Is it possible to resurrect the Russian pharmaceutical industry? Part 3

Bitter pill-3
Why the new law "On the turnover of medicines" is neededAlexander Emelianenkov, Rossiyskaya Gazeta, 19.11.2009.

(The first part of the article is reprinted here)

We live in an amazing time! I bought ointment or pills at the pharmacy – you can fall under the article as a bribe taker. Or as his accomplice.

I'm not exaggerating at all: Analysts say that 25 or even 30 percent of the price of any medicine, through passages and labyrinths invisible to the eye, like blood through the veins, go to bribery, offerings, payment of lobbyists, direct bribes and disguised kickbacks to officials involved in the circulation of medicines, experts, inspectors, doctors, budget managers in the capital and on the ground. Not to mention the fact that we spend about the same amount, without noticing it, on marketing and intrusive advertising of blockbuster drugs. So that for our blood money, they would then be handed to us with a polite smile through the pharmacy window: "Get sick to your health! We make money on it."

About the disease and the thermometerThe ex-head of the Compulsory Medical Insurance Fund Andrei Taranov and his subordinates-accomplices who profited from the purchase of medicines, cultivating corruption on the scale of Russia, and still got 47 years in prison for seven, for one thing I should say thank you.

The investigation of their actions revealed such lawlessness and protectionism in the circulation of medicines, such blatant bungling of officials and their conscious oblivion of state interests that it became impossible to hush up all this.

The head of state, the Chairman of the government, federal ministers and State Duma deputies have not let the "medicinal" topic out of sight since the spring of this year. And in the President's Address to the Federal Assembly, the development of medical equipment, technologies and pharmaceuticals is declared as "the most important area of work for our citizens." Judging by the level to which the problem has been raised and what forces are involved in solving it, we have reached a critical point. That is why extraordinary measures are being taken.

In order to bring down speculative prices for pharmaceutical products, which are wound up by all kinds of intermediaries-distributors and unscrupulous sellers, it was necessary to use administrative levers, and in some cases switch "to manual control" altogether. However, prices in pharmacies are a thermometer. And to fight them with the methods of administrative antipyretic is a hopeless task. There is not enough time and effort to check and compare who has added extra where. Or the entire Roszdravnadzor, together with the customs service and the Federal Tariff Service, should only do this.

Conclusion? It is necessary to get to the causes of the disease and heal inflammatory processes. In part, this was the subject of two previous publications in the framework of a journalistic investigation undertaken by RG.

Another important indicator of the state of Russian pharmaceuticals is the assortment on pharmacy shelves and offers coming from wholesalers and distributors. Now, at best, one or two out of ten tablets sold are designed and manufactured in Russia. Everything else is import. They are mainly carrying generics. They are looking for the cheapest offers outside of Russia, they buy the same substances at dumping prices in order to cut down the margin on wholesale resales at home. And let your own or affiliated pharmacy chains earn money on retail allowances.

What is especially touching is that 43 percent of such products (according to one data – by 1.4, according to others – by almost 3.5 billion dollars) are purchased for budget money. An analysis of the presence of the largest foreign pharmaceutical manufacturers on the Russian market (Eli Lilly, Jansen-Silag, Astra Zeneka and Roche) shows that they sell from 62 to 75 percent of their medicines not to commercial pharmacies, but under various programs prescribed in the regions. The Novo Nordisk company, a global insulin manufacturer, draws all 90 percent of its income in Russia from our budget.

And what about our pharmaceutical beacons – known in the past and appeared quite recently? It is unlikely that a breakthrough can be expected at the old production facilities created back in Soviet times, according to the head of the Ministry of Health and Social Development Tatyana Golikova. At the "Business Breakfast" at the "RG", she made it clear that she did not believe in saving the domestic pharmaceutical industry by directive consolidation of the assets remaining in state ownership.

– Pharmaceutical production is a special, clean production, – the transcript of her words preserved. – And a number of our enterprises have already fallen into disrepair. Do they need to be assembled, upgraded? What should be created on their basis if they no longer meet modern requirements?

With regard to the biotech holding, which is now being proposed to be created within the framework of the Rostechnologies Corporation, the minister spoke even more definitely and concisely: "I am not a supporter of this idea."

Meanwhile , at a meeting in Zelenograd , Prime Minister Vladimir Putin spoke as follows:

– One of the reasons for the lag of the domestic pharmaceutical industry is its de-integration. It is necessary to stimulate the consolidation of the industry, create integrated structures that unite developers and manufacturers of medicines.

And market mechanisms should be used for this, the Prime minister added. And pharmaceutical enterprises that will show interest, proposed to include in the program subsidizing interest rates on loans for technical re-equipment. According to him, the Ministry of Finance and the Ministry of Industry and Trade have already received such an order.

