Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

226. To ask the Minister for Health the options available to the family of a young person who has been prescribed and had been taking Ozempic, until earlier this year when supplies dried up, and with their hepatology team stressing the importance for their getting back on the drug for their health; if, given that the person has now spent many months without Ozempic, the person or his Department can try and source this abroad with their prescription; if such a purchase could be included in a person’s tax rebate claim at the end of year; the measures he or the EU Council of Health Ministers are taking to end this shortage; and if he will make a statement on the matter. [23351/23]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Shortages of the diabetes medicine Ozempic® are linked to the increased demand which has been attributed to the off-label use of the product to treat obesity. 

Novo Nordisk, the marketing authorisation holder for Ozempic, has notified the Health Products Regulatory Authority (HPRA) of intermittent supply issues with Ozempic® products due to increased global demand. The company anticipates that intermittent supply will continue throughout 2023. Similar supply constraints are being experienced in other EU countries.  

Novo Nordisk has implemented monthly allocations to help ensure continuity of supply and equitable distribution of Ozempic® stock to Irish patients. The company has issued letters to relevant stakeholders, including healthcare professionals, to ensure they are aware of this supply issue and its management.  

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, operated by the HPRA on behalf of the Department of Health.

Information relating to medicines shortages, including particular information relating to Ozempic®, can be found on the HPRA's website (Medicines Shortages (hpra.ie) . Information on shortages is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved. 

Regarding pricing and reimbursement ,The Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines under the Community Drug Schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the HPRA. In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). I, as Minister for Health, have no role in these decisions.

Semaglutide, which is marketed as Ozempic®, was approved by the HSE in 2018 for addition to the Reimbursement List for the treatment of Diabetes. Semaglutide has not been approved for reimbursement for any other indication. Controls are currently in place in relation to Semaglutide (Ozempic®) to restrict reimbursement support to the HSE approved indication of Diabetes. The HSE advise that reimbursement for Semaglutide (Ozempic®) is confined to those with eligibility under the General Medical Services Scheme (GMS) or the Long-Term Illness (LTI) scheme. This medicine is not available on the Drugs Payment Scheme.

Regarding sourcing abroad, Directive 2011/24/EU on patients’ rights in cross-border healthcare sets out the conditions under which a patient may travel to another EU country to receive medical care and reimbursement. It covers healthcare costs, as well as the prescription and delivery of medications and medical devices.

This provides that a prescription issued in one EU country is valid in all other EU countries - practitioners however are only entitled to prescribe medicinal products for which they are legally entitled to do in the EEA state in which the prescription is issued. Additionally, a medicine prescribed in one country might not be available or it may have another name in a different Member State and the prescription will be dispensed in accordance with the rules applicable in the state in which the prescription is presented.

Rules on cross-border prescriptions only state which information should be included on the prescription; there is no specific form or format for the prescription. In most cases, the prescription a patient uses in the home Member State should contain sufficient information to facilitate its use in another EU Member State. Further information may be accessed at europa.eu/youreurope/citizens/health/prescription-medicine-abroad/prescriptions/faq/index_en.htm .

It should be noted that the supply of prescription medicines under the cross border healthcare Directive only covers prescription presented in person (either by the person named on the prescription or their nominated representative) to a registered pharmacy business.