A meeting on issues of innovative development of the healthcare sector
Dmitry Medvedev: Good afternoon, colleagues. We are holding this substantial meeting today on issues of innovative development of the healthcare sector. And this meeting is also quite symbolic. I would like to note openly that I am very happy to be here with you, to discuss specific issues, and also because the first building of our innovation centre has been completed.
As you can see, this is a modern building. To my mind, it should match the spirit of Skolkovo itself. It is precisely here that the principles for establishing the innovation centre and a unique ecosystem will be tested. At any rate, Skolkovo is now, to some extent, a flagship, with regard to the development of architectural projects, urban-development and technological solutions. Incidentally, Russian architects were involved in one of such events, a biennale event, and scored high marks. Of course, I am very pleased to say this.
And now I would like to discuss our main issue. Today, we are talking about medical innovations. The development of medical technologies has a rather substantial multiplier effect for the economy. And the most important question is whether Russia will develop advanced technologies, modern equipment and effective medications. Naturally, the effectiveness of general treatment methods and, consequently, the health and lives of Russian citizens, depend on this. This is because specialists believe that modern biomedical technologies make it possible to create the real pre-requisites for increasing the average life expectancy by 30 years. I don’t know whether such estimates are well-justified, but they seem quite nice. It would be great if this happened in our lifetime.
Analysts estimate the 2011 Russian pharmaceutical market to stand at an impressive 670 billion roubles. At the same time, imported medications accounted for 76% of total sales. In 2011, 18 medications were registered in Russia, including Neovasculgen and Perchloson, which rank among the so-called breakthrough medications. It is common knowledge that relatively few innovative medications (10, 15, 20) are registered annually worldwide. It is heartening news that, this year, the Russian authorities have issued practically 2,800 patents for various medical inventions. Russian companies and Russian individuals hold 2,000 patents, and the remaining 770 patents belong to foreign companies and individuals.
Our task is to create favourable conditions for the development of innovative products and technologies and for their introduction into the national healthcare system. It should be admitted that the state channels substantial investment (at least, by Russian standards) into this system. No matter what anyone says, almost ten billion worth of budgetary funding has been allocated for this purpose in 2011-2012 in line with several federal targeted programmes. In addition, the Ministry of Healthcare has allocated 26 billion roubles over the same period for financing research at affiliated higher educational institutions, as well as for R&D projects at institutes, at the Federal Medical-Biological Agency (FMBA) and at the Russian Academy of Sciences.
Our commission on modernisation and technological development of the economy has also initiated the implementation of the five most promising projects on medical equipment and pharmaceuticals. Their total funding is about nine billion roubles, and I’m pleased to say that 80% of this come from extra-budget sources. Ten Russian patents and several foreign ones have been obtained in this sphere; production has been launched of a number of medicines, and dozens of new medicines are undergoing development and state registration.
The development of the potential of domestic universities is also an important and very sensitive issue. Cooperation between universities and industrial enterprises, and measures to attract leading specialists to universities, have been the most successful measures. The Government has allocated more than 3.3 billion roubles towards medical equipment and pharmaceuticals in 2010-2012. We will continue funding these projects. The Government will invest more than one billion roubles into the programme for the development of national research universities in this area.
We have done well with small innovative companies at universities – at any rate, a hundred registered companies are already producing medical equipment and pharmaceuticals. I hope they will be successful as well.
The bio cluster in Skolkovo has already been formed to include 156 participants, of which 28 have received grants worth about 1.5 billion roubles. The resident companies can appreciate the services operating in Skolkovo at the moment. This applies, for one, to an opportunity to apply for the registration of patents – 11 patents have been registered in Russia, two under the Patent Cooperation Treaty and another one on the Eurasian Patent Department.
Needless to say, much will depend on the financial and development institutions that are now addressing these projects. I’m referring to VEB, the Russian Venture Company, Rosnano and the Fund for Assistance to Small Technical Research Companies. Total investment in projects on medical equipment and pharmaceuticals has already reached a solid 41 billion roubles.
As you can see, the funding is already fairly impressive. Obviously, there is no limit to perfection and more funds will always be required, but this is a good amount of money anyway. What isn't so good is that the development institutes often overlap with each other for lack of proper coordination, so there is much room for improvement for them.
The mechanisms and instruments I’ve mentioned should form an integrated system of planning and management. I hope this will happen, including for such a sensitive issue as intellectual property. To match modern standards of innovation, we should develop infrastructure, establish modern laboratories, research and information centres (I hope Skolkovo will have all of these), encourage entrepreneurs that focus on new technology, and attract the best scientists and engineers for resolving these tasks. These are our plans. I hope that eventually they will help many people get rid of diseases and simply improve their living standards.
Let’s continue our discussion of the innovative development of medicine. I’d like to give the floor to our colleagues. Ms Skvortsova, go ahead please.
Veronika Skvortsova (Minister of Health): Thank you, Mr Medvedev. Ladies and gentlemen, in the next decade industrialised countries will start forming the technological base for economic systems, which would use the latest achievements in biomedicine and information and nano technology in many fields, including healthcare. Go back to the previous slide, please. This will make it possible to considerably change the parameters of health and the potentialities of the human body, and will turn healthcare into an industry producing an in-demand product by integrating fundamental, clinical and technological competence. Considering the urgency of ethical issues related to biomedicine, it is extremely important to note the longer biomedical research process that is required by the need to include translational medicine. It is also essential to introduce the results of biomedical research based on the procedures and standards of medical aid that guarantees its security and quality.
Next slide, please. In the last 50 years the development of biomedicine produced a highly specific and effective personal approach. According to forecasts, the next 50 years will see a breakthrough in the efforts to counter dangerous vascular, contagious and neuro-degenerative diseases. As Mr Medvedev mentioned, this may substantially increase a person's life span – by more than 30 years – and change the socio-economic and technological paradigms. There is no doubt that biomedicine is one the main factors in the development of civilisation as a whole.
Next slide, please. In the last few years biomedicine has registered rapid development, largely owing to the presidential commission on modernisation and technological development, which has made it possible to create and launch 27 biomedical projects. For the first time in many years, 18 new drugs were registered in 2011, as Mr Medvedev mentioned.
Next slide please. Russian biomedicine still has substantial research potential. Research centres and higher learning institutions reporting to the Ministry of Healthcare alone employ over 19,000 researchers and operate more than 5,270 laboratories. However, young employees under the age of 39 make up only 25% of the total workforce. Top-rated laboratories make up a paltry 3.8% of the total number of labs in Russia and 2.1% according to international rankings.
Next slide please. Unfortunately, if you look at Russia’s biomedical technical capabilities with an unbiased eye, it becomes clear that Russia is not among the leading countries. Primarily, this has to do with the lack of certain critical biomedical technologies (shown on the slide) and with few or no basic biomedical production techniques.
Russia ranks fourth in the world in terms of the number of scientists (in the biomedical sphere), ninth in terms of research funding and 15th in terms of the number of publications. Notably, in terms of the publication activity, Russia is not among the top twenty countries. Thus, it begs the important conclusion that funding is an important but not the decisive factor behind the development of the biomedical research.
