Thursday, 26 May 2022
Saincheisteanna Tráthúla - Topical Issue Debate
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.
I thank the Deputy for raising this issue. He is right when he says the 2020 programme for Government includes a commitment to establish a national medicines agency which will seek to reduce the cost of medicines for the State and for patients. As the Deputy is aware, the existing pricing and reimbursement process for medicines involves the work of a number of individual bodies and agencies. The collective contributions of these agencies are crucial to the HSE executive management team's decision-making with respect to medicine reimbursement.
First, the Health Products Regulatory Authority, HPRA, is responsible for the regulation of health products, including medicines, in Ireland and maintains a register of authorised products. Under the Health (Pricing and Supply of Medical Goods) Act, reference pricing involves the setting of a reimbursement price for a group of interchangeable medicines. This has enabled greater cost-effective dispensing and continues to contribute to cost avoidance. The Health Products Regulatory Authority's role under the 2013 Act includes the maintenance of a list of interchangeable medicines. This supports pharmacists to substitute medicines prescribed, provided they have been designated as interchangeable by the Health Products Regulatory Authority.
The National Centre for Pharmacoeconomics advises the HSE on the cost-effectiveness of new medicines. The National Centre for Pharmacoeconomics carries out health technology assessments in order to make recommendations on reimbursement to assist HSE decisions.
The HSE's corporate pharmaceutical unit is an important interface between the HSE and the pharmaceutical industry on application for reimbursement and the pricing of such medicines.
Its successful commercial engagements with the pharmaceutical industry achieve significant savings for the State each year, thereby providing access to as many medicines as possible for as many patients as possible. In December 2021, the State agreed two new multi-annual agreements with the pharmaceutical industry. It is estimated these agreements will result in the State paying between €600 million and €700 million less for medicines than it otherwise would have done. Since the finalisation of the agreements, the corporate pharmaceutical unit has been engaging extensively with the industry to implement the agreed measures. This has included the downward realignment of more than 800 prices.
The HSE drugs group is the national committee that makes recommendations to the HSE's executive management team on the pricing and reimbursement of medicines. Such recommendations are based on the outputs of the entire assessment process. As part of that assessment process, the national cancer control programme technology review committee, which was established in 2011, reviews funding proposals for new cancer drugs. It then makes recommendations on the reimbursement of new drugs to the HSE drugs group based on clinical need and cost-effectiveness. In 2018, the rare diseases technology review committee was established by the HSE leadership, with similar responsibility for reviewing proposals for funding of new drugs for rare diseases. That committee also contributes to the development and implementation of clinical guidelines for relevant drugs.
The establishment of a national medicines agency would require a significant body of work to be undertaken to integrate all these various work streams under a single function. It would also require extensive consultation and primary legislation. That work has yet to commence because the priority and focus of the Department up to now has been on tackling the Covid-19 pandemic. I am acutely aware of the Deputy's involvement in, and knowledge of, rare drugs. Sometimes when I read replies such as this, I feel I know very little about the subject at hand and perhaps less than the Deputy who is asking the question.
The real answer to my question was near the end of the Minister of State's response, when she said that "a significant body of work" needs to be undertaken and it will "require extensive consultation and primary legislation". Halfway through the life of the Government, if there is substantive work to be done, we really need to start doing it. That is the reality. If legislation and extensive consultation are needed, we are looking at needing a couple of years to do it when we are already halfway through the Government cycle. The message must go back to the Department of Health that we need to get real and that action on this issue needs to be instigated immediately.
I have looked at other responses that have been given to questions on this subject. I knew the Covid crisis would rear its head as an excuse at some stage. Surprise, surprise, there it is at the very end of the Minister of State's reply. However, the pandemic did not have an impact on some of the great announcements the Minister, Deputy Donnelly, has made over recent weeks, including, for example, in respect of women's health services. Nor did it have any impact on this week's announcement of the expansion of the human papillomavirus, HPV, vaccine programme in schools. When it comes to the issue of orphan drugs, however, the Covid crisis is given as a reason for lack of action. It is very frustrating to see the pandemic being used as an excuse in this regard.
As I said, we need to get real. We are talking about people's lives and their quality of life. The statistics I roll out every now and again about Ireland being a laggard in the European context should be a source of embarrassment to us nationally. Those statistics are referred to so often now that they roll off the tongue and seem to matter very little. It is embarrassing that Ireland, which is one of the largest pharmaceutical-producing nations in the world, ranks 24th out of 39 countries in Europe in terms of our provision of these drugs.
Provision regarding the health technology assessment, HTA, process is the substance of the Bill I am trying to progress. It is currently on Committee Stage. We are using an antiquated, outdated system and pretending it is achieving all these savings, as the Minister of State referred to in her response. The reality is Ireland spends a higher percentage in comparison with countries like Germany, Scotland, Sweden and many others on the drugs that are claimed through our reimbursement system. In those other countries, the medicines are supplied upfront, but we make patients wait a torturous 800 to 1,000 days. I would argue with the statistics claiming we are saving €700 million or €800 million because we are such great negotiators. It is a load of codswallop in my view.
I am happy to share some of my time to have allowed the Deputy to get in his last few words. He is correct in what he said. We must move away from the practice of saying why we are not doing a particular aspect of work. There is no denying that action on this issue is included in the programme for Government. As Minister of State, it is something I would like to see commencing, for all the reasons the Deputy outlined. First and foremost, orphan drugs make a significant difference to the lives of individuals. Second, what we all should be about is ensuring longevity for people. The fact we have access to these drugs in this country makes the current situation unbelievable.
Having said that, the Deputy will be interested to know that as of the start of May, the €30 million provision that was allocated in budget 2020 has enabled the HSE to approve 24 new medicines. The executive's robust assessment process and commercial engagement ensured as many new medicines as possible were made available to Irish patients in that period. This shows it was possible to access the budget quickly. I would love if my budget for disability services could be spent in June or July each year. The speed of expenditure in this case shows the great need in respect of orphan drugs and in terms of bringing more medicines on stream, which has a great benefit for the wider population. I will take the Deputy's remarks back to the Minister, who sends his apologies for not being able to be here this evening.
May I ask the Ceann Comhairle's indulgence to speak for a further 30 seconds?
I thank the Ceann Comhairle for his indulgence. I welcome Bill O'Brien and Ming Chang O'Brien, who are accompanying my sister, to the Visitors Gallery. They are visiting from the US and have called in this evening to have a chat.
It is good to have the Minister of State's guests with us.
Following on from the Minister of State's response to his question and with a view to being helpful to Deputy O'Sullivan, it appears to me that targeted questions focusing on the final part of the Minister of State's response and addressing the leadership, progression and timescales around the establishment of a national medicines agency could be very helpful to him. Any such questions should be carefully targeted.