To ask Her Majesty’s Government whether Osimertinib (Tagrisso), a cancer treatment drug recently approved by the Medical and Healthcare products Regulatory Agency, will be available to residents of Northern Ireland (1) on the same timescale, and (2) with the same ease of access, as in the rest of the United Kingdom.
My Lords, the innovative lung cancer drug Tagrisso has recently had its licence expanded to include patients with early-stage lung cancer through Project Orbis. I am pleased to confirm that Tagrisso is currently available to all patients, including in Northern Ireland, at clinical discretion with no delays. The UK Government are committed to supporting parity of access to medicines across all parts of the UK.
My Lords, people will be reassured to hear that but the fact of the matter is, surely, that the use of this drug for early treatment of lung cancer remains subject to the approval of the EMA and access at the moment is available on application by clinicians on an individual-case basis, which is not the same ease of access as exists in the rest of the UK. While it may be of some assurance that the EMA is expected to approve the drug’s use for early treatment in the near future, that remains wholly outside the Government’s control. What does that say about the integrity of our National Health Service and for how long can this situation go on?
My Lords, we estimate that there are currently just eight patients in Northern Ireland who would benefit from the expanded use of Tagrisso for early-stage disease. Perhaps I may reassure my noble friend that they will all have the same access as in the rest of the United Kingdom without any delay or restraint on that access.
My Lords, we should all wholeheartedly welcome the news of the agreement to enable early access to Osimertinib for early-stage lung cancer patients in England and I absolutely recognise that it is also available to patients in Northern Ireland. However, early diagnosis is as important as access to treatment. It is therefore deeply concerning that the number of people in England and, presumably, across the UK being seen by a specialist for suspected cancer, following urgent referral from their GP, has dropped dramatically. What steps are the Government taking to bring those waiting lists down? We certainly cannot wait for a reorganisation of the NHS, as proposed this year. Does the noble Lord acknowledge that reorganisations tend to have a chilling effect on the recovery of our NHS?
The noble Baroness is entirely right to be concerned about the backlog of oncological diagnostics. It is of grave concern to all of us. That is why the NHS has massively prioritised the tests she described. We are working extremely hard to get through the backlog. GPs are extremely focused on identifying those most at risk and those who are late for their tests are being followed up with great energy and endeavour. I pay tribute particularly to the role of NHS D, which is using the kind of data gains that we made during the pandemic to mobilise all the technology we can to get the right people into tests at the right time.
I am really pleased that this drug can now be used as I understand that it is something of a wonder drug. That is good news. Are there any other drugs that might fall foul of the Northern Ireland protocol? Will the Minister update the House on the current problems in Northern Ireland with over-the-counter medicines such as Strepsils and others that appear to have fallen foul of the protocol?
My Lords, can the Minister confirm that the Northern Ireland protocol runs the risk of medicines not being available, that there will be divergence in the availability of medicines—and, importantly, medical devices—because the approval process might be different, and that the Government are due to report in six months on the effect of that divergence?
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.
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?
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.
My Lords, the noble Baroness, Lady Thornton, rightly mentioned waiting lists. According to the most recent statistics, 9% of the population in England are on hospital waiting lists—the highest figure since records began in 2007. In Northern Ireland, the figure is 23% of the population, by far the highest proportion in the four home nations. The drug that we are discussing has been widely used in Northern Ireland to treat mid and late-stage lung cancer until now. Cancer patients in Northern Ireland now feel that they are being placed at greater risk than cancer patients elsewhere in the United Kingdom. Will the Minister confirm that the supply problems that Northern Ireland is facing would not exist if the United Kingdom Government had not agreed to the European Medicines Agency having jurisdiction in Northern Ireland?
My Lords, I do not agree with either the basis or detail of the noble Lord’s assertion. There is absolutely no delay or problem of access for this drug. He is entirely right to say that Tagrisso is currently offered to patients across the UK, including Northern Ireland, for mid and late-stage disease and it will now be offered to patients across the UK, including Northern Ireland, on exactly the same terms for early-stage disease.
My Lords, Northern Ireland is subject to EU law when it comes to the single market for goods and medicines because there is a grace period until 31 December 2021. After that, say representatives of the pharmaceutical industry, the supply of 98% of medicines from Great Britain to Northern Ireland is at risk of being discontinued. That is a truly outrageous and scandalous situation. The effects are already being felt. Can the Minister confirm that the Government will take whatever steps are necessary in terms of the protocol to guarantee the continued supply of medicines to Northern Ireland from Great Britain without any further regulation being required?