Health (Miscellaneous Provisions) Act 2024
|
Insertion of sections 32G to 32I into Act of 1995 | ||
|
10. The Act of 1995 is amended by the insertion of the following sections after section 32F: | ||
“Substitution by pharmacists in case of medicinal product shortage | ||
32G. (1) Where the Minister, having consulted with the Health Service Executive and the Health Products Regulatory Authority, is of the opinion that— | ||
(a) there is a medicinal product shortage, | ||
(b) arising from that shortage, there is likely to be a negative impact on the health service or the health needs of patients that cannot be addressed via other mechanisms, and | ||
(c) a protocol under this section would assist in addressing the impacts referred to in paragraph (b), | ||
he or she may prepare and issue a protocol to registered pharmacists authorising registered pharmacists to supply such alternative medicinal product or products as are specified in the protocol for the medicinal product that is in short supply under such conditions as are specified in the protocol and without the need for a further prescription. | ||
(2) In the preparation and issuing of a protocol under this section, the Minister shall act in accordance with regulations made under section 32H and shall consult with the bodies referred to in subsection (1) in relation to the content of the protocol. | ||
(3) A protocol prepared and issued under this section shall specify— | ||
(a) the medicinal product that is in short supply, | ||
(b) the substitutable product, | ||
(c) the circumstances in which the registered pharmacist may supply the substitutable product, | ||
(d) the time period for which the protocol is in place, and | ||
(e) such other conditions or information in respect of the supply by a registered pharmacist of the substitutable medicinal product as the Minister considers appropriate. | ||
(4) The Minister may, where appropriate and following consultation with the Health Products Regulatory Authority and the Health Service Executive, amend the time period during which the protocol is in place or any conditions specified in the protocol. | ||
(5) The Minister shall publish or cause to be published each protocol issued (or amended) under this section in such form and manner, including on a website maintained by or on behalf of the Minister, as the Minister considers appropriate. | ||
Regulations governing protocol | ||
32H. (1) The Minister shall make regulations providing for the issuing and operation of a protocol. | ||
(2) Without prejudice to the generality of subsection (1), such regulations shall include— | ||
(a) the procedures for the preparation and review of a protocol including in relation to— | ||
(i) the assessment of the impact of the medicinal product shortage on the provision of a health service and the health needs of patients, | ||
(ii) the assessment of existing mechanisms to address the negative impacts of a medicinal product shortage, including the availability of appropriate alternatives, | ||
(iii) the identification of a substitutable medicinal product and any conditions that should apply in accordance with its supply, and | ||
(iv) the persons who shall be consulted in relation to the preparation and review, | ||
(b) the procedure for the notification of a protocol (including any amendment made to the protocol) to registered pharmacists, | ||
(c) the procedure for the operation of a protocol, and | ||
(d) the requirements in relation to the notification of the supply of a substitutable medicinal product under a protocol to the person who prescribed the medicinal product that is in short supply. | ||
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.”. |