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Seanad
‹ Order of Business

Pembro and drug approval process

Summary

Senator Mullen welcomed Pembro's availability for cervical cancer patients but questioned whether ministerial involvement in the decision was appropriate. He suggested drug access should normally go through the standard pharmacoeconomic process.

I agree with what Senator Kieran O'Donnell has said. It should also be pointed out that Irish agriculture is extremely sustainable and clean by international standards, a point that is not highlighted regularly enough.

Like many Senators, I am contacted frequently by people who are in need of life saving drugs. I welcome the availability of the Pembro drug to women undergoing treatment for cervical cancer. While it is not likely to be effective for all patients, the limited results available are very promising. The news that it is to be made available generally is to be welcomed. Considering other steps that could be taken in this area, it would be good to hear from the Minister in the new year as to whether there will be an effort by the HSE and the relevant regulatory bodies to assess the potential benefit of the drug in treating other forms of cancer, as has been done in the United States. I believe the HSE has trials ongoing which are seeking to determine the effectiveness of Pembro. It would be good to get an update. In the UK the drug has been used successfully on apparently incurable prostate cancer where the standard treatments had shown no effect. This is all potentially good news and it is important that we are at our best on this issue. The drug is expensive; I believe it costs just under €145,000 a year for a recommended course of at least two years. However, as is the case with many drugs, we expect and hope the price will decrease over time as our pharmaceutical industry grows and adapts to patient needs. In that context, I am aware that MSD Biotech is planning to open a new facility in Swords by 2021 which will I hope be geared towards producing new lifesaving drugs such as these.

It is important that proper processes be followed to ensure these treatments are safe and can be used effectively. I was concerned by something I heard about the Pembro announcement.

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Paul Coghlan An Leas-Chathaoirleach Fine Gael

It would make a good Commencement matter.

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I will conclude shortly; this will not be a Second Stage speech. I believe I heard Professor Michael Barry, the head of the National Centre for Pharmacoeconomics, say on "Morning Ireland" yesterday that the decision was made at ministerial level in what he hoped was a one-off process. He said he would ideally like to see the drugs coming on-stream via the normal process. At the same time, I thought I heard the Taoiseach say, in response to a question in the Dáil yesterday, that Ministers did not have involvement in these things. I am open to correction, but I hope this is not the manifestation of a culture of spin, or an example of where the PR on these issues leads to ministerial responses. We cannot have Government by PR. While I appreciate and support the result in this case, it is important that we maintain consistency in the processes adopted for the review of these drugs and the decisions made about them. We have long experience of the taxpayer not getting value for money when projects are rushed and we also have safety concerns to consider. It is something on which we have to reflect on an ongoing basis.

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