Embed Size (px)
Citation preview
Analytical Description of the Ecosystem of
Smart Specialization Area “Biomedicine, Medical
Technologies, Biopharmacy and Biotechnologies”
30 November 2015 Member of the Board of “Fidea” SIA
Gundars Kuļikovskis
2015
Table of Contents1 Overall Information of the Ecosystem Descriptions......................................................................3
1.1 Aim of the Smart Specialization Strategy..............................................................................3
1.2 Smart Specialization Strategy................................................................................................3
1.3 Definition of the Field of Ecosystem.....................................................................................3
1.4 Methodology..........................................................................................................................3
2 Regulatory Framework of the Area of Biomedicine, Medical Technologies, Biopharmacy and Biotechnologies.....................................................................................................................................3
3 Description of the Key Participants of the Area.............................................................................5
3.1 Key Participants.....................................................................................................................5
3.2 Educational Institutions.........................................................................................................5
3.3 The Main Health Technology Enterprises..............................................................................7
3.4 Scientific Institutions...........................................................................................................10
3.5 Associations and Cooperation Networks of Industries Involved..........................................11
3.6 Public Administration Bodies Involved...............................................................................12
3.7 Graphical Representation of Participants of the Ecosystem.................................................13
4 Human Capital Available in the Area of Smart Specialization....................................................15
5 Results of the International Assessment of Scientific Institutions Working in the Area..............15
6 Industry Indicators in the Area of Specialization.........................................................................17
6.1 Sector Turnover in Accordance with the NACE Codes.......................................................17
6.2 Sectoral Export Performance by NACE Codes of Sectors...................................................17
6.3 Sectoral Investments in R&D..............................................................................................17
6.4 Number of Innovative Enterprises of the Area.....................................................................18
7 Goals of the Smart Specialization Area.......................................................................................19
7.1 Industry and Applied Research............................................................................................19
7.2 Ability to Conduct Research of Common Interest...............................................................20
7.3 Fundamental Research and Excellence................................................................................21
7.4 Smart Specialization Niches................................................................................................23
8 Discussions..................................................................................................................................24
9 Reference Sources:......................................................................................................................26
2
1 Overall Information of the Ecosystem Descriptions 1.1 Aim of the Smart Specialization Strategy Smart Specialization Strategy is aimed at the transformation of the national economy in order to build economic knowledge capacity by investing in research, innovation and events for their promotion. For building of economic knowledge capacity and efficient use of innovations, other conditions are also of importance. Other national development strategies and measures related to the Smart Specialization Strategy are prescribed for their implementation.
1.2 Smart Specialization StrategyTo focus limited resources for ensuring an increase in innovation capacity in the areas of knowledge, where the economy has the highest growth potential. Latvian Smart Specialization Strategy is a strategy for the transformation of the economy. It provides for building of the economic knowledge capacity, which leads to higher and sustainable productivity.
1.3 Definition of the Field of EcosystemThe smart specialization area includes all representatives of the industry, science and education, who create knowledge within the scope of the smart specialization area, to whom this knowledge is crucial for their ability to earn, as well as those who provide education based on this knowledge. Ecosystem is formed by the participants of the area, their relationships and transactions among them.
In this context, knowledge can be encoded, i.e. in the form of documents, it may be included in the technology or it may be uncoded, tacit knowledge, transferred in direct contact and through a discussion between the knowledge carriers or consumers.
Conditions directly influencing the participant – the market, financing, scale of the field of knowledge, the state aid instruments and the regulatory framework – are also addressed in the context of the ecosystem.
1.4 MethodologyConsidering that the ecosystem is very extensive, only the part of the ecosystem, which is directly linked to knowledge and can be influenced via public intervention through research, development, innovation investment or support, is viewed and analysed in the context of smart specialization.
The fields of biomedicine, medical technologies, biopharmacy and biotechnologies in aggregate form are referred to as health technologies, as they all have one overarching aim – application of knowledge and skills in dealing with health problems and improving the quality of human life. Knowledge and skills of health technologies are used as medical technological devices, medicines, vaccines, technological procedures and systems.
2 Regulatory Framework of the Area of Biomedicine, Medical Technologies, Biopharmacy and Biotechnologies
Laws regulating the area:
Medical Treatment Law;
3
Pharmaceutical Law; Law on the Rights of Patients; Human Genome Research Law; Law on the Protection of the Body of Deceased Human Beings and the Use of Human
Tissues and Organs in Medicine Education Law; Law on Institutions of Higher Education; Law on Scientific Activity; Law on Management of European Union Structural Funds and Cohesion Fund; Law on Management of the European Economic Area Financial Mechanism and the
Norwegian Financial Mechanism; Law On the Security of Information Technologies; Personal Data Protection Law.
Cabinet Regulations:
No. 899. Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medicinal Devices Intended for Out-patient Medical Treatment;
No. 468. Procedures for Approval of Medical Technologies for Therapeutic Use and Implementation of New Medical Technologies;
No. 1176. Procedures for Using Human Tissues and Cells No. 581. Procedures for Registration, Conformity Assessment, Distribution,
Operation and Technical Supervision of Medical Devices; No. 70. Regarding Use of Human Organs in Medicine, as well as Use of Human
Organs and Body of Deceased Human Being for Medical Studies; No. 60. Regarding Mandatory Requirements for Medical Treatment Institutions and
Their Structural Units; No. 134. Regarding the Common Electronic Information System of the Health Sector; No. 1529. Procedures of Organization and Financing of Health Care; No. 376. Procedures for the Registration of Medicinal Products; No. 416. Procedures regarding the Distribution and Quality Control of Medicinal
Products; No. 1316. Procedures for Calculation and Granting Base Funding for Scientific
Institutions; No. 994. Procedures for the Financing of Institutions of Higher Education and
Colleges from the Funds of the State Budget; No. 259. Procedures for Granting of Support for Participation in International
Cooperation Programmes in Research and Technology; No. 227. Procedures for Evaluation, Financing and Administration of Fundamental
and Applied Research Projects No. 634. Regulations on Mandatory Conditions to be Included in Personal Data
Transfer Agreements; No. 40. Compulsory Technical and Organizational Requirements for Personal Data
Protection.
