Transcript Diapositiva 1

LEGAL ASPECTS AND SOCIO-ECONOMIC IMPLICATIONS REGARDING
DRUG COUNTERFEITING
CIOBANU CONSTANTIN, CORCIOVĂ ANDREIA
Faculty of Pharmacy, Drug Analysis, Pharmaceutical Legislation and Deontology Department, Iași, România
INTRODUCTION AND OBJECTIVES
MATERIAL AND METHODS
The European law was compared with the Romanian
legal provisions. The presented data analysis is related to:
 the number of counterfeit medicines
 the origin countries of the counterfeit medicines
 the therapeutic categories which are most frequently
falsified and their estimated value.
Number of seized medicines
Medicine counterfeiting has become a worldwide problem affecting both
the developing and developed countries and has grown into a real menace to
the health system, pharmaceutical industry and of course to the patient
safety(1).
In 1992, the World Health Organization has developed a definition
according to which “a counterfeit medicine is one which is deliberately and
fraudulently mislabeled with respect to identity and/or source. Counterfeiting
can apply to both branded and generic products and counterfeit products may
include products with the correct ingredients or with the wrong ingredients,
without active ingredients, with insufficient active ingredients or with fake
packaging.” (2).
The purpose of this paper was to
present the legislative aspects relating to
counterfeiting of medicines and the impact
that this illegal activity has on the social and
economic level. The paper also exposes
some statistics provided by the World Health
Organization and other international
organisms involved in regulating the
provisions of medicine’s domain.
4500000
4000000
3500000
3000000
2500000
2000000
1500000
1000000
500000
0
2005
2006
CONCLUSIONS
Falsified medicines pose a major threat to human
health, therefore, a better involvement of the
authorities and a better public cooperation in
combating this phenomenon is necessary.
2010
2012
Year
RESULTS
100
Percent (%)
 In Romania, the authorities are closely monitoring the issue of
counterfeit medicines. In accordance with Directive 2011/62/EU all
necessary measures were taken in order to prevent the falsified
medicines from entering the legal supply circuit. According to
article no. 834 of Law no. 95/2006 regarding the healthcare reform,
any activity related to drug counterfeiting or the placing on the
market of a falsified drug is a crime punishable by law.
 Specialized websites were also created (www.crimemedicine.ro)
where any cases of counterfeit drugs may be reported by the
specialists in the pharmaceutical field and also by the population
(3).
 In some developing countries, the most used categories of
medicines are probably the antibiotics and antimalarics, so the
counterfeiters focus on their "production".
2007
80
2005
60
2006
40
2007
20
2010
0
2012
India
China
Egypt
UAE
Country
Switzer
-land
Hong
Kong
 In many developed countries of the European Union, the
most falsified medicines are those so-called “lifestyle
medicines” such as those used in the weight loss and
erectile dysfunction treatments (1).
REFERENCES
1. World Health Organization, 2003. Substandard and Counterfeit
Medicines. Fact Sheet No. 275, November.
2. World Health Organization 2010. Counterfeit medical products:
Report by the secretariat.
3. Official Journal of the European Communities 2011. Directive
2011/62/EU of the European Parliament and Council. L 174.