In this section...
The facts - medicines
The World Health Organization (WHO) estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. This figure rises to 10% globally, although in some developing countries they estimate one third of medicines are counterfeit.
- Counterfeit medicine is now a truly global phenomenon, at first thought to only affect developing countries, now known to impact upon developed countries.
- Counterfeiters now also target the most lucrative markets, copying high value, high turnover, high demand medicines.
- The UK is not typically a manufacturer of counterfeit medicine, however the UK is a transit point and end user market.
- There have been ten recalls of counterfeit medicines in the UK since 2004, which had reached pharmacy and patient levels.
- A further seven cases were discovered at wholesaler level before they reached the market.
- Counterfeit medicine is more commonly available to consumers via on line pharmacies, the WHO estimate 50% of medicines available from sites which conceal their physical address are counterfeit.
- Counterfeit medicine available in the UK originally focused upon ‘lifestyle’ medicines, including erectile dysfunction and weight loss medicines. Counterfeiters are now also focusing on ‘lifesaving medicines’ including cancer and heart medicines.
- No fatalities have been attributed to counterfeit medicine in the UK, although numerous fatalities have occurred around the world.
- Counterfeit medicine found in the legitimate UK supply chain has been specifically designed to deceive pharmacists and patients that it is genuine, often only laboratory analysis reveals the counterfeit product
- Counterfeit medicines discovered in the UK typically contain a reduced amount of the active pharmaceutical ingredient, although the wrong ingredient or no ingredient at all have been found less frequently.
- All counterfeit medicines are dangerous.
Is there a problem with counterfeit medicines?The supply of counterfeit medicines and medical devices is a growing problem worldwide and one which the MHRA is taking very seriously. We have had ten known cases of counterfeit prescription only medicines reaching patients through the legal supply chain in the UK since 2004. Prior to that, the last known counterfeit medicines case in the UK was over ten years ago. It is worth noting that each year over 850 million (rising to over 700 million) prescriptions for medicines are written in the UK.
One of our key responsibilities at the MHRA is to minimise the risk of members of the public receiving counterfeit medicines. We do this by licensing all steps of the medicines distribution system from manufacturing, distribution, storage through the supply chain, and by monitoring the supply and manufacture of medical devices. In addition, our Enforcement Group leads the UK Anti-counterfeiting Strategy.
How can counterfeit medicines and medical devices be avoided by the public?Some people will always break the law. Our objective here is to make sure that we have robust systems in place to prevent counterfeit medicines penetrating into the UK's pharmaceutical supply chain and if penetration occurs, to have safeguards to detect counterfeits early and protect the public accordingly. Worryingly, a growing number of purchases of medicines and medical devices are now made over the Internet, through online pharmacies, via internet auction sites, or by mail order.
The source of these products is often very hard to trace and it is highly unlikely that the 'manufacturers' behind these products conform to European standards of safety and effectiveness. This has led to people being deceived that the medicine or medical device they have bought was the genuine product.
Worse than this is the fact that substandard or counterfeit medicines may have little, none, or too much of the required quantity of the active ingredient - all of these scenarios could present significant risk of harm to the patient. The main areas of concern related to buying prescription only medicines over the Internet are:
- the medicine may seriously harm you or a member of your family
- they may not have been prescribed by a healthcare professional
- there may not be checks and controls on the quality and effectiveness of medicines supplied
- there may be no legal or judicial recourse in the event of problem.
Medicines - Enforcement Group
The Enforcement Group at the MHRA comprises of an Intelligence, Investigations, Prosecutions and Support unit of 44 staff based in London, Welwyn Garden City and York.
The Group has responsibility for the investigation of breaches of the medicines act and associated legislation, including the MHRA response to counterfeit medicines available through the regulated and unregulated supply chain.
Enforcement Group staff have statutory powers under the Medicines Act 1968 to enter business and private property in the furtherance of their duties and seize articles suspected of being concerned in breaches of the act and associated legislation.
The Group conduct investigations in accordance with all relevant legislation and submit recommendations for prosecution to Crown Prosecution Service solicitors.
The MHRA are usually engaged in approximately 30 prosecutions at any one time for a range of offences, in addition to this the Agency provide support to the Police for any prosecutions they are conducting which also include breaches of the Medicines Act.
Prosecutions can range from cases relating to illegal advertising or sale of unlicensed products heard at Magistrates Courts, through to large Crown court trials concerning global conspiracies to supply counterfeit medicines.
Investigations concerning counterfeit medicine are usually complex, involving networks of companies and bank accounts, often overseas. The individuals concerned have a thorough knowledge of the markets and different countries supply arrangements, procedures and laws. They will often try to exploit perceived weaknesses in supply chain arrangements. The extent of this type of criminal activity is serious and these types of cases are invariably referred to CPS solicitors recommending prosecution .
The MHRA has had to adapt to this rising challenge. The Enforcement and Intelligence group now employs specialists in conducting International investigations, financial investigations, crime analysts, internet investigators, disclosure officers, test purchasers, and specialists in the use of the Regulation of Investigatory Powers Act 2000.
The Enforcement Group principally rely upon the offences contained within the Medicines Act 1968, these carry a maximum two year sentence and/or unlimited fine. Cases involving counterfeit medicines are also prosecuted using the Trademarks Act 1994 carrying a maximum sentence of 10 years imprisonment and the Proceeds of Crime Act 2002 with a maximum sentence of 14 years. Consideration will now be given to using the Fraud Act 2006 for these types of cases. Civil injunctions have also been relied upon where appropriate.
Are medicines likely to be counterfeit if the labelling and instructions are in a foreign language?
This would not be an indicator in itself. Although medicinal products may carry labelling in the language of the source country, they must have an English patient information leaflet and English packaging or overlabelling. Many legitimate medicines are sourced outside the UK, often from other countries in Europe.