Singapore Jakarta Conf


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Singapore Jakarta Conf

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