Osimertinib Cancer Treatment

Lord Lansley Excerpts

Tuesday 18th May 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, we are watchful of the concerns to which the noble Lord refers but it is our hope and aspiration that there will not be the kind of delays or trouble that he explained. The Northern Ireland protocol means that Northern Ireland will stay aligned with EU rules, particularly for this kind of specific cancer medicine, but that does not mean that there need to be any delays. However, we are watching the situation carefully and the report that he described will give a full account of the problems, if there are any.

[Lord Lansley (Con)]

Can my noble friend, in this instance at least, explain the divergence between the MHRA and the European Medicines Agency? On 22 April, the EMA’s Committee for Medicinal Products for Human Use gave a positive opinion under an accelerated assessment, but the EMA has not yet given the new indication of marketing authorisation. What is the potential gap between MHRA authorisation and EMA authorisation?

[Lord Bethell (Con)]

My noble friend is, as ever, all over the detail. It is my understanding that the gap is a matter of weeks rather than there being any clinical divergence in assessment of the evidence. However, I am afraid to say that I would have to leave it to the EMA to think for itself on that.