The diffusion of counterfeit medicinal products is a growing problem at worldwide level. Governs, international and national authorities, and industries are working to make impossible that counterfeit drug can harm people

Altea Pierluigi

Christian Gross, Head of packaging design and artwork service, Aesica

Pharma World Magazine has discuss the counterfeit drugs issue with Christian Gross, Head of packaging design and artwork service, Aesica.

Which are the official worldwide data on counterfeiting in pharmaceutical sector?

The EU commission expects that 7-10% of medical products on the worldwide market are fake and this is set to increase over the course of the next few years. Approx $660 billion revenue loss worldwide last year. Asia and Africa are the no 1 markets for fake products, India accounted for 31% of all fake products, United Arab Emirates 31% and China 20%. Nevertheless in the last year more and more fake products entered the EU market. 80% of the fake products are discovered at the border. The German customs have experienced an increase of 400% in the year 2008. The most prominent types of counterfeiting comprised the following: less or no active ingredients, wrong ingredients and faked packaging.

Are there effective tools to fight this problem?

At first every pharmaceutical company has to evaluate how high the risk of their products being faked is, even if the high volume, very expensive products are most affected by counterfeiting. In the industrialised nations you find mostly a trusting supply chain, but in most third world states there are no regular supply chains. There are three steps involved when approaching a protected product:

1. Product integrity: Guarantee the integrity of the original manufacturers pack throughout the entire supply chain

2. Product Authentication: Use of overt and covert features to authenticate products

3. Product Identification: Use harmonised coding and identification systems for secondary packs.

You need an anti-counterfeiting strategy which is based on the following three pillars:

1. Passive: eg. Hologram, security labels

2. Active: RFID, optical, chemical (reactive ink)

3. Encoding: Digital labels, Encryption

What are pharmaceutical companies doing to fulfil the Falsified Medicines Directive 2011/62/EU (FMD)?

As I have mentioned, they have to go beyond the requirements of the Directive and take a prescriptive approach to the products that they sell and evaluate the individual risk factors. They have to evaluate how high is the risk for their products, eg. in which markets do they sell their products? Is the product expensive? Is there a counterfeit product already in existence? These are the questions that companies have to ask themselves.

What is your suggestion to get ready for this important deadline?

At present, there is a degree of confusion in the market place. The EU directive is in place but nobody knows how to translate the directive into reality. Technical solution is not the problem. There are a multitude of companies who provide more or less good solutions. Ensuring product integrity and product authentication is not a major problem. There are many solutions on the market for tamper evident boxes or seals. The real problem is that Europe has not defined uniform standard product identification. In Germany, the large pharma companies started a pilot project called “securepharm”. The project was designed to show how they can implement an end-to-end tracking system. In France or Italy, they can use their established system (Bollino, French Coding). This system makes it difficult for companies to find a solution that meets the varying requirements of all the different countries. If you buy a solution today, then you have to think about the future requirements. Therefore, you need a scalable and future-proof system. The companies have to start their planning now and observe the market.