Draft Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Debate between Nadine Dorries and Julie Cooper

Monday 7th October 2019 General Committees

[Ms Dorries]

I will not comment on the hon. Lady’s opening comments about a no-deal exit, because obviously we are where we are, we all stood on a manifesto to honour the result of the referendum, and it is not my position to comment on a no-deal exit.

I will answer the hon. Lady’s more specific points. It is important to make the point that at any one time in the UK there is a shortage of over a hundred medicines, and that has absolutely nothing to do with Brexit, as I am sure she knows. It can be to do with fires in factories, or a downturn in supply from abroad. At any one time there are shortages, and any shortages today have nothing to do with Brexit.

[Julie Cooper]

I absolutely agree with what the Minister has just said. I have personal experience of pharmaceutical provision in the UK and I know that what she has just said is true. However, does she not agree that exiting the EU with no deal will exacerbate existing problems?

[Ms Dorries]

The hon. Lady will not be surprised to know that I do not agree, because I believe—I cannot guarantee, but I believe—that all efforts are being made and all arrangements are in place to ensure a supply of drugs into the UK. Under just-in-time arrangements, drug companies would have a stockpile of a week’s supply, but now all drug companies have stockpiled six weeks’ worth of medications to be used in the UK, and I do not envisage a shortage of any drug that is required.[Official Report, 14 October 2019, Vol. 666, c. 1MC.] Obviously, I cannot guarantee that—that cannot be done—but every effort has been made by every Department and every official and in every negotiation with drug suppliers and pharmaceutical companies to ensure that they have a six-week supply ready for a no-deal Brexit. We do not see any problem with that.

The hon. Lady referred to drugs with short shelf lives, which cannot be stockpiled. In that instance, arrangements have been made for those drugs to be air freighted into the UK. She mentioned isotopes in particular. They cannot be stockpiled, but they will be airlifted into the UK, so we will see absolutely no shortage of isotopes either. I am sure that we can provide further information on that, but I hope that, now that hon. Members are aware that drugs that have no shelf life will be airlifted, we will not hear those stories. What worries me, and what worries many people, is the public perception when they hear stories that there will be no isotopes because they cannot be stockpiled. We must take our responsibilities very seriously here.

[Julie Cooper]

I can assure the Minister that I take my responsibilities in this very seriously. I know that many hon. Members here do too—including her, I am sure. But this is not just a case of political to-ing and fro-ing, trying to create a sense of panic in the community about this. When the medical professions are leading the voices of concern, surely the Government should be listening to their worries.

[Ms Dorries]

I assure the hon. Lady that we do, and I hope that they will see today’s debate and be reassured that there will be no shortage of drugs with short shelf lives, because they can be airlifted in.

The hon. Lady also asked how we can be confident that there are no more mistakes. I think she is referring to the grammatical errors and various technical errors that occurred in the previous SI, which was 700 pages long and very technical in its content. Those issues were not identified at the time by any party or any individual, but they have now been identified. The amendments that this new SI makes to the previous SI are minimal and include updates to the underlying EU regulations that have been brought forward since the original SI was finalised.

This particular SI has also undergone legal checking and been scrutinised by the Joint Committee on Statutory Instruments and the Secondary Legislation Scrutiny Committee, and we are confident that it will ensure that these regulations operate effectively after exit day. If the hon. Lady does not feel that she has had enough detail, we will provide anything in writing as a back-up.

The hon. Lady asked what paediatric investigation plans mean. This SI does not introduce paediatric investigation plans; they are already required by EU legislation. The previous no-deal SI simply transferred functions relating to those plans from the EU to the MHRA. She also asked why there was no impact assessment. There are no new policies in this SI, so there is no need for a further impact assessment. The MHRA ran a four-week public consultation and published an impact assessment on the previous SI. This SI ensures that the policies implemented are in line with the consultation and the responses to it.

On the protection of patients, the hon. Lady asked about an interim period relating to a transitional period for a pharmacovigilance system. The new proposed transitional period is for the pharmacovigilance system master file, which will be held in the UK. Companies will be required to operate a pharmacovigilance system from exit day. The master file is in the description of the pharmacovigilance system and the amending SI, which includes statutory contributions associated with a temporary exemption, to ensure supervisory capability of the companies, the QPPV and the MHRA.[Official Report, 14 October 2019, Vol. 666, c. 1MC.] I think that she also mentioned the safety aspects. Each pharmaceutical company will be required to have safety staff in the UK in line with this.

