Branded Health Service Medicines (Costs) Regulations 2018 — House of Lords, 2018-06-20
Topic: Health
Margaret Eileen Joyce Wheeler (Labour, Centre-left): My Lords, I thank my noble friend for tabling this Motion and for his excellent speech setting out the concerns we all share about NHS patients getting access to the drugs they need and how a number of CCGs are in effect placing a ban on expensive branded medicines—in this case ignoring NHS England’s advice concerning T3 in the treatment of hypothyroidism. I look forward to the Minister’s response to the key questions put forward by noble Lords on this issue The Motion has the full support from these Benches. I also commend the work of the British Thyroid Association and Thyroid UK in highlighting this issue, and the very helpful information on their websites, as well as the expert explanation from my noble friend Lord Turnberg on hypothyroidism. The websites include case studies of patient voices which clearly show the impact and suffering of patients who are either denied T3 or who are taken off it because of a decision made by their CCG. It is especially upsetting when patients who have successfully taken the drug for a number of years suddenly have to go back on to a drug, mainly T4, which they already know does not provide them with the treatment they need or will make them ill again. The case studies refer to both the T4 drug and the natural desiccated thyroid—NDT—drug, which I understand is the treatment given before T4 came on to the market but which is not now available in the NHS as it has to go through the Food and Drug Administration process, and it is not known when the branded NDT products will be licensed My noble friend and other speakers described their concerns over current CCG decisions that go against NICE guidelines and the advice of NHS England, and the increasing rationing of key services, so I will not repeat them and will await the Minister’s response. The NHS England recommendation and guidance on T3 needs to be clear and unambiguous. I hope that the Minister will acknowledge the confusion and concerns, and will ensure that NHS England informs CCGs that they must both comply with their guidance and amend it to end the scope for CCG misinterpretation. I hope that he will also acknowledge that access to T3 on the NHS is a matter of urgency for many patients and that he will give serious consideration to the call from Thyroid UK and ITT for the procurement of T3 from outside the UK for NHS prescriptions until its UK cost comes down On the regulations, I note paragraph 4.7 of the Explanatory Memorandum, which deals with provisions of the Health Service Medical Supplies (Costs) Act 2017 that have been included. This includes the promise of the annual review of the operation and objectives of the statutory scheme which is to be published and put before Parliament. Can the Minister tell the House what the current thinking is in terms of the review process and timing, and say when he would expect the first review to be completed The impact assessment also states that the implementation of these regulations will generate a saving of £33 million to the NHS between April 2018 and March 2019. The Department of Health and Social Care says that this will enable the provision of additional treatments and services estimated to provide NHS patients with an additional 2,213 quality-adjusted life years, valued at £133 million. Can the Minister explain to the House exactly how the Government have calculated the savings, and can he give more details of how this money is to be spent in the NHS The Explanatory Memorandum also says that the regulations set out other instances when the Secretary of State can give a direction specifying the maximum price of drugs—for example, when there are supply issues with respect to a particular branded health service medicine and the Secretary of State is satisfied that a new temporary minimum price needs to be provided to help resolve the supply issue. Can the Minister explain to the House how the Secretary of State is to decide on the temporary minimum price Finally, in respect of the provisions in the regulations for manufacturers and suppliers to pay 7.8 % of their net sales income to the Government, the impact assessment provides for those in the PPRS with annual NHS sales above £5 million to make percentage payments based on the difference between allowed percentage and actual percentage growth in NHS expenditure on branched medicines. Can the Minister provide more clarity on how this 7.8% figure has been reached?