4
3 Description of the Key Participants of the Area3.1 Key Participants There are four main stages of the creation of a new health technology – generation of basic and practical knowledge, development of the technology, clinical trials and introduction of new products on the market. Framework of each stage and the participants indicate the key participants of health technology ecosystem. Academic institutions and innovative industry of medical technologies are the key partners in creation of basic and practical knowledge. In recent years, this is considered the most essential facilitator of productivity by building a bridge between biomedical discoveries and their application in the creation of innovative products to improve productivity and reduce costs.
Health technology industry has specific characteristics that distinguish it from other industries. It is significant to list these specific characteristics, because they create a context for the composition and roles of participants of the ecosystem.
One of the characteristics is the highest proportion of innovative health technology industry investments in research and development, which was 14.4% of turnover for medicinal and biotechnology products in 2013. In comparison, the second highest indicator was that of the computer software development industry with 10.4%, but the average industrial indicator is 3.2%.
In the creation of new medical technologies, there are close and integrated relations among healthcare technology industry, clinical medical institutions and academic institutions, which all together are regarded the core of any biomedical, medical technology, biopharmaceutical and biotechnology ecosystem.
The area of health technologies has a long, complex and costly cycle of new product creation. The cycle of new drug and vaccine development and its main phases are shown in Diagram No. 1. Accordingly, productivity of this area requires political stability, good management and transparency and continuity of political decisions; access to capital and skilled labour; intellectual property protection mechanism, which has two main objectives – firstly, to promote investment in innovation, temporarily guaranteeing the inventor’s exclusiveness, and secondly, by promoting external cooperation, sharing of knowledge, which is possible if the intellectual property is protected. These requirements identify state and local government institutions as well as financial institutions as the participants of the health technology ecosystem.
The area of health technologies is highly regulated. The main expressions of this regulation – clinical professionals are regulated professions, clinical research is subject to strict requirements and must comply with the requirements for the use of research subjects’ personal information and their biological materials for research purposes. For the health technology ecosystem to function, it is important to predict this regulation, even though restrictive and demanding, in the long term.
3.2 Educational InstitutionsName of the educational institution
Branch of activity and role in the ecosystem
Rīga Stradiņš University
Rīga Stradiņš University has chosen a strategic specialization in life sciences and, accordingly, the largest number of students is in the study
5
programmes related to life sciences (study programmes related to the health technology ecosystem are specified here). Undergraduate programmes: pharmacy, medicine, paediatrics, audio speech therapy, occupational therapy, physiotherapy, diet, orthotics prosthetics, nursing studies, midwife studies, public health, health sports, dentistryMaster’s study programmes: biomedicine, physiotherapy, clinical pharmacy, industrial pharmacy, nursing studies, public health, nutrition scienceDoctoral studies: medicine, pharmacyThe educational role of RSU in the health technology ecosystem is to train professionals in the first-, second- and third-level educational programmes who will work in clinical medicine and public health policy-making, or will carry out research work in these areas.
University of Latvia
Study programmes of the University of Latvia that are related to the health technology ecosystem.Undergraduate programmes: biology, computer science, programming and computer network administration, physics, mathematician-statistician, optometry, chemistry, medicine, pharmacy, nursing studies, dentistry.Master’s study programmes: biology, nutrition, computer science, physics, optometry, chemistry, pharmacy, nursing studies.Doctoral studies: biology, computer science, chemistry.The educational role of the University of Latvia in the health technology ecosystem is to train professionals in the first-, second- and third-level educational programmes who will work and do research in clinical medicine, biology, information and communication technologies and chemistry. The ICT sector is a vital part of the health technology ecosystem due to development of connected health solutions, telemedicine and large-scale data collection and processing. Biology and chemistry specialists participate in the health technology ecosystem in directions of pharmacy, biomaterials and biomedicine.
Riga Technical University
Study programmes of Riga Technical University that are related to the health technology ecosystem.Undergraduate programmes: automation and computer engineering, computer systems, electronics and mobile communications, financial engineering, information technology, chemistry, chemical technologies, material science, medical engineering and physics, telecommunicationsMaster’s study programmes: automation and computer engineering, business informatics, computer systems, electronics, information technology, chemistry, chemical technologies, material science, medical engineering and physics, telecommunications.Doctoral studies: automation and computer engineering, computer systems, electronics, information technology, chemistry, chemical technologies, material science, telecommunications.The educational role of RTU in the health technology ecosystem is to train professionals in the first-, second- and third-level educational programmes who will work and do research in information and communication technologies and chemistry. The ICT sector is a vital part of the health technology ecosystem due to development of
6
connected health solutions, telemedicine and large-scale data collection and processing. Chemistry specialists participate in the health technology ecosystem in directions of pharmacy and biomaterials. Material science, medical engineering and physics specialists participate in the ecosystem in the development of medical devices.
UL Medical Postgraduate Education Institute
Institute was established at the University of Latvia, which carries out post-graduate training in medicine – resident training and a variety of continuing education courses.
