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

Debate resumed on amendment No. 2:
In page 13, between lines 14 and 15, to insert the following:
"(2) The Board shall, as soon as is practicable after the commencement of this section, establish and publish on its Internet website, and maintain, a list (in this Act referred to as the "List of non-Interchangeable Medicinal Products"), in such form as it thinks fit, of groups of medicinal products in respect of which it is satisfied, in accordance with section 5, as respects each such group, that all the medicinal products which fall within the group are, for prescription purposes, not interchangeable with each other.".
-(Deputy Billy Kelleher).

Amendment No. 2 has already been discussed. How stands the amendment?

I am pressing it.

Amendment put:
The Dáil divided: Tá, 45; Níl, 80.

  • Boyd Barrett, Richard.
  • Broughan, Thomas P.
  • Calleary, Dara.
  • Collins, Joan.
  • Collins, Niall.
  • Colreavy, Michael.
  • Cowen, Barry.
  • Crowe, Seán.
  • Daly, Clare.
  • Doherty, Pearse.
  • Donnelly, Stephen S.
  • Ellis, Dessie.
  • Ferris, Martin.
  • Flanagan, Luke 'Ming'.
  • Fleming, Sean.
  • Fleming, Tom.
  • Grealish, Noel.
  • Halligan, John.
  • Healy, Seamus.
  • Healy-Rae, Michael.
  • Higgins, Joe.
  • Kelleher, Billy.
  • Kitt, Michael P.
  • Lowry, Michael.
  • Mac Lochlainn, Pádraig.
  • McGrath, Mattie.
  • McLellan, Sandra.
  • Moynihan, Michael.
  • Murphy, Catherine.
  • Naughten, Denis.
  • Nulty, Patrick.
  • Ó Caoláin, Caoimhghín.
  • Ó Cuív, Éamon.
  • Ó Fearghaíl, Seán.
  • Ó Snodaigh, Aengus.
  • O'Brien, Jonathan.
  • O'Dea, Willie.
  • O'Sullivan, Maureen.
  • Pringle, Thomas.
  • Ross, Shane.
  • Shortall, Róisín.
  • Smith, Brendan.
  • Stanley, Brian.
  • Tóibín, Peadar.
  • Wallace, Mick.

Níl

  • Bannon, James.
  • Bruton, Richard.
  • Burton, Joan.
  • Buttimer, Jerry.
  • Byrne, Catherine.
  • Byrne, Eric.
  • Carey, Joe.
  • Coffey, Paudie.
  • Collins, Áine.
  • Conaghan, Michael.
  • Connaughton, Paul J.
  • Conway, Ciara.
  • Coveney, Simon.
  • Creed, Michael.
  • Daly, Jim.
  • Deasy, John.
  • Deenihan, Jimmy.
  • Doherty, Regina.
  • Donohoe, Paschal.
  • Dowds, Robert.
  • Doyle, Andrew.
  • Durkan, Bernard J.
  • English, Damien.
  • Farrell, Alan.
  • Feighan, Frank.
  • Ferris, Anne.
  • Fitzgerald, Frances.
  • Fitzpatrick, Peter.
  • Griffin, Brendan.
  • Harrington, Noel.
  • Harris, Simon.
  • Hayes, Brian.
  • Hayes, Tom.
  • Heydon, Martin.
  • Hogan, Phil.
  • Humphreys, Heather.
  • Humphreys, Kevin.
  • Keating, Derek.
  • Kehoe, Paul.
  • Kenny, Seán.
  • Kyne, Seán.
  • Lyons, John.
  • McEntee, Helen.
  • McGinley, Dinny.
  • McHugh, Joe.
  • McLoughlin, Tony.
  • McNamara, Michael.
  • Maloney, Eamonn.
  • Mathews, Peter.
  • Mitchell, Olivia.
  • Mitchell O'Connor, Mary.
  • Mulherin, Michelle.
  • Murphy, Eoghan.
  • Nash, Gerald.
  • Neville, Dan.
  • Nolan, Derek.
  • Ó Ríordáin, Aodhán.
  • O'Donnell, Kieran.
  • O'Donovan, Patrick.
  • O'Mahony, John.
  • O'Sullivan, Jan.
  • Penrose, Willie.
  • Perry, John.
  • Phelan, Ann.
  • Phelan, John Paul.
  • Rabbitte, Pat.
  • Reilly, James.
  • Ring, Michael.
  • Ryan, Brendan.
  • Shatter, Alan.
  • Spring, Arthur.
  • Stagg, Emmet.
  • Stanton, David.
  • Timmins, Billy.
  • Tuffy, Joanna.
  • Twomey, Liam.
  • Varadkar, Leo.
  • Wall, Jack.
  • Walsh, Brian.
  • White, Alex.
Tellers: Tá, Deputies Seán Ó Fearghaíl and Aengus Ó Snodaigh; Níl, Deputies Paul Kehoe and Emmet Stagg.
Amendment declared lost.

