The issue of falsified medicines has seriously been threatening public health. It is apparent that the effect of counterfeit medicines over the patient’s health, who has an acute or chronic disease, is far too greater than the harm of a counterfeit drug on the economy. It is not possible for health personnel following healthcare procedures and the results of drugs to understand whether a drug is fake or not without using track and trace technologies. In addition, when mentioning counterfeit medicines, only a dysfunctional copy of a drug should not come to mind. In addition to the dysfunctional copy, that the original products’ being portioned by diluting and trying to sell it with reduced effect by changing the expiration date are common methods.
Apart from these counterfeiting methods, it is known that there are many more methods related to counterfeit medicines that we do not want to mention. The main purpose of the falsified medicines directive is to eliminate falsified medicines and its irreparable harmful effects.
The World Health Organization (WHO) published a detailed report on counterfeit medicines on a global scale in 2017. The issue of counterfeit medicines was examined in the report with all its aspects and attention was drawn to the magnitude of the danger. This report explains why these falsified medicines directive are intended to put into effect by legislators in the short term. Please click here to access the report which has been translated into multiple languages.
From the point view of the enterprises, it is seen that the prestige of the honest and reliable manufacturer that produces the original products is being damaged by counterfeit medicines. It should also be remembered that this damage often causes irreparable commercial problems. That’s why, many countries have started to publish falsified medicines directive. In this article, the basic points of the falsified medicines projects that various countries have put into practice or are trying to take will be tried to be explained.
You can reach countries fight against counterfeit medicines by clicking the links below.
The legislator of each country defines a basic set of concepts in falsified medicines directive regulations. These concepts are as follows.
- Pharma serialization
- The Application of Tamper Evident Labeling
- Pharma Aggregation
- Data Exchange
The most basic technical step in fighting against counterfeit medicines is pharma serialization. If you are not familiar with the new track and trace concepts in the pharma industry, it is natural for you to ask this question.
Pharmaceutical companies submit medicines to patients in cartons, bottles, injections, and in similar packaging. The identification of each of these packaged medicines to contain unique data is called pharma serialization.
Serialization might be implemented by printing directly on the packaging, applying labels or using different technological methods.
Every pharma directive must define how pharma serialization will be implemented and the parameters of this serialization. Often countries define serialization processes based on the standards published by GS1. Pharma directives which have been prepared by ignoring these standards generally do not produce successful outcomes. The Falsified medicines directive that were tried to be implemented in China in 2015 is the best example of this. Please follow our blog to learn more about the GS1 directives.
During the medicine production process, it is necessary to integrate new stations and processes into the production line in order to implement pharma serialization.
The selection of hardware in accordance with the serialization regulation desired and the reorganization of the processes within the enterprise according to the serialization are important concepts. To give an example, a hardware investment only made considering for Turkey pharma serialization , will never meet the requirements of falsified medicines directive of Europe and Russia. For this reason, when making a pharma serialization investment, it should be questioned whether this serialization is supported by the hardware in countries with import or export potential.
Another method of fighting against counterfeit medication is to ensure that the patient should come into contact first after the production of the medicines. Medicines that are in bottled liquid and solid form, a simple type of this application has been practiced for years. However, this application has started to become widespread after 2019 for the products sold in blister and carton form all over the world. Firstly, the concept emerging as a mandatory requirement by the EU-FMD has started to be applied in very specific medicines by many countries such as Turkey. It is anticipated that all countries implementing pharma serialization will oblige tamper-evident seal applications over time.
The EU-FMD (European Falsified Medicines Directives) has made tamper evident seal application mandatory for all medicines circulating in the European market to ensure patient safety without suggesting any type of method. Many manufacturing companies have provided the requirement by sticking the tabs of the medicine cartons with special labels. The tamper evident seal application, which has become an obligation with serialization in Europe, has also led to the emergence of hardware that can perform both serialization and tamper evident seal labeling application together. Currently, tamper evident application with labeling remains the most popular and economical method.
These labels do not leave where they stick and even if they are torn or removed, leave evidence on the cartons and bottles. Currently, these label technologies are easily accessible.
It is not possible to provide traceability throughout the supply chain without implementing aggregation. However, many of these falsified pharma directive are still not mature enough about the issue of aggregation. it is predicted that the definition of aggregation will be added to both the EU and the US falsified medicines directive in the near future. Many multinational manufacturing pharma companies have foreseen this requirement when performing track and trace projects. In this way, they have had the chance to complete the track and trace projects at once. For more detailed information on aggregation, please visit our blog.
During the serialization and aggregation operations of falsified medicines directive there reveals a data. This data is used at various points in the life cycle of the product.
The task of counterfeit medicines directive will be to determine a set of rules regarding in which format and how this data will be shared. Since the country’s legislators have responsibilities to ensure the security and accuracy of data, almost every country uses a different data exchange method according to the dynamics of its domestic market. Russia is the country showing the most aggressive approach to data exchange. It has regulated its directives in order to make all data communication over a closed and encrypted network. As the legislators of the countries still cannot agree on the EPCIS standard of the GS1 organization, the cost of data implementation of drug manufacturers in the track and trace projects is increasing day by day.