Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I will now outline the proposed changes to the Irish Medicines Board Act 1995. This Act makes broad provision for arrangements for the control of medicinal products, including in respect of manufacture, sales, supply and distribution. The first amendment concerns access to certain approved prescription medicines. During Covid-19 we widened the pool of health professionals who could administer Covid-19 vaccines with the appropriate training and supports. This will be retained and extended so that we have a permanent ability to call on a wider range of healthcare professionals.

When it comes to the expanded role of pharmacists, we would all agree that pharmacies are accessible services, embedded in their communities throughout the country. Empowering pharmacists to provide more care will give people throughout the country more choice and more access to care, critically, closer to their homes, in their own communities. Pharmacists can play a much-expanded role in our health service. I therefore propose the introduction of further steps to support this.

I established an expert task force on the expansion of pharmacy last year to advise me and the Department. The task force is examining the introduction of different forms of pharmacy prescribing and I expect to receive its final recommendations on this in the coming weeks. Pharmacy prescribing will be a major change for health services in Ireland. Critically, it will be a major change for people in all of our communities who might have a simple condition, such as conjunctivitis or a very low-level rash, that requires a prescription medicine. At present, such people have to go to a GP. The GP does not really need to see them, so it is taking up the time of both GPs and patients. A person might have to pay €50, €60 or €70 to see the GP to get the prescription, and then bring it to a pharmacist. The reality is the pharmacists are highly trained healthcare professionals. With additional training, they will, in respect of a very specified set of ailments and conditions, be able to state that it is a skin rash or conjunctivitis, and provide what the person needs. It is going to be a better use of healthcare resources generally. It will be quicker for the public. It will be less expensive because, rather than having a GP and a pharmacist, there will now only be a pharmacist.

The first step, which is the introduction of prescribing for common conditions, is something we are looking to do very quickly. These common conditions are non-chronic conditions which for the most part only last for a short period and are easily treated. International experience is clear that pharmacists can play an important role in this. This Bill aims to enable prescribing activity by community pharmacists for a prescribed set of conditions. This will be a small set of conditions initially. It will expand over time, subject to appropriate clinical advice. This prescribing activity will also include oral contraceptive pills, where clinically appropriate. The activity will be governed by regulations to be set out in secondary legislation. Clinical guidance has been put in place and training for pharmacists is being developed. Pharmacists will have to participate in this training before they can undertake the prescribing activity.

I move now to medicine shortages. As Members will be aware, there is a global tightening of supply chains when it comes to medicines. We are seeing medicine shortages in Ireland, in the UK and right across the world. It is a global issue. A final set of changes to the Irish Medicines Board Act concerns the management of medicine shortages. The measures will introduce medicine substitution protocols which will help to mitigate the impact of these shortages. The protocols will allow pharmacists to therapeutically substitute a medicinal product in limited circumstances where a prescribed medicine is the subject of a shortage. This will be done in strict compliance with HSE drafted and ministerially approved protocols specific to a known or anticipated shortage and for a limited period of time. Ultimately, it will help us to be more agile in response to emerging shortages.

Additional reporting measures are also being proposed, requiring various entities in the supply chain, including manufacturers, wholesalers and distributors, to report on information. These reporting measures align with the EU approach. By strengthening access for the Health Products Regulatory Authority to information on medicines availability, we enhance our ability to introduce practical mitigations in a timely manner. That is an awful mouthful. Essentially what it means is that we do not have end-to-end sight of medicines at the moment. Different parts of the system can see different bits of it. Our regulator cannot currently predict shortages and balance and mitigate shortages as well as it would like to and is capable of doing, because it does not have end-to-end sight of where the shortages might be or might be coming, whether it is in manufacture, international or domestic distribution or in stock being held in certain pharmacies. This will allow it to see that in order to help to balance the load across the system and to predict where we are going to have a problem in order that we can quickly put a protocol in place to allow pharmacists to substitute for another medicine.

There is a key role for the pharmacy regulator, the Pharmaceutical Society of Ireland, in all of this. We are making changes to the Pharmacy Act 2007, which makes provision for the regulation of the profession of pharmacy in the State, including the regulation of retail pharmacy businesses and community pharmacies. The PSI is the regulator of both retail pharmacy businesses and the pharmacists themselves. The amendment to the Pharmacy Act will ensure that regulations made for retail pharmacies can include measures to regulate prescribing activities carried out in those settings by pharmacists. These amendments provide the framework for the PSI to regulate and support current and future developments in pharmacy, including in respect of the future evolution of prescribing functions. The final output of the pharmacy task force, which is due shortly, will be central to this. To support the provisions on the introduction of pharmacist prescribing, the Bill also contains brief amendments to section 59 of the Health Act 1970 and to the Health (Pricing and Supply of Medical Goods) Act 2013.

Finally, there is a technical amendment to the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 in this Bill. The Department is now moving towards commencement of the patient safety Act and, as part of this process, officials became aware of two minor technical issues which need to be amended in the legislation prior to commencement. They are purely technical amendments.

I look forward to hearing the contributions from colleagues. It is a miscellaneous Bill. There are various pieces in this but, ultimately, it will serve to enhance the role of pharmacists. There is a lot of untapped potential there and we have been working closely with them. It would be remiss of me not to say the following as well. I have spoken at various of their conferences and I meet community pharmacies all the time. Although, to their great credit, they are very enthusiastic about this and we had a really positive conference with them just a few months back, they are making the point that they want an ongoing conversation about pharmacy fees. These fees have not changed for a long time. I committed to pharmacists privately when I met their executive and publicly at their conference and, in the context of this Bill, it is worth putting on the record of the Seanad as well. I have asked my Department to engage with community pharmacists on all of this but, in the round, to include a review of the totality of the arrangement between the State and the pharmacies and a review of the fees.I have not committed to any changes or increases, but I have committed to my Department and the State engaging with them in good faith on the totality of charges that are paid to the State. This will be part of that.