Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 1:

In page 3, to delete line 5 and substitute the following: “An Act to amend the Health Act 1970, the Irish Medicines Board Act 1995; the Pharmacy Act 2007; the Health (Pricing and Supply of Medical Goods) Act 2013 and the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023; and to”.

The amendment concerns the addition of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 to the Long Title. The Department is now moving towards commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 and as part of this process, the Department became aware of two minor technical issues which it believes need to be amended in the legislation prior to commencement. These two amendments are purely technical and serve to restore wording to the Act that was omitted in the final drafting process. The Long Title is amended in the first instance to reflect its inclusion in the Bill.

Catherine Connolly (Galway West, Independent)
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Pursuant to Standing Order 187(3), it is reported to the Dáil that the Long Title has been amended.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 2:

In page 5, between lines 7 and 8, to insert the following: “Amendment of section 59 of Act of 1970

6. Section 59 of the Act of 1970 is amended in subsection (1A), by the substitution of “a registered medical practitioner, registered dentist or registered pharmacist” for “a registered medical practitioner or registered dentist”.”.

Section 59 of the Act concerns drugs, medicines and appliances. In introducing prescribing activity for pharmacists through these amendments, it is prudent to include a registered pharmacist in the professions from whom a prescription may be accepted under this section. Further development of the mechanisms involved, especially with regard to the dual nature of the role of pharmacists as potentially a prescriber and a dispenser, will be developed within the regulatory framework to be put in place.

There will be considerations as to appropriate governance, including clinical safety, financial probity and interactions with existing supports in place for those availing of medicine reimbursements. However, it would not be appropriate to exclude the possibility that challenges in this area would be overcome in time, and we include it now on Report Stage so there is a sound basis for further development.

Catherine Connolly (Galway West, Independent)
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Amendments Nos. 3 to 5, inclusive, are related and may be discussed together.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 3:

In page 9, to delete lines 11 and 12.

This group of three amendments will provide that the Minister for Health may make regulations for prescribing for common and uncomplicated conditions in retail pharmacy businesses, also called community pharmacies. Amendment No. 3 is purely technical in nature. It removes textual amendments to section 32(2)(l) of the Irish Medicines Board Act 1995 in order to accommodate new provisions. There are no implications for the Bill beyond this.

Amendment No. 4 makes the addition of the new provisions. As Deputies will recall, we undertook on Committee Stage to bring forward proposals to enable pharmacists to prescribe, and we very much appreciated the support to do so. The Minister for Health is anticipating the delivery of recommendations from the pharmacy taskforce which he established, and I am told these will be completed soon. We are aware that an important recommendation from the taskforce is that pharmacist prescribing should be introduced in a stepwise manner. We want pharmacists to play an expanded role in our health services alongside their colleagues in other healthcare professions. We know they can do so and there is a lot of success with this in other countries. It is important to introduce changes in a phased manner and in consultation with stakeholders.

The amendment of the Irish Medicines Board Act will allow the Minister for Health to establish the necessary secondary legislation to introduce the first phase of pharmacy prescribing. This first phase focuses on community pharmacies. The legislation will support prescribing activity by community pharmacists for a set of common conditions. This will be a small set of conditions initially but it could be expanded over time. It will also include prescribing for the oral contraceptive pill.

Following the passage of this Bill, secondary legislation will be drafted. This will be a set of regulations to govern the prescribing activity. Clinical guidance will also be put in place and training for pharmacists will then be developed. Pharmacists will have to participate in training before they can undertake any prescribing activity. The prescribing activity will be part of what can happen in a retail pharmacy business, which we also call a community pharmacy, and the regulations that govern those settings.

What we aim to do is to expand not just the role of the pharmacist but the range of options available to people, for where they can seek care and advice for some simple, common ailments and we want to free up some capacity in other areas of our health services. Pharmacists are already providing advice to people every day on their medication and this, in many ways, is an extension of what they are already doing.

I know the House will be interested to hear what the common conditions will be. There is not a final decision on this yet. The pharmacy taskforce has been considering common condition services offered by pharmacists in other jurisdictions. It is taking a clear and evidence-based approach to its recommendations. The Minister will be taking its recommendations into consideration and consulting the key stakeholders before making a decision.

Róisín Shortall (Dublin North West, Social Democrats)
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From what I understand of these amendments, I welcome what the Minister of State is saying there and the provision for the making of regulations.