3.3 The Main Health Technology EnterprisesName of the enterprise Branch of activity and role in the ecosystem
Grindex AS Main lines of activities: research, development, production and sales of original products, generics and active pharmaceutical ingredients. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
Olainfarm AS Main lines of activities: research, development, production and sales of original products, generics and active pharmaceutical ingredients. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
Rīgas Farmaceitiskā fabrika SIA
Main lines of activities: development, production and sales of original herbal products. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
AD SMART SIA Main lines of activities: development, production and sales of original herbal products. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
PharmIdea SIA Main lines of activities: development, production and sales of sterile forms of generics. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
Silvanols SIA Main lines of activities: development, production and sales of original herbal products. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
MolPort SIA Web site that provides chemical compound ordering and delivery service.
Silv Expo SIA Research, production, sales of dietary supplements. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
7
Solepharm SIA Development, production and distribution of dietary supplements. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
Unipharmalab SIA Development and research of solid dosage forms. The role in the ecosystem – the employer of pharmaceutical and chemical experts, entity that commissions research of research organizations and clinical medical institutions.
Onorach Baltic SIA Contract organization of clinical research that carries out clinical research assigned by its client – a manufacturer of pharmaceutical or medical technology products. Role in the ecosystem – provides health technology manufacturers with the opportunity to obtain research data necessary for registration of their products and positioning in the market.
Amber CRO SIA Contract organization of clinical research that carries out clinical research assigned by its client – a manufacturer of pharmaceutical or medical technology products. Role in the ecosystem – provides health technology manufacturers with the opportunity to obtain research data necessary for registration of their products and positioning in the market.
Bluebridge SIA ICT company that develops, maintains and sells solutions of medical information storage and data exchange for medical practices, clinics and hospitals. Role in the ecosystem – the products developed systematise and make available medical data for the needs of clinical and public health research.
Meditek SIA ICT company that develops, maintains and sells solutions of medical information storage and data exchange for medical practices, clinics and hospitals. Role in the ecosystem – the products developed systematise and make available medical data for the needs of clinical and public health research.
CoMed SIA ICT company that develops, maintains and sells solutions of medical information storage and data exchange for medical practices, clinics and hospitals. Role in the ecosystem – the products developed systematise and make available medical data for the needs of clinical and public health research.
Lattelecom SIA ICT company selling services to around 300,000 Latvian households and the major e-health solutions provider to the National Health Service. One of the lines of activities – development and sales of telemedicine solutions. Role in the ecosystem – data transmission and cooperation with clinical medical institutions on development of telemedicine solutions.
Nukleārās medicīnas centrs SIA
Commercial research services in the main directions: development and approbation of positron emission tomography / computed tomography (PET/CT) technologies; research of new drugs, medical preparations
8
and drug delivery systems in laboratory animals using PET/CT technologies; development, synthesis and approbation of new radiopharmaceuticals (RFP), including short-lived radionuclides and ligand molecules in laboratory animals using PET/CT technologies. The role in the ecosystem – the employer of pharmaceutical and chemical experts, radiology specialists and medical physicists. Contractor of research orders for academic and commercial institutions.
Future Medicine Group. MedRecordBank SIA
Online health data bank, which enables clients to store their medical information. Patients have an option to make this information available to the medical professional.
GenEra SIA A certified clinical diagnostic laboratory that provides a variety of genetic testing services, which also indicates to the company’s role in the ecosystem.
ASLA Biotech SIA It offers products and services in microbiology, molecular biology, immunology and biochemistry.
Cilmes šūnu tehnoloģijas SIA
A bank of adult stem cells for long-term storage of autologous stem cells for future needs.
Pauls Stradiņš Clinical University Hospital
Tertiary medical institution, which, in addition to treatment, is a clinical base for training of students and residents, where contract research is also carried out. Hospitals of the University have the status of a scientific institution in Latvia, however, they do not qualify for receiving science-based funding and they cannot fund research themselves. The specific role of Pauls Stradiņš Clinical University Hospital (the difference from Riga East University Hospital) in clinical medicine and research is in cardiology and cardiac surgery, transplantology, rheumatology, and interventional radiology. Currently, Pauls Stradiņš Clinical University Hospital is the main base for commercial clinical research in Latvia.
Riga East University Hospital
The major tertiary medical institution in Latvia. The specific role of Riga East University Hospital (the difference from Pauls Stradins Clinical University Hospital) in clinical medicine and research is in oncology and hematology, toxicology, gerontology, burns and frostbites. Currently, Riga East University Hospital is the main base for commercial clinical research in the field of oncohematology in Latvia.
Children’s Clinical University Hospital
The only tertiary medical institution of paediatric profile in Latvia.
Biosan SIA A joint venture of Latvia and England, which carries out sample preparation and analytics in the field of genomics, proteomics and cellomics and develops, manufactures and sells relevant laboratory equipment.
Biolat SIA Use of tree biomass, manufacturing biologically active products from ecologically clean forest raw materials, mainly green mass of trees – spruce and pine needles. Research activities cover research of chemical composition
9
of coniferous trees and the possibilities of using vegetable products, mainly extractives, in different economic sectors – the food industry, pharmacy, cosmetics, plant protection, feed preparation.
