On July 23, 2020, a meeting was held on the pharmaceutical industry led by Maksym Stepanov, Minister of Health of Ukraine.

The event was attended by representatives of state bodies, drug manufacturers and representatives of specialized organizations. During the meeting, the implementation of 2D coding of medicinal products was discussed in order to combat the spread of counterfeit drugs, as well as the issue of the introduction of an electronic prescription.

Oleksandr Komarida, Director General of the Pharmaceutical Directorate of the Ministry of Health of Ukraine, said that the Ministry of Health is constantly researching methods of combating falsified medicinal products, amendments to the legislation are being developed and adopted, which increase responsibility for the production and sale of medicines, but a significant improvement in the situation has not yet been achieved. Therefore, O. Komarida asked representatives of the pharmaceutical market to provide suggestions on steps that the Ministry of Health can take to improve the situation.

Maksym Stepanov noted that the Ministry of Health considers the introduction of a 2D drug coding system to be one of these steps, but the Ministry needs to understand how much time pharmaceutical companies need to adapt production to this system.

Since the costs of implementing 2D drug coding will primarily fall on manufacturers, clear goals and criteria for the effectiveness of introducing such a system should be developed.

The participants noted that it is necessary to implement 2D coding of medicines gradually. In particular, proposals were voiced that first of all it is necessary to introduce 2D coding of imported drugs, then those included in the “Affordable Medicines” program, and only after that to extend such a requirement to prescription drugs and finally to over-the-counter drugs.

With regard to the timing of the introduction of 2D coding, the manufacturers asked the Ministry of Health to consider the possibility of introducing the 1st stage at least in 1-2 years, since the equipment needed for the modernization of one production line is delivered no earlier than 6 months after its order. That is why in the European Union, the period of implementation of this system in different countries was 3-5 years after the entry into force of the relevant regulatory framework.

M. Stepanov agreed with the proposal regarding the gradual introduction of 2D-coding of medicines with its subsequent distribution to all medicinal products presented on the market of Ukraine.

During the discussion, 2D coding was seen as only one of the measures to be taken to combat counterfeiting. It was also emphasized the need for state control over compliance with the requirements of the Ministry of Health order No. 360 dated 19.07.2005 “On the approval of the Rules for issuing prescriptions for medicinal products and medical products, the Procedure for dispensing medicinal products and medical products from pharmacies and their structural subdivisions, Instructions on the procedure for storage, accounting and destruction of prescription forms” regarding the dispensing of prescription drugs without a prescription.

The participants of the event drew attention to the fact that even before the introduction of the quarantine, a working group was working at the Ministry of Health, which was developing uniform requirements and rules for 2D coding, but this work was not completed. Therefore, it is proposed to create a working group that will continue activities in this direction.

The Minister of Health agreed to its creation and asked to submit proposals for candidates for inclusion in the working group by July 27, so that it would be operational by July 28 and within the next 3 weeks could develop a draft of requirements and rules that could be fully discussed.

They also voiced a proposal to resume a pilot project on 2D coding, within the framework of which all possible problem points should be worked out, as well as for the Ministry of Health to take the initiative to exempt from import duties the equipment that will be imported for the modernization of production for 2D coding of medicines.

Electronic recipe

O. Komarida noted that the introduction of an electronic prescription will allow tracking the route of the drug from the manufacturer to the final consumer and will protect the latter from self-medication. This was confirmed by the issuance of drugs under electronic prescriptions under the “Affordable Medicines” program, which proved its effectiveness and showed that the state should move in this direction, gradually expanding the list of drugs. M. Stepanov added that, first of all, the Ministry of Health wants to introduce an electronic prescription for medicinal products that contain narcotics.

In the course of the discussion, the issue of the need to ensure the protection of personal data of patients during the dispensing of medicines by electronic prescription was also raised. Because this became the problem that stopped the development of electronic prescription. Therefore, when the state begins to demand that information systems meet at least the requirements of the cryptographic information protection standard, it will be a start for the introduction of an electronic prescription, the use of which will be safe for personal data of patients. Those present asked M. Stepanov to pay attention to this and put the safety of patient data as a priority, as well as to consider the possibility of stimulating doctors to work with medical information systems, because currently they have no desire to keep reports on prescribing prescriptions either in paper or electronic form.

To this, the minister noted that if such a problem currently exists, he will pay attention to it.

The minister’s attention was also drawn to the fact that electronic prescriptions are issued under international non-proprietary names, however, when a patient applies for an electronic prescription to a pharmacy that has a marketing agreement with a certain manufacturer, the drug of that manufacturer will be dispensed under this prescription. Therefore, the issue of marketing agreements should be resolved before the widespread introduction of e-prescription, which, among other things, will stimulate competition in the market.

In addition, the manufacturers noted that the certificates of compliance with the Good Manufacturing Practice (GMP) issued by the Ukrainian manufacturer are not automatically recognized in the EU and require confirmation by the EU regulatory authorities. However, GMP certificates issued in the EU are automatically recognized by Ukraine without additional inspections and checks. Therefore, the minister was asked to help solve this issue, in particular, for this, it is necessary to strengthen the role of the State Service of Ukraine for Medicines and Drug Control, providing for annual training of its inspectors in the EU, which will increase the level of trust in the inspections they conduct at Ukrainian enterprises