John Brassil (Kerry, Fianna Fail) | Oireachtas source

I must remind the Minister for Health of his statement on 27 September which can be summarised as, “I think it is broken too.” His comment then was accurate. However, his reply tonight denies the fact that the current system is not sufficient to allow for access to orphan drugs on reimbursement programmes.

The Minister of State and his officials have heard the debate and support for the Bill is evident. I am acting in good faith and request the Minister of State to work with me with a view to improving the process whereby orphan drugs can be made available in a more timely manner and which will ensure value for money for the HSE. Speaking on value for money, I have pointed out many times that savings of up to €300 million can be made on biosimilar products available to the HSE if it goes after it. At the Oireachtas health committee last month, the point was made that biosimilar products are not interchangeable. However, as the Minister of State knows as well as I do, if physicians are directed to prescribe biosimilar products, then the original brand will match the biosimilar price in order to maintain market share. That is simple economics. I am asking that part of the savings made with biosimilar products be ring-fenced for new orphan drugs every year. This I believe is practical, cost-effective and doable.

The history in this area is not good. Respreeza for Alpha-1 took the death of two people before it was sorted. Orkambi would never have been approved were it not for the protests and public outcry over it. Pembro, which did not even go through the National Centre for Pharmacoeconomics, NCPE, process, would not be available if it were not for Vicky Phelan. It is obvious the current system is not fit for purpose. Unless we amend the Act to give further direction and clarification to the HSE and NCPE, the current cycle will go on.

The PKU Association of Ireland has been exemplary in its approach in getting reimbursement for Kuvan. Last month we were told at the Oireachtas health committee that Kuvan was approved on a limited access basis. To my knowledge, it is still delayed and will only work among a small subgroup of patients. However, a newer product, Palynziq, which has FDA approval, should work for up to 85% of Irish sufferers. Are we to spend another two years waiting for this drug to go through the same process as we did for Kuvan? Similarly, for Spinraza for spinal muscular atrophy, this drug is needed now and has been proved to work specifically for type 1 sufferers.

I want to work with the Minister and the NCPE to improve the Act. My Bill will in no way oblige the HSE to reimburse any medicine which it does not believe represents good value for the State. Section 4, detailing the criteria which the HSE must consider when making a decision on reimbursing the drug, would ensure it weighs up the potential budget impact of the proposed medicine, as well as the resources available to the HSE at that time. It will place on a statutory footing the key criteria which should be assessed in reaching a timely decision on orphan drugs, including clinical and cost effectiveness, unmet need, the relevant views of patient organisations and the availability of the medicine in other European countries.

The HSE is doing good work in securing value for the State. However, the time it takes to reach such agreements for orphan drugs is unacceptable. Very often these medicines are available across Europe but not in Ireland. If patients are fortunate to be given access to such a medicine, it can take up to two years which in many cases is often too late. We need a system whereby value is secured in a timely manner, that is not undermined and, at its very foundation, affected by a flawed assessment process. Increasing the availability of orphan drugs would undeniably result in more cost. However, it is important to remember that rare diseases only affect a small patient population, between 5,000 to 10,000 people. Often one will hear about expensive medications per patient. However for rare diseases, the actual budget impact, namely, the cost of the drug multiplied by the total number of applicable patients, is typically small. Licensed orphan drugs only exist for a fraction of rare diseases. Any cost incurred will be viewed in the context of Ireland catching up with European countries where these medicines are already available. Every country in the world is faced with the decision to not purchase medicines and save money in the short term. However, this approach results in a widening gap in patient outcomes in Ireland versus the rest of Europe. In my view, this stance is morally wrong.

Will the Minister of State retract his opposition to this Bill and work with me through Committee Stage? The Bill will get the support of the rest of the House. I am trying to improve access and not break the HSE. I am aware of the constraints but there is a workable solution. I am asking the Minister to work with me on this.

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