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Osimertinib Cancer Treatment

Volume 812: debated on Tuesday 18 May 2021

Private Notice Question

Asked by

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, I am not aware of a Strepsil shortage in Northern Ireland but I would be glad to write to the noble Baroness if I have any information.

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?

My Lords, I have met with industry on this matter for the past 18 months. I am afraid that the message I get from it is not of the alarmist kind that the noble Lord described—quite the opposite. I pay tribute to the industry for its enormously collaborative sense of partnership and I really do not believe that there is any threat of the kind that the noble Lord described.

Speaking from Aberdeenshire, I know that drug approval can differ between Scotland and England. Now that we have left the EU, is it not inevitable that there will be differences in drug approval and timings from time to time? What are the Government doing, having signed the agreement, to opt out of the EMA and negotiate an arrangement that minimises disruption but does not pretend that it cannot happen because that is what they signed up for?

My Lords, there will be an occasional moment when there are slight differences between the EMA and MHRA; we are not anticipating them to be huge and, in this case, we are anticipating them to be a matter of weeks while one approval does not quite overlap with another. The UK Government and the MHRA are working closely with the Northern Ireland Executive and all relevant stakeholders to ensure that the supply of medicines to all UK patients, including those in Northern Ireland, remains smooth, seamless and efficient.

My Lords, I thank my noble friend for his calm and reassuring Answer, but does he accept that the real problem is the one pointed to by the noble Baroness, Lady Thornton, namely, that of waiting lists? Can we perhaps devise some sort of Nightingale solution to bring forward and have people seen in a special place or special places? The real danger is that people will be diagnosed too late, and then, whatever the drugs, they will die.

I endorse my noble friend’s recommendations. He is entirely right that the old method of diagnostics, which relied a lot on patients attending diagnostic appointments in hospital, feels very out of date after the pandemic. I note the review on diagnostics by Professor Sir Mike Richards, which recommended community hubs, and has a huge amount of support within the NHS. We need to build up our diagnostic capability, bring it closer to where people live and make it more approachable so that people get early interventions.

My Lords, I fear what seems to be a certain complacency in the Department of Health about what will happen in Northern Ireland from next January, when Brussels takes control of medicines coming into Northern Ireland. How can a Conservative and Unionist Party accept that our National Health Service will now be separated out, whatever the good will that my noble friend might express about making sure this does not happen?

My Lords, I reject the accusation of complacency. We have worked unbelievably hard with Northern Irish stakeholders, the pharmaceutical industry and EU colleagues to ensure the smooth running of the supply of medicines in Northern Ireland. The facts speak for themselves: so far, they have run extremely smoothly indeed. I reassure the noble Baroness that the UK Government are committed to parity of access to medicines across the UK, including Northern Ireland. Despite different approval routes, we have ensured that all patients have access to medicines at the same time, and we will maintain that commitment.

My Lords, will the Minister commit to meet the pharmaceutical industry, otherwise known as PAGB, which I met several weeks ago and which told me about problems that could ensue from 1 January next year in relation to the availability of over-the-counter medicines in Northern Ireland, due to the requirements of the protocol? Will the Minister undertake to meet this organisation to ensure that there are immediate discussions between the UK and the EU to resolve any ongoing difficulties and impediments?

I note the point made by the noble Baroness. As I mentioned in relation to the point made by the noble Baroness, Lady Jolly, on this issue, it is not one that I am not aware of, but I would be pleased to meet with the party she described in order to understand it better.