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Explainer: Is Ireland in danger of a medicines shortage because of Brexit?

Here we do our best to explain…

TAOISEACH LEO VARADKAR has admitted that Ireland will stockpile medicines in coming months over concerns that supplies could dwindle in the event of a ‘no-deal’ Brexit.

Last week, British health secretary Matthew Hancock said the country was set to stockpile medicines and blood supplies ahead of the UK’s departure from the EU.

Asked whether Ireland would be taking similar precautions before next March, the Taoiseach admitted plans were in place to do so, saying there was “a concern around medicines”.

But if Ireland isn’t leaving the EU, why does it have to worry about supplies of medicine? And what are the implications of stockpiling?

Here we do our best to explain…

Where is talk of stockpiling coming from?

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It’s just under eight months until the United Kingdom formally leaves the European Union on 29 March, but the type of Brexit deal the UK gets remains very much up in the air.

In the event that no arrangement is reached with the EU, the UK would exit the single market and customs union and resort to World Trade Organisation rules on trade.

That means significant tariffs would be imposed on goods entering the UK from the EU, and on goods the UK sends to the EU.

Among the vast array of products that would be affected in this so-called “no-deal” scenario are medicines and blood products.

370 million packs of medicine are imported by the UK from the EU every month, as well as blood plasma supplies and the radioactive isotopes used in X-rays.

Because the UK still doesn’t know which type of Brexit deal (if any) that it’s going to get, Hancock announced last week that stockpiling these products would begin in order to ensure the UK isn’t left in a situation where it ends up short.

Why would Ireland have to stockpile medicine?

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In short, Ireland could be affected by its place in the supply chain.

Currently, the NHS enjoys a free, unchecked flow of medicines from Europe, but many products that enter the UK later end up in Ireland. Sources in the health industry say that it is likely that the majority of medicines in Ireland have, at some point, been in the UK.

That’s because suppliers tend to send their products to the UK, the largest English-speaking country in the EU, to be packaged and labelled.

In fact, up to 60% of marketed medicinal products here share labels and leaflets alone with the UK.

For perspective, every month, 45 million patient packs of medicine are supplied from the UK to the EU27, and 37 million patient packs are supplied from the EU27 to the UK. That’s one billion medicines packs per year.

And because these products are exported to Ireland after they’ve entered the UK, a large number of companies simply view the UK and Ireland as one market.

So if there’s a disruption in the supply of medicines to the UK, it could have serious knock-on effects for Ireland.

According to Leo Varadkar, some companies may not bother dealing with Ireland at all if they think the Irish market is too small on its own, or believe that figuring out ways to supply the Irish market is too much effort.

If that happens, Ireland could be left without the medicines it imports from the UK.

The Irish Examiner quotes Varadkar as saying:

“Even in the event of a hard deal/no Brexit, it is not that it would be impossible to import from the UK.

“It would still be possible, but there would be restrictions obviously, so part of our contingency planning does involve making sure that we have a supply of medicines.”

What are the implications?

It’s important to note that stockpiling is a contingency measure, rather than an all-out panic.

As the Taoiseach pointed out, getting medicines from the UK (or those the UK traditionally imports) won’t be impossible.

Instead, the plan is to prevent shortages in the long-term, not create them in the short-term.

Varadkar also said that many medicines were made in Ireland (in fact, pharmaceuticals are our biggest export), which could help mitigate against the threat.

For the time being, it seems unlikely that Ireland will experience a medicine shortage before or after Brexit, even in a ‘no-deal’ scenario.

Meanwhile, the Taoiseach also reassured the public that blood supply issues were “not a concern” for Ireland, despite the cross-border agreement we have with Northern Ireland.

What are people saying?

The Irish Pharmacy Union said the uncertainty surrounding Brexit as a whole presented particular challenges for the industry, which will be among the “worst hit” next March.

IPU president, Daragh Connolly told TheJournal.ie that “medicine shortages were a very real concern”, but that the Health Products Regulatory Authority (HPRA) was planning contingencies in the meantime.

A spokesperson for the HSE told TheJournal.ie that it is working on contingency plans, which sources say include stockpiling or attempting other measures to “disentangle” the Irish medicines market from the UK.

“The HSE is working on contingency plans in a number of areas in relation to Brexit, including measures required to maintain patient services and continuity of supplies. This includes liaison with the Pharmaceutical Industry and distributors in relation to medicines, in order to identify risk areas regarding supply and to ensure that contingency arrangements are in place in the event of disruption arising due to Brexit.”

A spokesperson for the Irish Pharmaceutical Healthcare Association says that the sheer scale of imports and exports of medicine is “one measure of the importance of medicines for human health, facilitated by regulatory alignment and free trade”.

The association says that Irish customers must have access to medicines.

“Whatever the outcome of the Brexit negotiations, it is critical that Irish patients, as well as patients across Europe, can continue to access their medicines without disruption. The integrated nature of supply chains for medicines across Europe, and the shared regulatory framework, mean that Brexit preparedness has been a priority for our industry, working closely with the relevant public health stakeholders.”

A no-deal Brexit is one that the IPHA has discussed with the HSE, Revenue and the Health Products Regulatory Authority (HPRA).

A HPRA spokesperson told TheJournal.ie that it, too is planning contingencies.

“Medicines availability is at the centre of the HPRA’s Brexit strategy and we continue to monitor this closely as our priority is to ensure patients continue to have access to safe, high quality and effective medicines.

“The HPRA is actively planning Brexit contingencies and has established an internal working group to examine all issues under its remit relating to Brexit, including the ongoing availability of medicinal products. This group co-ordinates a number of ongoing HPRA actions related to Brexit.

“The HPRA is committed to minimising the impact of Brexit on the supply of medicines to the Irish market. In addition to maintaining existing marketing authorisations and joint packs with other markets, the HPRA will consider any specific concerns that arise in conjunction with Brexit and prioritise actions that can be taken to address these concerns.”

How likely is it all?

Stockpiling is happening, and sources say it’s just good practice. However, they say that a “doomsday” scenario is very unlikely to happen.

“In terms of will people be roaming the streets looking for vital medicines? I’d find it very hard to imagine,” said one.

“Whatever happens with Brexit, our authorities can’t let people go without the medicines they need.”

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