Is it possible to resurrect the Russian pharmaceutical industry? Part 1
A bitter pill
For seventeen years, Russian pharmaceuticals have been treated with the wrong medicineAlexander Emelianenkov, Rossiyskaya Gazeta, 17.11.2009.
Drug manufacturers earn six hundred dollars a year per American, the same in Japan, in France – 410, in the Czech Republic – 128. In Russia, the consumption of medicines per capita does not exceed 2.5 thousand rubles. But every new increase in pensions and the subsistence minimum, sellers of medicines and dietary supplements are waiting with no less lust than the elderly and the disabled.
Whose business exactly is thriving on our sores and who to thank in case of a happy deliverance from ailments – when the medicine really helped?
Russia is not represented in the list of the fifty largest pharmaceutical companies in the world. And half a hundred of the most prominent Russian manufacturers (including joint ventures with foreign firms) give a combined result of 0.284 percent of the world market, or $ 1.87 billion in sales in absolute terms. This is at the level of a single company Kyowa Hakko Kirin, which closes the Top-50 list of the global pharmaceutical industry.
Over the past seventeen years – since the Ministry of Medical Industry of the USSR was abolished and its functions were partially transferred first to the Ministry of Health, and in 1996 to the Ministry of Industry – the industry as a whole, managed, with the possibility of state formulation of tasks ceased to exist.
Meanwhile, the volume of the global pharmaceutical market has reached $657.7 billion (in producer prices). The largest companies – they are called "Big Pharma" for short – have an annual income of more than 3 billion and spend at least 500 million a year on new developments. The pharmaceutical industry that has survived in Russia produces cheap products of the same type and, at best, imported generics on imported substances.
Truth and statisticsThe "Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2020" is designed to reverse the trend and solve many accumulated problems, which was developed by the order of the Ministry of Industry and Trade at the Research Institute of Chemical Diversity of the Center for High Technologies "HimRar" CJSC.
The price of the issue, as follows from the passport of the program, is 177.62 billion rubles.
– The cost of the state contract for the development of the program itself is about 19 million, – Oleg Korzinov, head of the innovation department of the HimRar Central Research Center, said from memory. – Under our leadership, twelve or fifteen organizations acted as co-executors, including Pharm-Standard, Valenta-Pharm, Remedium, and the Medical Academy named after him. Sechenov and others.
For innovative projects in this area, the state is being asked for 30 billion rubles by 2017 (a billion dollars – for an even account). And then, they say, the companies will get on their feet, and the matter will go on by itself. However, one more little thing is needed: to obtain two hundred domestic innovative drugs (and this is the strategic goal), it is necessary to have four to five thousand young scientists and 400-500 specialist managers with research experience, as in leading foreign firms, by 2015. Where can I get them? Another billion dollars is being requested to organize postgraduate training and equip laboratories.
Otherwise, the failure between science and the Russian pharmaceutical industry, the authors of the new "Strategy ..." warn, risks turning into an abyss. And in order to avoid the worst scenario, they are already offering to fill up the gaping hole with two billion greenbacks.
Meanwhile, according to the Ministry of Industry and Trade, in 2005 Russian pharmaceutical enterprises produced drugs worth 30 billion rubles, in 2006 – already by 36 (in producer prices). And by the end of 2008, the sales volume of the fifty largest Russian pharmaceutical manufacturers reached 1.87 billion dollars, including foreign companies – 13.6 billion. This gave grounds to state that the pharmaceutical market in Russia, largely thanks to state programs, "is developing dynamically and in ten years the volume of sales of medicines in our country will be about 1.5 trillion rubles – in fact, we must reach the average European level of consumption of medicines."
The State Duma Committee on Health Protection is ready to applaud these plans. That's just how to translate them into a practical plane?
– The consolidated health budget, that is, everything that our country spends, including the federal level, the level of the subject of the Federation and the municipal, amounts to 1.2 trillion rubles today, – Deputy Chairman of the Duma Committee, Academician of the Russian Academy of Medical Sciences Sergey Kolesnikov shares his doubts. – In most civilized countries, the budget costs of medicines do not exceed 20-30 percent of the total cost of medical care. In this scenario, if we, of course, consider ourselves a civilized country, healthcare costs in Russia should grow to an unthinkable level now – 5 trillion rubles in today's prices. We doctors don't mind at all. And what about our thrice-beloved Ministry of Finance?
