The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has developed a strategy to combat falsified medical products with the objective of reducing risks to patients and consumers. The strategy aims to enhance legal frameworks at the European Union and Council of Europe levels related to falsified medicines and strengthen safety features and controls for actors in the medical supply chain. It also addresses issues like internet sales of medicines and controls on active pharmaceutical ingredients.
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The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
- 1. PRESENTATIONS THE UK (MHRA) APPROACH TO C O M B AT I N G F A L S I F I E D M E D I C I N E S GERALD W HEDDELL, DIRECTOR INSPECTION, ENFORCEMENT & S TA N DA R D S D I V I S I O N M E D I C I N E S & H E A LT H C A R E P R O D U C T S R E G U L AT O R Y A G E N C Y SEPTEMBER 28, 2012 N AT I O N A L P R E S S C L U B WWW.SAFEMEDICINES.ORG
- 2. Partnership for Safe Medicines Interchange 2012 “The UK (MHRA) approach to combating Falsified Medicines” Gerald W Heddell Director Inspection, Enforcement & Standards Division Medicines & Healthcare products Regulatory Agency ©
- 3. MHRA – Our Mission The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe Gerald Heddell Slide 3 Partnership for Safe Medicines Interchange – September 2012
- 4. Outline Falsified medical product situation – Global Falsified medical product situation – UK The Risks Legal frameworks MHRA Falsified Medical Products Strategy Conclusion Gerald Heddell Slide 4 Partnership for Safe Medicines Interchange – September 2012
- 5. Falsified Medical Products Situation - Global Europe Eur-Asia South North West East America Africa Asia Middle East Gerald Heddell Slide 5 Partnership for Safe Medicines Interchange – September 2012
- 6. Falsified Medical Products Situation - Global 2012 (all reported in the Press): • Nigeria (Jan): Smuggler arrested by Customs Service - 10m naira-worth (£40,293) of counterfeit medicines (Feed Fine cyproheptadine, antihistamine, vitamin tablets) concealed in textile materials. • Switzerland-Denmark-UK-USA (Jan): Avastin and Altuzan cancer medicines – hundreds of counterfeit packs originating in Turkey moved through Europe to the USA where they reached patients. • Russia (March):a Moscow police officers seized a large quantity of counterfeit Arbidol antiviral medicine (containing starch) distributed through a pharmacy chain. The flu remedy was produced in the Moscow region where 700 boxes were purchased by police in a covert operation. • USA (March): A former South Korean law enforcement officer was arrested at a US airport for trafficking in counterfeit goods, following the discovery of nearly 40,000 counterfeit Viagra, Cialis and Levitra pills in his luggage. • Armenia (April): Counterfeit medicines discovered within the licensed supply chain, listed as Actovegin Forte and Concor. It is thought that the medicines were within pharmacies for up to two weeks before the discovery. • China (April): Fake and expired medicines valued at more thank 100,000 yuan (£9,985) were seized by authorities from 18 rural pharmacies in Changsha. Separately a drug producer in east China was stripped of its licence and fined on charges of making counterfeit medicines - several oral liquids and syrups without authorization under a forged consigned manufacturing document. • Vietnam (April): Ho Chi Min City Department of Health seized quantities of fake or low quality oriental medicines circulating on the market - products were said to be contaminated with bacteria, illegally mixed with fresh medicine or had become mouldy. • Niger (April): A husband and wife were arrested following being found in possession of 25kg bags of Gelosyle, and large quantities of Paracetamol, Piriton and Flagyl tablets - suspected that they were using the raw pharmaceutical ingredients to manufacture counterfeit medicines. • Jordan (May): A Jordanian doctor has been referred to court for selling smuggled and counterfeit medicine - mainly sexual enhancers and psychotropic drugs in his own apartment. Gerald Heddell Slide 6 Partnership for Safe Medicines Interchange – September 2012
- 7. Falsified Medical Products Situation - UK • Vast majority of counterfeits discovered in the UK are supplied over the internet • 10 instances of counterfeit medicines in the legitimate supply chain that reached pharmacies and led to recall since 2004 • 850 million+ prescriptions written annually • Counterfeit medicines in the legitimate supply chain are rare • Obtaining medicines from unregulated sources significantly exposes the risk of receiving counterfeit medicines Gerald Heddell Slide 7 Partnership for Safe Medicines Interchange – September 2012
