Pauline Tully (Cavan-Monaghan, Sinn Fein)
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479. To ask the Minister for Health the reason for the shortage of the medicine tyvense; and the actions he is taking to ensure an adequate supply of tyvense. [52966/23]

Pauline Tully (Cavan-Monaghan, Sinn Fein)
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485. To ask the Minister for Health the reason for the shortage of the medicine tyvense; and the steps he is taking to ensure an adequate supply of tyvense. [53016/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 479, 482 and 485 together.

Takeda Pharmaceuticals International AG Ireland Branch has advised of shortages of some strengths of Tyvense (20mg, 40mg and 70mg) due to an unexpected increase in demand and manufacturing challenges. These shortages are affecting multiple EU countries, not just Ireland. The company has advised that resupply of all strengths is expected on 4th December 2023. The company has provided a letter to healthcare professionals detailing this information. To date, there have not been any notifications of shortages of the 30mg, 50mg or 60mg Tyvense capsules.

There are alternative medicines also available that are authorised for the treatment of ADHD. If patients or their carers cannot source their usual medicine at present, they are encouraged to discuss alternative options with their healthcare provider pending the resumption of normal supply.

I understand that the current shortage of this medication is causing a lot of distress and worry for patients and their families. My Department is progressing several workstreams for management of shortages, including primary legislative amendments to make regulations for management of shortages via the Health (Miscellaneous Provisions) Bill 2023.

Ireland has a medicines shortage framework in place which is operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The Medicines Shortages Framework’s aim is to help avert potential shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise. The multi-stakeholder framework includes representation from the pharmaceutical industry, healthcare professionals, the HSE, the Department of Health and patients. The Department and HPRA maintains regular contact regarding medicines shortages.

Ireland is heavily involved in work by the European commission and the European Medicines Agency to address European wide issues relating to medicines shortages. This includes work to ensure adequate supplies of medicines, for the coming Winter period. On the 24th October, the EU Commission published a communication, entitled Addressing medicine shortages in the EU. It reinforced the Commission’s plan to introduce a suite of short-, mid- and long-term actions to be undertaken to strengthen security of medicines supply in Europe.

Unfortunately, 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. Medicine shortages are, unfortunately, a feature of modern health systems worldwide and a global health problem. Shortages of medicines are not unique to Ireland and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries.

The HPRA publishes a list of medicines currently in short supply on its website (Shortages List (hpra.ie) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The webpage is updated daily as the HPRA receives new information.

The Department and the HPRA maintains regular contact regarding medicines shortages.