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

I thank the Chair and the committee. I believe we are taking this under Standing Order 141(3) and that it will hopefully be reported to both Houses. The Medical Practitioners (Amendment) Bill 2017, if enacted, will require "practitioners to declare any income or gift received from medical suppliers or pharmaceutical companies to the Medical Council in statutory declaration annually."

Section 1 of the Bill provides definitions. Section 2 of the bill amends section 45 of the Medical Practitioners Act 2007 in three ways. Firstly it provides that "A registered medical practitioner shall on an annual basis, give to the Medical Council a statutory declaration signed by him or her giving particulars of all declarable income and gifts received from any medical equipment suppliers, its servants or agents, and or any pharmaceutical companies, its servants or agents, within the previous 12 months not before the 31st day of January of each year."

Second, it provides that the Medical Council shall maintain a register of gifts and declarable income declared by each registered medical practitioner, which shall be published by the Council annually in electronic form in a publicly accessible and searchable manner. It also provides that failure to comply with the provisions as outlined shall result in the registered medical practitioner being the subject of a complaint under section 57 of the principal Act by the Medical Council. Section 3 provides the Short Title and commencement.

I will now outline for members the rationale behind the Bill. In 2016, €6.8 million was given directly to Irish doctors from pharmaceutical companies. The Health Service Executive has no record of any of this through the Standards in Public Office Commission. This obviously poses a number of questions, including ethical issues. First, patients deserve full transparency about how doctors make decisions about recommending new drugs for patients. All treatment should be based on international best evidence, free of any conflict of interest. Second, given the very large expenditure incurred on medication and other medical goods by the HSE, taxpayers need to know that large financial outlays are solely influenced by clinical outcomes and not by conflicted advice from doctors in receipt of concealed payments from companies in the medical arena. Third, the Revenue Commissioners ought to be informed about payments of €6.8 million to ensure fair compliance and collection of taxes. Incidentally, €10.6 million went directly to hospitals from drug companies and this will not be covered in the Bill. There is an onus, obviously, on the HSE to regulate this.

Earlier this year the Irish Independentreported that drug companies are paying the wages of a significant number of staff in the country's children's hospitals. Our Lady's Children's Hospital, Crumlin confirmed to the newspaper that pharmaceutical companies pay for a nurse and a health and social care worker there. Tallaght hospital also confirmed that it has three junior doctors and two nurses whose salaries are funded by the drug companies.

The Irish Pharmaceutical Healthcare Association gathers information annually on payments or so-called transfers of value by its members companies to doctors, but an opt-out clause means many of the recipients are not identified. In other words, there is a voluntary code within the Irish Pharmaceutical Healthcare Association, and it will publish payments, or what they call transfers of value, to doctors, but only if the doctor allows it to be published. They can opt out if they request to do so. According to the Irish Medical Times, in 2016 only 55% of doctors who were in receipt of funding from pharmaceutical companies actually declared it.

The Minister for Health ordered a review late last year after claims that up to one third of senior HSE clinicians are in receipt of money from pharmaceutical companies. The Health Service Executive responded to the Minister by saying that it did not know whether any of its senior staff have received direct payments from pharmaceutical companies. The HSE investigation failed to establish whether any payments were made, and found uncertainty as to whether existing rules were even being followed.

The pharmaceutical companies fund posts in many hospitals, and the HSE was unable to answer a parliamentary question seeking specific details in February this year. In the reply, the deputy national director of the acute hospital division said that information requested was not held centrally by the acute hospitals division, and while the deputy national director also liaised with the hospital groups on this information, it was not available currently in a consistent standard format. Clearly, there is a lack of information, even within the HSE, on the staff that it employs.

Professor Michael Barry, of the National Centre for Pharmacoeconomics, NCPE, told The Sunday Business Postin November 2016 that he believes payments from industry are influencing prescribing habits in Ireland. He said doctors were prescribing more costly branded medicines here than doctors in other countries. He said: "What is going on should not be happening. We need to stop making excuses for this." There are also indications of public support for changing the current situation. A poll on thejournal.ierevealed 89% of respondents did not believe that doctors should continue to receive payments from pharmaceutical companies.

All positions of employment in the Health Service Executive across all grade categories where the minimum salary point is equal to or above the minimum point of grade VIII have been prescribed in regulations as designated positions of employment for the purposes of the Ethics in Public Office Acts 1995 and 2001. However, in view of the fact that the HSE was unable able to answer parliamentary questions, and given the HSE's response to the Minister for Health that it does not know whether any of its senior staff have received direct payments from pharmaceutical companies and whether existing rules were being followed, it is clear that rules need to be strengthened. Currently, the Medical Council does not ask doctors about any conflicts of interest when they are registering each year.

I will now outline the legislation on which the Bill is modelled. In the United States, the Physicians Payments Sunshine Act came into force in 2010. The Sunshine Act, as it is known, requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid and the state children's health insurance program, SCHIP, to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the centres for Medicare and Medicaid services, CMS. The goal of the law is to increase the transparency of financial relationships between health care providers and pharmaceutical manufacturers and to uncover potential conflicts of interest. The bill allows states to enact additional requirements, as six states already had industry-pay disclosure laws.

France, Portugal, Belgium, Denmark and Slovakia are EU states with primary legislation governing such donations. In the United Kingdom this issue is still a huge problem with little clarity on where the money goes. It is an issue that is being debated quite vigorously. The British Daily Telegraphreported on 30 June this year that ,“Cash and hospitality given by the pharmaceutical industry to doctors has increased to more than £116 million a year, despite a drive to make the practice more transparent ... Experts ... called for a change in the law to bring Britain in line with the US where doctors are forced to publish all potential conflicts of interest.”

Doctors have to renew their Medical Council registration every year. It is an easy online process. It would be relatively simple to add a question asking for disclosure on payments on the renewal portal. It may require a little IT work, but this could then generate an annual report of all submissions made. The Medical Council will have to inform members of the sanctions faced if they fail to disclose payments. This can be done via its newsletter, so it is unlikely to give rise to additional costs.

I refer to the financial implications of this measure. It it hoped his will have the potential to ensure that the only drug treatments chosen by all doctors are those with clinical efficacy, thereby reducing expenditure on pharmaceuticals nationally. Declaration of payments could also mean that the Revenue Commissioners will have greater knowledge of any payments and it may serve as a revenue-raising measure.

Before I yield to Dr. O'Sullivan, I will make a final point. I am not inferring anything about the professional integrity of our clinicians, but there is an issue that has to be addressed. We must ensure that there is absolute transparency in payments received, or transfers of value, as they are called. Between all of the moneys and the transfers of value, almost €30 million a year is transferred from the pharmaceutical industry to health care organisations, health care professionals and advocacy groups. As medical technologies and medicines evolve, for example, through the development of fourth generation and orphan drugs, there will be an incremental increase in the cost to the Exchequer. The very least that patients deserve is transparency and the assurance that all medicines are being prescribed for medical efficacy. The taxpayer should also be entitled to ensure that he or she is getting value for money.