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A New Regulatory Framework for Platelet-Rich Plasma in Spain
05 February 2015
06 February 2015
30 April 2015 (online)
We have read with interest the article recently published by Fiorentino et al in the February issue of the Journal of Knee Surgery and entitled “European Definitions, Current Use, and EMA Stance of Platelet-Rich Plasma in Sports Medicine.”
The European regulatory framework that governs the use of platelet-rich plasma (PRP) in the European community is accurately outlined in this letter. Initially, the authors describe the common regulatory framework throughout Europe and subsequently detail the particular cases of four members of the European Union (EU), including Italy, Spain, France, and Germany. Furthermore, they provide information about the regulations in Switzerland, which despite not being an EU member state complies with the principles of the Directive 2002/98/EC.
Addressing the regulatory framework in Spain, we would like to make several remarks as the regulation has been recently updated. In May 2013, the Spanish Agency of Medicines and Medical Devices (AEMPS) together with different experts in the field of PRPs has performed a resolution establishing the classification of nonreplacement therapeutic use of autologous plasma and its fractions, components, or derivatives as a medicinal product for human use to meet specialized needs. In this resolution and in the accompanying report, the PRP is classified as a nonindustrial biological medicine for human use. In the same line, the AEMPS asserts that in Spain, the PRP therapy cannot be considered as an advanced-therapy medicinal product. In this way, with this new regulatory frame, the AEMPS aims to ensure quality, efficacy, traceability, information, and pharmacovigilance, as for conventional medicinal products.
Therefore, it is right that the authors comment that PRP therapy is governed by the Royal Decree 1088/2005 of September 16, 2005, but the current rule we are addressing is posterior (2013), and regulates more precisely this type of treatments as a human use medicinal product, according to the European definition of medicinal product reflected in the community code.
We fully agree with the authors that there is a lack of homogeneity among the different member of the countries of the EU and the need to reach a consensus to promote and ensure the safe use of PRP therapy in all member states, both in the sports medicine and in other fields of medicine. The new Spanish PRP regulatory framework represents a new context and potentially new situation for these types of autologous therapies. Being considered as medicines, the requirements in terms of fabrication, traceability, efficacy, safety, and information for patients should be more tight and demanding. Significantly, efforts are still necessary to ensure that all PRP products being used fulfill these requirements and therefore can be considered safe and predictable. Unfortunately, the long way has just begun. A more general European agreement on this topic would definitely push this field forward.
- 1 Fiorentino S, Roffi A, Filardo G, Marcacci M, Kon E. European definitions, current use, and EMA stance of platelet-rich plasma in sports medicine. J Knee Surg 2015; 28 (1) 51-54
- 2 Official Journal of the European Union. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:033:0030:0040:EN:PDF . Accessed February 4, 2015
- 3 Spanish Agency of Medicines and Medical Devices. Resolution establishing the classification of non-replacement therapeutic use of autologous plasma and its fractions, components or derivatives as a medicinal product for human use to meet specialised needs. [Resolución por la que se establece la clasificación del uso terapéutico no sustitutivo del plasma autólogo y sus fracciones, componentes o derivados, como medicamentos de uso humano para atender necesidades especiales.] Available at: http://www.aemps.gob.es/legislacion/espana/medicamentosUsoHumano/docs/medEspeciales/resolucion-PRP.pdf . Accessed February 4, 2015
- 4 Spanish Agency of Medicines and Medical Devices. REPORT/V1/23052013. The Spanish Agency of Medicines and Health Care Products' report on the use of Platelet-Rich Plasma. [Informe de la Agencia Española de Medicamentos y Productos Sanitarios sobre el uso de Plasma Rico en Plaquetas.] Available at: http://www.aemps.gob.es/medicamentosUsoHumano/medSituacionesEspeciales/docs/PRP-AEMPS-DEF-mayo13.pdf . Accessed February 4, 2015
- 5 Official Journal of the European Communities. 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. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons/dir2001_83_cons_20081230_en.pdf . Accessed February 4, 2015