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Establishing a national biobank. Biobanking infrastructure initiative in Slovakia - Public policy, legal and ethical issues
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Establishing a National Biobank. Biobanking Infrastructure Initiative in Slovakia - Public Policy, Legal and Ethical Issues ˇ ´ , Peter Cvapek Jozef Glasa , Drahom´ır Kollar , Helena Glasova´ , Martina Antoˇsova´ , Daniel Pella , Ivica Kvietikova´ PII: DOI: Reference:
S2211-8837(19)30076-0 https://doi.org/10.1016/j.hlpt.2019.11.005 HLPT 378
To appear in:
Health Policy and Technology
ˇ ´ , Peter Cvapek Please cite this article as: Jozef Glasa , Drahom´ır Kollar , Helena Glasova´ , Martina Antoˇsova´ , Daniel Pella , Ivica Kvietikova´ , Establishing a National Biobank. Biobanking Infrastructure Initiative in Slovakia - Public Policy, Legal and Ethical Issues, Health Policy and Technology (2019), doi: https://doi.org/10.1016/j.hlpt.2019.11.005
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Ltd on behalf of Fellowship of Postgraduate Medicine.
Establishing a National Biobank. Biobanking Infrastructure Initiative in Slovakia - Public Policy, Legal and Ethical Issues 2) Full names (first and surname) of all authors including academic degrees and affiliation(s) – indicated by numbers of the institutions given in the list below:
Jozef Glasa, Prof., MD, PhD, PhD1,2,3 Drahomír Kollár, PhDr.4 Peter Čvapek, Ing.4 Helena Glasová, Assist. Prof., MD, PhD1,2 Martina Antošová, Mgr, PhD, MBA5 Daniel Pella, Prof, MD, PhD6 Ivica Kvietiková, RNDr., PhD4
List of institutions: 1 Institute of Pharmacology and Clinical Pharmacology, Institute of Health Care Ethics, Slovak Medical University in Bratislava, Bratislava; Slovak Republic 2 Slovak Society of Clinical Pharmacology, o. b. Slovak Medical Association, Bratislava; Slovak Republic 3 Ethics Committee, Ministry of Health of the Slovak Republic, Bratislava; Slovak Republic 4 Institute of Research and Development, Ministry of Health of the Slovak Republic, Bratislava; Slovak Republic 5 Office of International and National Projects, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Martin; Slovak Republic 6 nd 2 Clinic of Cardiology, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Košice; Slovak Republic 3) Name, mailing and email addresses, telephone and fax numbers of corresponding author (with whom all correspondence will take place unless other arrangements are made) Prof. Jozef Glasa, MD, PhD, PhD. Slovak Medical University in Bratislava Limbová st. 12-14 833 03 Bratislava Slovak Republic e-mail: [email protected], [email protected] mobile phone: +421-905-208.146 office phone: +421-2-59370.547 4) Funding: None 5) Competing interests: None declared 6) Ethical approval: Not required 7) Acknowledgements: None 8) Key words: biobanking, research infrastructure, Slovakia, ethics, legislation, public policy 9) A running title (not more than 45 characters including spaces): BIOBANKING INFRASTRUCTURE INITIATIVE IN SLOVAKIA
1
Abstract Resulting from a multi-stakeholder initiative in 2017, a rapid process is underway in Slovakia with the aim of establishing a national system of biobanks by 2020. A combined top-down and bottom-up approach is being followed under the leadership of the Ministry of Health Institute for Research and Development. Relevant national stakeholders, with international expert partner institutions providing additional know how and networking, have been successfully involved since the very beginning of this initiative. State-of-the-art biobanking facilities are to be built in order to accommodate the Slovak National Biobank in the city of Martin (Central Slovakia) and the other major biobank in the city of Košice (Eastern Slovakia), while existing structures – future local biobanks – will be upgraded to achieve complete technical and logistical compatibility. This should enable full compliance of the Slovakia’s biobanking system with the appropriate international ethical, legal and professional standards. A related legislative activity has been started, aimed at a comprehensive updating of the existing Slovak biomedical research and health care legislation, to provide for the necessary legal certainty. After successful completion of the Initiative, the Slovakia’s biomedical research infrastructure is to be better set for supporting excellent domestic research and development efforts, as well as for its involvement in high-quality international research collaborations and partnerships. Key words: biobanking, research infrastructure, Slovakia, ethics, legislation, public policy
