Paper biotechnology

Two pictures from the same exhibition – and both in a minor.

Picture #1:
Thoughts about BiotechVladimir Sychev, STRF.ru
On October 15, parliamentary hearings were held in the State Duma "On improving the legislative support of the biotechnological industry".

The purpose of the hearing was to discuss measures to change the current laws governing Russian biotech.

The idea of holding this event – the first in the last ten years – belonged to the Duma Committee on Industry and the Ovchinnikov Society of Biotechnologists. State Duma deputies, heads of research centers, and representatives of biotech companies gathered on Okhotny Ryad.

Biotechnologies are one of the most important pillars of the innovation economy, along with nano– and information technologies. In combination with pharmaceuticals, the bioindustry ranks third in terms of capitalization among the leading sectors of the world economy, second only to banking and oil and gas. In the European Union, the turnover of the bioeconomy sector, which is based on biotechnologies, in 2008 amounted to over 1.5 trillion euros, it employs about 10 percent of the able-bodied population.

The USA, the European Union, China, India, Japan, Brazil and many other states consider biotechnologies as a key direction of their development and are intensively developing the biotechnological industry by adopting appropriate national programs, developing a legislative framework, providing the necessary economic preferences for their bioindustry.

Biotechnologies are considered to be one of the priority areas for the development of the innovative economy of Russia. This is also noted in the Concept of Long-term socio-economic Development of the Russian Federation until 2020.

At first glance, attention is paid to Russian biotech: it is constantly mentioned in a number of industries that can ensure the innovative future of the country. That's just the feeling that our biotechnologies are assigned to the main directions based on global trends, in reality still being in a state of stagnation. Moreover, Russian biotech is becoming increasingly uncompetitive – as on a turn, not only China and India, but also Poland, the Czech Republic, and the Baltic countries have already bypassed our country in terms of the growth of volumes of biotechnological products over the past few years.

"Russia is the only major country in which there is no unified program for the development of biotechnologies," explained Raif Vasilov, president of the Society of Biotechnologists of Russia. – The current state of the biotechnology industry in Russia, the lack of a long–term strategy for its development and a single regulatory body is a blatant anomaly. There is a lack of proper coordination and management of this most important area of activity at the national level. Within the framework of existing laws, there are no norms that would ensure systemic regulation of the biotechnology industry. Because of this, a pessimistic, inertial scenario for the development of our biotech is being implemented now."

We must pay tribute to the Society of Biotechnologists: this organization was the only one that at one time proposed a National program for the development of Biotechnology in the Russian Federation for 2006-2015, and now has initiated the creation of a Strategy for the development of biotechnology in the Russian Federation until 2020.

The strategy of biotechnology development, as explained by Raif Vasilov, correlates with the Concept of socio-economic development of the Russian Federation until 2020. The final revision of the document will be presented in December this year at the second All-Russian meeting of employees of the biotechnology industry.

Indeed, now the development of biotechnologies in our country is not regulated by a single document. Separate mentions of biotechnologies, of course, are contained in some federal and regional programs. That's just the fragmentary nature of their inclusion, without having a systematic approach, does not allow us to expect a serious change in the situation in this direction.

However, there is one (and fundamentally important) exception from the general picture of the state of domestic biotechnologies, which has really become the object of state attention. We are talking about the strategy for the development of the pharmaceutical industry in Russia until 2020, which was described in detail from the rostrum by Sergey Tsyb, Director of the Department of Chemical and Technological Complex and Bioengineering Technologies of the Ministry of Industry and Trade. "Russia is quite attractive for investors in terms of market volume," Sergey Tsyb said. "The global crisis has actually spurred the global pharma. Now there is a contraction of the world's largest markets, the merger of large companies, the migration of production capacities. There are also certain global trends in changing the structure of morbidity: new diseases lead to a change in priorities in the field of drug development. We are obliged to take such trends into account when developing strategic documents. Paradoxically, but all this has left its mark on the development of the domestic pharmaceutical industry, opening up new opportunities for Russia."

