Abstract
Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.
Highlights
Cell-based therapies have been available in veterinary medicine for years and are currently experiencing a growing demand
The practice of sending tissue such as bone marrow, fat, or blood as well as cells to a laboratory to get a usable product in return, or of acquiring finished products from national or even international suppliers is a legal minefield for the veterinarian, in as much as it is unclear for the veterinarian whether the third-party manufacturer holds an official European Union (EU) law compliant manufacturing license
Veterinary pharmaceutical law is currently being reformed on the European level
Summary
Cell-based therapies have been available in veterinary medicine for years and are currently experiencing a growing demand. They do play an import role within the preclinical testing of cell-based pharmaceuticals for human use but rather as cell-based therapies for animals per se [1, 2] Such cell-based therapies can, especially when performable in mammals, Veterinary Stem Cell Law in the EU serve as an example for the development of respective cell-based therapies for human use. Veterinarians across the European Union (EU) already offer such cell-based therapies to their clients and prepare the necessary cell-based therapy products either themselves or obtain them from suppliers in their respective member state or from abroad Despite their actual dissemination and meaning, for the development of pharmaceuticals for human use, (stem) cell-based pharmaceuticals for veterinary use have been widely ignored by legal practice, and no special-law provisions have been issued compared to (stem) cell-based pharmaceuticals for human use. The current EU and national legislations on veterinary medicines need to be reformed so as to bring about such legislative and actual improvements, which reflect the meaning of cell-based pharmaceuticals for veterinary use for the development of cell-based pharmaceuticals for human use
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