Tuesday, 5 February 2019

Questions (50, 67, 68)

John Brassil


50. Deputy John Brassil asked the Minister for Health the action he is taking to address the concerns being expressed regarding the falsified medicine directive; and if he will make a statement on the matter. [5264/19]

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Louise O'Reilly


67. Deputy Louise O'Reilly asked the Minister for Health if he is seeking a corporate transfer of responsibility in moving the responsibility for the provisions of the EU falsified medicines directive from the pharmacy owner or proprietor and onto pharmacists and employees; and if he will make a statement on the matter. [5315/19]

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Tony McLoughlin


68. Deputy Tony McLoughlin asked the Minister for Health if his attention has been drawn to the concerns expressed by HSE hospital-based pharmacists with regard to the provision of the EU falsified medicines directive and the statutory instrument that will be used to make it law here; and if he will make a statement on the matter. [5274/19]

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Oral answers (10 contributions) (Question to Health)

On 9 February, the EU falsified medicines directive will come into operation. Many concerns have been raised with the Minister, particularly by the cohort of hospital pharmacists. These issues include who is liable, the status of those pharmacists as HSE employees and not owners of the pharmacy, which is a major concern, staffing and IT requirements needed to implement this directive, technical problems that may occur which take precedent to the safety of the patient and a consultation regarding a statutory instrument. Has that now been finalised and will it be in place prior to 9 February?

I propose to take Questions Nos. 50, 67 and 68 together.

The safety features delegated regulation introduces new rules for the supply of medicines from 9 February 2019. As Deputy Brassil noted, the safety features include a form of an anti-tamper device and unique identifiers embedded in a two-dimensional barcode on the pack. The purpose of the regulation is to improve patient safety and maintain confidence in the safety of medicines supplied to patients.

A statutory instrument will provide that the Irish legislative system is consistent with the requirements of the regulation. Nothing in the new regulations seeks to alter the existing legal and regulatory responsibilities of persons authorised to place medicinal products on the market or supply them to the public. It will apply to manufacturers, wholesalers, pharmacy owners and pharmacists equally.

The regulation provided for a three-year transition period, starting in 2016, to facilitate preparation for its introduction. Details of the requirements of the delegated regulation have been communicated to all sectors during this period by the Irish Medicines Verification Organisation, the Health Products Regulatory Authority, the Pharmaceutical Society of Ireland and the Irish Pharmacy Union.

I recognise the sincere concerns raised by stakeholders and articulated by the Deputies regarding the practical implementation of the regulation. Above all, I want to ensure the normal supply of medicines to patients is maintained. I intend, therefore, to implement the system in a pragmatic manner and defer operating the offences provisions in the legislation for an initial period. This will allow everyone involved to develop familiarity with the new arrangements and overcome any teething issues before we proceed to the introduction of the provisions that deal with offences.

I considered the implementation issues and, on 25 January, decided that a pragmatic approach should be taken to the use of the system. This approach will ensure there is no break in the supply of medicines to patients, which is crucial, until the new system is bedded in, alleviate the concerns of pharmacists as to whether the offences and enforcement provisions would be commenced on 9 February and ensure that the offence's commencement and the proposed pragmatic implementation period will be subject to ongoing review. These three policy decisions, which I took at the end of January, were communicated by the implementation stakeholders to all parties concerned on Monday, 4 February in a co-ordinated manner, and have been well received by such stakeholders. We are trying to do what we need to do under the regulation and to achieve what we need to achieve, but in a pragmatic way that does not rush in offences until the new system is bedded in.

I welcome the Minister's response. Forgive me for not being up to date with the matter but 4 February was only yesterday. While many pharmacists who have contacted me, and Deputy O'Reilly and all the other Deputies will be delighted that a pragmatic approach is being taken, one or two issues arose. I was in contact with a number of pharmacists who were partaking in a pilot project to see how it would be implemented. On that pilot project, approximately 80% of the medicines put through the system were returned with a red flag, that is, if the medicine was operational at the time, the pharmacist would not have been able to dispense it even though he or she knew it was perfectly safe to do so.

There is much work required, therefore, to get the system working and operational. Particularly in the hospital setting, space, storage and IT systems are critical. I submitted a parliamentary question about robotic dispensing, which some hospital pharmacies have but most do not. There needs to be a levelling of the playing field in that area.

