Oireachtas Joint and Select Committees
Thursday, 14 March 2013
Joint Oireachtas Committee on Health and Children
Challenges Pertaining to Epilepsy in Ireland: Discussion
The meeting is in public session. I remind members and witnesses to ensure their mobile telephones are switched off rather than left on silent mode because they interfere with the broadcasting equipment. Out of respect for the staff, we should have uninterrupted audio coverage of the recording of these proceedings.
I welcome Mr. Mike Glynn, chief executive officer, Epilepsy Ireland, Mr. Peter Murphy, deputy chief executive officer, and Dr. Peter Widdess-Walsh, a consultant neurologist. They are all welcome to our meeting.
Witnesses are protected by absolute privilege in respect of their evidence to this committee. If they are directed by the committee to cease giving evidence in respect of a particular matter and they continue to so do, they will be entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise nor make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice, or long-standing ruling of the Chair, to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official either by name or in such a way as to make him or her identifiable.
This morning we will discuss the issue pertaining to epilepsy in Ireland regarding the forthcoming Bill. I invite Mr. Glynn to make his opening remarks.
Mr. Mike Glynn:
I thank the Chairman and the committee for this opportunity to address them on the health Bill and on the concerns held by people with epilepsy concerning generic substitution of anti-epileptic drugs, AEDs. We have sought this opportunity to speak to the people's legislators because the issue is potentially one of life and death for people with epilepsy - it is that serious - and all those close to them, their families and friends. We are not an organisation that is often in the public limelight and it is out of necessity to protect the health and well-being of people with epilepsy that we are here today.
Epilepsy is the most common serious neurological condition. It is characterised by unprovoked seizures which can occur at any time. About one in every 20 people will have a single seizure at some time during their lives. Seizures may take many forms, differing from one person to another. There are around 20 anti-epileptic drugs on the market and there are surgery options for suitable candidates. About 70% of people can become seizure-free.
Epilepsy is a source of major long term, yet often hidden disability. A diagnosis involves learning to cope with the physical impact of seizures, the medications prescribed to control them and impaired psychological and social functioning. Loss of one's driver's licence, in particular, and employment and education problems, loss of independence, social isolation and the lingering stigma attached to the condition are all potential challenges that may cause as many problems as the seizures themselves. According to the Department of Health's estimate, there are about 130 epilepsy-related deaths in Ireland each year, about half of which are due to a phenomenon known as sudden unexpected death in epilepsy, SUDEP, the cause of which we do not know but we definitely know that they are seizure-related.
Epilepsy Ireland is the national organisation for people with epilepsy, established in 1966, to work for and meet the needs of everyone with epilepsy in Ireland and their families and carers. Our vision is to achieve a society where no person's life is limited by epilepsy. Today, we have in excess of 8,500 members and ten offices located around the country, from which we provide services. In addition to providing a wide range of support services to people with epilepsy and their families, we are also committed to raising awareness of epilepsy, training and educating health professionals and supporting Irish epilepsy research.
We also act as an advocate for the condition of epilepsy and work to promote legislative and civil rights for those we represent. Like any health care charity, we have concerns about funding and service levels, including the recent issue of the epilepsy monitoring units at Cork University Hospital and Beaumont Hospital, which remain unopened because of staffing issues months after work to complete the units finished. The HSE has at least indicated recently that opening both units is now a priority and we expect to see them fully operational very soon. For the 37,000 people with epilepsy aged over five in this country - we do not know the number with epilepsy aged under five - an even bigger concern is that of generic substitution of anti-epileptic medication.
Next week, this committee will begin its consideration of the Health (Pricing and Supply of Medical Goods) Bill. The reason we are here today is to appeal to the members, as responsible legislators, to change the Bill that will come before them to ensure it specifically excludes anti-epileptic drugs from its terms relating to generic substitution and interchangeability. This is something the Moran report, published by the HSE and the then Department of Health and Children, recommended two years ago. Legislating for this exclusion will remove the risk that people with epilepsy will be exposed to through substituting generic drugs and the catastrophic effects which such exposure could bring up to and including massively increased risk of mortality.
