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

I thank Deputy Brassil for raising this issue. Securing access to new and innovative medicines in a timely manner is a key objective of the Minister for Health and the HSE. These new products are often very expensive, however, with a significant potential impact on the health service budget. The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion, as appropriate.

The Act specifies the criteria to be applied in the making of reimbursement decisions. They include the clinical effectiveness and cost-effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE, pursuant to the community drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list. The HSE’s decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds from the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist reimbursement decisions. The NCPE uses a decision framework to assess systematically whether a drug is cost-effective as a health intervention.

I have been informed that ocrelizumab, used for the treatment of adult patients with early primary progressive multiple sclerosis and for the treatment of adult patients with relapsing forms of multiple sclerosis, is currently undergoing a full pharmacoeconomic assessment by the NCPE. The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant moneys involved, it must ensure the best price is achieved, as these commitments are often multimillion euro investments on an ongoing basis. This can lead to a protracted deliberation process.

The Minister is keen to engage with the industry to explore ways in which new medicines might be more easily introduced. However, any innovative approaches which may be tabled must be compatible with the statutory provisions in place and must also recognise the context of finite Exchequer resources. The HSE is the decision-making body on the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. It is the HSE alone which will make the final decision whether ocrelizumab will be reimbursed taking into consideration the statutory criteria as specified under the 2013 Act. This Act does not give the Minister for Health any powers in the reimbursement process. The HSE does not require approval or consent from the Minister or the Government when making a reimbursement decision.

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