I welcome the deferral of the offences and the engagement that will happen, but will the Minister reconsider the manner in which the statutory instrument is being enacted? The directive places the responsibility on the corporate entity but the manner in which it will be implemented places much responsibility directly on the pharmacist but does not place enough emphasis on corporate responsibility. The employer has no obligation, for example, to provide the infrastructure or resources for a worker to carry out his or her duty. While it is all very well to defer the offences, if someone is guilty of an offence, regardless of when the offence might be introduced, there will be no allowance for the fact that it might not be his or her fault. There should be some obligation on the employer, therefore, to ensure the pharmacist has the best chance of not falling foul of the law.

I was not expecting the House to reach Question No. 68 but I heard the end of the Minister's statement and welcome it, although I hope he will send out a brief on the matter. Similarly to the other Deputies, I have been approached by HSE hospital-based pharmacists who had concerns about the matter. The Minister's comments are welcome and I hope we will continue to negotiate or, at least, that we will receive detailed updates from him.

A rare moment of harmony is to be welcomed. I thank Deputies Brassil, O'Reilly and McLoughlin, along with other Deputies, for their advocacy on this issue and for highlighting people's concerns. I will reflect on Deputy O'Reilly's comments and revert to her.

We will adopt a pragmatic approach. Once the new system becomes live on 9 February, it should be considered to be in a use-and-learn mode. Pharmacists will be able to continue for a defined period to dispense packs unless they have an overriding concern that a falsified medicine is involved. Within the defined period, which will possibly be between six months and a year, further intensive work can be carried out to devise and communicate a workable EU-wide process for the management of alerts and ensure that all parties affected by the regulation comply with its requirements and can join the new system. There will be a review by regulators after three months to assess the initial implementation period and whether the pragmatic approach needs to be continued for a further period. After 9 February, pharmacists will continue to carry out the professional product checks that they have carried out to date, which are important when dispensing any medicine to a patient.

Some other EU member states have voiced concerns about implementation at a technical group meeting in Brussels last week. While we cannot speak for them, it is likely that other member states, due to their size, will have similar implementation and alert problems and may well also operate a national pragmatic approach, such as that taken by Ireland.

I welcome the pragmatic approach. It is clear the Minister has read and listened to the concerns of the industry, but I reiterate the specific issue of hospital pharmacies. In a public hospital, the pharmacist does not have the authority to determine the human resources, space, logistics and equipment necessary to comply with the directive. All those factors must be taken into account to allow hospital pharmacists to carry out their duties without fear of being liable because they are not the hospital owner.

I look forward to working with the Minister and his Department on the implementation of the directive. Anything that improves safety of products is to be welcomed but must be done in the pragmatic manner we discussed.

We look forward to working with the Minister to implement the directive and I welcome that he will reflect on the points I made. They are practical points and are not made for any reason other than my belief that it is a little unfair to shift that level of responsibility onto an individual without placing the same level of responsibility on the employer to ensure compliance.

Another issue that was raised and must be considered is what will happen in the event of an IT malfunction. I welcome that the Minister will engage in some consultation and that there will be an opportunity to review. I ask that the concerns I have raised be taken on board.

Hospital pharmacists had concerns and I welcome the Minister's comments on them. He mentioned the date, 9 February, and I wish to be associated with his remarks on the matter.

It is fair to say that in recent weeks concerns were raised by hospital pharmacists and other pharmacists about who might be prosecuted for a breach of the statutory instrument, as noted in my initial reply. Pharmacists who are employees of a pharmacy owner or the HSE are concerned that if they were to dispense a medicine where the pharmacy was not connected to the new system through an omission of the employer or issue a medicine that failed in its alert, they could end up being prosecuted. The concerns that were raised were valid and helped to inform the decision that while certain elements of the statutory instrument will be commenced before 9 February, the offences provision will not be commenced for a period afterwards to let the final registrations of the new system take place, the system be bedded down and a definitive alert system be developed.

There are some challenges remaining, including the impossibility of predicting the volume of alerts and identifying the percentage which are true alerts. It would probably be a small percentage. There is also the matter of possible medicine shortages while alerts are investigated and medicine supply must be a key priority. We must also manage good communication between parties and queries from pharmacies about refunds for products with alerts. Ireland will proceed to implement the regulation, but it will do so in a common sense and pragmatic way. As I said, I do not expect that we will be alone in this with regard to the position of other EU member states.