Paschal Mooney (Fianna Fail)

I am glad you clarified it, Chairperson. My compliments to Senator Colm Burke and Fine Gael ON putting this motion before the House. Senator van Turnhout's reputation precedes her.

The Minister of State, Deputy Shortall, is very much on top of her brief so I assume that she may be aware of this, but I will put it on the record anyway. As a result of my networking with the Prader Willi Association, particularly in the UK since our child Siobháin was born, they are a great fund of knowledge in terms of updating on developments. There is a PW association here in Ireland, mainly based around Dublin, which has received funding from the Department for a permanent respite care centre for adult PW victims. I hope the Department will continue to fund that because it is vitally important.

The Government is represented on the committee for orphan medical products. I am grateful to the representative of the Irish Medicines Board but I will not mention her by name as she is a civil servant, although it is in the public domain. I am grateful to her for the information she provided to me. The lady in question has been a member of the committee for orphan medical products since September 2011. Each EU member state, along with Norway and Iceland, has a representative on the committee. These representatives are appointed by the Minister for Health in each country. In addition, there are three patient organisation representatives, as well as a small number of members of the European Medicines Agency's committee on human medical products, and representatives of the European Commission.

The committee meets in London every month for two days and at each meeting it considers applications for designation as orphan products. In general, designation happens at a fairly early stage of the development of a product. The condition must have a prevalence of fewer than five in 10,000 and must be life-threatening or debilitating. In addition, there should be medical plausibility - that is, there is some evidence that the product might work on a given condition. If there are already products available to treat the condition, the applicant must be able to demonstrate that their product will provide significant benefit over and above the currently used product.

Getting an orphan designation brings a lot of benefit to companies, such as not having to pay certain application fees and getting free scientific advice regarding the trials they need to do to prove the benefit or efficacy of their product. It also means that they get ten years market exclusivity for their product. Not all products that receive an orphan designation go on to get a marketing authorisation, often because they fail to show that they are of any benefit. The lrish representative is not sure of what the proportion is.

I have put this on the record of the House because the Prader Willi Association is lobbying within Europe for the granting of an orphan designation to a trial product called Carbetocin. Carbetocin is currently in its experimental stage. One or two companies are currently trying to come up with a product that would lessen the impact of Prader Willi syndrome. This particular condition is incurable. It is genetic in origin and whatever drugs are eventually developed and trialled will be of benefit in certain aspects because it is such a multi-layered condition. It affects a variety of parts of the body. As I said earlier, in our case, thank God, it is primarily an eating disorder. There are also issues concerning behaviour, bone structure and diabetes.

I am asking the Minister of State to ensure that the designation, if given, will incentivise pharma-companies to carry out clinical trials on medicines that may help to alleviate the condition. I ask the Minister of State to ask her officials if they would contact the Irish representative concerned with this matter. She is very much aware of this issue and I have been in correspondence with her. All of this information has come directly from her. This might be another area where, in the context of this wider debate on addressing rare diseases, full support would be given to the particular drug that is currently being put before the committee for orphan medical products. No decision has yet been taken on it, but I would be grateful if Ireland would support it.