Combating counterfeit medicines in Vietnam

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Combating counterfeit medicines in Vietnam

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Issues

• Definitions of counterfeit medicines and
  concerned legal documents
• National coordination
• Number of counterfeit cases detected

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Definitions of counterfeit medicines

• As indicated in the Pharmaceutical Law - 2005

• Counterfeit medicines are products manufactured
  in the forms of medicines on intention of
  fraudulence, falling in one of the following
  cases
• Without active pharmaceutical ingredient
• Containing API but with a different dosage from
  what has been registered
• Containing different API from the one printed on
  the label
• Imitating name and industrial design of anothers
  manufacturers product registered for industrial
  property right protection

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LEGISLATION ON COUNTERFEIT DRUGS

• Pharmaceutical Law (2005)?
• Law on Peoples Health Protection (Chapter VI)?
• Criminal Law (Article 156 and 157)
• Ordinance on Private Medical and Pharmaceutical
  Practices
• Decree No. 45/2005/NÐ-CP on administrative
  punishments related to health practices
• Medicine quality management regulations
  medicine registration regulations regulations
  on sampling medicines for quality validation
• Circular instructing medicine and cosmetic
  labelling Circulars instructing medicine
  import, export

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LEGISLATION ON COUNTERFEIT DRUGS

• Joint -Circular No. 27/TTLT on combating
  counterfeit medicines and rearranging medicine
  market (1990) ?
• Directive No. 31/1999/CT-TTg by the PM on
  combating against production and trading of
  counterfeit goods
• Joint Circular No. 10/1999/TTLB instructing the
  execution of Directive No. 31/1999/CT-TTg on
  combating against production and trading of
  counterfeit goods

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LEGISLATION ON COUNTERFEIT DRUGS
Pharmaceutical Law Article 9 Strictly
forbidden acts 1-Conducting drug trade without
Certificate of SDTC 2- Conducting drug trade
without Certificate of PP 3- Trading in drugs of
unclear origin, counterfeit drugs, substandard
drugs, expired drugs, drugs in the banned list of
import, drugs for clinical trials, drugs which
are not permitted for marketing, sample drugs
used for registration or for promotion to
physicians
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LEGISLATION ON COUNTERFEIT DRUGS
Pharmaceutical Law -Article 9 Strictly
forbidden acts 4- Counterfeiting, renting,
borrowing, leasing, lending certificates of
pharmaceutical practice, certificates of
satisfaction of drug trading conditions 6-
Selling drugs at places which are not lawful drug
selling establishments
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CRIMINAL ACT
Article 156 Production, trade in counterfeits
- Persons who produce, trade in counterfeit
products shall be liable to an imprisonment
Article 157 Production, trade in food and drug
counterfeit
- Persons who produce, trade in counterfeit
products that are food, drugs shall be liable to
an imprisonment of 2 to 7 years - Committing the
offences (depending on consequences) shall be
liable an imprisonment of 5 to 20 years, or live
imprisonment or death penalty - Guilty persons
shall be liable to a fine from 5 million to 50
million VND their properties shall be partly or
totally confiscatedbe prohibited from
professional practices or operating certain jobs
for a period of 1 to 5 years.
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The inconsistency of existing laws and
regulations of Vietnam on counterfeits

• 1. There exists the conflict between
  Pharmaceutical Law and Intellectual Property Law
  since the IP Law does not consider the act of
  imitating industrial design of certain product
  as counterfeiting.
• So the punishment is administrative and financial
  activities
• To resolve it Add the regulations which classify
  more details the indices of counterfeit drugs.
• 2. The sample collected on the market is only
  legal if the sampling process is conformed to the
  regulations on collecting sample and the sampling
  process is official. So that, drug regulators is
  not capable to capture the counterfeit drugs.
• To resolve implementation of buying the sample.
  And add the quality controllers.

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Intellectual Property Law 2005
Article 213. Intellectual property counterfeit
goods 1. Intellectual property counterfeit goods
include counterfeit mark goods or counterfeit
geographical indication goods... 2. Counterfeit
mark goods are goods or their packaging bearing a
mark or a sign which is identical with or
substantially indistinguishable from a mark or
geographical indication which is protected for
such goods without consent of the owner of such
mark or the management organization of such
geographical indication respectively.
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Systems of Agencies on Combating CD
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Functions of Steering Committee No. 127

• Assist the PM to direct and coordinate the
  collaboration the anti counterfeit inter-sectoral
  activities of Ministries and Bodies
• Monitoring, supervising and speeding up the anti
  counterfeit of Ministries, Provincial
• Directly settling the difficulty counterfeit
  cases, concerning many Ministries, or bodies, or
  inter-areas
• Synthetizing the situation and the results of
  anti counterfeit activities
• Give the petition to PM of measures to improve
  anti counterfeit activities.

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Process Flow
Lot of Source
DAV, Police, MC, Customs
DAV, Police, MC, Customs
Reporter report (Lot of sources)
Receives alert DAV, Police MC, Cust
Confirms alert DAV, Police MC, Cust
Investigations Police
Prosecutions
Tribunal
Recall
Case closed archived
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Number of CD Cases Detected

Suspected Confirmed Imported/ domestic Vital Medicines
2006 8 drugs 4 2 No-identified source 1 Antibiotic, 1 Artesunate
2005 17 drugs 4 6 3/ 3 4 No-identified source Some antibiotic,
Clamoxyl 20 000 sachets Postinor 30.000
tablets Acetaphen 24.500 ampouls Cefuroxim
1400 vials
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Number of CD Cases Detected

Number of Case
Patient Complaints 2
Health professional reports 0
Enforcement/Investigation works 3
Routine Check 2
Reported by affected manufacturer 10
Other