The art of war against the counterfeiters

Maud de Boer-Buquicchio of the Council of Europe addresses the escalating problem of counterfeit medicine.

An American stand-up comedian once said that there are two kinds of medicine: quick acting and long lasting – and when in pain we have to decide whether we want to feel better now or later. But there is a third category of medicine, counterfeit medicine, and this one is not funny at all. The risk is that, at best, it will never make you feel better – not now, not later, not ever. At worst, it will kill you.

Imagine a 16-year-old boy who receives a liver transplant and is dependent on therapy with high-tech, high-price medicine to treat his severe anaemia. Imagine that injections administered to him, as prescribed, produce painful side effects instead of the expected therapeutic outcome. Deeply concerned by the boy’s suffering, his family and treating physician are worried and left helpless for a long time – until it is revealed that the medicine was diverted by criminals and repacked on far from sterile premises which are not appropriately controlled. In order to increase profit, the medicine was repacked into smaller, insufficient doses and then reintroduced into the official distribution chain. The boy had received tampered-with medicine, which failed to provide the necessary treatment and put his life at serious risk.

Is this fiction made up by a crime and suspense author? No, it is a true story. It happened outside Europe, in a country with high standards for health care and pharmaceuticals. Unfortunately, such cases also happen on our continent, even though they are not common knowledge. But this is changing, and journalists across Europe are beginning to report on counterfeit medicines discovered in legal distribution chains in Europe.

Recently, an EU member state’s regulatory agency recalled a batch of counterfeit cholesterol-lowering medicine, just before it may have been used with a serious risk to patients. And this was not an isolated case. Let me summarise some facts about the counterfeit medicine situation in Europe:

• The World Health Organisation (WHO) estimates that counterfeit medicines make up 8-10 percent of the European pharmaceutical market, and in some countries even as much as 12 percent.
• Experts are convinced that counterfeiting medicine is on the rise in Europe.
• Counterfeit medicines often appear so like the genuine product that neither healthcare professionals nor patients can detect which is the genuine product before using it. Hence, the patient undergoes the risk of using an ineffective, less effective or even toxic compound not worth being called a medicine, or worth the price the individual or the health-care system pays for it.
• All categories of medicine are profitable targets for counterfeiters – so called life-style medicines as well as essential medicines like antibiotics and insulin.
• Several indicators suggest that organised crime has found a currently lucrative and nearly safe business of counterfeiting medicines to generate resources for other criminal activities. Organised crime puts public health and the health of individual citizens at stake, and aims at creating widespread corruption networks which hinder democratic and economic development and welfare. This also deprives the private sector of legitimate revenue.

Against this background, it is very worrying that there is no recognised central reference point in Europe entrusted with surveillance, trend analysis and policy recommendations in the field of counterfeit medicines. This situation helps the counterfeiters, who can rely on lacking national and international cooperation information gaps in Europe. Even when they are caught, they far too often get away with administrative fines with no deterrent effect.

If we want to deal with the problem of counterfeit medicines effectively, we must bring together public health professionals, law enforcement agencies and the pharmaceutical industry and trade. The Council of Europe (COE) can contribute to such an endeavour. Its 46 member states provide a large enough framework to develop and implement adequate measures and instruments. COE can provide unmatched competence and experience in European legal cooperation and is used to working with a large variety of partners from different countries and sectors of activities. Finally, the safety and the efficiency of medical treatment have a direct link with the Organisation’s core missions of protecting human and social rights of our citizens.

The ancient Chinese general, Sun Tzu, who lived 2500 years ago in north east China, was famous for his strategies. Some of them summarised in his Thirteen Commandments of The Art of War could inspire our battle against medicines counterfeiters:

We must take up battle position!
Already in 1999, the Committee of Experts on Pharmaceutical Questions gave an early warning about the risks created by counterfeit medicines

We must be leaders for others in the fight
The Council of Europe has the necessary competence to lead this fight through its expertise, experience and ability to foster cooperation on the basis of its founding principles and core values.

We must act carefully and stick to the facts
A key to success is to choose the right moment for action with careful preparation. The Committee of Experts on Pharmaceutical Questions has devoted time and resources to look into the counterfeit medicine situation in Europe within the member states of the Partial Agreement in the Social and Public Health Field and stakeholder associations in the private sector.

We must act quickly and pragmatically
The Council of Europe’s working methods and structures allow for great flexibility in the choice of effective working methods and partners across sectors and countries:

We must be innovative and take initiative
We need to identify new forms of cooperation and exchange of expertise and information in the field of counteracting counterfeit medicines. The recent ‘Combat Counterfeit Medicines’ seminar in Strasbourg tried to open up different aspects of the counterfeit medicines issue in legislation and law enforcement, public health practice and multi-sectorial cooperation, which in itself offers opportunities for addressing the problem. Let us widen existing opportunities within and across this organisation and take further bold initiatives. Whatever different views there are in European capitals today, I strongly believe we should have a comprehensive legal instrument to combat counterfeiting as our target for the years to come.

We must be cooperative
Cooperation partners inside and outside the organisation have worked together and united their knowledge and experience to build an alliance to counteract medicine counterfeiters through effective measures and mechanisms. This includes the European Commission, the European Patent Office, the US Food and Drug Administration, and WHO, as well as the CEO Parliamentary Assembly.

Producing and distributing counterfeit medicine is a crime, producing huge benefits at the expense of the pharmaceutical industries – but even more so, to the detriment of the patients, whose lives and well-being depend on proper medical treatment. A counterfeit medicine is not a fake Gucci bag or a poor imitation of Ray Ban sunglasses, which will cause you well-deserved hassle at the customs or make you look ridiculous in the company of snobs. It may well kill you and many others across Europe and the world.

Buying from e-pharmacies

A new campaign has been launched to highlight the risk of buying prescription only medicines from unregulated internet sites, as many are counterfeit.

In the UK alone, new research revealed that of 1000 people interviewed, only two percent believed prescription-only medicines were likely to be counterfeit compared to products such as DVDs and designer watches – a cause for concern since nearly two-thirds had received e-mails offering medicines for sale over the net.

Swiss-based drug manufacturer Roche has already warned consumers worried about reports that avian flu could mutate into a human virus not to buy its flu drug Tamiflu from internet sites as it cannot guarantee the goods they receive aren’t counterfeit. Instead, it urged those wanting the drug to get advice from their doctor and only buy from reputable pharmacies.

In a separate response to the increasing number of unregulated e-pharmacies offering medicines, Merck, Sharp & Dohme Limited (MSD), the UK subsidiary of leading US research-based pharmaceutical company Merck & Co, has launched a patient safety campaign to address questions raised by those concerned about counterfeit medicines.

Spotting the fakes

• In wealthier countries, the most frequently counterfeited medicines are new, expensive lifestyle medicines, such as hormones, steroids and antihistamines. In developing countries, the most counterfeited medicines are those used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS
• The US Food and Drug Administration estimates that counterfeits make up more than 10 percent of the global medicines market. It is estimated that up to 25 percent of the medicines consumed in poor countries are counterfeit or substandard. These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$32 billion globally (around €27 billion).
• Trade in these medicines is more prevalent in countries with weak drug regulation control and enforcement, scarcity and/or erratic supply of basic medicines, unregulated markets and unaffordable prices. However, one of the most counterfeited drugs today is Viagra, which is sold extensively via the internet in industrialised countries.
• Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.
• A study conducted in South-East Asia in 2001 revealed that 38 percent of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients and had resulted in a number of preventable deaths.