Next slide please. In 2011, the Ministry of Healthcare, the Ministry of Economic Development, the Ministry of Education, the Russian Academy of Medical Sciences, Russian Academy of Sciences, Moscow State University, Skolkovo and other members of the scientific community put all the know-how in the biomedical field available in Russia together in a single technological platform. This made it possible to create 14 specific biomedical platforms that are instrumental in prioritising work and organising medical research in specific areas.
Next slide please. Analysis conducted within each platform and between platforms led to the conclusion on the uneven development of different areas of biomedicine in our country and made it possible to single out the most promising areas in the short run. In 2012, we launched a pilot project to implement four of 14 platforms, including cancer research, infectious and cardiovascular diseases and promoting prevention.
Next slide please. In addition to encouraging pro-active studies and unlimited scientific research initiated by the Ministry of Education and development institutions, the platforms make it possible to develop specific technologies within each platform and develop integrated research programmes designed to create advanced biotech and biomedical products that require a coordinated effort of a large number of subcontractors in different areas of medicine and other industries.
Next slide please. An in-depth analysis of all biomedical competencies available in Russia revealed several areas that are ready for launching breakthrough biomedical products in the medium term. This includes new cell products for tissue repair and function rehabilitation, including the brain; new classes of regenerative medicine drugs and methods for targeted delivery of drugs and cell products; preventive technologies; a new generation of vaccines; a new class of medicines based on recombinant therapeutic antibodies, as well as neurocognitive and neurocomputing technologies.
Next slide please. Six of these projects may lead to developing prototypes of unmatched innovative products in 2016 already. I would like to briefly describe them. The issue is about being able to identify tumor markers based on complex molecular and genetic technology. This may make Russia the first country where the effective molecular diagnosis and monitoring of malignant tumours long before their clinical manifestations appear will become available nationwide.
Second, creating modular nanotransporters to perform targeted delivery of anti-cancer compounds and the ability to detect metastatic cells and turn them off using custom-made compounds. In fact, we are talking about curing currently incurable malignancies, such as carcinoma, melanoma or glioblastoma.
We are talking about creating an innovative poly-strain influenza drug based on the universal blockade of viral glycopeptides. The issue is also about creating genetically engineered subunit vaccine against tuberculosis, including for patients with altered immunity and innovative combined cell products for tissue repair and restoring bodily functions, including tissues made from patients’ own cells (bone, cartilage, skin, cornea), as well creating organs using patients’ own cells (esophagus, trachea, liver, and urethra) deserve special attention.
Notably, the Ministry of Healthcare completed revision of the federal law, On the Circulation of Biomedical Cell Products, without which it is impossible to use cellular and tissue products in medical practice. The bill will soon be submitted to the Government.
Also importantly, this area of research is an example of a coordinated development of not only medicine but also prototyping and material engineering, as well as creating biocompatible and biodegradable materials.
Neurocomputing interface technology is a similarly complex project that will bring about breakthrough innovative products by 2016. This technology makes it possible to control specific areas of brain and create a neurocommunication system for patients with limited mobility and speech disabilities, including eye-controlled keyboard typing and remote computer control. It also makes controlling exogenous manipulators and exogenous prosthetic devices possible.
Next slide please. To ensure continuous innovation and the launching of prototypes into mass production, we need to build translational medicine, particularly its pre-clinical part, which is new to Russia. Preclinical translational medicine cuts the risk of using ineffective or unsafe products in medical practice and clinical research by ten times and significantly reduces the huge spending that normally goes into clinical research. In 2013-2015, we will build preclinical translational centres in Skolkovo, four federal centres and 19 research and education clusters at leading medical universities, which will bring many new specialists to the biomedical field. Translational centres will be established at major federal research and educational institutions that are licensed for medical practice. We will also establish a system of routine clinical research protocols.
Next slide please. In addition to developing the infrastructure, we will need to address the shortage of the technically-proficient medical research personnel, increase the attractiveness of Russian medical science for investors, and increase the share of pharmaceutical products made in accordance with international standards, which is the goal of the federal programme for the development of pharmaceutical and medical industries. We will need to resolve this by 2014. In addition, we will need to overcome departmental dissociation (next slide please), which leads to fragmented funding of medical research and a lack of common priorities or shared responsibility for the results. Such a system is fundamentally different from the optimal system of innovative biomedical development shown on the slide, which significantly reduces the impact of research, and (next slide please) distorts and deforms the R&D cycle of biomedical research and more than doubles its duration.
Next slide please. In 2012, the Ministry of Healthcare, in conjunction with other federal authorities and representatives of the scientific community, is drafting a strategy for the development of biomedical research in Russia. The strategy will be submitted to the Russian Government in December. The basic building blocks of the strategy include establishing common government priorities in the biomedicine, building an environment conducive to innovation, strengthening scientific schools by creating research and education clusters at 12 leading universities, technically upgrading the research infrastructure and developing translational medicine, introducing targeted funding of medical research projects on the basis of the necessary institutional reforms, creating an intellectual property fund for managing innovation processes and effectively capitalising on new knowledge and technologies and involving businesses in all phases of the process, including small businesses and university biomedical clusters.
Next slide please. The implementation of just four of the following six breakthrough biomedical projects will bring significant economic benefits. Reduced mortality and morbidity will save over 106 billion roubles in budget funds yearly.
Next slide please. A lot of work was done in Russia in 2011-2012 by ministries and industries, which got everything ready for launching a set of measures beginning in 2013. We hope that this will not only reduce the gap between Russia and the most advanced in terms of technology and biomedical research countries, but also help achieve good results by 2020. Thank you.
Dmitry Medvedev: Thank you, Ms Skvortsova. I turn the floor over to the Minister of Industry and Trade Denis Manturov. Please go ahead.
Denis Manturov: Mr Medvedev and colleagues, the key goal of the pharmaceutical and medical industry is to supply the healthcare system with modern and effective drugs and medical products. Therefore, the first stage of the industry’s development focuses on the modernisation of the production process and manufacturing essential drugs and medical products in priority areas, especially through import substitution. This is why in the first stage of industrial development the emphasis is on modernising production and manufacturing medicines on the list of vital drugs as well as priority medical products, primarily to replace imports.
In the second stage we must transition industry to a model of sustainable innovative development with rising export potential. In so doing, we must orient our industrial policy to world trends of technological development. It will take about 10 years to develop and commercialise innovative products in this industry and for this reason it is very important to introduce innovative products during the modernisation process rather than after it. This is why the Government is already taking part in the funding of developments that are important throughout the world.
The second slide shows the map of the 50 most rapidly developing…
Dmitry Medvedev: This chart is so clear! It makes you dizzy.
Denis Manturov: This is an original slide that we’ve simply translated from English into Russian…
Dmitry Medvedev: That hasn’t made it any clearer.
Denis Manturov: …that was prepared by the international analytical company Frost & Sullivan. It shows the full range of connections between different fields of study and technological sectors, and these connections are essential for the manufacture of new products.
To transition to innovative development, we must use the potential of a broad range of industries – from composite materials and fine chemicals to cutting-edge information technology and robotics. We need a comprehensive interdisciplinary approach, and the effects that we can achieve will also embrace many industries. The production of pharmaceuticals and medical devices may act as a catalyst for the development of new industries.
In the last 10 years, the world’s pharmaceutical industry has been going through a major change triggered by the global redistribution of resources and competences. New countries and whole regions are getting involved in the development and manufacture of innovative products; the competition for customers is growing. New economies are becoming actively involved in technological chains, creating national infrastructure not as an isolated thing but as part of the global industry. Unfortunately, Russia is not yet playing an active role in this process.
