Anti-counterfeit medicines in the aspect of supranational regulation (CU)

Author: Oksana L. Kurochkina,
a barrister, a member of the Expert Council the Committee on budget and taxes
of the State Duma of the Federal Assembly of the Russian Federation

It is not a secret that every Russian consumer purchasing medications in a pharmacy near the house, in a kiosk in the metro or in the Internet-shop concerned with the question: is it a fake? And to these doubts, unfortunately, there are good reasons.

Currently in Russia, according to the available statistics, falsify drugs almost all pharmacological groups, and first of all antibiotics.

In most cases, these drugs do not correspond to the original medicinal products quality, efficacy or adverse effects. But even if they match the quality and other characteristics of the original compounds, their production and sales are performed without the supervision of the appropriate state bodies.

Experts also note the fact that the majority of fakes are produced in Russia by itself. International counterfeit drugs come mostly from Asian countries and Eastern Europe.

In the period of world economic crisis the consumer was forced to shift to more cheap medications, which was used by unscrupulous vendors selling falsified products at a lower price. However, the high cost of drugs cannot guarantee buyers of their quality.

The most dangerous for the consumer is sales of medicines over the Internet. The level of fraud in this market is estimated to be 50%. The volume of electronic commerce of drugs is growing rapidly.

Also relevant is the problem of fake pharmaceutical substances imported into the territory of the Russian Federation and is further used in the production of ready medicines.

Among the factors contributing to the creation of conditions for the manufacture and sale of counterfeit medicines experts call:

• Insufficient attention of the state authorities to this problem;

• Gaps in the legal framework, including the lack of a common terminology for concepts fake, fake, counterfeit products;

• Inefficient system of social protection, illiteracy and poverty of the population;

• Poor development of international cooperation, the almost complete lack of information exchange between the state and business.

The main task of the pharmaceutical industry is to provide consumers with effective and affordable medicines. In turn, the health of the nation, which is the main social value and the most important economic resource of the state and society, is an indicator of the level of socio-economic development, reflecting the achieved level of quality of life and economic prosperity of the country as a whole.

In this regard, the falsification of medicines is a real threat of an economic and social security of the country, the health of each person receiving medication. The victims of counterfeit drugs are not only citizens, but also manufacturers, distributors, who bear the losses and lose the trust of consumers, as well as incentives for the development of new drugs.

In the conditions of active development of the processes of globalization and the building of information society increases, the need to use common approaches and standards for the creation, registration and use of medicines, and also the improvement of national and supranational legislation in the sphere of fight against counterfeit and fake drugs.

The Russian Constitution recognizes the right of everyone to health and medical care in accordance with the universal Declaration of human rights and the International Covenant on economic, social and cultural rights and the European Convention for the protection of human rights and fundamental freedoms.

And in this direction is making a great job. So, in 2010, the Federal law «On circulation of medicines», which strengthened state control in the sphere of circulation of medicines, which allows you to more effectively combat the trafficking of counterfeit medicines. The implementation of this law is aimed at the formation in Russia of an effective system of admission of drugs to the market, which would meet international requirements and prevented the emergence of counterfeit and substandard drugs. In the realm of interstate cooperation has concluded the countries of the CIS Agreement on cooperation in combating counterfeit medicines from November 14, 2008.

Currently, however, in connection with creation of the Customs Union of Russia, Belarus and Kazakhstan, the expert community celebrates the aggravation of the problem of the distribution of counterfeit medicines.

With the entry into force of the Customs Union, who lifted the restrictions on the movement of goods between countries-members of the Customs Union on the territory of the Russian Federation it is important to intensify work on control over the handling of medicines. Because it is necessary in an extremely short period harmonize the key parameters and standards of treatment, control, including to determine and at the international level to fix the standard of liability companies-producers and sellers of the production and distribution of counterfeit medical products.

The moment of creation of the Customs Union, in our countries have similar but different mechanisms and efficiency of the legal system of regulation of economic relationships in the traffic of drugs. Their unification under uniform standards can mean «restructuring» of different degree of complexity and duration.

So, for the development of common approaches to assigning goods to medicines Commission of the Customs Union by the decision N 298 dated 18 June 2010, a plan was approved for mutual recognition of registration certificates for the drugs producers of the countries-members of the Customs Union, produced under good manufacturing practices (GMP). For these goals requires harmonization of regulations and standards in the sphere of circulation of medicines on the basis of international standards, recommendations of the world health organization and the European experience.