Background and the Whys of the Initiative Biobanking belongs to the sine qua non-pre-requisites for successful integration of any country's biomedical research institutions into international research collaborations, including high-quality basic, pre-clinical and clinical pharmacology research projects. (2) In Slovakia, a country which, since 1990s has undergone a deep, complex transformation, including its health care and biomedical research system capacities (4-6), development of human cell and tissue banking for health care provision purposes mirrored closely similar developments in ‘Western Europe’. This included also further development of the pre-existing ethical and legislative framework to provide both the necessary ethical assurance and legal certainty for health care providers, organ, tissue or cell donors and transplant recipients (7, 8). It also enhanced the potential for international collaboration and exchange. These activities resulted in the establishment of well-characterized collections of human cells and tissues maintained by several tissue banks working especially at teaching hospitals and highly specialised, usually national clinical institutes, and used as appropriate in health care provision. Historic collections of human biological specimens, most of them having been taken for diagnostic purposes, have also been growing in hospital and university clinical pathology departments. More recently, these have been complemented by collections that had originated from prospective population studies and, mostly international, clinical drug trials. These collections already constitute an invaluable national resource. They are already usually in good, orderly shape, and some of them, more recently, have been made potentially connectible with relevant health information and even provided with necessary ethical and legal ‘tags’. However, the lack of modern, robust biobanking facilities has been seriously hampering excellence of scientific projects at the national level as well as the Slovakian researchers' participation in high-quality international research. The research use of collections mostly held within the afore-mentioned local health care providerowned banking structures has suffered from lack of adequate legal backing, appropriate funding, coordination, standardization of operating procedures and several other shortcomings. In particular, the necessary national legislation was missing to reflect recent developments in the European Union (EU) (3) as applicable to the biobanking sector. Therefore in 2017 the Slovak Ministry of Health, together with relevant national stakeholders, and with support of international partners (e.g. BBMRI-ERIC, ECRIN (10) via the recently established SLOVACRIN (9)), launched a multi-stakeholder initiative aimed to achieve the necessary structural and organizational breakthrough deemed necessary to establish and guarantee sustainable biobanking infrastructure in Slovakia. This should provide needed support and help to develop substantially the existing national infrastructure for biomedical research. These developments are to be co-financed from EU Structural Funds and the Slovak Republic National Budget. Developments Achieved within the Initiative (2017 – 2019) In 2017, the Ministry of Health of the Slovak Republic established the Department for Science and
2
Development, transformed in 2019 into the Institute for Research and Development, to lead the Initiative. (1) Active working contacts with national stakeholders (11) and international partners have subsequently been established. An Expert Working Group has been set up by the Department/Institute to advise on concrete steps for the Initiative, to provide the necessary know-how, to contribute to the professional activities of the Initiative, and to liaise with other activities in the Slovak Republic research infrastructure developments. Several multilateral expert meetings were held. A basic survey on the actual situation in the Slovak Republic was undertaken by the Department/Institute. This included information on the performance of the existing predominantly tissue banking facilities. As a result of these preliminary activities, a draft national project/strategy on establishing and development of a national system of biobanks in the Slovak Republic and its utilization in domestic or international research activities was elaborated by the Department/Institute. In view of soon to be issued Call directed to establishment of systemic research infrastructures, such as biobanks, which are to be financed via EU structural funds, the Ministry of Health plans to partner in such consortia. In 2018, The Slovak Clinical Research Infrastructure Network (SLOVACRIN) (9) was established and it has gained observer status in ECRIN. Current biomedical research legislation (7) had originally been developed and passed in 2004, with, since then, only a few, minor amendments. The above Expert Working Group started intensive drafting work on new biobanking legislation. However, it soon became obvious that a substantial amendment to existing biomedical research legislation was necessary, combined with amendments to other relevant legislature, instead of writing a special ‘law on biobanks’. This was for practical, technical and legislative reasons as well as a pressing shortage of time. Besides necessary new provisions covering in detail the establishment and actual work of biobanks, the existing legal provisions on biomedical research definition and scope, on research ethics