FAS Russia: Our Task is to Create Necessary Conditions for Ensuring Patients Access to Innovative Medicines

22 September 2020

GMP News

“International practice tells us that as soon as generic medicines appear, the healthcare system switches to them, and the released money is directed to the purchase of innovative medicines,” Timofey Nizhegorodtsev, Deputy Head of the FAS Russia said during the plenary session “Availability of innovative medicines for the patient. Legislation and practice”.

The Deputy Head noted the risks of reducing the effectiveness of the Russian health system in terms of economic indicators and comparable therapeutic effects. It is possible to prevent negative effects by creating a more developed regulatory system, that will be based on and guarantee an honest attitude to reproduced medicines on the part of patients and medical professionals founded on scientific facts and international practice.

“Finally, it will allow to allocate the released budgets for the purchase of innovative medicines, that will have a positive impact on its active inclusion in the lists and wider practical application,” Timofey Nizhegorodtsev said.

Another issue that is inextricably linked to the availability of innovations for patients is to form lists of such medicines. Inclusion of medicines in this list is always associated with its pharmacoeconomics, because health budgets are always limited and require constant “balancing”.

The representative of the Antimonopoly Authority said that the Ministry of Health together with the FAS Russia will soon prepare a package of amendments to the Decree of the Government of the Russian Federation 871, providing for the possibility of including medicines in the list of life saving medicines for certain medical indications.

“Now the inclusion in the list is based on an international non-proprietary name. It means that the medicine can be purchased for all indications that are registered for it, without any exception. Sometimes it leads to the budget imbalance and, consequently, does not allow to include certain medicines in the list of life saving ones due to economic reasons, the Deputy Head of the FAS Russia explained. The essence of the amendments is that we will be able to include the most complex and expensive medications in the lists for certain indications where there is no another therapy. Accordingly, this will expand the list of life saving medicines at the expense of these medications and direct funds to its purchase for the neediest patients. In general, this approach will create an additional opportunity for citizens to access innovative medicines.”

The third point that Timofey Nizhegorodtsev noted in his speech is pricing: “By the end of the year, we will complete a large and important work related to the revision of prices for medicines, that will be a significant contribution to the health system budget and household budgets. In the Russian Federation prices for medicines will be brought to the average European level. It will free up large funds that can be spent on the purchase of additional, including innovative medicines.”

The question concerning the medicines that will eventually be purchased by the state is strictly medical. However, there are some pitfalls in the examination of the application of innovative medicines.

“We need to work out certain mechanisms related to prioritizing the inclusion of certain medicines in the lists, because it is hardly possible to include all innovative medicines in the list. In other words, prioritization will become one of the ways to quickly include the most important innovative medicines in the practice of widespread use through public procurement,” the Deputy Head of the FAS Russia summed up.



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