David Cullinane (Waterford, Sinn Fein)
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246. To ask the Minister for Health when he expects the ongoing medicine shortages problem to end; and if he will make a statement on the matter. [4991/23]

David Cullinane (Waterford, Sinn Fein)
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247. To ask the Minister for Health if he expects the medicine shortages problem and record levels of out-of-stock medicines to end after the winter flu season; and if he will make a statement on the matter. [4992/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 246 and 247 together.

Medicine shortages have become increasingly prevalent worldwide over the past decade. The causes of such shortages are multi-factorial, including shortages of raw materials, manufacturing difficulties, increased demand, product recalls due to potential quality defects, and industry consolidations. As such, medicine shortages can originate at any point in the supply chain, at any stage.

Medicine shortages and their prevention are not unique to Ireland. Similar increases in demand and medicines shortages have been observed in the UK, throughout the EU and across the world at present. In the case of medicines used most often in Ireland however, there are typically multiple alternatives available from various sources that remain available to ensure continuity of treatment. Of the products currently in short supply, alternative treatments are available for every product.

The Health Products Regulatory Authority (HPRA) publishes a list of medicines currently in short supply on its website with the reason for the shortage and expected dates for the return of supply. This information 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.

The list of shortages (which is continuously updated) is publicly available and can be found here: www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages

The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The HPRA continues to work with all marketing authorisation holders to increase supply to the market. They also continue to offer regulatory flexibility where possible to suppliers. Through this close engagement the HPRA has secured additional stock of many products currently in short supply for the Irish market.

David Cullinane (Waterford, Sinn Fein)
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248. To ask the Minister for Health if, given research showing medicine manufacturers in Ireland are getting paid up to four times as much for their products in the UK and seven other EU member states, he accepts that price is one of the factors contributing to the ongoing high level of medicine shortages. [4993/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Two new Framework Agreements on Pricing and Supply of Medicines 2021-2025 were signed in December 2021. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus facilitating sustainable and affordable access to medicines for patients in Ireland over the next 4 years.

Negotiations towards these new Agreements with industry began in May 2021, against a backdrop of a growing annual drugs budget, up from €1.95bn in 2016 to almost €2.25bn by 2020. 

The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in facilitating access to innovative new medicines for patients. The IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland. 

There are a number of clauses set out in both agreements in detail, which provide clear pricing rules for applicant companies, that have been agreed between the State and main Pharmaceutical Industry representative groups in Ireland as appropriate and intended to provide a predictable environment for Marketing Authorisation Holders (MAHs) to supply their products (and prevent shortages). These are grossly summarised as:

1. The pricing application form for new medicines is based on a basket of 14 countries (13 EU Member States and the UK). Pricing is permitted to be no more than the average price based on the pricing in these 14 countries.
2. The pricing of non-patented medicines (i.e., generic, biosimilar or hybrid medicine marketed in Ireland) is based on the originator medicine at a specific time point.

In the interests of continuity of supply, where it becomes uneconomic for a Supplier to supply a particular medicine under the terms of the Agreements, direct representations may be made by the Supplier to the HSE for variation of any term of the Agreement, in relation to that medicine, including its price terms. Where representations are made by the Supplier to the HSE, the HSE shall have the final decision on whether to vary the terms of the Agreement in any case, but will consult with the Supplier before reaching its decision. The HSE expects a robust submission of evidence to support any claim, from any Supplier, in the event that they wish to set out to the Executive an inability to meet pricing terms set out in said Agreements.

As of January 2023, there are 9 applications from 6 separate manufacturers/suppliers currently under review by the HSE, for a pricing increase request related to a claim of increased cost of goods making continuity of supply to the Irish market and Irish patients unsustainable.

In the case of such pricing increase requests the time taken to adjudicate on these is highly variable (on a case-by-case basis) and dependent on a number of factors, that the HSE is required to consider including the number of alternative suppliers for that medicine, the potential alternative therapeutic options, the clinical need for the product, the potential budget impact, and European pricing.

The HSE also takes an active role at the time of notification, in engaging with manufacturers/suppliers intending to discontinue priority medicines due to the lack of commercial viability of those products. In many of the cases where this arises as a scenario, the commercial decision relates to global discontinuations and is outside of the control of the HSE i.e., cannot be addressed through pricing increases at a national level.

The Agreements are the product of extensive collaboration between the State, HSE, and Industry. They remain current and appropriate for their purpose since their signing in December 2021.