The same and "HimRar"The small innovative enterprise "Binnopharm", which was shown to the head of government in Zelenograd, the research and production center of genetic engineering in the Cover of the Vladimir region, where the President of Russia had visited shortly before, and the high-tech center "HimRar" in Khimki – that's probably all that Russian pharmaceuticals is capable of showing off now.

The HimRar Central Research Center, which has high hopes, has been counting down its history since 1991. It was then that a group of Russian scientists organized a Research Institute for Chemical Diversity and began conducting custom-made research on fine organic synthesis for the companies Aldrich, Fluka, Akros and Sigma.

Around the same years, a new, as they began to call it, industrial, technology for finding new drugs was being worked out. The method is based on high–performance bioscreening. Since 2004, CJSC IIHR has been located on the territory of the Khimki-PRO technopark in the premises of the high-tech center, which was born as a joint innovative project.

At the meeting in Pokrov, it was emphasized that the ChemRar Research Center is a private and unique scientific complex conducting research in the field of innovative medicines.

– We are proud of such an assessment, – the general director of the center Dmitry Kravchenko did not slow down with the reaction. According to him, negotiations are underway to find an acceptable model for "localization on the territory of the Russian Federation not only of production, but also of modern research projects, including with the participation of Bolshaya Pharma."

Representatives of traditional pharmacology, including the heads of well-known research institutes in Russia and abroad, do not feel any euphoria about this. And not at all because they are afraid of competition from advanced youth.

– In my opinion, there is a clear misunderstanding of one and an overestimation of the other, – says Academician of the Russian Academy of Medical Sciences Sergey Seredenin. – The concept of bioscreening, which is now hoped for, showed itself well at a time when Soviet science did not recognize particularly Western patents. We found something interesting there, and we started looking in the same field or somewhere nearby. But today such schemes no longer work, and even more so they will not work tomorrow. Now in the West, if something worthwhile is discovered, not only the substance itself is patented, but also the entire variable field around.

Our academics are also not ready to agree with the fact that they give out left and right for innovative medicines. According to them, it is not necessary to push two or even three molecules of the active substance into one tablet or capsule. But this is not science, but only combinatorics. A derivative of the same marketing – how to sell more profitably.

The former director of the Center for the Chemistry of Medicines, academician Robert Glushkov, his former and current colleagues hold a similar opinion.

– The young guys who picked up in the West are now, of course, in plain sight. They are punchy, active. But there is a clear lack of fundamental education. Their own baggage of professional knowledge in pharmacology is very lightweight. They don't know the basics! And the impression is that they don't want to know, but flutter like butterflies on the tops.

– Maybe it's not necessary for everyone to dig into complex matters? – I tried to try on the role of a lawyer. – That is why you are aksakals-academicians. Ideas are from you, and promotion is behind them...

But my interlocutors did not agree. According to them, the punchy boys who find themselves in power or next to it, back up their arguments with the arguments of the same competitors who got rich overnight. They do not skimp on ritual words about the interests of the state, the support of science and the availability of medicines. But in fact, they push through decisions solely for their own benefit.

For example, we are persistently taught to think that the development of new drugs in the West is insanely expensive. What for? To show: we are noticeably cheaper. And they call the numbers: there – up to 1.5-2 billion dollars per drug, we can do it for 500 million. Just give me some money.

– I understand where they come from and for what purpose they give such figures, – says Academician Seredenin. – In fact, it takes 100-150 for scientific research to identify a promising molecule, and 200-250 million for production costs. And everything else is clinical trials and marketing around the world.

In other words, developers and potential customers of such drugs want not only to receive "starting" money for research, but also to ensure large-scale business promotion, including explicit and implicit advertising of a new drug.

Live resectionAny comparison, as you know, is lame.

But the experiment done with our pharmaceutical (and not only) industry can be described in terms that have long been used in pharmacology.

Wanting to test something new or to test the effect of some variables, they usually start with tests in a test tube - on fragments of biological material, living or already dead. In Latin – in vitro, that is, "in glass".

There is another way – to simulate on a computer (now it is called in silico), calculate the steps and evaluate the possible result in order to predict the consequences.

Back in the early 90s, experiments with Russian pharmaceuticals began immediately in vivo - live and live. She was dismembered, kept half-starved, thrown from one resector to another, teased with the smells of abroad, not letting the reflexes that were discovered by Academician Pavlov fade away...

Now, in hindsight, when there is practically no living, and even more viable, they are trying to set up, depicting activity and concern for state interests, local experiments in vitro – on dismembered, convulsed fragments of a once unified organism. Or even on frankly dead material.

