Mykhailo Radutskyi, People's Deputy of Ukraine, Head of the Committee on National Health, Medical Assistance and Health Insurance

To save Ukrainians from counterfeiting, a pilot project to place a QR code on medicines will be launched this year. It will allow the consumers to verify the authenticity of pharmaceutical products with the help of their smartphone.

Counterfeit medicines are sold online

Quarantine measures in Ukraine have stimulated the development of e-commerce. Ukrainians began to order medicines online to avoid going out unnecessarily. However, while the pharmacy controls the quality of medicines, no one knows what kind of medicines will be delivered from online shops.

Most online pharmacies operate without any permits; moreover, buying online is impersonal as the customer does not see the goods, the seller, the documents that prove the medicine is original, and he or she does not receive a check. According to experts, more than 80% of counterfeit medicines in Ukraine are sold online. In general, according to various estimates, counterfeit in Ukraine amounts to 10-15% of all medicines, and up to 40% of medical devices are of poor quality or counterfeit.

The whole world is struggling with the counterfeit of medical products because they are a critical threat to the health care system. Counterfeiting leads to a loss of trust in medicines, health care providers and the health care system in general. Our country has already taken several important steps to combat counterfeit medicines.

Increased penalties for counterfeit

Last autumn, the Verkhovna Rada approved the draft law No 1152-1, increasing the responsibility for falsification of medicines under Article 321-1 of the Criminal Code of Ukraine. The President signed this bill on November 24, 2019.

As a legislator, I am interested in analyzing the effectiveness of adopted laws. I try to find out how effective the changes we have proposed are. At my request, the Ministry of Internal Affairs provided information that since the beginning of this year, 9 criminal proceedings have been added to the Unified Register of Pretrial Investigations (ERDR) under this article. However, only one case reached the court, and the fraudsters were punished with….a fine.

Thus, the police work, but increase in terms of imprisonment didn't lead to real imprisonment of falsifiers. Obviously, relying only on repressive methods does not give a 100% result. A more effective approach is to create conditions in which counterfeiting cannot exist.

Following the example of the ProZorro system

The task of the state is to develop a system in various areas that will prevent violations of the law. Now, during the rapid development of information technology, some of the preventive functions can be transferred to the citizens.

We, Ukrainians, need transparency and openness in all areas of the country's activity. A good example of the effective work of government agencies is the ProZorro system. Thanks to its openness, it has answered numerous questions about the fairness of tenders. The state has created a system that protects itself from violations of the law. Of course, there are individual cases when even this system is bypassed by criminals, but in general, it is very effective. 

ProZorro is an example where the state transfers part of its functions to citizens. In the public procurement system, everyone can see all the information about the tender. But in case of doubt, one can contact the law enforcement. Instead of repressive means of combating violators of the law, we invited citizens to join the fight against corruption through public control. In my opinion, we need to act in a similar way in the fight against medicine counterfeiting.

Protect medicines with a QR code

All over the world, one of the effective options to combat counterfeiting is considered to be the placement of a QR code on the packaging of the manufacturer. This code is a unique identifier that allows specifying the name, pharmaceutical form, strength, size, type of packaging, national and serial numbers, expiration date and manufacturer's information. Prior to placing the batch on the market, the codes are entered into the electronic database of the state body. The QR code is read by a scanner and compared with the monitoring system. The system does not allow two identical serial numbers, so the packaging of the medicine cannot have a duplicate.

QR codes have been placed on medicines in the United States since 2015, and since 2019 in Europe.

In Ukraine, according to the decision of the Cabinet of Ministers, a pilot project on marking medicines with control signs (QR-codes) had to start on September 1, 2019. However, it turned out that the system of QR-code placement is different from the European one. Moreover, Ukrainian pharmaceutical companies need time to adapt the production and re-registration of already released batches of medicines. To solve these details, the project was postponed.

The new project start date is November 1, 2020. Initially, drug manufacturers will be able to join the project only if they wish, and from November 1, 2021, the marking will become mandatory.

Fix the QR-code in the legislation

The Committee on National Health has already initiated changes to the draft law on medicines to ensure it corresponds the European standards and to allow Ukrainian medicine manufacturers to compete on an equal footing with foreign companies. Another point of this draft law is the introduction of labeling of each package of a medicinal product with an individual QR-code, which, on the one hand, provides the regulatory body and the consumer with full information about the medicine, and on the other hand, prevents counterfeits from entering the market.

The Cabinet's pilot project is only the first step towards combating counterfeit medicines. We, as legislators, need to ensure the need to place QR-codes and adapt the Ukrainian system to the European one becomes part of the legislation. We need to put an end to the illusion that we can always achieve results by repressive methods.

Our ultimate goal is to enable the buyer to check the origin of medicines with the help of a smartphone to see whether it is a counterfeit or an original one. The introduction of labeling of each package with an individual QR-code and the establishment of mechanisms for rapid response to counterfeit medicines will allow us to combat counterfeit medicines more effectively.