Our current task is to create the technological foundation and upgrade the capacity of the pharmaceutical industry. That said, it is already clear that the goal of the second stage is to integrate the Russian industry into the world’s technological and production complex – this is a very important strategic objective. Its implementation will not only provide us with a permanent flow of innovations but will also considerably increase the share of our industry in the world market, primarily in high-tech sectors linked with new materials, preparations and technology. Obviously, neither Russia nor any other country can develop an industry with 100% competence. Therefore, in striving for integration we must clearly define our long-term priorities and directions for building up our capacity. We must also make active use of our industry and foreign technology, which can helps us achieve impressive results in healthcare right now. We can reach this goal if we resolve two strategic tasks – intensify a broad range of industries and integrate into global technological processes. In this way we’ll extend the notion of industry and influence not only the development of some product but build the whole cycle from R&D to the introduction of innovative preparations.
Along with budget funding, the development institutes are now playing an important role in building up the innovative potential of the pharmaceutical industry. You have already mentioned these institutes, so I won’t dwell on them.
Business is destined to play a much bigger role in this respect. The industry itself will generate the bulk of investment. Corporate funds and the resources raised by companies from the open market will become the main source of investment in this industry. We are resolving a number of issues with government support to reach this goal. Russian and international companies are establishing new industrial enterprises and forming infrastructure facilities like clinical test centres and national laboratories. They are mastering the production of key components and transferring projects to Russia. The innovative model that we plan to have by 2020 includes the involvement of business in the R&D process. Total investment in the innovative segment of the pharmaceutical industry is estimated to reach 150 billion roubles by 2020, out of which 70 billion are budget funds under the relevant targeted programme.
The successful introduction of innovations depends on the cooperation of R&D companies with medical experts. In modern medicine it is doctors who determine the directions of the advancement of medical products and methods of diagnosis and treatment. In the United States, for one, 22% of surgeons take part in R&D. So, one of our tasks is to maintain cooperation with the medical community. We must build an integrated system of cooperation between medical experts, researchers, engineers and, last but not the least, the business community.
Research and production clusters are now being set up in many regions, for instance, the Moscow Region, the Kaluga Region, the Leningrad Region and the Tomsk Region. Leading universities and research institutes with potential for development have been chosen as the main growth points. It is impossible to reach the ambitious goals of innovative development without adequate personnel. We as the government and the business community realise this in full. The industry is starting to actively cooperate with universities with a view to training new personnel to resolve the pressing issues of modernisation and innovative development. Industrial and R&D organisations are creating corporate chairs at leading universities, establishing testing and training centres and implementing a corporate programme for personnel training at universities. The proposed series of objectives and tasks for moving to the innovative path of development requires adequate regulatory support. We have resolved many tasks on regulating the production of preparations or are about to complete them.
Harmonisation of national and international norms and standards is a strategic objective. We are already working on this with the Eurasian Economic Commission.
In conclusion, I’d like to ask you, Mr Medvedev, to make a number of instructions based on the proposals that I’d like to formulate, including intellectual property, which you’ve mentioned. We’d like to draft a proposal on improving the regulatory framework that would determine the functioning of rights of property to the results of intellectual activities. In part, this proposal should provide for an opportunity to transfer exclusive rights to intellectual property to companies established by budget-funded, research and state educational institutions. We have already discussed and come to terms on this issue with the ministers of education and health.
Dmitry Medvedev: So, to whom are the rights transferred in this case?
Denis Manturov: This proposal envisages the transfer of intellectual property rights to subsidiaries of educational institutions that will set them on a commercial footing. I’m primarily referring to Law No. 217, which was adopted in 2009. This law regulates this kind of activities but seriously restricts the rights.
We also have a proposal to lift restrictions on the share of budget-funded, research and government educational institutions in the capital of established businesses. Today, this share is limited to 25% and does not allow third persons – investors – to take an active part in these activities.
And, third, we plan to draft a proposal to set up technology transfer offices at leading universities and research institutions. We don’t have to reinvent the wheel here; our foreign colleagues – the United States and Europe, for one – have already travelled down this road. This instrument is very efficient.
Thank you for attention.
Dmitry Medvedev: Thank you. Now, Mr Kirpichnikov, the dean of the Biology Department at Lomonosov Moscow State University, please go ahead.
Mikhail Kirpichnikov: Thank you very much, Mr Medvedev.
Mr Medvedev, colleagues. We are essentially discussing the problem of putting scientific knowledge to practical use, for medical practices. Therefore, with your permission, I’ll start with the main problem worldwide (this is not a Russian problem, this is a global problem), this is a temporal gap, I stress, and a mental gap between the striking achievements of the science of life in the past fifty years, and their use in medical practices. Here is just one example. The understanding of this gap has led to the creation of the National Centre of Translational Medicine, as part of the National Institute of Health, in December, 2011. This gap has objective causes: clinical and preclinical tests, the necessary registration, the moral and ethical problems that Ms Skvortsova mentioned; as well as some subjective causes (which are especially strong in Russia) – that is, personnel training. It is especially important to emphasise the occasional mental unpreparedness to grasp the achievements of fundamental science, the lack of adequate coordination in the sector of biomedical research. Indeed, special efforts are needed to translate fundamental research into practice. Incomplete or imperfect laws create an obstacle. Ms Skvortsova mentioned this in part when she spoke about transplantation medicine and cell technology in regenerative medicine. And, of course, everybody has always been complaining about inadequate funding. But in my view it will be necessary to make haste with funding only after we have worked out the organisation and logistics of the process. So here is my first proposal: to create, within the system of the Ministry of Healthcare, an organisation or a division similar to the National Institute of Health. To date this is probably the most efficient system worldwide that translates the achievements of fundamental science into practice. I suggest that this system should include the following basic functions: first, budget formation and distribution; second, formation of priorities and programmes; and third, expert review of projects, programmes and proposals for infrastructure formation. I want to underscore that the last two functions should be carried out with the deciding vote of the best experts of science and business, independent of their departmental affiliation (I mean the choice of priorities and expert reviews).
Meanwhile, in my view, especially at the outset, there is no need to change subordination, let research institutions do their job, otherwise this could lead to an unnecessary conflict of interests, which already exists today. Moreover, because I have cited the example of the United States, the history of the creation of the NIH there was completely different. The funding of NIH’s internal programmes accounts for only 10% of the budget that the NIH spends on its international programmes for universities and so on. But this purely logistical measure makes it possible both to overcome departmental disagreement and avoid a conflict of interests, and also overlapping of functions; it will also optimise the system of tests and registrations and improve logistics on the whole.
As for infrastructure. This slide shows its progression from an idea to the patient. I do not expect any innovations here. I only want to highlight the first position – education – because the mental gap in Russia is mostly associated precisely with education. It is necessary to change a lot in education and bring a medic in the field closer to an expert in fundamental science. And the third line is technological engineering, updating the technology created by science to make it appealing for business.
You see, Russia, if you'll allow me, has always been a nation of Guinness World Records, starting with Cross-eyed Lefty from Tula. However the creation of commercial technology has always been a problem in this country. This problem is not particular to modern Russia; this is just the way it has always been.
