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Health (Pricing and Supply of Medical Goods) Bill 2012 [Seanad]: Report Stage (Resumed) (Continued)

Wednesday, 24 April 2013

Dáil Éireann Debate
Vol. 800 No. 4

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(Speaker Continuing)

[Deputy Billy Kelleher: Information on Billy Kelleher Zoom on Billy Kelleher] For all of that, the Minister is not saving any money. There will be very few savings in the area of anti-epilepsy drugs, AEDs. There will be beneficial savings in other areas. I have tabled amendments to make generic substitution mandatory in other areas but in this context it is critically important.

  A written declaration pursuant to rule 123 of the rules of procedure on epilepsy, signed by, among others, Gay Mitchell and Marian Harkin, who were MEPs at the time, was presented to the European Parliament. It states:

1. Calls on the Commission and Council to:

- encourage research and innovation in the area of prevention and early diagnosis and treatment of epilepsy;

- prioritise epilepsy as a major disease that imposes a significant burden across Europe;

- take initiatives to encourage Member States to ensure equal quality of life, including in education, employment, transport and public healthcare, for people with epilepsy, e.g. by stimulating the exchange of best practice;

Some European countries, therefore, have already highlighted the need for AEDs to be removed from the interchangeable list. It further states:

- encourage effective health impact assessments on all major EU and national policies;

The next part of the text is critically important. It states:

2. Calls on the Member States to introduce appropriate legislation to protect the rights of all people with epilepsy.

  This legislation gives the Minister a golden opportunity to ensure that the rights of people with epilepsy are protected but not only in the context of legislation. It sends a strong message to the individuals that they have security in terms of medicines that suit and control their condition.

  I cannot plead any more with the Minister. Deputy Ó Caoláin has articulated the argument. Other Deputies will articulate it also. I ask the Minister at this late stage to come around to the view that is now international best practice with regard to this issue. Many countries have removed anti-epileptic drugs from their interchangeable lists or did not include them in the first place. That is something of which we should be conscious. I have a list of the countries that do not allow substitution of anti-epileptic drugs with generics. The Minister will be familiar with them. They include the United Kingdom, Austria, Belgium, the Czech Republic and Greece. In addition, countries that have excluded many anti-epileptic drugs from substitution include Denmark, Finland, Germany, Portugal, Spain, Sweden and Switzerland.

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White Is this by statute or is it in accordance with rules that are established under statute? It is important to tell the House that.

Deputy Billy Kelleher: Information on Billy Kelleher Zoom on Billy Kelleher Obviously, the Minister knows as much or more about it in that context.

Deputy Alex White: Information on Alex White Zoom on Alex White No. I am carefully following the Deputy's point.

Deputy Billy Kelleher: Information on Billy Kelleher Zoom on Billy Kelleher Yes, but the point-----

Deputy Alex White: Information on Alex White Zoom on Alex White This may be of help. What I am asking is whether the countries on the list the Deputy gave are countries in which the relevant authority - the equivalent of the Irish Medicines Board - has decided not to substitute, or countries that have decided by statute not to substitute. That is the issue we are dealing with.

Deputy Billy Kelleher: Information on Billy Kelleher Zoom on Billy Kelleher I can get clarity on that in the next few minutes, but the point being made is that the Irish Medicines Board will not be obliged by this legislation to exempt the drugs from interchangeability. That is the key issue.

Deputy Alex White: Information on Alex White Zoom on Alex White Or to include them.

Deputy Billy Kelleher: Information on Billy Kelleher Zoom on Billy Kelleher Or to include them, yes. The point I am making is that this amendment, in effect, would remove that concern. I urge the Minister to accept it.

Deputy Róisín Shortall: Information on Róisín Shortall Zoom on Róisín Shortall There is always a tendency for Ministers and their Departments to hold the line on something and maintain that they are right. Obviously, they have done a lot of the work on it and there is generally a reluctance to accept amendments from the Opposition. That is standard practice regardless of the Minister's party, but it is an old-fashioned way of doing business in many ways and demonstrates an assumption that the Minister has a monopoly on wisdom. It would be much more meaningful, in terms of having real debate in this Chamber if, from time to time, the points made by the Opposition were listened to and the Minister gave a meaningful response to those points.

As has been said already, everybody speaking in the House supports this Bill. We all agree that much more needs to be done to reduce the drugs bill, and generic substitution is one element in a range of measures that must be put in place to bring our drugs bill into line with those of other European countries, because it is way out of line at the moment. We pay more for drugs than any other country in Europe. That is a matter of serious concern and it is causing ongoing difficulties with the health budget.

We have all come here in good faith to raise genuine concerns about what is seen to be a genuine issue with one aspect of this legislation. We support all of the rest of it. We are not doing that to waste time or for something to do. We are here because, having met with people who have epilepsy and various groups campaigning in this area, we believe that a genuine issue arises.

I was not at the Committee Stage debate but I do not believe there has been real engagement on the part of the Minister of State in regard to this issue because he has not explained to us the reason he is not prepared to exempt epilepsy drugs for people who have epilepsy.

Deputy Alex White: Information on Alex White Zoom on Alex White I have, and I will again.

Deputy Róisín Shortall: Information on Róisín Shortall Zoom on Róisín Shortall I have not heard that. The Moran report has made it clear that the generic substitutes for drugs for persons with epilepsy that are listed among the categories for use and for prescribing for people with epilepsy are currently not safe. If the Minister accepts that, action must be taken to avoid the potential risk for people in the event - and it is not an unlikely event - that somewhere along the line they would be given a generic substitute for their epilepsy drugs, either by a prescribing doctor, consultant or nurse or by a pharmacist. As far as I can see, the Minister of State is not in a position to give a guarantee that that will not happen and therefore there is a real and substantial risk that it could happen in certain cases. The impact of that is potentially very serious for the person concerned and it could be catastrophic.

  A case was brought to my attention recently of a young woman who has epilepsy that is very well controlled by the medication she is on. She is living a full and independent life as a result of that medication, but recently she changed consultant and her new consultant decided to change her medication. That has had a hugely negative impact on her life because the change in medication, which was done professionally and so on, has resulted in daily fits, so that she is unable to go to work or drive and is highly dependent on her parents to manage from day to day. This illustrates the delicate balance involved in proper prescribing for an individual with epilepsy. Getting that balance of medication right for a person with epilepsy is a huge challenge. In switching a person to a substitute drug, the potential for hugely life-limiting implications is very real. I cannot see how, under these arrangements, we can avoid a situation in which a person with epilepsy may be prescribed or given a generic substitute for their epilepsy drug. I cannot see how we can prevent that from happening. This point is not being made regarding all epilepsy drugs per se but in respect of epilepsy drugs prescribed for people with epilepsy. There are real risks in this regard. I am not in any way reassured by the points that have been made so far that the system being proposed under this legislation is sufficiently robust to avoid that kind of risk.


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