Fact checking Sir Michael Rawlins statements in relation to Insulin and #Brexit. Should we be worried?

If you’re a person with Type 1 Diabetes, it’s very hard not to have seen the news about Sir Michael Rawlins’ (Chair of the UK medicines regulator, MHRA) statements in relation to Insulin supplies in the event of a hard Brexit. And it would be no surprise if you were pretty worried about that.

But are his statements correct, and what is the impact? I looked at some of these issues in an article before the referendum, and here I’ll try and address what we can find out in relation to a hard Brexit and drug supplies, as this wouldn’t just affect insulin.

 What was Sir Michael’s statement?

It is reported that he said to the Pharmaceutical Journal:

“There are problems, and the Department for Exiting the EU and the Department of Health and Social Care need to work out how it’s going to work.

“Here’s just one example why: We make no insulin in the UK. We import every drop of it.

“You can’t transport insulin around ordinarily because it must be temperature-controlled.”

“Disruption to the supply chain is one of the ways that patients could be seriously disadvantaged. It could be a reality if we don’t get our act together.

“We can’t suddenly start manufacturing insulin – it’s got to be sorted, no question.”

Now that’s enough to scare a lot of people very quickly. But is it true?

Well, yes and no. Technically the UK does produce insulin, but it doesn’t produce Human or Human Analogue Insulin, only Bovine and Porcine insulin. All Human and Human Analogue Insulin is imported from one of Novo Nordisk, Sanofi or Lilly.

In terms of Bovine and Porcine insulin, based on NHS England prescribing data from April 2018, they make up a total of around 0.3% of all insulin prescriptions, so the vast majority of people using insulin are using Human or Human Analogue insulins.

Digging further into this, the three companies providing Human insulin come from two different regions. Novo Nordisk are Danish, Sanofi are French-German and Eli Lilly are American.

However, all Lilly insulin products licensed for distribution in Europe come from the Dutch entity, Eli Lilly Nederland B.V. and are made in France or Spain. So while the owner of the patent is a US company, they are still, technically, being imported from the EU.

If you look at Twitter, you’d see there are a lot of comments relating to “If they’re from the US, then it’s easy as that’s not an EU country”. Leaving aside, for a moment, the issues relating to trade negotiations and tariffs, the UK doesn’t use any US-produced insulins anyway, and those that have patents held by US companies account for a little over 25% of all insulin prescriptions for NHS England.

That means that 99.7% of insulin prescribed in the UK is imported from the EU.

If the UK Healthcare services were to try and come to an agreement with Eli Lilly US for import from the US, it would be new ground, a completely new set of contracts, and an interesting challenge in respect of logistics, so it’s not the immediate panacea that has been suggested on Twitter.

If people had no choice other than to use UK made animal insulin, you’d also be reversing a decades long movement to Human insulins, and you’d have to deal with significant changes and the side effects of those changes, for example insulin durations:

Source: IDDT

Or in other words, there’d be no Rapid acting insulins available, and we’d be operating in a model that was last used on MDI in the eighties and nineties (ignoring whether or not people were able to live with non-Human insulin). Brexit equating to a reduction in healthcare doesn’t seem like an equitable outcome.

Technically then, what Sir Michael Rawlins said about insulin production is not true, but given the reality of how insulin is used in the 21st Century, it might as well be.

What about his concerns relating to transportation?

As has been stated in many places, if we hard Brexit, then trade has to revert to WTO rules until agreements are signed with other countries. While this is an easy place to start from and report, as with most Brexit related negotiations and treaties, it’s not that straightforward, and this paper, written in September 2016, sets out multiple end points as to what might happen, although it provides all parties with the ability to take whichever view they want.

The UK submitted its new schedule to the WTO on July 24th, however, the US, Australia and Canada all disapproved of the terms, so what the UK ends up with remains very unclear and subject to negotiation.

Then there is also the WTO Tariff Schedule relating to Insulin specifically. Insulin is one of the few pharmaceuticals to have its own schedule, and there is plenty of documentation looking at how these tariffs are applied, for example, this one by Health Action International.