We will also reflect on what has been said: 1.5 trillion rubles (or $ 50 billion) is almost a fourfold increase from the total volume of current sales of pharmaceuticals in Russia. That is, during these ten years, sales volumes should grow by 40 percent annually. And if we take into account that the share of domestic production by this time should be equal to the volume of imports of medicines (50-50 – so it is written in the "Strategy ..."), then the Russian segment of the development and production of pharmaceuticals should grow by 130-140 percent annually.
From where and how? After all, no one plans to nationalize the most delicious islands of the domestic pharmaceutical industry that have gone into the market, and it is unlikely that this will give the expected effect. And it seems to be too late to collect in a fist under the wing of the state and pump up with budget money what is still in federal ownership. Not to mention that it has met, meets and will meet hidden resistance.
There is no need to go far for examples: attempts to consolidate the remaining assets of the Russian pharmaceutical industry, suppress corruption in the sphere of circulation of medicines and somehow designate the role of the state here, and therefore the interests of the majority of the population, have been made repeatedly.
Trying is not torture?The author of these lines happened to be among the organizers of the "round table", which was held in the Ministry of Health of Russia on January 22, 1997.
The central topic that was discussed then was "Issues of national policy in the field of medicines. Who supplies the country with what drugs today?", is fresh and relevant, as if more than eleven years have passed since then. Representatives of the State Duma Committee on Health Protection, which was headed at that time by Nikolai Gerasimenko, did not skimp on examples. Even then, they stated, a significant part of Russian manufacturers switched to bottling and packaging products of foreign firms. From what was heard – bryntsalovsky "Verein" and Danish insulin. The sale of pharmaceuticals without a license, with expired expiration dates, obsessive advertising of dietary supplements – all this was the background on which the law "On Medicines" was born in agony.
– The corrupt system is actively fighting against the law, – its developers claimed. – She swept out and rejected most of the specialists who were interfering with her, replaced them with people convenient for the system.
A year later, in the summer of 1998, the State Duma passed the law "On Medicines". And the participants and those invited to that discussion, First Deputy Minister of Health Alexey Moskvichev, head of the Department of State Control of Medicines and Medical Equipment of the Ministry of Health Ramil Khabriev, Chairman of the Pharmacy Committee in the Government of Moscow Elena Telnova, and the head of the Duma Committee on Health Protection Nikolai Gerasimenko, worked for a long time in their former and new positions, and others are still keeping their finger on the pulse the Russian pharmaceutical market, carefully taking care of its filling.
Another attempt to "save the medical industry" was made in the fall of 2002, when the Ministry of Health of Russia was headed by Yuri Shevchenko, the Ministry of Industry, Science and Technology of the Russian Federation – Ilya Klebanov, and the Deputy Prime Minister of the government in charge of the social sphere, for many years was Valentina Matvienko. By the way, she graduated from the Leningrad Chemical and Pharmaceutical Institute in 1972.
I do not know for what reason the choice fell on the Pushkin Literary Museum in Moscow, but it was within its walls on December 18, 2002 that a meeting was held to discuss in detail and finally correct the unenviable fate of the Russian pharmaceutical industry. The skirmisher was the Committee of the Chamber of Commerce and Industry of the Russian Federation for the development of the biological and medical industry and its then chairman Valery Khaykin. The list of names and positions of the participants of that meeting was already impressive: Academician Rem Petrov, Chairman of the Pharmaceutical Committee under the Ministry of Health of Russia, Academician Mikhail Kirpichnikov, First Deputy Minister of Industry, Science and Technology, Director of the Serbsky Research Institute of Forensic Psychiatry, and in the recent past, Russian Minister of Health Tatyana Dmitrieva, Secretary General of EurAsEC Grigory Rapota, Director of the Bioengineering Center" RAS academician Konstantin Scriabin, as well as lower-ranking officials from the Ministry of Health, the Ministry of Agriculture and other interested departments.
In a word, far from amateurs gathered that time, and the quorum was iron. But what is especially symbolic is that the official position of the Ministry of Industry and Science was voiced by First Deputy Minister Andrei Fursenko. And it consisted, in short, in the fact that "intellectual property, scientific developments should be transferred to the domestic industry free of charge, provided that these developments will be put into production."
What happened next? The department, which at that time combined industry with science and technology, prepared a list of measures "for the strategic development of the medical industry until 2010." The goal was proclaimed essentially the same as today – "the creation of a high-tech, competitive industrial complex for the production of medical products" in order to provide at least 70 percent of their country and its population with high-quality medicines and medical products. At the structural level, a course was taken to "create large sustainable pharmaceutical corporations." Thus, they tried to make up for the loss of unified management in this area.
