The State's response to the latest wave of Covid-19 can be described as haphazard and somewhat chaotic. It lacks urgency, cohesion and rationality. This is particularly evident in the approach to antigen testing, which is more like Lanigan's ball - in again and out again - than fact-based and deliberative. As we now know, the Government led pharmacists and retailers on a merry dance during negotiations to agree a subsidy for the tests, before abruptly walking off the dance floor. The Minister for Health, Deputy Stephen Donnelly, in a casual aside during a long interview yesterday revealed that a subsidy is no longer being contemplated, apparently because the market will provide. According to the Minister, a person can now get tests for €4 in certain supermarkets. The State's role in making tests affordable has been replaced by the market, or has it?

There are a number of glaring problems with the State's hands-off approach to the provision of antigen tests. First, I will address the issue of quality. Between June and early October, the European Commission rejected 160 separate applications from various producers of antigen tests, while six tests were removed altogether from the list during that time. Clearly, there are a lot of sub-par tests out there. There is no regulator for diagnostic tests in Ireland. The Health Products Regulatory Authority regulates medicines but it has no role in regulating antigen tests, nor does any other body. While retailers may be supplying tests at somewhat reduced rates, what assurance does the State have that these tests have been subject to any kind of quality control and are reliable?

Does the individual's personal responsibility in the fight against Covid-19 now extend to policing standards for antigen tests that may be on the market? It is also a reality that antigen tests at €3 or €4 each, when the advice is that they should be taken twice a week, are simply out of reach for many low- and middle-income workers who are already struggling to cope. The Minister for Health’s glib advice that people should simply shop around for the best price is beneath contempt.

Can the Taoiseach be clear? First, is this Government is happy for those who do not live near large discount supermarkets to pay through the nose no matter what their financial circumstances? Second, how does the State propose to ensure a consistent supply of affordable tests in the absence of having some role in their provision and supply? Third, and probably most important, does the Government have any plans to regulate diagnostic tests, specifically antigen tests, or does it also intend to foist responsibility for that work on to ordinary citizens?

The Deputy said the Government’s Covid-19 response in general was haphazard and chaotic. I would like to put that comment in context. More than 8.1 million vaccines have been administered in Ireland. We have the highest vaccination rate in the European Union, with 93.4% of the adult population fully vaccinated. The executive director today of the European Medicines Agency, EMA, outlined how Ireland has the highest vaccination rate in Europe and stated:

... the deaths per 1 million population over the last 14 days were 15. But in two other European countries with vaccination rates of less than 50% the equivalent death rates were over 250 per 1 million of [its] population.

I respectfully suggest to the Deputy that this country and this Government's performance on vaccination is anything but chaotic and haphazard. The plan this week is to administer 220,000 to 240,000 primary vaccines and, of course, the booster vaccine. Already, 800,000 booster vaccines have been administered.

Some 212,000 free lab tests were completed in the past seven days. This is the highest volume of lab tests completed to date in a seven-day period. Approximately 1.1 million tests have been conducted in the past six weeks. Total expenditure on testing and tracing during the pandemic is at approximately €846 million. Since 28 October, 93,346 - and it is closer to 100,000 as of today - close contacts have used antigen tests. We have sent out 100,000 free antigen tests to close contacts. Antigen testing of close contacts in schools has commenced and 8,000 were dispatched yesterday alone, all free of charge.

Yes, we did engage with leading retailers to achieve a price target of between €2 to €3 for antigen tests. In our view, if one takes, for example, the serial testing, which is also free, in respect of agriculture, where well over 100,000 free tests have been used in food production centres, and in universities and the third level sector, which have been using free antigen tests, we have a very targeted and effective approach. This also applies to the quality of the test where there are established tests that the major multiples adhere to. The European Commission has published a guide and has given advice to member states on the range of quality tests that are currently on the market.

The broader picture, as the Deputy knows, is that the public health authorities have not been as enthusiastic as she is I support the position on the use of antigen testing. Where we are now is a very significant advance on where we were previously during the pandemic.

I will not mention the lack of capacity in testing, chaotic scenes at vaccination centres or the lack of action on ventilation in schools. I raised questions specifically on antigen tests.

How can the Taoiseach guarantee affordability and quality? The current European direction states: "The performance of antigen tests is self-assessed by the manufacturers prior to their release." The group chaired by Professor Mary Horgan, which examined this issue, made very clear that it does not recommend specific tests for use and, therefore, it is important that we "ensure there is robust ongoing monitoring and evaluation of the performance of the test". How does the Taoiseach propose to ensure there is "ongoing robust monitoring" of these tests to ensure quality standards? At the moment, the market decides the price and, if people are chasing a low price, it is inevitable poor-quality tests will come on the market, given the lack of regulation in this area. How does the Taoiseach propose to ensure quality and affordability in regard to these tests?

First, we are living in a very fast-moving pandemic. No one, including the Deputy, at any stage suggested that we should, prior to utilisation of antigen testing, establish a regulatory framework governing them in advance. She has been an advocate for antigen testing for the past number of weeks and is of the view it should be happening much faster, etc.

It is reasonable to expect there to be regulation.

Now she has come back around the scrum to say, well, actually, slow down somewhat now and do not have it as freely available on the basis of the quality.

Does the Taoiseach not think there should be regulation?

Of course, and we need very strong communications around the types of tests people should buy.

Should there be regulation?

What is important as well is that, in key targeted areas, like schools and the food industry, we are up to 130,000 and close to 100,000 in terms of close contacts, which have been dispatched freely. In key target groups, they are free, have been free and will continue to be free.

Not for the public.

I went through all the different sectors where that currently is happening. More generally, the price range now has come way down, because of engagement, by €2 up to €3, which is a very significant advance.

Go raibh maith agat, Taoiseach.

However, we must always remember that PCR testing remains our core response and 210,000 were given out and done for free, properly so, last week.

The Taoiseach is doing nothing about quality. There is no regulation.

We are over time and I am moving on. The next speaker is Deputy Pringle of the Independent Group.