The reason for this is that AEDs have a particularly narrow therapeutic range. Unlike the vast majority of medications used to treat other illnesses and conditions, any variation in the manufacture and composition of a tablet or capsule introduces a factor that can disturb balance and result in otherwise avoidable "breakthrough" seizures. As things stand, finding not only the right medication but also the right dosage is a matter of expert skill and a degree of trial and error. An epilepsy specialist such as Dr. Peter Widdess-Walsh or a neurologist will increase the dosage slowly over time until an ideal level is attained, something which will vary with each patient. It is an very individual thing. AEDs, therefore, are carefully concentrated for each individual to ensure good seizure control. Introducing a generic that can vary significantly in form from the original branded medicine and, especially, from other generics of the same origin, introduces a factor that can undo years of work in stabilising an individual's seizures.
Under the proposed legislation, as it stands, patients can be switched between different generics from month to month which can mean that they might receive a generic medicine with effectively 25% more active ingredient than the branded medication on one occasion and one with effectively 20% less active ingredient on the next occasion. It is this large window for "generic to generic" substitution that is the real problem for people with epilepsy. There are also potential concerns around the role played by inactive substances or additives, which do not need to be identical, in the absorption of the active substance.
These safety concerns have been highlighted in numerous studies. As a result, treatment guidelines in countries such as the United Kingdom, our nearest neighbour, and France discourage anti-epileptic drug, AED, switching. Other countries that do not allow substitution of particular AEDs include Austria, Belgium, the Czech Republic and Greece. Countries that have excluded some AEDs from substitution include Denmark, Finland, Germany, Portugal, Spain, Sweden and Switzerland.
Furthermore, as I stated earlier, the Moran report, published by the Department of Health and Children and the Health Service Executive in 2010, specifically recommends AEDs be excluded from any system of generic substitution in Ireland. It is because of these undisputed safety concerns that we are asking the members to include our amendment in the Bill, thereby legislatively guaranteeing the safety of people with epilepsy.
There are four important points that need to be made. First, there is no risk of the floodgates being opened if AEDs are exempted. We understand that no other patient group or organisation has come or sought to come before the committee seeking an exclusion for any other range of drugs. The only group of people likely to be disadvantaged as a result of generic substitution are people with epilepsy.
Second, Epilepsy Ireland is not against the general concept of generic substitution. We welcome moves to reduce the State's annual drugs bill. We are also in favour of the use of generic AEDs when they are prescribed for new patients by an epilepsy specialist and on the
Third, the cost implications of excluding AEDs from substitution through the legislation are negligible. While official figures we have seen indicate that €75 million is spent annually on AEDs, almost €40 million of that figure is accounted for by one drug, which was licensed as an AED but is prescribed almost exclusively now for neuropathic pain and other conditions, and for less than 1% of cases of people with epilepsy. We want to be clear that our proposed amendment does not seek to unnecessarily exclude AEDs from substitution if they are prescribed for reasons other than preventing seizures.
Fourth, it is important to note that the points we are making here today are backed up by the entire epilepsy community, including epileptologists, consultant neurologists and others caring for people with epilepsy.
Regarding the Department of Health's view, next week the Minister will tell the members that the Bill is intended to merely establish a framework for generic substitution and that it should not exclude any particular class of drugs from substitution. He will say that the Irish Medicines Board solely should have the authority to decide which drugs are deemed interchangeable, and which are not. He will say that there is no need for an exemption for AEDs in the Bill, and that there are safeguards in the Bill to satisfy our concerns.
Epilepsy Ireland understands this position and accepts that from an administrative point of view, it is neater not to specifically exclude a class of drugs such as AEDs. However, this issue is much greater than a desire for administrative neatness or a desire to make negligible savings within the State's annual drugs bill.
Refusing to incorporate the exclusion of AEDs into the primary legislation would mean passing up an opportunity to safeguard people with epilepsy. Allowing for the possibility of substituting AEDs will create a dangerous environment for people with epilepsy.
