Medicines

December 2018

Medicines

fAs part of a whole of Government response to Brexit, the Department of Health is working to ensure a comprehensive and coordinated set of preparations to ensure continuity of health services and supply of medical products in a no deal Brexit. This work involves the Department and its key agencies including the HSE and Health Products Regulatory Authority (HPRA) in engaging in intensive Brexit preparedness and contingency planning.

A number of issues are being examined and contingency planning for a  range of eventualities is  underway. A key issue will be to ensure that there is minimum disruption to health services and that essential services are maintained on a cross-Border, all-island and Ireland-UK basis. Priorities include ensuring continuity in the supply of medicines/medical devices,ensuring access to services, staffing in our health services, continuation of existing cross border health co-operation and public health arrangements.

The Minister, Secretary General and the Department are inputting to a wide range of Inter-Departmental and EU Commission fora and have identified legislative and cross cutting issues. The Department is actively reviewing legislative aspects of contingency planning including statutory instruments that may assist the supply of medicines and access to treatments. Officials and Irish experts also have inputted into EU Commission preparedness discussions and Minister Harris has met with the EU Commissioner and counterparts.

The Secretary General has established a schedule of regular meetings with  the Director General of the HSE, and the CEOs of the HPRA and the Food Safety Authority of Ireland (FSAI) to ensure alignment and focus on Brexit Preparedness and Contingency Planning.

The regulation of medicines and the pharmaceutical supply chain is particularly complex. A priority for Ireland is that Irish patients should not be at a disadvantage or deprived of medicines as a result of Brexit.

The Department of Health and its agencies have had positive engagement at national and European level, to ensure that regulatory issues arising from Brexit are addressed in a comprehensive and pragmatic manner.

The HPRA has encouraged and supported the transfer of medicines authorisations and other industry functions from the UK to Ireland and are exploring the potential for joint labelling of medicines with other EU Member States.

Nationally, the HSE and the HPRA have communicated with and facilitated ongoing engagements with medicines manufacturers to ensure that they are Brexit-ready, to discuss any potential issues that could affect the supply of medicines to Ireland and to identify solutions to maintain supply to the market.

Work is ongoing with pharmaceutical wholesalers and other stakeholders to risk assess product lines that may be vulnerable as a result of a no deal Brexit and put in place the necessary mitigation measures to ensure continuity of supply. All of this work is informing requirements and ensuring that we are prepared in all scenarios.

 

July 2019

Supply of Medicines and Medical Devices Health Sector

As part of the whole-of-government response to Brexit, the Department of Health has established dedicated structures to manage the approach to preparing for the UK’s exit from the EU. A high-level group chaired by the Secretary General and comprising the heads of the HSE, HPRA, FSAI and senior officials was established to oversee the health sector’s overall approach to contingency planning and to monitor progress. An Operations Team comprised of senior officials from the Department of Health, the HSE, HPRA and the FSAI was established to identify and resolve issues and to escalate them to the high-level group if necessary.

An inter-agency communications group, chaired by the Department, has also been established to plan for all aspects of a communications strategy to ensure that the public and stakeholders, including industry remain fully informed of the implications for the health sector of either a central case Brexit or a no deal Brexit.

Supply of Medicines and Medical Devices

The Department of Health, the Health Products Regulatory Authority (HPRA) and the Health Service Executive (HSE), with the full support of stakeholders, are implementing a comprehensive and coordinated set of preparations to ensure continuity of health services and continued supply of medicine and medical devices in a ‘no deal’ Brexit.
The preparations include developing contingency plans to mitigate medicines and medical device supply problems arising from Brexit. There has been positive, ongoing multi-agency engagement with industry, including pharmaceutical manufacturers, wholesalers and healthcare professionals, and the health service as a whole, to highlight the importance of preparing for a no deal Brexit and ensuring that pragmatic steps are taken to mitigate any identified risks.

