1. Copyright of the Health Sciences Authority 2007 ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007 Singapore Situation Report

2. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 HSA – Organisation & Function

4. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 Legislative Infrastructure Importer (foreign source) Manufacturer (local source) Wholesaler Retailer User Model supply chain for medicines

6. Copyright of the Health Sciences Authority 2007 Legislative Infrastructure However, at present time, medicines control laws –do not 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. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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; or – it is presented with any false information as to its manufacturer or origin.

12. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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 skills and experience in enforcement

15. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007 Cases of Counterfeit Medicines Number of Cases Investigated YearSuspectedConfirmed Imported/ Domestic Vital Medicines 2005117ImportedNil 200684ImportedNil 200755ImportedNil Note : Cases all involved ED drugs - Viagra, Cialis and/or Levitra

18. Copyright of the Health Sciences Authority 2007 Cases of Counterfeit Medicines Number of Confirmed Cases Source of Case200520062007 Patients complaints000 Health professionals reports000 Enforcement/Investigation work110 Referrals from other agencies215 Reported by affected manufacturer000 Detected at border checkpoints420

19. Copyright of the Health Sciences Authority 2007 Cases of Counterfeit Medicines Number of Cases Prosecuted YearManufacturer Importer/ Wholesaler Retailer Informal Sector 20050007 20060004 20070005 Note : Offenders in all cases convicted – no cases pending

20. Copyright of the Health Sciences Authority 2007 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. Copyright of the Health Sciences Authority 2007