Darren O'Rourke (Meath East, Sinn Fein)
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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.

Kieran O'Donnell (Limerick City, Fine Gael)
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I move amendment No. 1:

To delete all words after “That” and substitute the following: "Dáil Éireann resolves that the Healthcare (Transparent Payments) Bill 2022 be deemed to be read a second time this day twelve months, to allow the Joint Committee on Health and the Department of Health to consider matters further.".

I acknowledge the intention behind this Bill and thank the Deputies for raising such an important matter. I am taking this matter on behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill.

Transparency in the relationship between the pharmaceutical and medical devices industries and healthcare professionals and healthcare organisations is of great importance. The Government agrees with the general principles of this Bill. There should be transparency in transactions between commercial interests and healthcare providers. This is so the public can be assured patient care is based solely on clinical evidence and experience and is in the best interests of patients and their safety.

Payments or other financial supports between the pharmaceutical industry companies, commonly known as market authorisation holder, MAH, companies, to healthcare providers, HCPs, or healthcare organisations, HCOs, are referred to as transfers of value by the industry. Such financial supports are common both in Ireland and abroad. These transfers have had a positive impact on our healthcare system and benefit patients and the public by advancing medical research, conducting clinical trials and ultimately delivering numerous innovative medicines. It is important that such partnerships continue. However, transfers of value can create conflicts of interest, and I understand that some international research has linked them to higher prescribing rates, higher costs and lower prescribing quality.

This Bill seeks to enhance transparency by establishing a statutory register of transfers of value. The Government is not opposing the Bill as enhanced transparency is ultimately aimed at protecting the public. However, transparency is only one way of ensuring accountability, minimising and eliminating conflicts of interest and thus ensuring the best care possible. There is already a suite of measures in place designed to ensure transparency, accountability and public disclosure while minimising conflicts of interest, which measures I will now outline across four broad areas.

First, there are the Medicinal Products (Control of Advertising) Regulations 2007, which are enforced by the medicines regulator, the Health Products Regulatory Authority, HPRA. The HPRA operates an advertising surveillance programme to ensure compliance with the regulations. The HPRA’s monitoring of the giving of moneys or support by pharmaceutical companies to healthcare professionals and healthcare organisations falls within the remit these regulations, via regulation 21, which relates to inducements and hospitality. If breaches are identified by the HPRA through the different elements of its advertising surveillance programme, including during inspections, the HPRA takes appropriate follow-up action with the MAH company to address those breaches.

Second, there are the Ethics in Public Office Acts 1995 and 2001, as amended, which require HCPs in designated public positions or directorships to disclose interests that could influence their official duties. Sections 17 and 18 of the 1995 Act and section 11 of the 2001 Act mandate the disclosure of material interests. This act requires HSE employees at or above grade VIII salary, which is €81,144, to declare interests that could influence their duties. Examples of declarations include: occupational income over €2,600 from non-HSE sources; travel, accommodation and meals funding; shareholdings over €13,000 or 5% of a company; or gifts, property or services over €650.

For public health employees outside the remit of this Act, section 17 of the HSE's national financial regulations prohibits all employees from receiving benefits or hospitality that could compromise integrity. Nominal benefits must be disclosed to their line managers. In addition, the code of practice around the governance of State bodies advises against giving and receiving gifts or benefits that could affect judgement and that could reasonably give cause or be perceived to cause a conflict of interest.

