“Brexit”, noun, the withdrawal of the United Kingdom from the European Union.

If only it was that simple.

Whilst the UK left the EU on 31 January 2020, the relationship was largely unchanged until 31 December 2020, by way of the transition period.

With the new year came new rules governing the relationship between the UK and the EU. The new relationship will change how people, goods and services will move from the EU to the UK and how medicines are regulated in the future.

All will have effect providers operating within the health and social care sector and provider action is required to reduce the potential for disruption in the early part of 2021.

IMMIGRATION REFORM

It is estimated EU nationals make up 104,000 of those working in care in the UK. However, carers are now considered low skilled workers by the new immigration process and will not receive preferential access to UK jobs within the care sector.

From 1 January 2021, new immigration rules came into force. The headline is that the eligibility of EU individuals to work in the UK will no longer be automatic as the UK no longer acknowledges the free movement of people among EU member states.

EU Settled Status

There will be no change in the position for workers from within the EU who have; (i) entered the UK, and (ii) applied for EU Settled Status before 31 December 2020.

There will be a grace period for EU Settled Status applications to be processed, ending on 30 June 2021, after which all EU workers will need to prove they have EU Settled Status.

From 1 January to 30 June 2021, employers will not have the right to ask employees if they have applied for EU Settled Status, nor force them to do so.

Employers can ask when they arrived in the UK, safe in the knowledge that if they arrived after 1 January 2021, they will not be able to apply for settled status. Due to Covid restrictions, it is unlikely many EU citizens will have moved to the UK after 1 January in practice.

From 1 July 2021, all workers from inside or outside the EU will need to be able to demonstrate either; (i) EU Settled Status, (ii) a pre-existing working visa, or (iii) a new working visa.

Practically, these will cause recruitment challenges for providers, particularly at the lower paid end. Due to the new points-based system, employees at the lower paid end will not be eligible to apply for a new visa under the Skilled Worker route.

Skilled Worker

The Skilled Worker route is applied to EU and non-EU citizens equally and has been put in place so that working visas are only awarded to those people who; (i) have job offers from a Home Office licensed sponsor, (ii) the job offer is at a required skill level (A level or above), and (iii) they speak English to a required standard.

In addition to the three requirements above, applicants will also have to satisfy a salary threshold depending on the job type, have a PhD in a subject relevant to the job, or have a job offer in an occupation on the Shortage Occupation List, as designated by the Migration Advisory Committee.

Whilst not currently on the Shortage Occupation List, the Migration Advisory Committee has recommended senior care workers and nursing assistants be added. However, most frontline occupations in the sector will be ineligible for the Skilled Worker route and will not be added to the Shortage Occupation List.

Advice to the sector from the Migration Advisory Committee has been to focus on making the frontline jobs more attractive to UK workers as the pool of potential employees increases. It is predicted that, by March 2022, 2.6 million people will be unemployed, and many of them are switching to work in the care sector.

As a result of the new immigration rules, the short-term effect will mean recruitment will prove more competitive and staffing more expensive. There is an early indication that UK workers previously in other industries are transferring to social care giving providers a larger pool of candidates to choose from. Provider will need to recruit from this pool in order to address the shortfall in EU workers who are eligible to work post 1 July 2021.

SUPPLY OF MEDICINES

Up until 1 January 2021, the UK’s trading relationship was unaffected under the terms of the transition period. However, now that the transition period has ended, new border and customs procedures will apply to all goods entering the UK from the EU, except for Northern Ireland.

General Trade Disruption

Border controls at UK ports are to be implemented over three stages to minimise disruption, but the Government still forecasts that the flow rates of goods coming into the UK will be down to between 60%-80% of pre-1 December 2020 flow capacity. This flow rate could be even lower at short strait border controls between the UK and France, at places such as Holyhead, Folkstone, and the much-publicised Dover Port.

To provide some perspective of scale, in 2019 UK ports handled 486 million tonnes of import goods, with trade from the EU accounting for 41% of this total. This continued to make the EU the UK’s largest trade partner.

The threat to the timely supply of medicines is therefore very real, and providers should be prepared for disruption, especially in the first three months of 2021 during the implementation of the initial stage of border controls.

Continuity of Medical Supplies

The Department of Health and Social Care (“DHSC) has put measures in place to mitigate against and prepare for, the new border controls and customs procedures.

The supply of ‘Category 1’ goods, which include medicines, medical devices, vaccines, nutritional specialist feeds and biological materials, has been protected following procurement of the government secured freight capacity. This has been procured to support the health and social care sector and will facilitate the transport of medicines via alternate, Government secured routes.

