Stephen Kinnock

I am grateful to my hon. Friend the Member for Edinburgh South West (Dr Arthur) for bringing this Bill before the House, and I congratulate him on getting it to Report. Amendment 1 allows amendment 2 to be inserted into the Bill. Amendment 2 would require the Secretary of State, having carried out the review described in clause 1, to set out a timetable for implementing changes to the law recommended by the review. However, it would not be appropriate to presume the outcome of the review of orphan drug regulations that is outlined in clause 1. Amendment 2 presupposes that the review will recommend changing the law, and that there are changes the Secretary of State would be willing to support, following a legal consultation. That is not considered appropriate at this stage. Amendment 3 is unnecessarily restrictive, introducing wording that confines the review unnecessarily. We want to ensure that a thorough review is conducted, and my hon. Friend the Minister for Secondary Care will be working with her officials to ensure that that happens. For amendment 4, the three-year timeframe to prepare and publish the review and the necessary resourcing requirements have been discussed with officials in my Department and at the Medicines and Healthcare products Regulatory Agency. I remind Members that the text in the Bill reflects the statutory deadline, but we will endeavour to publish a report ahead of the three-year timeframe, which has been put forward to be consistent with the MHRA’s overall workplan. On amendment 5, there are different definitions of a rare cancer, and we worked with my hon. Friend the Member for Edinburgh South West to agree the definition in the Bill as a cancer that affects not more than one in 2,000 people in the UK. However, a level of discretion for the Secretary of State is required over what falls within that definition, since the facts underlying and the data on diagnoses are constantly changing. The amendment would make it difficult to implement the clause in practical and operational terms. Amendment 6 would remove the ability of the Secretary of State to exercise discretion as to how their duty would be discharged. This is not considered appropriate, since it makes the operation of clause 2 less workable in practice, and would lack the Government’s assessment of what in all the circumstances would be the most appropriate manner of implementation. Amendment 7 would introduce a specific timeframe—just six months—to allow the appointment of the specialty lead. Although I agree that we will need to appoint the specialty lead promptly, introducing a statutory timeframe is not considered workable for practical reasons. There could be unforeseen delays; for example, recruitment processes might delay the appointment beyond six months. On amendment 8, as mentioned previously there are different definitions for a rare cancer. That is because the data on cancer diagnoses is constantly changing, and decisions on whether the criteria for a rare cancer are met will inevitably involve an element of judgment. The amendment would make it difficult to implement the clause in practical and operational terms. I turn finally to amendment 9. It is essential that information relating to people’s health and care is shared appropriately, lawfully, and in line with their reasonable expectations. Amendment 9 would remove the provision confirming that any sharing of information pursuant to the powers created by the Bill, and under NHS England’s existing powers, must be in accordance with data protection legislation. That includes compliance with key principles such as lawfulness and fairness. That layer of assurance is essential for the protection of patients, and clause 3 is a standard provision that makes that explicit. For those reasons, I ask the hon. Member for Christchurch (Sir Christopher Chope) to withdraw all nine of his amendments.