Róisín Shortall (Dublin North West, Social Democrats)
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1331. To ask the Minister for Health if he will allow community pharmacists to dispense oral contraceptives without the need for a prescription, in line with WHO best practice; if not, the reason for continuing this barrier to accessing oral contraception; and if he will make a statement on the matter. [12986/23]

Hildegarde Naughton (Galway West, Fine Gael)
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The free contraception scheme for women was launched in September 2022, and is currently open to women aged 17-26 who are ordinarily resident in Ireland. The scheme will be expanded further, in September, to include women aged 30 and under. Funding through Budget 2023 was also allocated to expand the scheme to 16 year-olds, but this is subject to consultation across Government, legal advice and legislative amendment.

Over 2,200 GPs and 1,850 pharmacies have signed up to provide products and services under the scheme to date. The role of pharmacists currently involves dispensing prescription contraception prescribed for individuals by a medical practitioner, typically their GP or family planning clinic.

Some forms of contraception, most commonly the progesterone only Pill, but also in certain circumstances, a combined hormonal contraceptive (the “combined” Pill) are available through pharmacies, without the need for a prescription, in other jurisdictions. Providing some services in this manner in Ireland may improve access to contraception for women. Work on developing potential options for an enhanced role for pharmacists in relation to the provision of contraception is ongoing.

In Ireland at present, accessing oral contraceptives is regulated and requires a prescription from a medical practitioner in accordance with the requirements of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended. These regulations apply a comprehensive system of control to medicinal products and identify those products which may only be supplied on medical prescription, and also specify the circumstances excluding medicinal products from prescription-only control. Schedule 8 to the regulations lists those medicinal products which may be supplied and administered by pharmacists pursuant to regulation 4B, where that pharmacist has completed approved training regarding the administration of such products and the management of any adverse reaction. In order to enable pharmacists to supply the specified products alluded to in your question without the need for a prescription, detailed clinical consideration is required in the first instance to ensure that various patient safety issues are fully respected.

Following previous engagement with representative groups, my officials at my direction, are currently engaged in a process, which includes obtaining recommendations from relevant clinical experts within the HSE as to the clinical appropriateness of making some forms of currently prescription controlled contraception, available through pharmacies without the need for a prescription. This process is ongoing.

Thereafter, and with due consideration of the policy position adopted and underpinned by appropriate clinical recommendations and advice, the modality of giving effect to this decision will be considered. Any mechanism introducing this change, or indeed giving effect in a given instance to any other policy decision, must be robust, appropriate in the given context, and legally sound.

Róisín Shortall (Dublin North West, Social Democrats)
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1332. To ask the Minister for Health the reason community pharmacists are not reimbursed for administering the shingles vaccine; and if he will make a statement on the matter. [12987/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE does not supply vaccines or provide reimbursement support for vaccines through community pharmacies under the Statutory Drug Schemes. When the public health imperative to support particular vaccines to defined cohorts becomes national policy, vaccines are directly procured by the HSE and supplied through the national vaccine distribution arrangements to GPs for eligible cohorts.

The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation.

The NIAC continues to revise recommendations to allow for the introduction of new vaccines in Ireland and to keep abreast of changes in the patterns of disease. Therefore, the immunisation schedule will continue to be amended over time. Shingles vaccination is not currently provided as part of the national immunisation programme.

However, it is open to an individual to source a vaccine from a GP or pharmacy, where available, outside of the national immunisation programme on the basis of a private arrangement.

Róisín Shortall (Dublin North West, Social Democrats)
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1333. To ask the Minister for Health the timeline he is working towards to develop a new rare disease strategy; if this strategy will address the significant delays in the drug reimbursement approval process, which can lead to a huge financial cost for people with rare conditions; and if he will make a statement on the matter. [12994/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I recently announced my intention to bring forward a successor plan to the existing National Rare Disease Plan 2014 - 2018. While this work was delayed by the pandemic, the Government has continued to invest significant resources in the area of new medicines in recent years. In 2021 nineteen (19) orphan medicines for rare diseases were added to the reimbursement list. In 2022, the number was sixteen (16), and to date in 2023, already there are twenty-seven (27) new orphan drugs undergoing pricing and reimbursement assessment.

Last month, I published the Mazars Review which examined the governance arrangements around the HSE’s Drug Pricing and Reimbursement Process. I fully support the recommendations contained in the Mazars report that improve the process, provide easier access, and support value for money. An implementation group is being established between my Department and the HSE to consider and progress the various recommendations contained in the Report as well as other options to improve the process. The Group will engage with stakeholders including patient groups and industry, in seeking to bring about further improvements to the reimbursement process.