MHRA Anti-counterfeiting Strategy and Supply Chain Guidance

Safeguarding public health MHRA Anti-counterfeiting Strategy and Supply Chain Guidance PQG Annual Meeting for QPs 24 Mar 2010 Nimo Ahmed Head of Intelligence Medicines and Healthcare products Regulatory Agency

Outline PART A: MHRA Enforcement Counterfeit Situation - The Threat to the UK - The Risks to Public health MHRA Anti-Counterfeiting Work and EU Commission Proposals - The Response - Proportionality - Necessity PART B: Supply Chain Guidance PART C: Conclusion Questions & discussion

PART A MHRA Enforcement

MHRA Chief Executive Kent Woods Licensing Vigilance & Risk Management of Medicines Inspection, Enforcement & Standards Devices, Technical & Safety Devices Clinical Policy Finance & Operations Human Resources Information Management Communications

Enforcement Group Head of Enforcement Policy Advisor Executive Support Head of Intelligence Head of Operations Prosecutions Manager Business Manager Case Referral Centre Analysts Intelligence Officers Investigations Manager Disclosure Officer Property Officer Office Manager Investigation Team London Investigation Team York Investigation Team Welwyn Financial Investigators Support Staff

Enforcement Powers Medicines Act (1968) Legislation and Powers Medicines Act 1968 max sentence 2 years and/or unlimited fine (array of administrative sanctions also) MHRA will use most appropriate offence available in addition to Medicines Act, typically Trade Marks Act but in future Fraud Act Departmental (Ministerial) solicitors Powers available to MHRA Officers: Entry to commercial premises and private dwellings Inspection Seizure MHRA has surveillance powers under RIPA 2000 MHRA pursues Proceeds of Crime under POCA 2002

Illegality - Types Illegal advertising Illegal wholesaling Illegal sale and supply Illegal importation Illegal manufacture Counterfeit medicine Clinical trial fraud Unlicensed medicines Internet supply Illegal herbal medicines Diversion Stolen medicines

PART A (cont) Counterfeit Situation - The Threat

The Threat - Counterfeit Medicines Incidents, UK Regulated supply chain 6 5 4 3 2 Pharmacy level Wholesale level Clinical Trial 1 0 1994-2003 2004 2005 2006 2007 2008 2009 Pharmacy (recalls) Wholesale - Anti-cholesterol, Anti-platelet, Anti-psychotic, Erectile dysfunction, Prostate cancer, Appetite suppressants, Chronic asthma. - Anti-cholesterol, Anti-inflammatory, Alopecia, Erectile Dysfunction. Clinical Trial - Anti-platelet

PART A (cont) Counterfeit Situation - The Threat - The Risks

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/traders: public health as above reputational damage financial impact

PART A (cont) MHRA Anti-Counterfeiting Work - The Response

The Response - MHRA Anti-counterfeiting Strategy Communication Public and Healthcare professionals Collaboration Internationally, Industry, Law Enforcement and regulators Regulation Threat Assessment, Targeted Market Surveillance, Investigation and Prosecution Review UK Supply chain, point of importation to point of dispensing

1. Communication Aim of Stakeholder Awareness Raising Campaigns: to ensure that patients/consumers are best placed to make informed choices about how they obtain their medications so that they are at decreased risk of obtaining counterfeit/substandard/unlicensed medicines to enable stakeholders to take responsibility, maintain vigilance and use reporting hotlines

1. Communication (cont) Completed Initiatives: Counterfeit Hotline Press Activity ongoing opportunities Pfizer Advertising Campaign

1. Communication (cont)

1. Communication (cont) Completed Initiatives: Counterfeit Hotline Press Activity ongoing opportunities Pfizer Advertising Campaign MHRA-RPSGB Leaflet Pilot Campaign

1. Communication (cont)

1. Communication (cont) Completed Initiatives: Counterfeit Hotline Press Activity ongoing opportunities Pfizer Advertising Campaign MHRA-RPSGB Leaflet Pilot Campaign Healthcare Professional Awareness

2. Collaboration - domestic Anti-counterfeit Stakeholders (ACS) Group: Function Twice yearly Assess recent seizures Identify trends Future threat products Produce watch list Membership ABPI, PSI BAPW BAEPD (Parallel distributors) HMRC/UKBA RPSGB Police chemist liaison MHRA

3. Regulation Targeted Market Surveillance Regulated Supply Chain Projects focused upon at risk medicines Sampling throughout the supply chain, wholesalers and pharmacies Laboratory analysis Un-Regulated Supply Chain On-line pharmacies with UK presence Test purchase of at risk medicines Laboratory Analysis