In 2011, the European Parliament approved a Bill overwhelmingly, which was signed by a huge number of MEPs, introducing the European declaration on epilepsy. That was sent to all health Ministers in the EU asking them to ensure that people with epilepsy were looked after and that research and care for people with epilepsy was affirmed in legislation in particular. If this Bill as currently drafted is passed, Ireland's first reaction, at the time of its Presidency of the EU, will be to put people with epilepsy at risk rather than supporting them, as the European declaration intends.
Epilepsy Ireland is already aware of a number of cases where an individual's epilepsy has worsened having been switched from a regular brand to a generic. This switching is taking place even now, despite the absence of legislation and of interchangeable lists. Many pharmacists appear to lack awareness that AED substitution differs from other drugs. They are already acting as though the legislation has been passed and are not making a differentiation for epilepsy or any drug. This problem will worsen significantly if the Bill as drafted is passed.
As an association devoted to the interests of all people with epilepsy, we have prioritised this issue over many other pressing issues because we genuinely believe that the Bill as drafted presents a real and present danger to the well-being, safety and, ultimately, the lives of people with epilepsy. That is not a claim we make lightly. We do not doubt the bona fides of the Minister and the Department. However, we urge the members of this committee, as legislators, to put aside party loyalties and use their critical role in the legislative process to put the wider public interest and the safety of people with epilepsy ahead of administrative neatness and convenience. I thank the members for their time. We will be happy to answer any questions they may have on the issues raised.
At the outset I would like to extend a warm welcome to all three witnesses, Mr. Mike Glynn, Mr. Peter Murphy and Dr. Peter Widdess-Walsh.
It is hugely important for us as legislators, leaving aside our respective party and non-party hats that we wear here, to inform ourselves as we prepare to engage even more deeply on the detail of upcoming legislation, and this particular legislation on the pricing and supply of medical goods Bill. I do not have extensive exposure to epilepsy, but I have had a number of experiences, including a very close friend who has been through this experience. The words "been through" are important because Mr. Glynn has indicated that with proper medication and treatment, some 70% to 75% of people come out the other side and that there is a good result for many of those who have a seizure experience at some point in their lives, and this could present for any of us in this room who may have never had the experience previously. That is important.
Mr. Glynn made a point regarding the immediate impact following a seizure or a series of seizures, and the life-changing consequences of that. He mentioned the driver licence issue and not being able to self-transport, the employment and education consequences, and the loss of independence. Sadly, as with many other issues we have addressed here over the years, there is also a social stigma aspect. We often think of the stigma attached to mental health, something that we, as an all-party committee, concentrate on trying to break, and will continue to do that, but there is a social stigma attached to epilepsy also and a reluctance on the part of some, perhaps many, to even expose the fact that they have this particular condition. That must be addressed.
I have a number of questions. On the increased risk of mortality in the event of generic substitution and the inexactitude of the replacement drug, do we have any statistics in terms of either domestic or international circumstances that present? I am sure it is not just anecdotal, but the witnesses may not have the detail with you here today. Would any of the three guests be able to offer any further information on the increased risk of mortality as against any of the other likely or possible consequences of not having that exact drug consistency continuing?
On the international situation, I note some uncertainty in the witness's presentation.
He referred to guidelines in regions such as the neighbouring island, north of the Border and France that discourage AED switching. However, he then stated countries that did not allow the substitution of AEDs included Britain and the North of Ireland. Can I receive clarification on this point? Are there guidelines or more prescriptive provisions?
The deadline for the submission of amendments to the Bill has passed. I advise members that I have taken the opportunity to table appropriate amendments. Members who may not be clear on this point should note that the door is not shut, even now. If concerns are raised on Committee Stage, we can introduce amendments on Report Stage. I claim no monopoly in getting this right and I am just making the point that if another issue arises, we will have another opportunity to address it next week with the Minister. Report Stage will be taken in the Dáil Chamber.
With regard to pharmacists and a lack of awareness, what engagement has there been with the Irish Pharmacy Union to try to address that significant deficiency? Outlining the problem here is not enough. Have steps been taken, through the Irish Pharmacy Union's fine periodical and other means, to inform its members of this concern?
