Zholdybayeva G.Zh.
Baimagambetova Z.M.
(scientific adviser)
Al -Farabi Kazakh National University, Kazakhstan
International legal regulation of protection of
medicines' consumers rights
Human rights are rights inherent to all human beings,
whatever our nationality, place of residence, sex, national or ethnic origin,
color, religion, language, or any other status [1]. They
are an international indicator of civility and democratic state, as well as an
indicator of wealth and culture of its population. This “indicator” consists of
different categories of rights. One of categories is economic and social rights.
Economic and social rights represent important
conditions of adequate standard of living, human security and happiness [2].
Adequate standard of living is
possible when a person meets his needs of decent quality. This implies that the
subjects of social and economic rights are “sellers” and “consumers”. These two
subjects are equal in rights and obligations, but in fact “consumers” are more
unprotected. Since many people do not know basic consumers rights, they can be
unfairly treated by sellers.
But
sometimes, even awareness of consumer rights will not prevent an unfair
treatment. Today, many criminal groups fill markets with counterfeits, expired
and illegal products for the purpose of obtaining maximum profit. They try to
adapt the most vital areas of human life which are directly linked with
purchases. One of these areas is a medicine, specifically
pharmaceuticals.
Today
medicines have become an inherent part of every human being. In this rapid
cycle of life medications became the main source of people’s life, health,
cheerfulness and youth. Thereby, traffic of medicines is one of the most
lucrative businesses in the world. So the fact that organized crime has covered
this sphere of trade is not surprising.
Counterfeit
medicine is a deliberately and fraudulently mislabeled with respect to identity
and/or source [3]. This definition implies that the counterfeit medicines can
be defined as a violation of copyright but also as consumer fraud. Counterfeit drugs not only pose a massive
threat to the life and health of mankind, they also undermine the credibility
of the official medicine producers, pharmaceutical workers, state health system as a whole. Moreover falsifiers
create the risk of global progress of a civilized market of goods and services.
So it is not a local problem, it is a global problem, which could be solved
only by joint efforts.
Trade
in counterfeit medicines is gaining momentum every year and becomes more
serious because of number of reasons.
Firstly, methods of producing
falsified medicines become more sophisticated.
Producers use a wide variety of mimic products which could be changed every
single day. They can change these methods from day to day, so when the results
of a study are released, they may already be outdated.
Secondly, producers and sellers started to use more
flexible ways to smuggle contraband across borders and to sell it within the
countries.
Thirdly, the variety of information sources makes
compiling statistics a difficult task. Sources of information include reports
from national medicines regulatory authorities, enforcement agencies,
pharmaceutical companies and nongovernmental organizations, as well as ad hoc
studies on specific geographical areas or therapeutic groups [4].
Fourthly, a vast number of
people (no matter rich are they or poor) become victims of counterfeit drugs’
impact. In some countries it is a rare incident, in other it is an everyday
reality. It is very difficult to prove that
person’s death was due to counterfeit medicines impact.
Thus,
according to WHO statistic 70% of all selling counterfeit drugs distributes in
Latin America, Africa and Asia countries, 20% in CIS countries and 5-6% in
developed countries [4].
All
these factors are a major obstacle for governments in the fight against
counterfeiting. It is a global problem
and combating requires the collaboration at international level. On this occasion, in 1985 the World Health
Organization held a special conference of experts on the rational use of
medicines. This meeting marked the beginning of further conferences. Under
these conferences states started to share experiences, conducted various
trainings for inspectors, and tested medicinal products to speed up the fight
against counterfeit medicines.
In
2006 World Health Organization and INTERPOL organized a voluntary grouping of governments, organizations, institutions,
agencies and associations from developing and developed countries, aimed at
sharing expertise, identifying problems, seeking solutions, coordinating
activities and working towards the common goal of fighting counterfeit medical
products - International Medical Products Anti-m Counterfeiting Task Force
(IMPACT) [5].
In 2010 in Strasbourg the Committee of Ministers of the Council of Europe
adopted the Convention Combating counterfeiting of medical products and
similar crimes — MEDICRIME. This document is the first international
instrument of criminal law obliges States Parties to criminalize the
falsification of medicines. The Convention is a big step in the fight against
falsification. It currently involves 47 countries, including Kazakhstan since
2011.
IMPACT and other world organizations require countries to toughen their
legislation and to add following measures:
1. Clearly
define falsification of medicines as crime that is different and more serious
than counterfeit pother kinds of goods because its effects go far beyond the
economic sphere and hit people’s health [6];
2. To
provide effective international coordination mechanism among different
countries structures;
3. To
improve border control and exportation and distribution system;
4. Systematic
inspection of pharmacies by independent bodies.
In conclusion I want to say that medicine is one
of the significant inventions for mankind which help us in everyday life. But
the crime was able to get into this sphere of production and trade violating
not only consumers rights but also official medicine producers. Moreover
production of counterfeit drugs suspends progress in the development of
pharmacological research. That is why it is so important to take this issue
very seriously and to join all countries’ effort in fight against
counterfeiting.
References:
1. Official website of the UN Human rights office of high commissioner for
human rights http://www.ohchr.org/EN/Issues/Pages/WhatareHumanRights.aspx
2. A legal recourse guide. Edited by Scott Leckie and Anne Gallagher.
University of Pennsylvania Press, 2006.
3. Bogdanich, W. and Hooker, J. From China to Panama, a trial of poisoned
medicine // New York Times. 6 May 2007. www.nytimes.com/2007/05/06/world/06poison.html
4. World Health Organization Fact sheet ¹ 275. May, 2012.
5. Official website of International Medical
Products Anti-Counterfeiting Taskforce (IMPACT)
http://www.impactglobalforum.org/
6. Official website of Pharmaceutical Security
Institute's (PSI) http://www.psi-inc.org/counterfeitSituation.cfm