Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

I will be taking this matter on behalf of Minister, Deputy Harris.

The issue of orphan medicines, with very small patient populations, and the price barriers for health systems in supplying them to patients, is worldwide. Orphan product manufacturers have exclusive patents and are monopoly suppliers. They can, and frequently do, seek extraordinary prices for these products.

The HSE seeks, where possible, to give patients early access to new treatments. However, it must work within the budget provided by the Oireachtas. The prices manufacturers seek for new and orphan medicines make this extremely challenging.

In the statutory reimbursement process, supported by the 2016 framework agreement with the industry, the HSE makes decisions on objective scientific and economic grounds. Criteria include the population's health needs, the product’s cost and clinical effectiveness, opportunity costs, the budget impact and available resources.

HSE decisions are supported by health technology assessments, HTAs, which systematically assess whether a drug is a cost-effective health intervention. Currently, most new medicines, including orphan products, undergo HTAs. However, not all applications have sufficient information for assessment and this must be sought. In addition, as HTAs frequently cannot demonstrate value for money for items at the price sought, lengthy price negotiations may be needed. These factors contribute significantly to the length of the approval process. Put simply, some manufacturers, as monopoly suppliers, use markets like Ireland to set very high prices which may not reflect the drugs' effectiveness and are unsustainable for our health service.

Under the 2016 agreement for very expensive treatments, especially where the price does not reflect therapeutic value, the HSE may negotiate price and supply conditions. As seen with some high profile drugs, reaching a sustainable pricing structure can be a long process.

Where the HSE decides to reimburse a medicine but considers it cannot do so from existing resources, it may inform the Department of Health. The Minister may, if deemed appropriate, bring a memorandum to Government on the funding implications. However, the price should still reflect value for treatment.

Since July 2016, when the agreement was introduced, the HSE has referred ten treatments, including Orkambi or Kalydeco, which it decided to reimburse in May. There are currently nine products under consideration, with a five-year cost of €120 million, of which eight were referred since May. The Minister, Deputy Harris, expects that the process will be completed shortly for these items.

It is right to exercise diligence when considering such huge commitments. With the sums involved and the competing demands across the health service, every effort should be made to secure the best outcome for the health service and the taxpayer. This includes seeking realistic and sustainable pricing and supply models for new treatments.

I am pleased to inform Senators that, as well as pursuing better pricing within our system, Ireland has this year begun working with other member states, through Beneluxa and the Valletta Declaration, to explore ways to share expertise and resources, so we can all gain access to new treatments in realistic time frames and at fair prices.

I have read the report of yesterday's health committee meeting and will report back to the Minister later today.