Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank Deputy John Brassil for raising this issue. I appreciate the sincerity with which he approaches it. I think we can all agree in this House that medicines clearly play a vital role in improving the overall health and well-being of patients. The pipeline for new medicines is very strong and it is estimated that in the region of 45 new molecules are due to receive market authorisation in Europe each year over the next five years. It is vital that all new medicines are thoroughly assessed to determine both their clinical and cost effective value to ensure that resources are committed to medicines that deliver a high clinical and cost effective return. The HSE has carefully considered the pricing and reimbursement of Respreeza through its decision-making process which was aligned with the statutory criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013.

I would like to highlight the importance of that Act. That was an Act that this House passed to give powers to the HSE, and not the Minister for Health, to decide which drugs to reimburse or not to reimburse. I do not mean this in relation to Deputy Brassil directly, but if Deputies in this House have a difficulty with that, they should come forward with an alternative. That is the law of the land. It is the law that was passed by this House. The HSE has the statutory power, not the Minister of the day, to decide to reimburse or not reimburse. It is important that, as legislators, we accept the responsibility that we have in that regard and the legal reality.

Following an extensive review process over the past 18 months, the HSE has written to CSL Behring, the manufacturer of Respreeza, advising it that the HSE will not support reimbursement at this time. The HSE informed me that it was unable to recommend Respreeza as there is not enough evidence to suggest that patients will derive a clinically meaningful benefit from augmentation therapy with the human inhibitor. It is not my view but the clinical view put forward by the HSE. The HSE also considered its cost-effectiveness and deemed that the current price was not a cost-effective use of resources. I appreciate Deputy Brassil's point in this regard. Many in this House have heard that this drug is being provided at a much cheaper cost to other countries and it is despicable that any drug company would try to exploit our patients or our taxpayers for a higher price than it is demanding in other countries.

I am aware that there are a number of patients on a compassionate access scheme for Respreeza which is operated by the drug company. Following recent media reports, it appears that the company could be considering terminating this scheme. However, no formal notification has been received by the HSE from the manufacturer of its intention to discontinue access to this scheme. I take the point Deputy Brassil makes about the Alpha One Foundation but I suggest that this company should come out and make a statement on this and on why, if it intends to do so, it would behave in such an unethical way. As I have stated previously, and I hope it is something that all politicians in this House would agree on, there should be no link between compassionate access schemes and reimbursement decisions. That is not just my view. The World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects indicates that, in medical research involving people, informed consent requires that these subjects are adequately informed of a range of criteria including post-study provisions and that post-study provisions should be provided for in advance of a clinical trial.

In fairness to our own Irish Pharmaceutical Healthcare Association, it is clear publicly, in its view, that there should be no link between clinical trials and reimbursement. There is no reason this patient should not receive the drug. While rightly raising it in this House, I would hope that we would all call on the company to comply with what is normal ethical practice with regard to decoupling clinical trials. It should be decoupling clinical trials from the reimbursement process. I have requested and directed the HSE to seek assurances from the relevant hospital, Beaumont Hospital in this case, that appropriate care arrangements are in place in the event that any access programme is discontinued in an unethical fashion, and that appropriate guidelines have been and continue to be followed in relation to all aspects of the clinical trial and access programme. It is the responsibility of both the company and what is known as the investigator, in other words, the clinician, to ensure that they have considered and made arrangements for their patients, including in circumstances where the product is not reimbursed by the HSE.

It is completely inappropriate and unethical for any company to link reimbursement decisions to compassionate access schemes. When I attend round table meetings with other EU Health Ministers, drug companies and the drugs industry, they are at pains to tell us that there is no link between reimbursement and clinical trials. I do not want a situation where they are using as leverage human beings who are concerned about their health and well-being. I genuinely appreciate the Deputy's issue of concern. I hope that in the next week, we can all work together to ask this company to behave in a normal ethical way. I do not think that is too much to expect.

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