Given the shortages of healthcare staff, we need to maximise the capacity of all existing staff and services. Community pharmacies have particular benefits for the roll-out of different health initiatives, not least because they are in every single community and are very accessible. To a large extent, people feel freer about going into a community pharmacy. Generally speaking, there is a strong relationship between what I would call customers of pharmacies, who are also patients, and the pharmacies. That relationship has strengthened in recent years. It makes a lot of sense, given the shortage of GPs, but from the point of view of the efficiency of the health service, it just does not make any sense not to maximise the use and capacity of community pharmacies.

The Minister of State did not refer to the term "chronic illness". Am I right in assuming that is one area she is speaking about? We know that about 70% of healthcare activity relates to chronic illness. We also know that the bulk of chronic illness is lifestyle related. It makes sense to provide all the capacity available to deal with this and to advise people of changes they could make to their lifestyle and medication, and have that kind of monitoring and screening. That would include things like weight management, blood pressure measuring and cholesterol. All of those areas could be easily done well by community pharmacists. I hope that we are moving towards that. I would just like to hear from the Minister of State that she is actually talking about chronic illness management.

In my experience, we have been talking about better chronic illness management for at least 20 years. In the last ten years, the six or seven chronic illnesses have taken up significant time for doctors and hospitals. They could be addressed at a much earlier stage, which is obviously what we should be doing. We should be identifying conditions which may get much more serious, with people ending up in hospital. If there was early intervention and much more focus on prevention, we would be able to tackle those and reduce the exceptionally high level of chronic illness. I welcome what I think the Minister of State is saying. I would like her to confirm that we are talking about chronic illnesses. I will hold my comments on the availability of oral contraceptives off prescription until my amendment comes up.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy. I agree with what she said about the need to maximise capacity and the strong relationship between the customer, or sometimes the patient, and the pharmacist. We normally return to the same pharmacy, especially in smaller communities. What we are referring to in the Bill currently are what we call common conditions, including some of those the Deputy referred to, such as blood pressure, weight management and things like that. Regarding chronic illnesses, this states, "The Minister shall, within six months of the passing of this Act, prepare and lay before Dáil Éireann a report on expanding the role of pharmacists in chronic disease management." The pharmacy taskforce has been considering common conditions and chronic illnesses. Its deliberations are still under way.

Róisín Shortall (Dublin North West, Social Democrats)
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My other amendment is on contraception. Is the Minister of State saying that these amendments will facilitate the extension of the management of chronic illness as a set of conditions by community pharmacists?

Mary Butler (Waterford, Fianna Fail)
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The current amendments will not facilitate the chronic disease management role. The amendment the Deputy tabled, which I think might be No. 7, was seeking on a report on the role of pharmacists in that respect.

Róisín Shortall (Dublin North West, Social Democrats)
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That has been ruled out of order, unfortunately.

Mary Butler (Waterford, Fianna Fail)
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It has been ruled out of order. It states, "The Minister shall, within six months of the passing of this Act, prepare and lay before Dáil Éireann a report on expanding the role of pharmacists in chronic disease management." That is where we want to get to. It is really important. At the moment, what is included in this legislation is what is called common conditions as opposed to chronic illness and conditions.

Róisín Shortall (Dublin North West, Social Democrats)
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I think that is a missed opportunity. It is a pity the Minister of State did not go further, because we would presumably need additional primary legislation to have the management of chronic illnesses placed in the hands of pharmacists. It is regrettable that we did not. I regret that my amendment has been ruled out of order. I welcome what the Minister of State's amendments are doing, insofar as they go.

Mary Butler (Waterford, Fianna Fail)
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The Minister wants to take it forward, like the Deputy said, with regard to chronic illness. It is just the timing of the pharmacy taskforce considering the services offered by pharmacists in other jurisdictions. This states, "The Minister shall, within six months of the passing of this Act, prepare and lay before Dáil Éireann a report on expanding the role of pharmacists in chronic disease management." The Deputy has been asking for that.

Róisín Shortall (Dublin North West, Social Democrats)
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Is that the Minister or Department saying that?

Catherine Connolly (Galway West, Independent)
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I have strayed outside the rules, allowing all this interaction.

Mary Butler (Waterford, Fianna Fail)
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The Minister is saying that.

