Falsified Medicines Directive: don’t lose track of compliance

The Falsified Medicines Directive (FMD), otherwise known as Directive 2011/62/EU, was implemented in July 2011 due to a marked increase in falsified medicines making their way into European supply chains. Member states of the EU were required to comply by January 2013, which added to the already heavily regulated sector, and licensing, manufacturing and distribution of medicines remains tightly controlled.

Increases in the number of falsified medicines globally have been dramatic. In 2013, the World Health Organization (WHO) launched a global surveillance and monitoring system designed to encourage Member States to report incidents of substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products in a structured and systematic way. Up until January 2016, 920 medical products had been reported across all main therapeutic categories and included both innovator and generic medicines – from inexpensive pain medication to very expensive products for the treatment of cancer.

Benoit Goyens of the World Customs Organization (WCO), speaking at the Medicines for Europe Conference in Croatia last year, predicted that criminal organisations could generate up to £1bn in 2017 from the sale of illicit medicines – many of which will be purchased through seemingly bona fide websites via the internet. The figures are staggering, therefore improvements to the regulations were necessary to help in the fight against this highly dangerous, often fatal, practice.

What are falsified medicines?

Falsified medicines are products that have been made illegally to ‘mimic’ real medicines. Essentially they are fakes that pass themselves off as the real thing. The ingredients used in these products can be of a significantly lower quality than the approved genuine version and often have lower levels of the active ingredient require for effectiveness. Dosage levels can also be wrong, or the wrong ingredients altogether could be used in their preparation, and fake packaging is generally used to conceal the source of the product and the identity of its manufacturer.

Medicines that are falsified are often confused with counterfeit products and it is very important to make the distinction between the two. While counterfeit products are illegal, they are generally produced using patented technologies that are not the rightful property of the manufacturer. This technology can be used accurately to produce medicines that do not comply with intellectual property rights or trademark laws – thus making them counterfeit. Falsified medicines, by contrast, represent a higher risk to the public as they are made to resemble genuine products.

Unfortunately, this distinction between falsified products and counterfeit products made in the EU is not necessarily used around the world, and in the language people use they will sometimes refer to counterfeit when they actually mean falsified.

How has the FMD changed where coding and marking is concerned?

The introduction of the FMD has presented challenges to the pharmaceutical industry, in that it requires a far higher level of data management than ever before. Section 11 of the FMD states that: ‘Safety features for medicinal products should be harmonised within the [European] Union in order to take account of new risk profiles, while ensuring the functioning of the internal market for medicinal products. Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering’.

These requirements were set out recently in a Deregulated Regulation (EU2016/161), published in February 2016. It states that two new safety features must be present on the packaging of most medicines that are intended for human use – a unique identifier and an anti-tampering device.

Serialization will be required at secondary pack level, information for which must be provided via a 2D barcode and in human readable form. The information present must include a unique serial number, expiry date, batch number and product code. At present, there are differences that exist in terms of classification of medicines. Some member states may consider a product a prescription item, for example, while another deems it an over the counter product. The directive only applies to prescribed medicinal products so, depending on the destination country, a national reimbursement number may also be required. This will be added by manufacturers and repackagers accordingly.

Products will need to be guaranteed authentic via an end to end verification system, in addition to risk-based verification by wholesalers. A final level of security is provided by further verification of the product at pharmacy level – ensuring authenticity at point of sale. For products sold via the internet, a new online logo has also been designed to indicate companies that are operating legally. This can be clicked to check the authenticity of the company in question against a verified database.

These new measures will apply as of 9 February 2019.

Coding and marking – a vital piece of the FMD puzzle

The two most common technologies for serialized marking are laser and thermal inkjet (TIJ), as both are able to produce high resolution codes that meet the detail requirements for 2D DataMatrix codes. TIJ printers fire tiny ink drops onto packaging as it passes by the cartridge, or printhead. These ink drops are propelled out of a row (or rows) of fine-gauge nozzles by the rapid cycling of a small resistor underneath each nozzle. These resistors boil a small amount of ink which creates a small steam bubble that propels the ink drop. In contrast, laser coders use a focused beam of light to inscribe or physically alter the top layer of a substrate. The beam of light is steered by two mirror galvanometers which direct the laser beam in two planes.

In the first instance, manufacturers should look at the packaging substrate they intend to code or mark. Pharmaceutical cartons and paper labels are commonly used and often feature an aqueous overcoat to protect the packaging material. Historically this would be an issue for TIJ, as water-based inks would not adhere to the surface of the packaging. Advances in ink technology, however, have seen the introduction of methyl ethyl ketone (MEK) or other light-solvents – broadening the spectrum of applications TIJ can address. Substrates such as foils, films, plastics and coated paper stocks are all now addressable with a TIJ technology that utilizes MEK-based inks.

Laser systems are able to mark on a wider range of materials, such as paper, plastics, metal and glass. Lasers are also able to code on curved surfaces such as vials or bottles. There are two considerations when it comes to verifying suitability of the substrate with laser technology: absorption of laser light and creating a print window with sufficient contrast for high quality codes. Absorption is a function of the substrate and the selected wavelength of the laser and the correct combination should be recommended by an expert coding and marking supplier. For proper code contrast, it is commonly required to modify packaging with a print window of dark ink, referred to as a "flood fill." The laser burns off the top layer of dark ink to expose the lighter underlying substrate – making a negative image.

Data management is critical

Manufacturers will find it necessary to adopt track and trace technology to enable compliance with the FMD and its associated delegated regulations, and the ability of coding and marking systems to interact with these technologies cannot be overlooked. There are a number of ways in which these interactions can take place.

Asynchronous communications, for example, allows the coder to send unsolicited information to the line control system. This functionality provides the dual benefits of active notification of a printer event and reduced network traffic, which translates to faster notifications and higher potential throughput. Remote communication protocols too enable sensitive information and commands to be passed between the coding system and the host data system. This is important to remember when choosing a coding and marking system, as using a printer that features a tested, validated and secure protocol and command set designed specifically for managing sophisticated communications is critical.

Finally, buffer management is key to consider. Can your chosen system code and mark unbuffered, where variable data is received and printed one record at a time, or buffered, where multiple records are sent at the same time but are only printed once each. These features are particularly important to consider in countries where serial numbers have to be purchased. Correct management will enable manufacturers to redeem those codes that have not been used, which represents a useful cost saving.

Whichever technology is best for your individual needs, what is clear from the legislation is that coding solutions for FMD need to feature robust data management, seamless integration into manufacturing equipment and high resolution print capability to convey information throughout the supply chain. Through working with an expert supplier, manufacturers can ensure that the products they produce can be 100% authenticated at all points along the supply chain – helping to make the illegal falsification of medicines a far more difficult practice going forward.