committees, and informed consent had to be further developed. The new legislation proposal also contains provisions on the transfer to biobanks and subsequent research use of so-called ‘older samples’ and of samples that were originally not obtained for research purposes. As of writing this paper (August 2019), the finalised proposal is on track to be approved by the Ministry of Health and subsequently by the Legislation Office of the Government of the Slovak Republic, as a Governmental law proposal, with the aim to start, as soon as possible, legislative procedures by the Slovak Parliament (the National Council of the Slovak Republic), the first reading to take place in September or October 2019. The legislation is expected to pass rather smoothly, and hopefully to enter into force in January 2020. Biobanking, as a prerequisite of excellent biomedical research and development, is currently supported in a limited extend only, as allowed within the existing national legal framework, via systemic activities of the National Cancer Program 2018-2020 (financed by the Slovak Republic National Budget) and specifically reflected in its Action Plan under the Priority Area No. 5 – Promotion of cancer research and improved availability of clinical trials to patients. (1) This also includes establishment of the organisational-professional structure – ‘Oncoincubator’ intended to support academia and entrepreneurs turning ideas and innovations into scalable business entities with the initial focus on oncology applications (e.g. drug discovery, medical technology, diagnostics) with omics (i.e. genomics, transcriptomics, proteomics, cytometrics and metabolomics) platform tools.
Present and Near Future Challenges for the Initiative Despite considerable professional efforts, very positive institutional engagement? and well-secured support from the relevant national stakeholders (including the Slovak Government) that have been won for the Slovak ‘Biobanking Initiative' (1), there are still some risks entailed to be addressed accordingly. Though those are thought to be relatively mild, they still may, if not dealt with properly, hamper, slow, or even derail the whole Initiative. Among those, the ‘democratic' peculiarities of the legislative process may be mentioned. To overcome those, standing political support across the whole political spectrum is already sought and probably already secured. Another possible hurdle may be posed by cumbersome procedural issues in preparation and realization of the planned construction of new biobanking facilities, and reconstruction and substantial upgrading of existing capacities. These risks are hoped to be relatively low and manageable. Yet another risk consists of an overall and deepening shortage of appropriately trained and motivated personnel to run the biobanks (and related research facilities) at the desired level of quality. This is a more general and rather complex problem, which is nowadays faced by almost all countries of Central, Eastern and Southern Europe (and elsewhere) that are experiencing a considerable and long-term ‘brain drain’ in favour of countries
3
that are deemed more attractive for young researchers and highly qualified personnel. The building of a highquality (biomedical) research infrastructure, including biobanks, however, is seen by the Government, by the concerned national research institutions, and also by opinion-leading professionals, as one of the effective and necessary means to attract precisely those young, prospective, highly talented professionals and to convince them to return back to Slovakia’s research and clinical institutions after successfully completing high-quality postgraduate (doctoral and other) training abroad. The Slovak ‘Biobanking Initiative' is an important element within efforts by Slovakia to revitalize its research and development. It remains to be seen how successful the Initiative may prove itself to be, with obvious dependence upon willingness to allocate necessary national resources (material and human) to these vitally important developmental domains. Other practical questions relate to possible political changes in the Slovak Republic (with the approach of general elections in 2020) and respective changes of some national (including research) priorities and policies. These risks, however, are hoped in general to be rather unlikely to materialize, and even in the situation of a less positive scenario they are still deemed to be manageable. Another important challenge might be posed by the quality and relevance of the results of work by the biobanks, as well as by the speed (or rather slowness) of their involvement in international biobanking research and collaboration. This is where the quality of available manpower and of the conceptual and research work being able to be achieved comes to the forefront. Thus, success of the Slovak ‘Biobanking Initiative' depends upon the success of the development and innovations in the whole of Slovakia’s biomedical and other research sectors. (1) These reforms are already a long time overdue.