Róisín Shortall (Dublin North West, Social Democrats)
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Okay. That is good.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 4:

In page 9, to delete lines 13 to 15 and substitute the following: “(III) by the insertion of the following subparagraphs after subparagraph (iii):

“(iv) subject to subsection (11A), such medicinal product or class of medicinal products as may be used for the purpose of treating mild or moderate illnesses or ailments, pursuant to a prescription issued by a registered pharmacist—

(I) who has reached the required standard of education and training in relation to prescribing medicinal products in accordance with the rules of the Council of the Pharmaceutical Society of Ireland made under section 11(3A) of the Pharmacy Act 2007,

(II) where the prescription is issued under the governance of a retail pharmacy business (within the meaning of the Pharmacy Act 2007) in accordance with regulations made under section 18 of the Pharmacy Act 2007, and

(III) in accordance with such other rules made, and codes of conduct drawn up by the Council of the Pharmaceutical Society of Ireland under sections 7(2)(a)(iii) and 11 of the Pharmacy Act 2007,

or

(v) subject to subsection (11A), by a registered pharmacist, in accordance with such conditions as are specified in the regulations in relation thereto,”,”.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 5:

In page 9, between lines 15 and 16, to insert the following: “(b) by the insertion of the following subsection after subsection (11):

“(11A) Before making regulations under section 32(2)(l)(iv) or (v), the Minister shall consult the Health Service Executive and the Council of the Pharmaceutical Society of Ireland, and may consult any other person or body as he or she considers appropriate.”,”.

Róisín Shortall (Dublin North West, Social Democrats)
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I move amendment No. 6:

In page 10, between lines 7 and 8, to insert the following: “Report on prescription-free oral contraceptives

9. The Minister shall, within six months of the passing of this Act, prepare and lay before Dáil Éireann a report on allowing pharmacists to dispense prescription-free oral contraceptives.”.

This concerns an issue that has been around for quite some time, which is the need to move to a situation where oral contraceptives can be provided off prescription by community pharmacists. I know the Minister of State referenced that in talking about her own amendments but she did not provide any particular timescale. She was saying that she was providing for regulations, which would allow various things to happen. I would like to try to pin this down. For that reason, I have proposed that the Minister be required to provide, within six months of the passing of this Act, a report on allowing pharmacists to dispense prescription-free oral contraceptives. There are many reasons we should move to do that as soon as possible.

We know that there continues to be a problem in this country with crisis pregnancy. Having better access to contraception of all kinds - oral contraception is what I am speaking about here - has significant potential for reducing the level of crisis pregnancy. That is a pressing issue, in my view. On the point I made about chronic illness, pharmacists are much more accessible than GPs. It would seem like it does not make any sense to require people to go to a GP and to wait possibly two or three weeks for an appointment to have the expense of seeing a GP in order to get a prescription. For that reason, why not allow people to go directly to the pharmacy to get oral contraception off prescription? It has been reported often, both in Ireland and internationally, that women would much prefer to receive their oral contraception from a pharmacist who they know well and have built up a relationship with.

Of course, we know that Irish pharmacists have been providing emergency contraception off-prescription for quite some time and that works very well. I have not heard of any issues or difficulties whatsoever being raised with that. For the past number of years, all pharmacies have had a private consulting room and that can be used in the same way as it is used for emergency contraception. It is recognised that there is no clinical reason at all that this move could not be made for pharmacists, who are very well trained and experienced. It seems to make sense on many different fronts. Therefore, while I recognise that the Minister of State is saying that her amendments will allow for that to happen at some point in the future, it should not be put on the long finger. For that reason, I propose that the Minister of State accepts an amendment here that would require the Minister to report on how that could be done and how that change could be made. That report should be made available in six months. I hope the Minister of State will support that.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy for her amendment but at this time the Government does not propose to proceed with its inclusion. The Deputy will be aware that the Bill, as previously drafted, aimed to provide for regulations to be put in place to enable pharmacists to sell and supply certain prescription products in line with protocol, and this aimed to facilitate the sale and supply of oral contraceptive pills on that basis. However, oral contraceptive pills will now be included in what can be prescribed by pharmacists working in a retail pharmacy business who have undertaken appropriate training and in accordance with regulations. At no time was the purpose of the Bill to change the status of oral contraceptive pills from prescription only to non-prescription products and that is not what we will do.

We welcome the Deputy’s support for enhanced access to contraception but six months is not a feasible timeframe to introduce the necessary changes and report back on impacts. While we share her ambitions in this area, our focus will be on introducing expanded options for women, enabling prescribing activity by community pharmacists and embedding awareness of these changes. It is important that women have choice and options for contraception and the Minister introduced the free contraception scheme, which has been very successful and is being further expanded.

In extending prescribing activity for oral contraceptive pills to pharmacists, we will want to preserve the good model of care that has been put in place as part of the free contraceptive scheme and we will be approaching this carefully. As the Deputy said, it is important that women have access to the right contraceptive method for them, their health and their needs.

