Creon

Question

Asked by

To ask His Majesty’s Government what steps they are taking to address the shortage of Creon, a cancer medication, reported by the National Pharmacy Association, and what steps they plan to take to prevent similar shortages in future.

My Lords, while some supply constraints remain, predominantly with the higher-strength product, Creon stock is regularly being delivered to pharmacies. Alternative products and unlicensed imports are also available. Guidance has been issued to the NHS on prescribing available alternatives and utilising serious shortage protocols to limit quantities dispensed, with actions for integrated care boards to ensure that patients are not left without Creon or an alternative. We continue to work on the long-term supply resilience of Creon.

My Lords, I thank my noble friend the Minister for that Answer, but there are some suggestions that pharmacies are struggling to obtain this important medication, which addresses pancreatic enzyme therapy. Given the struggles that pharmacies are facing, could my noble friend the Minister therefore outline what consideration has been given by the Government to provide a national plan to address shortages and to support patients with alternative care? What approval would be given to highly trained pharmacists to use their professional judgment to supply alternative medicines, where that is medically safe and appropriate, in the event of the prescribed version being unavailable to ensure that patients can enjoy longer, healthier lives?

I can say to my noble friend that serious shortage protocols are a tool that we have and use to manage and mitigate medicine and medical devices shortages. They enable community pharmacists to supply a specified medicine or device in accordance with a protocol rather than a prescription, with the patient’s consent, without needing to seek authorisation from the prescriber. They are used in cases of serious shortage, and we develop those protocols with input from expert clinicians. In addition, we are currently examining options around pharmacists’ flexibilities, including how any risks could be managed, and further details will be set out on this. I hope this gives some reassurance to my noble friend.

My Lords, we know that these unexpected shortages occur from time to time, and that this obviously causes patients to worry. As the Minister said, I understand the advice is that alternative therapies are available but may not be sufficient for all patients. Given this, can the Government reassure patients that they are confident that those who cannot turn to alternative therapies will be able to get the appropriate doses of Creon that they require? Also, do the Government have any idea, or have they been given any indication, of when they expect this particular shortage to end?

The supply situation has improved since last year and there is now sufficient stock of lower-strength Creon to meet normal demand. There are still some supply constraints, as I have said, with the higher-strength product stock, but stock is regularly being delivered to pharmacies. As we have discussed, alternative products and unlicensed imports are also available. I totally accept that patients may have concerns, and that is why we have worked closely to keep in communication with patients to assure them that they will not be going without the medication they need. For example, it may be that lower strength in multiple provision can be made, or there are the alternatives that I have described. If any noble Lords are aware of real-life examples of shortages, I would be grateful to hear about them, because we believe that we have made the arrangements, and I can reassure noble Lords that these very important medicines are being provided to those who need them.

My Lords, I suggest that the Minister ask her officials immediately to speak to the National Pharmacy Association, which published a survey at the end of last month that said that 96% of community pharmacies were finding problems with getting stocks of Creon and 89% of community pharmacies were having problems with alternatives. In light of that and the bigger picture, what actions are the Government taking to establish new suppliers and manufacturers of enzyme replacement therapy to reduce reliance on a limited number of manufacturers?

The noble Lord makes a very good point, because the reality is that there are very limited manufacturers of pancreatic enzyme replacement therapy—which applies to a number of people, not just those who have pancreatic cancer—so I do understand that point. It is the case that several non-UK suppliers have expressed an interest in bringing their products to the UK, and they are currently under review with the MHRA. Of course, I hope noble Lords are aware that this Government prioritise UK life sciences, and that is absolutely key. We have established incentives to encourage manufacture, including up to £520 million to support businesses that invest in life-science manufacturing products.

My Lords, may I put it to my noble friend the Minister that there is also an underlying problem, which was also revealed during COVID, that too often the end-use manufacturers are highly dependent on a supply chain that is often in countries that are either unreliable or, indeed, even hostile? These may seem to be basic supplies, but in fact they are enormously important for the final product. Should not the Government in this area, and indeed in others, be looking at this more seriously?

I believe that we are looking at this very seriously. Of course, medicine supply chains are complex, global and highly regulated, so there are a number of reasons why supply can be disrupted and a number of reasons why supply might not be specifically as we would like. Unfortunately, some of those are out of government control. To be honest, we cannot prevent all medicine shortages, but we can take as many steps as possible. I can assure my noble friend that the whole point about increasing resilience of the UK medicine supply chain remains a key priority. We work with industry, we work with the regulator and we will improve the position of the UK as a destination for life sciences and manufacturing in this regard.

My Lords, the Minister referred to Creon being needed for a number of conditions. In Sheffield, when I was visiting POLARIS, the pulmonary lung and respiratory imaging centre, I met a mother of a cystic fibrosis patient—a young child, quite a small child—and that mother was suffering significant distress at having to spend time chasing around Sheffield to try to lay hands on Creon. The Minister just said that this is out of government control. Does she agree that this is a case where relying on markets to supply essential drugs is not working and that there needs to be more government control in the supply chain?

The noble Baroness puts forward an interesting perspective. There will always be a number of matters that are outside any Government’s control. What is in the Government’s control is what action we can take. In terms of alternatives to Creon, for example, supplies of Nutrizym have more than doubled since last year, and Essential Pharma has also secured additional manufacturing capacity for Pancrex. In May last year, pancreatin preparations—the active ingredient in the medicine we are talking about—were added to the list of medicines that cannot be exported from the UK or hoarded in order to reserve supplies. These actions, along with some of the ones that I have just mentioned and more, all show a very active government position.

My Lords, since we have a bit of time, perhaps I may be allowed a supplementary. Given that part of the answer is to import unlicensed medicines, what quality-control procedures are there in place to ensure that people can be reassured that these unlicensed medicines are suitable and fit for patients?

It would not be possible to prescribe them if they were not fit and safe for use. I am grateful to the noble Lord for allowing me to make that reassurance. There is very clear information on ordering and prescribing unlicensed imports on the NHS Specialist Pharmacy Service website, should the noble Lord or any other person wish to be reassured of what that means.