I move: "That the Bill be now read a Second Time." I welcome the opportunity to discuss the Healthcare (Transparent Payments) Bill 2022, which I am co-sponsoring with my colleagues Deputies David Cullinane and Seán Crowe. I thank Dr. James Larkin, senior postdoctoral fellow at the Royal College of Surgeons in Ireland, for his research in this area and for his help in preparing the legislation. The Bill seeks to make it mandatory for pharmaceutical companies and medical equipment suppliers to declare payments, gifts, donations and all other transfers of value made by them to healthcare professionals and organisations. In some cases, these payments create problematic conflicts of interest that can have significant consequences for patients and the public finances. We know payments to healthcare professionals and organisations can create conflicts of interest. Evidence shows that receipt of payments from the pharmaceutical industry is associated with higher prescribing rates, higher prescribing costs, increased use of specific drug classes, including opioids, and lower prescribing quality. This is significant and, of course, has the potential to have a profound impact on patient safety and the public purse. The popular show "Dopesick" highlighted this to great effect in the context of the opioid epidemic in the United States. In Ireland, tens of millions of euro are paid to healthcare professionals and organisations each year by the pharmaceutical industry. While a voluntary register of these payments is currently in place and maintained by the Irish Pharmaceutical Healthcare Association, research conducted at the Royal College of Surgeons in Ireland found that the identity of many recipients is anonymous, while other payments may not be reported at all. The current voluntary system is inadequate. The Healthcare (Transparent Payments) Bill 2022 is needed to bring Ireland in line with international best practice and is a measure in the interest of industry, professionals, organisations and the general public. This legislation would require pharmaceutical companies and medical equipment suppliers to declare all payments to the HPRA on an annual basis. Failure to do so could result in a fine of €100,000. The Bill also provides for the HPRA to establish and maintain the register and ensure it is searchable and accessible to the public. The establishment of a centralised, State-run mandatory disclosure system in Ireland would enhance health service trust and integrity, create a fair and competitive innovation environment, support Ireland’s clinical trials landscape and provide significant cost savings for the HSE. Legislation similar to this has been proposed by TDs from other parties, including Fianna Fáil through former health spokesperson Billy Kelleher MEP. In the US, similar legislation was introduced with cross-party support. Correspondence from the Secretary General of the Department of Health, Mr. Robert Watt, to the Committee of Public Accounts in 2021 noted: The Private Member’s Bill [this Bill] presents an opportunity for a review of the arrangements in place in the context of improving transparency in transfers of value between pharmaceutical companies and healthcare providers. It is generally positive in that regard. Again, we cannot rely on the current fragmented transferofvalue.ie and transparentmedtech.eu transparency systems. Peer-reviewed research outlined extensive shortcomings in these systems. The significant consequences of poorly managed conflicts of interest in healthcare have been highlighted in many countries. Examples include the US opioid epidemic, which I mentioned, and the pelvic mesh scandal in Britain. These crises resulted in significant personal costs for thousands of people and significant financial costs for health systems. Ireland is not immune from this and transparency legislation is a key step in preventing such crises. The shared commitment across parties to a strong health service and thriving life sciences sector must be underpinned by a transparency system that ensures a level playing field for ethical industry actors while safeguarding patients. Legislation in the US, France and other countries has proven that payment transparency strengthens public confidence and supports a more competitive and fair research and innovation landscape where the majority of ethical industry actors are not at a disadvantage by comparison with the few unethical industry actors. It is in the interest of everybody to have transparency in the system so we can know and shine a light on conflicts of interest. I look forward to the debate on this and welcome the opportunity to hear from others.

