Experts told how Russia can achieve medicinal independence

To whom the third is superfluous, and to whom the second

According to Aleksey Kedrin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union, the pharmaceutical industry has been overtaken by the turbulence caused by the crisis, so companies need to change their strategic approaches to work in the long and short term: “It is difficult to create an innovative drug in 5-6 and even 10 years, and for For pharmaceutical manufacturers, it is important to see at least hints of a horizon until 2035-40, to understand what drugs will be in demand in the future. Today we are discussing the content of the Pharma 2030 strategy, and in parallel, discussions are underway on the project of the country’s technological sovereignty. The strategy includes control over all stages of the technological process, new tax regimes to encourage scientific research, a system for accelerated registration of a number of strategically important drugs, and much more.”

The new strategy for the development of the pharmaceutical industry “Pharma-2030” is focused on seven main indicators of the development of the industry. Thus, by 2030 the volume of the Russian market should reach 3.7 trillion rubles, the share of domestic drugs should be 42.6%, and the share of drugs produced in a full cycle and included in the list of strategically important ones should be increased to 80%. The export growth target should be $3.4 billion.

Experts note that in the context of new challenges, solutions need to be found to overcome the industry’s dependence on imports of raw materials and capital goods, increase the volume of innovative developments in the portfolios of Russian pharmaceutical companies, ensure product sales, achieve harmonization of drug development and registration regulations with large pharmaceutical markets and other.

As Ekaterina Priezzheva, Deputy Minister of Industry and Trade of Russia, said, in 2022 one of the most commonly used expressions was “drug defects”: “A number of Western manufacturers have left our market; restrictions were imposed on the supply of equipment; the usual logistics has completely changed. But, according to the results of 2022, fortunately, few companies have suspended the work of their branches and representative offices in the Russian Federation. However, we monitored the situation with the availability of drugs in order to prevent the risks of shortages, worked out logistical difficulties, chose new alternative routes, conducted a three-level monitoring of the availability of drugs in the regions, localities and directly in pharmacies, and as soon as the stocks became three months old, we corrected the situation. As a result, according to Priezzheva, the growth rate in 2022 was not only maintained, but, compared to 2021, the production of Russian medicines increased by 10.6%. “9 new production sites were put into operation, and 4 more were put into operation in the first quarter of 2023,” said Priezzheva. completed a difficult and unpredictable year 2022 show that we will definitely reach the goals set in the Pharma-2030 strategy and ensure not only import substitution, but also import advance.”

According to Sergey Glagolev, Deputy Minister of Health of the Russian Federation, “today we do not see assortment defects in certain international generic drugs. In the EU today there is a shortage of antibiotics – something we cannot think about, this niche is closed for us. We were helped, among other things, by experience covid”.

In addition, Sergei Glagolev said that today the country is very interested in both the production of innovative Russian drugs and domestic drugs “second in class” – less risky in production, but able to control healthcare costs, but at the same time providing therapy to patients.

Ekaterina Priezzheva emphasized that the Pharma-2030 strategy more clearly defines national drug safety priorities, and the main focus is on full-cycle drug production, including the synthesis of the active ingredient molecule, as well as on the production of original drugs.

In addition, Priezzheva noted that it is planned to revise support measures for domestic producers depending on the degree of localization of domestic production: “Now the support measures are general, regardless of what the stage of localization is. Now it will be different: the more localization, the more preferences. To do this, we we will establish a mechanism for confirming the locality of production.”

It is also planned to implement the programs “the third extra” and “the second extra”. In the “second superfluous” priority will be given to blood products. Recall that the programs imply a ban on state purchases of imported drugs if they have two or one domestic analogue.

Government representatives recalled that at the end of last year, the country adopted a law on industrial pharmacies, aimed at reviving them and closing the need for patients in certain medicines that are not profitable for large companies to produce.

In addition, the country has adopted a mechanism for accelerated registration of strategically important drugs: today, 8 innovative drugs have already been registered in the EAEU under this scheme. It is also planned to introduce drug registration based on real clinical practice data. “This is a new mechanism that allows you to work in the digital environment for drug safety research, which is important for updating the assortment,” said Sergey Glagolev.

Where do drugs costing up to 100 rubles go?