Do these matter? Under the current models, the insulins we use are EU made and therefore have no tariffs applied.

Imported insulins from the EU after Brexit will have tariffs applied at the port of entry (assuming no agreements) and that will be included in the pricing throughout, so in overall cost terms, and using “Most Favoured Nation” terms in WTO speak, it’s likely to have tariffs of around 3% added, increasing costs to the NHS.

But this all leads to a lack of clarity about what actually needs to take place at UK borders when shipments of Insulin arrive. Clarity on tariffs makes importing easier and alongside this, there will still need to be the appropriate border checks.

Border checks? Don’t we do those already? Yes, we do, but on roughly 46% of our imports. 54% of them come from within the EU free trade area, and this is where the concerns about transportation come from.

Instead of having to check less than half our imports, including those coming from non-EU countries into the EU then into the UK, until there are appropriate agreements in place, and those will need to be intra and extra EU, we will need to check all imports into the UK for appropriate tariffs. It’s worth bearing in mind that the technology that is currently in use for Customs is also old and was supposed to be scrapped five years ago.

Suddenly our border infrastructure, that has been set-up to deal with the EU for forty years needs to handle twice as many imports with old technology. That’s where Sir Michael’s concern about transportation comes from. With a little over eight months, is it likely that we will have the appropriate infrastructure in place to handle the entire flow of goods?

The two points of view differ dramatically, with some saying, “Well it only takes 6 seconds for WTO goods to pass border checks” to others taking the point of view that the increased scope and complexity of border controls will cause significant delays. Many large industry participants are taking the latter viewpoint. I’m sure the truth lies somewhere in between.

And what’s the government doing about it?

Matthew Hancock, the Secretary of State for Health and Social Affairs told the Commons Health committee:

“We are seeking to avoid a no-deal Brexit, I am confident that it can be avoided. But any responsible government needs to prepare for a range of outcomes, including the unlikely scenario of no deal.

“Since I have arrived in the department, I’ve asked this work to accelerate and I’ve met with industry leaders to discuss it.

“We are working right across government to ensure that the health sector and the industry are prepared and that people’s health will be safeguarded in the event of a no-deal Brexit.

“This includes the chain of medical supplies, vaccines, medical devices, clinical consumables, blood products. And I have asked the department to work up options for stockpiling by industry.

“We are working with industry for the potential need for stockpiling in the event of a no-deal Brexit.

“We are also focusing on the importance of a continuous supply of medicines that have a short shelf life – so some of the medicines most difficult to provide in a no-deal scenario where there is difficult access through ports will need to be flown in.”

So the government is aware of the issue and is talking about doing something about it. I’m sure more will come of that in the near future. In the meantime, I expect that we’ll hear from NHS England on this topic as well. But if the response from the pharmaceutical industry is anything like that from the food industry on the same topic (where it is industry and not the Government that is being expected to do the stockpiling, presumably at their own cost), then there is a vast amount of work to be done and significant implications of that.

Looking at it as a whole then, do the facts stack up to the statements?

While the detail of what was said was incorrect on the production front, we import the vast majority of insulin used in the UK, so whether Sir Michael was correct or not is largely irrelevant.

His concerns about transportation remain valid while nobody can answer questions about the ability of the UK’s border infrastructure to cope in a changed world. And it’s the uncertainty here that is the biggest issue, rather than whether any of it is true or otherwise. No-one can say categorically “Yes it will work” or “No it won’t”. Either response provides a clear set of actions. Uncertainty doesn’t, and you therefore have to plan for the worst.

So where does that leave us as patients?

It’s a difficult situation. You have a choice. You can believe the government. You can believe journalists. You can believe Twitter. But fundamentally, it would be untrue to say that this doesn’t cause concerns for people with long term health conditions, and this only touches the surface in talking about Diabetes. There are plenty of other conditions where the situation is similar.

I’d like to think that common sense will prevail and concerns are unjustified, but just like that issue with transportation, I simply don’t know.

However you may look at it, I can’t imagine that a UK government would allow 400,000 members of its population to die as a result of their inaction. Can you?