Joint Committee on Health díospóireacht -
Wednesday, 8 May 2024

I thank the Chair. I am delighted to talk about the draft instrument under the auspices of the WHO to strengthen pandemic preparedness. As the Chair mentioned, I am joined by Dr. Collette Bonner and Mr. Joe Hanly from the Department, who will be able to answer questions inasmuch as they can, given that negotiations are still ongoing. We will do our best to assist the committee in any way we can.

Arising from the pandemic, agreement was reached at the second special session of the WHA, World Health Assembly, to begin the process of negotiating a convention, agreement, or other international instrument to strengthen pandemic prevention, preparedness, and response, commonly known as the pandemic agreement. The session also agreed to further strengthen the international health regulations through a series of targeted IHR amendments aimed at strengthening global health emergency response and operationalising equity in relation to same. The IHR are a long-standing set of regulations first adopted in 1969 and have been revised on several occasions. The aim of the IHR is to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with, and restricted to, public health risks and which avoid unnecessary interference with international traffic and trade.

At the outset I should say that the pandemic agreement is a member state-led process, driven by the member states. Any decision as to whether to ratify the agreement will be a matter for individual member states alone to decide. It is important also to point out that, as currently drafted, this agreement presents no loss of sovereignty, based on our opinion, to Ireland or to other countries which are involved in this negotiation process. Specifically, any decisions in relation to actions, such as quarantines or travel restrictions or any such measures that may be taken in the context of a future pandemic, are decisions the Irish Government with the support of the Irish Parliament, as necessary through laws or instruments, will be required to take.

During the Covid-19 pandemic, the global disparity in access to necessary medical products and vastly different levels of national health system response capacity were made apparent. As mentioned, the WHA acknowledged the need to address gaps in prevention, preparedness and response to health emergencies, including in the development and distribution of, and unhindered timely and equitable access to, medical countermeasures such as vaccines, therapeutics and diagnostics, as well as strengthening health systems and their resilience, with a view to achieving universal health coverage. This new instrument is intended to have a whole-of-government and whole-of-society approach, prioritising the need for equity in a global health emergency response and stressing that member states should be guided in their efforts to develop such an instrument by the principle of solidarity with all peoples and countries, which should comprise practical actions to deal with both the causes and consequences of future pandemics.

An intergovernmental negotiating body, INB, was established and met for the first time on 24 February 2022. The INB has met nine times to date to progress work on the drafting of this agreement. Officials from the Department are attending talks from 29 April to 10 May. A progress report was delivered in May 2023 and the ambition is that the pandemic agreement will be presented to the 77th WHA for adoption at the end of this month. It is important to note that adoption does not mean Ireland accepts the agreement. Any international agreement will be subject to Government approval before ratification.

The pandemic agreement contains measures on prevention, surveillance, One Health which includes human, animal and environmental health, protection of health workers, encouraging collaborative research and development, diversification of production and sharing of technology, a new pathogen access and benefit sharing system and a financing mechanism to assist state parties, in particular developing countries, in improving their domestic health surveillance and prevention systems. If members wish to see more detail, the draft text being drafted is publicly available on the WHO website and I believe it has been circulated to member of its committee for consideration.

It is fair to say that discussions on this agreement have been difficult, not least because of the whole range of provisions that are included but also because of the constrained political and financial environment in which many countries find themselves. Despite this, the EU and departmental officials continue to work hard towards achieving a positive result that will strengthen global health systems and pandemic preparedness, noting that no one is safe until everyone is safe.

If members have any specific questions they wish to raise, we are very happy to seek to answer them, having regard to the fact that negotiations are ongoing and the agreement is still subject to change. We are very much available to keep committee members up to date over the coming weeks as the process is coming to an end. I presume an agreement will be put to the Government for ratification.

This is one of these issues that are subject to public commentary. It is important for us to get some clarity on some issues so the public fully understands what this is and what it is not. In his opening statement, Mr. Watts states the agreement presents no loss of sovereignty, which is an important statement to make, and that it does not mean Ireland will be forced to put in place quarantine or travel restrictions and this will still rest with the member state.

I have several questions, the first of which is a general and more fundamental one. Is it the case, despite this treaty, and I accept what is being said that it is about seeking agreement on preparedness and actions that need to be taken, that specifically public health measures, such as those we saw taken in the course of the Covid pandemic, will still be competencies of the member state? I am speaking about what we described as lockdowns, travel restrictions and all of these issues. They will still be competencies of member states.

We had very helpful commentary by the World Health Organization during Covid on public health generally and how we see it and how we see public health services. There was the notion of solidarity among member states first and foremost. As was said, nobody is well until everybody is well, or whatever the phrase was. Public health is very important and globally equity is important in terms of vaccines. What lessons have been taken from all of this for the agreement with regard to public health, public health services and equity of access to healthcare? Do they run through the agreement?

