Abstract
In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the FDA in 2012, the commercialization of medicinal or industrial products produced in the field has yet to emerge in either Europe or the US. In the current paper, we discribe the regulatory environment in Europe and the US surrounding GM crops, and provide case studies for experimental field releases of PMP and PMI producing plants in both regions. Suggestions for reducing the regulatory burden for GM plants will be discussed, also in light of the emerging new technologies to modify the genetics of plants. Since regulations surrounding the commercialization of GM crops are very costly and not appropriate for most of the PMP/PMI applications in Europe, we propose that amendments to the EU Directive 2001/18/EC are necessary to allow for the commercialization of products from GM plants without the need of an ‘authorization’. To fully acknowledge the overall outcome of adopting plants to produce PMP/PMI, the conclusion is that broader and more balanced legislative oversight is needed in Europe; while specific legislation is not needed in the US.
Keywords: Plant molecular farming (PMF), plant made pharmaceuticals (PMP), plant made industrials (PMI), genetically modified plants, GM plant regulation, GM plant risk assessment.
Current Pharmaceutical Design
Title:Risk Assessment and Regulation of Molecular Farming - A Comparison between Europe and US
Volume: 19 Issue: 31
Author(s): Penelope Sparrow, Inge Broer, Elizabeth E. Hood, Kellye Eversole, Frank Hartung and Joachim Schiemann
Affiliation:
Keywords: Plant molecular farming (PMF), plant made pharmaceuticals (PMP), plant made industrials (PMI), genetically modified plants, GM plant regulation, GM plant risk assessment.
Abstract: In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the FDA in 2012, the commercialization of medicinal or industrial products produced in the field has yet to emerge in either Europe or the US. In the current paper, we discribe the regulatory environment in Europe and the US surrounding GM crops, and provide case studies for experimental field releases of PMP and PMI producing plants in both regions. Suggestions for reducing the regulatory burden for GM plants will be discussed, also in light of the emerging new technologies to modify the genetics of plants. Since regulations surrounding the commercialization of GM crops are very costly and not appropriate for most of the PMP/PMI applications in Europe, we propose that amendments to the EU Directive 2001/18/EC are necessary to allow for the commercialization of products from GM plants without the need of an ‘authorization’. To fully acknowledge the overall outcome of adopting plants to produce PMP/PMI, the conclusion is that broader and more balanced legislative oversight is needed in Europe; while specific legislation is not needed in the US.
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Cite this article as:
Sparrow Penelope, Broer Inge, Hood E. Elizabeth, Eversole Kellye, Hartung Frank and Schiemann Joachim, Risk Assessment and Regulation of Molecular Farming - A Comparison between Europe and US, Current Pharmaceutical Design 2013; 19 (31) . https://dx.doi.org/10.2174/1381612811319310007
DOI https://dx.doi.org/10.2174/1381612811319310007 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
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