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Articles from May 2008

Surge in European seizures of fake medicines

European Union statistics released yesterday indicate the number of fake medicines, cosmetics and toys seized coming into Europe has soared in the past year. Seizures of counterfeit medicines climbed 51% and included fake treatments for conditions such as hypertension, osteoporosis and cholesterol. Laszlo Kovacs, EU taxation and customs commissioner, stated that the 2007 figures showed: “some new and alarming tendencies”. Read the whole article here. (20 May 2008, The Financial Times, UK)

UK warned to avoid parallel-imported Clexane

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has warned against parallel imports of packs of Clexane (enoxaparin sodium) pre-filled syringes. This is because some packs supplied to overseas markets have higher levels of the contaminant over-sulphated chondroitin sulphate (OSCS) than is considered acceptable by the Commission on Human Medicines.

Last month the MHRA issued a Class 4 drug alert about Clexane but stated that batches contaminated with levels of OSCS below 5 per cent could continue to be supplied. This advice still stands but the MHRA is now advising parallel importers not to distribute certain batches of Clexane pre-filled syringes within the UK and reminding potential recipients of the batches that parallel importers may modify the originator’s batch number by adding a prefix or suffix or by using their own number. More information and the relevant batch numbers can be found on the MHRA website. (17 May 2008, The Pharmaceutical Journal)

Chinese welcome bar codes in the fight against fake medicines

The Chinese State Food and Drug Administration’s (SFDA) draft plan to introduce labels to aid medicine monitoring is being warmly received by industry insiders, as the bar code-like labelling system may help companies and government alike to crack down on counterfeit drugs. The draft plan, named National Drug Code Management Methods, requires manufacturers to include a label on the packaging of their products containing a code which can be read electronically as well as by humans. The code will be a 14-digit number, which will indicate the product’s country of origin, manufacturer, type of product and the drug specification.

Counterfeit drugs have been a focus of concern for Chinese pharmaceutical companies in recent years. China’s drug administration authorities at provincial and lower levels have also been on the look out for fake drugs. One of the priorities on the SFDA’s agenda last year was stemming the flood of fake human albumin products on the Chinese market, as shortages of the blood product worsened.

Last month, Yan Jiangying, the SFDA’s spokesperson, explained that the labelling policy would be applied this year to blood products, vaccines, finished traditional Chinese medicines in injection form and mild psychotropics. (13 May 2008, Interfax.com)

Combating counterfeit medicines

Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant –oversulfated chondroitin sulphate – has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters.

If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries.

The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics.

This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade.

There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised. (12 May 2008, www.DrugSafetyHub, The Lancet 2008; 371:1551)

Two die taking illicit ‘Valium’

A man and a woman died after taking a drug they believed to be Valium, UK police have announced. The deaths of the 36-year-old man and the 22-year-old woman are not directly linked but they had both taken the same illicit drug. Both victims died in their sleep after taking the blue tablet with a white powder, a police spokesman said. They were found dead in separate addresses in the same town on Saturday. Detective Chief Inspector Kevin Connelly, of Dorset Police, said: “For those people who continue to use illicit drugs, I urge them to seek medical help and support.” (11 May 2008, BBC News online)

Dubious drugs

A senior divisional medical officer (DMO) in India has blown the whistle on the supply of fake drugs to Danapur Railway Hospital. This seizure could be just the tip of the ice-berg, for medical practitioners have long suspected a fake drug racket in major Indian government hospitals. Police reveal that the extent of the scam is as yet unknown and it is suspected that medics may be involved. Danapur DMO Ranjit Das lodged his concerns with the Khagaul police station against three pharmaceutical companies after the patients failed to respond to drugs supplied by these firms. It was found that the drugs (all commonly prescribed and purchased in bulk by most hospitals) lacked effectiveness and that the quality and weight of cotton and bandage used were also sub-standard.

