Jim Daly (Cork South West, Fine Gael) | Oireachtas source

I wish to thank Deputies Dino Kenny and Deering for raising this issue. Medicines play a vital role in improving the overall health of Irish patients. Securing access to new and innovative medicines in a timely manner is a key objective of the Irish health service. However, the challenge is delivering this objective in an affordable and sustainable way. Under the community pharmacy schemes alone, over 70 million prescription items will be

dispensed in 2017 at an estimated cost of approximately €1.7 billion - taking account of fees and ingredient cost. In addition, the HSE will spend in excess of €500 million in 2017 on medicines through a range of other schemes in hospitals and in other care settings, for example, in nursing homes.

Expenditure on medicines represents one of the largest areas of expenditure across the health service and will continue to grow in the years ahead as our health service continues to meet the needs of our citizens. This is most welcome and can have a transformative impact on the health of patients. However, as the Minister has stated previously, the cost that some companies are seeking to charge for their medicines may result in a situation where certain treatments may never become available to patients. This is the case not only in Ireland but across Europe. That is why it is essential that Ireland has a scientific, robust and evidence-based assessment process in place. This ensures that decisions relating to the reimbursement of medicine are made on an objective and scientific basis recognising the health needs of the population and other factors.

The Health (Pricing and Supply of Medical Goods) Act 2013 provides the legal framework in Ireland for such a process. This Act gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines taking account of expert opinion as appropriate. The HSE follows the process set out in the Act for the assessment of all drugs. In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been sought by the HSE, including, for example, advice from the NCPE.

Sapropterin, or Kuvan, was previously considered under the national pricing and reimbursement processes in 2009. At that time, insufficient evidence was available to support the pricing and reimbursement application submitted by Merck Serono for Kuvan. In December 2015, Merck Serono advised the HSE that the market authorisation for Kuvan was transferring to Biomarin in 2016. The HSE met with the new market authorisation holder Biomarin in May 2016 and was advised that it would be submitting a health technology assessment dossier relating to Kuvan. The NCPE assessment of the Biomarin dossier was completed on 15 September 2017. The NCPE did not recommend Kuvan for reimbursement as it was not deemed to be cost-effective. The HSE assessment process is ongoing and the HSE will take into account the expert advice of the NCPE when making its decision in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

See this speech in context