We welcome this legislation coming forward as we believe many of the reforms covered by the review are overdue. This Bill set the groundwork for us to modernise the way we regulate medicines and medical devices and ensure that consumers can have the confidence to use them.
Whilst we do provide some comments on the key issues covered in the legislation we think it is important that they are looked at as a package. In particular we draw the Committee’s attention to the reforms to strengthen post-marketing activity which were a key theme in our Submission to the initial review. The move to improve adverse event reporting and have more post market monitoring and surveillance is critical to ensuring the integrity of the system. The reforms to this component of the regulators work cannot be overemphasised from a consumer confidence perspective and without this many of the other proposed reforms would not be acceptable.