Brexit and it’s implications on medicine supply
Nobody has a crystal ball regarding Brexit and what, when, how (and if) it will occur. Thankfully the EU are on Ireland’s side in insisting that a “hard border” on the island of Ireland is not acceptable, but ironically this is the very issue may be the stumbling block that may cause a “No deal Brexit” which could result in a hard border. As Teresa May and her Government stumble from crisis while the EU can’t be seen to give Britain major concessions due to risk of contagion (i.e. encouraging other EU countries to leave if Britain get a good deal), Britain’s withdrawal from the EU remains in a state of flux. As I write this (Feb 26th) it looks like Teresa May could extend the Brexit date from March 29th to later in the year while Jeremy Corbyn of Labour party this week announced his party supports a second referendum. While the likelihood of a “Hard Brexit” appears less likely this week (compared to last week), it is still a major risk. This article explains preparations made by Irish Government through the Department of Health and the HPRA (Health Products Regulatory Authority which is the body responsible for medicine supply in Ireland) as well as other stakeholders like medicine manufacturers and pharmacies to reduce the risk of medicine shortages in the case of a no deal Brexit. The good news relating to medication supply is that in the case of a “No Deal” or so called “Hard Brexit”, there are contingency plans in place to keep disruption to medicine supply to a minimum.
Brexit plans in relation to medicine supply in Ireland
Pharmacists have sought and received assurances that everything that can be done is being done to anticipate, plan for, and mitigate against any potential problems that may arise, and to develop solutions to protect medicine supplies to Irish pharmacies and patients, with a focus on the supply of those that have been identified as critical medicines.
As part of a whole-of-Government response to Brexit, the Minister for Health has outlined a comprehensive set of preparations to ensure continuity of health services and supply of medical products in the event of a ‘no deal’ Brexit. This work involves the Department of Health, the HSE, the Health Products Regulatory Authority (HPRA) and other agencies engaging in intensive Brexit preparedness and contingency planning
Brexit Contingency and Preparedness Plan
On January 15th, the Government released an update on their Brexit Contingency and Preparedness Plan. This covered all aspects of areas that will or may be impacted by Brexit including finance and taxes, transport, agriculture, health etc. As medicines supply is critical to the health of the nation, there is very detailed plans to minimise disruption. To summarise the Governments plans on protection of the medicine supply chain, they state “There are approximately 4,000 medicines marketed in Ireland, of which 60-70% come from, or transit through, the UK. The HSE and HPRA have advised that the supply of a small number of these products may be vulnerable for reasons such as their short shelf life, special storage and transportation requirements, and single supplier reliance. The HSE and HPRA are progressing contingency plans...and where necessary, identifying clinically appropriate alternatives to these small number of vulnerable products.”. The Government’s contingency plan goes on to state “The Department of Health, HSE and HPRA do not anticipate an immediate impact on medicine supplies should there be a no deal Brexit on 29 March. There are already additional stocks of medicines routinely built into the Irish medicine supply chain, and these additional stocks, together with planning by Revenue to allow the fast-tracking of essential drugs into Ireland, will help deal with any delays and shortages that may arise.”
No need to stockpile medicines in advance of Brexit
The Department of Health state “It is important to note that there is no need for hospitals, pharmacists or patients to order extra quantities of medicines, as doing so could disrupt existing stock levels and hamper the supply of medicines for other patients.”
Current Medicine shortages and how shortages are kept to a minimum
The Department of Health has advised that there are currently no medicine shortages attributable to Brexit. The HPRA has an existing Medicine Shortages Framework in place prevent shortages from occurring and reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise. This framework is already used to manage and address an average of 45 shortage notifications a month. I find from my work as a pharmacist in Whelehans two pharmacies in Mullingar, this Medicine Shortages Framework works well and keep shortages to a minimum and where there is a shortage, a safe alternative is generally always available.
As an additional safeguard, consideration is being given to those categories of medicines which are considered most essential to public health. Both the HPRA and HSE have requested that companies highlight any issues regarding the availability of specific products associated with Brexit – they have confirmed that no major issues have been identified to date. They also confirmed that if any potential issue is identified, it will be managed through the existing shortages framework, outlined above. The HPRA is continuing to support companies in making the necessary changes to marketing authorisations and committed to ensuring that they will put no regulatory barriers in the way of medicine supply to Irish patients.
There are already significant stocks of medicines routinely built into the Irish medicines supply chain model, and these stocks will help buffer any supply delays because of Brexit.
I will keep you posted in the coming weeks and months as the outcome of Brexit becomes clearer.
Thanks to the IPU, HPRA and Department of Health for the information needed to prepare this article
For health advice and information call in to Whelehans Pharmacies, log on to www.whelehans.ie or dial 04493 34591 (Pearse St) or 04493 10266 (Clonmore).