BIA submission to MHRA fees consultation

BIA responds to MHRA consultation on statutory fees

Last week the BIA responded to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on proposals to increase statutory fees. The consolidated BIA response was developed with input from our Regulatory Affairs Advisory Committee. We provided BIA members’ feedback on the following proposals and the impact of these proposed changes on the innovative life sciences industry including SMEs, which would apply from 1 April 2023:

  1. A 10% indexation uplift across the Agency’s statutory fees.
  2. A further uplift for 61 significantly under recovering fees, on top of the indexation uplift, to achieve cost recovery.
  3. The introduction of 22 new fees for services that require cost-recovery since the last fee changes for medicines and medical devices.

Generally, BIA member organisations would support the proposals. This will ensure the MHRA is adequately resourced with talented and experienced staff and financially sustainable in the long term, benefiting both the life sciences industry and UK patients while protecting public health.

However, these proposals are likely to have a disproportionate impact on SMEs that are developing innovative therapies. The BIA is advocating for fee reductions and waivers for the Innovative Licensing and Access Pathway (ILAP) and the Early Access to Medicines Scheme (EAMS) for SMEs to support and encourage innovation in the UK.

It is worth adding that the proposals in this consultation could have an impact on the development and access to medicines for rare conditions. The increasing costs for scientific advice mechanisms and medical device assessment may discourage some companies developing products for smaller patient populations from making marketing authorisation applications or device submissions in Great Britain.

It is important that the consultation outcome supports the ambitions of the Life Sciences Vision and ensures that a world-leading regulatory agency can fulfil its regulatory functions and deliver responsive and efficient services for the life sciences and biotech industry.

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