A Brexit Operations Team has been established with key personnel from the HSE, the HPRA, the Food Safety Authority of Ireland, and from across the Department of Health. Among other things, this Team has enabled the Department of Health to intensify its oversight and support for the work of the HSE and the HPRA in implementing contingency plans to protect the supply of medical goods post Brexit.

In January 2019, groups of experts on medicines and medical devices were convened by the HSE and HPRA as sub-groups to the Brexit Operations Team. The experts were tasked with undertaking criticality assessment exercises to scope out key risk areas and focusing contingency planning efforts on potentially vulnerable medicines and medical devices. The groups were established to seek additional assurances from stakeholders involved in their supply, verify contingency planning to date and, where necessary, identify clinically appropriate alternatives.

Medicines

The Department of Health is working closely with the Health Service Executive (HSE), and the Health Products Regulatory Authority (HPRA) at national and EU level to ensure that regulatory issues and any potential supply issues arising from Brexit are addressed, in so far as is possible, to protect the continuity of supply of medicines.

As a result of measures undertaken at industry, national and EU level, Brexit is not expected to have an immediate impact on the supply of medicines. Pharmaceutical manufacturers and wholesalers have provided assurances that there will be sufficient stocks to bridge any initial issues at ports, should they occur. However, given the size of our market, Brexit may cause those with a small share of a particular medicine market to consider the ongoing viability of supply to Ireland. However, any products that may be affected would be unlikely to be critical to continuity of care as there are and will be alternative suppliers or therapeutic alternatives available.

The HSE and HPRA have completed a criticality assessment exercise to seek additional assurances from stakeholders, including pharmaceutical manufacturers, wholesalers and healthcare professionals to verify contingency planning to date and, where necessary, identify clinically appropriate alternatives for those products most critical to public health with potential to be vulnerable to supply issues. Work on this will continue up to and in the months following Brexit including:

 Ongoing engagement with industry to adapt supply chains, where necessary, to minimise potential disruption;

 Ongoing monitoring to ensure that adequate stocks of medicines are routinely built into the Irish medicine supply chain.

The HPRA continue to support companies to achieve regulatory compliance including those availing of temporary batch testing exemptions as per guidance published by the Commission. This includes supporting the transfer of medicines authorisations and other industry functions from the UK to Ireland. Post Brexit, joint-labelled medicines for the Irish and UK markets will continue to be permitted where they continue to comply with EU labelling requirements.

In terms of communications, advice has been given to the public, hospitals and community pharmacists which informed people that there is no need for hospitals, pharmacists or patients to order extra quantities of medicines, or for doctors to issue additional prescriptions, as to do so could create supply issues in the system. There are established multi-stakeholder procedures in place to anticipate and manage medicine shortages. These will be deployed for any additional shortages, should the need arise as a result of Brexit. No shortages currently affecting the Irish market are attributable to Brexit.

Medical Devices

A large number of medical devices available in the EU are assessed by Notified Bodies in the UK. Post Brexit, all medical devices must be certified by Notified Bodies based in the EU27. This may create issues for the availability of medical devices.
The Government has put in place a range of mitigation measures, including:
 Established a criticality assessment group for medical devices;
 Ongoing comprehensive and intensive work to monitor and manage risks to medical devices supply in the months before and after Brexit;
 Engaging with medical device suppliers and manufacturers to encourage swift action to move certifications from UK notified bodies to Notified Bodies based in EU27).

Next Steps

 Between now and 31 October, the Department, the HPRA and the HSE will work closely with industry to ensure that all possible steps are taken to ensure regulatory compliance and continued availability of medicines and medical devices for patients in Ireland.
 Verification of contingency actions for all products will be repeated in advance of 31 October.
 The Department of Health, HSE and HPRA will continue to work and engage with the all relevant stakeholders.

 The Department of Health and the HPRA will also further engage with the European Commission to identify the most appropriate means to mitigate the risk to the supply of medical devices posed by a no deal Brexit.