According to the market expert, Corresponding Member of the Russian Academy of Sciences Dmitry Kudlay, today we must realize that not everyone around us loves: “But if you look from the outside, we are a big and fat market for those who supply drugs, we are money that people like everyone in the background of all the events. And we are not satisfied with the fate of the natives, whose gold is exchanged for beads. Our residents are counting on the help of their country, because it is difficult to count on the help of other countries – we understood this even during the covid. Today, the pharmaceutical industry has entered the top 13 priority areas for supporting the industry, and the educational sphere, the sphere of intellectual activity, and the receipt of the country’s gross domestic product will be focused on them. And the main focus is on the full-cycle production of drugs. Manufacturers should integrate with domestic and foreign research teams

and do not forget about private science.

Of the domestic promising developments of innovative drugs, Kudlay noted a breakthrough in the creation of bispecific monoclonal antibodies for oncohematological diseases, the treatment of severe conditions in bronchial asthma and seasonal pollinosis that cannot be stopped by anything, achievements in the field of regenerative cell therapy.

Meanwhile, Alexey Kartashov, a representative of one of the Russian pharmaceutical companies, stated with regret that while the portfolios of domestic pharmaceutical companies mainly consist of generics, innovative developments are rare: “We must not only copy, but also create new, especially innovative, biological products on a new target. After the pandemic and due to the new geopolitical situation, we see that the portfolios of our companies are still made up of generics, which creates risks of defectives. And this against the backdrop of the curtailment of clinical trials by Western companies and the suspension of the recruitment of candidates for them. What will it result in? Over the course of 5-10 years, about 300 innovative original drugs will not enter our market.”

One of the most urgent problems is the situation with domestic pharmaceutical substances – compounds from which finished drugs are produced. Total dependence on their supplies remains. A representative of one of the pharmaceutical companies, Alexander Semenov, said that he and his colleagues counted only 10 companies in the country that produce molecules; about 10 more – who not only produce, but also supply substances to others. And of these, only 2 companies produce more than 5 substances. “Despite all the declared incentives, investors do not invest in the production of pharmaceutical substances. Of course, it is more low-margin than the production of finished drugs, and this is a more complex production. 5 years ago in Europe, for the first time, they thought about the independence of the production of pharmaceutical substances from China and found that there is almost no production of them in the EU. A corporation was created, which includes 6 large production sites – today they already produce 200 active pharmaceutical substances that are supplied to the European market. They plan to increase production to 500 substances. Similar programs have also been launched in India, where they have realized with horror how dependent they are on China during the pandemic. The global trend is to achieve drug safety, which clearly does not imply globalization. Everyone understands that it is necessary to protect their markets.”

Semenov notes that it is necessary to work with chemical industries, but without incentives for the entire commodity-producing chain, it is extremely difficult, if not impossible, to solve the problem of drug sovereignty. “From September, the country will earn preferences for full-cycle manufacturers, the “second extra” program will spread to the production of not only innovative, but also general consumer strategically important products (it is time to update their list – add 45 more positions to 215). At some stages, the cost of substances will be high, and state assistance will be required, which should compensate for the costs of producing active pharmaceutical substances within 5-10 years. Measures of customs regulation are needed – to remove duties on those substances and intermediates that we cannot produce yet, and to increase others. And we also need to separate the wheat from the chaff: today there are companies that create “paper tigers” – they re-stick labels under the guise of chemical raw materials, and the Chinese pharmaceutical substance becomes Russian”

Meanwhile, Deputy Head of the FAS Timofey Nizhegorodtsev said that today many manufacturers register maximum selling prices for drugs just like that – but the drugs themselves are not produced. And first of all, this concerns the segment of drugs costing up to 100 rubles. “About 12% of manufacturers have registered prices for drugs up to 100 rubles. And only 12% of them applied for price indexation by 18% in terms of inflation. Or they feel great even in low-margin markets, despite the logistics and increased production costs. Or more than half of the price registrations are junk: companies do not produce or collect them. And although these drugs are not circulating on the market, this affects price regulation. Therefore, a cleaning of the register is required today so that the price registration is based on real data.”

In addition, according to Nizhegorodtsev, it’s time to start exporting: in Russia, many successful biosimilars of innovative drugs have been created that are not available in other markets: “This is our advantage. It is necessary to provide conditions for the export of products of Russian pharmaceutical manufacturers. We have great prospects in the markets of the CIS and Southeast Asia.”