Indeed, biopharmaceuticals are the main component of biotechnologies. But the rest of the biotechnology sectors should not remain in the shadow of the main direction. The experts who spoke next applied them in large strokes to the overall, generally bleak, picture.

Corresponding Member of the Russian Academy of Sciences Vladimir Debabov, scientific director of the SSC GosNIIgenetics outlined the state of affairs in another area of biotech: "In the near future, a fourth of the chemical industry in developed countries will be associated with so-called "white" industrial biotechnologies. "White" biotechnologies are primarily factories. But we don't actually have them. In recent years, the situation has deteriorated so much that if in 2005 it was still possible to talk about the resuscitation of industrial biotech, now we are talking about its creation from scratch. What could be the advantage of Russia? For example, we can produce large–tonnage products - for example, wood hydrolysate. But do not think that small companies will launch "white" biotechnologies – the state should do it."

According to Sergey Kryukov, General Director of Rosagrobioprom, agriculture and veterinary medicine face the same problems as in medical biotechnologies. There is an expansion of imported drugs, primarily vaccines. There is no single program to combat diseases common to humans and animals – for example, rabies and brucellosis. And the costs for the purchase of drugs allocated from the federal budget do not coincide with regional budgets. And large biotech centers, such as factories in Obolensk and Pokrov, have already turned into separate enterprises that do not work for the country as a whole.

And although the main topic of the parliamentary hearings related to the improvement of laws regulating biotechnology, there were not very many real proposals. They mainly concerned legislative measures to stimulate the work of biotechnological organizations, exemption from customs duties of imported equipment, mandatory compliance by manufacturers with GMP standards, as well as the preparation of a Federal law on the production of biofuels.

The actual discussion of initiatives for legislators did not work out – the further, the more reports were made on the actual presentations of projects of individual research centers and laboratories, and the parliamentary hall gradually emptied.

Concluding the hearing, Anatoly Gubkin, Chairman of the Expert Council on the Biotechnology and Pharmaceutical Industry of the Duma, actually urged not to have any illusions about rapid changes for the better:

"If all biotechnologies are reduced only to pharmaceuticals, then in this case there is a good chance not to carry out a strategy through the government – they will tell us that there is one strategy, but there is no need to produce mountains of papers. But it will not be possible to pass laws on biotechnologies without the support of the government. Of course, we will prepare documents, collect them, send them to the government, but this process will not be fast, because different areas of biotechnology may well fall into the sphere of interests of different ministries."

If so, then the foreseeable future of our biotechnologies does not look rosy. The strategy of their development (and this is obvious due to the heterogeneity of the structure of the biotech sector itself) will be more complicated than the strategy of the development of the pharmaceutical industry, which a number of experts see not without flaws. But while the new "bio-strategy" is being prepared, some areas of domestic biotech may simply die out, and Russia will see new countries ahead of it that have overtaken it.

Picture #2:
How to stop a color bio-leak?Olga Orlova, Radio Liberty
Parliamentary hearings were held in the State Duma on the topic of improving laws regulating biotechnology.

Officials, deputies, scientists, industrialists discussed whether it was possible to make it so that it would not be dangerous and even profitable to engage in biotechnology in Russia.

Biotechnologies using living cells are conditionally divided by color by specialists. "Red" technologies are called related to human health – obtaining medicines, dietary supplements, vaccines. "Green" biotechnologies are used in agriculture – new animal species, new plant varieties, feed, genetically modified organisms (GMOs), biofuels. "White" is widely used in industry – from the production of bioplastics, amino acids to various purification methods. There are also "blue" applying marine organisms.

