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Singapore Jakarta Conf

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  • 1. ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007 Singapore Situation Report
  • 2. Legislative Infrastructure
    • Regulatory authority for medicines (and related health products) in Singapore
      • Health Sciences Authority (HSA)
    • Medicines control laws currently in force
      • Medicines Act
      • Poisons Act
      • Medicines (Advertisement and Sale) Act
      • Sale of Drugs Act
  • 3. HSA – Organisation & Function
  • 4. Legislative Infrastructure
    • Medicines control laws regulate key activities in supply chain
      • manufacture
      • import
      • wholesale supply (including export)
      • retail supply
    • Dealers (e.g. manufacturers, importers) subject to licensing/registration control
  • 5. Legislative Infrastructure Importer ( foreign source ) Manufacturer ( local source ) Wholesaler Retailer User Model supply chain for medicines
  • 6. Legislative Infrastructure
    • However, at present time, medicines control laws
      • do no t have specific provisions against dealing in counterfeit medicines
      • do not have specific definition of “counterfeit medicine”
    • In terms of policy and practice, adopt WHO definition of “ counterfeit medicine ”
  • 7. Legislative Infrastructure
    • WHO definition of “ counterfeit medicine ”
      • “ ... a medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source …”
      • “… can apply to both branded and generic products …”
      • “… may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging … ”
  • 8. Legislative Infrastructure
    • Anti-counterfeiting measures mainly in intellectual property laws
      • Trade Marks Act
      • combination of criminal provisions and civil remedies (by rights holder)
      • applies to all manner of counterfeit goods (e.g. clothing, apparel)
      • no specific measures to deal with counterfeit medicines
  • 9. Legislative Infrastructure
    • Main gaps and insufficiencies in current medicines control laws
      • no specific provisions against counterfeit medicines ~ offenders usually dealt with on basis of unlicensed or unauthorised dealing
      • relatively low criminal penalties (e.g. penalty for an offence under Poisons Act is a fine of up to $10,000 and/or imprisonment for up to 2 years or both)
  • 10. Legislative Infrastructure
    • Newly-enacted Health Products Act
      • passed by Parliament in 2007
      • will come into force gradually over next 3-4 years
      • eventually consolidate and replace existing medicines control laws
      • applicable to medicines and medical devices as well as other categories of “health products”
  • 11. Legislative Infrastructure
    • Improvements in new Health Products Act
      • specific definition for “counterfeit health product”
        • “ a health product is counterfeit if –
          • it is presented in such a manner as to resemble or pass off as a registered health product when in fact it is not; o r
          • it is presented with any false information as to its manufacturer or origin . ”
  • 12. Legislative Infrastructure
    • Improvements in new Health Products Act
      • specific prohibitions against dealing in counterfeit health products
        • manufacture
        • import
        • supply
      • heavier penalties for offences relating to counterfeit health products (i.e. fine of up to $100,000 and imprisonment for up to 3 years)
  • 13. National Coordination
    • Collaborations with other regulatory and law enforcement agencies in Singapore
      • Immigration & Checkpoints Authority (ICA)
      • Singapore Customs (Customs)
      • Singapore Police Force (SPF)
      • Central Narcotics Bureau (CNB)
      • Agri-Food & Veterinary Authority (AVA)
      • Housing Development Board (HDB)
  • 14. National Coordination
    • Benefits of operational collaboration
      • enforcement agencies often have ‘first contact ’ in the field (e.g. border control by ICA, neighbourhood patrols by Police)
      • able to leverage on strength of other agencies
        • larger pool of trained officers
        • more extensive enforcement powers (e.g. power of arrest )
        • more s kills and experience in enforcement
  • 15. National Coordination
    • Limitations and difficulties
      • differing priorities of other agencies (i.e. cases involving medicines not necessarily considered to be high priority)
      • lack of knowledge and technical expertise of officers in other agencies (e.g. differentiating between authentic and counterfeit medicines )
      • no formalised central coordinating body at national level ~ arrangements made on ad hoc case-by-case basis
  • 16. Cases of Counterfeit Medicines
    • General overview of cases in Singapore
      • occurrence
        • largely confined to ‘fringe’ or black market
        • no penetration into mainstream healthcare system and formal sources (e.g. hospitals)
      • type of medicines involved
        • mostly ‘lifestyle’ drugs, particularly those for erectile dysfunction (e.g. Viagra , Cialis )
        • essential drugs (e.g. antibiotic) not affected
  • 17. Cases of Counterfeit Medicines Number of Cases Investigated Note : Cases all involved ED drugs - Viagra, Cialis and/or Levitra Nil Imported 7 11 2005 Nil Imported 5 5 200 7 Nil Imported 4 8 2006 Vital Medicines Imported/ Domestic Confirmed Suspected Year
  • 18. Cases of Counterfeit Medicines Number of Confirmed Cases 0 0 5 0 0 0 2007 2006 2 4 Detected at border checkpoints 0 0 Reported by affected manufacturer 1 2 Referrals from other agencies 1 1 Enforcement/Investigation work 0 0 Health professionals reports 0 0 Patients complaints 2005 Source of Case
  • 19. Cases of Counterfeit Medicines Number of Cases Prosecuted Note : Offenders in all cases convicted – no cases pending 7 0 0 0 2005 5 0 0 0 200 7 4 0 0 0 2006 Informal Sector Retailer Importer/ Wholesaler Manufacturer Year
  • 20. Proposals for Action
    • Enhance information exchange and technical cooperation between countries
    • Enhance cooperation between relevant agencies within country
    • Strengthen national control/regulatory system to further secure supply chain for medical products
  • 21. Thank You

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