Human Medicines (Amendment) Regulations

Debate between Jonathan Ashworth and Anne Marie Morris

Monday 18th March 2019 Commons Chamber

[Jonathan Ashworth]

My hon. Friend raises a very important point. There have indeed been reports of shortages in certain medicines. In recent weeks, we have heard of shortages of Naproxen, an arthritis medicine, with similar reports about EpiPens a few weeks ago. I have heard from some community pharmacists, directly themselves, that there is even an shortage of aspirin. I emphasise that these are anecdotal reports rather than information based on any national reporting that I have seen—this is what community pharmacists have told me when I have been in their pharmacies discussing this with them—but yes, there are shortages now as a result of the uncertainty in the pharmaceutical market.

Diabetes UK has warned that

“despite reaching out directly to the Department of Health and Social Care in December, we still have not seen the concrete detail needed to reassure us—or people with diabetes—that the UK Government’s plans are robust enough to guarantee no impact on insulin and medicine supplies in the event of a no-deal Brexit.”.

It was a similar story from the epilepsy bodies, who said:

“We do not have confidence in the current arrangements to ensure the continuity of life-saving medications for people with epilepsy.”

The Government have sought to reassure patients that their contingency plans are failsafe, but the report in The Lancet that I referenced earlier also said that

“stockpiling arrangements cannot cope for more than a few weeks.”

It also noted that some affected products, such as radioisotopes needed for treating some types of cancer, simply cannot be stockpiled. This chimes with the Royal College of Radiologists, which last month issued staggering concerns about the supply of medical isotopes, spelling out how the expected disruption would force clinicians to alter treatment plans and mean the prioritisation of some cancer patients over others. That is why the Government are proposing the serious shortages protocol contained in this statutory instrument and effectively using Henry VIII powers to enable Ministers to issue a protocol to pharmacies for them to follow.

As I said, this is an extraordinary power grab. It will effectively mean that a GP’s prescription can be changed by a pharmacist. No longer would a medicine be prescribed by a doctor who knows the medical history of the patient but instead by a pharmacist acting in accordance with a protocol drawn up by the Government. That is why these emergency measures have, quite rightly, raised alarm among various patient groups—because these changes could cause real problems for people with long- term conditions.

[Anne Marie Morris (Newton Abbot) (Con)]

Does the hon. Gentleman accept that it would be sensible if there was a sunset clause, because clearly giving that much power to a pharmacist as opposed to a physician who knows the patient is very dangerous if it is to be used for the long term or perpetually and not just to deal with the current crisis?

[Jonathan Ashworth]

The hon. Lady makes an entirely reasonable observation. I trust that the Minister took note of it and look forward to her reply to that point.

--- Later in debate ---

[Jonathan Ashworth]

My hon. Friend is right. That is exactly the point that community pharmacists put to me in Loughborough about three weeks ago when I visited them to discuss this. Echoing her point, the BMA has said that it does not support a “blanket approach” to allowing pharmacists to provide therapeutic equivalents where a prescribed drug is not available. The National AIDS Trust has said:

“The only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant.”

SUDEP Action, alongside a broader coalition of epilepsy charities, is particularly worried about these proposals.

After facing pressure from those groups, the Government accepted that replacement drugs were unsuitable for epilepsy patients, but they have left it open to pharmacists to reduce the strength or dosage of epilepsy medication. I am not convinced that that will eliminate the big risks faced by these patients. As the right hon. Member for North Norfolk (Norman Lamb) said, many patients with epilepsy—especially the elderly—are on other medications, and any changes require careful management because of the interaction between different medicines. Up to 90% of people with epilepsy state that even a deterioration in their mood can have a negative effect on seizure control. Anti-epileptic medications have more significant interactions than any other group of drugs.

There are situations where the specific brand, type, form or strength of a treatment must be carefully tailored to the individual based on their responses, which is done by the prescriber and the patient over time. If that is changed by a professional who does not know the patient or their individual risks, some have warned that the consequences could be a loss of control of the condition, failed treatment and an unnecessary emergency, with very serious consequences indeed.

[Anne Marie Morris]

The hon. Gentleman is making a first-class point. This puts patients at risk, and it is not appropriate for the pharmacist to make that decision. People think that generics are the same thing as branded drugs, but they are not. For some, a particular brand is crucial. I commend him for what he is doing.

[Jonathan Ashworth]

I am flattered to receive such commendation from the Conservative Benches, and I commend the hon. Lady for her extremely well-made point, with which I agree entirely. I hope that the Minister will respond to the second good point that the hon. Lady has made.

The stakes are too high to get this wrong, yet there has been no impact assessment or risk assessment undertaken on serious shortage protocols for this statutory instrument. This is an unacceptable risk to anyone with a long-term condition and should be recognised by anyone making contingency plans. I was particularly horrified to read in the explanatory memorandum for this SI—it is quite shocking:

“The main benefits of the protocol would be the NHS cost savings associated with GP time.”

In the same breath, it casually goes on to say:

“There may be some risks to patients”.

That is in the Government’s own paperwork. It is astonishing. How can the Government seriously prioritise NHS cost savings over patients’ lives and allow an explanatory memorandum to go out with that sort of wording in it? I hope that the Minister can explain how that got in there and at least reassure us that it is not the Government’s position. If it is the Government’s position that there may be some risks to patients, that suggests that the Government should have come to the House sooner to explain why they are making this regulatory change and not left it to the official Opposition to table a prayer motion to get this debate.

I would like clarity from the Government on a few things. It is not entirely clear from the legislation exactly when these powers would be used. I would like to hear from the Minister whether these powers will be introduced in a no-deal Brexit scenario only or whether we can expect them to be more permanent. I am also concerned that there will only be a review of new powers one year after a serious shortage protocol is issued by Ministers. This speaks to the point made by the hon. Member for Newton Abbot (Anne Marie Morris). One year is too long to wait if this causes serious problems for patients and the wider sector.

Considering that the stakes are so high, it is be essential that the Government deliver extensive communication and training to GPs, pharmacists, other healthcare professionals and the public, to help them understand any new protocols and manage expectations and any dissatisfaction. I would be grateful if the Minister outlined the Government’s plans. I talk and listen to frontline NHS staff all the time, and I know that there is a well-founded fear about the implications of a no-deal Brexit for hundreds of thousands of people in need of life-saving medicines. I am interested to hear from the Minister what information about these protocols has been shared with the health sector and professionals involved.

When the Secretary of State gave evidence to the Health and Social Care Committee a few weeks ago, he informed it that he will prioritise medicines over food. That glib assertion from the Secretary of State hardly offered the reassurance that patients deserve. Brexit should not compromise patient safety in any way. It is up to the Minister to allay the widespread concerns, but if she is not able to do so, we will test the opinion of the House. I commend our motion.