Counterfeit Medicines

– in the House of Commons at 7:17 pm on 26th January 2006.

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Motion made, and Question proposed, That this House do now adjourn.—[Mr. Coaker.]

Photo of Charles Walker Charles Walker Conservative, Broxbourne

The counterfeiting of drugs is a global problem. The World Health Organisation estimates that between 8 and 10 per cent. of the global medicine supply chain is counterfeit. That represents up to £20 billion worth of medicines.

In developing countries, up to 60 per cent. of public and private health expenses are used to buy medicines. The WHO estimates that 25 per cent. of those medicines are fake, and in some countries the figure could be as high as 40 per cent. In the world's poorest and most vulnerable communities, people are dying needlessly of AIDS and malaria. Counterfeiting hot spots include Mexico, Pakistan, India, China and Russia.

Counterfeits are dangerous for a variety of reasons. They may be contaminated, they may contain too much or too little of the active ingredient, or they may contain none at all. Counterfeits are totally different from generics. Generics must have the same bio-equivalence as the original patented drug; counterfeits are fakes, and often lethal fakes.

In China in 2003, nearly 1,000 drug-counterfeiting factories were closed and millions of fake drugs were seized. It is estimated that 100,000 Chinese people died that year as a result of taking counterfeit medicines.

In Africa, half of malaria medicines are thought to be fakes. In the west, drugs are normally finished and packaged to a higher standard. For that reason, it is almost impossible for patients and many professionals to see the difference between real and counterfeit medicines. In wealthier countries, the most frequently counterfeited medicines tend to be new, expensive lifestyle drugs. For example, it is estimated that half the Viagra sold over the internet is worthless.

The profits from pharmaceutical counterfeiting are huge and the risks lower than those involved in trafficking narcotics. Counterfeiting is linked to all forms of organised crime such as money laundering, drug trafficking, terrorism and other illegal activities. Distribution channels mirror those of the illegal drugs trade, and in many developing countries drugs often disappear into a black hole. Corruption is rife. Retroviral drugs sent to Africa at reduced prices are often intercepted by corrupt officials or gangs and sold back to Europe to be replaced by worthless copies in Africa.

As borders become more porous, the global trade is expanding. Counterfeiting is no longer a cottage industry; it is big business. Criminal gangs are so professional that they will buy the same manufacturing and packaging equipment as drug companies, allowing them to produce up to 50,000 tablets an hour.

Pharmaceutical products are attractive to criminal gangs because they are easily transportable and command a high price per unit. Profits from fake pharmaceuticals can be larger than those from narcotics such as heroin and cocaine. The added bonus for traffickers is that the trade carries a lower risk than that in narcotics because law enforcement agencies are perhaps not as aware of the problem.

The problem of illegal medicines needs to be handled carefully. Fortunately, in the UK, counterfeits remain extremely rare when sourcing is done through recognised pharmacies. The UK supply chain remains one of the most difficult to penetrate, with 600 million prescriptions written annually. However, in July last year, counterfeit Lipitor, a powerful cholesterol-busting drug, was discovered. The counterfeit was made to look like a UK pack and was traced by the Medicines and Healthcare products Regulatory Agency to two separate licensed UK wholesalers. Of course, the manufacturer of the genuine drug issued a total recall. Of those packs returned by pharmacists, however, more than 50 per cent. were found to be fake after being analysed.

Fifteen months earlier, in April 2004, detectives raided a warehouse near Wembley stadium and found a factory producing thousands of fake prescription medicines every day. Enough mixture was seized to make more than 20,000 tablets an hour—Viagra, steroids, tranquilisers and antidepressants. They were expertly packaged and labelled, and some active ingredients were present, but not the right ones.

When dealing with counterfeits, criminals are taking the long-term view. Fake drugs are offered at just below market price so as not attract attention and the continuing growth in counterfeiting comes when there is increasing concern about the integrity of the UK wholesale supply chain.

UK wholesalers are licensed by the MHRA, but gaining a licence is relatively easy. Those applying for licences are rarely asked to produce a passport, birth certificate or driving licence and it is even unclear whether a Criminal Records Bureau check is routinely undertaken. Against that background, the number of wholesale licences issued has risen tenfold in the past 12 years, providing additional entry points for counterfeits. Once a licence is granted, wholesalers can trade almost without restriction.

The growth in the number of wholesalers mirrors the growth in parallel trading. In recent years, a new market has emerged that has understandably seen the national health service and other purchasers exploit price differentials in medicines across the European Union. Each year, 140 million medicines are parallel traded across the EU of which perhaps 70 per cent. are destined for the UK. Parallel trade accounts for up to 20 per cent. of all prescription medicines sold in this country.

Medicines are sourced at the cheapest unit price across the EU, but, to comply with the language and packaging requirements of national markets, drugs are often repackaged and the seals broken. The growth in parallel trading means that, often, pharmaceutical products pass through the hands of multiple distributors, creating a highly fractured supply chain that can be accessed by determined counterfeiters.