Conclusion A first national system of biobanks is aimed to be established within a short timeframe in Slovakia, using a combined top-down and bottom-up approach under the leadership of the Ministry of Health Institute for Science and Research: relevant national stakeholders and important international expert partner - institutions have been successfully taken on board and appropriately involved since the very beginning of this well-concerted initiative. State-of-the-art biobanking facilities are to be built anew to accommodate the Slovak National Biobank in the city of Martin in Central Slovakia, with a further major biobank in the city of Košice in Eastern Slovakia. Existing structures – future local biobanks – will be upgraded to achieve complete technical and logistical compatibility. This should allow Slovakia’s biobanking system to achieve full compliance with relevant international ethical, legal and professional standards. Comprehensive legislative activity started in 2018, aimed at comprehensive updating of the existing Slovak biomedical research and health care legislation to provide for the necessary legal framework. After the successful completion of the initiative, Slovakia’s biomedical research infrastructure will be better set for supporting excellent domestic research and development efforts, as well as better suited for involvement in high-quality international research collaborations and partnerships.
Abbreviations and Acronyms BBMRI-ERIC – The Biobanking and Biomolecular Resources Research Infrastructures – The European Research Infrastructure Consortium ECRIN – The European Clinical Research Infrastructure Network, a not-for-profit intergovernmental organisation that supports the conduct of multinational clinical trials in Europe. As of 2013, ECRIN has the legal status of a European Research Infrastructure Consortium (ERIC). EU – European Union SLOVACRIN – Slovak Clinical Research Infrastructure Network, has an observer status with ECRIN.
4
Notes and References 1.
Annual Report of the Ministry of Health of the Slovak Republic for the Year 2018 for the Area of Science, Research and Innovation, available (in Slovak) at https://www.health.gov.sk/Zdroje?/Sources/dokumenty/mzsr/vyrocne_spravy/Vyrocna-sprava-MZSR-2018veda.pdf (accessed August 9, 2019)
2.
European Commission, Directorate-General for Research and Innovation, Science in Society. Biobanks for Europe - A challenge for Governance. Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research. Publications Office of the European Union, Luxembourg, 2012, ISBN 978-92-79-22858-2, 63 pages, available at https://publications.europa.eu/en/publication-detail//publication/629eae10-53fc-4a52-adc2-210d4fcad8f2/language-en (accessed August 9, 2019)
3.
Examples (not complete): Regulation (Eu) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation); Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Clinical Trials Regulation).
4.
Glasa J. Bioethics and the Challenges of a Society in Transition: The Birth and Development of Bioethics in Post-Totalitarian Slovakia. Kennedy Institute of Ethics J 2000;10(2):165-170.
5.
Glasa J. Ethics Committees (HECs/IRBs) and Healthcare Reform in the Slovak Republic: 1990-2000. HEC Forum 2000; 12(4): 358-366.
6.
Glasa J. National Regulations on Ethics and Research in the Slovak Republic. Office for Official Publications of the European Communities, Luxembourg, 2003, ISBN 92-894-8092-0, 60 pgs.
7.
Law of the National Council of the Slovak Republic No. 576 of 21 October 2004 on healthcare, services related to the provision of health care and on amendments to certain laws as later amended (health law), available (in Slovak) at https://www.slov-lex.sk/static/pdf/2016/317/ZZ_2016_317_20170429.pdf (accessed August 9, 2019)
8.
