In St. Petersburg the VII International partnering-forum Life Sciences Invest.Russia took place on November 8-9. Representatives of business, the power, science, educational community discussed problems of pharmacy, biotechnologies and other sciences about life.
During the opening ceremony the acting as the Governor of St. Petersburg Alexander Govorunov reminded that pharmaceutical industry – one of the most fast-growing sectors of urban economy. In 2016 St. Petersburg a pharmpredpriyatiya made products for 30 billion rubles, in comparison with 2015 growth made 40%. City producers export drugs to 26 countries of the world, at the same time export in recent years grew almost three times.
"Diseases treat not eloquence, but drugs. I think, professionals of the market who came to this action, understand it better than many. And a conversation which will go at a forum how to develop the industry, very important. Especially as products which you turn out are the major making national security of the country", - Alexander Govorunov emphasized.
The chairman of the board of Association of the Euroasian economic community (EEU) in the field of the pharmaceutical market Dmitry Chagin also noted progress of the St. Petersburg pharmklaster. According to him, in St. Petersburg monitor development of the industry not only in Russia, but also in EEU.
"We are happy that our forum takes place in St. Petersburg. This year the Forum is devoted to the fourth industrial revolution. I am sure that many participants of the Forum really revolutionaries in good sense of this word who understand what is the new directions and at the same time treat the past with respect", - Dmitry Chagin told.
The forum was opened by a substantive session "the IV Industrial revolution: the main trends and ways of development of the pharmaceutical industry" during which heads of the companies and representatives of profile departments discussed problems and achievements of the industry. So, the minister of technical regulation of the Euroasian economic commission Valery Koreshkov was positive for work of the uniform market of drugs in EEU which works since May of this year. At the same time work on standardization is continued.
"We created pharmacopoeian committee into which the best representatives of our states entered (on seven people from the state, including two from the veterinary industry). We received originals of pharmacopoeian documents practically of all states, including the European Union, the United States of America because we want to consider all the best that is in the international practice. We were already registered in World Health Organization and we plan to receive the first volume of documentation in the first quarter 2018", - Valery Koreshkov reported.
Within the Forum the enlarged meeting of Coordination educational and methodical council of NOMK concerning improvement of methodical approaches to preparation of pharmaceutical shots took place. During the discussion the responsible secretary of the working group of National council at the Russian President on professional qualifications on use of professional standards in education and training Alexander Zhidkov noted that now there is an active process of review of professional standards.
"There is a remarkable experience when the joint appraisal centers of standards are created. They include higher education institutions and employers. They consider standards on compliance to requirements of the industry to the statement at the state level", - Alexander Zhidkov told. He expects further improvement of the state educational standards in the field of pharmacy in the next years.
In turn, the adviser at administration of the St. Petersburg state chemical and pharmaceutical academy (SPHFA) Elena Zima pointed to a number of problems which prevent implementation of new standards. According to her, often there are no adequate descriptions of new types of activity in which have to train higher education institutions. It concerns, for example, an internship in "pharmaceutical technology". Stirs also the indistinct description of borders of professional activity.
The senior teacher of UEF SPHFA department, the candidate of pharmaceutical sciences Yulia Ilyinova told about the principle of "kraftovy education", that is, training of specialists under specific objectives of producers. In the report she noted that even for the training term (five years) the educational standard can become outdated. Therefore, considers Yuli Ilyinov, it is necessary to develop "frame educational standards" which would allow higher educational institutions to adapt the program for the training course.
On Wednesday, November 8 also there took place the thematic session "Development of the Domestic Pharmaceutical Market in the conditions of Import Substitution and Localization of Production". According to her moderator of the vice rector of the St. Petersburg chemical and pharmaceutical academy, the chairman of the board of NP Union of Pharmaceutical and Biomedical Clusters Zakhar Golant, the tsenooborazovaniye mechanism on medicines became a subject of year. Other participants also spoke about prices of medicines.
According to the executive director of the Union of the Professional Pharmaceutical Organizations Lilia Titova, the industry the new technique of pricing of drugs which would create the fair prices of drugs is necessary. Such approach which would suit both the state, and the consumer, and producers is necessary. By the present moment two options of a technique of calculations are presented, but so far to participants of the market they seem insufficiently balanced. Lilia Titova hoped that the final version of a technique of pricing will be weighed, and terms of its entry into force are accurately registered. She also suggested to draw the attention of the Federal Antimonopoly Service (FAS) not only to cases of overestimate of the prices, but also to cases of conscious understating of the prices (dumping) that too happens.