The epilepsy monitoring units at Cork University Hospital and Beaumont Hospital remain unopened. When do the delegates expect the delay to be overcome?
I thank the delegates for attending and their presentation. I have a few points on which I seek clarification. Can the international position be clarified? In other countries is there statutory prohibition or are there guidelines in place? What is the breakdown in various countries, particularly those in western Europe? Will the delegates clarify the range of risks involved? Are there figures available? However, there may be none.
The HSE and the Department of Health have recommended in reports the course of action being recommended by the delegates. Have the delegates any idea why the recommendations are not included in the legislation?
Mr. Glynn stated patients might receive a generic medicine with, effectively, 25% more active ingredient than the branded medicine on one occasion and one with 20% less active ingredient on the next. Is that the case? Is this the position right across the range of generic drugs or is it just in the case of those mentioned?
Mr. Glynn has mentioned four important points that need to be made. The second suggests the delegates are in favour of the use of generic AEDs when they are prescribed for new patients by an epilepsy specialist and on the condition that there will be an adequate supply of the required generic drug available in the longer term. Can this be clarified? Is there no difficulty if the patient starts on the generic drug?
I thank the delegates for their evidence. Some months ago Senator Tony Mulcahy bent my ear on this issue and he has been pressing a number of us on it in recent months. What we are discussing is not alien to most of us. Our former colleague, the late Senator and Deputy Joe Doyle, had epilepsy. He was a great advocate for people with epilepsy and a great role model.
What is the legal position in the United Kingdom? Is the system based on primary legislation, regulations or guidelines? Will the delegates furnish the committee with the wording, be it in a regulation, statutory instrument or primary legislation? This would be helpful in our consideration of the Bill because of the similar legislative processes in both jurisdictions.
My next question concerns the fact that switching is taking place. Some pharmacists are switching, although the legislation is not in place. It has already given rise to difficulties. I refer not only to the point made on epilepsy. The point made this morning was very valid and is one we will be putting to the Minister next week. If one is taking only one type of medicine, switching may not have a huge impact, but many older people who may be on 14 or 15 types of medicines may be affected. If a medicine is being substituted, the pharmacist should explain to the patient or his or her family that this is the case. It is important that it be explained to patients that a particular medicine is being prescribed for them. To avoid confusion, they ought to know whether their heart or epilepsy medicine, for example, is being substituted.
Is it not better to have a provision in the legislation that would tie a pharmacist to prescribing a specific medicine? The delegation made a very strong case for patients with epilepsy. There will be a very small cohort who, for one reason or another, will have suffered adverse effects on moving to another formulation of medicine, although the active ingredient will have been the same. The last outcome one wants is a set of circumstances in which the patient must try, every time he or she enters the pharmacy, to convince the pharmacist that he or she needs a particular type of medicine. Should we focus purely on AEDs or should we table an amendment that would allow the doctor or consultant to stipulate that a certain medicine should not be changed in any circumstance because of the patient's particular illness or the characteristics thereof? I include people with epilepsy but also a very small cohort who, for various reasons, may not be able to adapt to changes in the formulation of their medication.
Mr. Mike Glynn:
I will ask Dr. Peter Widdess-Walsh to answer the medical questions.
Most of the countries that allow generic substitution have many epilepsy specialists and neurologists. If somebody gets into trouble, he or she can be referred to one of these specialists very quickly. This cannot happen in Ireland. There are so few neurologists, let alone epilepsy specialists such as Dr. Widdess-Walsh, that it may take a very long time to gain access to one of them when in trouble. Getting somebody back on the rails can take much more time than it should and this must be remembered.
In 2011 the United Kingdom was going to allow the substitution of AEDs. I believe this is not included in the legislation.