Third, there are professional codes of conduct and ethics for healthcare practitioners. While HSE employees have obligations under the Ethics in Public Office Act, many healthcare professionals are not HSE employees. However, across the regulated professions, there are codes of conduct and ethics in place. These codes of practice set standards for conduct, and include stipulations such as the following: professionals must avoid entering into agreements that may result in actual or perceived conflicts of interest; manage and declare conflicts of interest; not accept inducements, financial or otherwise, or incentives that could reasonably be perceived as affecting their professional judgement for reasons of personal or commercial benefit; and must not accept any gifts or favours from healthcare pharmaceutical companies or patients and that could reasonably give cause or be perceived to cause a conflict of interest. For example, codes of conduct across professions include: the Medical Council's Guide to Professional Conduct and Ethics for Registered Medical Practitioners; the Nursing and Midwifery Board of Ireland’s Code of Professional Conduct and Ethics for Registered Nurses and Midwives; the Dental Council’s Code of Practice relating to: Professional Behaviour and Ethical Conduct; the Pharmaceutical Society of Ireland's Standards and Ethics for Pharmacists; and CORU's Codes of Professional Conduct and Ethics for its regulated professions.

I will outline the voluntary pharmaceutical industry's self-regulation codes of practice. There are two main pharmaceutical trade bodies in Ireland, the Irish Pharmaceutical Healthcare Association, IPHA, and Medicines for Ireland, MFI. They operate a disclosures system for their members. IPHA represents pharmaceutical companies that manufacture or supply originator or on-patent medicines. MFI is a pharmaceutical industry body that represents member companies which manufacture non-patent medicines such as generic, biosimilar or value-added medicines. Members of both IPHA and MFI must disclose financial interactions with healthcare professionals and healthcare organisations, HCOs. Examples of transfers of value include payments for research and development, donations, sponsorships, consultancy fees, registration fees, and travel costs. Disclosures can be made on IPHA's website, which includes data from up to 50 companies, 11 of which are non-IPHA members. These disclosures are filed annually and are available for three years. However, this method of voluntary disclosure is only mandatory for IPHA members.

While the measures across the four areas I just outlined contribute to improved transparency, accountability and public disclosure, the Bill before the House gives us the opportunity to do more. The Government is supportive of the principles outlined in the Bill, and such measures would also be welcomed by key stakeholders, including patients. However, broader consideration than what this Bill currently provides for is needed. This Bill presents a potential opportunity to ensure that it is built on a national framework that achieves a balanced approach of enhanced transparency, ethical collaboration, accountability and public disclosure to maintain public trust in our healthcare system. The welcome development of a national framework should include analysis of: existing measures and their effectiveness; international best practice; minimising unintended consequences; proportionality of an enhanced framework for transparency, and structural engagement with key stakeholders. In particular, consideration of costs is required, particularly as the Bill envisages expanding the role of the HPRA to receive declarations from pharmaceutical companies, maintain a register of payments made by pharmaceutical companies and carry out audits and inspect the books of pharmaceutical companies. Any such granting of powers would require resources and additional capacity. Therefore, an appropriate funding model will need to be scoped, assessed and determined, including in the context of whether Exchequer funding is required.

These proposals contain wide-ranging powers and responsibilities. In addition to assessing the funding model, consideration of the parameters and safeguards of these powers will also need further consideration. This is to ensure a proportionate approach and to also acknowledge circumstances where commercial sensitivities may arise. In this context, the Minister for Health, Deputy Jennifer Carroll McNeill, has written to the Joint Committee on Health outlining these matters and her support for an exploration of them in further detail. The Department of Health will also give consideration to how well current measures are working and to what more could be done. It will consult further with the HPRA about the role proposed. Such due diligence is necessary in advance of implementing measures such as legislating for a register as set out in this Bill. As a result, the Government amendment seeks to allow time for the committee and the Department of Health to conduct their analysis and consideration before the Bill progresses. This is necessary as, given that a suite of measures is already in place to encourage transparency, a holistic consideration encompassing regulatory and legal considerations is required in advance of the introduction of any further measures. This is needed to ensure that any measures are proportional and achieve their goal of increased transparency with minimal or no unintended consequences. I welcome the debate and again thank the Deputy for raising this important matter.

Verona Murphy (Wexford, Independent)
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Deputy Toole might permit me to welcome the members of Comhaltas Ceoltóirí Éireann from Wexford who performed for us earlier. I am sure everybody had the pleasure of their music today. Welcome all, especially Aggie and Michael.