3.4 Scientific InstitutionsName of the scientific
institutionBranch of activity and role in the ecosystem
Rīga Stradiņš University RTU priority research areas: factors of biological aging processes and quality of life of Latvian population; structural, functional and biomechanical research-based development of disease diagnosis and treatment algorithms; research of exogenous and endogenous factors threatening the health of Latvian population; the role of infectious agents in the modern view in the origin and processes of current infections in Latvia; research of factors causing child mortality and disability; research of clinical and molecular features of malignant tumours for improvement of early diagnosis and treatment strategies; immunohistochemical, radiological and clinical research of face and jaw deformations and anomalies; clinical epidemiology of functional limitations caused by health problems in Latvia; social, economic, legal and medical issues of globalization.Personnel resources (2014, FTE): scientific staff – 176 people, 68 of whom have a doctoral degree
University of Latvia Personnel resources (2014, FTE): scientific staff – 674 people, 352 of whom have a doctoral degree
Riga Technical University Personnel resources (2014, FTE): scientific staff – 948 people, 308 of whom have a doctoral degree
Augusts Kirhenšteins Institute of Microbiology and Virology
Research areas: research of clinical and molecular features of malignant tumours for improvement of early diagnosis and treatment strategies; structural, functional and biomechanical research-based development of disease diagnosis and treatment algorithms; the role of infectious agents in the modern view in the origin and processes of current infections in Latvia.
RSU Institute for Occupational Safety and Environmental Health
Research activities on the research of exogenous and endogenous factors threatening the health of Latvian population.
RSU Institute of Oncology Scientific, educational activities, as well as activities related to acquisition and improvement of scientific qualification in oncology and personalized medicine.
UL Cardiology Research Institute
Research areas: cardiovascular disease epidemiology and prevention; interventional cardiology; coronary and peripheral atherosclerosis; research of gene polymorphism profiles for evaluation of coronary heart disease; research of secondary risk factors of cardiovascular diseases.
UL Institute of Experimental and Clinical
Research in endocrinology, cardiology, cancer development, cell processes and bone metabolism processes.
10
MedicineInstitute of Microbiology and Biotechnology
Research areas: metabolism of microorganisms of industrial producers, physiology and biotechnology; microbial degradation and environmental biotechnology; food biotechnology.
Institute of Mathematics and Computer Science of the University of Latvia
Ecosystem-related research areas: bioinformatics (modelling of gene regulatory networks and development of methods for analysis of network behaviour and stability, as well as development of evolution-based methods for comparison and analysis of protein structures, data storage and software development for integrated accumulation and analysis of molecular biology data); development of e-infrastructure.
Institute of Organic Synthesis
Innovative merger of academic research in organic chemistry and pharmacology with expertise in addressing tasks of applied research in medical chemistry; full-scale research work necessary to ensure development and introduction of new medicinal products.
Institute of Food Safety, Animal Health and Environment “BIOR”
Areas of competence of “BIOR” – food quality, safety, production technology and risk assessment; veterinary medicine, infectious diseases and their risk assessment; public health and environment.
Latvian Biomedical Research and Study Centre
Basic and applied research in molecular microbiology, vaccine development, cell biology, genomics and proteomics, cancer biology, immunology, structural biology and other directions.
3.5 Associations and Cooperation Networks of Industries InvolvedName of the non-
governmental organizationBranch of activity and role in the ecosystem
Association of Latvian Chemical and Pharmaceutical Industry (LAĶĪFA)
Participation in the development of sectoral business development concept and strategy proposals; participation in the development of a professional training system for specialists in the sector; participation in the development and improvement of sectoral legislation, providing opinions on projects developed by public authorities.
Life Science Cluster of Latvia
Cluster is a cooperation network of enterprises and institutions working in the sector, which aims to foster growth of each individual enterprise and the sector as a whole. Cluster support programme in Latvia is offered through the ERDF funding, with the support of which LAĶĪFA implements the cluster project of pharmacy and related industries “Promoting cooperation of participants of the pharmacy and related industries cluster for increasing productivity and export capacity of the industry through the combined method of strategic planning, cooperative logistics and marketing, and specialised research-technological infrastructure”.
SIFFA and LPMA Associations representing foreign pharmaceutical
11
manufacturers, whose role in the ecosystem is commercialization of innovative medicinal products, organization of clinical research, lobbying influence on the contents of Latvian and EU pharmaceutical laws and regulations.
Professional associations of doctors
They influence the development of clinical medicine knowledge and practice in Latvia, which is a factor for the possibility to carry out research and technology transfer in respective fields of clinical medicine.
3.6 Public Administration Bodies InvolvedName of the public administration body
Branch of activity and role in the ecosystem
Ministry of Health Develops and implements health policy. Influence on the ecosystem: the ministry is responsible for development of human resources; it directly manages a range of ecosystem participants – RSU, Pauls Stradiņš Clinical University Hospital, Riga East University Hospital, Children’s Clinical University Hospital; it influences the purchase of services and the volume of funding for medicine.
State Agency of Medicines Develops and implements a framework for clinical research and registration of pharmaceutical products.
National Health Service Registers medical technologies and decides on their funding from the public funds of Latvian residents.
Investment and Development Agency of Latvia (LIAA)
The objective of LIAA is to promote business development in Latvian, promoting an increase in foreign investment and improving the competitiveness of Latvia in domestic and international markets. The objective is attained by supporting business start-ups, as the liaison body in the administration of the EU funds and the Norwegian Financial Mechanism, external marketing and using the possibilities offered by the Enterprise Europe Network.
Ministry of Education and Science
Develops and implements national policy in education and science. It supervises the activities of UL and RTU.
State Education Development Agency
Implements national policy in the field of the European Union (EU) structural funds, life-long learning, foreign scholarships and cooperation programs, implementation of the European Economic Area financial mechanisms and grant schemes in education, science and research.
An increasingly important role in health technology innovation is played by the network cooperation mechanisms, where information is exchanged and cooperation groups are formed by industry partners, academic institutions and scientific groups supported by governments. Such cooperation mechanisms are necessary, since there is a need to understand the reasons for diseases in more detail, to reduce the cost of innovation, to use biological and genetic databases. These mechanisms of operation and needs point at the health technology ecosystem as a logical model of cooperation and shows the chances of finding a niche of participation for participants of various types, levels of development and capacity.