Sentiment score: 0.33

I thank all the Deputies on both sides of the House for their contributions on this Second Stage debate. In particular, I thank Deputy Toole, my constituency colleague, with whom I previously discussed this legislation. She has a particular interest. This is an important intervention we are trying to make from a number of different perspectives. We have touched on a few of them. I point to the marketing budgets of pharmaceutical companies and compare them with their research and development budgets and ask why they are as they are. At the root of this is the suggestion - and there is plenty of evidence to support it - that marketing and advertising has a direct influence on the prescribing behaviours of clinicians. Not only that, there are examples, including extreme ones, such as the OxyContin epidemic in the United States, where powerful, wealthy pharmaceutical companies influenced clinical indications in respect of pain. There are many examples where new conditions have been identified on the basis of there being a product available to treat them, the medicalisation of many conditions that were not medicalised in the past. Why? It is because a product needs to be sold. With such significant amounts of money - and these companies have eye-watering amounts available to them - there is potential for conflicts of interest and perverse incentives. We have seen many examples of that over the years. I can point to the examples of OxyContin, opioids, Sacklers' Purdue Pharma and the "Dopesick" example which is at the extreme end of it. We heard yesterday in the audiovisual room from two people I want to thank, Dr. Kieran Harkin, medical director of Merchants Quay Doctors and co-founder of Access to Medicines Ireland, and Ms Kath Sansom, founder of Sling the Mesh UK. The impact of those products on many people was very damaging and there is certainly a case to be answered. The patient safety issue has been well articulated and well evidenced. The connection between givinostat and Duchenne muscular dystrophy is not about patient safety at all. The issue is about a finite health budget. In every country in the world, as those on that side of the House will rightly say, the amount of money we are spending on medicines is increasing. It is eye-watering and the demands are increasing because of innovation, much of which is publicly funded and much of which is privately funded. Incredible medicines are being produced. However, if we use branded products and patented products where generic or biosimilar medicines are available, we are not using that pool of resources efficiently. We are just doing that because that is what we do, it is what we have done in the past or because we have a special relationship with a sales representative or, worse, the company has treated us to X, Y and Z or certain gifts or benefits. From the point of view of the public purse, there is harm and damage. The risk is, if we are being flaithiúlach, lazy and not diligent about how we are spending taxpayers' money at one end because we are familiar and have those relationships, we cannot support the children in need who have Duchenne muscular dystrophy. The budget will have run out because we have wasted it or not used it efficiently. That is where we need transparency and accountability about how we use these funds. That is where the connection is for those children. I fully support them in their need to access givinostat. If the potential is there for early access on an all-Ireland basis, or however we go about it, we certainly must pursue it. We have processes for assessing those products and we know they have been licensed at EMA level. We need to get them to children in Ireland and in this jurisdiction. This relates directly to this Bill in the sense that we have to use the available resources for spending on medicines and health technologies as efficiently and effectively as possible, particularly in the context of the opportunity to avail of a drug like givinostat, which can provide incredible benefits. I have a nephew with degenerative muscular dystrophy who lives in Belgium. He left Ireland, as did the child of one of my constituents who now lives in England because the supports there are far better. Deputy Ó Murchú mentioned another family. This drug is transformational. There is a child in the clinical trial who, at 18 years of age, is still walking. He is a huge Donegal GAA fan, goes to all of their training sessions and does the announcements. He is statistics mad. To see that when in very many of these cases, including that of my nephew, children are wheelchair-bound at 12 or 13 years of age shows that this is transformational stuff. One sibling in the family has had the benefit of this drug in a clinical trial and the other sibling is waiting, like all of the rest of the children in Ireland. This stuff is incredible. I have no issue with it being put through the system in terms of the assessments and all of that. I understand the need for objectivity but we should not deny these children access to this drug. I may have gone off on a slight tangent but I hope I am making the point clearly that we have a limited resource and we have to use it well. This legislation will help us to use that limited resource well and, in doing so, increase the opportunities for new and groundbreaking drugs to be made accessible to children in need. I do not support the 12-month delay. This is a 2022 Bill. It has already been on the books for three years. We have our slow processes in here but I do not think anything the Ministers of State have given as a reason for delaying it for 12 months cannot be done without such a delay. We will have Committee Stage. In reintroducing this Bill and rolling it over from the previous Dáil, there was a suggestion that we would amend it, but that would have delayed it further. I recognise the need for changes to this Bill and would 100% welcome further scrutiny at committee and from other stakeholders. I welcome the considered response from the Ministers of State and the general positivity around where we need to go with this, but I hope they will understand that we cannot live with the 12-month delay. That said, I know how the numbers work in this House but whatever the outcome of the vote on Wednesday, I encourage us to get cracking on this legislation. I welcome all of the contributions to the debate this afternoon.

Sentiment score: 0.16