Today it is one of the most dynamically developing areas of high technology. The global biotechnology market is estimated at $ 200 billion, of which no more than 15 billion rubles are produced in Russia – that is, less than 0.3%. Although Russia was one of the world leaders until the early 90s, its share in this area was 5% of the world market. Now some types of biotechnologies in the country have come to naught. It is enough to recall how in the 90s the destruction of pharmacology occurred, new drugs were no longer created and produced.

The conversation that the Russian biotech needs resuscitation has been going on for about ten years. There is a Society of Biotechnologists in the country. Biotechnologies are included in the list of priority areas for the development of science and technology. Last year, the state corporation "Biotechnologies" was created. And the country's leaders have already started talking about the fact that in the next 5-10 years Russia should once again become one of the biotech leaders. And the case is not moving from a dead point.

Experts point to laws that paralyze every link in a complex biotechnological chain – from a scientist's experiment in the laboratory to the release of a finished product at the enterprise. A few scientists decide at their own risk to carry biomaterials for research secretly across the border. If we are talking about large-scale laboratory studies, then official transportation through customs takes so much time that biomaterials requiring special conditions of transportation and storage die right at the border. Another example. If scientists need a special line of mice for preclinical testing of a new drug, it is impossible to buy these animals abroad. An extensive list of absurdities was heard in the parliamentary hall, which the creators and manufacturers of biotechnologies rest against. And now the participants of the hearings have prepared proposals on how to legally facilitate the birth of biotechnologies. Alexander Golikov, one of the developers of the Law on Genetic Engineering, as well as the Cartagena Protocol on Biosafety, an expert of UNEP (UN Environment Program), evaluates them in an interview with Radio Liberty:

– Today we listened to the right words about how deputies support the development of biotechnologies in Russia. But, nevertheless, for more than a year, the federal law that regulates genetically modified organisms and other types of "green" biotechnologies has been lying motionless in the Duma. It passed public hearings, it was adopted in the first reading, it was approved by ministries. Then he returned to the State Duma and was stuck there for a year.

– Most of the speakers in the State Duma spoke about the need for a federal program. Is it really the state that should play a decisive role in the revival of biotechnologies?

– It all depends on the specific state. I think in the USA, for example, they would be very surprised by such a decision. Especially the employees of their biotech companies, which are entirely private there. The state only provides them with the opportunity to work and makes sure that they do not do outrages. The state is engaged in the regulation and control of security.

– What priority measures, in your opinion, should be taken?– We need to create a system that would regulate biotechnologies.

The entire scheme of state regulation in this area should be spelled out from beginning to end. It is prescribed so that a completely independent person, who wants to produce a biotechnological product, knows how, under what conditions and where it will be considered. What it will cost him, who is responsible for it, and where in the end this product can be put.

According to Alexander Golikov, until the responsibility and protection of scientists and developers is legally prescribed, biotechnologies will be exported from Russia at the earliest stage – the idea stage:

– Scientific biotechnologies are less research for the sake of research and more applied work aimed at a specific product. They can be scooped up with a spoon, put in your mouth, spread on a sore spot. This product needs to be made. And in Russia today, when a person starts doing it, he does not know whether it should be done or not. Without a legal support system, there is a possibility that when he produces a biotechnological product, it will either not be necessary, or he may be imprisoned for it when it turns out that all his actions are prohibited. I think that's why there is the biggest brain drain in the applied fields of biology. After all, people who have received a good education, have worked with people who have taught them a lot, are beginning to understand exactly what they want to do. And as soon as they have ideas, they go abroad to implement them.

One of the participants in the parliamentary discussion, Alexander, head of the laboratory at the Institute of Bioorganic Chemistry named after M.M.Shemyakin and Yu.A.Ovchinnikov, recalled the story of how two employees of their institute, transporting biomaterials, were detained by the security service at the railway station in Britain. However, it took 30 minutes to clarify the circumstances of what, where and why the scientists were taken. No one knows how long it would take in a similar situation in Russia today. But the fact that Russia should become a biotech leader is already known.

Portal "Eternal youth" http://vechnayamolodost.ru19.10.2009