12
The overarching aim of the ecosystem – application of knowledge and skills in dealing with health problems and improving the quality of human life. Knowledge and skills of health technologies are used as medical technological devices, medicines, vaccines, technological procedures and systems. A schematic diagram of ecosystem participants and their network is shown in Diagram No. 1.
13
3.7 Graphical Representation of Participants of the Ecosystem
14
4 Human Capital Available in the Area of Smart SpecializationNumber of students
When summarising data on the number of students in the area of biomedicine, medical technologies, biopharmacy and biotechnologies, the following results were obtained:
CSB data, calculation of “Fidea” SIA
The table below sums up institutions, companies and organizations, where research work is carried out
2012 2013 2014Number of scientific
institutions
Scientific staff
Number of scientific
institutions
Scientific staff
Number of scientific
institutions
Scientific staff
Higher education sector 62 2607 61 2348 60 2291Public sector 19 703 19 707 19 681Business sector 343 594 342 570 411 776
Total: 424 3904 422 3625 490 3748* Source: Central Statistical Bureau
As the table shows, the number of companies carrying out research work is growing every year, which points at positive trends in the achievement of the RIS3 overarching objective (investments in R&D&I amounting to 1.5% of GDP in 2020).
Number of employees
When summarizing data in the area of biomedicine, medical technologies, biopharmacy and biotechnologies in accordance with the NACE codes over the last five years, the following results were obtained:
Field/year 2009 2010 2011 2012 2013Biomedicine, medical technologies, biopharmacy and biotechnologies 116,068 109,276 112,825 110,860 109,422
CSB data, calculation of “Fidea” SIA
5 Results of the International Assessment of Scientific Institutions Working in the Area
Ten scientific institutions were recognised as the main ones in the area of biomedicine, medical technologies, biopharmacy and biotechnologies. These institutions were included in
15
the independent international assessment of 2014 carried out by “Technopolis Group”. International assessors have conducted a large-scale evaluation of Latvian research, development and innovation system as a whole, and about 150 individual scientific institutes. Five aspects that are more extensive were set as the assessment criteria, namely, the quality of research, the influence of the institute’s research on the industry, economic and social impact, research environment and infrastructure as well as development potential. Each criterion was assessed with 1–5 points (5 points being the best result). Conclusions were made and recommendations for further action were given after the overall average assessment. The assessment of 10 institutions in the area of biomedicine, medical technologies, biopharmacy and biotechnologies is the following:
5 points (excellent, the institution is a global leader) – 1 institution;o Institute of Organic Synthesis;
4 points (very good, the institution is a powerful international player) – 2 institutions;o Institute of Food Safety, Animal Health and Environment “BIOR”;o Latvian Biomedical Research and Study Centre;
3 points (good, the institution is a strong national player with international recognition) – 4 institutions;
o Rīga Stradiņš University (Medical department);o University of Latvia;o Riga Technical University;o Institute of Mathematics and Computer Science of the University of Latvia;
2 points (satisfactory, the institution is a satisfactory national player) – 2 institutions;o UL Cardiology Research Institute;o UL Institute of Microbiology and Biotechnology;
1 point (weak, the institution is a weak national player) – 1 institution;o UL Institute of Experimental and Clinical Medicine.
Research Quality
Impact on the scientific discipline
Economic and social impact Research env. and infrastructure
Development potential
0
5
Average assessment of scientific insti-tutes in the area of biomedicine, medical technologies, biopharmacy and biotech-
nologies
16
The average assessment of scientific institutions in the area of biomedicine, medical technologies, biopharmacy and biotechnologies in Latvia is 3 points. International assessors indicate that the level of research in natural sciences and medicine is quite low on the international scale. The assessors point at the outdated infrastructure and overall lack of a vision in medical sciences. In terms of human resources in Latvia, according to the assessor, young researchers have a great potential, if it is properly managed, although at present it is not fully used.
6 Industry Indicators in the Area of SpecializationWhen identifying the participants in the smart specialization area in accordance with NACE codes, the following participation in the field was used in the description of the ecosystem:
NACE Economic sector
A Agriculture, forestry C Food industry C Chemical industry C Manufacture of electrical and optical
equipment
6.1 Sector Turnover in Accordance with the NACE CodesSector turnover (net turnover, million EUR)
Field/year 2009 2010 2011 2012 2013Biomedicine, medical technologies, biopharmacy and biotechnologies 2925.8 3464 3795.2 4051.8 4285.4
CSB data, calculation of “Fidea” SIA
6.2 Sectoral Export Performance by NACE Codes of SectorsSectoral exports (exports, thousand EUR)
Field/year 2009 2010 2011 2012 2013Biomedicine, medical technologies, biopharmacy and biotechnologies 799,289
1,010,219
1,234,953
1,418,727
1,546,258
CSB data, calculation of “Fidea” SIA
6.3 Sectoral Investments in R&DIn 2014, compared to 2013, the funding for research and development in Latvia increased by 0.08% and amounted to 0.68% of GDP. On average, R&D investment in Europe accounted for 2.01% of GDP in 2013.
In 2014, 162.8 million euro were invested in research in Latvia, where foreign funding accounted for the largest share – 44.2% of total funding for research works, 27.8% – business financing, 25.6% – public funding, but 2.4% – funding of institutions of higher education. It should be noted that the business enterprise R&D expenditure (BERD) of Latvia constituted 0.17% of GDP in 2013, which is significantly lower than the EU average – 1.28% of GDP.
