It is the Government’s assessment that there is a significant risk of a no deal Brexit on 31 October. Recent correspondence from the Department of Health, the Health Service Executive (HSE), the Health Products Regulatory Authority (HPRA) and the Food Safety Authority of Ireland (FSAI) confirmed that they have and continue to be engaged in extensive Brexit planning and action to ensure that the health sector is prepared, to the greatest extent possible, for any adverse impacts as a result of Brexit.

As part of the continuing efforts to prepare for a no deal Brexit, they have advised that, together with industry, they have been working to minimise and address any risks to continuity of supply.

Some key messages to emphasise from this correspondence are;

• In Ireland they have, since 2016, been working to determine and address the risks to medicines supply as a result of Brexit. As a consequence, they have developed a comprehensive and coordinated set of preparations to ensure, as far as is possible, continuity of supply of medicines.
• Unlike in the UK, there are already additional stocks of medicines routinely built into the Irish medicine supply chain and these stocks will help to absorb any short-term delays that may occur. The health system is therefore well placed to anticipate and respond to any additional shortages, should they arise because of Brexit.
• There is no need for hospitals, pharmacists or patients to order extra quantities of medicines, or for doctors to issue additional prescriptions. Doing so could disrupt existing stock levels and hamper the supply of medicines for other patients.
• No shortages currently affecting the Irish market are attributable to Brexit.        

Furthermore, Diabetes Ireland continues to liaise with pharma industry regarding continuous access to insulin following a no deal Brexit. Below are the current positions of Novo Nordisk and Sanofi:

Novo Nordisk:

“All of our medicinal products come from continental Europe and currently these arrive in Ireland via the UK land-bridge. By-passing the UK has been tested as part of Novo Nordisk’s Brexit risk planning. In the event of a no-deal withdrawal of the UK from the EU on 31 October 2019 or they see a breakdown in transit time, products will be delivered directly to Ireland from continental Europe, thereby by-passing the UK.

Novo Nordisk has also increased stock levels in Ireland to ensure continuity of supply to Irish patients after 31 October 2019 and will closely monitor stock levels going forward. They therefore advise patients taking Novo Nordisk medicines to continue to access their prescribed medicines as they normally do”. For queries or further information, contact 1850 665 665 or email [email protected]

Sanofi:

“Our main priority is to ensure people in the European Union (EU) and UK have continued access to the medicines and vaccines they need. Sanofi is working to ensure that Brexit does not negatively impact the supply capacity, processes and time-frames for new and existing medicines and vaccines reaching EU and UK patients.

The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Patient safety and continuity of supply is our main priority and, amongst other actions taken, we have restructured our supply chain to exclude the UK from inter-EU-27 distribution routes.

Sanofi is confident that its contingency plans will ensure that patients and citizens in the EU-27 can continue to access the treatments they need after the UK leaves the European Union”.

In relation to other medical devices, the HSE and the HPRA are in ongoing engagements with manufacturers and suppliers to ensure that they are Brexit-ready, to discuss any potential issues that could affect supply to Ireland and to identify solutions to maintain supply to the market.