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

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

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 ”

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 … ”

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

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)

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”

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 . ”

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)

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)

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

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

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

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

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