Russia has always had problems with its culture of production. And this is precisely what is meant by the line “technological engineering,” which highlights the need for small enterprises that test and develop technologies to hand over these technologies to serious industries.
How is this infrastructure being implemented citing the example of Moscow State University? Education, traditional departments – it is extremely important to increase the motivation of future professionals at this level. Fundamental experts should be more ready and should be closer to practical tasks. On the other hand, it is necessary to develop the interest of practical medics to more fundamental achievements of the life sciences.
Various forms of non-standard, additional education involving “big pharma” are extremely important, and we are engaged in this. We have programmes and separate modules of several lectures that enjoy great success, with such companies as Pfizer, AstraZeneca and Novartis. And again, two lines down, there is the line of technological engineering: here, in the infrastructure section of this programme, we, along with the Ministry of Industry and Trade, are completing a biotechnological business incubator in 2013. This business incubator began under the Ministry of Economic Development, but currently it is part of this programme.
And this will be a very serious innovation: the Centre of Supremacy in the Development of National Medicinal Drugs and Biotechnological Products Based on Genome and Post-Genome Technology. The centre is also being created under the programme of the Ministry of Industry and Trade, and it will include this business incubator. And that is precisely the stage of development for a technology to create such processing lines where companies will take their projects, startups and achievements to the required level.
Then comes preclinical stage – it is no less important but I will not go into it because everybody is talking about it. A clinic is the same thing. The university is a unique place: we have the entire chain, from education to the university clinic, which will probably be commissioned in 2013, at least I hope so. And then the chain involving Farma, where the links are naturally reversible, and the Farma clinic, will fully launch.
What can we do? I only want to say that everything I have said concerning the last two slides has been implemented with substantial assistance from the development institutions – I will not name them, they have been mentioned already. I will add only one (which is the dearest to me) – the Fund for the Development of Small Business, which has supported small businesses in this country for many years, and continues to do so. Recently we have seen the appearance of such infrastructure components as technology platforms. I will say a few words about at least two platforms. The first platform, which is without doubt the main one and which is related to the point of our discussion, is the Medicine of the Future platform, and the second platform is BioTec2030. They possess all the foundations of modern medicine.
For a bit of fun, I will share some examples with you of what is happening in our department. There is a well-known issue – the brain-computer interface. According to Jonathan Wolpaw, this system enables an individual to interact with the world, bypassing nerves and muscles. The right part of this slide shows various uses of this system, which is a separate product. And if we connect a prosthetic appliance to it, we get a specific, different product; and if we connect a robot, we get a third product, if we connect a manipulator we get… and so on. This is the right part of this slide.
I will not distract you here, this is a complicated slide highlighting the essential pattern of the brain-computer interface. The right part highlights two concrete projects that are being implemented here, in our system, as I have said. The first project is the development of a prosthetic hand, conducted jointly with Skolkovo, and a grant under the federal targeted programme from the Ministry of Industry and Trade for an external prosthesis of the knee joint. I have selected very different examples intentionally. These are therapeutic antibodies, which is probably the most universal and most modern therapeutic method to date. All the most serious diseases listed here are in reality treated only with antibodies. This is the mechanism for fighting a disease; this is what these artificially created antibodies are, and it is a very expensive thing. The last slide, the last column: the current market of 30 antibodies accounts for $51 billion. And another 350 antibodies are currently being developed. You see that these figures are colossal.
We have a project on individual therapy of autoimmune diseases; it has just received support at Skolkovo. The scheme shows business organisations that are investing 150 million and 220 million. The project is being conducted by our biological department, the Institute of Bioorganic Chemistry at the Russian Academy of Sciences, by the outstanding Scripps Research Institute in the US (over five Nobel Prize laureates work at this institute, and its president personally participates in the project), the Farmsintez company in St Petersburg and a subsidiary of TEVA (Teva Pharmaceutical Industries) in the US, the world's largest producer of generic drugs.
Here is a quite different project; I am deliberately selecting very different projects. I will introduce a term: microbiome, which refers to an assembly of microorganisms that exist within a human. It turns out that generic research has become possible due to the development of modern methods of sequence analysis.
Genetic research and profiling makes it possible to extremely accurately determine the correlation between different bacterial organisms in patients, depending on stress, diseases and other factors. There may be many thousands of such bacteria. This can be seen using the so-called microbiome-analysis method, which is highlighted in dark blue, which can be used to assess the bacterial environment of a human body, which, as a rule, comprises many thousands of bacteria, and can also be used to diagnose various pathologies and to test people in emergency situations.
The previous slide showed the results of the Mars-500 project, which was implemented by us. The six prospective astronauts involved in the project were placed inside a chamber and subjected to medical checkups during their subsequent recovery process. This method has proved extremely fruitful.
I would like to mention the latest example, which is very interesting. This method is very much in fashion right now and is causing a great deal of discussion. In effect, we assess natural processes, and we use these processes for our own ends. In this case, one can talk about specific methods for delivering medications, or in this case of nano-vaccines using nano-platforms. The left section shows these nano-platforms, including the tobacco mosaic virus. Once it is processed using a very simple and cheap method, the tobacco mosaic virus turns into these nanospheres. Incidentally, Mr Medvedev, this project was implemented by Iosif Atabekov, a Member of the Russian Academy of Sciences, and my department. In 2009, you awarded him the State Prize. In effect, these nano-platforms (nano-spheres) are an extremely convenient method for applying antigens. On the left, you can see the diagram and on the right you can see what the nanosphere coated with antigens looks like. This is what causes the body’s immune response. As a result, it has become possible to prepare the latest generation of vaccines. This process is very cheap, reliable and safe. In fact, the vaccines are manufactured from plants.
In conclusion, I would like to mention one particularly important issue. I will make it very simple because Mr Manturov has essentially already discussed it. I would like to say a few words about the long-awaited Federal Law No 217. We have accumulated some positive experience and see the obstacles that prevent its usage. In the future, universities should be allowed to sell their stakes in small innovative enterprises using the notification procedure. This reflects to a large extent the statements made by Mr Manturov. If someone voices distrust, then we can introduce specific ceilings rather than ask the owners for permission, because this is linked with an extremely lengthy and not always transparent procedure. At the same time, control is always retained during the notification procedure. You can always monitor the situation in case any problems or doubts arise.
Secondly, the concerned parties should be allowed under Law No 217 to make exclusive rights or exclusive licenses for the results of intellectual activity part of the statutory capitals of these small innovative enterprises. Currently only non-exclusive licenses can be contributed. Obviously, strategic investors are not interested in these non-exclusive licenses. And finally, universities should be allowed to reduce or scale down their respective stakes in statutory capital while attracting investment for small innovative enterprises during subsequent rounds. A university stands to gain anyway if the project is successful. At the same time, a venture capitalist has no incentive for working in this field at a time when the proportion of higher educational institutions remains the same. So, this is the third proposal.
Summing up, I would like to note that a concept similar to the NIH philosophy should be introduced at the federal level. Secondly, we need to establish an agency, a prototype version of which in terms of translational medicine probably already exists at the Lomonosov Moscow State University. The focus should be on the education and technological engineering stage. And here is a proposal regarding Federal Law No. 217.
Thank you for your attention.
Dmitry Medvedev: Thank you, Mr Kirpichnikov. I would like to give the floor to our Skolkovo residents, including Mr Werner Cautreels.