Gillian Toole (Meath East, Independent)
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Gabhaim buíochás leis an gCeann Comhairle, an Aire agus an Teachta Uí Ruairc. I thank Deputy O'Rourke for raising this most important issue. I thank the Minister of State for providing the Minister for Health's quite comprehensive briefing notes. I have only skimmed through them, but I will refer to them.

I have to state the obvious. We have an ageing and increasing population, with a rise in chronic diseases, new diseases and increasing reliance on health services, drug interventions and surgeries. All of this will come at a significant cost to the individual patient and, of equal importance, the State, from the perspective of reimbursement. If we look back to the foundation of medicine, which underpins all of our endeavours through health services and those working to deliver them, the Hippocratic oath is founded on the principle "First, do no harm". That persistent balance of risk and benefit has to be paramount in all decisions that we take. Everything must be patient focused from the outset.

If we take a business analogy, which is probably linked to our national focus on economics, economic development and GDP, as have said on many previous occasions, if we consider the well-being of our citizens, then as important as value for money and risk-benefit analysis are for fiscal prudence, they are of paramount importance for both the patient and the entity responsible for reimbursement - in this case, the State. The patient and the State must know that there is no bias in the system.

I have a couple of suggestions that may be helpful for today and for whatever the outcome or decision by Deputy O'Rourke is. If companies want to help to inform patients about health, they could perhaps pay into a central independent body, that could then give grants to people with a track record of giving evidence-based information to the public. As a pharmacist who no longer practises, I believe that any company running a disease awareness campaign should declare in its advertising that it is doing so because it is developing or marketing a product to treat that ailment. Similarly, all educational materials should bear the same declaration.

I will not go too deep into this because I struggle with it, despite having had to study some of it for a time. Difficult in all as they are to navigate, econometric models suggest - the evidence is there - that marketing has more influence on drug usage patterns than the publication of new evidence. Therefore, an in-depth exploration of the proposal is required. There has been a lot of information gathered over the past 30 years from the United Kingdom. It is quite weighty research.

I wish to mention the matter of voluntary self-regulation codes of practice. The very word "voluntary" must have a red ring around it. Disclosures can be made on the IPHA website. Even a simple review of the current processes, and possibly changing the description to "must" rather than "can", will instil confidence and contribute to transparency. I note that this method of voluntary disclosure is only mandatory for IPHA members. We are now in a space in this country where, because of shortages of product, there is the sourcing of many unlicensed or exempt medicinal products from companies that may not actually be members of IPHA. There may be gaps in information, but I am saying this purely to put it into context. I will go through the information after this debate.

Another example is that of the World Health Organization, WHO, and the World Health Assembly, WHA. The WHA is effectively the executive of the WHO. It was initially set up to be 100% funded by the member states. According to information from the WHA website, though, the funding is 84% from philanthropy and 16% from the member states currently. The philanthropic section has undeniable links to industry funding. There are different pathways. It has been that way for many years. There is an absolute need in that regard. It is beyond our scope, but on 19 May, we signed up to the WHO pandemic treaty, so there will be a connection between our national system and the WHO system. That is something that we also have to have on our radar in the context of Deputy O'Rourke's Bill.

At the end of the day, this is about getting the maximum benefit in a transparent fashion for the patient, first and foremost, and for us. We are moving towards a State-funded drug reimbursement scheme, which is to name only one of the devices used in the public and the private sectors. We are using the National Treatment Purchase Fund to avail of the private hospital system to help clear waiting lists. There is that inextricable link now between the public and private health services. The transparency of the sponsor must be to the forefront of our consciousness. We get the best outcome for the patient, but we should be fully conversant with all parties involved in achieving that outcome.

