Adverse clinical trials not only affect the participants but will have a serious impact on valuation of the biotech company and its ability to raise capital for future R&D. Proposals for clinical trials of drugs and medical devices, whether conducted in Australia or overseas, require careful planning, scrutiny and independent expert and legal review to minimise the risk of serious adverse reaction or informed consents being invalidated. Reporting of test results must be accurate so that existing and potential investors are not mislead as to the drugs potential for regulatory approval and commercialisation. Independent review and audit of clinical trial processes and results can be used to limit the company’s and its directors’ exposure to legal claims.
Regulatory Approval of Therapeutic Goods
The import, export, manufacture or supply of drugs and medical devices in Australia require regulatory approval by the Therapeutic Goods Administration ( ‘TGA’). The process can be complex and lengthy.
The Australia-US Trade Agreement has resulted in a number of changes to the application and registration process. Companies relying on third party data of a registered drug to establish safety or efficacy of their product, as a part of the TGA approval process, must provide the TGA with a certification as to whether the marketing of the product will infringe an existing Australian patent. Where a certification has been provided, the patent owner cannot commence legal proceedings for infringement until it assures the TGA that the proceedings will be commenced in goods faith, have reasonable prospects of success and will be conducted without unreasonable delay. Significant penalties are imposed where false or misleading certifications are provided.
We assist our clients with the regulatory process including advice with respect to patent infringement or invalidity.
Links to Publications
© Stephens Lawyers & Consultants, June 2009. Written by Katarina Klaric.
Disclaimer: This is not intended to be a substitute for obtaining legal advice.