- 8. Falsified Medical Products Situation - UK 6 5 4 Wholesale level 3 Clinical Trial 2 Pharmacy level 1 0 04 05 06 07 08 09 10 11 3 00 20 20 20 20 20 20 20 20 -2 94 19 Wholesale - Anti- cholesterol, Anti- inflammatory, Anti-platelet, Alopecia, Erectile Dysfunction, Rheumatoid Arthritis, HIV. Pharmacy - Anti-cholesterol, Anti-platelet, Anti-psychotic, Erectile dysfunction, Prostate cancer, Appetite suppressants, Chronic asthma. Clinical Trial - Anti - platelet Gerald Heddell Slide 8 Partnership for Safe Medicines Interchange – September 2012
- 9. The Risks To public health: The products are sub standard in terms of their method of production and/or pharmaceutical ingredients/impurities and/or contamination Consumers and patients deserve to have a high degree of confidence when obtaining their medical products especially with a prescription from a pharmacy Counterfeit medical products undermine that level of trust, and lead to recalls, further damaging consumer confidence A number of fatalities and serious adverse reactions have been seen around the world To industry/trade: public health as above reputational damage financial impact Gerald Heddell Slide 9 Partnership for Safe Medicines Interchange – September 2012
- 10. Legal Frameworks EU Falsified Medicines Directive Safety Actors in the features supply chain Directive 2011/62/EU on falsified medicinal products Internet Active sales substances Gerald Heddell Slide 10 Partnership for Safe Medicines Interchange – September 2012
- 11. Falsified Medicines Gerald Heddell Slide 11 Partnership for Safe Medicines Interchange – September 2012
- 12. Legal Frameworks CoE Medicrime Convention Gerald Heddell Slide 12 Partnership for Safe Medicines Interchange – September 2012
- 13. MHRA Falsified Medical Products Strategy Download from: www.mhra.gov.uk Gerald Heddell Slide 13 Partnership for Safe Medicines Interchange – September 2012
- 14. MHRA Falsified Medical Products Strategy Objective: The aim of the strategy is to: reduce the risks to patients and consumers increase the risk to those behind the illegal activity Gerald Heddell Slide 14 Partnership for Safe Medicines Interchange – September 2012
- 15. MHRA Falsified Medical Products Strategy Strategy key themes: • Prevention • Incident handling • Investigation Gerald Heddell Slide 15 Partnership for Safe Medicines Interchange – September 2012
- 16. MHRA Falsified Medical Products Strategy Use of Social Media: Engagement Accessibility Targeted Mass audience Gerald Heddell Slide 16 Partnership for Safe Medicines Interchange – September 2012
- 17. MHRA Falsified Medical Products Strategy Impact (last 5 years): No of counterfeit incidents significantly reduced No of individuals convicted – 24 No of years sentenced: – 30 yrs 2 months imprisonment – 5 yrs 9.5 months suspended – 930 hours Community Service – £1,300 fines Total costs awarded – £66,000 Total amount of proceeds of crime ordered to be confiscated from criminals - £15.3m Gerald Heddell Slide 17 Partnership for Safe Medicines Interchange – September 2012
- 18. Conclusion No supply chain is impenetrable No room for complacency Collaborative effort from all key stakeholders is the only way to successfully tackle this issue Legal frameworks and/or a national strategy can be very helpful to combat this issue and act as a deterrent Protecting public health is the overarching aim Gerald Heddell Slide 18 Partnership for Safe Medicines Interchange – September 2012
- 19. © Crown Copyright 2012 About copyright All material created by the Medicines and Healthcare products Regulatory Agency, including materials featured within these MHRA presentation notes and delegate pack, is subject to Crown copyright protection. We control the copyright to our work (which includes all information, database rights, logos and visual images), under a delegation of authority from the Controller of Her Majesty’s Stationery Office (HMSO). The MHRA authorises you to make one free copy, by downloading to printer or to electronic, magnetic or optical storage media, of these presentations (excluding Agency logos) for the purposes of private research, study and reference. Any other copy or use of Crown copyright materials featured on this site, in any form or medium is subject to the prior approval of the MHRA. Further information, including an application form for requests to reproduce our material can be found at www.mhra.gov.uk/crowncopyright Material from other organisations The permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned. Gerald Heddell Slide 19 Partnership for Safe Medicines Interchange – September 2012
- 20. Safeguarding public health Thank you All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre [email protected] or tel +44 (0)20 3080 6330 Gerald Heddell Director Inspection, Enforcement and Standards Division Medicines and Healthcare products Regulatory Agency +44 (0) 203 080 6500 [email protected] Gerald Heddell Slide 20 Partnership for Safe Medicines Interchange – September 2012