TY - JOUR
T1 - Access to bacteriophage therapy
T2 - Discouraging experiences from the human cell and tissue legal framework
AU - Verbeken, G.
AU - Huys, I.
AU - De Vos, D.
AU - De Coninck, A.
AU - Roseeuw, D.
AU - Kets, E.
AU - Vanderkelen, A.
AU - Draye, J. P.
AU - Rose, T.
AU - Jennes, S.
AU - Ceulemans, C.
AU - Pirnay, J. P.
N1 - Publisher Copyright:
© FEMS 2015. All rights reserved.
PY - 2016/1/21
Y1 - 2016/1/21
N2 - Cultures of human epithelial cells (keratinocytes) are used as an additional surgical tool to treat critically burnt patients. Initially, the production environment of keratinocyte grafts was regulated exclusively by national regulations. In 2004, the European Tissues and Cells Directive 2004/23/EC (transposed into Belgian Law) imposed requirements that resulted in increased production costs and no significant increase in quality and/or safety. In 2007, Europe published Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products. Overnight, cultured keratinocytes became (arguably) 'Advanced' Therapy Medicinal Products to be produced as human medicinal products. The practical impact of these amendments was (and still is) considerable. A similar development appears imminent in bacteriophage therapy. Bacteriophages are bacterial viruses that can be used for tackling the problem of bacterial resistance development to antibiotics. Therapeutic natural bacteriophages have been in clinical use for almost 100 years. Regulators today are framing the (re-)introduction of (natural) bacteriophage therapy into 'modern western' medicine as biological medicinal products, also subject to stringent regulatory medicinal products requirements. In this paper, we look back on a century of bacteriophage therapy to make the case that therapeutic natural bacteriophages should not be classified under the medicinal product regulatory frames as they exist today. It is our call to authorities to not repeat the mistake of the past.
AB - Cultures of human epithelial cells (keratinocytes) are used as an additional surgical tool to treat critically burnt patients. Initially, the production environment of keratinocyte grafts was regulated exclusively by national regulations. In 2004, the European Tissues and Cells Directive 2004/23/EC (transposed into Belgian Law) imposed requirements that resulted in increased production costs and no significant increase in quality and/or safety. In 2007, Europe published Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products. Overnight, cultured keratinocytes became (arguably) 'Advanced' Therapy Medicinal Products to be produced as human medicinal products. The practical impact of these amendments was (and still is) considerable. A similar development appears imminent in bacteriophage therapy. Bacteriophages are bacterial viruses that can be used for tackling the problem of bacterial resistance development to antibiotics. Therapeutic natural bacteriophages have been in clinical use for almost 100 years. Regulators today are framing the (re-)introduction of (natural) bacteriophage therapy into 'modern western' medicine as biological medicinal products, also subject to stringent regulatory medicinal products requirements. In this paper, we look back on a century of bacteriophage therapy to make the case that therapeutic natural bacteriophages should not be classified under the medicinal product regulatory frames as they exist today. It is our call to authorities to not repeat the mistake of the past.
KW - Advanced therapy medicinal products
KW - Bacteriophage therapy
KW - Biological medicinal products
KW - Hospital exemption
KW - Keratinocytes
KW - regulatory
UR - http://www.scopus.com/inward/record.url?scp=84960171994&partnerID=8YFLogxK
U2 - 10.1093/femsle/fnv241
DO - 10.1093/femsle/fnv241
M3 - Article
C2 - 26678555
AN - SCOPUS:84960171994
SN - 0378-1097
VL - 363
JO - FEMS Microbiology Letters
JF - FEMS Microbiology Letters
IS - 4
M1 - fnv241
ER -