Billy Kelleher (Cork North Central, Fianna Fail) | Oireachtas source

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.

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