Dáil Éireann Debate, Tuesday - 22 February 2022
888. Deputy Holly Cairns asked the Minister for Health the reason that pyridoxine and doxylamine which is only available on prescription is classified as a food supplement and not a medicine; and if he will make a statement on the matter. [10120/22]
View answerFirstly, I would like to provide a status update on the ongoing work that the HSE is carrying out in relation to Cariban. The Medicines Management Programme (MMP) has submitted a clinical review and the HSE are now considering if there are potential reimbursement options based on the MMPs recommendations. I am hopeful that the HSE can achieve a positive outcome and my Department and the HSE are continuing to work closely together on this issue.
In order to address the question raised by this PQ, I need to provide an updated position on the classification of Cariban. The position previously presented by me and my Department was based on inaccurate information we received.
My officials recently contacted Health Products Regulatory Authority (HPRA), which is the competent authority for medicinal products in Ireland, to seek advice in relation to the classification of Cariban. On 18 February 2022 the HPRA advised my Department that while Cariban does contain Pyridoxine hydrochloride which, as per Directive 2002/46/EC, is permitted for use in the manufacture of food supplements, it also contains doxylamine succinate which is an antihistamine. Therefore, the HPRA has said that Cariban is classified as a medicinal product, not a food supplement. Furthermore, Cariban is classified as a medicinal product as it meets the definition of a medicinal product under Article 1 of Directive 2001/83/EC as amended by Directive 2004/27/EC.
The HPRA have also advised that Cariban is currently not licensed for use in Ireland. There are three similar products, Xonvea (doxylamine 10 mg and pyridoxine 10 mg), Navalem (doxylamine 10 mg and pyridoxine 10 mg) and Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets (doxylamine 10 mg and pyridoxine 10 mg) that are licensed for use in Ireland. However, the companies holding the authorisations/licences have not marketed the products in Ireland to date, and the HPRA cannot compel a company to market a medicinal product. Similar to Cariban, all three of these products are classified as medicinal products, not food supplements.
I sincerely apologise to the House for presenting information in relation to the classification of Cariban that I now know to be inaccurate. Unfortunately, I only became aware that the information was inaccurate in recent days.
