Healthcare and #Brexit – what would it mean if we left the EU as someone with a chronic disease? #InOrOut

There’s something very large at stake here, and no-one’s yet talked about it. It’s pretty important, and not just for diabetics. A quick recap of the pharma industry and regulation is required here.

Pharma comes up with a new product. To get it into patient’s hands it needs a license or approval. In the US it goes to the FDA where it spends, often, a very long time in a queue. In the EU it goes to the European Medicines Agency (EMA) where it gets EU wide approval. More than that, EU wide approval tends to happen relatively quickly. Why is that? Let’s take a quick look at the EMA.

On its website, the EMA is described as:

It is effectively a European representation of the National Competent Bodies of each of the member states, Norway, Iceland and Liechetenstein. Now what you might hear from the Leave campaign is that this is yet another additional overhead imposed on us by the European Overlords. Yes, it is, and the purpose it serves is to provide a common set of rules that allows one homologation for all EU countries, meaning that you don’t have to pass the regulatory checks of each and every country. That makes a lot of sense to me. It also means that the approval is handled by panels made up of a larger pool of people than individual bodies might be.

It also has a number of processes that allow for this approval. They are much better documented in this PDF and on the EMA’s website than I can put in here. Suffice to say that for Diabetes, there is a compulsory centralised approval model, which allows access to all member states and those in the European Trading Area. Note that Switzerland isn’t part of this. For the Pharmaceutical companies, this means that they get one approval and can market to all of the 550 million population in the EU. In the context of T1D, this means that one approval gives access to roughly three million type ones in the EU.

Now let’s consider leaving. If we leave the EU, we are no longer part of the EMA. If we had decided that the EMA was a benefit to us, then it would require that we included it in our exit negotiations. Given the number of new products continually being produced, that the expertise of 28 countries can be used to approve once for all, this would seem to make sense, rather than having the UK’s body, the MHRA, having to approve each and every single product.

But that’s a lot of background discussing what appears to be an arcane EU institution. Why should we care?

Well, it’s those numbers again. If we are out of the EU, and don’t ensure membership of the EMA, we become a separate, additional regulatory environment that all pharma and medtech companies need to get approval in, and a market that is only about 11% of the bigger EU market. Where would that put us in the pecking order for release of new products? Behind the EU, at the very least. It would simply mean that new products took longer to get to us.

A really good example of this is the Freestyle Libre from Abbott. The UK was in the vanguard of the release of this product. Instead we’d have ended up like Australia, waiting 18 months before it got anywhere near us.

Of course, there’s also the European Health Insurance Card. Whenever I go to Europe, I carry this little card, which guarantees me, as a member of the EU the following:

• Any medical treatment that becomes necessary during your stay because of either illness or an accident.

• The card gives access to reduced-cost or free medical treatment from state healthcare providers.

• It allows you to be treated on the same basis as a resident of the country you are visiting i.e. you may have to pay a patient contribution (also known as a co-payment). You may be able to seek reimbursement for this when you are back in the UK if you are not able to do so in the other country (and limited to the equivalent cost on the NHS).

• It includes treatment of a chronic or pre-existing medical condition that becomes necessary during your visit.

• It includes routine maternity care, (provided the reason for your visit is not specifically to give birth).

• It includes the provision of oxygen, renal dialysis and routine medical care.

But that’s only one issue, and it doesn’t really affect me unless I’m travelling in the EU. The leave campaign would argue that this enables immigrants to come to the UK to obtain healthcare services that might be unavailable in their home countries. I wouldn’t disagree, but then, I’m not overly concerned by that either. Take the “I” word out of the argument please.

And of course we can’t ignore the number of non-UK citizens working in the NHS. That’s no small proportion of people either!

Finally there’s the free movement of goods. Brexiting with no trade agreements in place means that all those drugs we rely on (yes, Insulin) that are made outside the EU or outside the UK are now subject to border controls where we don’t have adequate border infrastructure to manage this. Imagine your insulin getting stuck for weeks at the border because it simply can’t be processed… And of course this would be done at World Trade Organisation tariffs, increasing the costs to the NHS (but no-one in the Leave camp wants you to realise this).

So what’s the purpose of this post? It’s to open up the idea that in healthcare, the EU is really rather useful. If you have a chronic disease, it affects you directly. The medical approval processes mean that you get new treatments when they get European approval. If we aren’t part of that, then, simply, we have to wait. And there’s no telling how long.

Now I’m sure that if we do leave, we would rejoin the EMA, and I’d expect us to want to remain part of it, as it offers far more than cutting it adrift would. Iceland, Norway and Liechtenstein all seem to think it does… But we have to negotiate participation, and like all of these things, it will come at a price, when we are there already in our current position.

Finally there’s the movement of goods in and out and the agreements needed to make that work. We simply don’t have them. They won’t be done by the end of the article 50 period. So where does that leave those of us requiring insulin?

So while EU membership might not seem to affect our healthcare, it does so in a positive way that we shouldn’t be ignoring and need to be aware of. Brexit is much more than simply immigration.