– The functions of the former Ministry of Medical Industry of the USSR were distributed between the Ministry of Industry and Science, the Ministry of Health and partly the Ministry of Economic Development, – lamented Mikhail Grigoriev, then head of the Department of Medical and Biotechnological Industry in the department of Ilya Klebanov. – And without normal administration, it is impossible to solve the problem of technical re-equipment of enterprises based on new technologies and updating the range of products.
What calmed the heart of Mr. Grigoriev, history is silent. No noticeable traces of the initiatives declared six years ago have been preserved in it.
Doubts and temptationsThe last, at least in my memory, the desire to shake up and consolidate the assets of the Russian pharmaceutical industry was noticed in the spring of 2007.
Then it was proposed to create JSC "Russian Pharmaceutical Technologies". The editorial office has copies of documents indicating a very high degree of elaboration of this proposal – a draft presidential decree (with appendices), a draft government decree (in development) and explanatory notes to them of the established sample are almost ready for signing.
To begin with, it was proposed to transfer to the authorized capital of the integrated structure stakes in seven joint-stock companies that were then federally owned. In particular, it was about the Moscow Chemical and Technological Production Association named after. Semashko, the State Design Research Institute of the Medical Industry, the State Research Institute of Biosynthesis of Protein Substances and four other organizations outside the capital – including the All-Russian Scientific Center for the Safety of Biologically Active Substances in the village of Staraya Kupavna near Moscow, the State Research Institute of Medical Industry Technologies in Belgorod, a pharmaceutical factory in Kaliningrad and the Vostokvit enterprise in Biysk.
At the same time, it was proposed to transform six specialized FSUEs into joint-stock companies and, upon completion of this procedure, also add their shares to the authorized capital of Rosfarmtechnologies OJSC. In order not to bore with names, I will not list these FSUEs, I will only say that three of them are located in Moscow, one each in Astrakhan, Belgorod and Troitsk of the Krasnodar Territory.
It was planned to complete the formation of the integrated structure by December 2007.
But there were, apparently, other opinions in high offices on this score, and the heads of the mentioned factories, factories and research institutes had their own views on self–determination in the temptations of the market element. Clearly fearing the strengthening of the role of the state as a regulator in this area, assets still preserved in state ownership began to be urgently sold off. And there was someone to look up to.
It was during these years that the German Stada Arzneimittel AG, which already owned the Chemopharm-Obninsk plant, bought the Nizhpharm plant in Nizhny Novgorod for 80 million euros and Makiz–Pharma in the Ryazan region for 135 million dollars. The oldest pharmaceutical plant in Russia "Akrikhin" (Moscow region) was acquired by Polish Polpharma, the transaction is estimated at 80-100 million dollars. The controlling stake (51 percent of shares) of the ZiO-Zdorovye pharmaceutical plant near Moscow was bought by Actavis (Iceland) for $ 60 million.
In a word, nothing expected came out of the venture called JSC "Russian Pharmaceutical Technologies": the draft decree and resolution remained projects. The last of the ministers of the medical industry of the USSR, Valery Alekseevich Bykov – Doctor of Sciences, professor, academician of the Russian Academy of Medical Sciences and RASKHN – headed by that time the All-Russian Research Institute of Medicinal and Aromatic Plants and watched with quiet sadness from there the disintegration and degradation of a well-known industry.
"It cannot exist and develop in isolation from the country's economy," he said diplomatically in the spring of 2005 at a round table in the Moscow Domzhur. And he repeated almost the same thing in a telephone conversation now, when a new concept for the development of Russian pharma is being widely discussed.
– The state of the domestic pharmaceutical industry is an integral reflection of the overall technological development of the country and the development of its productive forces.
And to this, as they say, neither decrease nor add.
The position obligesIn May 2008, when some still cherished hope for the appearance of the Rosfarmtechnology holding, and others clearly and not explicitly resisted it, the federal agency Rosprom was abolished, and most of its functions were transferred to the relevant departments of the Ministry of Industry and Trade.
Shortly before that, a new person was appointed to the post of director of the Department of Chemical and Technological Complex and Bioengineering Technologies in the Ministry of Industry and Trade - 39–year-old Sergey Tsyb, a graduate of Pleshka, who has worked in Moscow since 2000 as CEO of Medbiopharmacenter CJSC and Radiopreparat LLC.