Law of the National Council of the Slovak Republic No. 317 of October 19, 2019, on requirements and procedures for the collection and transplantation of human organs, human tissues and human cells and amending certain laws as later amended (transplant law), available (in Slovak) at https://www.slovlex.sk/static/pdf/2016/317/ZZ_2016_317_20170429.pdf (accessed August 9, 2019)
9.
SLOVACRIN – history, general information, activities and partners, available at https://slovacrin.sk/en/about-us/ (accessed August 9, 2019)
10. Statutes of The Biobanking and Biomolecular Resources Research Infrastructures - European Research Infrastructure Consortium (BBMRI-ERIC), available at http://www.bbmri-eric.eu/wpcontent/uploads/2016/07/BBMRI-ERIC_Statutes.pdf (accessed August 9, 2019) 11. The most important of those are as follows: SR Ministry of Education, Research and Sport, Slovak Academy of Sciences (several Institutes of the Academy are (to be) involved), University Faculties of Medicine in Slovakia, University Biomedical Research Parks in Slovakia, National Clinical Research Institutes in Slovakia, Departments of Clinical Research at the General and Teaching Hospitals, and others (see SLOVACRIN). (Other literature at the authors.)
Acknowledgements Helpful comments and editorial suggestions kindly provided by Professor Donald RJ Singer after reading the original manuscript are gratefully acknowledged by the authors.
5
Establishing a National Biobank. Biobanking Infrastructure Initiative in Slovakia - Public Policy, Legal and Ethical Issues ˇ ´ , Peter Cvapek Jozef Glasa , Drahom´ır Kollar , Helena Glasova´ , Martina Antoˇsova´ , Daniel Pella , Ivica Kvietikova´ PII: DOI: Reference:
S2211-8837(19)30076-0 https://doi.org/10.1016/j.hlpt.2019.11.005 HLPT 378
To appear in:
Health Policy and Technology
ˇ ´ , Peter Cvapek Please cite this article as: Jozef Glasa , Drahom´ır Kollar , Helena Glasova´ , Martina Antoˇsova´ , Daniel Pella , Ivica Kvietikova´ , Establishing a National Biobank. Biobanking Infrastructure Initiative in Slovakia - Public Policy, Legal and Ethical Issues, Health Policy and Technology (2019), doi: https://doi.org/10.1016/j.hlpt.2019.11.005
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Ltd on behalf of Fellowship of Postgraduate Medicine.
Establishing a National Biobank. Biobanking Infrastructure Initiative in Slovakia - Public Policy, Legal and Ethical Issues 2) Full names (first and surname) of all authors including academic degrees and affiliation(s) – indicated by numbers of the institutions given in the list below:
Jozef Glasa, Prof., MD, PhD, PhD1,2,3 Drahomír Kollár, PhDr.4 Peter Čvapek, Ing.4 Helena Glasová, Assist. Prof., MD, PhD1,2 Martina Antošová, Mgr, PhD, MBA5 Daniel Pella, Prof, MD, PhD6 Ivica Kvietiková, RNDr., PhD4
List of institutions: 1 Institute of Pharmacology and Clinical Pharmacology, Institute of Health Care Ethics, Slovak Medical University in Bratislava, Bratislava; Slovak Republic 2 Slovak Society of Clinical Pharmacology, o. b. Slovak Medical Association, Bratislava; Slovak Republic 3 Ethics Committee, Ministry of Health of the Slovak Republic, Bratislava; Slovak Republic 4 Institute of Research and Development, Ministry of Health of the Slovak Republic, Bratislava; Slovak Republic 5 Office of International and National Projects, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Martin; Slovak Republic 6 nd 2 Clinic of Cardiology, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Košice; Slovak Republic 3) Name, mailing and email addresses, telephone and fax numbers of corresponding author (with whom all correspondence will take place unless other arrangements are made) Prof. Jozef Glasa, MD, PhD, PhD. Slovak Medical University in Bratislava Limbová st. 12-14 833 03 Bratislava Slovak Republic e-mail: [email protected], [email protected] mobile phone: +421-905-208.146 office phone: +421-2-59370.547 4) Funding: None 5) Competing interests: None declared 6) Ethical approval: Not required 7) Acknowledgements: None 8) Key words: biobanking, research infrastructure, Slovakia, ethics, legislation, public policy 9) A running title (not more than 45 characters including spaces): BIOBANKING INFRASTRUCTURE INITIATIVE IN SLOVAKIA
1