David Cullinane (Waterford, Sinn Fein)
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249. To ask the Minister for Health if, in light of comments from the executive director of the European Medicines Agency stating that the very low price of generic medicines threatens the sustainability of supply of medicines, he will now move to initiate a full review of the 2019 medicines pricing agreements. [4994/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Medicine supply issues and their prevention are not unique to Ireland. Similar increases in demand and medicines supply issues have been observed in the UK, throughout the EU and across the world at present. In the case of medicines used most often in Ireland, there are typically multiple alternatives available from various sources that remain available to ensure continuity of treatment. Of the products currently in short supply, alternative treatments are available for every single product.

Management of medicine supply issues necessitates a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. To that end, at the request of the Department of Health, the Health Products Regulatory Authority (HPRA) has assumed a coordinating function in Ireland’s response to managing medicine shortages when they occur.

The HPRA publishes a list of medicines currently in short supply on its website 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 information relating to shortages on the HPRA website 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. Of those medicines listed as in short supply at the end of January, the most common reasons provided to the HPRA were manufacturing delays and unexpected increases in demand.

Two new Framework Agreements on Pricing and Supply of Medicines 2021-2025 were signed in December 2021. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus facilitating sustainable and affordable access to medicines for patients in Ireland over the next 4 years.

Negotiations towards these new Agreements with industry began in May 2021, against a backdrop of a growing annual drugs budget, up from €1.95bn in 2016 to almost €2.25bn by 2020.

The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in facilitating access to innovative new medicines for patients. The IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland.

There are a number of clauses set out in both agreements in detail, which provide clear pricing rules for applicant companies, that have been agreed between the State and main Pharmaceutical Industry representative groups in Ireland as appropriate and intended to provide a predictable environment for Marketing Authorisation Holders (MAHs) to supply their products (and prevent shortages). These are grossly summarised as:

1. The pricing application form for new medicines is based on a basket of 14 countries (13 EU Member States and the UK). Pricing is permitted to be no more than the average price based on the pricing in these 14 countries.
2. The pricing of non-patented medicines (i.e., generic, biosimilar or hybrid medicine marketed in Ireland) is based on the originator medicine at a specific time point.

In the interests of continuity of supply, where it becomes uneconomic for a Supplier to supply a particular medicine under the terms of the Agreements, direct representations may be made by the Supplier to the HSE for variation of any term of the Agreement, in relation to that medicine, including its price terms. Where representations are made by the Supplier to the HSE, the HSE shall have the final decision on whether to vary the terms of the Agreement in any case, but will consult with the Supplier before reaching its decision. The HSE expects a robust submission of evidence to support any claim, from any Supplier, in the event that they wish to set out to the Executive an inability to meet pricing terms set out in said Agreements.

As of January 2023, there are 9 applications from 6 separate manufacturers/suppliers currently under review by the HSE, for a pricing increase request related to a claim of increased cost of goods, making continuity of supply to the Irish market and Irish patients unsustainable.

In the case of such pricing increase requests the time taken to adjudicate on these is highly variable (on a case-by-case basis) and dependent on a number of factors, that the HSE is required to consider including the number of alternative suppliers for that medicine, the potential alternative therapeutic options, the clinical need for the product, the potential budget impact, and European pricing.

The HSE also takes an active role at the time of notification, in engaging with manufacturers/suppliers intending to discontinue priority medicines due to the lack of commercial viability of those products. In many of the cases where this arises as a scenario, the commercial decision relates to global discontinuations and is outside of the control of the HSE i.e., cannot be addressed through pricing increases at a national level.

The Agreements are the product of extensive collaboration between the State, HSE, and Industry. They remain current and appropriate for their purpose since their signing in December 2021.

David Cullinane (Waterford, Sinn Fein)
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250. To ask the Minister for Health if, further to a public statement by his Departmental spokesperson indicating that the HSE completed a comprehensive review of the published HPRA shortages list on 16 January 2023, he will publish this review in full. [4995/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Of the shortages listed on the Health Products Regulatory Authority (HPRA) website on that date, there was no evidence that framework agreements / pricing matters were notified as cause of the shortage. 

Of the 208 notified shortages, the cause were noted as follows:

Additionally, across the notified shortages on HPRA website on that date, in 80 cases the relevant company has confirmed “multiple countries affected”.

David Cullinane (Waterford, Sinn Fein)
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251. To ask the Minister for Health the annual spend under the health vote on ingredient cost elements, excluding fees, of exempt medicinal products in each of the years 2020 to 2022. [4996/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.