I will make a comment and Mr. Hanly might come in. As we say, no country is safe until we are all safe because a pathogen of the type we had previously can cross borders and we are in an interconnected world. As we discovered, it is very hard to keep something out. We all have to work in a collaborative way. Lessons have been learned on access to vaccines and access to the technology. We remember the discussions we had at the very start about PPE and ventilators. It is to ensure that we work collaboratively in a way that ensures, as best we can given the fact we have sovereign nations, that when it comes to these practical issues we work in a collaborative way to learn the lessons from Covid.

I have several questions. One is on public health measures and that they would still be the competency of the member state, for example, lockdowns and other public health responses. My other questions is on vaccines. At present they are not mandatory and nobody is asking for them to be mandatory. There is some online commentary that this is what the treaty is about and the purpose of my question is put this to bed. It is not about that.

Public health measures will stay the competency of the member states and this is very clear in the agreement. Vaccine policy is a matter for individual member states. What the pandemic agreement is trying to get at is access to vaccine material itself and the technology and know-how behind it, conscious that some of it is commercial intellectual property and conscious of the nuances around the issue. It is about information being shared as equitably as it can be. The broad aim is towards equity, whereby member states of the WHO that have less developed or less resilient health systems would get support from other member states that have more developed and more resilient services, and that they have access to medical countermeasures including PPE.

There is a section in the agreement on countering misinformation, disinformation and vaccine hesitancy but it is about providing clear and accurate information to citizens. It is not in any way about restricting a member state in terms of what its vaccination policy would be.

I thank Mr. Watt for the briefing. These points are very important to stress. This agreement will not interfere with national competencies and the principle underpinning this, that no country is safe until all countries are safe, is very important. That was brought home to everybody during Covid.

I am curious to know who is leading on this for Ireland. Who is negotiating it? What will be its impact in terms of fair and equal access to vaccines and future developed vaccines, which was an issue the last time, and on other medicines that might be associated with a pandemic?

There are approximately 170 member states to the WHO. The negotiations are done in regional blocs. Ireland is part of the European bloc and within that there is a EU subgroup. In the negotiating room, as it were, the EU speaks on behalf of all member states. The participants comprise two officials from the Department of Health and there are also officials from the Department of Foreign Affairs, the permanent representative and the ambassador, who very closely watch it. They get the copies of the text, the amendments, and there are discussions and side meetings as well but in the negotiation room, it is the lead person from the group who speaks on behalf of the group.

The Department of Health, through the health security unit, which Mr. Hanly leads on and which I advise into as medical and public health advice, keeps in very close contact with our negotiating team in Geneva to see how things are going and if there are any areas of particular controversy, we get involved and give instruction on that.

Sure, but the objective of this agreement is global equity in pandemic preparedness. As Mr. Hanly pointed out, that relates to access and counter measures, especially for countries that were less well developed and less able to do that during the previous pandemic. From that point of view, we feel this is quite a health competency related area. Obviously, we take into consideration all the other factors around that such public health measures, etc., but at the moment we do not feel that is necessary.

It was, and remains, one of the major sticking points in the negotiations. The intellectual property involved is not in the gift of the negotiating teams to negotiate away. It belongs to commercial companies, in the main. I am conscious that there are very complicated and lengthy supply chains and manufacturing chains in producing all the medical counter measures such as vaccines, medicines or even PPE. On how the WHO has come around this or attempted to do so, originally it was looking for technology and know-how transfer at some level to the less developed nations. There are questions around the location of manufacturing facilities in the less-developed countries but there are side or parallel questions around the viability. These are very major investments with a ten- or 20-year lifetime around them. Concerns have been raised that they would be uneconomic. Other ways have been come around to address this. Built into this, and this is still up for negotiation, is that the more developed counties would assist the less developed countries. It is a combination of a direct monetary contribution, which would be administered by the WHO itself.

Then it has sought, or at least put up for discussion, that a percentage of available vaccines or medicines in the country would be given as a donation and another donation might be given at cost, so there would be a cost-neutral supply. That is to enhance or guarantee some level of genuine supply from developed countries to the less developed countries and to help them in developing their health systems and responding to a pandemic.

How is it proposed that circumstances will be different from, say, the SARS virus in 2003 and the latest pandemic? Are there practical areas of change? Any pandemic brings about new understanding and learning. Internationally, in terns of co-operation or planning, what is the big picture on the lessons learned and how things are proposed to be different?

