Mary Butler (Waterford, Fianna Fail) | Oireachtas source

I move amendment No. 4:

In page 11, after line 27, to insert the following: “Reporting of information to support the security of supply of medicines

32I. (1) The Health Products Regulatory Authority may require a relevant person to provide to the Authority, in such form and manner and within such period as may be prescribed by regulations made by the Minister, such information in relation to medicinal products within the possession or control of the relevant person as the Authority considers necessary for the purpose of the management of the availability of medicinal products in the State, including—

(a) the monitoring of the current and future supply of medicinal products, and

(b) the identification and management of medicinal product shortages.

(2) A relevant person shall comply with a requirement set out in regulations made under subsection (1).

(3) In this section, ‘relevant person’ means the following persons involved in the manufacture or supply of a medicinal product:

(a) the holder of a manufacturer’s authorisation granted under Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007);

(b) the holder of a marketing authorisation granted in accordance with the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(c) the holder of a community marketing authorisation within the meaning of the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(d) the holder of a wholesaler’s authorisation granted under Regulation 9 of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007);

(e) a retail pharmacy business within the meaning of the Pharmacy Act 2007;

(f) a hospital;

(g) such other persons or legal entities, being persons or entities authorised or entitled to supply medicinal products, as may be prescribed in regulations made by the Minister.”.”.

As committee members will be aware, issues surrounding the security of medicines supply have been increasingly well characterised, both nationally and internationally, in recent years. The causes of such supply issues are multifaceted, ranging from pandemics to geopolitical events and potential shortages of raw materials. Medicine availability is complex and involves the interface of the medicine regulatory system, clinical policies, national policies, pricing, and reimbursement policies. While the temporary unavailability of a medicine, that is, a shortage, is one potential consequence, supply chain security and sustainability are broader issues.

Because of the interlocking challenges facing the world, medicine shortage management requires constant development to achieve the best outcomes for patients. For this important and complicated work, Ireland needs to implement policies focusing on what feasible solutions can be achieved.

Now is the time to implement an update to Ireland's medicine shortages framework to utilise how it can be more effective prior to and when a shortage occurs and to accelerate learning and improvement cycles. Improved information and early notification will be vital in the management of our medicines shortages.

The amendment would mandate "relevant persons" to provide information on medicinal products in their possession or control to the Health Products Regulatory Authority, as requested by it as the medicines regulator. It is envisaged that this information, while simple in theory, will yield multiple benefits for our national management of medicines availability. This reporting obligation will allow for additional visibility of the presence of medicines in Ireland, increase our ability to mitigate the impact of shortages and increase our capacity to prevent them occurring at all, while allowing us to feed into European shortages mitigation measures such as the European shortages monitoring platform, which is to be functional in February 2025.

These measures will support the national system for the management and security of medicines supplies and will facilitate a more proactive system for the management of medicines shortages. I will ask Mr. O'Connor to answer the second part of the question.