Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

I am glad to be here this morning to take this Commencement Matter on behalf of the Minister, Deputy Harris. I thank the Senator for raising this issue. PKU and HCU are lifelong conditions, with serious dietary restrictions for people who have them. Essential clinical nutritional products, specifically for PKU and HCU, as well as some low-protein foodstuffs, are reimbursed under the community drugs schemes. I am aware that there has been little or no variation in this list for several years.

The HSE primary care reimbursement service, PCRS, has just published revised guidelines for manufacturers and distributors on the reimbursement of clinical nutritional products. These guidelines were last updated four years ago. The expert group which revised the guidelines was drawn from hospital and community settings, and included procurement support. Manufacturers and distributors were consulted on the draft guidelines, as was the Food Safety Authority.

For a product to be reimbursed, the supplier must apply to the HSE for approval, and products must meet published criteria. For pricing, the HSE is prepared to consider several factors. However, there are a number of broadly similar products, and it intends to have a single price mechanism for such products, so that similar patient benefit receives similar reward. When the HSE receives applications for clinical nutritional products under the new guidelines, it must consider the approval criteria set out in the 2013 Health (Pricing and Supply of Medical Goods) Act.

Regarding reimbursement criteria, the Senator may be aware that, as PKU is on the long-term illness scheme, the HSE has, in the past, made exceptional arrangements for essentials such as bread and other like products. It is prepared do so again, on an individual basis, taking into account the price constraints I have outlined. For example, where a product is dietician-recommended and is less than an existing reimbursable item, it may continue to be approved on a patient-specific basis.

I would like to see expansion of the range of items available for people with PKU and HCU. Over a decade ago, the situation was similar for gluten-free foods, especially for dietary staples like bread. Now, quality, choice and availability have vastly improved and people who need these items can get them in a wide range of outlets.

However, the State does not commission for reimbursement - suppliers must make their products available. New products have come to market elsewhere in recent years and suppliers have not sought reimbursement yet in Ireland. Specialised products for PKU and HCU are unlikely to appear outside pharmacies, but in particular low-protein food staples should follow the path of gluten-free products. These are not technical products or specific to PKU and HCU, and should be available to anyone who wants them. I would like to see their range and availability increase, as happened for gluten-free foods, so that people on these extremely restrictive diets can have a much better choice and variety of food, as everyone else does.

That is the reply from the Minister. I have taken some notes and I will take more after the Senator responds.