However, they communicated with patients, people with epilepsy and epilepsy specialists. They had a listening consultation over a period of months and when they saw the case was so overwhelming, they stepped back and listened. This is what we want to do here. In respect of the United Kingdom, I note there is a proposal under the peace process that in the north west, services for both sides of the Border will be focused on Altnagelvin Hospital. In that case, someone from Lifford who gets a prescription from Altnagelvin will be in a different position to someone from Sion Mills who gets one. This would be a ludicrous situation and I note something similar happened years ago in respect of driving, when there were major problems with different legislation for epilepsy and driving. This is the position in the United Kingdom. While I do not believe it is in legislation, it is effective nonetheless that the Government there has indicated it will not allow substitution of anti-epileptic drugs, AEDs. I will now hand over to Dr. Peter Widdess-Walsh.
Dr. Peter Widdess-Walsh:
I thank the joint committee for the opportunity to speak. I have been an epilepsy specialist for almost nine years and have treated hundreds of people with epilepsy and share Mr. Glynn's view and concerns about generic substitution of anti-epileptic drugs. It is a specific class of drugs that should be protected. In the case of other medications such as, for instance, cholesterol or blood pressure medications, a couple of points in difference might not make too much difference. However, when one is talking about the chemistry of the brain, where even a slight alteration in brain chemistry in a patient with epilepsy can result in destabilisation of the epilepsy and seizures, this is a major concern. Epilepsy is common and we think there is a prevalence of approximately 1%, or one person in 100 in western populations, which means it will affect every community in Ireland. A patient with epilepsy who lives down the road and who gets a generic substitution will have a higher risk of having a seizure which, by its very nature is unpredictable and could occur at any time including when such people are behind the wheel or when there are kids crossing the road. Consequently, there is both major concern for the patients themselves and a certain public safety concern.
As for answering some of the medical questions, I refer to the risk of death from epilepsy. While we do not have exact figures on sudden death related to generic substitution, we do know that sudden death in epilepsy is much more common than in the general population. It is at least twice the risk of that which obtains in the general population and for patients who have more delicately controlled or difficult to control epilepsy, the risk is up to 20 or 30 times for sudden death when compared with a general population risk. Consequently, we would expect to see some increased risk of death on foot of destabilisation. In addition, studies have shown specifically after generic substitution that there have been increases in injuries and seizure-related complications, which have then required a switch back to the brand. There are studies showing high rates of switching back from generic to brand for anti-epileptic drugs as opposed to many other studied classes of medications.
As for the 20% to 30% change to which reference was made, these are pharmacological parameters and there can be relatively wide variations in such pharmacological parameters between different generics. For a single drug, one could have up to 20 to 30 different generic formulations and again, a patient could get any particular one of those generic formulations when they go to the pharmacy on that particular month. It is of major concern that there can be such a wide variation. This number, when it boils down to actual absolute changes in the concentrations of medications in the body, would be in the order of 3% to 5%. However, from our perspective these still are huge numbers in respect of those chemistry changes in the brain that can result in destabilisation of the epilepsy.
Mr. Peter Murphy:
As Mr. Glynn stated, we have started the process of educating health professionals, including pharmacists, and getting the message across that AEDs are to be treated differently than, as Dr. Widdess-Walsh has noted, the likes of blood pressure medications, cholesterol drugs and so on. It is a long process and I do not believe this message can be promulgated in a matter of weeks or months. There is much education to be done both for health professionals, including pharmacists and general practitioners, and for people with epilepsy. This is a highly complicated area and it is important to be aware that many people with epilepsy do not necessarily understand the significance of switching. People are not necessarily going to be vigilant in the long term. The question is whether they will be assertive enough, when visiting their GP, to insist the words "Do not substitute" are written on the prescription as the Bill currently provides. The Minister will argue the words "Do not substitute", as provided for in section 13 of the current Bill, is a measure that should satisfy our concerns. The argument is that a GP or a prescriber can write "Do not substitute" and the problem is solved. This is not the case and as we have seen, pharmacists already are beginning the process of switching despite the absence of legislation and of interchangeable lists. If the Bill goes through as it currently stands, our role will not be limited to educating pharmacists. We also will be obliged to conduct what I would call an unnecessary educational process to get across the message to the tens of thousands of people with epilepsy in Ireland that they will need to insist to their doctors that the words "Do not substitute" are written on their prescriptions. In my opinion, this certainly is placing too much of an onus on the patients to look after their own health care in a complicated issues such as this one. Moreover, in recent weeks alone, we have received approximately ten separate reports directly from people with epilepsy of switching actually having taken place. A number of those concerned have allowed us to use the details to highlight this condition.