According to the CEO of BIOCAD Dmitry Morozov prohibition on import of the localized drugs is necessary. Such measure could improve significantly a situation in the industry that shows experience of other countries. It, including, Morocco and Algeria.
During the session participants also discussed new rules of marking of medicines which have to become effective since January 1, 2019. For many enterprises of an innovation bear big risks, the chairman of Coordination council of National association of producers of pharmaceutical products and medical products Nadezhda Daragan considers. In her opinion, marking is important for expensive medicines, and here need of marking of iodine, peroxide of hydrogen or brilliant green does not seem to pharmproizvoditel reasonable.
Advertizing of medicines became one of the most urgent for pharmproizvoditel to those recently, the CEO of Association of Russian Pharmaceutical Manufacturers Victor Dmitriyev declared. According to him, a number of decisions not in favor of the pharmaceutical market was accepted recently. For the analysis of these decisions of pharmaceutical company combined and prepared the analytical report. Its results will be soon presented to professional community.
A series of scientific reports was submitted during the thematic session "Innovations in Pharmacy". Participants of a session discussed the latest developments, the priority directions in a research of dosage forms, problems of development of organizational and technological structure of support of a pharmotrasla, new methods of synthesis of medicinal substances.
The important place in discussion was taken by perspectives of use of natural compounds. So, the doctor of pharmaceutical sciences, professor Elena Molokhova told about a research in the Perm state pharmaceutical academy of phytosom from ekdisteroida. According to her, drugs of this sort have potential at treatment of a hypoglycemia, their antiischemic properties are perspective. In the Perm pharmakademiya expect to create in the future soft dosage forms with regenerating properties on the basis of phytosom. Drugs were already tested on rabbits and showed the efficiency in comparison with standard remedies.
The doctor of pharmaceutical sciences, the department chair of pharmaceutical technology of faculty of professional development of health workers, the director of the Center of collective use (the scientific and educational center) FGAOOU WAUGH "The Russian Peoples' Friendship University" Rimma Abramovich told colleagues about work of the organization. In recent years the center significantly updated the equipment, received a number of grants, actively cooperates with foreign universities (Turku and Basel). The center studies perspective drugs (including, for treatment of HIV infection) instant peroral films. Other direction of researches – the additive technologies in pharmaceutical development, that is, 3D-printing in pharmaceutical industry. The 3D technology - the press allows to receive those details which cannot be received stamping or casting for production, Rimma Abramovich noted.
The director of the Regional engineering center of the active pharmaceutical substances (APS) Elena Petrova also told participants of the Forum about establishment which began work this year. She thanked the Government of St. Petersburg for financial and organizational support in creation of the center which is carried out within development of a cluster of medical, pharmaceutical industry and radiation technologies. Elena Petrova told about developments the Centers and the applied techniques, in particular, about microreactor synthesis. It allows to increase efficiency of synthesis of AFS and to accelerate implementation of drugs in production and its scaling.
Official opening of a forum was preceded by a press breakfast of representatives of the pharmaceutical industry, profile authorities with the leading business media of the city. The first deputy chairman of committee on industrial policy and innovations Ivan Skladchikov addressed participants at the event. He noted the active growth of a pharmaceutical cluster and noted positive dialogue of the industry and the city authorities. According to Ivan Skladchikov, the city helps the pharmaceutical companies with advance of products on other sales markets, and also renders assistance in implementation of new investment projects. In particular, Special economic zones, Fund of development of the industry and the Engineering center work. The minister of technical regulation of the Euroasian economic commission Valery Koreshkov during a press breakfast wished to participants of a forum to achieve the planned results and to find ways of further development of the pharmaceutical industry. He also reminded that year was unusual as preparation for formation of the uniform pharmaceutical market within EEU came to the end.
During a press breakfast participants listed the main questions and tasks which it is necessary to solve the industries: these are pricing problems, staffing, localization of production of pharmaceutical substances, development and export of original drugs, etc. Noted that the pharmaceutical industry during the crisis period managed to keep a trend on development.
