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Legislative Infrastructure

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)

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Legislative Infrastructure

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  1. ASEAN-China Conference on Combating Counterfeit Medical ProductsJakarta, 13-15 November 2007SingaporeSituation 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. 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

  4. Legislative Infrastructure • However, at present time, medicines control laws • do nothave 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”

  5. 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…”

  6. 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

  7. 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)

  8. 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”

  9. 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.”

  10. 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)

  11. 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)

  12. 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

  13. 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

  14. 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

  15. Cases of Counterfeit Medicines

  16. Cases of Counterfeit Medicines

  17. Cases of Counterfeit Medicines

  18. 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

  19. Thank You

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