DEVELOPMENT OF THE MEDICINE PROVISION SYSTEM SHOULD BE CARRIED OUT THROUGH DIGITALIZATION
At the same time, the antimonopoly service believes that without a decision to the issue of data standardization and verification of information sources, the switch to digitalization will be impossible
The participants of the session entitled "The evolution of the procurement system: global trends and technologies", which was held within the framework of the forum "Medicine Safety" discussed the issue of improving the medicine provision for patients.
Timofey Nizhegorodtsev, the Deputy Head of the FAS Russia, noted that the system of public medicine procurement has recently undergone a number of important changes. Among them, the establishment of generic requirements for the description of the procurement object, the use of a single mechanism for calculating and setting the guaranteed maximal contract price (GMCP), as well as the introduction of a mandatory the Unified Directory-Catalog of Medicines (UDCM).
Further improvement of the system of public medicine procurement, according to the Deputy Head of the FAS Russia, "in general, should be carried out through digitalization, standardization, automation of the collection and accounting from the medical institutions of information on the need for medicines, as well as verification of information sources. The switch to an automated public procurement system is not possible without harmonization of all data provided in the information systems."
The FAS Russia has always been a fervent advocate of procurement centralization, especially since this possibility is provided for by the Law on the Contract System. To date, it has been carried out only for medicines procured under federal programs and has shown its economic effectiveness.
"If we establish reliable medical statistics of medicine consumption in all regions of the Russian Federation within the standardization and digitalization, as well as determination of the needs for medicines, we will be able to reach a new decision-making level on the issues of centralization and cost planning," Timofey Nizhegorodtsev said.
FAS Russia also supports the introduction of long-term contracts as an additional guarantee that would ensure stable access of patients to innovative medicines. At the same time, such contracts must be concluded with producers of medicines that are subject to patent protection and subject to a reduction in the initial maximum price for the entire term of the contract.
"As soon as the patent protection has been completed and the generic medicine has been registered in the market, procurements should be carried out with the standard bidding process," the Deputy Head of the FAS Russia noted.
According to the representative of the FAS Russia, the risk-sharing mechanism* is a special case of the medicine procurement system, and its application in Russian practice is possible only if a number of conditions are fulfilled:
- the medicine must be innovative (reference);
- the medicine must have no registered treatment analogues;
- the retail medicine price should not exceed the price in the reference countries;
- the result should be determined using clearly measurable effectiveness indicators;
- patients must be insured and have guarantees for continued funding in case of termination of the contract, subject to the determined effectiveness in relation to a particular patient;
- the implementation of the contracts should be carried out according to the uniform rules, requirements, and sample documents developed and approved by the Ministry of Health of the Russian Federation.
"At the same time, since 2016, the antimonopoly service has not received a single project or proposal for the assessment of the implementation of a risk-sharing mechanism," Timofey Nizhegorodtsev lamented.
The representative of the antimonopoly service also noted that the future is global medicine reimbursement. However, for switching to the above-mentioned medicine reimbursement it is essential to determine the model of medicine reimbursement, to have reliable data on the medicine needs, as well as to launch pilot projects to clarify the budget and determine the regulatory control of the chosen model.
* The risk-sharing system assumes that the state pays the producer for usage of only those innovative medicines that have shown their effectiveness. That is, if the medicine has not shown its effectiveness, no payment is made.