Werner Cautreels (CEO/President of Selecta Biosciences) (as translated): Thank you very much. It is a great honour to address this meeting. Here in Skolkovo, I represent the Selecta Biosciences company, which is a leader in its field, and which has also become a Skolkovo resident.
Selecta Biosciences was established at Harvard University. We develop new-generation technologies in the field of immunotherapy. I believe that you are familiar with this terminology. Selecta RUS was established in November 2011 in order to assist the RUSNANO Corporation. We are still in the initial development stage.
What can be said about vaccines? As you know, a vaccine is used in the field of preventive medicine, primarily for treating flu and other diseases. This new technology can help create a universal multi-role vaccine. As a result, it will not be necessary to vaccinate people every year. Vaccines can also treat chronic diseases such as cancer and hepatitis C; and they may also enable us to address other problems. And finally, we can regulate the immune system with the help of these nanoparticles in order to prevent these diseases and to control the immune system, including efforts to control atherosclerosis, diabetes and allergies. This most important aspect is a new trend, which has already been mentioned. We will be able to create the types of vaccines capable of fighting immune systems that are preventing the treatment of these specific diseases.
So, where does this technology come from? This technology includes substantial knowledge in the field of immunology. Charles Landry, one of the scientists who represents the Massachusetts Institute of Technology, as well as others… We develop synthetic viruses in the form of plastic nanoparticles. These plastic pieces comprise all the substances that are part of the virus, and we can make them very simple. They are manufactured using synthetic methods, no fermentation is required, we can produce them quickly in nano-volumes, and the production costs themselves are trivial.
This is a private company and we have very good investors. Up to 2011, we worked with first-class investors from the United States. We drafted a production plan with the assistance of RUSNANO. Right now, we have a very good and responsible investor in RUSNANO. First of all, we would like to develop a nicotine vaccine for smokers. As you know, smoking is a major problem. And I would like to congratulate the Ministry of Industry and Trade because we have received a grant for developing this product. There are plans to conduct various tests and this phase is now underway. I also hope that the Ministry of Healthcare will become involved in this project because we will file an application to approve these tests here.
We are also working on other projects. Although malaria is not a serious problem in Russia, it is a huge problem in other countries. Malaria is a very serious disease worldwide. Cancer and chronic diseases also require our attention. I have mentioned diabetes. Teenage diabetes is another major problem.
You know the range of issues being addressed by our Selecta RUS company, which owns the copyright for all products made and sold in the CIS. We will do some work in Boston and some more work in Russia. We will work together in some cases. This is absolutely irrelevant because of our global approach. Selecta RUS and all CIS countries will have enough of these products.
We have already involved leading specialists from Russia and they are currently receiving training in these technologies in Boston because this is very important for our work. We are working on this.
I also mentioned that smoking is a major problem, but as you can see, I am also telling the Minister of Healthcare that smoking is linked with a whole range of diseases. Therefore smoking itself breeds diseases.
There are 350,000 smoking-related deaths each year. That’s why we need to develop these products. In this connection, we would like to discuss the contribution of our company.
We have been in existence for only three years and we have been operating in Russia for nine months. As has already been noted, we need time. We can examine all of the industry’s problems under the Pharma 2020 programme. We can introduce innovations and create a platform. And we can move forwards once the platform structures have been developed.
We have learned a lot while establishing our Selecta RUS company, we have learned many new things. We have seen very talented and capable scientists who behave in a responsible manner here. We have become acquainted with RUSNANO, which is an extremely responsible investor for us, and we have found that people can work effectively here at different levels. It’s true we need to address a number of issues. Cooperation with foundations is not very common and I believe that this area could be improved. In my opinion, support for clusters and their development is very important. Tax breaks and funding are also essential. These are the types of problems and issues that currently exist. I hope that you will be able to assess the results of our work in the next few months. Thank you very much.
Dmitry Medvedev: Thanks a lot. Next is Igor Pivovarov, Gemakor Group’s CEO.
Igor Pivovarov: Mr Medvedev. Ladies and gentlemen, I’m the CEO of Gemakor. We are a biotechnology group developing and manufacturing diagnostic devices. Our main focus is diagnosing cardiovascular disease, which is currently the leading cause of death across the world and, unfortunately, Russia is at the top of heart-related mortality rankings.
Almost 57% of deaths in this country are caused by thrombosis as a direct consequence of disorders in the circulatory system. Serious medical problems such as thromboembolism, venous thrombosis, strokes, and heart attacks are related, one way or another, to thrombosis. And thrombosis is a really big problem, as existing diagnostic tests are unable to detect it at an early stage. But we’ve now developed what we believe could be an effective tool for diagnosing the disorder. Named Thrombodynamics, this comprehensive test allows for early detection of bleeding and blood clot formation.
These videos show the essence of our new technology, so I won’t expand on it at length. We can induce coagulation with the help of that special biotechnological nano-covering you can see in the upper part of the image. What we get is a close imitation of the natural process, which enables us to produce an accurate physical model, one that is much more sensitive than all currently employed tests. Here, in the centre image, you can see a healthy person with a coagulation rate of 1.5 millimetres per 20 minutes. The right-hand image, meanwhile, shows a thrombosis patient with faster coagulation and clots formed in places that have not previously sustained any damage. In a real body, such clots could be formed in the heart, in the lungs, and in the brain. We believe that Trombodynamics is the only test capable of detecting thrombosis in the early stages.
Our project goes back fifteen years. It started off as a basic research project. In 1994 the first related paper came along. The first experiments were launched in 1997, and in 2003 we got the first clinical prototype. In 2007, we began commercial activity under this project, raising money from angel investors and securing sponsorship within the framework of the Fund for the Support of Small Businesses. In 2010, we received investments from Rusnano and Sberbank Capital, and this was when our project became full-fledged. We joined Skolkovo in 2012, and now we’ve applied for a grant to advance this particular project and do research on whole blood tests.
Next image, please. This one comes with a brief profile of our company. We’re just two years old, but already have a staff of 85 and a budget of about 550 million roubles, provided in investments. We already hold thirteen national patents, with sixteen other patent applications pending official approval.
We cooperate with strong corporate players – leaders in science and engineering – the world over. Here just a few of our partners are shown. Our product is inherently global. The problem that we’re trying to solve is relevant around the globe. Blood clots are a frequent cause of death around the world. We are glad this is a Russian invention, but right from the start of our project, we’ve been oriented toward the world market.
We are working in line with modern medical trends, about which Ms Skvortsova spoke – personalised medicine, because the Trombodynamic test is not only capable of pinpointing the problem but can also determine the required medical dose and even choose the most suitable medicine for each particular patient. We believe that if the government approved a federal screening and blood-clotting prevention programme, this would reduce the death rate dramatically, possibly making Russia a global leader in terms of addressing this disease.
And lastly, about our expectations of Skolkovo. We only became a Skolkovo resident quite recently. But we have been working together with RUSNANO for a long time. RUSNANO supports mature projects, of which there will be about a dozen this autumn. Skolkovo is helping these types of projects to develop and we hope that it will help us to accelerate the marketing of new products – this is currently the main objective of businesses. In this sense, we hope that Skolkovo will lower administrative barriers (in any way possible) and we also hope to receive grants and to have our tax burden reduced, because the bulk of our spending goes on people, our staff, our researchers.