The process of health technology R&D&I is long, costly and risky. On average, it takes 12 years from the synthesis of an active substance in biopharmacy until it reaches the market in the form of a registered product. For medical devices, this period is 5–7 years. Research and development of a single chemical or biological product costs EUR 1.17 billion (2011, EFPIA); on average, one of 10,000 substances synthesized in a laboratory will reach the market. The biggest R&D&I investments in Europe are made in Germany, Switzerland,
17
France, the UK and Belgium. 25% of investments are made in preclinical studies and about 50% of investments are made in clinical trials of phase I–III.
Diagram No. 2. Biopharmaceutical R&D&I cooperation networks and process duration.
The participants of health technology ecosystem of Latvia have the opportunity to participate in each phase of the R&D&I process. Currently, participation is mainly carried out in the clinical trial phase.
Enterprises of the ecosystem of Latvia currently are not carrying out a full cycle of development of new health technologies and their introduction on the market.
The innovative health technology industry is currently undergoing changes by replacing the linear, internal R&D&I framework model with network innovation. The old model was focused on internal skills and processes, largely ignoring the achievements of other organizations and protecting its information. Within the framework of this model, enterprise R&D&I costs grew rapidly, with the R&D&I productivity not increasing or even decreasing. Price per innovation unit reached a level that could not be maintained in the long term.
In today’s modern networking innovation model, different participants can find opportunities for participation in any research and product development stage, using their special expertise and skills. Various cooperation organizations and consortia are formed within the framework of such a model. They provide opportunities for participants of Latvian health technology ecosystem to find and participate in such an innovation network. An example of such cooperation is the Structural Genomics Consortium (SGC) – a non-profit organization that supports research before the competition phase in structural biology. The SGC identifies and maps the three-dimensional structures of human proteins, which then become target proteins of active pharmaceutical ingredients. The participants of this consortium include a number of pharmaceutical companies, University of Toronto, University of Oxford and the Karolinska Institutet, science foundations and more than 200 scientists cooperate there, whose research results are freely available to all participants.
6.4 Number of Innovative Enterprises of the AreaInnovation Scoreboard 2015 indicator SMEs introducing product or process innovations as percentage of SMEs establishes the proportion of innovative SMEs that have introduced new or improved products or production processes from the total number of SMEs (technological innovation). According to the Innovation Scoreboard 2015 data, the proportion of Latvian
18
innovative SMEs that have introduced new or improved products or production processes constitutes 15.7% from the total number of SMEs (EU – 30.6%).
According to the CSB’s latest innovation survey data, an average of only 30.4% of Latvian enterprises (EU average – 52%) were innovative during the period from 2010 to 2012. Innovation survey data suggest that the average proportion of innovatively active enterprises in the services sectors is 31.4% of the total number of enterprises in the respective group, while in the manufacturing industry – 29.6% of the total number of enterprises in the respective group. However, when analysing the innovation performance by sectors, it can be concluded that there is a number of sectors in Latvia, where the proportion of innovative enterprises is higher than or close to the EU average, and the proportion of innovative enterprises is higher than 50% of the total number of enterprises.
7 Goals of the Smart Specialization AreaKnowledge specialization areas are divided according to the goal pursued:
1. Industry and applied research – supported knowledge specialization areas aimed at significantly increasing the number of specialists and increase their competence in the industry and applied research;
2. Ability to conduct research of common interest – supported knowledge specialization areas aimed at building the capacity of the existing professionals and their renewal, primarily focusing on quality;
3. Fundamental research and excellence – supported knowledge specialization areas aimed at achieving excellence in the existing volume of specialists, with a significant focus on quality and research challenges in the fundamental science.
7.1 Industry and Applied ResearchSome innovators and engineers can ensure a significant increase in the said industries, creating innovative products to improve the profitability of individual enterprises. It is assumed that industry growth is ensured in these areas, resulting in a significant influx of specialists. For example, providing electronics or IT enterprises with high-quality professionals, they can create more knowledge-intensive, high value-added products that will lead to significant economic growth through the enterprise’s success.
19
Constituent areas of knowledge:
7.2 Ability to Conduct Research of Common InterestIndividual groups of scientists can have a great impact on economic results, when engaging in projects of common interest.
For example, development of forestry can significantly increase the amount of resources available, but there is no need for a forestry specialist in each enterprise, since knowledge and projects are projects of common interest.
20
ResultsTasksGoalsIndustry and applied research
The absorption capacity of the
industry
Number of innovative employees working in
the industry
R&D jobs
Applied research aimed at individual
innovation
Capacity and number of researchers in
research organizations
Cooperation with the industry
102 Computer science and informatics
204 Chemical engineering
206 Medical engineering
209 Industrial biotechnology
Constituent areas of knowledge:
7.3 Fundamental Research and ExcellenceExcellence is required in the existing volume, with a significant focus on quality and research challenges in the fundamental science.
21
ResultsTasksGoalsAbility to conduct
research of common interest
Industry expertise in cooperation with
research organizations
Industry expertise. Renewal of the
number of highly qualified experts
Applied research of common interest
Effective excellence groups
106 Biology science
104 Chemistry
301 Medicine
ResultsTasksGoalsScientific excellence as a
challenge and talent attraction
Focus means to create excellent research groups
World-renowned scientific excellence-oriented
groups, researchers and research
Ability to create a strong base of teachers ensuring the quality and prestige of
education
Excellence groups create internationally networked
human resources for applied research
Constituent areas of knowledge:
There is a single main policy goal in all areas of smart specialization – the total number of R&D jobs. The number of R&D jobs demonstrates the volume of R&D activities/product.