Róisín Shortall (Dublin North West, Social Democrats)
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It is regrettable that the Minister of State is not taking this on board. She said the timescale is too short, but I am requesting that the Minister provides a report within six months and that is reasonable. I am not saying that a scheme has to start within six months; I am saying that we should have a report on it and I think that is a reasonable request to make. It makes absolute sense to allow this to happen. I do not know why the Minister of State would not at least provide a report on it. It is disappointing that she is not accepting this and I am pressing the amendment.

Mary Butler (Waterford, Fianna Fail)
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I have just been informed that the aim is to move the secondary legislation as soon as possible and that will include what the Deputy's ask entails. It is the aim of the Department to move that as a priority.

Róisín Shortall (Dublin North West, Social Democrats)
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When will that happen? A lot of other health legislation is backed up that is supposed to be a priority. Is it the case that there is no timescale?

Mary Butler (Waterford, Fianna Fail)
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There is no timeframe.

Róisín Shortall (Dublin North West, Social Democrats)
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I will press the amendment.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 8:

In page 12, after line 22, to insert the following:

“PART 4

AMENDMENT OF PHARMACY ACT 2007

Amendment of Pharmacy Act 2007

10. The Pharmacy Act 2007 is amended—

(a) in section 7(1)—

(i) by the substitution of the following paragraph for paragraph (a):

“(a) to regulate the profession of pharmacy in the State, including prescribing by pharmacists, having regard to the need to protect, maintain and promote the health and safety of the public,”,

and

(ii) in paragraph (d), by the insertion of “in relation to prescribing and” after “including”,

(b) in section 11—

(i) by the insertion of the following subsections after subsection (3):

“(3A) The Council shall make rules specifying the education and training which a registered pharmacist must receive to enable him or her to prescribe medicinal products in accordance with regulations made under section 32(2)(l)(iv) of the Irish Medicines Board Act 1995.

(3B) Rules made under subsection (3A) shall include—

(a) the standard of education and training required to be reached by a registered pharmacist in order to prescribe medicinal products in accordance with regulations made under section 32(2)(l)(iv) of the Irish Medicines Board Act 1995, taking into account any practical professional experience of prescribing which the registered pharmacist may have, and

(b) any other relevant continuing professional education.”,

and

(ii) in subsection (5), by the substitution of “subsection (2), (2A), (2B), (3) or (3A)” for “subsection (2), (2A), (2B) or (3)”,

and

(c) in section 18(1)—

(i) in paragraph (g), by the substitution of “prepared, supplied, sold or prescribed” for “sold or supplied”,

(ii) in paragraph (i), by the substitution of “supplied, sold or prescribed” for “sold or supplied”,

(iii) in paragraph (j), by the substitution of “to whom medicinal products are being sold, supplied or prescribed” for “being sold or supplied with medicinal products”,

(iv) in paragraph (k), by the substitution of “sold, supplied or prescribed” for “sold or supplied”, and

(v) by the substitution of the following paragraph for paragraph (l):

“(l) the keeping of records of and in connection with the preparation, prescribing, sale and supply of medicinal products and the preparation and dispensing of medicinal prescriptions;”.”.

Deputies will all be aware that pharmacy is a tightly controlled and highly regulated profession. It is essential that we allow the PSI, the pharmacy regulator, to continue its work and expand its regulatory function in tandem with the expansion of activities in pharmacy. The amendment clarifies that the functions of the PSI will include the regulation of prescribing activities by pharmacists. This is a very important clarification, which will ensure that the PSI can now set about the work we will task it with to bring prescribing activities by pharmacists forward. The amendment refers to the need to protect, maintain and promote the health and safety of the public. The PSI, in ensuring good professional regulation, and having oversight of qualifications for the practice of pharmacy as well as continuing professional development, is an essential safeguard for the public.

The amendment will immediately support the plans to enable pharmacist prescribing activity in community pharmacies. It will allow the PSI to make rules for the training pharmacists will need to undertake for a common conditions service and provide the regulatory guidance pharmacists will need. However, it is not limited to that. Pharmacist prescribing is not one thing; it can be many different kinds of specialised activity. There is a huge scope for expansion of pharmacy in primary and secondary care settings, which will take more time to develop but the amendment makes it clear that the PSI may support the development of pharmacist prescribing activity in the round, and that this authority lies with it as a regulatory body.

