Thomas Gould (Cork North-Central, Sinn Fein)
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2071. To ask the Minister for Health whether there is any regulation of the price of medicines to ensure cheapest possible access. [44588/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health (Pricing and Supply of Medical Goods) Act 2013 is the primary legislation that governs medicine pricing and reimbursement procedures and policies. Under the 2013 Act, the Health Service Executive (HSE) has the power to set the relevant reimbursement prices for certain medicinal goods. Section 21(2) of the 2013 Act sets out the factors that the HSE must take into account when setting the relevant reimbursement prices proposed by the supplier of a medicine, which are as follows:

(a) the equivalent relevant prices (if practically available) of each item in all other Member States where the item is marketed,

(b) the relevant prices of therapeutically similar listed items,

(c) the potential therapeutic benefits in each case,

(d) the budget impact of each item,

(e) the ability of suppliers to meet demand,

(f) the resources available to the Executive, and,

(g) any agreement on pricing in place with industry

The HSE has also agreed and set out standard processes with industry in relation to the assessment of pricing and reimbursement applications for medicines. In that context, the 2021-2025 multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represented an important step in reducing the cost of medicines and improving access to innovative new medicines for patients. Preparations for negotiating a successor agreement are currently underway.

As part of the pricing and reimbursement process for applications for new chemical entities, a manufacturer submits a price application form (PAF) for any medicine it wishes the HSE to include on its reimbursement list / for hospital pricing approval. Under the IPHA agreement, the price included in the PAF must be no more than the average price based on 14 nominated states. The states include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (UK). This is referred to as external reference pricing (ERP) whereby the price in a ‘basket’ of reference countries is used to derive an acceptable price.

For generic and biosimilars, reimbursement is automatically approved, provided the pricing is in line with the generic and biosimilar (and hybrid) pricing framework/agreement. The pricing of such medicines is linked to the price of the originator or patented medicine.

HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The purpose of challenging the pharmaceutical company pricing is to arrive at a position of value for money. In doing so, resources are used as effectively as possible to reimburse a wide range of medicines.

In terms of the private pharmaceutical market the Minister has no powers around the commercial decision-making of a private entity.