Abstract Resulting from a multi-stakeholder initiative in 2017, a rapid process is underway in Slovakia with the aim of establishing a national system of biobanks by 2020. A combined top-down and bottom-up approach is being followed under the leadership of the Ministry of Health Institute for Research and Development. Relevant national stakeholders, with international expert partner institutions providing additional know how and networking, have been successfully involved since the very beginning of this initiative. State-of-the-art biobanking facilities are to be built in order to accommodate the Slovak National Biobank in the city of Martin (Central Slovakia) and the other major biobank in the city of Košice (Eastern Slovakia), while existing structures – future local biobanks – will be upgraded to achieve complete technical and logistical compatibility. This should enable full compliance of the Slovakia’s biobanking system with the appropriate international ethical, legal and professional standards. A related legislative activity has been started, aimed at a comprehensive updating of the existing Slovak biomedical research and health care legislation, to provide for the necessary legal certainty. After successful completion of the Initiative, the Slovakia’s biomedical research infrastructure is to be better set for supporting excellent domestic research and development efforts, as well as for its involvement in high-quality international research collaborations and partnerships. Key words: biobanking, research infrastructure, Slovakia, ethics, legislation, public policy
Background and the Whys of the Initiative Biobanking belongs to the sine qua non-pre-requisites for successful integration of any country's biomedical research institutions into international research collaborations, including high-quality basic, pre-clinical and clinical pharmacology research projects. (2) In Slovakia, a country which, since 1990s has undergone a deep, complex transformation, including its health care and biomedical research system capacities (4-6), development of human cell and tissue banking for health care provision purposes mirrored closely similar developments in ‘Western Europe’. This included also further development of the pre-existing ethical and legislative framework to provide both the necessary ethical assurance and legal certainty for health care providers, organ, tissue or cell donors and transplant recipients (7, 8). It also enhanced the potential for international collaboration and exchange. These activities resulted in the establishment of well-characterized collections of human cells and tissues maintained by several tissue banks working especially at teaching hospitals and highly specialised, usually national clinical institutes, and used as appropriate in health care provision. Historic collections of human biological specimens, most of them having been taken for diagnostic purposes, have also been growing in hospital and university clinical pathology departments. More recently, these have been complemented by collections that had originated from prospective population studies and, mostly international, clinical drug trials. These collections already constitute an invaluable national resource. They are already usually in good, orderly shape, and some of them, more recently, have been made potentially connectible with relevant health information and even provided with necessary ethical and legal ‘tags’. However, the lack of modern, robust biobanking facilities has been seriously hampering excellence of scientific projects at the national level as well as the Slovakian researchers' participation in high-quality international research. The research use of collections mostly held within the afore-mentioned local health care providerowned banking structures has suffered from lack of adequate legal backing, appropriate funding, coordination, standardization of operating procedures and several other shortcomings. In particular, the necessary national legislation was missing to reflect recent developments in the European Union (EU) (3) as applicable to the biobanking sector. Therefore in 2017 the Slovak Ministry of Health, together with relevant national stakeholders, and with support of international partners (e.g. BBMRI-ERIC, ECRIN (10) via the recently established SLOVACRIN (9)), launched a multi-stakeholder initiative aimed to achieve the necessary structural and organizational breakthrough deemed necessary to establish and guarantee sustainable biobanking infrastructure in Slovakia. This should provide needed support and help to develop substantially the existing national infrastructure for biomedical research. These developments are to be co-financed from EU Structural Funds and the Slovak Republic National Budget. Developments Achieved within the Initiative (2017 – 2019) In 2017, the Ministry of Health of the Slovak Republic established the Department for Science and