Thank you, everyone. Thank you Skolkovo for this opportunity to speak here. I am ready to answer any questions. Thank you.
Dmitry Medvedev: Thank you very much. We have one more speaker, Mr Ram Sasisekharan, Professor of Health Sciences & Technology and Biological Engineering at the Institute for Integrative Cancer Research. Go ahead, please.
Ram Sasisekharan (Professor of Health Sciences & Technology and Biological Engineering at the David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, MIT) (as translated): Mr Prime Minister, ladies and gentlemen. It is a great honour for me to speak at this meeting in this wonderful centre that has just opened.
The next slide, please.
I’d like to talk about things that are vital for the centre. I think that much has been said here about the important issue of infectious diseases. This issue is changing due to changes in the environment and many other factors.
The three major challenges facing the world in 2012 are the West Nile virus, Hantavirus, which is a major risk for many people, and hand, foot and mouth disease, of which there have been major epidemics in the Asia-Pacific region.
The main issue we have to discuss is why we need to do research? This is a constantly changing problem and our thinking has to keep pace with the changes. The first example that comes to mind is influenza A in humans. The most interesting thing is how these viruses are transmitted to pigs and birds for example, how they mutate and how they subsequently affect people. We can talk about four pandemics, including the 1918 Spanish flu pandemic, which killed more people than both (world) wars in the 20th century, and the 1977 Russian flu pandemic, which had a terrible impact on the country. (…) New flu strains appear and hence I’d like to provide a good example about flu pandemics, that is, to talk about the period after 2009. It was a rich experience not only for research centres, but for all healthcare establishments.
I want to talk about the medical achievements that became possible thanks to research. This issue is not only about the diagnosis of the disease, but also about detection and curing patients. Also, research is connected with medicine. Considering this, one of the key issues I’d like to talk about is influenza A, which has been detected and led to the need to combine academic studies with medical research, to try to understand the reasons behind this flu. It takes the coordinated efforts of science, medicine and technology to deal with this disease and, as far as possible, to prevent potential damage from it. In the first weeks after this virus was detected, it was very difficult to deal with it without having a strategic interface.
This is why, following this small historical detour, what we are proposing is a unique model, one that is not only based on research and one that will be necessary because of its natural qualities, but is also a vital fusion of science, medicine and industry in order to make the necessary steps toward resolving this issue. For this purpose, we need researchers not only in Russia but across the world to work together on a solution to this problem. I also want to say that the next slide will demonstrate four or five key steps which indicate what we will try to do in the context of the research centre.
The first is concerned with the main diseases, which are particularly widespread in Russia: tuberculosis, flu and hepatitis. Of course, we need a good diagnosis here. What we will try to do is use a combined approach. We would like this project to be based at the centre for the study of human infectious diseases. We need to create a special mechanism to develop measures to prevent these infectious diseases. This requires the cooperation of Russia, the United States and the rest of the world. All researchers across the world should be involved in this project. We also need ideas to combine the opportunities for developing this project and for reducing the gap between medicine, industry and technology. We want to make a breakthrough so we can move forward to a new phase in the struggle against infectious diseases on a broad scale.
Next slide, please. You can see many people here who are also involved in this project. These are real people, a team of researchers both from Russia and from Harvard and Boston. These people will devote their time to ensure this mission succeeds.
We also have a special team from Boston, whose task is to see to it that our plans are substantiated not only with regard to problems that have a solution, but also those problems which still need to be resolved. We need to understand the issue and propose hypotheses and better ways to diagnose these diseases, as well as treatments, which requires tightly coordinated operations on all sides.
To achieve more than just a scientific understanding of the issue, we need to work together to implement this project. And it is not only companies that have to be created but also technology to effectively bolster the development of medicine.
We have already spoken about the new companies that are being established in this field, by which I mean clinical testing and diagnosis, but since we are going to do it… Next slide, please. Taking flu as an example, we will consider all related aspects, including its impact on society, how each particular person falls ill, how the disease spreads, and how we can cure patients. This huge range of issues, from the appearance of the disease, its proliferation and the cure, all this goes hand in hand and we will try to consider each phase separately.
As for the research programmes which our colleagues spoke about… The goal is not to focus on elements of research, but to determine very quickly how they can be monitored in different parts of Russia and across the world, because this is not just a Russian problem but a global issue. How can we create vaccination strategies that could be integrated throughout this project? For this purpose we will build special centres, and it will be a common paradigm that will embrace all opportunities offered by this project. In Russia, this means many programmes that need to be implemented and about which I have spoken before, on hepatitis, or flu or other diseases. It will be necessary to try to understand the essence of these diseases, to learn to diagnose them, to study them and to subsequently cure people.
Another major issue is intellectual property, which offers a range of opportunities for creating new companies and new partnerships. So we not only hope that research will be undertaken and various ideas will be presented, but also that intellectual property, innovations will integrate in a reasonable and pragmatic manner, so that in 18 months this technology, this engine will start working and bring success. In short, I’d like to say that this research centre will not only provide a new basis for research, but also combine all the main forces necessary for implementing its results. These are engineering, medicine and industry, which must be brought together. Several partners will be involved, including in Russia, to bring success to our undertaking.
Also, I’d like to say that we need a variety of education strategies. This is, of course, a combination of clinical medicine, translational medicine, and technology that can be created thanks to our advance to a new level in this area. In the context of the pharmaceutical business model, we hope that by 2020 it will not only become an engine for uniting all human resources, but also unite innovation with production capabilities. Thank you.
Dmitry Medvedev: Colleagues, we have heard some very interesting presentations. Does anyone want to add anything in addition to what has been said here about the innovative development of medical technologies and the legal foundation for our work? Please, go ahead.
Andrei Ivanov (Deputy Finance Minister): If you allow me, I’d like to say a few words on behalf of the Finance Ministry in addition to the proposal made by the Ministry of Industry and Ministry of Healthcare concerning the objectives that Prime Minister Medvedev mentioned in his opening address. We believe that the implementation of these complex and capital-intensive tasks is impossible without attracting investments in major innovation medicine projects.
It seems to us that the discussions of past years and today have shown the conditions are right for attracting these investments.
I would like to quote a few figures. According to the budgets currently being implemented in healthcare, over 220 billion roubles was directed into the purchase of medicines and dressings jointly by the Ministry of Healthcare and the Federal Compulsory Medical Insurance Fund (FOMS) in 2011. And that’s just for one year! In this regard, if we survey the market of these purchases until 2020, we will see that this volume could be as high as two trillion roubles. Within the federal targeted programme for the development of the pharmaceutical industry we are to allocate something like 130 billion roubles until 2020. Over the past few years we have already spent about 300 billion roubles to purchase medical equipment and we will be spending something like 20 billion every year just under the Ministry of Healthcare budget.