Seán Crowe (Dublin South West, Sinn Fein)
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I am delighted to be one of the Bill's cosponsors with my colleagues, Deputies O'Rourke and Cullinane. I am disappointed that the Government is putting this on hold for 12 months. I thank Dr. James Larkin, who is a senior postdoctoral fellow at the Royal College of Surgeons in Ireland, RSCI, for his research and assistance in the preparation of the Bill.

When this issue first arose, most people listening in on this debate would have thought there was already sufficient legislation in place. Unfortunately, when we dug deep down, that was not the case. It is very much an issue of self-regulation. As my colleague stated, payments to healthcare professionals and organisations can create a conflict of interest. Evidence from this jurisdiction and others is that payments from the pharmaceutical industry is associated with higher prescribing rates, higher prescribing costs and an increased use of specific drugs. There is a saying: "Big pharma, big pockets". Unfortunately, that issue has impacted families and individuals across the world. There are many horror stories about how this happened that we are all familiar with. The idea that we would ask people to voluntarily register for these payments does not make sense in the world that we live in today.

One of the facts that has emerged is that the RCSI found that the identities of many of the recipients are anonymous. This is supposed to be the register of interests of those who have got payments, yet we have come across entries with no name. It does not add up; it does not make sense. The Bill is proposing that failure to register would result in a large fine of €100,000. We are open to amendments if people feel that should be higher. The Minister of State is talking about referring it to the health committee and having more discussion on it. Why is this not already in situ? What is the delay? What was the reluctance to try to legislate in this area? It seems like a logical practice that, if people are getting funding off a particular pharmaceutical organisation or group, there should be some sort of tracking device. That is what the Bill tries to set out. It is good for patients. It is good for the industry that it be monitored. It is good practice for, and in the interests of, everyone involved.

I was in the audiovisual room earlier. There were people there from Queen's University. They were talking about the hugely positive work and co-operation that they were doing in the whole area of health, North and South. We travelled north when I was Chair of the health committee. We looked at all-Ireland cancer facilities. People in County Donegal were availing of cancer treatments there. There are others. It makes sense that we try to work with one another across the board. The idea that the industry can have carte blanche or that someone can pay some individual to possibly prescribe a drug is nonsensical and bizarre. It is totally wrong.

I raised earlier with the Tánaiste the case of children with muscular dystrophy and, again, it is children on the island of Ireland. The challenge for these children is that they cannot access this drug, and the families are saying it is time-sensitive. What happens to the child, and it is mostly young boys it affects, is that they basically waste away and end up in a wheelchair and eventually die very young. There is a child in my constituency called Archie and his family have been doing massive fundraising. They are not only seeking access to this drug that is currently not available in the South of Ireland, but they are also trying to fundraise for a genetic procedure in the US and trying to raise millions of euro. The Minister of State might have come across it. In the North, it is similar. There is a child there called Alfie and, again, his family are trying to do it. The problem in the North is that they have access to the drug, but they do not have the funding to roll out the drug. In the South, we have the funding to roll out the drug, but we do not have the drug. I suggested to the Tánaiste that he raise it possibly on a shared island basis and that we would try to look at this.

I thank the Ceann Comhairle for allowing me to raise this particular issue. I am raising it as part of this Bill because it is important for patients, but it is also important for their families. There is no linkage between this company trying to pressurise people to roll out this drug or anything else. There is no linkage on that basis.

I will go back to the question again as to why we are delaying it. The surprise for most people is that they would have thought there was already robust legislation in this whole area for monitoring the payments to individuals and groups. That is at the heart of what we are trying to do in this Bill, but there are other elements of it as well. I am disappointed we are kicking the can down the road and leaving it for another 12 months. If the Bill was passed, it would probably take a number of years to try to get it up and running and so on. There are a lot of practical solutions within the Bill, particularly with regard to those who would hold the register and so on. There has been a lot of thought put into the Bill. I commend those who were at the centre of drawing this up and those who brought it to our attention. I say well done to all who drafted the Bill and brought it before the House. I look forward to others taking part in this debate. I ask the Minister of State to try to clarify the reason for the delay and why this legislation is not in place.