And at the same time, cynically realizing that there is no prospect in the antediluvian test tubes of academicians and elderly head teachers, they raise the phraseology and methods in silico to the shield and take them at the ready. Although much more often – only phraseology. Computer modeling and simulation of biological processes that find application in modern pharmacology are ready to declare almost a panacea for this science and the only chance to revive pharmaceuticals as an industry in Russia. On the same instrumental and methodological "basis" speculative forecasts and variable scenarios are generated, how and in what directions "Big Pharma" will develop and what Russia may fall from there.

With all due respect to information technology, marketing, franchising, rebranding and other market realities, such a foundation is clearly too thin for the development strategy of the Russian pharmaceutical industry and new federal target programs, where the state is offered to invest heavily.

In this regard, an important and extremely necessary cementing agent could be the adoption of a new federal law "On the turnover of medicines" – this was specifically emphasized by the President of Russia in his Message to the Federal Assembly. The fact that a difficult fate awaits this bill, we spoke frankly with the director of the Department for the Development of the pharmaceutical market and the market of medical Equipment of the Ministry of Health and Social Development, Diana Mikhailova, shortly after the text was sent to ministries and departments and posted in open access on the Internet.

The diagnosis is interrogativeTo understand where we are, how and why we ended up here and which way to move on, we need to answer three consecutive questions.

First and foremost

What is our goal: a healthy person and, therefore, prevention, prevention of diseases – with an emphasis on promoting a healthy lifestyle and targeted use of all previous experience and new achievements of world pharmacy? Or a sea of bottled medicines from a thousand and one manufacturers for the treatment of all already known and newfangled ailments?

The Concept of the State Drug Policy could help determine the answer to this question.

The second, resulting from the first

Are we ready to admit that the laws of the free market in the field of drug provision, combined with the principle of accessibility of medical care and the course towards the creation of a welfare state, require adequate mechanisms of state regulation and transparent control by society and its democratic institutions?

This requires a flexible, but not corrupt law "On the turnover of medicines", which, among other things, would regulate advertising in this area.

The third, arising from the first and second

Do we need to revive the domestic pharmaceutical industry on the scale that existed on the eve of the collapse of the USSR – with dozens of technologically backward enterprises, a relatively narrow range of products and one directive management center?

Or, recognizing the thesis of the need to ensure the "drug independence" of the state as a vestige of the "cold war", are we ready to open the borders for the free import of missing drugs and their substances, and we ourselves wish to focus on those market segments where Russian developers have retained or are opening promising opportunities?

This is what the "Strategy..." should be aimed at.

However, there are questions about what is declared in it. The business that its developers rely on will rush primarily to those drugs that sell well. And who will deal with orphan, or so-called "orphan" drugs? The demand for them is limited, but they are extremely necessary, because they are conditioned by the vital indications of very specific patients.

Personnel: 4-5 thousand specialists of the new generation by 2015. Who will take care and place an order for their preparation? Where will they get teachers and scientists-mentors for this? Where are the guarantees that in 5-6 years such graduates will not be lured away by Western pharmaceutical companies "localized" in our market?

How can we still ensure that the innovation market is fueled with fresh ideas? If you don't create a mechanism for investing in fundamental science, where will pharmacists get original ideas and developments? Its own, Russian "unfinished" has already been cleaned up – everything that is more or less suitable for use has been bought in academic and departmental research institutes. And in the West, they are unlikely to sell us something really worthwhile for cheap. Except on the principle: for those, God, that we are no longer fit...

Through which such channels will we establish exports? After all, in fact, a single principle is being implemented - "technology in exchange for the market." As a one–way street (to our market) - it is clear. But is it acceptable? And to what extent? Export only to third world countries? So there we will meet the same competition – with the same companies that broke through to us. And if we enter into an alliance with 2-3 of the largest of them and under their flag promote something produced on our territory according to the patterns of these pharmaceutical monopolists across the Russian borders? So where, in this case, is the reason for inflating the cheeks – they say, we are exporters? What is our valor? In cheap labor?

The statement that the pharmaceutical market and the volume of sales of medicines will increase exponentially can be justified only if we completely stop paying attention to the prevention of diseases, and we will deal exclusively with the treatment of sores and cultivate the fashion for healing with expensive – innovative – drugs, and we will ridicule proven medicines, including traditional medicine.

The development of high-tech medical care as an inevitable consequence of technological progress and a derivative of the development of science cannot and should not be an excuse for the automatic rise in the cost of drug provision and non-stop price increases for all or individual groups of drugs.

With the help of what levers and mechanisms to ensure control in this area? How to create healthy competition in the pharmaceutical market? And can the now proposed "Strategy..." become the only possible strategy for healing the industry?

In the near future, we will gather our Expert Council in the "RG". And your comments can already be sent to the address yemel@rg.ru

Portal "Eternal youth" http://vechnayamolodost.ru19.11.2009