Seanad debates
Thursday, 9 November 2023
Nithe i dtosach suíonna - Commencement Matters
Medicinal Products
9:30 am
Martin Conway (Fine Gael)
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I thank the Minister of State for giving up his time to take this matter. I tabled it because I am greatly concerned about the lack of availability of standard medicines in the pharmacy network throughout the country. I welcome the fact that we have extended the qualification threshold for medical cards. An awful lot more of our citizens now qualify for medical cards compared with a few years ago. That is good because it follows through on the principle of Sláintecare and ensuring that we have a public health service that is accessible to everybody.
I will outline a problem. On one hand, we are making it more affordable and easier to access medicines by providing medical cards to more people and reducing the drugs payment scheme. On the other, because of the shortage of medicines - and internationally at this stage - people cannot get the medicines they require either through the drugs payment scheme or with medical cards in a growing number of cases. For example, a specific medicine is unavailable but there is a licensed alternative. However, that is not available through the medical card or the drugs payment scheme. People who are vulnerable or financially stressed – as we know, people are very challenged at the moment – are not in a position to fund their medicines, so they end up not taking medicines and they wait until the medicines that are listed under the various schemes come back into stock. This is putting pharmacists in an awful situation. They are trying to advise people to take their medicines, which have been prescribed for very good reasons. If people cannot afford to pay for alternative medicines, they decide not to take them for a couple of weeks.
I cite the example of a medicine that is used for thyroid issues. Forgive my pronunciation, but a drug called NeoMercazole is usually prescribed by GPs. The alternative, which is licensed and recognised, is a medicine called carbimazole. Unfortunately, it is not listed for use under the medical card or drugs payment scheme. If it was listed, people with thyroid difficulties who did not have the prescribed medication could get a licensed alternative.
If we were really interested in ensuring that people are as healthy as possible, drugs would be as accessible as possible to those who need them. We need to review the schemes and increase the medications listed under them dramatically. The shortage in medicines will not be resolved today or tomorrow. It will take a long time. I ask for a full review of the medicines listed under the drugs payment scheme and the medical card scheme.
Seán Fleming (Laois-Offaly, Fianna Fail)
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I thank the Senator for raising this issue. I will be providing an answer on behalf of my colleague, the Minister for Health, Deputy Stephen Donnelly.
This issue is becoming well known, and there is not a pharmacy, region or family with many prescriptions that has not encountered it. The HSE has statutory responsibility for pricing and reimbursement decisions under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Under that Act, the company that holds the marketing authorisation must apply to the HSE to add its medicine to the reimbursement list. The Act also permits community pharmacists to dispense alternative products on the basis of prescriptions. However, to do so, the medicines must have been designated as interchangeable by the Health Products Regulatory Authority, HPRA.
Many interchangeable alternatives are available to patients availing of the community drug schemes. These schemes include the general medical services scheme - the medical card scheme - which provides access to healthcare for people on a means-tested basis and, in some cases, on a discretionary basis. The drugs payment scheme, which is available to any person normally resident in the State, limits the cost of approved medicines to €80 per month. Spending above this threshold, which was reduced twice last year, is refunded, provided that the medicines dispensed are eligible.
In its reimbursement list, the HSE sets a common reimbursement price for all medicines in any group of interchangeable products. This is known as reference pricing and includes both generics and branded medicines. Where a patient chooses to receive a product above the reference price, he or she is required to pay the difference. This probably applies more to private patients rather than those on the schemes I mentioned. Generally, if a generic manufacturer chooses not to apply to the HSE to be added to the reimbursement list, the medicine will not be eligible for reimbursement under the community drug schemes. However, in cases where a medicine is not on the reimbursement list and the full cost must be paid, an application can be made for discretionary hardship arrangements to be considered by the HSE. All applications under these arrangements are reviewed on an individual basis. The HSE must be satisfied that the patient requires the item for clinical reasons and that there is no item on the reimbursement list that is a suitable alternative for that patient.
Shortages of medicines are not unique to Ireland. There is no evidence that shortages disproportionately impact patients here compared with other countries.Ireland has a medicine shortage framework in place that is operated by the HPRA, which I referred to earlier, on behalf of the Minister for Health. This framework aims to help avert potential shortages 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 Department of Health, the pharmaceutical industry, healthcare professionals, the HSE and patients.
In the case of medicines that are used most often in Ireland, when there is a shortage, there are typically multiple forms, strengths, brands and generic medicines available from a range of sources. In the event there are some supply issues for individual medicines, alternative options such as alternative strengths, brands and generic medicines may be available to ensure continuity of treatment. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.
Martin Conway (Fine Gael)
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I thank the Minister of State for his reply and his acknowledgement this is becoming a major issue in pharmacies. We need a more comprehensive response from the HSE. I raised a Commencement matter seeking the appointment of a chief pharmacist officer at the Department of Health to oversee all this. While I fully acknowledge the good work done by the stakeholder engagement group, the HPRA and so on, this needs more far more intensive engagement both with the IPU and pharmacists in general. This can and should happen. Initially, there would be the appointment of a chief pharmacist officer. The immediate problem must be looked at within the Department, namely, the non-availability of standard medicines and the fact other medicines that are licensed as alternatives are not covered within the schemes. Then, on an immediate to long-term basis, there must be engagement to come up with a strategy, because it is a Government policy that community pharmacists should have a greater role in the provision of healthcare, and rightly so. For that to happen, we need a proper strategy within the Department.
Seán Fleming (Laois-Offaly, Fianna Fail)
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I thank the Senator. As I have already mentioned, under the Act, a company that holds a marketing authorisation must apply to the HSE to add its medicine to the reimbursement list. I will follow this up with the Department to ensure there is no undue delay for companies that have applied to have something on the reimbursement list being approved in the meantime. The introduction of the medicine substitution protocol would allow pharmacists to supply a specified medical product without the need to seek authorisation from the prescriber, in other words, going back to ring the original GP and asking can one medicine be changed for another. Substitution will be under the strict direction of the protocol drafted by clinical experts and approved by the Minister. It would only be used when other existing measures are likely to be ineffective and in certain defined serious shortages. The community drugs schemes are designed to address the financial barriers, which the Senator mentioned. The State is committed to enabling safe access to medicines for as many people as possible. This requires the pharmaceutical industry to continue to engage with the public health system, which includes companies applying to the HSE to have their medicines added to the list of reimbursement items.