Currently, a draft Agreement providing for the vesting of the Eurasian economic Board of the authority for coordination and approval of harmonized requirements and creation of a single regulatory and information system in the sphere of circulation of medicines, necessary for the mutual recognition of registration certificates for pharmaceuticals producers of the member States of the Customs Union, produced under conditions of good manufacturing practice (GMP).

Also developed Rules of good laboratory practice (GLP) applications based on the rules of the European Union, the Rules of good clinical practice (GCP), on the basis of the Rules of the International conference on harmonization of technical requirements for registration of pharmaceuticals for human use and the European Union, the Rules of good manufacturing practice (GMP) with applications based on the rules of the European Union, Common rules of confirmation of conformity of production of medicines GMP requirements, Uniform rules for the inspection of the production and recognition of inspections on the basis of the existing rules of the international system for pharmaceutical inspections(PIC/S), the Rules good distribution practices (GDP) based on the rules of the European Union, the Rules of good pharmacy practice (GPP) based on the rules of the European Union.

In addition to the plan of actions it is planned to develop requirements of Instructions for medical use of drugs (for consumers) on the basis of the rules of the European Union, Uniform requirements for the labeling of medicinal products on the basis of the rules of the European Union, Uniform requirements to registration dossier, the structure and content of the expert report on the conducted examination of documents of the registration dossier of the medicinal product in accordance with the rules of ICH and the European Union, the Uniform rules for the monitoring of adverse reactions of drugs.

By the plan the Commission is also envisaged to harmonize national pharmacopoeias standards with European Pharmacopoeia.

In the Customs Union will be the creation of a unified regulatory and information system in the sphere of circulation of medicines, containing information on registered medicines in the countries-members of the Customs Union, of poor quality, counterfeit medicines, and the results of the monitoring of adverse reactions of drugs.

Unified information system of the Customs Union in the sphere of circulation of medicines (hereinafter – information system) is a subsystem of the Integrated information system of foreign and domestic trade of the Customs Union.

Information system is created for efficient exchange of information in the sphere of circulation of medicines, for the information interaction with information systems of countries-members and permanent exchange of information between state authorities.

Information will be provided by specially authorized body of a member state of the Customs Union.

The purpose of creation of such an information system are to ensure effective regulation and necessary inspections drug circulation on the customs territory of the Customs Union with the use of information telecommunication technologies for moving goods and vehicles across the customs border of the Customs Union.

The system of informing will include the following information resources:

• The state registers of medicines of countries-members of the customs Union;

• Information Fund of quality standards for medicinal products: pharmacopoeias article (FS), temporary pharmacopoeias article (VFS), specifications (JV), normative documents (ND), temporary documents (GNI), state standards (GOSTs), and the standards of the countries-members of the customs Union;

• Information on rational use of medicines;

• Information Fund information about importing/exporting of medicinal funds;

• Information Fund information about certification of medicines, counterfeit and contraband products;

• Information Fund of information about adverse reactions;

• Information facility identification of drugs.

Register of medicinal products, registered and permitted for use in the territories of countries-members of the Customs Union will be a platform for a single software package of the Single register of medicines.

It is assumed that in identifying the territory of countries-members of the Customs Union adulterated, poor quality of the medicinal product national competent authority in each state of the Customs Union within 3 working days will bring the information into the electronic database of counterfeit medicines identified on the territory of a country-member of the Customs Union.

In addition, according to the plan by December 2012 it is necessary to develop a regulation on mutual recognition of results of quality control of drugs, and a draft agreement on the procedure of mutual recognition of registration certificates for pharmaceuticals producers of the member States of the Customs Union, produced under conditions of good manufacturing practice (GMP).

With regard to the cross-border movement of drugs and pharmaceutical substances, their import into the Customs Union is based on the Statute on the order of import on customs territory of the Customs Union of medicines and pharmaceutical substances, approved by the EurAsEC interstate Council (the Supreme body of the Customs Union) at the level of heads of state on 27 November 2009, N 19.

This Provision shall apply to legal and natural persons registered as subjects of entrepreneurial activity engaged in the import of medicines and pharmaceutical substances. subject to prohibitions or restrictions on the import or export of member States of the Customs Union within the Eurasian economic community in trade with third countries, as well as foreign manufacturers of medicines in the person of authorized representative offices (branches) or their proxies and on individuals engaged in import of such goods for personal (non-commercial purposes) is determined by the member state of the Customs Union within EurAsEC.

In other words, in the near future, we can predict the concentration of efforts on the problems of the struggle with fake and counterfeit drug products on the territory of the Customs Union and Common economic space.