I move amendment No. 3:

In page 13, between lines 17 and 18, to insert the following:

"(3) The Board shall arrange for that part of its Internet website which contains the List of non-Interchangeable Medicinal Products to ordinarily be accessible by members of the public.".

Amendment put and declared lost.

Amendments Nos. 4 and 18 are related and may be discussed together.

I move amendment No. 4:

In page 14, between lines 23 and 24, to insert the following:

"(3) The Board shall, in determining an application under subsection (2), have regard to the desirability with respect to efficacy and safety of refusing to add medicinal product in the anti-epileptic drug class, used in the treatment of persons with epilepsy for the purpose of preventing seizures, to the List of Interchangeable Medicinal Products.".

I am joined in presenting that amendment by Deputies Catherine Murphy and Billy Kelleher. As I indicated in the earlier engagement in respect of amendments Nos. 1 to 3, inclusive, this is the meat of what we are about in the Health (Pricing and Supply of Medical Goods) Bill 2012. Amendments Nos. 4 and 18 get to the nub of the issue. These amendments arise from the concerns of people with epilepsy. Concerns about the need to ensure that there is no inappropriate substitution of their medication is not a small matter: it is a hugely important issue. As he has indicated, the Minister is well aware of the concerns of people with epilepsy in this regard and has confirmed that today. There is a particular issue with regard to the precise formulation of anti-epileptic drugs, AEDs, and the concern that generic substitutions are not exact replicas and with possibly very negative consequences.

Other Deputies and I have received direct testimony during the course of hearings at the health committee, as well as through meeting individual sufferers of epilepsy and their representative voices in Epilepsy Ireland. That direct testimony from those who have suffered negative effects from unsuitable generic substitutes tells us this is a real issue. It is not a case that it might happen. The fact of the matter is that it has happened and the evidence is available to support this. People who moved to unsuitable generic substitutes have had to revert back to their original prescriptions to re-stabilise their circumstances. I know people with epilepsy and can assure the Minister and the House of the genuineness of their concerns in this matter. It is not about Opposition Members seeking some minor note that we have managed to amend a government Bill - far from it. It must be acknowledged, too, that each and every one of us on these benches indicated on Second Stage that we absolutely supported the Bill’s thrust and that we would be a party to its final passage.

Amendment No. 1 sought to include the definition of non-interchangeable medicinal products, but the Minister would not accept it, which is reflective of the Government’s general disposition to Committee and Report Stage amendments from the Opposition. The section covering definitions defines everything, including "the Minister", except non-interchangeable medicinal products. Including that definition would not have altered the Bill one iota, yet the Government voted down the amendment. Earlier, as indicated by a nod from the Minister of State, he accepted we were into the real core issue. I am deeply concerned that the Government is demonstrating that it is not willing to accept any change, that it knows best, that we are wasting our time going through a long examination of the minutiae of legislation, while offering, in good spirit, important, relevant and necessary amendments.

