Kathleen Lynch (Cork North Central, Labour) | Oireachtas source

I thank the Senator for raising this important issue. Anything to do with alcohol consumption in an Irish context is very important.

The decisions on which medicines are reimbursed by the taxpayer are not political or ministerial; rather, they are made on objective, scientific and economic grounds by the Health Service Executive, on the advice of the National Centre for Pharmacoeconomics, NCPE. The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013 which requires consideration of a range of statutory criteria prior to reimbursing any medicine, including clinical need, cost-effectiveness and the resources available to the HSE.

The HSE received an application for the inclusion of nalmefene in the GMS and community drug schemes. Nalmefene, or Selincro, to give it its brand name, is indicated for the reduction of alcohol consumption in adults with an alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms, and who do not need immediate detoxification. The application is being considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines. In accordance with these procedures, the NCPE conducted a pharmacoeconomic evaluation of nalmefene and its report was published in April. It estimated that the investment required by the taxpayer to provide access to nalmefene would be between €6.7 million and €12 million in the next five years, as the Senator indicated. The advice of the NCPE to the HSE also made it clear that the introduction of nalmefene required the availability of appropriate psycho-social supports. The availability of these supports is being considered by the mental health, health and well-being and primary care divisions of the HSE.

The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. It is appropriate for the HSE, prior to committing scarce resources, to assess whether the required supports are in place and, if not, the resources required to put such supports in place to ensure appropriate use of this medicine. While medications such as nalmefene can be used at the individual level to impact on alcohol consumption, at a wider societal level more must be done to reduce alcohol consumption and tackle alcohol misuse. To address this issue, the Government approved an extensive package of measures to deal with alcohol misuse, including the drafting of a Public Health (Alcohol) Bill. It is hoped to publish a general scheme of the Bill shortly.

I will endeavour to find out for the Senator the status of the application in the process and when we are likely to have a decision on it.