In addition to the secured freight capacity for medicines, the DHSC has retained the services of three specialist logistics providers who can support the urgent movement of medicines and medicinal products to providers and service users, including rapid air freight, if the more traditional trade routes experience extensive delays.

Buffer Stocks

As part of the Government’s contingency plan, it has been advising UK medicinal suppliers to hold additional stock within the UK to protect against disruption. Providers and service users should not stockpile locally, however. This advice to suppliers has been balanced with re-routing supply chains away from inevitable disruption and the use of secured freight, in order to prevent the delayed supply of medicines.

By operating in such a manner, suppliers will be ready for, and remain operational during, the first few weeks following 1 January 2021, when there is expected to be an acute strain on imports into the UK.

The DHSC continues to work alongside NHS Supply Chain to prepare a buffer of stock for fast moving clinical consumables and medical devices. In 2019, the DHSC said that it was on course to achieve its target of maintaining six weeks’ worth of buffered stock by the end of the transition period.

Since 1 January 2021, there have been limited reports of lorry drivers being turned away from ports for not having the correct paperwork. Whilst limited, this has caused concerns among logistics providers that more severe problems could occur as trade flow increases throughout January.

How this will directly affect the supply of medicines to UK medicinal suppliers, and onto front line providers, is not yet clear. The Government’s reluctance to guarantee a level of supply does suggest that delays and strain to some extent are expected in the short term.

The DHSC is confident the buffering measures it has put in place will prevent an acute shortage of medicines to the health and social care sector, although some disruption is expected. Providers and service users are asked to have confidence in this procedure and have been discouraged from local stockpiling of medicines as this could cause shortages in other areas.

Shortage Management

Should a shortage of medicinal supplies occur as a result of the UK’s new relationship with the EU then suppliers will raise this through the established routes.

The DHSC has stepped up its National Supply Disruption Response to assist with the demands on supply and they insist the usual business approach is suitable to address shortages following the end of the transition period.

If the Secretary of State for Health and Social Care is of the opinion (following consultation with medical experts) that there is, or may be, a serious shortage of medicine then they can decide to issue a Serious Shortage Protocol. This will provide an exception to the rule that prescription medicines may only be supplied in accordance with said prescription.

A Serious Shortage Protocol is intended to speed up service user access to appropriate treatment by affording pharmacies the ability to dispense an alternate medicine to that prescribed in line with a protocol, without having to go back to the prescriber first.

Such protocols will be used alongside well-established processes for managing shortages in collaboration with manufacturers, suppliers, and clinicians.

REGULATION

The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance to help ensure the continuity of supply of medicines and medical devices from 1 January 2021.

The MHRA will unilaterally recognise certain EU regulatory processes for a period of two years following the end of the transition period. This means the MHRA can rely on a decision taken by the European Commission on the approval of a new market authority when determining an application for a marketing authority in the UK.

In practice, this will have little effect in the short term as the MHRA will continue to act within its legal framework and consider decisions made on medicines regulation in the EU with regards to safety and efficacy.

In the long term, the UK’s relationship with the EU and its medicines regulation is unclear. No doubt policy makers will use the next two years to determine to what extent there will be consistency between UK and EU regulatory standards.

One issue the UK will experience having left the EU is that it will no longer receive some data on the collection, detection, assessment, monitoring and prevention of adverse effects with medicinal products authorised for sale and supply. This means there is a limited potential for the UK to be ignorant of problems with drugs and devices on the domestic market.

CONCLUSION

The new immigration rules will have a significant effect on the makeup of the care sector’s workforce. Coupled with reduced occupancy rates and an expected increase in the national minimum wage, providers will come under financial and operational pressures to maintain suitable staffing levels. Whilst this will be alleviated by the expected influx of UK workers into the social care jobs market, it is unlikely to ease operational pressures on smaller residential providers.

Notwithstanding the potential for a long-term benefit to the workforce in the sector, providers increased operational expenses will cause business continuity problems, and will have a knock-on effect on the funding of placements by local authorities as the cost of care increases. As the public purse tightens, local authorities may start putting an increased emphasis on keeping service users at home with a continued shift towards domiciliary care services.

In summary, providers should:

  • take comfort in the importance and resources invested into the post-transition period supply chains of medicines;
  • be in close contact with their suppliers and remain aware of developments across the market; and
  • not stockpile locally, nor encourage service users to do so, as this will cause an imbalance in the carefully curated methods by which the DHSC hopes to maintain medicinal supply.

The above article will be published in the next edition of Expert Care Manager published by Forum Business Media.