A Bermuda triangle has been formed by parallel trade, counterfeits and online pharmacies. It is the growth of unregulated internet pharmacy that provides the best opportunity for counterfeit and illegally re-packaged medicines to enter the supply chain. The internet is like a sweetshop, except one can buy painkillers, tranquilisers and even methadone; indeed, one can buy methadone from hundreds of sites. Most online pharmacies are unregulated and will dispatch dangerous medicines without prescription. Many people, including patient groups, pharmacists and doctors, believe that online pharmacies represent a significant danger to those ordering prescriptions over the web.

There are now more than 2,300 sites selling drugs direct to the consumer. The five most advertised drugs are Viagra; Phentermine, a weight loss drug; Xenical, a weight loss drug; Propecia, a hair loss drug that would be lethal to women; and Adipex, a weight loss drug. Those sites are domiciled around the world but in almost all cases they are unlicensed to sell or prescribe prescription medicines.

Over the past six years, across the Atlantic, US drug enforcement agents have made 180 internet drug arrests but they know that they are just scratching the surface. Internet pharmacy sites are inexpensive to create and hard to shut down; up to 80 per cent. of drugs sold online are counterfeit.

The nature of this internet trade is frightening. A UK charity, the Depression Alliance, was able to buy prescription medicines for depression over the internet with a discount on bulk purchases; no consultation, no diagnosis, no prescription and no pharmacist. The Depression Alliance bought enough of a tricyclic antidepressant to kill eight people. Even after entering into online consultation that revealed that the potential buyer suffered from a pre-existing diabetic condition, self-harmed and repeatedly tried to commit suicide, the drug was still dispatched.

As I have said, this country still has a robust regulatory system. However, I am concerned that it may not be keeping pace with the emergence of a distribution channel that is tailor-made for sending counterfeit drugs to the UK. Of course, the last thing that we want is to create unnecessary panic. However, we need to accept that counterfeiting is a growing global problem fuelled by organised crime, unrestricted parallel trading and the growth of internet dispensing.

In the UK, internet pharmacies pose a growing threat to public health. They are largely unregulated; in the best case, these illegal pharmacies are dispensing sugar and, in the worst case, poison. I hope that as a result of this short debate the Government will take a good look at our regulatory system to see what measures can be taken to safeguard the public from this new and emerging threat.

Photo of Jane Kennedy Jane Kennedy Minister of State (Quality and Patient Safety), Department of Health 7:27 pm, 26th January 2006

I congratulate Mr. Walker on securing this important debate, and on his informed and balanced assessment of the threats posed by counterfeit medicines. Compliments from Ministers to Opposition Members rarely enhance their careers, but they are merited in this case. I shall seek to reassure him and the House that I and the Government take a great interest in the issue.

I can assure the hon. Gentleman that the Government take the issue of counterfeit medicines extremely seriously. Counterfeit medicines are often unknown and can enter the market in many ways. Although not a new problem, the international nature of the pharmaceutical industry and of markets means that the manufacture and distribution of counterfeit medicines can present new opportunities to criminals who are growing in enterprise and sophistication. Indeed, trade in counterfeit medicines is now a global problem; the World Health Organisation estimates that up to 10 per cent of medicines worldwide may be counterfeit. As the hon. Gentleman suggested, an even higher proportion of medicines in poorer countries are thought to be counterfeit. This has obvious, and serious, consequences for public health and costs the pharmaceutical industry many billions of pounds annually.

The manufacture and distribution of counterfeit medicines is a real problem for countries where the regulatory framework is weakest, and the EU systems do provide substantial protection. Nevertheless, there is some evidence of counterfeit products being provided direct to UK customers in the UK by mail order, via the internet or on a personal basis. I certainly share the hon. Gentleman's and the public's concern about the availability of potentially counterfeit and unregulated medicines through these routes. They cannot be guaranteed for safety—as the hon. Gentleman described—quality or efficacy. While the UK's legitimate supply of medicines through pharmacies, hospitals and retailers is tightly controlled and internationally acknowledged as difficult to penetrate, I recognise that no supply chain can ever be completely secure. Proper regulation and robust inspection, surveillance and enforcement are constantly required to preserve the integrity of the market and to protect public health.

The Medicines and Healthcare products Regulatory Agency, to which the hon. Gentleman has rightly drawn attention, regulates the use of medicines in the UK. The MHRA is responsible for ensuring compliance within a comprehensive EU regulatory framework that imposes strict controls on the licensing, manufacture, sale, supply and advertising of medicines. That includes the licensing and inspection of all UK manufacturers, wholesale dealers and importers of medicines. The agency also inspects manufacturers in non-EU countries exporting to the UK. Controls on sale, supply and advertising of medicines direct to the public apply without distinction across all types of retail outlets—traditional and electronic.

The MHRA has developed an anti-counterfeiting strategy that builds on that regulatory framework and aims to minimise further the risk of counterfeit medicines reaching UK consumers and patients either on a personal basis or through the legitimate supply chain. For example, the agency will continue its enforcement role to ensure that counterfeiters are prosecuted and counterfeit products withdrawn from the market. It will extend its medicines surveillance scheme to sample and test medicines across the whole supply chain. It continues to develop its inspection functions to ensure that all its inspectors are trained in up-to-date counterfeit inspection methods and techniques. It will maintain a close working relationship with industry to ensure that regulators and manufacturers continue to work effectively together to combat the counterfeiters. It has developed an education programme targeted at all key stakeholders to raise awareness of counterfeit medicines and of what to do if such medicines are discovered or suspected. It will, of course, constantly keep the legislation and its operation under review.

