About 10% of the drugs consumed in developing countries are of low quality or counterfeits. This was indicated in 2017 by a study carried out by the United Nations (UN) based on data collected in 88 countries. With this information as the main argument, the World Health Organization (WHO) urged states to improve detection and control systems for drug marketing.
Our Government took note and in 2019 put into operation the Spanish Drug Verification System (SEVeM) , which works in coordination with similar tools of the European Union. The supervision of this system is the responsibility of the Spanish Agency for Medicines and Health Products (AEMPS) and the national health authorities.
Thanks to SEVeM, in Spain it is possible to differentiate one drug container from another by means of a unique identifier, “which makes it practically impossible for counterfeit drugs to enter the legal supply chain,” according to the National Business Association of the Pharmaceutical Industry, Farmaindustria . This is thanks to the collaboration of laboratories, manufacturers, distributors and pharmacies. To detect products that have been altered, the anti-counterfeiting system has two security elements: first, an identifier in the form of a Datamatrix code , that is, a two-dimensional verification code in readable format, which contains a number of twenty characters generated by a randomization algorithm and indicating the lot number and expiration date. With this tool the authenticity of each medicine container is verified. The second device is an anti-tampering system to ensure that the container has not been opened from its exit from the production line until it is sold at the pharmacy.
The method has proven its effectiveness: by the end of 2020, the SEVeM had signed contracts with 490 drug marketing authorization holders. In addition, 325 distribution warehouses, 22,100 pharmacies and 197 private hospital pharmacy services had joined its network. The connection with public hospitals will be made when the SNS Farma Node is available, a computer tool of the Ministry of Health, Consumption and Social Welfare that enables the exchange of information between the agents involved.
SEVeM data indicates that at the end of last year there were more than 18,000 drug references loaded into its system, more than 2.7 billion unique identifiers, more than 750 million verified packages and more than 500 million drugs deactivated due to irregularities , a figure that illustrates the magnitude of the problem.
The advances of the states in the authentication of drugs have found an ally in digitization , essential to follow the evolution process of a product in each of its stages. Apart from state regulations and international organizations such as the European Union, there are tools and methods developed by companies to improve fraud detection. For example, the Swiss company SICPA, which collaborates with both states and private organizations, has created a label that allows identifying and tracing the plastics used to make medical devices, so that copies are discovered, no matter how well they are made. It also has stamps and even invisible inks that are applied to the original drug containers, which criminals dilute or even alter with toxic substances. It is a very important task: according to SICPA, these products are responsible for 700,000 annual deaths caused by malaria and tuberculosis , almost all in poor countries.
SICPA’s Director of Business Development, the Spanish Fabián Torres, highlights that this type of procedure is more necessary than ever given the enormous number of covid-19 diagnostic tests that take place daily around the world. The possibility of altering them has made it essential to use encryption methods or invisible ink on documents to detect fraud. In addition, the verification of the European Digital Covid Certificate, known as the covid passport, is essential to avoid infections and outbreaks. “We are advising governments and authorities to prevent the falsification of passports and coronavirus tests ,” says Torres, who believes that “robust measures should be implemented to prevent these frauds.”
