Zero Tolerance For Counterfeit Medicines

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist
Article Date: 14 May 2008 - 1:00 PDT

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Counterfeit medicines, already widespread in the developing world, are now being found increasingly in the EU. While Internet-based sales are the main source of counterfeit medicines, these products are also appearing in the traditional supply chain. Urgent measures are required to protect European patients, including a ban on medicine repackaging.

"Even one single case of counterfeit medicine is unacceptable", commented Brian Ager, Director General of EFPIA. "Counterfeiting medicines is a highly lucrative criminal activity that can have serious consequences for the patient and can undermine public confidence in medicines. Recent seizures of counterfeit medicines in the EU have shed light on the vulnerability of the pharmaceutical supply system and on practices that undermine efforts made by the industry to protect patients."

Counterfeits have been found to contain toxic substances. Others contain no active ingredient, or the wrong amount of it - damaging to any medical treatment, but dangerous when patients are being treated for serious illness. In most cases, it is impossible for the non-expert eye to distinguish the fakes from the originals.

Under current EU rules, products can be re-boxed, re-labelled or over-stickered. Tablets can be removed from their blisters and reconditioned. These repackaging activities can involve removing the security seal and damaging unique identification codes, which ensure product traceability. Such practices make it even harder to distinguish real medicines from fakes.

In addition to the development of security features on medicine packaging, individual companies are assisting authorities in different ways, for example by training officials to recognize fakes and by assisting with international police investigations. However, these initiatives alone are not enough.

In its response to the public consultation launched in March by the European Commission, EFPIA stressed that the number one focus of the forthcoming EU legislative reform should be to ensure that the integrity of the original package is absolutely guaranteed throughout the entire supply chain, from the time it leaves the original manufacturer to the point that it reaches the end user. This is a prerequisite for an effective anti-counterfeiting strategy.

Liabilities should be more clearly defined for all involved in the distribution chain, including brokers, traders and agents. Heavy penalties should be enforced for trafficking in counterfeits. Penal sanctions should be all the more severe when counterfeiting threatens public health.

Efforts to set up a harmonized EU-wide identification system for medicines should be encouraged. EFPIA is making plans to launch a pilot scheme of a unique bar code system, which will enable the pharmacist to verify each medicine pack before dispensing it to the patient.

Background

The growth in the counterfeit medicines trade is driven by a combination of factors. The huge profits to be made have attracted organised crime gangs. The increased sophistication of counterfeit operations makes it harder to detect fake drugs. The European Commission has observed the following worrying trends in particular:

- A sharp increase in seized counterfeit medicines
EU Statistics report the seizure of a total of 2.7 million medicinal products (articles) at EU customs borders in 2006. This is an increase of 384% compared to 2005.

- A trend towards counterfeiting of life-saving drugs
Counterfeit medicines in the EU originally focused on 'lifestyle' medicines, including erectile dysfunction and weight loss medicines. Now, criminals increasingly target life-saving medicines, including medicines to treat cancer and heart disease, psychiatric disorders, and infections.

- A trend towards targeting the classical supply chain
Recently, there has been alarming evidence that, besides the Internet, the licensed distribution chain, including authorized wholesalers, traders and pharmacies are being increasingly targeted by counterfeiters, as they allow distribution of high volumes of medicines. The UK MHRA reported that incidents affecting the regular distribution chain have steadily increased since 2004, with counterfeit medicine reaching patients on 9 occasions, necessitating batch recalls, and discovered at wholesale level on a further 5 occasions.

- A blurred line between counterfeit and sub-standard active substances in medicinal products
The risk of counterfeit or sub-standard active substances entering the supply chain towards a medicinal product poses additional risks to patients. For example, in the early 2000s, numerous deaths and side effects were connected with antibiotics containing gentamicin as an active substance. These effects are assumed to be related to faulty manufacture and impurities of the active substance.

Did you know?

A new unit dedicated to Intellectual Property Rights (IPR) Enforcement has been set up within the European Commission's DG MARKT as of the 1st of January 2008. In this context, an important High Level Conference on Counterfeiting is taking place on 13 May 2008 in Brussels, bringing together the Commission, the Parliament and various industrial sectors. The conference will look at the implications of counterfeiting and piracy for health and safety of European citizens; controlling international trade flows of counterfeit products; and fighting illegal downloading and sale of counterfeit goods over the Internet.

About EFPIA

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 32 national associations and 43 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world.

http://www.efpia.org