The hon. Gentleman raised concerns about the integrity of the UK wholesale supply chain and the procedures for gaining wholesale dealer licences. His concerns echo recent media interest in the issue. Let me put it in context. There are currently 1,600 wholesale dealers' licences, and a comprehensive system is in place to control those. Once granted a licence, wholesale dealers are subject to repeated inspections, both planned and unannounced. Nevertheless, the MHRA has examined its procedures and will introduce further safeguards to check the bona fides of named individuals on wholesalers' licenses.

The hon. Gentleman also referred to parallel importation as a possible source for counterfeit medicines, which has been drawn to my attention on several occasions. Currently, there is little evidence in the UK that the repackaging processes of parallel trade have been the route for introducing counterfeit medicines into the legitimate supply chain, but I have asked the MHRA to continue to monitor the situation and to take appropriate action if there is evidence that that is the case. If there is such evidence, I would be more than happy to see it.

Sale of medicines direct to the public presents a different challenge, especially given the global nature of the internet. It is certainly true that some websites offering medicines belong to unscrupulous vendors, some of which the hon. Gentleman described. Many of those vendors sell unlicensed and prescription-only medicines and some sell counterfeit drugs that are potentially harmful. That is particularly true of so- called lifestyle drugs, such as those to which he drew attention—medicines aimed at male impotence, slimming products or hair loss products. We are keen to ensure that the public make informed choices about their health, and they need to be aware that products purchased in that way cannot be guaranteed for safety, quality or efficacy.

I should say at this point that the bona fide internet pharmacies must be operated from pharmacy premises that are registered through the Royal Pharmaceutical Society of Great Britain. Consumers are always advised to consult the RPSGB online register before purchasing medicine via the internet. The MHRA will not hesitate in taking appropriate enforcement action over illegal supply over the internet. It is currently investigating 103 cases involving internet sales and has prosecuted 12 cases since 2000.

Photo of Charles Walker Charles Walker Conservative, Broxbourne

Does the Minister feel that there will be a role for Customs to be alert to the threat of medicines being imported into the UK once the order is made?

Photo of Jane Kennedy Jane Kennedy Minister of State (Quality and Patient Safety), Department of Health

My experience of such organised crime—there is no question but that, as the hon. Gentleman rightly points out, it is organised crime—is that the more co-ordination and sharing of information there is between law enforcement agencies and, in this case, the MHRA, the more effective the outcome will be. I take his point on board and will look to ensure that co-ordination is as good as it can be, including with Customs where necessary.

Given the uncontrolled nature of the internet, and the fact that many sites will be based abroad, as the hon. Gentleman described, a key aim is to ensure that the public understand the risks of buying medicines from such sites and are warned against them. The MHRA has an active campaign to educate the public on issues associated with the purchase of medicines on the internet. That includes regular information and advice, targeted to specific sectors of the population or in respect of specific products, and delivered through its website and the media to ensure that consumers can make fully informed decisions about their health.

As I said earlier, counterfeit medicine is a global issue and is of global concern. It is under active discussion in a range of international forums, particularly within the EU, the Council of Europe and the World Health Organisation. The MHRA takes an active part in all those discussions and, particularly during the recent UK presidency, has been leading the debate on an EU strategy to combat counterfeit medicines. It will continue to do that.

On a practical level, the MHRA liaises regularly with other regulatory and enforcement agencies at home and abroad to conduct joint investigations, to exchange expertise and experience and to share knowledge and intelligence. That will also continue. For example, the hon. Gentleman may be interested to hear that the MHRA is leading a Europe-wide Tamiflu counterfeit surveillance project, and he may be aware that the MHRA recently carried out a large seizure of suspect Tamiflu in London, confiscating some 6,800 packets of the medicine representing a retail value in excess of £1 million.

The MHRA is also co-ordinating a training programme to deliver training for European partners through the EU medicines enforcement officers network and the Council of Europe. We hope to extend such accredited training through the Permanent Forum on International Pharmaceutical Crime, which includes drug regulatory authorities from the EU, the United States, Australia, South Africa and Singapore.

It is clear that the problem of counterfeit medicines is of growing concern. If it grows unchecked and is not combated effectively, it may become an increasing threat to public health. We cannot afford to let that happen and I have asked the MHRA to continue to treat that as a priority and to keep me regularly informed on progress in its work in this area.

I am particularly pleased to have had the opportunity to report to the House in my response to the debate. I am grateful to the hon. Gentleman for allowing me to consider what he was going to say, so that I could respond as fully as possible. I hope that the House will be reassured that we take what he said seriously and are working hard to ensure that we combat that threat.

Question put and agreed to.

Adjourned accordingly at twenty-one minutes to Eight o'clock.