14-03-2013 | Presentation to Joint Oireachtas committee on generic switching of AEDs

14 March 2013
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Presentation to Joint Oireachtas Committee on Health


on the Health (Pricing & Supply of Medical Goods) Bill

March 14th 2013

We want to thank the Chairman and this Committee for the opportunity to address you this morning about the Health (Pricing & Supply of Medical Goods) Bill and about 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 and indeed all of their families and friends. 

We are not an organisation which 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 before you today. 

Epilepsy is the most common serious neurological condition. It is characterised by unprovoked seizures which can occur at any time. About 1 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 but with around 20 AEDs on the market in addition to surgery options for suitable candidates, up to 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 & social functioning. Loss of one's driver's license, employment and education problems, loss of independence, isolation and the lingering social stigma attached to the condition are all potential challenges that may cause as many problems as the seizures themselves. There are about 130 epilepsy-related deaths in Ireland each year, about half of which are due to a phenomenon known as SUDEP or Sudden Unexpected Death in Epilepsy.

Epilepsy Ireland is the national organisation for people with epilepsy, established in 1966 in order 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 10 offices located around the country. In addition to providing a wide range of support services to people with epilepsy and their families, we are also committed to raising epilepsy awareness, training and educating health professionals and supporting Irish epilepsy research.

Of course, 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 healthcare 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 that opening both units is now a priority and we expect to see them fully operational within the coming months.

But, for the 37,000 people with epilepsy in this country, an even bigger concern is that of generic substitution of anti-epileptic medication.

Generic Substitution and AEDs

Next week this Committee will begin its consideration of the Health (Pricing & Supply of Medical Goods) Bill.

The reason we are here today is to appeal to you, as responsible legislators, to change the Bill that comes before you so that it specifically excludes Anti-Epileptic Drugs from its terms relating to generic substitution and interchangeability. 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 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 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. The epilepsy specialist or neurologist will increase the dosage slowly over time until an ideal level is attained, something which will vary with each patient. AEDs therefore are carefully concentrated for each individual to ensure good seizure control. Introducing a generic that can vary significantly in from the original branded medicine and, especially, 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, 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 medicine on one occasion and one with effectively 20% less active ingredient on the next. 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 (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 UK and France discourage AED switching. Countries that do not allow substitution of AEDs include the UK, Austria, Belgium, Czech Republic and Greece. Countries that have excluded many AEDs from substitution include Denmark, Finland, Germany, Portugal, Spain, Sweden and Switzerland.

Furthermore, The Moran Report, published by the Department of Health and the HSE 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 you 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:

1. There is no risk of the floodgates being opened if AEDs are exempted. No other patient group or organisation is seeking an exclusion for any other range of drugs. The only group of people likely to be disadvantaged as a result of generic switching are people with epilepsy.

2. 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 condition that there will be an adequate supply of that generic available in the longer term.

3. The cost implications of excluding AEDs from substitution through the legislation are negligible. While official figures indicate that 75m euro is spent annually on AEDs, almost 40m euro of this is accounted for by one drug, licenced as an AED but prescribed almost exclusively to treat neuropathic pain. 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.

4. Finally, 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.


The Department of Health's view

Next week the Minister will tell you 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 within the Bill for AEDs and that there are safeguards within 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 indeed 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 guarantee the safety of people with epilepsy. Allowing for the possibility of substituting AEDs will create a dangerous environment for people with epilepsy. 

Epilepsy Ireland is already aware of a number of cases where an individual's epilepsy has worsened having been switched from their regular brand to a generic. This switching is taking place in the absence both of legislation and of interchangeable lists. Many Pharmacists appear to lack awareness that AED substitution differs from other drugs. This problem will certainly worsen if the Bill is passed as currently drafted.


As an Association devoted to the interests of 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 wellbeing, safety and ultimately the lives of people with epilepsy.

It is not a claim we make lightly, we do not doubt the bona fides of the Minister and the Department. However we urge this Committee, as legislators, to put aside party loyalties and to use its 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.

Thank you for your time this morning. We would be happy to answer any questions members may have on any of the issues raised.

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