Anne Rabbitte (Galway East, Fianna Fail) | Oireachtas source

I thank the Deputy for raising this issue. He is right when he says the 2020 programme for Government includes a commitment to establish a national medicines agency which will seek to reduce the cost of medicines for the State and for patients. As the Deputy is aware, the existing pricing and reimbursement process for medicines involves the work of a number of individual bodies and agencies. The collective contributions of these agencies are crucial to the HSE executive management team's decision-making with respect to medicine reimbursement.

First, the Health Products Regulatory Authority, HPRA, is responsible for the regulation of health products, including medicines, in Ireland and maintains a register of authorised products. Under the Health (Pricing and Supply of Medical Goods) Act, reference pricing involves the setting of a reimbursement price for a group of interchangeable medicines. This has enabled greater cost-effective dispensing and continues to contribute to cost avoidance. The Health Products Regulatory Authority's role under the 2013 Act includes the maintenance of a list of interchangeable medicines. This supports pharmacists to substitute medicines prescribed, provided they have been designated as interchangeable by the Health Products Regulatory Authority.

The National Centre for Pharmacoeconomics advises the HSE on the cost-effectiveness of new medicines. The National Centre for Pharmacoeconomics carries out health technology assessments in order to make recommendations on reimbursement to assist HSE decisions.

The HSE's corporate pharmaceutical unit is an important interface between the HSE and the pharmaceutical industry on application for reimbursement and the pricing of such medicines.

Its successful commercial engagements with the pharmaceutical industry achieve significant savings for the State each year, thereby providing access to as many medicines as possible for as many patients as possible. In December 2021, the State agreed two new multi-annual agreements with the pharmaceutical industry. It is estimated these agreements will result in the State paying between €600 million and €700 million less for medicines than it otherwise would have done. Since the finalisation of the agreements, the corporate pharmaceutical unit has been engaging extensively with the industry to implement the agreed measures. This has included the downward realignment of more than 800 prices.

The HSE drugs group is the national committee that makes recommendations to the HSE's executive management team on the pricing and reimbursement of medicines. Such recommendations are based on the outputs of the entire assessment process. As part of that assessment process, the national cancer control programme technology review committee, which was established in 2011, reviews funding proposals for new cancer drugs. It then makes recommendations on the reimbursement of new drugs to the HSE drugs group based on clinical need and cost-effectiveness. In 2018, the rare diseases technology review committee was established by the HSE leadership, with similar responsibility for reviewing proposals for funding of new drugs for rare diseases. That committee also contributes to the development and implementation of clinical guidelines for relevant drugs.

The establishment of a national medicines agency would require a significant body of work to be undertaken to integrate all these various work streams under a single function. It would also require extensive consultation and primary legislation. That work has yet to commence because the priority and focus of the Department up to now has been on tackling the Covid-19 pandemic. I am acutely aware of the Deputy's involvement in, and knowledge of, rare drugs. Sometimes when I read replies such as this, I feel I know very little about the subject at hand and perhaps less than the Deputy who is asking the question.

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