STOCKPILES OF MEDICINES to last until the New Year are in place in case of a “worst case scenario” no-deal Brexit, according to the Health Products Regulatory Authority (HPRA).
The Oireachtas Health Committee will today be told that since the beginning of this year the HPRA’s preparations for Brexit and engagement with stakeholders have intensified.
It will also be told no major supply concerns have been identified to date.
“A key part of their Brexit planning is to ensure that there is sufficient stock in Ireland so that temporary delays during transportation will not significantly affect access by patients to medicines,” Lorraine Nolan, Chief Executive of the HPRA will state in her opening statement.
The HPRA will tell the committee today that all primary wholesalers have provided assurances that for the vast majority of medicines eight to ten weeks of stock will be held.
“This level of stock holding will allow Ireland manage short-term disruptions to the supply of medicines. We have also, as part of our engagement with companies supplying the market, requested them to confirm that they will have sufficient stock levels (8 to 10 weeks) at 31 October and can maintain these levels post-Brexit period by appropriate replenishment procedures,” committee members will hear.
Medicine shortages unlikely
“Ireland is unlikely to face general medicine shortages in the period immediately
after the 31st October. Any emerging supply issues will, in the first instance, be
dealt with from existing supplies held within the domestic distribution chain. This
supply chain is different to that of some other markets, including the UK,” Nolan will say.
In relation to the supply of medicines post-Brexit, the HPRA states that it needs to be recognised that some products will still either come from the UK by air or sea or by necessity be transported across the UK.
While assurances from suppliers have been made, the HPRA will state that “significant and prolonged delays anywhere along these routes could potentially interrupt
supply to the Irish market”.
“While our preparations are focused on ensuring that such impacts are prevented or minimised, there are no absolute guarantees,” Nolan will state.
The HPRA will reiterate that its shortages protocol framework, which predates Brexit (as medicines shortages can occur for various reasons on an ongoing basis) is in place.
“The health system is, therefore, well placed to deal with any additional shortages as a consequence of Brexit, should they occur,” the committee will hear.
For medicines where stock levels are less eight to ten weeks, the HPRA is “actively working” with the wholesale sector on addressing potential Brexit impacts to ensure “that cases where continuity of patient care could be compromised are in so far as possible addressed”.
“This includes the ability if possible to build additional stock levels and the development of contingency arrangements to ensure a sustained process of stock replenishment. The work remains ongoing,” Nolan will tell politicians.
In terms of the supply of critical medicines, which have a short shelf-life, have refrigerated supply chains, and have time-critical logistics, the HPRA is working with the HSE to review supply arrangements for all prescription medicines.
The review involves liaising directly with hospitals, companies and distributors to identify supply routes and ensure companies have contingency plans in place if their supply routes come from or through the UK.
Critical medicines
Giving practical examples of radiopharmaceuticals and insulin, Nolan said some medicines do make their way to Ireland via the UK.
Some radiopharmaceuticals, which have a short shelf-life and need a specialised transport and storage arrangements are flown from continental Europe to Ireland via East Midlands airport by one logistics company.
Nolan will tell members today that companies who use this route have previously received assurances from their logistics provider that it will continue to operate these supply routes post-Brexit as it does currently.
“We have been in contact with the companies who supply these products to the Irish market who have confirmed their intention and plans to continue the supply to Ireland post Brexit. We have also requested written assurances from the logistics provider involved. Separately there is ongoing direct engagement with the logistics provider in question to ensure that their service can be relied upon and if necessary consider alternative solutions that may be required.
“Currently all the responses we have received indicate that all parties believe that they can continue to supply the Irish market and all parties are actively considering contingency plans,” Nolan will state.
In terms of insulins, which are critical medicines for diabetic patients, the HPRA has engaged with the three suppliers of insulins to Ireland who have all provided assurances that they will have a minimum of eight to ten weeks stock of all insulins in Irish wholesalers on 31 October.
In addition, all suppliers have taken steps to ensure that they are in a position to replenish these stocks post-Brexit, including the use of alternative transport routes which do not involve supply from or via the UK, the committee will be told.
Do not stockpile
The HPRA will again repeat its warning to hospitals, pharmacists and patients that there is no need for them to stockpile medicines.
Due to the already additional stocks of medicines routinely built into the Irish medicine supply chain and due to there being a different wholesaling model than the UK not stockpiling is needed.
Stockpiling extra quantities of medicines could disrupt existing stock levels and hamper the supply of medicines for other patients, the committee will be told.
“Patients should continue to fill their prescriptions as normal,” the HPRA chief executive will state.
In his opening statement to the committee today, Jim Breslin, Secretary General of the Department of Health will state that he is “satisfied that the health sector is working well to prepare for Brexit.
He will tell members that the department has engaged extensively with suppliers both in their industry and on an individual company basis in respect of products, stressing to them the importance of providing early information on any emerging issues.
“We have assured them that we are in problem solving mode. We are focused on pre-empting or solving problems using pragmatic solutions and we will be there to trouble shoot with industry issues that arise in the days and weeks following Brexit,” Breslin will state.
Health spending going to Brexit planning
The committee will hear that this year, the government has committed over €10 million in funding to health sector Brexit preparations.
While the health budget is in a precarious position just two weeks out from the Budget, Breslin will tell the committee today that if Brexit proceeds on a no-deal basis on the 31st October next, “it will be necessary to incur further costs this year and on an ongoing basis”.
He will also state that such funds could have been used for other health projects.
“We could do much to improve our health services with this money but instead we must use these resources to mitigate any potential Brexit impact on population health.
“Neither is Brexit a temporary or once-off adverse event – it represents permanent
change in many aspects of daily life encompassing how we trade, import and
regulate goods and services including health-related products,” Breslin will state.
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