Gino Kenny (Dublin Mid West, People Before Profit Alliance) | Oireachtas source

I welcome the opportunity to contribute on orphan drugs. There debate on the issue has been ongoing since I was elected to the Dáil in February 2016. The Bill will go some way to providing equity for those who live with rare conditions in Ireland. The campaign by those affected by cystic fibrosis for access to Orkambi probably brought this issue to the fore. Since then, parents and families those with rare diseases have had to consistently protest and highlight their situation.

I refer to Kuvan and Spinraza. Kuvan is used in the treatment of phenylketonuria, PKU. It is readily available in mainland Europe but, bizarrely, is not available to those who have PKU in Ireland. Ironically, the drug is made in Ireland, as are many orphan drugs that are not available to Irish citizens. It is incredible that parents are forced to fundraise, beg or go public to get access to these drugs.

Some pharmaceutical companies get large grants from the IDA and benefit from low levels of corporation tax. Big pharma has governments and patients over a barrel. The companies make vast profits. Pharmaceutical companies across the world have grown exponentially in the past 15 or 20 years because there are significant money and profits to be made from drugs.

It is probably no exaggeration to state that the public perceives the current evaluation of orphan drugs process to be unfair. I read the Oireachtas Joint Committee on Health report on evaluating orphan drugs published in February of this year and it is a really good document.

Some of the documents published in the Oireachtas probably never see the light of day. I encourage Members to read this one, however. It is a really good piece of work. Some of the recommendations are bang on the money. They include changing the evaluation process, more patient participation and a review of the 2013 Act, which is what we are speaking about today. Also included are recommendations on reimbursement and pricing and compassionate use. It is recommended that the National Centre for Pharmacoeconomics QALY processes be revised and replaced. This is at the heart of the debate. It is the committee's view that unless the State has some involvement in the research and development element of orphan drugs, we will constantly be on the back foot with regard to funding. This is really important work by the joint committee. The committee recommended that the State have a role in drugs manufacturing, research and so forth.

This is about life and death. Nobody has a monopoly on compassion, regardless of what side of the House one is on. Everybody wants to see the best done for those we engage with, who need this medicine. It is absurd to force families to campaign to get medication. When their lives are at risk, they cannot get it because it comes down to money. To me and most people, that is absurd. Medicine has made astronomical strides for humankind but when it comes to profit it has made strides backwards. It is absurd in this day and age that one cannot gain access to medicine. Therefore, we welcome this Bill.

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