The hon. Lady asked whether new and innovative medicines would be delayed in the UK under a no-deal scenario. The MHRA intends to provide free scientific advice for UK-based small and medium-sized enterprises and has introduced a new targeted assessment procedure to authorise medicines as soon as possible following an EMA-positive opinion. In addition, it will often accelerate an assessment route to enable licensing more quickly than in the EU. The MHRA would monitor application volumes in a no-deal scenario.

I thank the hon. Lady for her valuable contribution to the debate. As promised, we will get back to her with further information in writing if she requires it. I am confident, as was the case in March, that we have a shared intention to protect and improve the safety of patients using medicines and medical devices, while enabling their access to the most innovative treatments.

Our regulator, the Medicines and Healthcare Products Regulatory Agency, has more than 30 years’ experience as a leading regulator in the EU. That expertise and experience is globally recognised and respected, and we want to ensure that continues, to the benefit of all UK patients. It is with that at the forefront of our minds that the UK’s plans for the regulation of medicines and medical devices in a no-deal scenario have been developed.

Question put and agreed to.

Children with Life-limiting Conditions

Debate between Nadine Dorries and Julie Cooper

Tuesday 29th January 2019 Westminster Hall

[Julie Cooper]

I totally agree, and I will come to that point in a moment.

The average NHS contribution to children’s hospices is only 9%. Recent additional costs relating to the implementation of the NHS staff pay award and extra pension costs have pushed many hospices into a dire financial position, with closure a real possibility. Where hospices are forced to close, the NHS is left to fund the entire cost of health and social care for those children and young people.

In that context, the announcement by NHS England in December of £25 million of extra funding for children’s hospices was extremely welcome. However, children’s hospices do not know how to access that extra funding. Derian House Children’s Hospice in Chorley, which currently supports 12 families from my constituency, told me this week that there is no clarity about how that newly committed funding can be accessed. As many Members mentioned, since the publication of the NHS 10-year plan there has been confusion about what exactly has been promised.

The Minister will be aware that the 10-year plan promises that, over the next five years,

“NHS England will increase its contribution by match-funding clinical commissioning groups (CCGs) who commit to increase their investment in local children’s palliative and end of life care services including children’s hospices.”

Does she agree that that is confusing, and will she clarify the following points? Will the £25 million promised in December be only for children’s hospices or for a wider group of children’s palliative care services? Can she guarantee that, as a result of the long-term plan, the £11 million children’s hospice grant will be protected and increased to reflect the growing demand and complexity of care provided by those lifeline services? The total spend on children’s palliative care in hospices, hospitals and the community currently exceeds £25 million, so the promised funding could be viewed—I am sure this is unintentional—as a cap on NHS spending on children’s palliative care. In the light of that, can she reassure me that the NHS will indeed provide additional funding for children’s hospices?

I turn briefly to the financial pressures that parents of children with seriously ill children often experience. The 2018 “Counting the cost” survey of families who provide long-term care for a disabled child found that many experienced huge financial difficulties. A third of all families surveyed said they had additional costs of more than £300 each month. Some 46% of families had been threatened with court action for non-payment of bills. That is hardly surprising given that 87% of the families surveyed were unable to work because of their caring commitments.

CLIC Sargent has highlighted that children suffering with cancer often have to travel longer distances than adult patients for regular treatments, placing a significant additional financial burden on parents already coping with so much. Will the Minister commit to introducing a package of financial support that includes a children and young people’s cancer travel fund for parents who care for children with life-threatening diseases? Will she also spare a thought for bereaved parents and accelerate the introduction of the children’s funeral fund that so many Members have requested?

In conclusion, I ask that the Minister answers the specific points that I and other hon. Members have raised, and commits to implementing a comprehensive strategy that provides a consistent standard of joined-up, adequately funded children’s palliative care that has full parity with adult care.

[Ms Nadine Dorries (in the Chair)]

Minister, will you leave one minute at the end for Mr Shannon to wind up?