In addition, the deputy noted: Not only Russia, but also the countries of Europe, Japan, the USA - all the advanced pharmaceutical powers are faced with problems of poor-quality and falsified medicines.
And the risk of such illegal production increases proportionally with the growth of the volume of the pharmaceutical market. It should be noted that the greatest danger in the spread of counterfeits is the sale of medicines via the Internet, which attracts criminals with the opportunity to act anonymously.
The level of falsification in this segment of the market is quite high. At the same time, the volume of electronic trade in medicines, including transboundary, is increasing. However, at the legislative level, this form of trade has not yet been restricted. If even one country severely restricts the Internet trade in medicines, introduces significant administrative and criminal sanctions against violators, the problem will still not be solved.
Internet portals open in neighboring countri
Therefore, one of the measures that we propose to implement at the interstate level is to counteract the development of Internet trade in medicines. Medicines are a special commodity. This is not a household appliance, and not even a food product. Medical preparations must, first, be stored in a certain way. Secondly, their leave should be carried out only by a specialist who will give the necessary explanations for the application.
According to the World Health Organization, at the global level, the number of incidents detected in 2010 increased to 2,000 or more, i.е.more than 5 cases per day, an increase of almost 10 times compared with 2000. This increase may reflect improved detection, but may also indicate an increase in the scale of the problem. The production and marketing of counterfeits has acquired a global character. According to many foreign experts, most of the falsified medicines are imported to the world market from India and China.
However, the world professional community did not fully understand the level of threat posed by a substandard medicinal product. In most countries, falsification of medicines is considered as a problem of protection of intellectual property or rights of trademark owners. The existing legislation in this area in many states has become obsolete for 50 years. In a number of countries, the severity of the prosecution of counterfeit medicines is consistent with penalties for copyright infringement.
Only in 16 states there are legislative provisions, including medicines in the number of goods mentioned in connection with the threat of falsification.
In the area of monitoring compliance with official requirements, the main problems are: the shortage of trained inspectors and analyst chemists, corruption in supervisory bodies and insufficient international cooperation. When confronting the risk associated with poor-quality and falsified medicines, even more important are joint scientific works, modern standards and coordinated opposition.
We need a simple and at the same time operative system of information exchange and taking measures in emergency situations arising as a result of accidental or deliberate falsification of medicines and their ingredients. In order to improve the effectiveness of state control of the quality of medicines, it is necessary to intensify the work on the creation of modern laboratory complexes in every federal district of Russia and the organization of mobile express laboratories on their basis.
In the future it will be necessary to have such laboratories in all regions of the Customs Union.
According to the recently adopted Federal Law "On the circulation of medicines", in 2014 the domestic pharmaceutical industry must pass to the standards of GMP( Good Manufacturing Practice - good manufacturing practice).The introduction of such standards will strengthen the incoming and outgoing control over the activities of producers. Expensive GMP standards will make financially uninteresting production of low-quality and falsified products.
Medicinal falsification is a problem that threatens any state.
Even special services( to say nothing of a simple inhabitant!) Are difficult to detect forgery, track their way into the market, it is difficult to deal with them. Governments of states should be aware that when the danger becomes visible, many patients have already suffered harm. The spread of the Internet, the improvement of technological capabilities of criminals, a false sense of security among residents of developed countries - all this contributes to the spread of counterfeit medicines in the world.
To solve the problem of falsifications at the international level, it is first of all necessary to have all interested parties access to a single database of falsifications, which will become the main source of information for pharmaceutical companies, and oblige all pharmaceutical companies to provide information on detection of counterfeits to law enforcement agencies. In addition, it is necessary to organize studies on the effectiveness of measures to combat counterfeiting of medicines, which will further improve the system of protecting the pharmaceutical market from penetration of counterfeits.