Pádraig O'Sullivan (Cork North Central, Fianna Fail) | Oireachtas source

I thank the Minister of State, Deputy Rabbitte, who has been here on more than a few occasions to answer questions in regard to rare diseases and orphan drugs, and now this issue pertaining to the establishment of the medicines agency. As the Minister of State is aware, this is a commitment in the programme for Government. We are over two years into government and while I can probably guess the answer that has been given to the Minister of State, very little work has been done in this area. The purpose of the question is to see exactly what has happened up to now in terms of delivering this agency and the Minister of State might give a timeframe for the establishment of such an agency. I know the Minister of State is well aware of the issues in this sector, particularly with regard to the question of access to drugs for rare diseases.

I would like to acknowledge the work the Minister, Deputy Donnelly, has done in this area. He has provided the largest budget over the last two years in terms of approval of new medicines, which is to be welcomed. However, I must preface that commendation by saying that in this sphere the Government has made very little progress, and we need to acknowledge that and be truthful about it.

It is welcome that the programme for Government allows for the establishment of the national medicines agency but it is regrettable that the focus seems to be solely on lower pricing and reimbursements. Obviously, this is important. The National Centre for Pharmacoeconomics already has this job and continues to conduct assessments of new medicines and getting the State bang for its buck. However, a national medicines agency needs to be more ambitious, to my mind. It needs to take on the entire reimbursement system and make sure patients get quicker access to the drugs they require. It needs to ensure greater budget predictability. I mentioned that the Minister has supplied the largest budget in this space over the last two years but at various times in the past decade, no money was given over to the budget in this space. Greater budget predictability is a must.

We also need to ensure greater patient involvement. I have met a number of patients groups which complain about the lack of transparency in decision-making for approval of these medicines. They do not feel involved in the process and there is not very much interaction between them and the National Centre for Pharmacoeconomics. We need to develop a specific pathway for orphan drugs because no such pathway exists at present.

The Minister of State, Deputy Rabbitte, attended a cross-party grouping on rare disease day on 28 February last, so she is quite aware of the issues. Going forward, this agency needs to focus in particular on consulting with various stakeholders, patients, patient groups, clinicians, the industry and health economists. Ultimately, this is part of the wider picture in terms of rare diseases and orphan drugs. As I have said in the House in the past, one of the hardest conversations I ever had was to sit down with somebody face-to-face. We can make all the excuses in the world but I want to give some statistics to the Minister of State. In Ireland, the latest data from the European Federation of Pharmaceutical Industries ranks Ireland 24th out of 39 countries in terms of timely access to medicines for all diseases. The same report ranks Ireland 29th out of 39 for access to orphan drugs and 27th for oncology medicines. The most galling thing about all of this, as we noted previously, is that all the large pharmaceutical companies that are providing these drugs worldwide are here on our doorstep. We are shipping drugs to every corner of the Continent and of the planet, yet we are one of the laggards when it comes to approving and getting reimbursement for those drugs. I am interested to see if the Minister of State can give me an update on the establishment of the agency.

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