Mr. Peter Murphy:
We have not spoken to the Irish Medicines Board directly on that issue. These are reports that are happening in recent weeks in particular. As the passage of the Bill draws nearer, some confusion exists and certain pharmacists, we do not know how many, appear to think the Bill already is in place and they now either are allowed or perhaps are obliged to substitute.
Mr. Peter Murphy:
We have sought the engagement of the Irish Medicines Board in recent months and over the past year in particular. However, it has been hesitant to engage until the Bill is passed. Our limited engagement really has not reassured us that it will be taking our considerations into account if and when it falls to the Irish Medicines Board to make decisions on the interchangeability of AEDs. Consequently, we currently have no idea as to how the Irish Medicines Board will treat AEDs. It may designate all, none or some of them as being interchangeable. I should state we have no reason to doubt that the Irish Medicines Board will do anything other than the best job, following the best international practice, if the time comes and if it is obliged to make decisions on AEDs.
Mr. Peter Murphy:
Again, we have had a limited discussions with the Department. Before Christmas, we attended a briefing session held by the Department, the HSE and the Irish Medicines Board on the Bill. During that session, I raised the issue of AEDs. We also of course have met the Minister of State, Deputy White, on the issue in January and outlined our concerns to him. At the time, the Minister of State was quite adamant that the Bill is, as he described, merely a framework to establish substitution.
We believe it should be a lot more than that. There is no reason why it has to be just a framework. As we have heard, there is strong evidence which I do not think is generally in dispute. We do not see the value in delegating such an important power to the Irish Medicines Board when such strong evidence exists. In basic terms, why should the safety, well-being and health of people with epilepsy have to depend on the discretion of the Irish Medicines Board? That is where we think this committee comes into play. There is an opportunity here to do the right thing, to enshrine people's rights within the legislation through a relatively simple amendment. It is one exception and there are no flood-gates.
We can take the Irish Medicines Board out of the equation, as well as all the confusion, by having an amendment to the legislation. It may not be administratively neat or exactly what the Minister wants but there is a lot at stake here. Surely the Bill's objective is not simply to be administratively neat. Surely the objective should be to do the best for public health.
When we met the Minister in January, his parting comment was that the Bill was intended to serve the public health of the country. Of course it does in reducing the cost of medicines and enabling substitution where there are no difficulties - that is serving the public interest. However, the interests of 37,000 plus people in Ireland will not be served if the Bill goes through exactly as it is. That cannot be forgotten.
There is not a problem with that, Chairman. Having listened to what Mr. Murphy has said, however, we know that the Minister of State, Deputy Alex White, has corresponded on this matter following the January meeting. The Irish Medicines Board expects to have the full responsibility and is unlikely to offer a view that will in any way dislodge that expected responsibility. There is no problem in asking but I do not know if we will get any-----
Mr. Mike Glynn:
Thank you for allowing that, Chairman. We very much appreciate that the amendment was made also. Our understanding on Beaumont is that the exemptions have been lifted and they are recruiting. It is unlikely, however, that the unit will be open before May or June, optimistically.
Cork University Hospital is much more worrying. The HSE says it will be open in the third quarter of this year. From experience, the third quarter does not mean 1 July. If it means 30 September we will be lucky. As there has not been anything in Cork there is a huge built-up need for the services. CUH covers not just Cork and Kerry but also right across Munster generally. We would hope that it can be speeded up. It is really essential that, having spent the money on these units, we will now get them in operation.
Are we happy with that? If so, we will suspend the meeting. I thank the witnesses for coming in. We will articulate their presentation and concerns to the Minister here on Tuesday at the meeting of the select committee. That meeting will be at 3.30 p.m. next Tuesday, 19 March 2013.