The PSI also regulates the retail pharmacy business, that is, the community pharmacy, and set the standards for the operation of those settings. The amendment ensures it has to authority to include prescribing activity in community pharmacists in its regulatory oversight and it can be then included in its inspection function. We have every confidence that the PSI will undertake the necessary work to help develop and oversee the introduction of pharmacist prescribing in an appropriate way and in consultation with stakeholders.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 9:

In page 12, after line 22, to insert the following:

“PART 5

Amendment of Health (Pricing and Supply of Medical Goods) Act 2013

Amendment of Health (Pricing and Supply of Medical Goods) Act 2013

11. The Health (Pricing and Supply of Medical Goods) Act 2013 is amended in section 2 —

(a) in the definition of “prescriber”, by the substitution of “(a), (b), (c) or (d)” for “(a), (b) or (c)”, and

(b) in the definition of “prescription”—

(i) in paragraph (b)(iii), by the substitution of “order,” for “order, or”,

(ii) in paragraph (c), by the substitution of “Nurses and Midwives Act 2011, or”for “Nurses and Midwives Act 2011;”, and

(iii) by the insertion of the following paragraph after paragraph (c):

“(d) a registered pharmacist who is for the time being registered in the register of pharmacists established under section 13(1)(a)(i) of the Pharmacy Act 2007;”.”.

It is very technical. Similar to the amendment above of section 59 of the Health Act 1970, in introducing prescribing activity for pharmacists through these amendments, it is prudent to include a registered pharmacist in the professions from which a prescription may be accepted. This is a minor change to include registered pharmacists in the definitions of "prescriber" and "prescription" in section 2, the interpretation of the Act. This will allow us to further consider the development of appropriate mechanisms to support prescribing for common conditions in community pharmacies.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 10:

In page 12, after line 22, to insert the following:

“PART 6

AMENDMENT OF PATIENT SAFETY (NOTIFIABLE INCIDENTS AND OPEN DISCLOSURE) ACT 2023

Amendment of Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

12. The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 is amended—

(a) in section 19(7), by the substitution of “the patient or the relevant person (or both of them) may” for “the patient may”, and

(b) in section 50(7), by the substitution of “the patient or the relevant person (or both of them) may” for “the patient may”.”.

The Department is now moving towards commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023. As part of this process, the Department became aware of two minor technical issues which it believes need to be amended in the legislation prior to commencement. These two amendments are purely technical and serve to restore wording to the Act that was omitted in the final drafting process. This wording is already used on a number of occasions elsewhere in the Act and is fully in line with the intent of the legislation. The Act, as drafted, currently appears to state that, following a refusal by the patient or relevant person, it is only the patient who is permitted to request the health services provider to make the open disclosure within a period of five years. It is the intent of the Act that the relevant person is also permitted to initiate the open disclosure within five years but this was not reflected in the final legal text. The same applies in respect of Part 5 reviews. It is important that this amendment is made to ensure the Act fully serves its function of ensuring patients and their families have access to comprehensive and timely information.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputies. I was pleased to bring these amendments forward today. As was said earlier, pharmacists are an easily accessible, highly trained and regulated valuable health resource. The value and capability they bring has been clearly evidenced in the role they played throughout the pandemic, ensuring continuity of patient care and helping to maximise access to vaccinations. Patients value the expertise of pharmacists and trust in pharmacists is at an all-time high. The Minister appointed the expert task force on the expansion of the role of pharmacy, which began its work at the end of August 2023. Its final report will contain recommendations on a range of prescribing activities which could be performed by pharmacists. The report will be finalised in early July for submission to the Minister for Health. It will provide a much-needed advice base for the expansion of the role of pharmacy and help give practical effect to expanding the role of pharmacists. Its recommendations are not confined to prescribing for common conditions in community pharmacies, but anticipating this recommendation, and given the ambitions we hold for pharmacy, it was appropriate to progress this at this time so we may move forward at pace. There is much more work to be done to further develop these plans and to develop the full potential of pharmacists, but this is an important step forward and a truly significant day for the profession of pharmacy. We look forward to more developments in the near future. I thank Members for their co-operation. It is much appreciated.

Róisín Shortall (Dublin North West, Social Democrats)
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I commend the Minister of State on bringing this legislation through all Stages in the House. I thank the officials involved. It is important legislation. While I would have liked it to go further, we await the report of the expert group. I hope when it is delivered to the Minister in July, he does not sit on it for too long and it is published so we can move forward in utilising and exploiting the huge potential of community pharmacists.

We need a chief pharmacist officer in the Department of Health. There is big demand for that across the board. I had hoped we would move with that when we appointed a Chief Nursing Officer, which made a huge difference. The appointment of the Chief Officer for Health and Social Care Professionals put that profession on the agenda. The same needs to happen in pharmacy.

There is an issue with hospital pharmacists because there is no career structure. It is hard for hospitals to retain pharmacists. Will that be looked at somewhere in the Department? We cannot afford to lose more pharmacists from our hospital system.

Catherine Connolly (Galway West, Independent)
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Cuirfear an Bille chuig an Seanad. The Bill will be sent to the Seanad.