This was not the first time that fake drugs have been discovered at this hospital. Previously, use of an anxiety disorder medicine manufactured by a Uttar Pradesh-based company had been banned after a batch was found to be of low quality and ineffective following a laboratory analysis. Counterfeit insulin containing impurities has also been found at the hospital in the past. (6 May 2008, The Times of India)

Counter measures

Operation Stormgrand, an investigation by the The Medicines and Heatlthcare Products Regulatory Agency (MHRA), uncovered the largest ever counterfeit medicines racket in the UK with £1,500,000 worth of fake drugs being seized by HM Revenue and Customs (HMRC). Four men were convicted in September 2007.

Counterfeiting operates on a global scale. The men convicted as a result of Operation Stormgrand were only part of the UK distribution arm of a worldwide counterfeiting ring, operating from China, India and Russia and extending to the Caribbean and the US.

Estimates of the market share of counterfeits range from 1 per cent for developed countries and 10 per cent for developing countries. Total sales of counterfeit drugs could surpass $75bn in 2010, according to the World Health Organisation (WHO). Internet sales are a particular problem; the WHO estimates that medicines purchased online from sites that conceal their physical address are counterfeit in more than 50 per cent of cases.

From a legal perspective, dealing in counterfeit pharmaceuticals is wrong on several fronts. First the supply of counterfeit medicines constitutes a breach of medicines marketing legislation. All pharma­ceuticals must have been granted a marketing authorisation before they are launched on the market and it is generally an offence to market a medicine that has not been authorised.

The most obvious and dangerous form of counterfeit drug is fake pharmaceuticals manufactured by unlicensed producers. Often no attempt is made to replicate the therapeutic attributes of the original product and, worse, dangerous chemicals may be added.

Another form of counterfeiting involves tampering with the product; liquid medicines are diluted, tablets can be crushed, mixed with other ingredients and then reconstituted into tablets at lower dosages.

A third type of counterfeiting is where the product itself is not tampered with, but the packaging is re-labelled to indicate, for example, a higher dosage than is actually present, or to obscure an expired use-by date.

One viewpoint is that the greater the range of packaging on the market for the same product, the greater the acceptance by customers that the genuine product comes in many different guises, and the more likely it will be that counterfeits will go unnoticed.

Counterfeits also often involve an infringement of the intellectual property rights of the original producer. Fake products frequently infringe the trademarks and/or copyright in the original packaging and patient information leaflets. In addition to giving rise to civil liability, both the unauthorised use of a trademark and dealing in articles that infringe copyright, constitute criminal offences.

Pharmaceutical companies have been implementing measures to help identify and reduce the incidence of counterfeit products. Two such remedies are supply chain management and product identification and tracing.

SUPPLY CHAIN

The more tightly a supply chain is controlled, the fewer the opportunities counterfeiters have to put their illicit goods on the market unnoticed. Many pharmaceutical companies are therefore now monitoring their products more closely throughout the supply chain. This may involve reducing the number of wholesalers; obtaining further details of relevant partners, transit providers and port locations; and monitoring contract manufacturing partners to ensure that they are producing only authorised products and not running an extra shift to produce goods for illegal distribution.

Some UK companies have introduced direct-to-pharmacy (DTP) supplies where a logistic services provider arranges physical supply of the product to pharmacies, but the product remains in the ownership of the pharmaceutical company until it is delivered to the pharmacist. One of the principal reasons for such an arrangement is to help avoid counterfeits entering the normal wholesaler supply chain.

Competition law is particularly relevant in the context of supply chain management techniques and should be carefully considered before such techniques are implemented.

PRODUCT TRACING

Genuine products may be tagged by various means to ensure either their traceability through the supply chain or to enable them to be easily differ­entiated from counterfeit products, or both.

Tagging may be overt or covert, with covert tagging being more difficult for counterfeiters to detect and imitate but also also more expensive.