2
Development, transformed in 2019 into the Institute for Research and Development, to lead the Initiative. (1) Active working contacts with national stakeholders (11) and international partners have subsequently been established. An Expert Working Group has been set up by the Department/Institute to advise on concrete steps for the Initiative, to provide the necessary know-how, to contribute to the professional activities of the Initiative, and to liaise with other activities in the Slovak Republic research infrastructure developments. Several multilateral expert meetings were held. A basic survey on the actual situation in the Slovak Republic was undertaken by the Department/Institute. This included information on the performance of the existing predominantly tissue banking facilities. As a result of these preliminary activities, a draft national project/strategy on establishing and development of a national system of biobanks in the Slovak Republic and its utilization in domestic or international research activities was elaborated by the Department/Institute. In view of soon to be issued Call directed to establishment of systemic research infrastructures, such as biobanks, which are to be financed via EU structural funds, the Ministry of Health plans to partner in such consortia. In 2018, The Slovak Clinical Research Infrastructure Network (SLOVACRIN) (9) was established and it has gained observer status in ECRIN. Current biomedical research legislation (7) had originally been developed and passed in 2004, with, since then, only a few, minor amendments. The above Expert Working Group started intensive drafting work on new biobanking legislation. However, it soon became obvious that a substantial amendment to existing biomedical research legislation was necessary, combined with amendments to other relevant legislature, instead of writing a special ‘law on biobanks’. This was for practical, technical and legislative reasons as well as a pressing shortage of time. Besides necessary new provisions covering in detail the establishment and actual work of biobanks, the existing legal provisions on biomedical research definition and scope, on research ethics committees, and informed consent had to be further developed. The new legislation proposal also contains provisions on the transfer to biobanks and subsequent research use of so-called ‘older samples’ and of samples that were originally not obtained for research purposes. As of writing this paper (August 2019), the finalised proposal is on track to be approved by the Ministry of Health and subsequently by the Legislation Office of the Government of the Slovak Republic, as a Governmental law proposal, with the aim to start, as soon as possible, legislative procedures by the Slovak Parliament (the National Council of the Slovak Republic), the first reading to take place in September or October 2019. The legislation is expected to pass rather smoothly, and hopefully to enter into force in January 2020. Biobanking, as a prerequisite of excellent biomedical research and development, is currently supported in a limited extend only, as allowed within the existing national legal framework, via systemic activities of the National Cancer Program 2018-2020 (financed by the Slovak Republic National Budget) and specifically reflected in its Action Plan under the Priority Area No. 5 – Promotion of cancer research and improved availability of clinical trials to patients. (1) This also includes establishment of the organisational-professional structure – ‘Oncoincubator’ intended to support academia and entrepreneurs turning ideas and innovations into scalable business entities with the initial focus on oncology applications (e.g. drug discovery, medical technology, diagnostics) with omics (i.e. genomics, transcriptomics, proteomics, cytometrics and metabolomics) platform tools.
