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Dáil Éireann Debate, Tuesday - 3 November 2020

Tuesday, 3 November 2020

Questions (23)

Matt Carthy

Question:

23. Deputy Matt Carthy asked the Minister for Agriculture, Food and the Marine to outline the process carried out to grant approval for a product (details supplied); if the product was physically tested; and the cause for delay in recalling the product. [33509/20]

View answer

Oral answers (7 contributions)

I wish the Minister good morning. I hope no one planning to tune in tonight is accidentally watching the US presidential results instead. I thank the Minister for being here so late.

My first question relates to the ViraPro product. Was the product physically tested by the Department in advance of it being approved? What was the cause of delay in recalling the product? Will the Minister refer to the subsequent issue pertaining to 50 other products being recalled from our schools?

It is certainly good to see so many in the Chamber this late in the evening. I have no doubt that by the time we finish these questions, we will know a little more about what is in store across the Atlantic than we do now.

Biocidal products, including hand sanitisers, may only be marketed and used in Ireland once they have been registered with the Department of Agriculture, Food and the Marine and entered on the biocidal product register in accordance with Regulation 20 of SI 427 of 2013.

The hand sanitiser ViraPro was approved by our biocides unit and registered on 21 April 2020. Administrative checks applied at registration included the provision of a safety data sheet for the ViraPro product from the supplier which was submitted with the application for registration. As this is an administrative process, no samples were required as part of the approval process. The product was approved on the basis that it contained 70% ethanol, which is a common standard for hand sanitiser products and fully complies with World Health Organization guidelines.

Following international notification of potential concerns regarding a consignment imported into Ireland, my Department took immediate steps to quarantine, investigate and test this consignment. Following investigations, laboratory results received on 16 October showed that the products did not meet the standards for approval, particularly with regard to the presence of methanol. The consignment being investigated remained under quarantine throughout this process. The company was immediately instructed to retain all product in its possession and recall all remaining product under the ViraPro name from the market or in use by the public. On 20 October, ViraPro hand sanitiser was removed from the Department's biocides register.

The primary responsibility for the withdrawal of products rests with the company concerned. On Thursday, 22 October, it became evident on the basis of communication from the company that the recall of products had not yet commenced. At that point, my Department took the additional step of issuing a statement outlining the possible risks posed by ViraPro and advising members of the public not to use it. I was informed of the situation by my Department for the first time on the evening of 22 October.

Additional information not given on the floor of the House

We are taking this matter seriously and will continue to follow up and investigate as appropriate. My Department is continuing to increase its testing of product on the market to provide reassurance in respect of compliance with approved product specifications. Test results available so far indicate no safety issues with other sanitiser products sampled. I have asked my Department to review this matter to ensure that lessons are learned regarding communication of the incident.

The question I asked was whether the product had been tested before it was approved by the Department. That is a crucial issue. We know, for example, that the HSE purchased 3 million units of this product, some 1 million of which were being sent to healthcare centres, including nursing homes and perhaps even hospitals. That is above and beyond the issue pertaining to schools.

What is the process for these types of products? Is it that the Department simply receives written documentation from these companies and then approves the products? Are spot samples taken? Is it a case of companies being taken at their word? More important, what recourse is there with regard to State expenditure? Is there provision within the Department to recoup the cost, which was substantial? I understand it runs to tens of millions of euro across all Departments.

It is late at night. I am keeping everyone to time.

As I outlined, it is a paper-based application process for a licence from the Department of Agriculture, Food and the Marine. Once that is approved by the Department and the composition of any sanitiser is made clear in respect of the licences provided, the legal responsibility is then on the company to ensure it actually meets the requirements of the licence which was provided.

There is therefore an ongoing legal obligation on the company to ensure that its product is fit for purpose and does what it was licensed to do. My Department is conducting ongoing tests on products that are on the market. I have ensured that a number of those have been increased to ensure there is confidence in the products that are on the market. However, that cannot at any point take away from the fact that the legal obligation is on the company providing these products, and it must provide them in compliance at all times with the licence. If one were to sample a product at the point of licensing, there would be no guarantee that the product being sampled would be the same as any product subsequently produced. The legal onus is on the company at all times to ensure that what it produces does what it is licensed to do.

I welcome that clarification on the legal obligation. The question remains: is there then recourse for the State to recoup the money that was spent on a product that was subsequently found to be deficient? The Minister told the Dáil he was informed of this issue on, I think, Thursday, 22 October. We know that the recall happened on 20 October, the previous Tuesday. We know that previously, on 16 October, the Department had recognised that this product was harmful. On 8 October, I think, there were signals that all was not right with the product. Back in September the first indication from Revenue, via OLAF, was made to the Department that the product may not have been what it had been set out to be. Does the fact that the Minister was informed only on 22 October cause him concern? Who is in charge of these issues? Will the Minister take this issue by the scruff of the neck, as is warranted at this stage?

I assure Deputy Carthy that I am certainly the one who is responsible and in charge here. I am very clearly of the view that I should have been informed on 16 October, or whenever the recall notice was issued to the company. Recalls are not unusual. They tend to be operational in nature so they would not always be escalated within the Department. This one should have been, given the nature of what was involved, and I have initiated a review of the handling of this incident. The initial recall to the company was on 16 October. It became clear, from communication with my Department, that by Thursday, 22 October, that recall had not proceeded. At that point I was informed and then the public notification went out and a public recall initiated. There are, however, undoubtedly lessons to be learned here, and I am determined they will be learned in the future.

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