Counterfeit medicines and devices

This section provides information on how we are tackling the problem of counterfeit medicines and medical devices.

Counterfeit medicines and medical devices
There are often stories in the media about counterfeit medicines and medical devices - should I be worried about this?

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 nine recalls of counterfeit medicines in the UK in the past three years, which had reached pharmacy and patient levels.
• A further five 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 UK is frequently 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.

The facts - medical devices
There have been very few counterfeit medicines or medical devices identified in the UK. However, it is important to continue to be vigilant as trade in counterfeit medicines is expected to increase around the world.  

• The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames.
• Counterfeiters concentrate on low cost, high turnover, high demand products.
• There are no known cases of counterfeit devices being manufactured in the UK.
• The UK is an end user market or transit point for the products.
• Most UK cases have involved the supply of counterfeit devices direct to consumers rather than healthcare professionals, through small retail outlets.
• Counterfeit medical devices have been seen as commodities used in VAT carousel fraud.
• Cases in the UK that are known to have reached consumers include condoms, and dental material for use in fillings.
• Incidents of counterfeits intercepted before reaching consumers include glucose test strips for use in conjunction with Insulin, and corrective contact lenses.
• Counterfeit devices seized within the UK are usually packaged to a high standard and difficult to distinguish from the genuine article.
• In the past 12 months there have been ten reported incidents all concerning counterfeit condoms.
• Counterfeit devices are also supplied through Internet websites.
• Unlike medicines, wholesalers do not require a licence to trade in medical devices.
• Counterfeit medical devices are dangerous, they are deficient in terms of quality and performance.
  

Is there a problem with counterfeit medicines and medical devices?
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 nine 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 650 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 E&I 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 do not 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.
  

Reporting a counterfeit medicine or device
If you have been offered what you suspect to be counterfeit products, or have seen them for sale or have bought them we would like you to tell us.

If you have any concerns or information that may assist us in tracking down those responsible for counterfeit medicines and devices you can e-mail the Enforcement Group at counterfeit@mhra.gsi.gov.uk or you can ring our 24 hour dedicated hotline on 020 7084 2701 or you can write to us at Counterfeits, The Intelligence Unit, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.

For all concerns regarding defective medicines and their reporting please continue to contact the Defective Medicines Reporting Centre (DMRC):
› Reporting suspected defects in medicines

For all concerns regarding medical device adverse incidents and their reporting please continue to contact the Adverse Incident Centre (AIC):
› Reporting adverse incidents involving medical devices


So what is the MHRA doing about counterfeits?
The MHRA E&I Group is responsible for the UK Anti-counterfeiting Strategy which was launched in November 2007:
› Anti-Counterfeiting Strategy 2007 - 2010 (195Kb)

We monitor medicines and medical devices sold or distributed in the UK.  We have powers which enable us to prosecute those who manufacture and distribute counterfeit products in the UK. We work closely with other law enforcement agencies such as the Police, Customs and Trading Standards Officers.

The European Commission have issued a Public Consultation in preparation of a legal proposal to combat counterfeit medicines for human use. We have submitted the UK government response to this consultation which is available on our website (76Kb).

Medicines - Enforcement and Intelligence (E & I) Group 
The Enforcement group at the MHRA comprises of an Intelligence, Investigations, Prosecutions and Support unit of 42 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 Department of Work and Pensions 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 DWP 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 and Intelligence 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.

Medical devices - Compliance Unit
The Devices Compliance Unit is responsible for enforcement of the Medical Devices Regulations. To do this, we are legally obliged to operate two separate programmes:

• A pro-active programme where manufacturers are chosen by us for investigation; and
• A re-active programme where we investigate possible breaches of the Regulations reported to us by various third parties.
  

Where non-compliances are identified we, will work with the manufacturer to resolve the problem. However, where necessary and justified we have the powers detailed below to take formal enforcement action against an manufacturers (subject to fulfilling various EU obligations).

The Medical Devices Compliance Unit has responsibility for implementing and enforcing the Medical Devices Regulations in an effective and efficient way taking appropriate and proportionate action where necessary to correct any breaches identified. In particular:

1. Complete reviews of a programme of manufacturers and products selected by the Agency for inspection; and
2. Complete investigations into suspected breaches to the Regulations reported to us by third parties.
   

Consider, make proposals for, and implement a joint enforcement programme with one or more of our EU partners with a view to developing effective inter-state co-operation in the field of enforcement.

The Medical Devices Regulations are made under the Consumer Protection Act 1987 and the majority of the powers that can be used in carrying out the enforcement function are also derived from the Act. These include the power to inspect goods, enter premises, require records to be produced, seize and detain goods in order to find out if there has been a contravention of the safety regulations. Then if a contravention is found to issue notices suspending or prohibiting the supply of the product or as mentioned above if the manufacturer fails to bring the product into compliance voluntarily or adhere to formal enforcement measures to prosecute the offence. We also have additional powers for consumer products available direct to the public under the General Product Safety Regulations which include the power to require a manufacturer to recall faulty product. A successful prosecution under the Medical devices Regulations carries a maximum penalty of a £5,000 fine per offence or six months imprisonment and under the General Product Safety Regulations of a fine of £10,000 per offence or 12 months imprisonment.