In this respect, we believe that if we are guided by the practice which is now widely adopted in the European Union … The Treaty on the Functioning of the European Union in section 7 of the Common Rules on Competition, Taxation and Approximation of Laws indicates that a state joins some or other innovation projects as the main investor if the market is unable to sustain these projects. If the state is able to do so, then … If it is unable, then the state creates the conditions in some way; if these conditions are inadequate, then it is the key investor. In this sense we consider that within those declared budgets there is the possibility of formulating a sort of proposal for a protocol instruction and the creation of the conditions for attracting investment into large-scale investment projects. The first thing that could be done would be to instruct the Ministry of Healthcare, the FOMS, the Finance Ministry and the Economic Development Ministry to formulate a long-term government order until 2020 – taking into account the possibilities of the programme – to purchase one or other type of medical equipment and medicine. Now that we are adopting a programme-targeted budget from next year, this is perfectly possible within the government programmes. We should place such a technical order and pencil in qualitative, quantitative and cost characteristics into it. We should also, together with the Ministry of Economic Development, commit ourselves to a long-term contract in budget terms, a contract that could on the one hand make investors understand that they can fund and purchase certain volumes… And even fund some research and development projects, in the knowledge that the state will buy its products.
Next point. the Ministry of Economic Development, the Ministry of Healthcare and the Finance Ministry should, within the technology platforms (since these tools have already been created, and were mentioned in the presentations), hold appropriate dialogues between business, science, innovators and, correspondingly, us as the government to see how these purchases can be organised in such a way that businessmen understand our long-term expectations.
Thirdly, the Ministry of Economic Development, the Ministry of Industry and the Ministry of Healthcare should determine territorial clusters in which … Since, on your instructions, we are now distributing jointly with the Ministry of Economic Development our state infrastructure support within the territorial clusters, the key pilot territorial clusters should be determined which under the state programme and within our order could create the conditions for the implementation of these investment projects.
Accordingly, we at the Finance Ministry, the Ministry of Economic Development, and the ministries of healthcare and industry need to formulate proposals on updating the legislation to make it possible to attract extra-budgetary investment into these long-term investment projects in innovative medicine. It seems to us these projects are quite feasible. In the past, also on your instructions and as part of a national project, we considered the Kirovsky plant for the production of blood products. If it had attracted extra-budgetary investment, it would have recouped its costs in the space of two years according to our estimates, given the prices the Ministry of Healthcare had at the time of the decision to construct (purchasing prices) for these kind of pharmaceutical products. It seems to us this is an achievable goal. It will, of course, require some organisational and legislative efforts, but jointly with our colleagues from other ministries and State Duma deputies it seems we could, given your appropriate instructions, achieve this goal.
Dmitry Medvedev: Thank you, Mr Ivanov. Please, colleagues, go ahead.
Valentin Vlasov (Director of the Institute of Chemical Biology and Fundamental Medicine of the Siberian branch of the Russian Academy of Sciences): Mr Medvedev, colleagues. I would like to dwell briefly on two issues which are common to Skolkovo and science centres dealing with the issue of innovative medicine. It would be good if the pictures I brought along could be shown, but if not I can do without them.
The Siberian branch of the Academy of Sciences (main centre) is located, as you know, in Novosibirsk. It was in effect an idea similar to the Skolkovo project implemented at the dawn of the era.
This is a photo of our Science City from the air, and here are several dozen research institutes. Shown and listed on the right are institutes dealing purely with medical or biomedical problems. These are the institutes of the Academy of Sciences and of the Medical Academy, and next to them our technology and biotechnology parks. In brief, here in the Science City, we produce about 70% of the diagnostic kits to detect infectious diseases. We supply the whole country with components and instruments for laboratory diagnostics and we also export them.
What are the problems we are experiencing? They are of the same kind which are likely to occur in Skolkovo in the future as it develops. I see the area here is comparable in size with our Science City, but it will need to be expanded in the future. One of the problems facing centres like our Science City is the vicinity of large urban centres, because the centre must be attractive to live in. Companies that work here are efficient, and their staff can choose where to live, including abroad. Accordingly, the area must be attractive to live in, be focused on cooperation and successful work between firms and research organisations. In this context, these areas have to be protected from unrelated developers’ projects. Such a request was sent to Mr Medvedev, and the instruction to draft the necessary proposal was issued, and is being processed. It is important to ensure this is done and also taken into account for other centres, too.
There is also a second point I would like to raise. Ms Skvortsova outlined a long list of problems that are hampering the development of our innovative activities. I would like to highlight the worst bottleneck – translational investigations. We are desperately short of pilot-scale units producing biopreparations; in fact there are virtually none. Yet a substance cannot make it from an investigator’s flask right into clinical practice all by itself. Some kind of instruction seems called for for the Academy of Sciences, or for the ministries to set up small-scale pilot plants for making biopreparations.
And secondly. As Mikhail Kirpichnikov said, a translational structure has been formed. In general, the United States has about 100 translational medicine structures. We need a breakthrough, because today the winner is not the biggest and strongest, but the fastest. We cannot afford to lag behind, and it would be a good idea to try to accelerate this process. For example, the Siberian Branch has included the organisation of an institute of translational medicine in its concept, but it would help if we received good directives from the top in order to speed up the process. I am aware that a similar structure is about to be set up at Moscow University and Krasnoyarsk University. And apparently Skolkovo should also have such a structure. Thank you.
Dmitry Medvedev: Thank you.
Lyudmila Ogorodova (chairwoman of Medicine of the Future technological platform): Thank you, Mr Medvedev. Today Veronika Skvortsova presented an impressive programme of the Healthcare Ministry on how to structure innovative development of biomedicine. I would like to speak about the effectiveness of state support. When you signed a decision to launch such instruments as technological platforms, innovative development programmes and regional clusters, it was a historic decision.
Mr Medvedev, when we talk about private-public partnership and the need for state support to be effective, we are talking about business partners whom we try to bring into our technological platform, Medicine of the Future, which I am representing today. We try to win orders for R/D and for the development of scientific projects. But businesses that offer support for a scientific project must know exactly what developments will emerge from this or that scientific project. So, to attract private business, a project needs to be long-term and it needs to span a whole business cycle. This raises the problem of inter-sectoral and inter-agency coordination.
Yes, many instruments and a lot of money are available, but we need instruments to coordinate various stages, because today inter-sectoral technologies form the basis of the current agenda. I would like to suggest that if technological platforms are truly to work and if they are to develop and support the private-public partnership and make state support more effective, the development of state programmes, if only on the basis of a pilot programme, should be included in the schedule. We are ready to work on that.
My second point. I am speaking on behalf of two structures, because the innovative regional development clusters have asked me to report on their behalf. An Interra conference held in Novosibirsk hosted a very serious discussion about how business can help biomedicine, about what proposals to put forward and what form support should take. Today we are borrowing technologies. The clusters launched by the Ministry of Economic Development, innovative biopharmaceutical clusters today are using global products and are opening such world-class companies as GlaxoSmithKline, and so on. These clusters need trained engineers in such specialities as “biopharmaceutics”, “biotechnology” and so on. The Kaluga biopharmacluster is ready to act as the trailblazer in training engineering personnel, because we need to develop an educational standard, to develop professional standards… The process is accelerating with the participation of business and innovative instruments, and in my opinion this is an important measure that would make state budget support more effective.
Dmitry Medvedev: Thank you. Next, please.
Dominik Wehner (Fresenius company Executive Vice-President CIS/Eastern Europe/Middle East/Africa): Thank you. Mr Prime Minister, ladies and gentlemen. My name is Dominik Wehner and I am senior vice-president of the German concern Fresenius Medical Care. We are the biggest producers of dialysis equipment and disposables in the world, and a major operator of dialysis services worldwide. Our company will turn 100 years old this year. The company owns more than 3,000 dialysis clinics across the world, at which 250,000 patients are receiving treatment. We have been in Russia for 30 years, and as of today we have managed to open 25 dialysis centres catering to more than 4,000 patients.
