Billy Kelleher (Cork North Central, Fianna Fail) | Oireachtas source

I move: "That the Bill be now read a Second Time."

I welcome the opportunity to present this Bill to the House and hope it receives broad support in terms of what we are trying to achieve. Its purpose is to make it a legislative requirement that there be a statutory declaration by consultants, clinicians and other medical practitioners who receive gifts or donations from pharmaceutical and other companies involved in the health care sector. These could include medical devices and other technologies. The purpose is to bring transparency. Medical practitioners may, at times, receive a gift or some other service from a company that might be providing medicines, therapies or technologies either to the clinician or broader health care sector. It is a meaningful and purposeful Bill. I am not alleging that there are diminished standards among the health care professions but I believe it appropriate for gifts worth over €600 to be declared statutorily and that they be registered with the Medical Council. That would bring transparency and openness to the system.

As we know, in the years ahead there will be major changes and advances in technologies and medicines, including fourth-generation medicines and orphan drugs. There will be a major increase in the State's requirement to fund these. Of course, with that comes a need to ensure full openness in how we assess and prescribe medicines across the health care sector.

There are some guidelines, including ethics guidelines, in play but they are all voluntary. If a clinician decides he or she does not wish his or her name to be published, it does not have to be. Pharmaceutical companies have a code of conduct but if the clinicians decide they do not want to have their name included, that is the way it is. That is not good enough. There needs to be full accountability and a proper register established whereby people who receive a gift or another service from a company would have to declare it on a statutory basis, as with Oireachtas Members and others.

When one looks at health care systems across the western world, significant increases in health spending are evident, in both the public and private health care sectors. The percentage of GDP spent on an annualised basis will increase substantially in the future. There are a number of reasons for this and they include advances in medicine, fourth generation medicines, orphan drugs, new technologies and medical devices and the fact that the population demographics in many countries in the western world indicate that there is an ageing population. With it comes greater costs and, accordingly, a greater requirement for the taxpayer to invest in and fund the health care service. At the very least, taxpayers should be entitled to know who is receiving a gift or a service from a company that may benefit from the State's investment in purchasing services from it.

Eminent consultants and clinicians who are internationally recognised and may be carrying out wonderful research work in a health care setting carry enormous weight in terms of their influence on the medicines that are prescribed, used and recommended across the western world. Their endorsement could have a significant impact on a company's profitability. For that reason, there is always an incentive to induce or encourage by means of supporting a person, either through soft supports, be they gifts or donations, or harder supports such as research funding. In some cases medical posts in this country are funded by pharmaceutical or medical device companies. I welcome the philanthropy, given that the State is at times financially stretched. The posts funded in full include physiotherapists, junior doctors and nurses in some hospitals and health care settings. There is nothing wrong with this in cases where it is a purely philanthropic endeavour by a company, but it does place people in a very invidious position, not only the individual whose salary is being paid by the company but also the health service in general because the staff are provided by the company. This issue needs to be addressed.

We must ensure there are clean lines of demarcation and that there is no overlapping or greying of the ethical barriers critical to health care provision. The Bill will act for the good of health care provision, openness and transparency and ensure medical practitioners will not be subject to suspicion about how they are funded. There were reports recently that the Health Service Executive had warned that it might stop buying medicines from pharmaceutical companies which do not name the individual doctors and health care organisations in receipt of multimillion euro payments from them. The HSE recently proposed including clauses in its contracts with pharma companies that would obligate them to identify all payments made. The head of the HSE's corporate pharmaceutical unit wrote to the Irish Pharmaceutical Healthcare Association, IPHA, expressing concern about hospitals and relevant agencies "claiming not to know about payments to health care organisations, HCOs, which then feeds into public discomfort or media controversy around the issue." There is concern among professionals who are dealing with the companies on behalf of the State and spending vast sums of taxpayers' money for the benefit of patients. He also warned that the refusal of "individual health care professionals, HCPs, to allow themselves to be identified" made it "easy for the media to point to a lack of transparency." It also makes it easier for me to bring forward this Bill and show that it is needed and deserves support.

The head of the HSE's corporate pharmaceutical unit also indicated that agreement was needed to ensure companies would no longer be able to make payments to health care professionals who refused to disclose moneys they had received. He outlined: "The HSE could obviously consider doing this unilaterally but my preference would be to agree the optimal solution and avoid any unnecessary conflict." If my Bill is put on a statutory basis and a register is established, compliance will be required and that will resolve all issues and remove potential conflicts of interest in the context of the State negotiating with pharmaceutical or medical device companies to purchase services and products from them for the benefit of the health service in general. It will ensure a very open and transparent system.