Ruairí Ó Murchú (Louth, Sinn Fein)
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I would like to take this opportunity to follow up on Deputy Crowe's point. Many of us attended that briefing in the audiovisual room on those suffering from Duchenne muscular dystrophy. As Deputy Crowe said, we are talking about it impacting children and young boys at a very early stage. He made the most significant point of all, which is that there is very little time, as all these families know. In one case, we met with a family who had two boys, one of whom gets the givinostat, because he was on a previous pilot, but the other does not. They are absolutely fearful of the impact of not having it because they have seen the benefit of having it. Deputy Crowe put forward a possible cross-Border solution, a shared island solution, or call it what you will. I ask the Minister of State to bring that back to his colleagues in government. It is absolutely necessary. I do not think he will find too many people complaining about delivering on that.

I commend Deputies O'Rourke, Cullinane and Crowe on the Healthcare (Transparent Payments) Bill. I would much prefer if this was progressing beyond this point. If there are anomalies or issues that needed to be dealt, they can be dealt with on Committee Stage. The Minister of State, Deputy O'Donnell, provided a comprehensive solution.

I accept the argument is won with regard to the necessity of this legislation. What are we talking about? We are talking about making 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. We have research carried out by the Royal College of Surgeons in Ireland, RCSI, and James Larkin. A fair number of us have seen "Dopesick", have read Empire of Pain and have seen what happened with the Sackler family and the Purdue company and OxyContin. To call it a disgrace is inadequate; there is no term for what was done other than it was utter and outright evil. The reality is when payments were made, it made it a hell of a lot easier for them to sell their drug. The biggest issue of all was the fact that it was based on a complete and utter lie, which was the idea that they had found this pain relief mechanism - this opioid - that would be slowly released and work absolutely perfectly and there would be no issues as regards addiction. We know the time release was dealt with very quickly. People just had to lick the particular tablet to get around it. Following accidents or whatever, people who never would have found themselves in this situation ended up with brutal addictions and when they could not access OxyContin, they ended up on street drugs such as heroin and other drugs. It ravaged many communities in America. There was the whole scenario then of people who followed up with pill mills and all the rest of it.

We are aware of the issue we have with prescribed drugs and narcotics in this State. We need to make sure we are playing on a level playing field and have a system that works. The biggest problem is the lack of transparency regarding these payments at this point. We are talking about a huge number of conflicts of interest.

There are consequences for patients but also for public finances. I spoke earlier about the fact that there are certain life-altering, life-changing, life-improving and life-saving drugs at which we need to look. I accept that at times it can be expensive, but we definitely do not need to be losing money while others are getting rich. As I said, we need to ensure transparency and that we do not certain allow scenarios. It was not just one dirty deal, as happened in the situation we spoke about with Purdue, it was a million dirty deals. The impact has been phenomenal. It is an impact that will continue long after this period of time.

We know the current voluntary system is absolutely inadequate. We need a centralised State-run mandatory disclosure system. Obviously, this would enhance the HSE as regards trust and integrity. It would be a fair and competitive innovation environment and it would support Ireland's clinical trials landscape, which is absolutely necessary. At times we come in here to request additional finance for additional services and medicines, but we could be talking about cost savings here. I get it that the argument is won in this regard.

I agree with Deputy Crowe that this should have happened a hell of a lot sooner. A fair question is around why it has taken so long. As I said, I do not buy the idea that it will take a year, but within that year, we need to make sure this is ready to run. There can be no hold-up in this regard. Nobody is going to come in here and vote against this or make an argument against this. This is about improving human health and ensuring people are looked after properly and that everything is absolutely above board.

My colleagues spoke about the declarations to the HPRA, if there is a need, and that if there were breaches, there would be a means of enforcement. We mentioned fines of €100,000. However, we are all open to changes in that regard. When we have breaches, we need to ensure we provide real enforcement, real leverage and real power. We all accept that we cannot leave big pharma or uncontrolled capital to have its way. This is about protecting people and patients and ensuring we look after our people and the public finances.

