PLAYING A FORTUNE-TELLER AND GETTING READY FOR THE BIG GAME: BEING READY FOR EMA TO BUILD A BRIDGE BETWEEN CODED AND SEMI-STRUCTURED DATA BY VIRTUE OF A DIGITAL FIT STRATEGY

  • Arturs Mietulis MD, MPH, LL.M, «Miolars» consultancy, Riga, Latvia
Keywords: European Medicines Agency (EMA), common standards for data, data silo, reuse of standardised data, pharmacovigilance.

Abstract

The article deals with digital solutions in the field of healthcare. The author outlines pros and cons of new modern technologies, including big data and its analysis techniques in the said field. The activity of the European Medicines Agency as a model for developing promising data strategies for internal reuse of standardized data has been analyzed. The importance of investing in pharmacological examination has been substantiated.

References

2011/C 172/01, Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clini- cal trials on medicinal products for human use (2011). Brussels: European Commission.

Bernard Marr & Co.(2020). Data Use Case Template. Accessed on 4 July 2020. URL: https://www.bernardmarr.com/img/PDF%20Templates-2.pdf

Cavanillas, J. M., Curry, E. & Wahlster, W. (2016). New horizons for a data-driven economy: A roadmap for usage and exploitation of Big Data in Europe. Cham: Springer International Publishing. p. 4.

COM(2017) 135 final, Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (2017). Brussels: European Commission.

COM(2018) 233 final, Communication from the Commission to the European Par- liament, the Council, the European Economic and Social Committee and the Committee of Regions on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society (2018). Brussels: European Commission.

COM(2013) 472 final – 2013/0222 (COD), Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmaco- vigilance activities in respect of medicinal products for human use’. Brussels: European Economic and Social Committee.

Cordon, C., Garcia-Milà, P., Ferreiro Vilarino, T. & Caballero, P. (2016). Strategy is digital: How companies can use Big Data in the value chain. Lausanne: Springer Inter- national Publishing, p. 16-18.

Davis T. (1994). Adopting a policy of reuse. IEEE Spectrum, 31:6, 44-48. doi: 10.1109/6.284792.

Van Dijck, J. (2014). Datafication, dataism and dataveillance: Big Data between scientific paradigm and ideology. Surveilance & Society, 12:1, 197-208.

Dimitrov W., Syarova S., Petkova L. (2018). Types of dark data and hidden cyber- security risks. Epub ahead of print. doi: 10.13140/RG.2.2.31695.43681.

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (2018). Brussels: European Commission.

eHAction – Joint Action Supporting the eHealth Network (2019). Deliverable 6.1 Preparation and background for a roadmap on future eHDSI use cases and feature. Accessed on the 27 May 2020. URL: https://ec.europa.eu/health/sites/health/files/ehealth/ docs/ev_20190611_co212_en.pdf

Electronic product information for human medicines in the EU: key principles A joint EMA–HMA–EC collaboration (2020). Amsterdam: European Medicines Agency.

Elish M.C, Boyd D. (2018). Situating methods in the magic of Big Data and AI, Communication Monographs, 85:1, 57-80. doi: 10.1080/03637751.2017.1375130.

EMA/111947/2015, Task Force for the implementation of International Standards on Identification of Medicinal Products in the EU (i.e. EU IDMP/SPOR Task Force) (2015). London: European Medicines Agency.

EMA/193130/2012, European Medicines Agency Information and Communications Technology Standards (2010). London: European Medicines Agency.

EMA/503895/2018, New Organization First User QPPV/RP or Change of EU QPPV/ RP (2019). Amsterdam: European Medicines Agency.

EMA/676106/2019, Products Management Services – Implementation of International Organization for Standardization (ISO) standards for the identifica- tion of medicinal products (IDMP) in Europe (2021). Amsterdam: European Medicines Agency.EMA/680018/2017, EMA action plan related to the European Commission’s recom- mendations on product information (2018). London: European Medicines Agency.

EMA/680018/2017, EMA action plan related to the European Commission’s recom- mendations on product information (2018). London: European Medicines Agency.

EMA/732656/2015, Introduction to ISO Identification of Medicinal Products, SPOR programme (2015). London: European Medicines Agency.

Ernst & Young Global Limited (2015). Beyond standard procedure: how to take advantage of new rules on medical product data. Accessed on the 5 June 2020. URL: https:// www.de.ey.com/Publication/vwLUAssets/EY-getting-ready-for-the-Identification-of-medic- inal-products/$FILE/EY-getting-ready-for-the-Identification-of-medicinal-products.pdf

European Commission (2017). Legal framework governing medicinal products for human use in the EU. Accessed on the 1 June 2020. URL: https://ec.europa.eu/health/ human-use/legal-framework_en.

European Commission Decision C(2017)2468 of 24 April 2017 (2017). Horizon 2020, Work Programme 2016-2017, 8. Health, demographic change and well-being, SC1- PM-18-2016 – Big Data supporting Public Health policies. Brussels: European Commission.

European Directorate for the Quality of Medicines (2020). European Pharmaco- poeia (Ph. Eur.) 10th Edition.

European Medicines Agency (2015). Substance, product, organisation and referen- tial (SPOR) master data. Accessed on 31 May 2020. URL: https://www.ema.europa.eu/en/ human-regulatory/research-development/data-medicines-iso-idmp-standards/substance- product-organisation-referential-spor-master-data.

Gal M., Rubinfeld D.L. (2019). Data Standardization. NYU Law Review (2019) Forthcoming, 737:94, 737-770.

Kirmse A., Kraus V., Hoffmann M., Meisen T. (2019). An Architecture for Efficient Integration and Harmonization of Heterogeneous, Distributed Data Sources Enabling Big Data Analytics. Proceedings of the 20th International Conference on Enter- prise Information Systems (ICEIS 2018), pp. 175-182, ISBN: 978-989-758-298-1, doi: 10.5220/0006776701750182.

Lazer, D., Radford J. (2017). Data ex Machina: Introduction to Big Data. Annu. Rev. Sociol., 43, 19-39. doi: 10.1146/annurev-soc-060116-053457.

Open Data Institute. The Data Spectrum. Accessed on 20 May 2020. URL: https:// theodi.org/about-the-odi/the-data-spectrum/

Porter M. E. (1991). Towards a dynamic theory of strategy. Strategic Management Journal, 12, 95-117.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (2004). Brussels: European Commission.

Roghé F., Toma A., Messenböck R., Kempf S., Marchingo M. (2013). Breaking free of the silo. Creating Lasting competitive advantage through shared services. The Boston Consulting Group.

Tames J. (2013). A New, Evidence-Based Estimate of Patient Harms Associated With Hospital Care. J Patient Saf, 9:3, 122-128. doi: 10.1097/PTS.0b013e3182948a69.

The content of summary of product characteristics is described in Article 11 of Directive 2001/83/EC.

Author Biography

Arturs Mietulis, MD, MPH, LL.M, «Miolars» consultancy, Riga, Latvia

MD, MPH, LL.M, «Miolars» consultancy, Riga, Latvia miolars@inbox.lv

Published
2021-02-22
How to Cite
Mietulis, A. (2021). PLAYING A FORTUNE-TELLER AND GETTING READY FOR THE BIG GAME: BEING READY FOR EMA TO BUILD A BRIDGE BETWEEN CODED AND SEMI-STRUCTURED DATA BY VIRTUE OF A DIGITAL FIT STRATEGY. Medicne Pravo, (1(27), 78-90. https://doi.org/10.25040/medicallaw2021.01.078
Section
Articles