3. Regulation Investigation and Prosecution Regulated Supply Chain Incident Handling Procedure Protection of Public Health Seizure of product Potential recall of medicine Criminal prosecution Trace audit trail Arrest of offenders Suspension of licences Trace and restrain offenders assets for later confiscation Pro-active publicity

3. Regulation - Threat Assessment Scope risk to public health Scope economic impact Deep analysis of each incident Identify drivers, trends Identify common denominators, MOs Identify weaknesses Predict future trends Make recommendations to Government, through review of the UK supply chain

4. Review - UK Review of Medicines Supply Chain Proposals Wholesale Dealers fit and proper person requirements, due diligence obligations Responsible Persons minimum qualifications, continuous presence, due diligence Medicines imported for export authority to inspect, due diligence, record keeping Storage and Transit of Medicines comply with GDP, powers to inspect, named on licenses Pharmacies pharmacies engaging in wholesaling to obtain wholesale dealers licence Criminal Sanctions consider new criminal offences for manufacturing or distributing counterfeits, with commensurate sentencing powers

PART A (cont) MHRA Anti-Counterfeiting Work and EU Commission Proposals - The Response

European Medicines Supply Chain Proposals Obligatory safety/authenticity traceability features for certain medicines e.g. bar coding to pack level, medicines selected on risk criteria Extending regulation to traders and brokers ensuring all those persons engaged in trading pharmaceuticals are subject to licensing Increased auditing obligations placed on wholesale distributors Due diligence requirements placed on wholesalers Increased controls on imports of API s from 3 rd countries Requirements placed upon manufacturers to audit API

PART A (cont) MHRA Anti-Counterfeiting Work and EU Commission Proposals - The Response - Proportionality - Necessity

Proportionality Any changes must be proportionate to the problem All proposals are subject to public consultation Stakeholders are encouraged to participate in the consultation process The intention is to respond appropriately and create a secure supply chain which minimises the risk of counterfeit medicine penetration

PART B Supply Chain Guidance

Supply Chain Guidance Aim to maintain vigilance across the UK supply chain from the point of importation to the point of dispensing to safeguard public health MHRA is conducting thorough examination of supply chain arrangements All in supply chain to bear responsibility by maintaining vigilance One small piece of information from you, may: prevent a counterfeit medicine reaching patients result in the closing down of a counterfeit distribution arm

Supply Chain Guidance (cont) What we want from you: intelligence gaps help fill them report all suspicious approaches conduct thorough due diligence make use of MHRA hotline by email to counterfeits@mhra.gsi.gov.uk or by phone on 020 7084 2701

Supply Chain Guidance (cont) Good Examples: BAPW Gold Standard for GDP full-line wholesaler discovering two counterfeits from vigilant procedures so intercepted before reached pharmacies/patients anonymous tip-off from short line wholesaler led to discovery and seizure of 15,000 packs of counterfeit Casodex for prostrate cancer and 20,000 packs of Plavix for post heart operation treatment no of examples of suspects reported from visual examination which turned out to be pack design change

Supply Chain Guidance (cont) Bad Examples: suspicious approaches turned away but not reported wilful blindness, not enough due diligence buying parallel traded product in very large quantities from 3 rd EU country wrong medicines delivered, unlicensed for UK sale so keep hold of them inappropriate use of unlicensed brokers

Supply Chain Guidance (cont) Due Diligence : All UK counterfeit cases could have been prevented by sufficient due diligence: risk assessment of new suppliers and products risk assessment should be reviewed annually by the RP and made available to MHRA Inspectors as part of the inspection process failure to conduct a risk assessment, update them or fail to submit them to an officer of the MHRA on request could lead to a deficiency against the licence holder and responsible person, and could lead to regulatory or criminal sanctions

Supply Chain Guidance (cont) Suspicious Approaches : it is being considered that a legal obligation is placed upon those engaged in the sourcing of medicines from the EEA, wholesaling and retailing of medicines to report any suspicious transactions or offers to the MHRA failure to report could attract regulatory or criminal sanctions

PART C Conclusion

Conclusion No supply chain is impenetrable Supply chain review is a unique opportunity to tighten the whole of the UK and EU supply chain have your say by participating in consultation Recommendations should aim to be future proof Mandatory legislative changes will be made with appropriate sanctions Collaborative efforts from all stakeholders is the only way to successfully tackle this issue DO NOT wait for the major incident that causes serious physical harm or fatalities

PART C (cont) Questions and Discussion?

Safeguarding public health Thank you All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk or tel +44 (0)20 7084 2330 Nimo Ahmed Head of Intelligence, Enforcement and Intelligence Group, Medicines and Healthcare products Regulatory Agency. +44 (0) 207 084 2576 nimo.ahmed@mhra.gsi.gov.uk