AntiCounterfeit Workshop for Pharmaceutical Products

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Anti-Counterfeit Workshop for Pharmaceutical
Products
Dr. Siriwat Tiptaradol Secretary General, Thai
Food and Drug Administration Ministry of Public
Health, Thailand
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Consequences of counterfeit medicines (1)

• In 1995, around 2,500 people are believed to have
  died in Niger after they were given a fake
  meningitis vaccine.
• In 1999, at least 30 people died in Cambodia
  after taking counterfeit antimalarials prepared
  with sulphadoxine-pyrimethamine (an older, less
  effective antimalarial) which were sold as
  Artusenate.
• The consumption of medicines prepared with
  glycerin that mixed-up/contaminated with
  diethylene glycol (a toxic chemical used in
  antifreeze) led to several hundreds deaths around
  the world during 1937 to 2006.

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Consequences of counterfeit medicines (2)
Glycerin/Propylene glycol contaminated/mix-up
with Diethylene glycol
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The extent of the problem (1)

• Researchers at Oxford University in the United
  Kingdom reported in April 2005 that 15 percent of
  all drugs sold worldwide are fakes.
• This means the annual global market value of
  counterfeit medicines is 35 billion, close to
  the U.S. FDA. estimate of 32 billion.
• The Centre for Medicines in the Public Interest,
  in the United States, predicts that counterfeit
  drug sales will reach 75 billion globally in
  2010, an increase of more than 90 from 2005.

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The extent of the problem (2)

• Most developed countries with effective
  regulatory systems and market control currently
  have a very low proportion, i.e. less than 1 of
  market value.
• Many developing countries of Africa, parts of
  Asia, and parts of Latin America have areas where
  more that 30 of the medicines on sale can be
  counterfeit. Other developing markets, however,
  have less than 10 overall, a reasonable
  estimate is between 10 and 30
• Many of the former Soviet republics have a
  proportion of counterfeit medicines which is
  above 20 of market value.

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The extent of the problem (3)

• Medicines purchased over the Internet from sites
  that conceal their actual physical address are
  counterfeit in over 50 of cases.
• Many Internet pharmacies are based in countries
  known for high levels of pharmaceutical
  counterfeiting.
• Governments must cooperate domestically and
  internationally to stop the global spread of
  counterfeit medicines

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The Declaration of Rome

• political will, adequate legal framework and
  implementation commensurate to the impact of this
  type of counterfeiting on public health and
  providing the necessary tools for a coordinated
  and effective law enforcement
• inter- sectoral coordination based on written
  procedures, clearly defined roles, adequate
  resources and effective administrative and
  operational tools
• creating an awareness about he severity of the
  problem among all stake holders and providing
  information to all levels of the health system
  and the public
• development of technical competence and skills in
  all required areas and
• appropriate mechanism for ensuring vigilance and
  input from healthcare professionals and the public

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The International Medical Products
Anti-Counterfeiting Taskforce (IMPACT)

• There are 5 strategies recommended to be explored
  and implemented which are
• Legislation
• Regulation implementation
• Technology
• Communication
• Enforcement

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Thai FDA Vision

• The vision of the Thai FDA focuses on the
  increasing consumers' confidence in health
  products. It states that
• By the year 2007, the FDA will be the principal
  and most trusted organization in Thailand in
  public health protection by ensuring the quality
  and safety of health products and promoting
  proper consumer behavior through reliable
  scientific evidence and appropriate technology .

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Thai FDA Mission

• Regulate and monitor health products to meet
  quality and efficacy standards.
• Promote Good Manufacturing Practice in the
  production and quality control of health products
  to ensure consumer safety and to encourage
  exports.
• Research and develop the effectiveness of the
  consumer protection system for health products.
• Promote and support the capability of health
  product consumers and society to be able to
  protect themselves and be self-reliant.
• Encourage and enable all stakeholders and
  non-government parties to share in the consumer
  protection role.

