Alan Kelly (Tipperary, Labour) | Oireachtas source

I very much support this Bill which I feel strongly about. I congratulate Deputy Brassil on all his work, which I have seen first hand in committee. I have worked closely with Deputy Brassil on some aspects of how we need to proceed with orphan drugs. I would go as far as to say, as I stated to Deputy Brassil previously, that if he was not able to get this Bill through I would even look at providing some Labour Party time, or co-signing it to help him if needs be, because I feel that strongly about it.

This is absolutely necessary. We have to change quickly what we are doing in regard to orphan drugs. If we do not, we will let down people all over the country. My party was the only one that put forward a separate ring-fenced budget for orphan drugs in our proposals for the previous budget and a requirement for extra funding and for it to be distinguished and separate.

The 2013 Act, while progressive at the time, is limited. That is because this issue is moving so quickly. It is moving all the time. We are getting to the stage where drugs will be customised for the individual patient. Later, I will get to other issues relating to that, specifically to do with genetics. That is where we are going. The legislation and protocols need to change rapidly to reflect this dynamic situation.

On the process of getting through a health technology assessment, HTA, as currently identified, Professor Michael Barry, in fairness to him, admitted straight-up that a drug that can affect fewer than 100 patients would never meet the thresholds. That goes for a range of potential drugs. We obviously have a serious problem in that this needs to be changed.

We need to get to a position where we find out whether drugs are worth it from a medical point of view for the patient rather than merely from a cost or return point of view. In many cases, we cannot get to that because there is not enough capacity to generate data to analyse because we are not getting them through in the first place.

It is a chicken and egg scenario and that is a big problem. There are major delays in orphan drugs being approved in Ireland compared with other countries and issues in terms of how they are reimbursed. The process in Ireland is far slower than those of most other European countries. The health technology assessment process is not just about cost-effectiveness or affordability as other issues such as equity of access, prioritisation, severity of the condition and the demographics of those affected must be taken into account in the decision-making process.

I acknowledge the decision of the Government to create a national rare disease plan for Ireland and the positives that have come from that plan. I also acknowledge the decision to joint the BeNeLuxA initiative although I have not seen much progress in that regard and it has had little impact. However, both are positive developments. There is such rapid change in this area that we must act far more quickly. Multi-annual budgets for orphan drugs should be brought in to allow us to plan ahead in terms of the approval process. As other Members have stated, funding must be ring-fenced.

The Oireachtas Joint Committee on Health carried out a significant amount of work in preparing a report on orphan drugs. I was not impressed by the contributions of representatives of the Department and the HSE with regard to our report because I was unsure that the impact of the committee's comments or its emphasis on areas of particular concern were fully taken on board.

There are issues in regard to clinical trials and how they are managed. The Minister made reference to my neighbour, Marion Kelly, one of two Alpha-1 antitrypsin deficiency patients who died as a result of a clinical trial which was stopped. There are again concerns regarding the provision of Respreeza. However, that situation should not have happened.Until very recently, the communication in regard to that matter was disastrous, as Deputy Brassil and others in the Chamber are aware. Families must be kept informed on such issues and the HSE must decide on how drugs are to administered and people looked after. Communication with the families and support groups was extremely poor.

Immunotherapy will be critical in terms of the future of drug provision. Obviously, there will be more orphan drugs and they will provide greater benefits. However, I have a serious concern with our ability to provide such drugs and make decisions in that regard if we do not build up our capacity for genetic diagnosis. The recent issue in Crumlin hospital should be a warning to all Members that our capacity in terms of genetic analysis is far from where it ought to be. We need more genetic services, consultant geneticists, genetic counsellors and genetic testing facilities to be able to take advantage of drugs that will come onto the market and analyse patients for suitability. Until those services are put in place, waiting lists will grow, decisions on drugs will be deferred and we will not be able to do the best for those who need it. I ask the Minster of State, Deputy Stanton, to relay to the Minister, Deputy Harris, my concerns which regard to both the protocols and budget provision for orphan drugs and the process by which we will customise our future decision making and how that can be done without the required genetic services.

It is obvious that we cannot continue with the current situation with regard to the provision of the drugs referred to by Members and the continuous lobbying for access to such drugs. I do not blame anyone for such lobbying.People are entirely right to lobby for them. They are passionate about the issue. Family members or friends of patients consistently hold briefings in the audiovisual room or protest outside the gates of Leinster House to lobby for access to certain drugs. It is a myth that the decision on access to drugs is solely in the remit of the HSE and the NCPE. I explored this issue at the health committee. The Minister has the power to bypass that process, as was done for Orkambi. It can be done for any other drug, as evidenced by the making available of pembrolizumab to 221 women affected by the CervicalCheck scandal. An article by Professor Michael Barry in last weekend’s The Sunday Business Postaddressed political interference in this area. The majority of political interference in terms of circumventing the process for assigning drugs in this country is at the hands of the Government, as was the case for Orkambi and pembrolizumab. Members argue in favour of certain drugs. However, the Government has decided to circumvent the process in certain circumstances instead of it being progressed exclusively by the HSE and the NCPE. That power is referenced in the agreement with the Irish Pharmaceutical Healthcare Association.

With the support of other Deputies, I have raised the critically important issue of access to pembrolizumab on numerous occasions. The Government decided to assign pembrolizumab for Vicky Phelan. We cannot continue with the situation whereby Áine Morgan and Tracey Brennan, who are watching these proceedings, are not being allowed to access pembrolizumab but Vicky Phelan is getting it for free. The State cannot treat women differently. On three occasions, the Minister has publicly committed to sorting out this issue. This is the Christmas present those women want. I urge and implore the Minister of State, Deputy Stanton, to ensure the Minister grants them their Christmas wish. They deserve it, as do other women with stage 4 cervical cancer. Those women must not be treated differently from Vicky Phelan, who has campaigned for equal access to the drug. I speak to her regularly on this issue. This badly needs to be done. The current situation is very unfair and must end. The women must be given immediate access to the drug free of charge. Legally, two sets of women must not be treated in that way in this country.

See this speech in context