FAS Russia believes that the development of the drug supply system should be carried out through digitalization. At the same time, the department believes that without resolving issues with data standardization and verification of information sources, the transition to digitalization will be impossible.
The participants of the session "Evolution of the procurement system: global trends and technologies" discussed the improvement of drug provision for patients. The session was held within the framework of the forum "Drug safety".
Deputy Head of FAS Russia Timofey Nizhegorodtsev noted that recently the system of state procurement of drugs had undergone several important evolutionary processes. Among them, the establishment of uniform requirements for the description of the procurement object, the use of a single mechanism for calculating and setting the initial maximum contract price, and the introduction of a mandatory single reference catalogue of medicinal products.
Further improvement of the public procurement system for drugs, according to the Deputy Head of the FAS Russia - "in general, should go through digitalization, standardization, automation of collection and accounting of information about the need for drugs in medical institutions, as well as verification of information sources. Without bringing all data in information systems to uniformity, the transition to an automated public procurement system is impossible".
FAS Russia has always been a consistent supporter of centralization of purchases, especially since this possibility is provided by the 'Law on the Contract System'. Until now, it was carried out only with drugs that are purchased under federal programs and has shown its economic efficiency.
"If we succeed, within the framework of standardization and digitalization, as well as determining the needs for drugs, to create reliable medical statistics of their consumption in all constituent entities of the Russian Federation, then we will be able to reach a new level of decision-making on centralization and cost planning," said Timofey Nizhegorodtsev.
as an additional guarantee that would ensure stable access of patients
to innovative medicines, the antimonopoly authority supports the
implementation of long-term contracts. At the same time, such agreements
must be concluded with manufacturers of drugs 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 is over and a generic drug has been registered on the market, purchases should be organized through regular tenders," Mr Nizhegorodtsev emphasized.
As for the risk-sharing mechanism,
according to the representative of the FAS Russia, it is a particular
case of the drug procurement system, and its use in Russian practice is
possible only if several conditions are met:
- the medicinal product must be innovative (reference);
- the drug must have no registered therapeutic analogues;
- the selling price for a medicinal product should not exceed the price in reference countries;
- the result should be determined using clear, measurable performance indicators;
- patients must be insured and guaranteed to continue funding in the event of termination of the agreement, subject to established effectiveness in relation to a particular patient;
- the implementation of agreements should be carried out according to uniform rules, requirements, samples of documents developed and approved by the Ministry of Health of Russia.
"At the same time, since 2016, the department has not received a single project or proposal to assess the possibility of introducing a risk-sharing mechanism," lamented Timofey Nizhegorodtsev.
The representative of the FAS Russia also noted that the future belongs to universal drug reimbursement. However, to switch to it, it is necessary to determine the model of drug reimbursement, have reliable data on the demand for drugs, and also implement pilot projects to clarify the budget and select the regulatory framework for the chosen model.