The press breakfast came to the end with signing of the cooperation agreement between Association of pharmaceutical producers of the Eurasian Economic Union and the All-Russian sports movement "Strong Russia". The signatures under the document were appended by the chairman of the board of Association Dmitry Chagin and the head of the movement Konstantin Blochin
The thematic session "Innovative Approach in Preparation of Pharmaceutical and Medical Shots" in which heads of departments of personnel of the leading pharmaceutical companies participated opened the second day of the Forum.
Opening a session, the chairman of the board of Association of pharmaceutical producers of the Eurasian Economic Union Dmitry Chagin reminded that St. Petersburg was always the capital of pharmaceutical science. The experience accumulated by scientific and production associations of the city allowed to make serious break in this sphere. For the further growth of the industry it is important to impart this experience and to prepare new shots, Dmitry Chagin told.
The head of department of educational work and additional education of Committee on Education of St. Petersburg Elena Spasskaya noted that succession of educational programs and career guidance have to become key problems of an education system and pharmaceutical industry. According to committee, more than 1 thousand school students took part in the open lessons devoted to the pharmaceutical industry. More than 22 thousand children are engaged in circles and sections of a natural-science orientation which are offered by system of additional education. Besides, at 17 schools of St. Petersburg profile classes work.
Now more than 40 agreements on training with the enterprises of the St. Petersburg industry work. The range of professions covers 70 workers and 59 qualified specialties. "Understanding a staff deficit problem in the industry, the Committee on Education is ready to expand the list of implementable professions and specialties", - the head of department of Committee on Education reported.
The personnel director of Geropharm Group Anna Devitskaya told that at the company the system of interaction with higher education institutions is adjusted. At the same time recently the enterprise decided to concentrate on work with school students. The company regularly conducts tours to the production sites and thematic quizes on the Pharminnotekh platform which allows school students and students to get acquainted with problems of the industry more in details.
The deputy CEO for human resource management of LLC NTFF Polisang Maria Guruleva reported that in connection with production expansion demand for personnel for the enterprise will significantly increase by 2018 - the beginning of 2019. At the same time the company is interested not only in graduates of profile higher education institutions, but also in IT specialists, physicians and biologists.
The head of department of training of directorate of personnel of the R-Pharm company Ekaterina Repkina told that the company is engaged in career guidance not only with school students, but even with pupils of kindergartens. For children hold different entertaining events during which a simple language tell about chemistry and biology. Also the company keeps the project on target training of students from the Yaroslavl region (where one of the R-Pharm enterprises is located) in the St. Petersburg Chemical and Pharmaceutical Academy (SPCPA).
During the session representatives of the pharmaceutical companies awarded pupils of the St. Petersburg schools for progress in studying of profile disciplines, and also their teachers. Awards were received by pupils of schools No. No. 197, 38, 617 and 66.
Besides, in the second day of the Forum there took place the seminar "Practical questions of preparation of the request of RUTI (Patent Cooperation Treaty – the Contract on Patent Cooperation) for protection of intellectual property in the countries of the Middle East and China". As the moderator the head of a chair of chemical technology of medicinal substances SPHFA Boris Lalayev, "pharmaceutics - the most innovative and at the same time the industry, sensitive to questions of intellectual property, that it is connected with its social importance" noted it. Now, Boris Lalayev noted, the industry looks for balance of interests of producers of original and non-original drugs.
The head of department of pharmaceutics of federal institute of industrial property Nikolay Lyskov told about practice of patenting of pharmaceutical substances in Russia. According to him, in a year the institute receives about 2,5 thousand applications. The most part of them is made by requests for patents for individual chemical means. At the same time a considerable share – repeated addresses or requests for extension of action of already granted patent.
The question of forced licensing is urgent. It can be provided in a situation when the owner of the patent does not work the invention (or insufficiently actively uses it). Also forced licensing is provided in a case of sozavisimy inventions or in a situation of threat of national security, Nikolay Lyskov told. So, in Egypt "Viagra" in 2002 was compulsorily licensed under the pretext of threat of national security. Practice of other countries (Canada, Thailand, India, Latin America) shows that the institute of forced licensing makes rather negative impact on the industry, Nikolay Lyskov considers. For example, in India after a case of forced licensing in 2012 foreign investments into pharmaceutical industry decreased twice.
