Post Brexit Supply of Medicines – Lexology

The EU Commission has recently been involved in a row with the UK and vaccine manufacturer AstraZeneca over the supply of vaccines to the EU bloc.

In a step to protect the EUs supply of vaccines, the EU Commission suggested they would put in place export controls on vaccines produced within the bloc, with the UK left off the list of more than 120 nations exempted from the proposed controls.

The EU Commission has since rowed back on its proposal following claims it breached the withdrawal agreement as it effectively created a vaccine border between Northern Ireland and the Republic of Ireland.

Whilst it appears the current impasse has been cleared, it highlights the potential for disruption to the supply of medicines into the UK and brings focus onto what steps are in place to ensure health and care providers are not left without vital medicines at the point of delivery.

Up until the 1 January 2021, the UKs 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 UKs largest trade partner.

The threat to the timely supply of medicines, including Covid vaccine doses, 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 will 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.

An example of rapid airfreight has been seen when military aircraft were used to secure the import of the Pfizer vaccine from Belgium to the UK, in accordance with the terms of the withdrawal agreement.

Buffer Stocks

As part of the Governments 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.

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 with the easing of Covid restrictions.

How this will directly affect the supply of medicines to UK medicinal suppliers, and onto front line providers, is not yet clear. The Governments 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 because of the UKs 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.

Conclusion

The UK continues to import the Belgium-manufactured Pfizer vaccine and so any export controls could potentially affect the UK governments vaccination programme.

Notwithstanding export controls, the post-transition flow of goods was always likely to slow as new border control measures were put in place.

However, it appears the measures discussed above have so far prevented an acute shortage of medicines for health and care providers at the sharp end, whilst those providers should be aware of what the DHSC has put in place should a shortage occur.

As the number of people vaccinated nears 9 million (at the time of writing), the UK continues to import doses of the Pfizer vaccine tariff free and in accordance with the withdrawal agreement.

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Post Brexit Supply of Medicines - Lexology