Singapore Jakarta Conf

Copyright of the Health Sciences Authority 2007

ASEAN-China Conference on Combating ASEAN-China Conference on Combating Counterfeit Medical ProductsCounterfeit Medical ProductsJakarta, 13-15 November 2007Jakarta, 13-15 November 2007

SingaporeSingaporeSituation ReportSituation Report


Legislative InfrastructureLegislative 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



• 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



• 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”



• 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…”



• 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



• 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)



• 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”



• 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.”



• Improvements in new Health Products Act– specific prohibitions against dealing in

counterfeit health products manufactureimportsupply

– 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 CoordinationNational 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)



• 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 agencieslarger pool of trained officersmore extensive enforcement powers (e.g.

power of arrest)more skills and experience in enforcement



• 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 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 involvedmostly ‘lifestyle’ drugs, particularly those

for erectile dysfunction (e.g. Viagra, Cialis)essential drugs (e.g. antibiotic) not affected


Cases of Counterfeit MedicinesCases of Counterfeit Medicines

Number of Cases Investigated

Year Suspected ConfirmedImported/ Domestic

Vital Medicines

2005 11 7 Imported Nil



Note : Cases all involved ED drugs - Viagra, Cialis and/or Levitra



Number of Confirmed Cases

Source of Case 2005 2006 2007

Patients complaints 0 0 0

Health professionals reports 0 0 0

Enforcement/Investigation work 1 1 0

Referrals from other agencies 2 1 5

Reported by affected manufacturer 0 0 0

Detected at border checkpoints 4 2 0



Number of Cases Prosecuted

Year ManufacturerImporter/

WholesalerRetailer

Informal Sector

2005 0 0 0 7

2006 0 0 0 4

2007 0 0 0 5

Note : Offenders in all cases convicted – no cases pending


Proposals for ActionProposals 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


Singapore Jakarta Conf

Business

counterfeit health products

vital medicines

current medicines control

enacted health products

related health products

categories of health

health professionals

manner of counterfeit