Those who have campaigned for the exclusion of AEDs, anti-epileptic drugs, from the terms of the legislation want to have their concerns recognised in the Bill. It is important that they have certainty. They have asked us, as legislators, to provide that certainty. Epilepsy Ireland has spent considerable time and, unquestionably, a significant part of its limited resources in a stoical effort to avert the problems that could present and which have already done so. I commend its efforts and record my disappointment that despite its sincere efforts, the necessary protections will not be built into the Bill. I am also disappointed that the stance being taken by the Government will see the rejection of amendments Nos. 4 and 18. As I put it to the Minister of State last week, I hope he will prove me wrong. I urge the Minister to accept these amendments in the spirit in which I and others have brought them forward. It is not an exercise to get one over on the Government; rather, it is an exercise to give proper and due service to the concerns of a cohort of citizens, concerns which the Minister of State has acknowledged and accepted. I cannot understand why the Government will not accept the validity of the amendments and act accordingly. I, therefore, urge the Minister of State to accept amendments Nos. 4 and 18.

I am not being repetitious or idly talking to highlight this issue which is critically important. Epilepsy Ireland has stated:

The safety of people with epilepsy should not have to depend on the discretion of the Irish Medicines Board. People with epilepsy should not have to deal with fears concerning substitution, in addition to all the other physical and psychosocial effects of epilepsy, when a simple amendment can reassure them.

That is the crux of the matter and the body of evidence is overwhelming. The Minister of State has even stated substitution for generics is not the key issue but the interchangeability of medicines. I cannot understand for the life of me why he will not accept this amendment to give a cast iron assurance to the people affected. Other countries in which there is generic substitution and the interchangeability of medicines have excluded AEDs. We are now going down a route that is not accepted as best practice. People with epilepsy need to be secure in the knowledge that they can get on with their everyday lives because they have access to the medicine that has suited them in controlling their condition.

We are supporting this legislation and have been calling for its publication for some time to ensure savings are made in this area. Epilepsy Ireland and Brainwave are the only organisations which have expressed grave concerns about this matter. They have pleaded with us, with eminent consultants who deal with people with epilepsy, to encourage the Government to change its position on the interchangeability list and AEDs. As Deputy Caoimhghín Ó Caoláin said, this is not about point-scoring or trying to win against the Government. We heard the passionate pleas and concerns to change this provision. Many of those with epilepsy have other challenges and now the Government is heaping extra ones on top of them by undermining the security they should have in being guaranteed the same medicine that suits them and controls their condition.

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.

Is this by statute or is it in accordance with rules that are established under statute? It is important to tell the House that.

Obviously, the Minister knows as much or more about it in that context.

No. I am carefully following the Deputy's point.

Yes, but the point-----

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.

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.

Or to include them.

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.

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.

I have, and I will again.

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.

As I said earlier, there is evidence that generic substitution is already taking place in the case of anti-epileptic drugs, AEDs, for people with epilepsy in the hospital setting. It is all very well to give an assurance in the House that this will not happen, but it is already happening in certain circumstances. Nothing that has been said here today gives any kind of reassurance that those issues will not continue to arise and that mistakes will not be made, irrespective of the kind of guidelines given.

If the Minister of State is not prepared to accept these amendments, which provide for a reasonable approach to the issue could he, even at this late stage, give a firm assurance to people with epilepsy and state clearly that no person who suffers from epilepsy will be subject to generic substitution on those medications where it is unsafe to do so? Will he give a clear and categorical assurance in the House today that this will not be the case where AEDs are substituted in the case of people with epilepsy?

I missed some of the debate and hope I will not repeat what somebody else has said. One thing we are pretty good at in this country is looking at something that has not worked elsewhere and then trying it out here to see whether it works here. Volume 9, issue 3 of The Lancet in 2010 referenced a Canadian study on the issue of generic drugs. The article stated that doctors, patients and advocacy groups in England and elsewhere are concerned that generic anti-epileptic drugs might not be therapeutically equivalent to branded drugs, which could put patients at risk of break-through seizures or adverse events. It went on to state that according to retrospective review - which is as conclusive as one can get because one can see how something played out - of medical and pharmacy claims in Canada, the rates of switch-back to a branded drug after generic substitution were greater for AEDs than for non-AEDs. Also, health care costs were greater in patients who received generic medication compared to the branded version.