Late last year following an investigation by TheSunday Business Postit was claimed that drug companies were funding dozens of medical and nursing posts in some of the biggest hospitals in the country, while almost one third of the HSE's most senior doctors were receiving money from pharmaceutical firms. The investigation also found that hospitals were unable to account for millions of euro that pharmaceutical companies stated they had paid them. Hospitals stated they had no sight of many of these payments which were sometimes made to individual departments and organisations controlled by groups of doctors. TheSunday Business Post claimed that more than €17 million had been paid out in 2015. This figure excludes funding for research and development or clinical trials. Drug and health care organisations stated they could not disclose what some of the payments were for, citing "contractual obligations and associated confidentiality clauses". Some companies are also said to be paying millions of euro in fees to doctors to cover education, travel, speaking fees and payments to sit on advisory boards for pharma and medical device companies. This issue needs to be addressed. I hope that with support from all sides of the House the Bill can move through the legislative process and provide certainty. There is a significant pharmaceutical and medical devices industry in this country and it sits very easily and is compatible with the broad industrial policy of the country in attracting foreign direct investment, as well as major investment and incentives for research and development. The close symbiosis between universities and industry in general in research and development and scientific trials is all very welcome, but if it is to have international recognition, there must not be any suspicion of involvement in funding trials, clinicians or consultants. An air of suspicion is enough to cause concern in that regard.

The Bill will require some things to be done by the Minister, including, for example, the establishment of a register by the Medical Council, which is something we would like to see happen. As the Bill moves through the legislative process, I hope it will not be unduly delayed, given the large sums the taxpayer is spending on drugs, medical devices and other pharmaceutical products from companies located in Ireland and across the globe. I hope we will proceed in a timely fashion.

Drug firms are paying salaries in children's hospitals. Earlier this year the Irish Independentreported that drug companies were paying the wages of a significant number of staff in the country's children's hospitals. Our Lady's Children's Hospital, Crumlin which has been in the eye of the storm over waiting lists for scoliosis patients confirmed that pharmaceutical companies paid for a nurse and a health and social care worker who are doing wonderful work. I welcome the philanthropic approach of companies, but we must ensure no suspicions are raised about the companies in question.

A spokesman for Tallaght Hospital which incorporates the National Children's Hospital has also confirmed that there are three junior doctors and two nurses whose salaries are funded by drug companies. He has said they are involved in research and that some of the doctors also participate in the regular on-call rota. The companies are Merck, Pfizer and Sanofi. All of the staff are paid according to HSE pay scales. This shows an intertwining and an interdependence. For that reason, we must address the issue.

Children's University Hospital, Temple Street has indicated that three posts are funded by drug companies. They include a senior physiotherapist, a consultant and a research nurse at the national centre for inherited metabolic disorders. All the part-time posts are research-based, according to the spokesperson. The part-funding of the senior physiotherapist post is for assessment and input into treatment of children undergoing enzyme replacement therapy. It has contributed to research nationally and internationally. This is critical.

I am attributing nothing to any of the posts in the sense that there could be any conflicts of interest. However, what is most important is that no one else could. A statutory register would address all those issues. That is why I am presenting the Bill.

I am also presenting the Bill because clinicians approached me and asked me whether I would sponsor a Bill. They were concerned that the situation was undermining their professional integrity and the integrity of research and development. I am seeking clear stated lines of demarcation, barriers that cannot be greyed or frayed away at the edges. We need full confidence in our clinicians, in prescribing and in research and development. That is why I brought the Bill to the House. I was asked by eminent principled consultants to do so. These medical practitioners expressed concern that this could undermine the integrity of the profession if it were allowed to continue and evolve over the years.

Another issue that will have to be addressed is the way we fund all these drugs, including orphan drugs, fourth generation drugs and other high-tech advances in years to come. That is for another day but it has to be done soon. Otherwise we will have a situation whereby we will continue to have patient advocacy groups lobbying - begging, effectively - for the State to fund drugs that could have a major impact on their lives. We have to discuss those issues with the National Centre for Pharmacoeconomics as well as how we assess and fund drugs now and in future. That is for another day but it has to happen quickly. In the meantime, I commend the Bill to the House.

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