Dr. Lorraine Nolan:

I thank the Chairman and the joint committee for giving me this opportunity to speak to its members about our Brexit preparations. I am the chief executive of the Health Products Regulatory Authority, HPRA. I am joined by my colleagues, Ms Rita Purcell, deputy chief executive, and Mr. Larry O’Dwyer, scientific affairs manager.

The HPRA, as the regulator of medicines and medical devices, has been engaged in preparing for the United Kingdom’s exit from the European Union since Article 50 was invoked. Since the beginning of the year our preparations and engagement with stakeholders have intensified and been based on the worst case scenario associated with a disorderly Brexit.

At a high level, there are three major strands to our work. Since Brexit was announced we have been working with companies to ensure they understand their obligation to be in regulatory compliance by 31 October. We have also been working intensively and proactively with the Department of Health and the HSE on the supply of medicines deemed to be critical to patient care. We have been assisting the HSE in its review of the supply of medical devices.

This has been supported through our work with primary wholesalers, who introduce stock to the market, to review their capacity to hold stock in the event of a disorderly Brexit. I will speak more about those shortly. The HPRA has detailed plans not only to address the immediacy of a hard Brexit, but also to continue with its participation as a key European regulatory agency in the aftermath of Brexit.

The final area of focus has been supporting the Department of Health in engaging with the many relevant stakeholders to ensure a common understanding of the issues and a co-ordinated approach to interaction and communication. In all our work to date, our aim has been to ensure, to the fullest extent possible, that the necessary preparations are completed in time so as to mitigate any potential adverse impacts on patient care.

I will now provide an update on specific elements of our preparations for a no-deal scenario. The committee will be aware from its meeting on 30 January this year that the HPRA has been engaged in an extensive industry engagement exercise with the Department of Health and the HSE, focused on the supply of critical medicines. These are medicines with a short shelf life, refrigerated supply chains, time-critical logistics or compounded for specific patients or patient groups. However, working with the HSE, we have also been able, through this exercise, to review supply arrangements for all prescription medicines regardless of criticality. 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 have been from, or through, the UK. This exercise was first conducted in quarter 1 of this year and work has been ongoing since that time. In advance of the 31 October deadline, we are again repeating this co-ordinated outreach to companies to seek final reassurances of their supply arrangements and contingencies for 31 October in the event of a disorderly Brexit. This work is continuing.

Radiopharmaceuticals, which have a short shelf life and very specialised transport and storage requirements, are one example of this work. While some of these do not transit the UK, the majority are flown from continental Europe to Ireland via East Midlands Airport by one logistics company. Companies which use this route have previously received assurances from their logistics provider that it will continue to operate these supply routes post Brexit. We have been in contact with the companies which supply these products to the Irish market and they 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 to ensure that its 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 they can continue to supply the Irish market and all parties are actively considering contingency plans. This is a good example of the complexity of the issue and the many players involved in getting product to Ireland. In this case, as the product is intended for both Ireland and the UK, it must stop first at East Midlands Airport. This introduces an element outside the control of all parties. While there is no indication that this will cause a problem, it is indicative of the general position that where there are multiple independent players involved in the supply chain, it is not possible to rule out all risks. However, the HPRA and the HSE plan to actively monitor this situation and manage it as necessary.

Another example is insulins, which are critical medicines for diabetic patients and need to be refrigerated during transportation and storage. We have engaged with the three suppliers of insulins to Ireland all of which have provided assurances that they will have a minimum stock of eight to ten weeks of all insulins in Irish wholesalers on 31 October. In addition, all have taken steps to ensure they are in a position to replenish these stocks post Brexit, including by using alternative transport routes which do not involve supply from or via the UK.

A key part of our Brexit planning is to ensure that there is sufficient stock in Ireland in order that temporary delays during transportation will not significantly affect access by patients to medicines. We have contacted all the primary wholesalers which have provided assurances that they will hold between eight to ten weeks of stock for the vast majority of medicines. This level of stockholding will allow Ireland to manage short-term disruptions to the supply of medicines. We have also, as part of our engagement with companies supplying the market, requested that they confirm they will have sufficient stock on 31 October and can maintain these levels in the post-Brexit period by appropriate replenishment procedures. We have also continuously stressed to companies the need to be aware of, and comply with, customs procedures and requirements and have issued individual letters, follow-up calls and a checklist to that effect.

For medicines where stock levels are less than that, we are actively working with the wholesale sector to address potential Brexit impacts and ensure that cases where continuity of patient care could be compromised are addressed insofar as possible. 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. Work in this regard is ongoing.