The Canadian study appeared in the Neurology academic journal in June 2009, Volume 72, No. 24. The conclusion stated that multiple generic substitution was significantly associated with negative outcomes, such as hospitalisations, injuries and increased health care costs. Furthermore, the risk of head injury or fracture was almost three times greater in patients who switched from one generic version to another compared with patients who continued on a branded version. This is quite conclusive and comes from a very reputable source. Generic substitution has been tried, but has had to be reversed. Why do we ignore this kind of evidence as we are doing here?

Deputy Shortall suggested that if the Minister of State was not willing to accept these amendments, he could use some other mechanism to deal with the issue. For example, he could insert a section that would allow for a ministerial order at some stage so that we do not have to come back with primary legislation in order to change a provision if we discover it is necessary. We may discover that what has happened elsewhere happens here also. We are not of a hugely different genetic make-up to the rest of the world and if something has happened elsewhere, it is likely the same experience will occur here if drugs are interchanged and outcomes are poorer as a consequence.

I support the comments made by Deputy Catherine Murphy regarding the research in Canada and the fall-out from the introduction of interchangeability of AEDs in Canada. The Canadians have seen the errors of their way and there has been a knock-on fall-out as a result in the context of additional costs for the health service for people with epilepsy presenting with conditions associated, directly and indirectly, with the substitution of their branded AED. It is important to reiterate that we are not against using generic medicines for people with epilepsy. What we are against is the interchangeability of a particular medicine.

I am sure the Minister of State has spoken with the Irish Medicines Board, IMB, on this issue and I am sure the board has indicated to him that it is very unlikely AEDs will ever fall into the interchangeability category. However, in light of the consistent research that has been conducted across the world on the interchangeability of AEDs, it surely makes sense to provide legal certainty to people with epilepsy by ensuring AEDs are removed from the list of medicines possible for interchange at some date. I realise there are issues with including this in primary legislation, but an alternative would be to make provision for a statutory instrument to be published in tandem with the legislation.

This secondary legislation could specifically state that AEDs will not fall into this category. The secondary legislation could also deal with the list published in the Moran report and provide for it to be altered at a future date as medical research changes. A statutory instrument provision would, at least, give statutory reassurance to people with epilepsy, something they do not have currently. It would also send out a clear message to them. The fear is that once this legislation is enacted, a carte blanche approach will be taken in regard to drug substitution. We know that is not the case and that each case will be dealt with by the IMB. However, all we need is for one mistake to be made somewhere along the prescription line for an individual and this could have long-term consequences for that individual.

If the Minister of State is not prepared to amend the legislation in order to make a specific provision in regard to AEDs, will he at least give a commitment to making a provision that will allow him introduce secondary legislation that will make specific reference to AEDs where they are being prescribed for people with epilepsy so that they will not be prescribed on an interchangeability basis.

It should not be assumed that because a Minister or Minister of State stands up and disagrees with issues raised by colleagues on the opposite side of the House, that he is not listening to them or that he doubts their genuineness. I do not doubt the genuineness of anybody in this House or their good faith. It should not be assumed that because I am not accepting what has been proposed, that I question the genuineness of Deputies. I want to make it clear to people in good faith that I have listened carefully to everything that has been said on this issue.

I mentioned earlier that in addition to the responsibilities I have as Minister of State, I am aware of the issue being raised here in regard to anti-epileptic drugs. Even if I was not aware of it, I would have a responsibility to go and read up on it. Deputy Shortall should not assume that what I am doing here is "mouthing a line", as she described it.

I am not taking a view that I have been told I have to take. I know Deputy Róisín Shortall and I am quite sure she went through the documentation, the arguments and the issues carefully when she was Minister of State, just as I have done. Ministers are expected to read the documentation - they are paid to do so - rather than simply accepting a line. Of course, advice is available, but I am not here to mouth anybody's line. I take very seriously the job I have been asked to do. I know the Deputy did likewise when she was in the same job. I carefully analyse what I am asked to do in order that I understand it. I ask for the same recognition of what we are doing from my colleagues on the Opposition benches that I give to each and every one of them. I do not for one moment doubt the good faith of Deputies in highlighting this issue, nor do I doubt the genuineness of those involved in the Irish Epilepsy Association who raised it in the first instance.

Debate adjourned.