Introduction
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Amgen Australia Pty Ltd
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 25 – The Review heard that there may be areas of overlapping regulatory oversight between the Gene technology regulator and some product regulators, and that work could be undertaken to investigate potential solutions and any required legislative changes.
Amgen agrees with the finding, and strongly supports the undertaking of any work to explore the harmonisation of the OGTR’s reporting timeframes for adverse events (AEs) for Licensed Dealings involving genetically modified (GM) therapeutic goods with those of the Therapeutic Goods Administration (TGA).
Finding 26 – The Review heard that there are potential mechanisms in other schemes (for example, the Therapeutic Goods Act 1989 Special Access Scheme) that could be adopted to strengthen the Scheme, and there may be benefit in additional investigation being undertaken.
The Special Access Scheme, as administered by the Therapeutic Goods Administration, allows patient access to unapproved therapeutic goods on a case by case basis where there is a demonstrable clinical need. Amgen strongly supports the Special Access Scheme and is supportive of any efforts by the Department of Health to investigate whether a similar provision could be adopted under the Gene Technology Scheme, facilitating timely access to therapeutic goods for patients whilst ensuring appropriate checks and balances are in place to manage any potential risks.
Amgen agrees with the finding, and strongly supports the undertaking of any work to explore the harmonisation of the OGTR’s reporting timeframes for adverse events (AEs) for Licensed Dealings involving genetically modified (GM) therapeutic goods with those of the Therapeutic Goods Administration (TGA).
Finding 26 – The Review heard that there are potential mechanisms in other schemes (for example, the Therapeutic Goods Act 1989 Special Access Scheme) that could be adopted to strengthen the Scheme, and there may be benefit in additional investigation being undertaken.
The Special Access Scheme, as administered by the Therapeutic Goods Administration, allows patient access to unapproved therapeutic goods on a case by case basis where there is a demonstrable clinical need. Amgen strongly supports the Special Access Scheme and is supportive of any efforts by the Department of Health to investigate whether a similar provision could be adopted under the Gene Technology Scheme, facilitating timely access to therapeutic goods for patients whilst ensuring appropriate checks and balances are in place to manage any potential risks.