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Why a no-deal Brexit could lead to a shortage of medical products in Sweden

If the UK leaves the EU without a deal, Sweden risks facing shortages of important medical products, something the Swedish Medical Products Agency has said it is working hard to avoid.

Published: 1 April 2019 09:00 CEST

Why a no-deal Brexit could lead to a shortage of medical products in Sweden

File photo of a doctor working in a Swedish hospital: Isabell Höjman / TT

Products such as pacemakers, implants, diagnostic devices, hospital equipment and many other items classified as medical devices could be in short supply across the EU if the UK crashes out of the bloc with no deal, as German Health Minister Jens Spahn recently warned in a letter to the EU Commission.

The Swedish Medical Products Agency has said it is aware of the risk and is working intensively to prepare for it.

“There are products that there could be a problem with,” Lena Björk, the agency's regulatory head, told the TT news agency.

The issue isn't related only to products and devices manufactured in the UK, but to how these products are certified.

UPDATED: Essential no-deal Brexit checklist for Brits in Sweden

Within the EU, all medical products and devices considered high-risk are inspected by a so-called 'notified body', a private company tasked with awarding certificates which mean a certain product is safe and cleared for use throughout the entire EU.

The European trade association MedTech Europe has estimated that around 40 percent of medical devices sold in the EU are certified by UK bodies. But if the UK leaves the EU with no deal, certificates given out by British notified bodies would no longer be valid within the EU.

Although the UK has said it will continue to recognize devices approved by EU-based notified bodies for “a time-limited period” in the event of a no-deal Brexit, the EU has not agreed to reciprocate.

Products which have already been cleared for use by these bodies would be unaffected, but for each new version of a product, a new certificate must be issued.

“Even if a product is produced in Sweden, it might be that the relevant body is located in the UK, and that's where there might be a problem. Then, the product can't be used in the EU. So either the notified body has to move, or the manufacturer has to find a new body within the union,” explained Lena Björk.

It's unclear how widespread this problem would be if it arose; there are thousands of medical devices within the EU and many notified bodies, including some that specialize in working with a specific kind of product.

What's more, the EU is currently implementing a new medical device regulation, which means that there's a backlog at many EU-based notified bodies.

“There are very many different types of product and it's not possible to say how many a certain country has,” said Björk.

She added that the agency was working intensively with other EU countries to try to solve the problem.

“If we had been forced to be ready, we would have had a plan, because we're aiming to do this in the same way. But we will do all we can to ensure there is no shortage,” she said.

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'I feel exiled': How Brits in Europe are locked abroad with foreign partners

Europe is home to hundreds of thousands of British nationals, many of whom have foreign partners and children. But if they want to move to the UK to live and work it will soon become more difficult.

When it comes to getting a partner visa, the UK has some of the strictest rules in Europe. In addition to hefty fees and a healthcare surcharge, the Home Office requires British citizens and long-term residents who bring their foreign partner to the UK to have a minimum income showing they can support them without relying on the social security system.

The minimum income up until now was set at £18,600 (€21,700), or £22,400 (€26,100) if the couple had one child, plus another £2,400 (€2,800) for each other child.

But these income requirements will rise steeply from April 11th 2024.

How it works: What Brits in Europe should know about UK’s new minimum income rules

From this date the minimum a British national or long-term resident will need to earn if they want to return home will increase to £29,000 (€33,800) and up to £38,000 (€44,313) by spring 2025, although there will no longer be an additional amount for accompanying children.

Alternatively, families need to prove they have at least £62,500 (€72,884) in cash, which from 11 April will increase to £88,500 (€103,207).

‘Family life has been destroyed’

To put this in context the Migration Observatory at the University of Oxford suggests that around 50 percent of UK employees earn less than the £29,000 threshold and 70 percent less than £38,700. The Observatory also says that while the number of people affected by the policy is small compared to the overall UK immigration (family visas represent 5 percent of all entry visas), the impacts on concerned families can be “very significant”.

The Migration Observatory notes that other European countries apply income thresholds to sponsor foreign partners. Spain, for instance, requires sponsors to have an annual income equal to the social security salary. In Denmark, sponsors must not have claimed social benefits in the three years before the application. But in Spain and the US, the partner’s foreign income also counts towards the threshold.

So what does this mean for mixed British and international families living in Europe who might want or even need to return to the UK to live?

Campaigners have complained that many Britons with foreign partners have simply been “locked abroad” or families have been separated while they try to meet the minimum income or savings requirement.

