Counterfeit Medicines – a serious danger to public health

One of the reasons why medicinal products command what some consider to be high prices is the statutory requirements that have to be complied with before a marketing authorisation is granted and the monitoring and inspection which is required to be continually enforced from the start of manufacture to the administration to the patient.  This whole process has become known as the supply chain.  Because of the opportunity for the suppliers of unlicensed products to make considerable profits by introducing such products into the supply chain then the production of counterfeit medicines can be a lucrative business.  

These unlicensed medicines are frequently unsafe, inefficient or of poor quality as they may not include the stated amount of, or indeed any of the active ingredient or are not manufactured in licensed premises.  Examples of these products have in the past been what are commonly referred to as ‘lifestyle’ drugs and as such did not represent a serious threat to human health.  However, there is now strong evidence that these unlicensed drugs that are available have been extended to include innovative or life-saving medicines and that these are now being infiltrated into the legal supply chain.

Counterfeit medicines form part of the broader phenomenon of substandard pharmaceuticals which do not satisfy the established standards of quality, safety and efficacy.  They are usually fraudulently and deliberately mislabeled in terms of their source or identity and purport to be both branded and generic products either of which may contain no active ingredient.  The WHO has a specific interest in identifying and eliminating counterfeit medicines and a definition of which is provided in their fact sheet.

Counterfeit lifestyle medicines have been introduced into wealthy countries and include such agents as steroids, hormones and antihistamines.  In developing countries the diseases targeted are malaria, tuberculosis and HIV/AIDS.  The range of products being promoted is constantly expanding and now includes anti-cancer and antiviral agents.  The callous attitude of the counterfeiters has even led to the offer of vaccines for immunisation against the swine flu virus, A/H1N: these products often contain no active substance so their potential to produce harm is immeasurable.  

One of the most influential conduits for the sale and supply of counterfeit medicines is the internet. The magnitude of the problem cannot be accurately determined but the figures that are available suggest that the increase could be exponential.  At the end of 2007, WHO estimated that between 10 and 30% of medicines used in numerous developing countries (Africa, Latin America and parts of Asia) were counterfeit.  At the same time only about 1% of the market value of medicines was counterfeit in countries where effectively regulatory bodies were in place.  Between 2005 and 2006 the increase in counterfeit medicines seized by customs officials at European borders had increased by 380%.  More than 50% of medicines purchased through internet websites that conceal their address are counterfeited.

On 19th November 2009 the UK MHRA made a press release reporting that the efforts of 24 countries had been coordinated by INTERPOL and WHO in the launching of Operation Pangea II.  The global operation concentrated on three pivotal components of an illegal website – the Internet Service Provider, payment systems and the delivery service.  More than 16,000 packages were inspected, 167,000 counterfeit dosage units were seized and during the exercise 750 websites were found to be offering controlled or prescription only drugs.  In the UK, premises in eight towns and cities were raided, three arrests were made, six websites were closed down and illicit medicines with a value of £300,000 were confiscated.  The counterfeit medicines offered for sale were claimed to treat hair loss, erectile dysfunction, weight loss, pain and asthma or to be contraceptives.  The products were being supplied without prescription and stored inappropriately by unqualified personnel.  The main problem is that the websites often look official and in an attempt to prevent this misconception the Royal Pharmaceutical Society of Great Britain has introduced an internet pharmacy logo.  The Head of Enforcement at the MHRA stated that “people dealing in these types of businesses are criminals, often at the higher end of the pay scale.  They substantially benefit financially from this unlawful trade”.

There is also a financial penalty for companies and patients who use properly licensed products and follow the laws of the country in which they reside.  In order to ensure that a product is genuine and has been delivered by an approved supply chain, then there will have to be increased inspection and licensing of all parts of the chain, the costs of which will have to be borne by the patient.  When it is remembered that deaths have resulted frorm the use of counterfeit products then the extra cost may seem trivial to inhabitants of the wealthier countries. However patients residing in poorer countries may not be able to avail themselves of the genuine products which might represent a luxury when it is considered as a fraction of their total income.

In March 2009 the Dutch customs authorities detained several batches of generic drugs which were in transit through the Netherlands from India to Nigeria.  The reason for the action taken was that it had been claimed that the product infringed the patent of the inventor.  This has given rise to a debate between the European Union whose legislation to prevent the supply of counterfeit medicines conflicts with the World Trade Organization rules providing for the free transit of goods and which it is claimed may impede developing countries’ access to essential medicines.  Of course it could also speed up their exposure to counterfeit products although this is quite obviously not of course the intention of the legislation.

It is now 10 years since internet sites began offering medicines for sale: the first product was Viagra but since that time the range of products has diversified.  Seizures of illegal products had risen by 24% by 2007 involving 403 different products in 99 countries.  The value of these products is estimated to have been $3 billion.  The proliferation of the internet will undoubtedly be accompanied by a concomitant increase in the availability of counterfeit products.