The lawyer, the patent agent of the Russian Federation and the Eurasian Economic Union, the managing partner of AK Patent Law Group Vitaly Kastalsky also spoke against forced licensing. "Forced licensing seriously is capable to frighten off foreign investors. Mechanisms of compulsoriness and restriction of the rights are alien to civil circulation", - the lawyer considers. According to its data there are no researches which objectively would motivate need of forced licenses. Vitaly Kastalsky considers that there are alternative voluntary mechanisms within social responsibility of business."At all there is no need to change the current legislation about forced licensing", - told during the seminar the rector of the Russian state academy of intellectual property Ivan Bliznets. According to him, addresses with requests for extradition of the forced license never came to Rospatent. "The problem is decided", - Ivan Bliznets is sure. According to the head of legal practice of EY in St. Petersburg Anna Kostyra, the discussion rests against the legal principle "everything that is not forbidden, it is authorized". Excessive detailing of the legislation will damage to a private initiative, the expert told. Also within the Forum seminars "Practical questions of functionality and increase in quality control of semi-products for the cosmetic industry" and "Practical questions of functionality and increase in quality control of semi-products for the food industry" took place. State regulation of the perfumery and cosmetic industry in Russia is dynamic today, the assistant manager department of management and economy of pharmacy, the associate professor of SPHFA Oksana Nemyatykh noted in the report. From the last changes – regulation of drugs for a chemical peeling and the fluorinating toothpastes. Now on interstate approval of the countries of the Eurasian Economic Union there is a number of changes. It concerns, first of all, dental cosmetics and means of intimate hygiene, expansion of options of designation of periods of validity of products, marking of propilenosoderzhashchy cosmetics, interpretation of the list of ingredients of products. The manager of division of Bruker Optices Shamil Mizitov told about the new equipment which is used to quality control of products. The company actively works in the field of infrared (IK) spectroscopy which allows to investigate both quantitative, and qualitative composition of substance. As IR spectrums are unique for each substance like fingerprints, in the presence of library of ranges the analysis takes several minutes. At the same time the sample can be both firm, and liquid it is, enough, that it covered surface area in 1,5х1,5 mm. Now the technique is certified in the territory of Russia, all accredited laboratories can use it. The head of department of quality control of LLC NTFF Polisang Galina Nechayeva told about automation of quality control on production. "For us, producers, it is important to find defect as soon as possible. And it is even better - to construct production so that at each stage to understand what quality of products we have and that we will receive at the end", - she told. Meanwhile traditional is a quality control of products at the end of a production chain (or at several of its stages). He demands the tough specification of a product and leads to overestimate of percent of marriage. Besides, he does not allow to explain why and when there was a deviation from parameters. New approach "The quality which is built in design" allows to vary production process. At the same time control is exercised not postadiyno, and in real time and does not demand withdrawal of tests. The thematic session "The Best Practicians in the field of Integration of Business, Science and Education" took place. During it experts discussed professional standards and requirements to education of profile specialists in the conditions of bystry change of technologies and globalization. Modern education is influenced by bystry change of technologies, globalization, need of the solution of tasks on a joint of adjacent areas, the rector SPHFA Igor Narkevich told attendees. One of the most perspective directions in education he called model of "kraftovy preparation" under specific objectives and productions. Also, according to the rector, modern realities demand active implementation of distance programs of training. The head of higher education institution noted need of changes of the legislation for the educational sphere. In particular, decrease in a number of requirements to contents of training programs and to a package of documents for licensing. He suggested to formulate offers on change of the legislation and to send them to the Ministry of Education and Science. One more of requirements of the industry which was noted by participants of a session consists in harmonization of professional requirements of employers and educational programs. The vice rector of SZ GMU of Mechnikov Alexander Melzer spoke about it in the report. He emphasized need to consider possibilities of material resources of educational institutions. In this regard consolidation of higher education institutions with business is important. On its production sites it is possible to create basic departments and to show to students possible development of their specialty, Alexander Melzer told. Took place a forsayt-session also on November 9 "Digital transformation of professions: youth look" and round table "Topical issues of development of pharmaceutical industry of St. Petersburg, city infrastructure of support of producers and developers of medicines". The forum Life Sciences Invest took place two days, on November 8 and 9. The action combined specialists in the field of "sciences about life", representatives of pharmaceutical business and authorities. Organizer of the event: Union "Medico-pharmaceutical projects. 21st century". The action is supported by Committee on industrial policy and innovations of St. Petersburg, the Ministry of Economic Development, the Ministry of the industry and trade, the Ministry of Health of the Russian Federation, and also the Government of St. Petersburg. Sponsors: "Samson Med", Ernst & Young, Polisang, Mikrogen, AbbVie.