Reunite Families UK, a non-profit organisation supporting people affected by the UK spouse visa rules, says this policy causes distress, especially for children.

Some 65 percent of respondents in research carried out by the group said that their child received a diagnosis of a mental health condition due to the separation of their parents.

“Since its introduction, this policy has destroyed the family life of countless people and children,” Matteo Besana, Advocacy and Campaigns Manager at Reunite Families UK said.

“Women have been forced to become single parents to their children and live away from their partner and the father of their children only because they didn’t meet the threshold.

“As shown by our research on the mental health impact of the policy, these are scars that, particularly for children, will be carried for the rest of their lives,” Besana said.

The people most likely to be affected are women, who tend to earn less or not work because they took on caring responsibilities. Also heavily impacted are people under 30 and over 50 years of age, people living outside London and the Southeast of England where wages are higher, and those belonging to specific ethnicities, according to the Migration Observatory.

The Local spoke to two British women, in Italy and Sweden, struggling to return to the UK with their families because of these rules.

More savings needed

Sarah Douglas, who has been living in Italy since 2007, was planning to return to Scotland with her Italian husband and three children.

“It was always our long-term goal to move back to the UK after we had our children and once we’d have saved enough to buy a home in the UK,” she said.

“In hindsight, we should have gone after the Brexit referendum, but in the beginning it wasn’t clear what the final deal would be and I naively assumed that situations like mine would be taken into account and we would have the right to return… Once it did become clear, we were in the middle of the pandemic and it wasn’t the time to move,” she said.

Having stayed home to take care of the children, Sarah will find it hard to land a job near her family in Scotland that meets the minimum income required to sponsor a foreign partner for a UK visa.

Her husband, a computer programmer, has been trying to get an employment visa, “but most of them state that you must already have permission to work in the UK,” Sarah says. And applying for British citizenship is not an option for a non-UK resident spouse.

‘People need to be aware’

Sarah and her husband are trying to save as much as they can, an alternative to the income requirement, but the amount they need is rising to almost £90,000, meaning it may be a long time before they have enough to move home.

While the aim of the UK’s policy is to ensure families moving to the UK are not a burden on the taxpayer, the reality is that people arriving on a family visa are not able to claim any benefits from the UK government.

“They should judge the overall financial viability of the family unit, rather than just the earning potential of the sponsoring partner,” Sarah says.

“We could live well with my husband’s salary and he could work remotely. We are stable and financially secure, but because I don’t earn any money, they say we are not able to support ourselves.”

Sarah says that most of the British public are unaware of the minimum income requirement.

“People think if you are married, your husband is allowed to come to the UK, but when I say no, it doesn’t work like that, they are really surprised. A lot of people are not aware of how this could affect them,” she said.

Looking for a job from abroad

Another British women who lives in Sweden with her South African husband and two children and plans to move to the UK told The Local how the minimum income requirement had put them in a “precarious and stressful situation”.

The woman, who preferred to remain anonymous said: “After having the two children, I was very fortunate to find a research position and do my PhD, which is a salaried position in Scandinavia, and now that I finished, we are looking to leave.

“But I need a job in the UK to sponsor my husband, and as a new graduate with limited work experience, it is not easy. It is even more difficult when you are not in the country and I missed out on opportunities because they wanted an immediate start. I really don’t want to move without my whole family,” she said.

She says the UK’s policy is “gendered and geographically discriminatory” because it makes life harder for women and also harder for anyone who is planning to move to a part of the country that isn’t in London, where salaries are higher.

“I feel exiled from my country and separated from my family there,” she said.

Her husband, she argues, has his own company and could continue working remotely from the UK, earning well above the requirement. He would also pay taxes and national insurance while having to pay the healthcare surcharge, a form of double taxation, she argues. But that would not entitle him to a visa.

“Our house is on the market now. We have booked removal companies for the 6th of June. The dog is booked for his transport. I just think this policy is so out of touch with the modern world,” she said.

Reunite Families UK has called on the government to recognise the right for British or settled citizens to bring their close family members to the UK and scrap the minimum income requirement. Alternatively, the group says the rules should take into consideration the earning potential of both partners and consider “the best interests of children”.

A petition on the UK parliament website asks the government to reconsider the minimum income policy. If it reaches 100,000 signatures, it will have to be debated in parliament.

This article has been produced by Europe Street news.

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