June 8 on-site biotechnology company BIOCAD, located in the special economic zone “Saint-Petersburg” (special economic zone the Neudorf), took place the meeting of Chairman... Domestic manufacturers of orphan drugs will receive support from the state

June 8 on-site biotechnology company BIOCAD, located in the special economic zone “Saint-Petersburg” (special economic zone the Neudorf), took place the meeting of Chairman of Federation Council Valentina Matvienko with the leaders of the pharmaceutical industry.

Roundtable with speaker of the upper chamber of executives BIOCAD, GENERIUM, GEROPHARM, Nanolek, Polysan, JSC SEZ “Saint-Petersburg” and Sankt-Petersburg chemical-pharmaceutical University raised a number of topics, in particular, on measures of state support for producers of expensive orphan drugs.

“We as the Parliament is ready to provide maximum support for the further development of this branch — if necessary as the legislative and regulatory and administrative. Because this is one of the most sensitive issues for our people, for our people”, — said the speaker of the Federation Council.

According to Valentina Matviyenko, it is important that the drug was created in Russia — this will allow you to produce a unique product and compete in foreign markets. First of all it concerns orphan drugs, because in this region there are several problems that create obstacles to domestic producers to bring to market new medicines. We are talking about imperfect method of pricing where each subsequent orphan, biosimilar applied reduction factor, and a fairly small list of diseases included in the program 7 WNV, in which drugs are purchased centrally from the Federal budget.

“If priority attention from regulators is a problem in three major orphan drugs can be solved in 2018. This is the logical end of the program “Pharma-2020” are already available in 7 WNV rare diseases. Three types of hemophilia, cystic fibrosis, Gaucher disease, and pituitary dwarfism – is that already implemented in Russia on a full cycle. The next logical move should be to deal with the “list of 24″ in the context of the decisions of the Federation Council on April 26, 2018, which provides a pilot project of federalization of such procurement,” – said General Director of JSC “GENERIUM”, Professor Dmitry Kudlay.

In June 2017 on the Prime Minister received a complaint of Valentina Matvienko, which spoke of inclusion in the list of 7 WNV diseases such as mucopolysaccharidosis three types of hemolytic-uremic syndrome and paroxysmal nocturnal hemoglobinuria. According to experts, the expansion of the Federal program will annually save the state billions of virtually any.

“The regions have no such financial resources. And if they will be forced to allocate funds, it will suffer other categories of ill people. This should not be. The position of the Federation Council lies in the fact that all costly purchases of drugs were transferred to the Federal level. The difference in procurement matters. If drugs are purchased for two people – it’s one price. And wholesale is a great discounts and big savings. The draft resolution even as a temporary measure I do not support. There is nothing more permanent than a temporary solution. We will insist on centralized procurement. This will give a clearer accounting, control and guarantee that every patient will receive assistance. This ideology will insist. I hope this year the decision is made, and from 2019 to begin a new life,” said Valentina Matvienko

As for the pricing methodology, the use of reduction factors may deter potential producers to go in this narrow niche. Development of drugs for rare diseases is difficult and not always commercially profitable, but has enormous social significance.

“The issue of pricing when you register, including biosimilars in the field of rare diseases in the Russian Federation must be considered separately. Russia is one of 5 countries in the world, which is creation, including biosimilars in this area, so to find examples in the relevant countries is not easy. In addition to Russia that countries like Korea, China, Iran and the United States. Given the ongoing lack of resources for diagnosis and treatment of rare diseases in all civilized countries there are government program to support “orphan” projects, both original, including biosimilars. Support is of a material nature and regulatory (Fast Track registration). This is because producers in mereschitsya units and the economic component of production of drugs “orphans” often does not make sense”, – concluded Dmitry Kudlay.

Source: JSC “Generium”

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