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.