On the supply of medicines post Brexit, it needs to be recognised that some products will still either come from the UK by air or sea or, by necessity, will be transported across the UK. The assurances received from companies are based on the continued operation of these transport routes combined with the maintenance of sufficient stocks levels in Ireland. However, 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.

No major supply concerns for continuity of patient care have been identified to date and we have, through our shortages protocol, plans in place to address issues should they arise. This framework predates Brexit, as medicines shortages can occur for various reasons on an ongoing basis. I emphasise again that there is no need for hospitals, healthcare professionals or patients to order extra quantities of medicines ahead of Brexit. To do so could disrupt existing stock levels and hamper the supply of medicines for other patients.

Marketing authorisations for medicines place a number of regulatory obligations on the holder. These include that the holder must be based in the EU and that each batch of product imported from a non-EU country must be retested and released in an EU member state. Regulatory compliance among companies has been improving steadily as affected operations have moved from the UK to an EU 27 country. In a repeat of the exercise conducted in quarter 1 of this year, we issued a list of questions in August to those companies which potentially may not be in regulatory compliance on 31 October, or 31 December if they availed of a Commission approved temporary waiver of retesting requirements on importation into the EU. A medicine which is non-compliant as of 31 October does not automatically present an immediate risk and we will work to ensure that regulatory issues associated with Brexit will not hinder the supply of medicines in the immediate aftermath. We are continuing to engage with companies to ensure that they address outstanding regulatory actions in a timely manner.

Medical devices, unlike medicines, are not authorised by the HPRA. Each medical device on the market requires a conformité Européenne, CE, mark to demonstrate conformity with the regulatory framework and for medium to high risk devices a CE certificate must be issued by a notified body located in any EU member state. The HSE, as the main procurer of medical devices for the Irish health system, has engaged in an in-depth exercise of analysing medical devices for exposure to the UK - landbridge or manufacturing - and for certification from a UK notified body.

The HPRA is participating in the HSE-led criticality assessment group for medical devices and is sharing information with the HSE to assist in its risk assessment of critical medical devices supplied to and used in the health services. The HPRA has communicated with manufacturers and authorised representatives at national level a number of times to ensure appropriate awareness of the implications of a disorderly Brexit for medical devices. We have also led on EU work with other competent authorities to promote awareness and to prevent adverse impacts on medical devices used in Ireland. From our engagement, we know that larger manufacturers have measures in place to transition their UK medical device certificates to an EU 27 notified body, while many small and medium sized manufacturers have indicated that their main challenge is in securing an EU 27 notified body to issue new certificates. As such, it remains the case that a significant number of UK certificates have not transitioned to an EU member state.

There are a number of factors contributing to this. Historically, there has been a high dependency on UK notified bodies for medical device certification activities. This is due to the broad ranging designation scope which the UK notified bodies have to conduct such activities and to their size. Notified bodies throughout Europe are also preparing for new EU regulations which apply from May 2020, a factor which is impacting on their ability to take on additional certification activities.

The HSE is reviewing the impact of this on medical devices on the Irish market. The situation is not unique to Ireland, although our market is likely to be more impacted. The HPRA and other EU authorities are working together to develop and agree with the European Commission a European approach to manage UK certificates that have not transitioned by the deadline.

If such an approach is not agreed, the HPRA has developed contingencies to manage this. Given that a medical device which becomes non-compliant with regulatory requirements after 31 October does not present an immediate risk, we will work to ensure continuity of care for patients while ensuring that products return to compliance as quickly as possible.

As Government public communications have recognised, any Brexit outcome that does not include regulatory alignment will mean change as the UK and Irish markets adjust over time. Brexit will bring change across all areas and in the dynamics of the supply chain and model in Ireland for both medicines and medical devices. The issues we see in the longer term may be quite different to those in the immediate aftermath.

It is realistic to expect that companies may after a period of time make commercial decisions with respect to the continued viability of supply of certain products to our market. We have stressed to companies that, in advance of making any such decisions, they should let us know of their plans as soon as possible. The earlier we have this information, the better we can plan for change, including working with HSE colleagues. Alternatively, we may be able to help in identifying a course of action to prevent such an outcome.

In closing, I would like to assure the committee of the strenuous efforts being made by HPRA staff in relation to protecting the supply of medicines and health products to Irish patients post Brexit. I also wish to acknowledge the considerable collective efforts of our colleagues in the Department of Health and the HSE and the substantial engagement by industry and healthcare professionals. It is this open and co-operative approach among stakeholders across the health products sector that will help to ensure we effectively and collectively manage the potential impact of Brexit on supply and availability.

We will be happy to address any questions.