability of pharmaceutical products will enter into force across France. In this interview, Valérie Marchand of GS1 France, gives her expert opinion on the consequences of the new regulation and use of the Datamatrix system.

Can you explain the role GS1 Healthcare to us in a few words, and particularly its work in the area of product traceability?

V. Marchand: In 2005, following demand from a number of international pharmaceuticals companies, GS1 set up the GS1 Healthcare traceability working group. The objective was to harmonise the traceability requirements of different health ministries. GS1 Healthcare's mission is to ensure that these requirements allow the implementation of efficient, standardised traceability solutions from the supplier to the patient's bed, and therefore provide improved healthcare safety.

Can you briefly explain the new regulations on the traceability of pharmaceutical products which will be implemented in France from 2011?

V. Marchand: This regulation was implemented by French Agency for the Sanitary Safety of Healthcare Products (AFSSAPS). The main goal is to ensure the traceability of the medicine up to the patient's bed.

The new AFSSAPS regulation, which enters into force on Jan. 1, stipulates that pharmaceutical companies that wish to market their products in France must print a Datamatrix directly on to the secondary packaging, while including the AMM (marketing authorization) 13-character code, a batch number and a use-by date. The second section of this regulation strongly recommends that pharmaceutical companies, distributors and hospitals be able to trace products through the receipt and transmission of an electronic shipment notice.

What advantages will this new regulation provide for the pharmaceutical industry?

V. Marchand: Today, the pharmaceutical companies know what they have supplied, both to the distributors and to the hospitals, but traceability often stops there. The strong point of this new regulation for the supplier is that it will send the information included in the Datamatrix code electronically. It will allow automatic integration by the various players in the traceability information chain to improve product monitoring and enhance flow management. In a nutshell, the regulation improves the traceability of products from the production chain to the patient's bed.

What is Datamatrix?

V. Marchand: GS1 Datamatrix is a two-dimensional code, whose minute size is highly suited to small products while making it possible to hold a great deal of data. Another type of barcode, the GS1 128, is able to integrate traceability data.

Does this system make it possible to combat counterfeit medicines?

V. Marchand: Absolutely, even though it is not Datamatrix itself that will enable us to combat counterfeiting, but the use that can be made of it. By integrating a series number into the symbol and linking scanning systems to databases that reference these series numbers, it is possible to verify whether the manufacturer has indeed placed this product on the market and whether it has already been registered for sale or not.

What is the role of GS1 in this new regulation?

V. Marchand: Using an international standard allows pharmaceutical suppliers to harmonize their product marking systems for all of their customers, regardless of the countries concerned. Hospitals will be able to manage all of the products supplied and received based on the same structure, and thus to trace them more effectively. All of this will make it feasible to reduce the costs linked to successive handling of products and, in turn, improving patient safety.

Are pharmaceutical laboratories beginning to embrace this standard?

V. Marchand: According to our information, only some large laboratories are beginning to print these codes; others are in the phase of choosing technical solutions, but many are still in the project phase. As we have already seen in other sectors, it is very probable that the majority of pharmaceutical companies will equip themselves in the six months prior to the effective date of the regulation.

What difficulties are the laboratories likely to face when switching from traditional barcodes to a Datamatrix code?

V. Marchand: The difficulty is not linked to the transition from one code to a different type of code, but rather in switching from a code that incorporates fixed information to a code that incorporates variable batch number and use-by date data. This obliges pharmaceutical companies to equip all of their manufacturing processes with marking systems.

How important is an experienced partner company in helping to standardize a company's production to the new regulation?

V. Marchand: The services companies able to help pharmaceutical companies in this approach are generally members of GS1 partners, which guarantees companies that they use GS1 standards. The list of these services companies is available on the GS1 website.

What are the upcoming developments on product traceability, and notably in terms of an international extension?

V. Marchand: Internationally, France is not the only country to regulate the transmission of traceability information; Turkey has requested the equivalent for all of the medical products supplied in hospitals, with a series number for some of these. In the U.S., the Food and Drug Administration (FDA) is likely to promulgate a law on UDI (unique device identification) that makes it possible to track implantable medical devices. This law would then be taken on by the European Commission for adoption by all of the countries in the EU.

So you think there will be a harmonization of coding standards in the EU?

V. Marchand: Yes. As soon as the FDA has completely established legislation that is common to the U.S., the European Commission will adopt the work so that European legislation also exists.

Over time there will be a European standard and even an international standard, as the goal is for everyone to have the same criteria across the world. But this takes time. We have already been working with the FDA on regulation at the international level for the past two years. As the person in charge of this file at the European Commission has said, reaching agreement among 25 countries is not straightforward.

What are the differences between Datamatrix and RFID?

V. Marchand: Datamatrix and RFID each meet different needs and priorities. While the RFID is more often used in logistical applications for high added-value products, the cost price of the chip is higher than the Datamatrix. Using RFID obliges hospitals or pharmacies to be equipped with RFID scanners. It is also necessary to have a 100% reading rate, because the interest of RFID, for example, is to be able to read an entire pallet, which will facilitate quantitative inspection on receipt while maintaining very important quality controls in the case of health products.