Individual programmes can set autonomous goals related to ensuring environmental factors for achieving the RIS3 objectives, and the project complies with the RIS3 when it complies with the specific task.
RIS3 OVERARCHING OBJECTIVE INDICATORS
Base value 2017 2020 Data source
Investment in R&D&I (% of GDP) 0.6 (2013) 1.2 1.5 CSB
Position in the European Innovation Union Scoreboard
modest (2013)
moderate follower EC
Productivity in manufacturing industry (EUR per 1 employee)
20,126 (2013)
24,500 29,000 CSB/MoE
RIS3 MACRO-LEVEL INDICATORS Base value 2017 2020 Data sourcePrivate sector investment in R&D&I (% of the total investment)
21.8 (2013)
46 48 CSB
Proportion of innovative enterprises (% of the total number of enterprises)
30.4 (2012)
35 40 CSB
Proportion of high- and medium-high-tech sectors in Latvian exports of goods (%)
23.8 (2012)
27 31 CSB/MoE
Number of scientific staff in R&D (public and private sectors)
5593 (2013)
6300 7000 CSB
A smaller number of stronger publicly funded research institutions
42 (2013)
30 20 MoES/SEQS
Proportion of graduates (ISCED level 5 and 6) in the STEM fields from the total number of graduates, %
19 (2012)
25 27 MoES
Monitoring micro-level indicators
License/patent income of scientific institutions (EUR); Enterprise co-financing of R&D projects (EUR); Number of enterprises that have received aid for the introduction of new
products/technologies; Enterprise’s turnover from commercialization of research results of their
implementation in economic activity;
22
101 Mathematics
103 Physics
104 Chemistry
106 Biology science
New enterprises (spin-off) established by scientific institutions Number of newly established enterprises that have received support; Number of new scientists that have received support for their post-doctoral research; The newly created jobs, including those, in which the research staff is employed in the
public sector / business sector; Funding raised by approved H2020 project applications (LV part; EUR); Scientific articles published in international databases (Scopus, Web of Science); Employees trained; Number of master’s and doctoral students involved in R&I projects.
(Source: Informative report “Smart Specialization Strategy Monitoring System”)7.4 Smart Specialization Niches
Chemical and biotechnological methods and products of production of pharmaceutical and bioactive substances;
Development and research of new and existing human and veterinary medicinal products;
Molecular and individualized treatment and diagnostic methods and cell technologies; Functional food, medical cosmetics and bioactive products of natural substances.
Performance of full cycle of health technologies requires large capital investment, knowledge and skills, and time resources. There are no enterprises in Latvia that could carry out a full cycle of development of a biopharmaceutical or medical technology product.
The huge expenses in the field of pharmacy have not significantly increased the volumes of registration of newly created original medicinal products, and data point at the relatively ineffective innovation systems of the major pharmaceutical companies. In recent years, the major companies, inter alia, have closed a number of research institutes, reduced investment in the initial stages of research and given up the clinical research field work (recruitment, data collection, etc.), using outsourcing instead.
In theory, the location of outsourcers should not affect cooperation networks. Consequently, changes in the innovation system of the pharmaceutical industry could be beneficial for Latvian research institutions (especially, the internationally acclaimed Institute of Organic Synthesis), for which, given the high research costs, it would be too expensive to ensure the whole process of development, testing and registration of new medicinal products, but it is profitable for them to engage in the international network carrying out specific tasks themselves or through outsourcing. However, empirical data show that international cooperation networks are dominated by national clusters. There are separate research institutes, the activities of which are truly international and which cooperate with the majority of the major pharmaceutical companies, but the national research systems form around companies rather than vice versa. Consequently, some Latvian research institutes most likely can and will be able to find profitable niches in the current innovation system of the pharmaceutical industry, but it could be difficult to create an internationally competitive national research system.
Outsourcing and globalization of clinical trials is another change that has affected the pharmaceutical industry. It has increased particularly rapidly in some Central European countries like the Czech Republic and Poland. The new EU Regulation on clinical trials of medicinal products will harmonize and facilitate acquisition of authorizations for clinical
23
trials and reduce administrative costs. This should contribute to the attractiveness of the EU as a place, where clinical trials are conducted, and the number of trials conducted. The number of trials tends to increase, however, the importance of clinical trials and their positive impact on scientific research capacity has been decreasing in recent years, since most of the trials carried out in Latvia are trials of the last phase – the phase before approval or phase III – and they are conducted by Latvian branches of international contract research organizations. Moreover, Latvia is involved at the bottom of the supply chain – on the patient and hospital level.
The major companies increasingly rely on their cooperation partners for production of pharmaceutical products. Outsourcing providers focus on the production of active pharmaceutical ingredients and maintenance of certified plants as well as their availability to other companies for production. Value adding activities are increasing – development of production process, design creation, preparation of registration documents, etc. In general, contract research organizations in the pharmaceutical industry produce about one third of total volume of production. Handing over of the production process to partners is facilitated by patent expiry of original products, when they can be freely produced by anyone. It is expected that the global market share of generics will increase from 27% in 2012 to 36% in 2017 and, accordingly, open up development opportunities for contract manufacturers. An additional market development trend is that the chemically synthesized generics currently on the market will be supplemented with biosimilars. Development of biosimilars is more expensive, but there are more profit opportunities.
The said market changes open up opportunities for the Latvian ecosystem participants, for whom the production of generics and active pharmaceutical ingredients is an essential part of business. Synthesis of biological medicinal products opens up opportunities for pharmaceutical research institutions. Focused specialization will be an important factor of success, given the size of the Latvian ecosystem participants.
