COUNTERFEIT MEDICINES: THE NECESSITY FOR A HARMONISED EUROPEAN APPROACH

Counterfeit medicines are a growing threat to patient health. Across the globe counterfeit medicines provide a very effective way to make huge profits quickly and as a result have been linked to funding organised crime including terrorist activity. Medicines sell for high prices, are in constant demand and, even better from a criminal perspective, they are consumed - meaning they leave little or no evidence behind. However, the harsh reality is that counterfeit medicines can harm you or even kill you.

While many recognise this issue, it is an urban myth that the problem of counterfeit medicines is confined to illegal internet sales. Few even consider that medicines sold through the legal supply chain in Europe may not be what they claim to be. However, the latest EU report on goods seized when entering Europe revealed the alarming fact that counterfeit pharmaceuticals are increasing at an exponential rate, with 11.5 million packs seized in 2009 alone. The law of odds suggests that, despite the best efforts of customs officials, these seized goods are just the tip of the iceberg.

New Legislation will increase Patient Safety

However, change is on the horizon, with draft European legislation shortly to be completed is aimed at addressing this very issue. This new directive will require pharmaceutical manufacturers to apply safety features to their products to ensure that operators in the supply chain and health professionals can identify and authenticate medicinal products.

Whilst this is excellent news for patient safety, the industry faces some major challenges regarding the practicalities of implementation; specifically regarding which safety features are applied and how these are authenticated. Observing the recent issues in Turkey and Brazil underline the importance of clarifying the basic tenants as early as possible. Due to a lack of clarity on data carrier and identification standards, overly complicated or indeed insufficient solutions have been proposed. Therefore, if Europe is serious about protecting consumers, it needs to consider both the safety features and authentication mechanism at an early stage, ensuring there is no room for doubt. Anything else runs a high risk of failure and will continue to put patients at risk.

A unique Opportunity for Harmonisation

The task of protecting European consumers is complicated by Europe's 27 member states, each with their own market and regulator. Do you remember the pre-euro days when travel around Europe required multiple wallets to handle all the different currencies - not to mention the cost of converting one currency into another! As the introduction of the euro simplified travel across much of Europe in one sweeping change, so the European Commission (EC), together with industry and other stakeholders, has a unique opportunity to implement a harmonised anti-counterfeiting mechanism. The unpalatable alternative is a hotchpotch of up to 27 different safety measures which would be costly, inefficient and leaving potentially dangerous loopholes open to exploitation.

It is positive that the draft legislation has gone some way to address this problem. Article 290 specifically gives power to the EC to develop a pan-European harmonised approach: "since a high level of patient protection cannot be sufficiently achieved by member states as they cannot adopt individually harmonised measures, safety features should be established at a Community level". But in defining and implementing the solution, the EC need to ensure that they adequately specify a fully harmonised approach for Europe that can be rigorously applied by all stakeholders and in all markets that is underpinned by legislation.

A Case Study: learning from past Mistakes

The risks of the inadequate specification of safety features can be illustrated through the following example:

In the US, the Californian Board of Pharmacy (CBOP) planned to introduce 'e.pedigree' to track and trace all medicines throughout all points of the supply chain. However, since the CBOP did not provide any direction as to the coding structure or data carrier to be used, each manufacturer developed their own solution to meet the legislative requirements. Consequently, wholesalers and pharmacists had to develop plans to deal with a multitude of different scenarios. This was developing into something that was costly, complicated and ultimately unworkable. Luckily for the pharmaceutical supply chain, a decision was taken by the CBOP to delay implementation to 2015. The US Food and Drugs Administration (FDA ) have since consulted on a US-wide solution. The first activity the FDA undertook was to issue a discussion paper on a harmonised coding structure for the entire US market.

To avoid a repetition of the problems encountered in California, we welcome a harmonised European coding standard; however there is more complexity to harmonisation than the data carrier itself.

The Way forward: Issues to consider

The legislation needs to address harmonisation in three key areas; the coding standard, the data carrier and the authentication system that can interpret and authenticate the data carrier. These are the basic requirements to support a harmonised, cost-effective and efficient approach to identifying counterfeit medicines within Europe.

But what does a harmonised approach actually mean for those involved either in the manufacturing process or in the supply chain?

(i) The coding Standard
Without a standardised approach to applying the numerical digits within the data carrier, there is a risk that different manufacturers will inadvertently duplicate codes, compromising the security of the system. A harmonised coding standard is therefore essential for Europe.

Due consideration must also be given to existing reimbursement codes in the generation of a coding standard. These codes are already in use in multiple systems across the majority of European markets and there would be very strong resistance to changing these.

Elements that need to be harmonised within the coding structure are: country code, manufacturer, product number, reimbursement number (note, all these may be included within a global identifier), batch number, expiry date and serial number. The combination of all of these elements would create one unique identifier that would be applied to each pack. The best approach here is to work with a coding standards organisation, such as GS1, to ensure that the standard chosen is workable and supportable.

(ii) The data carrier
This element is critical for manufacturers who need to know if the data carrier is a 2D code, linear code or RFID tag. If member states all choose different data carriers the cost impact would be significant. Considerations in the selection of the type of data carrier include the attributes of cost, size, security, speed of application, speed of reading and robustness. Currently, the general view in Europe is that a 2D data matrix code would provide these attributes.

(iii) The authentication database.
The authentication database must be able to operate without borders across the 27 member states to ensure that the database will recognise a duplicate pack in which ever country it appears. Furthermore, imported and exported medicines must comply with the EU legislation and these too must be authenticated. Given that medicinal packs are transferred between member states, the database must not operate in isolation. By this we mean that member states could not operate their own individual databases without some interoperability.

A single server using discreet databases within the server to hold country-specific information would provide the optimum combination of speed and cost (Figure 1). This mechanism is also easier for the manufacturers to interface with. Independent national databases held within each member state and each set up on a local server, would increase the cost of the service exponentially and create risks that they are not set up and maintained identically, creating weaknesses within the system.

Authentication: the optimal Approach to Patient Protection

Authentication offers a proactive check of every medicinal pack before it is received by the consumer. It can also offer wholesalers and importers/ exporters the facility to sample check before buying or selling. This is a significant step forward as until now, the only mechanism to detect counterfeits was to wait until a patient complained, retrieve the pack and carry out forensic testing.

Creating a harmonised European Legislation across Europe is a significant undertaking but the process is expected to be concluded during 2011. Article 290 within the legislation, gives the Commissioner power to define the harmonised measures which are essential for European pharmaceutical products. This will help to ensure that the chosen approach will meet patient safety needs across all European markets, whilst also being cost-effective and efficient for all parties involved in the manufacture and distribution medicine.

Author:
Graham Smith
... is Senior Vice President Business Development at Aegate Ltd.