Present and Near Future Challenges for the Initiative Despite considerable professional efforts, very positive institutional engagement? and well-secured support from the relevant national stakeholders (including the Slovak Government) that have been won for the Slovak ‘Biobanking Initiative' (1), there are still some risks entailed to be addressed accordingly. Though those are thought to be relatively mild, they still may, if not dealt with properly, hamper, slow, or even derail the whole Initiative. Among those, the ‘democratic' peculiarities of the legislative process may be mentioned. To overcome those, standing political support across the whole political spectrum is already sought and probably already secured. Another possible hurdle may be posed by cumbersome procedural issues in preparation and realization of the planned construction of new biobanking facilities, and reconstruction and substantial upgrading of existing capacities. These risks are hoped to be relatively low and manageable. Yet another risk consists of an overall and deepening shortage of appropriately trained and motivated personnel to run the biobanks (and related research facilities) at the desired level of quality. This is a more general and rather complex problem, which is nowadays faced by almost all countries of Central, Eastern and Southern Europe (and elsewhere) that are experiencing a considerable and long-term ‘brain drain’ in favour of countries
3
that are deemed more attractive for young researchers and highly qualified personnel. The building of a highquality (biomedical) research infrastructure, including biobanks, however, is seen by the Government, by the concerned national research institutions, and also by opinion-leading professionals, as one of the effective and necessary means to attract precisely those young, prospective, highly talented professionals and to convince them to return back to Slovakia’s research and clinical institutions after successfully completing high-quality postgraduate (doctoral and other) training abroad. The Slovak ‘Biobanking Initiative' is an important element within efforts by Slovakia to revitalize its research and development. It remains to be seen how successful the Initiative may prove itself to be, with obvious dependence upon willingness to allocate necessary national resources (material and human) to these vitally important developmental domains. Other practical questions relate to possible political changes in the Slovak Republic (with the approach of general elections in 2020) and respective changes of some national (including research) priorities and policies. These risks, however, are hoped in general to be rather unlikely to materialize, and even in the situation of a less positive scenario they are still deemed to be manageable. Another important challenge might be posed by the quality and relevance of the results of work by the biobanks, as well as by the speed (or rather slowness) of their involvement in international biobanking research and collaboration. This is where the quality of available manpower and of the conceptual and research work being able to be achieved comes to the forefront. Thus, success of the Slovak ‘Biobanking Initiative' depends upon the success of the development and innovations in the whole of Slovakia’s biomedical and other research sectors. (1) These reforms are already a long time overdue.
Conclusion A first national system of biobanks is aimed to be established within a short timeframe in Slovakia, using a combined top-down and bottom-up approach under the leadership of the Ministry of Health Institute for Science and Research: relevant national stakeholders and important international expert partner - institutions have been successfully taken on board and appropriately involved since the very beginning of this well-concerted initiative. State-of-the-art biobanking facilities are to be built anew to accommodate the Slovak National Biobank in the city of Martin in Central Slovakia, with a further major biobank in the city of Košice in Eastern Slovakia. Existing structures – future local biobanks – will be upgraded to achieve complete technical and logistical compatibility. This should allow Slovakia’s biobanking system to achieve full compliance with relevant international ethical, legal and professional standards. Comprehensive legislative activity started in 2018, aimed at comprehensive updating of the existing Slovak biomedical research and health care legislation to provide for the necessary legal framework. After the successful completion of the initiative, Slovakia’s biomedical research infrastructure will be better set for supporting excellent domestic research and development efforts, as well as better suited for involvement in high-quality international research collaborations and partnerships.
Abbreviations and Acronyms BBMRI-ERIC – The Biobanking and Biomolecular Resources Research Infrastructures – The European Research Infrastructure Consortium ECRIN – The European Clinical Research Infrastructure Network, a not-for-profit intergovernmental organisation that supports the conduct of multinational clinical trials in Europe. As of 2013, ECRIN has the legal status of a European Research Infrastructure Consortium (ERIC). EU – European Union SLOVACRIN – Slovak Clinical Research Infrastructure Network, has an observer status with ECRIN.
4
Notes and References 1.
Annual Report of the Ministry of Health of the Slovak Republic for the Year 2018 for the Area of Science, Research and Innovation, available (in Slovak) at https://www.health.gov.sk/Zdroje?/Sources/dokumenty/mzsr/vyrocne_spravy/Vyrocna-sprava-MZSR-2018veda.pdf (accessed August 9, 2019)
2.
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Law of the National Council of the Slovak Republic No. 317 of October 19, 2019, on requirements and procedures for the collection and transplantation of human organs, human tissues and human cells and amending certain laws as later amended (transplant law), available (in Slovak) at https://www.slovlex.sk/static/pdf/2016/317/ZZ_2016_317_20170429.pdf (accessed August 9, 2019)
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Acknowledgements Helpful comments and editorial suggestions kindly provided by Professor Donald RJ Singer after reading the original manuscript are gratefully acknowledged by the authors.
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