I commend everyone who spoke today and, in particular, Deputies O'Rourke, Cullinane and Seán Crowe for making it happen and following up on a huge body of work done by the RCSI. We need it to happen. It is as simple as that.

Neale Richmond (Dublin Rathdown, Fine Gael)
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I thank the cosponsors for bringing the Bill to Second Stage and all the Deputies for an engaging discussion on the issue. It is an important matter and, as previously stated, the Government fully supports transparency in the relationship between the pharmaceutical industry and healthcare professionals regarding transfers of value to healthcare professionals or organisations.

It is clear that we all agree on the need for transparency and high ethical standards in healthcare professions. There should be transparency about transactions between commercial interests and healthcare providers. This is the Government's intention and we have measures that place obligations on healthcare professionals as well as the pharmaceutical and medical products industry to achieve this. As outlined earlier by the Minister of State, Deputy O'Donnell, such measures include: the Medicinal Products (Control of Advertising) Regulations 2007; the Ethics in Public Office Acts 1995 to 2001, as amended; professional codes of conduct and ethics for healthcare professionals; voluntary self-regulation; and codes of practice for industry. These measures clearly support accountability and transparency and ultimately promote a high standard of patient care. However, a whole-of-system approach is needed so the public can be assured that healthcare provider recommendations are based solely on clinical evidence and experience. This prioritises the best interests of patients and patient safety. Transparency is important, but it forms only one part of ensuring accountability and ethical collaboration and eliminating conflicts of interest.

The Government appreciates what this Bill aims to achieve, but a broader consideration is needed to achieve this. The Minister for Health supports the broad principles of the Bill and has written to the Joint Committee on Health stating her support for an exploration of transfers of value between the pharmaceutical industry and healthcare practitioners and organisations.

It is necessary that any examination encompass the regulatory and legal aspects in advance of any measures being introduced. Such considerations need to include international experience and best practice, a review of current measures, consideration of the appropriate monitoring of measures to provide assurance on compliance, minimising unintended consequences, opportunities for improvement in an Irish context aligned with best practice findings, and value for money and data protection considerations. It is clear that progress in this area needs to be multipronged and involve engagement with the pharmaceutical sector, medicines agencies and international experts. Our goal should be first to establish best practice, benchmark the existing measures in Ireland against it and consider any improvements that could be achieved. In particular, proportionality of future measures needs to be considered to ensure any sanctions are proportionate to the obligations and that any potential measures are in line with international experience and best practice. Consideration of minimising unintended consequences is also required to ensure any proposed improvements are aligned with best practice.

It is necessary to ensure that any future measures achieve the objectives outlined above and are appropriately aligned with data protection obligations. While the Government is supportive of the broad principles outlined in the Bill, as are key stakeholders, including patients, further and broader consideration is needed in advance of this Bill progressing. The amendment to the motion that seeks to have the Bill read a Second Time in 12 months is to provide the opportunity to see this additional due diligence completed. We should not lose sight of the fact that transparency forms only one part of ensuring accountability and managing conflicts of interest. Our joint goal should be to provide the best care possible for patients and healthcare service users. It is essential that further and broader consideration take place in advance of this Bill progressing. The amendment to the motion will allow for this further consideration and analysis of how the Bill interacts with existing transparency and accountability measures.

I thank the Deputies for raising this important matter, and Deputies Crowe and Ó Murchú for raising the situations regarding muscular dystrophy and the individual cases they already raised with the Tánaiste. I undertake with the Minister of State, Deputy O'Donnell, to put our collective shoulders to the wheel on that issue as well.

Darren O'Rourke (Meath East, Sinn Fein)
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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.

Verona Murphy (Wexford, Independent)
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In accordance with Standing Order 85(2), the division is postponed until the next weekly division time.