We have adopted a new investment programme based on two major projects in Russia. The first project involves localisation of the production of equipment and disposable materials for haemodialysis. We are building a plant in the Dubna special economic zone in the Moscow Region. The project is implemented by the Frerus joint venture, created by Fresenius and Concor, our Russian partner.
The second project is the creation in Russia of a network of 150 specialised dialysis centres by 2020. This project also involves our Russian partner, Concor, which acts as the developer while we, Fresenius, are the investors and operators of these centres. At this point I would like to thank the Ministry of Trade and Industry for its help in finding the right approach to launching these projects. But I would like to take this opportunity, and as a foreign company representative, share with you the problems that we foreigners face in planning to produce and sell innovative products in the Russian market.
First, corporate law has yet to be finally regulated. I can say that we have solved this problem, but we have encountered it as well.
Second: discrepancies between construction, medical, technological and other standards and European laws. This involves the need to adapt the projects already implemented in Europe to Russian regulations, which of course increases the project’s budget and the implementation time. By the way, this issue was raised by the Healthcare Minister.
However, most importantly – and this is not our experience, but our desire – we believe that innovative production calls for government support in stimulating the procurement market, because an innovative product cannot be cheap, at least while it is being introduced on the market, but this scares away the potential customer, the consumer of the innovative product. So, we and our Russian partner believe that the time has come to adopt a national programme to stimulate the market of Russian-made innovative products that would establish the criteria for the procurement of innovative products, and I think that the Russian business community of producers of innovative products will support us (we have talked with producers from St Petersburg here).
I would like to conclude by going back to where I started: we have been here for 30 years, we think that the investment climate is good and improving every year, and is providing us with the grounds to develop our business in Russia. Thank you.
Dmitry Medvedev: Thank you very much, including for your optimistic assessment of the investment climate.
Colleagues, would anyone else like to make an observation?
Sergei Zheleznyak (Deputy Speaker of the State Duma): Mr Medvedev, esteemed colleagues. I would like to stress that many speakers today have urged the need to coordinate, not only legislation, but also technical regulations, in order to speed up the launching and adaptation of products to our conditions. We have passed the relevant acts, but there are huge problems with enforcing them. There are many barriers at the middle management level. We have received many complaints about this from non-governmental organisations of businesses, and from research centres. That is the first issue. We must, together with the Government, work out measures to give the green light for innovative development and introduction of its results.
Secondly. We have been speaking here about flaws in corporate legislation. I would like to tell you that we are currently discussing a large body of amendments to the Civil Code, which has been submitted at the initiative of the Prime Minister. If necessary, as part of that work, we may adopt the amendments emanating from the business community and we are ready to accept them, like any other proposals concerning legislation. The Duma is committed to maximum cooperation in the field of innovation. Thank you.
Dmitry Medvedev: Thank you. Next please.
Marina Girina (President of the non-profit partnership, Medical and Ecological Instrument Building and Biotechnologies Cluster): Mr Medvedev, colleagues. Representatives of production clusters have highlighted the difficulties in introducing new production methods in clinical practice, and we would like for technological platforms to provide a sort of launching pad. You can invent anything, we’ve been inventing things for 20 years, our cluster has 100 enterprises that export to 70 countries, we have a colossal amount of experience. In the world, a technological platform is an instrument for introducing developments in clinical practice. This is the key issue not only in Russia but also abroad, so we should design this mechanism and launch it analogously with how it works in Europe and America.
And the second question – and this has been raised more than once during the course of this meeting – has to do with the need to hand over developments to production facilities, which was why the clusters were created in the first place. They have many years of successful experience entering markets in Russia and other countries. The clusters were created to enable research organisations to pass on their developments to such a successful base that has such successful experience. That is all.
Dmitry Medvedev: Thank you. Well, colleagues. With your permission, I’ll wrap it up. Incidentally, our meeting is a follow-up to the work we conducted about a week ago when we were meeting in Penza and were also discussing medical technology issues. Today we are summing up the results of two weeks of our activities.
A whole range of proposals made here by the heads of our ministries, agencies and other structures, and by our residents, including foreign partners, should be taken into account in our future work. As regards amendments to legislation, I am prepared in principle to support the range of proposals that have been made at least tentatively dealing with intellectual property and with the share in authorised capital. Permission to transfer a stake in small innovative enterprises also merits attention, upon the understanding, of course, that these innovative enterprises are state-owned and that the state must know what is happening to its property. We should weigh how to use this mechanism, because otherwise it may so happen that tomorrow all these innovative forms that we will be creating on the basis of our higher education establishments will pass into other hands. That would not be quite fair. But I agree that there needs to be more flexibility in the matter of the created companies changing hands.
Introducing exclusive rights and exclusive licences in the authorised capital of such an innovative enterprise, an innovative company, is an issue that requires further analysis, but I think that in principle that is a possibility.
And finally, the right of universities to diminish their share in the authorised capital. Yes, in some cases this may be absolutely practicable, because we are not creating them in a certain form once and for all – we are creating them so that they deliver a product, a result, intellectual property and so that they ultimately generate profit for their founders and those who take part in their activities. So, I think this can be done.
Regarding some ideas put forward by the Finance Ministry. The Finance Ministry always takes a rather firm stand, but in this case I would like to go along with what the Deputy Finance Minister said about the long-term state order for the period until 2020, so that we know which way we are moving, and about identifying territorial pilot clusters as proposed by the Healthcare Ministry, the Industry Ministry and the Ministry of Economic Development (I would like you to attend to this matter), and of course about finalising legislation on off-budget resources. Let us work on these issues.
The main positions have been mentioned by the speakers here. I would like to support the need to improve corporate law. As Sergei Zheleznyak said, the State Duma is working on this with regard to the Civil Code, and the State Duma is ready to improve legislation. In short, we expect corresponding proposals from you.
Of course it is important to go back to the decisions we have taken and the projects that we have launched. I think we will be able to do this in the format of other meetings that will be held here.
Once again I would like to express my satisfaction for the fact that we have finally received our first home – our first, but of course, not our last. There are sites on all sides, on this side and on that side. I understand that Skoltech (the Skolkovo Institute of Science and Technologies) will be opposite this building, and over there will be the other buildings of our innovative centre. So, it’s the first step that is difficult. I hope that we will be having more house-warming parties and that we will hold meetings in various places as Skolkovo’s potential grows. I invite all of you to take part in them. Thank you very much.
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The Skolkovo foundation carries out research in five areas:
- energy efficiency and energy conservation, including the development of innovative energy technologies;
- nuclear technologies;
- space technologies, primarily in the sphere of telecommunications and navigation systems, including the creation of ground infrastructure;
- development of medical equipment and medicines; and
- strategic computer technologies and software.
Currently, 647 companies from 40 Russian regions have received the status of Skolkovo foundation participant; 45 venture funds have been accredited in Skolkovo, of which 25 are foreign ones.
The key element of the Skolkovo innovation centre is the Skolkovo Institute of Science and Technology, which is being established in partnership with the world's leading research university, the Massachusetts Institute of Technology (MIT). The plans for the development of the Skolkovo Institute of Science and Technology stipulate the establishment of 15 research centres involving leading Russian and foreign scientists.