The most common form of overt tagging is the use of holograms and digital printing techniques. Covert tagging mechanisms include:

• Electromagnetic tags – which give off a signal when scanned

• Radio frequency identification (RFID) tags – where chips store and transmit this data to a local receiver

• Bio-molecular ‘taggants’ – where a complex molecule may be introduced into packaging or the product itself.

Taggants are extremely difficult for counterfeiters to detect but manufacturers need to use complex forensic methods to examine products for taggants. Many manufacturers use a combination of methods to help protect their products against counterfeiting.

GLOBAL SOLUTIONS

The legal enforcement procedures that were employed in Operation Stormguard were only enacted when the goods entered the UK. Although many other countries have similar measures in place, countries with rapidly developing economies, do not.

There have been recent attempts to harmonise and co-ordinate the criminal enforcement of intellectual property rights across Europe. A draft directive on the criminal enforcement of intellectual property rights has been adopted by the European Parliament and is currently being considered by the European Commission.

Unfortunately, the draft has become somewhat mired since it strayed from its original focus on counterfeiting and piracy to seek to criminalise all intellectual property infringements. This broadening of scope has been much criticised for potentially limiting free trade, by stifling the ability of businesses to challenge each other’s intellectual property for fear of criminal sanctions. This could make it very difficult for new market entrants.

A wider initiative to address counterfeiting was launched by the European Commission in October 2007. The Commission announced that it would seek a mandate from the European member states to negotiate a new Anti-Counterfeiting Trade Agreement (ACTA) with major trading partners, including the US, Japan, Korea, Mexico and New Zealand.

The goal of ACTA is to combat counterfeiting by increasing international co-operation, leading to harmonised standards and better communication between authorities.

It is hoped that additional countries will sign up to ACTA over time, helping to spread harmonised standards.

In particular Increased co-ordination between more developed nations may help to increase the pressure on countries such as China to toughen its stance on counterfeits.

To prevent, or at least reduce, the escalating problem of counterfeit medicines, co-ordination is required between existing national authorities (such as MHRA and HMRC in Operation Stormgrand) and between government authorities and pharmaceutical companies. Recent initiatives instigated by the European authorities should encourage such co-operation. (1 May 2008, PMLive online)

Why Kenya is losing the war against fake medicines

The Kenyan Pharmacy and Poisons Board (PPB) is losing the war against counterfeit medicines due to the lack of a law against fakes and proxy wars between manufacturers and importers. Kenyans are believed to be spending millions of US dollars each year on fake medicine, exposing them to health complications arising from taking drugs that are not effective against the illnesses they purport to cure.

There are now fears that the war against counterfeits is about to be lost as illegal traders search for new avenues to quick riches following the substantial success of global efforts against narcotics. Analysts say that Africa is an easy target for counterfeiters because of the weak policing environment. Kenya in particular is targeted because of the bigger drug market. Kenya is currently the largest producer of pharmaceutical products in the Common Market for Eastern and Southern Africa (COMESA) region, supplying about 50 per cent of the market.

At the centre of the counterfeit merchants is a proxy war between local drug manufacturers and the parallel drug importers, in which the PPB finds itself in the middle. Parallel drug importers are generally traders licensed by the government to import and register medicines which are under patent and are already registered in Kenya, and which originate from anywhere approved by the Board. Ideally, such medicine should be cheaper than what is available in the country to ensure as many Kenyans as possible benefit.

In September 2006, the board, together with the industry partners developed guidelines for parallel importation of medicines in Kenya. Manufacturers accuse the board of failure to implement the guidelines, leaving the public at the mercy of importers of counterfeit medicines. The pharmaceutical companies say they are not opposed to parallel imports but would like to see the rules enforced. The guidelines require that imported medicine should have the same formulation, quality and proprietary name as those already registered in Kenya.

Local manufacturers also say because of poor monitoring, the price benefit accrued from parallel imports is not being passed on to patients. It has also been difficult to ascertain whether the medicines come from factories that meet minimum pharmaceutical manufacturing standards. (1 May 2008, allafrica.com)