8 Discussions Research: The pharmaceutical industry cooperates with scientists in several fields of
technology on a regular basis. For the industry to be able to compete in global markets, applied research, technology and innovation centres must be developed in 2-3 directions. Provisions of Cabinet Regulations restrict more active participation of scientific institutions in the programmes of Competence Centres (CC). Orders of enterprises are not regular enough to ensure permanent workload for the scientific staff. More flexible conditions for research institutions should be introduced in CC programmes.
Biomedical and medical technology sector has no orders from the private sector; government is the contracting authority, since it pays for the medical service. It is therefore necessary to review the SF support mechanisms, establishing that the government may also be the contracting authority. Legal status of university hospitals – a limited liability company – is not suitable and it hinders hospitals from engaging in research and innovation, which is one of the types of activities of university hospitals;
Human resources: The field of natural sciences lost professionals in the 90s and now it has a shortfall of middle-aged specialists, which is why one of the main aims – the
24
growth in human capital and sustainability of development of smart specialization strategy areas – is very important.
Poor knowledge in the STEM fields in secondary education, insufficient number of students and budget places in STEM fields, consequently, a lack of qualified human resources. Support is required for investment in education, especially in ensuring placement possibilities in research institutes and enterprises. It is necessary to assess the overly extensive use of the term “STEM”, since part of the profession of medical and pharmaceutical specialists falls outside the STEM fields. The human resource programmes of SF 2007–2014 period were assessed as positive, and they should be continued. ESF support must be planned for human resource development in doctoral and post-doctoral programmes.
Human resource fragmentation and mutual competition, which does not promote concentration of resources and global competitiveness. Call for the creation of a thematic doctoral centre in the health sector in accordance with the strategic specialization of institutions of higher education, with sub-specialization areas in accordance with industry priorities: oncology, cardiology, neurology, psychiatry, child and maternal health, public health, infectious diseases. Call for establishment of an industry competence centre at RSU, in the form of cooperation of industry and health care institutions.
Infrastructure: There is a lack of an infrastructure for standardized preclinical research. Open laboratories have to be established as a continuation of National Research Centres (NRCs). Support and additional investments are required to the industry to complete the development of medicinal product ingredients and the research carried out in the industry – to carry out clinical trials of phase I and pilot production. Currently, enterprises commission services from outside Latvia, leaving funds abroad. It is necessary to purchase equipment for enterprises. Suggestion to support GLP (Good laboratory practice) in development of solid dosage forms and capsules, pilot production laboratories and clinical trials of phase I for the needs of industrial pharmaceutical science and technology transfer. It is necessary to fund the feasibility studies of projects.
In the discussions of the biomedicine and medical technology sector, it was proposed to form the knowledge and technology transfer infrastructure as a shared infrastructure at research institutions or as a cluster; to establish an early-phase clinical research centre to transfer the knowledge created in Latvia to competitive products.
Entrepreneurship: SMEs lack the marketing and management knowledge and skills necessary for growth. Latvian entrepreneurs and research institutions lack the desire / ability to cooperate with foreign partners. Global cooperation is also needed when the appropriate industry has already been developed for a sector in Latvia. To increase the productivity of the pharmaceutical industry, it is necessary to continue to support the co-financing of industrial research of high value-added programmes and CC programmes. State Agency of Medicines has to ensure the registration of generic preparations within 6 months.
There is no cross-border medical service payment model developed in Latvia that interferes with providing medical services to foreign patients. A proposal to develop a cross-border medical service payment model.
25
9 Reference Sources:1. Guidelines for the Development of Science, Technology and Innovation 2014–2020
(Cabinet Resolution No. 685 of 28.12.2013);2. National Industrial Policy Guidelines for 2013-2020 (Cabinet Resolution No. 282 of
28.06.2013);3. Guidelines for the Facilitation of Exports of Goods and Services of Latvia and
Attraction of Foreign Investment for 2013-2019 (Cabinet Resolution No. 249 of 17.06.2013);
4. Informative Report “Regarding the Progress in Developing the Action Plan for Implementation of the Guidelines for the Development of Science, Technology and Innovation 2014–2020, including the Smart Specialization Strategy Action Plan and a Description of the Result Indicator System” (adopted at the Cabinet meeting of 21.10.2014);
5. Informative Report “Regarding the Implementation of the Structural Reforms in Latvian Science Sector until July 1, 2015” (adopted at the Cabinet meeting of 19.08.2014);
6. Draft Informative Report “Smart Specialization Strategy Monitoring System” (announced SSS on 4 June 2015, SSS minutes No. 22, Paragraph 18);
7. Information available on the website of the State Education Development Agency regarding RIS3 and discussion cycles organised in the framework thereof: http://viaa.gov.lv/lat/zinatnes_inovacijas_progr/viedas_specializacijas_iev/vieda_specializacija_jaunumi/;
8. Database of the Central Statistical Bureau;9. http://www.who.int/topics/technology_medical/en/ ; 10. The 2014 EU Industrial R&D Investment Scoreboard, European Commission,
JRC/DG RTD;11. Advancing translational research for biomedical innovation. Measuring industry-
academic connections. Biotechnology Industry Organization (BIO), prepared by Battelle Technology Partnership Practice, June 2015;
12. www.efpia.eu ; 13. www.ifpma.com ;14. www.rsu.lv ; 15. www.lu.lv ; 16. www.rtu.lv ; 17. www.lakifa.lv ; 18. www.izm.gov.lv ; 19. www.vmnvd.gov.lv ; 20. www.vm.gov.lv; 21. Competitiveness Report of the Pharmaceutical Industry. Certus, 2015.
26
