Singapore Jakarta Conf
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Singapore Jakarta Conf

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    Singapore Jakarta Conf Singapore Jakarta Conf Presentation Transcript

    • ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007 Singapore Situation Report
    • 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
    • HSA – Organisation & Function
    • 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
    • Legislative Infrastructure Importer ( foreign source ) Manufacturer ( local source ) Wholesaler Retailer User Model supply chain for medicines
    • 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 ”
    • 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 … ”
    • 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
    • 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)
    • 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”
    • 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 . ”
    • 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)
    • 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)
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • Thank You