It is lessons learned. The stand-out element of the Covid pandemic was its duration. SARS-1 was a more short-term, more localised event. Covid was practically global and a duration of two years. With preparedness for that level of response, looking at the available surge capacity in hospital systems and the development of vaccines, the latest pandemic brought the MRNA vaccine or at least MRNA-based vaccines so there was more rapid development and getting them out. Normally a vaccine would have taken ten years. With older technologies, a pandemic would be come and gone and we would still not have a vaccine out there. There have been developments in AI that short-circuit or at least shorten some of the early stage trials and can help focus on the more realistic candidate to progress from that. It goes back to the same message: "No one is safe until everyone is safe". Looking across the globe, there are health systems that are reasonably well prepared, some are very well prepared - Ireland did very well in relative terms in the latest pandemic - and there are health systems in many of the less developed countries that are not at all prepared. They are overwhelmed by business as usual in their day-to-day work and they have no surge capacity and, therefore, helping them in the interpandemic periods to build up some capability. There is a section in this on the professional healthcare workforce. Again, technology and training transfers from more developed to less developed countries. I mentioned funding mechanisms and donations earlier. It is about, broadly speaking, levelling the playing pitch in so much as we can for the less developed counties because the more developed countries will have a level preparedness anyhow.

Buildings per se are not in this. This year, the Mater Hospital Group will commission a national isolation unit that will be able to deal with patients with highly infectious diseases. Preparedness is in the main about the acute hospital system, ICUs, ventilation and the managing of those assets.

The HSE is about to sign off on an upgrade to its pandemic plan. It is due to be done within the next two months or so. It is there in draft for board or executive approval. Big capital investment is not mentioned specifically here but there is a reference to development of and assistance with laboratory and diagnostics. That is under the general background preparedness. It does not go into specific building requirements or anything like that.

I was going to talk about the intellectual property side of it. There was an issue but Deputy Shortall has it well covered. Has the Department had any engagement with any pharmaceutical companies, given that so many of the big ones have their European headquarters here? Has the Department sought any guidance or been influenced in any way by them in its negotiations?

It is nearing an endpoint but not yet agreed. There is provision for a financial contribution that would be administered by the World Health Organization, expectations of donations and at-cost supply. In response to the Senator's earlier question, it calls on state parties to encourage manufacturers in their states to share information.

On the agreement itself, the document states the Department is attending talks between 29 April and 10 May. Do amendments come up at that meeting within those talks? How does the Irish side feed into that? This is the first time, politically, that the health committee has engaged with this. What engagement has the Department had, aside from those who are attending? I am talking about the political system and health system in Ireland. How is the Department feeding into that? Are there rules that, for example, amendments have to be in before a certain time? Is the deadline the end of these talks? Can amendments go in after 10 May? How does that work? Will Mr. Hanly talk us through that? I am asking this for people at home who might be interested in this too.

There is not an avenue for general amendments to be submitted. It is done through the negotiating teams. They are supported by a secretariat from the WHO. Those people obviously sit in and listen in on all the sessions. They constantly revise and tweak the text. There are revisions of text and new paragraphs are put back out to the general groups to discuss and give their observations, whether good, bad or indifferent, whether they will not have it, are all for it, and everything in between. The bureau takes the sense of that. The objective when this started was to have a full agreement to go to the WHA on 27 or 28 May.

This current session is an extra session that was not planned in the original timetable. They believe there was some possibility of getting to an agreement, which they believe is absolutely necessary. Some elements of this will be put out. It will be agreed or at least included in the text at a high level. There are two areas. One is the area of One Health, which is poorly understood by less developed countries, which have significant concerns about it. It is the bringing together of veterinary, plant and humans as related ecosystems. You have to protect all the ecosystems, including the animal, the human the plant, to maintain world health. A working group is to be set up following the WHA. That has a lifetime of two years, by which time its work will become substantive.

The other area is called PABS, which is pathogen access and benefit sharing. This is about some of the intellectual property material, access to knowledge and DNA information and DNA sequencing, so the first country that sequences the latest pathogen would make it freely available, more or less like what happened during the Covid pandemic, when the Chinese authorities released the first sequence of Covid. All the other laboratories worked on it thereafter. That type of co-operation and doing so quickly and on an equitable basis is part of this. Those areas are still highly contentious among the group but it believes there is enough at a high level that it can include for an agreement and that a working group will complete that work over the next two years. It all becomes substantive on 31 May or 1 June 2026.

There are two stages. It is scheduled to be completed this Friday. The signals are that it will be a long night on Friday. That is what I am hearing from the team. They have no plans to go beyond that. The pandemic agreement text, or at least the negotiations on it, will be finalised late this Friday night or early Saturday morning. Then the bureau has to tidy up that text and translate it into seven languages for circulation to the membership before the WHA. On Thursday and Friday next week, 16 and 17 May, there will be the final session on international health regulations. They are related but separate. They will be brought for adoption at the WHA. Following adoption at the WHA, there is a process of about 13 months where member states then have to go back to using the parliamentary procedures within their countries to get them ratified. In the same way as this, it will initially be an exercise of the executive powers of Government, because it is an international agreement, but because of the financial implications and the continuing cost implication for the State, it will have to come before the Dáil subsequent to that before it can be finally ratified.