Another role of the MHRA is to provide advice to the public on the safest ways to purchase medicines and medical devices, for example by buying prescription only medicines over the Internet only when you have a prescription and to use a reputable e-pharmacy which is registered with the Royal Pharmaceutical Society of Great Britain (RPSGB) and can be checked at www.rpsgb.org/registrationandsupport/registration/searchourregisters (external link); or by ensuring that devices come from a reliable source, are well-maintained, come with instructions and carry a valid CE mark.

What else does the MHRA anti-counterfeiting strategy cover?
Whilst the UK legitimate pharmaceutical supply chain is tightly regulated, it is recognised that no supply chain is impenetrable - whatever the regulatory and surveillance safeguards that may be in place. The MHRA operates a comprehensive Anti-counterfeiting Strategy, led by its E&I Group. It is the only European Drug Regulatory Authority (and one of very few worldwide) that has its own dedicated Intelligence Unit and distinct Operations Unit responsible for criminal investigations. The E&I Group currently has 40+ personnel which compromises investigation officers and intelligence officers. It is headed by a Group Manager who was the former Operational Commander of the UK Police National Hi-Tech Crime Unit.

This is the first Anti-counterfeit strategy published by the MHRA tackling the availability of counterfeit medicines and medical devices in the UK. The strategy sets out a three year plan to combat counterfeit medicines and devices through a sustained programme of communication, collaboration and regulation.

The MHRA has developed and implemented strategic and operational measures designed to minimise the risk of counterfeit medicines and medical devices reaching patients through both the regulated and unregulated supply chains. The Agency is approaching the issue on three broad fronts, and eight separate streams of work:

• Communication

Ensuring both the public and healthcare professionals have sufficient information about counterfeit medicines, how to avoid them, and how to report any suspicions to the MHRA. This will include the launch of a 24hour anti-counterfeiting hotline. In addition, the MHRA has in association with the RPSGB produced guidance on counterfeit medicines for pharmacists:
› Counterfeit medicines: Guidance for pharmacists (159Kb)

and separate guidance for members of the public.

• Collaboration

The MHRA will ensure full participation in all relevant International initiatives to tackle counterfeit medicine and medical devices which impact upon the UK. This will include the World Health Organisation (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

The Agency will continue to forge close working relationships with law enforcement agencies and other regulatory bodies to ensure an awareness and recognition of the threat from counterfeit medicines and devices, and encourage collaborative working where appropriate.

The MHRA will continue to work closely with all relevant sectors of the pharmaceutical industry, to encourage a focus on the threat posed by counterfeiters.

The Agency will continue to host the Anti-counterfeiting Stakeholders meeting between Regulators, Law Enforcement and Industry.

• Regulation

The Intelligence Unit within the MHRA will conduct a threat assessment of the risk from counterfeit medicines and devices, based on all known incidents in the regulated supply chain.

Maintain targeted market surveillance projects throughout the supply chain on the medicines most at risk from counterfeiting.

Thoroughly investigate all reports of counterfeit medicines, and wherever appropriate prosecute and confiscate the assets of those involved.

The MHRA will thoroughly examine all aspects of the supply chain in view of recent incidents of counterfeits reaching patients and make any necessary recommendations for change.

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.

Drug Alerts issued relating to counterfeit medicines

Year	Product	Batch no and expiry date	Drug Alert
Aug 2004	Cialis 20mg	A031410 - 06/2006 A041410 - 06/2006	EL(04)/07 (50Kb)
Sep 2004	Reductil 15mg	65542 - 01/2007	EL(04)A/08 (129Kb)
Jul 2005	Lipitor 20mg	004405K1 - 11/2007	EL(05)A/11 (40Kb)
Jul 2006	Lipitor 20mg	004405K1 - 11/2007	EL(06)A/16
Aug 2006	Lipitor 20mg	067404K3 - 05/2007	EL(06)A/17
May 2007	Zyprexa 10mg	A200127 - 02/2009 A216454 - 03/2009 A229505 - 03/2009	EL(07)A/06
May 2007	Plavix 75mg	3098 - 08/2008 6Y098 - 07/2009	EL(07)A/07
June 2007	Casodex 50mg	65520 - 07/2011	EL(07)A/08
June 2007	Plavix 75mg	3103/1 to 3103/20 inclusive - 07/2009	EL(07)A/09
July 2007	Sensodyne Original and Sensodyne Mint 50ml Tubes	Fake batch PROD 07 2005 / EXP 08 / 2008	EL(07)A/13