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THAILAND

• Location South East Asia
• Boarder line
• Northern Myanmar Lao P.D.R.
• Southern Malaysia
• Eastern Lao P.D.R. Cambodia
• Western Myanmar
• Capital City Bangkok
• Provinces 76
• Population 63 Millions

BANGKOK
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Thais Strategy to combat counterfeit medicines
(1)

• establish the new import-export control office in
  the border provinces of Thailand
• strengthen our enforcement by stringent
  inspection at the port of entry which we have
  arrested many cases last year ( detailed of
  number and amount will be added later)
• performing our duties governed by Law and
  Regulation by cooperation within country and
  international level.

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Thais Strategy to combat counterfeit medicines
(2)

• Work closely with other national drug authorities
  agencies such as
• Provincial Health Offices (Local monitoring and
  surveillance agency)
• Department of Medical Science (National Control
  Laboratory)
• Work closely with national law enforcement
  agencies such as
• The Royal Thai Police
• The Customs Department.
• Immigration Bureau

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Thais Strategy to combat counterfeit medicines
(3)

• Foster bilateral agreements with neighbor
  countries (e.g. Lao P.D.R., Cambodia, Myanmar and
  Malaysia) in particular with countries sharing
  common borders to prevent cross boarder trade and
  smuggling.
• Foster multilateral agreements with ASEAN
  countries developing common strategies,
• timely exchange of information and Rapid Alert
  System,
• harmonization of measures to prevent the spread
  of counterfeit drugs

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Thais Strategy to combat counterfeit medicines
(4)

• Foster cooperation with international
  organizations,
• coordinating function for WHO activities in the
  Mekong countries.
• Encouraging the societys involvements
• Educate the public
• Disseminate information
• Establishing of Center for Combating Counterfeit
  Drug

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Center for Combating Counterfeit Drug (1)
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Center for Combating Counterfeit Drug (2)

• Provide data and pictures of illegal medicines
  founded in Thailand
• Counterfeit medicines (1998-present)
• Smuggling medicines (Non-register in Thailand)
• Banded medicines
• Situation along border line Cambodia and Thailand
  in 2004
• Suspected counterfeit case report form
• Email complain_at_fda.moph.go.th.
• Relate Links.
• http//wwwapp1.fda.moph.go.th/drug/eng/zone_counte
  rfeit/fak001.asp

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Thais FDA Policy and Direction

• amendment of law and regulation that will
  support more efficient work of combating the
  counterfeit medicines including more stringent
  penalty for law violation.
• establishment of more import-export office in
  border provinces
• capacity building in performing the preliminary
  test at the import-export office at the port of
  entry such as screening test for suspected
  medicines.
• strengthen cooperation at all level from
  officers, regional and international agency
• capacity building in investigation technique
• facilitate and support the manufacturer to comply
  with GMP

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Drug Act, B.E. 2510 (1967)

• All drug manufacturing, importation and
  distribution activities are carried out in
  premises approved by the Drug Regulatory Agency,
  and that individuals and companies engaged have
  license to operate such activities.
• All drug are assessed and registered before they
  are introduced to the market.
• Legislation prohibiting the manufacture,
  importation, exportation, distribution and sale
  of counterfeit drug.

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Penalty for Manufacture, Import and Sell
Counterfeit medicines

• Manufacturer
• Imprisonment for a term from three years to life
  and fine from ten thousand to fifty thousand
  Baht.
• Importer or Seller
• Imprisonment for a term from one to twenty years
  and fine from two thousand to ten thousand Baht.

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Conclusion

• There is no simple solution or remedy that can be
  applied to eliminate counterfeit medicines nor
  can the problem be solved by an individual
  company or government.
• Combating counterfeiting of medicines is ? shared
  responsibility to which all interested parties
  have to contribute.
• The problem has reached ? global dimension and
  needs ? global approach.