– Judging by your patronymic, academician of the Russian Academy of Medical Sciences and director of the Radiological Center in Obninsk Anatoly Fedorovich Tsyb is not just your namesake? – I clarified just in case at a personal meeting with the new head of the department.
– Yes, he is my father, – Sergey Anatolyevich became animated. – Do you know each other? It's nice...
A native of the scientific and medical environment, he has almost ten years of independent work in the pharmaceutical business, now in public service - at the very center point of what we are trying to figure out. Well, how not to ask him direct questions?
– Of course, you have heard about the idea of the Russian Pharmaceutical Technologies holding? What prevented its implementation?
– I do not know why the idea was not supported. This was before the appearance of our department in the Ministry of Industry. And it's hard for me to comment. I'll just give my opinion. Pharmaceuticals is a special industry, high–tech and very capacious in terms of money. Therefore, the creation of a state structure, in my opinion, is justified only in the segment where it is impossible to cope with the task of obtaining some high-tech drugs without the support of the state. And such structures have already been created in Russia. For example, Rosnanotech is a state corporation...
"But that's not what I'm talking about. I'm talking about the preserved state assets in the Russian pharmaceutical industry. Is there something suitable for consolidation? And what are you going to do with them?
– There are no specifics on this issue yet. Although the "Strategy ..." plans to create integrated structures based on public-private partnership. But I can't say anything specific about it yet.
– One of the functions of the department is to support scientific research. Over the past two years, what has been financed?
– There were many proposals from the Russian Academy of Sciences and the Russian Academy of Medical Sciences in terms of R&D. But this is a serious enough question. We are not just talking about supporting some projects. All projects proposed by research institutions should be in line with the "Strategy ..." of the development of the pharmaceutical industry. For example, we conducted a detailed analysis of the market of drugs that are not produced in Russia. We have created several interdepartmental working groups with the Ministry of Health and Social Development...
– Can you give examples? What have your working groups already done?
– I think closer to the end of the year we will decide – in terms of our competence in this matter...
The cure for deja vuAt some point in our dialogue, I begin to feel that I'm always asking the wrong question.
On the opposite side of the table – strategy, scale, perspective. And from my corner I keep pestering with examples, figures, details. Some kind of conversation is not equivalent. And in order not to be tormented by doubts, it is better to re–open the "Strategy ..." - everything is set out there with examples and figures. Until 2020. Delve into it. Evaluate the minted formulations of tasks, alternative scenarios and long-term forecasts.
But the clingy deja vu still does not let go. Because you see one thing on paper, and another outside the window. French Servier opened its own factory in the Moscow region in the summer of 2008. And everyone applauded in unison: 40 million euros of investment!
The KRKA-Rus plant in the same Moscow region was built by KRKA (Slovenia). Hungarian Gedeon Richter, following the same example, opened its own production "Gedeon Richter-Rus". Now it is called the rounded term "localization", expanding the format of negotiations with the largest foreign companies Novartis, GlaxoSmithKline, AstroZeneca, Sanofi-Aventis, Teva. And on the other hand, including the companies Wyeth, Jansen, Merek Sharp & Dohme, without skimping on words and beautiful promises, strive to persuade Russian partners to the role of a packer of their drugs.
P.S.
Not so long ago, a meeting of two committees of the Chamber of Commerce and Industry of the Russian Federation was held in the State Duma under the auspices of the Fair Russia faction - issues of accessibility and quality of medicines were discussed in the context of the same "Strategy...". The meeting participants, in the presence of Deputy Head of Roszdravnadzor Elena Telnova, unanimously decided: to discuss the "Strategy..." widely and publicly with involving the business community BEFORE SUBMITTING the document to the government.
Pharmlikbez
An innovative drug is a drug that has a pharmaceutical substance protected by a patent or patented technologies for obtaining a finished dosage form, as well as a method and methods of drug delivery to a "biological target", that is, to an object of exposure in the human body.
Generic is a medicinal product created on the basis of a substance with expired patent protection.
A generic brand is a medicinal product whose active substance (substance) has escaped patent protection, but its trade name is actively promoted.
Royalties (from the English royalty – royal privileges) are periodic cash payments to holders of patents and related copyrights in the form of fixed deductions from the sale of medicines under patent protection.
The GMP (Good Manufacturing Practice) standard is a system of norms, rules and guidelines for the production of medicines, medical devices, food additives and active ingredients in pharmaceuticals. Such a standard is accepted as mandatory in most developed countries.
Portal "Eternal youth" http://vechnayamolodost.ru19.11.2009