Health (Miscellaneous Provisions) Bill 2016: Report and Final Stages

I move amendment No. 1:

In page 8, between lines 1 and 2, to insert the following:

"(c) and by the insertion of the following paragraph:

"3. In the case of any emergency hormonal contraception included on the Reimbursement List that is normally available without prescription, there shall be no requirement that a prescription be presented in order for patients to be reimbursed under the General Medicines Services Scheme ('GMS'), and the procedure for recording and documenting the service provided and for claiming reimbursement of the fee and ingredient cost shall be as for all medicines dispensed under Community Drugs Schemes.".".

This concerns an issue I highlighted on Second Stage. The amendment was moved by me through Deputy Billy Kelleher on Committee Stage. I thank the Socialist Party for tabling it for Report Stage. I admit it is not the most elegant of amendments. It is not the best in terms of wording but the reason it is so worded is to highlight the importance of the issue. I acknowledge the input and dialogue of the Minister for Health, Deputy Simon Harris, behind the scenes over recent weeks in trying to advance this issue through telephone conversations and e-mails. That is very much appreciated. It is a good way of doing business.

We know section 9 allows for emergency contraception without prescription to be reimbursed by the HSE but not for women who are on a medical card. Women with medical cards will still need to go to the doctor to get a prescription for a non-prescription drug. It is unacceptable that this type of two-tier system would continue to prevail. Throughout the debates, the Minister made many points about addressing the issue. In fairness, a lot of work has taken place in recent weeks to try to unlock this problem.

The reason I retabled the amendment is that the Irish Pharmacy Union, IPU, gave the Department a proposal to make the morning after pill available without prescription to women on medical cards in June 2015. That was more than a year and a half ago. That we are only beginning to discuss it and that there was no discussion whatsoever with the IPU since it made its proposal is why we are discussing this on Report Stage. The morning after pill became available through pharmacies without prescription in 2011, not today or yesterday. The pill is critically time-dependent. It is 95% effective if taken within the first 24 hours of unprotected sex, with its effectiveness falling dramatically the longer time goes on. We know from the National Association of General Practitioners that there is an average waiting time for a GP appointment of 34 hours. In essence, a woman with a medical card will not be able to gain access to the pill within the 24-hour window, as indicated by best practice. That is what the amendment is trying to address.

On Second Stage, certain Deputies stated one could go into a pharmacy and pay for the pill if they were that bothered about it. The fact that the morning after pill can cost between €30 and €35 is an issue. This is a huge amount of money for somebody on social welfare. In that context it does not present an opportunity for her. The flu vaccine, for example, has been available to medical card holders without prescription and pharmacists have had a system for claiming back the costs of this since 2011. Why can it not be done in this case?

The IPU has stated the administrative hurdles are not onerous. The proof of the pudding is that the required system is already operated for the flu vaccine. Emergency contraception should be freely available over the counter to all women rather than from behind the counter, as is the case at present. It can be costly for private patients. None the less, the IPU pointed out over 18 months ago that the scheme could be implemented easily and quickly from a professional perspective. There is no further training required. The procedure in place for recording and claiming the reimbursement of fees could be the same as for other medicines dispersed under the community drugs scheme.

I have two questions for the Minister of State. The IPU proposed that pharmacists receive a fee over and above the standard dispensing fee for providing the proposed service. It suggested one in line with that for the flu vaccine of about €15. I do not know whether that is a fair price but I do know that it is substantially less than the cost of a visit to a general practitioner. Can we be assured that cost and negotiations are not a reason for stalling? Have there been any discussions with the IPU? There have been discussions with the HSE and I am anxious that there be a discussion with the IPU. The Minister seemed to suggest in dialogue outside the Chamber that this proposal is deliverable in 2017. On that basis and in recognition of what I acknowledge has been a lot of work behind the scenes, I will not press the amendment.

I support the amendment. This could and should be introduced in 2017. The purpose of the amendment is to ensure that women with medical cards will be able to obtain emergency contraception without presenting a prescription. In April 2015, the pharmacists passed a motion at their annual conference calling on the HSE to make the morning-after pill available to women with medical cards directly from the pharmacy free of charge. It was reported at the time in the.journal.ie that pharmacists claimed that making women with medical cards attend their doctor for a prescription in order to obtain the pill free of charge was farcical, discriminatory and unacceptable.

As Deputy Daly pointed out, the average waiting time for a GP appointment has trebled in five years, to 34 hours in 2015. It is even longer for GMS doctors in low-income areas, where there are fewer doctors and there tend to be longer waiting times. In addition, a medical card patient does not have the luxury of shopping around for another doctor who can see her faster. She has to go to the GMS doctor with whom she is registered.

As for the argument that I believe was made at an earlier Stage, namely, that anybody can go into a pharmacy and buy the pill without a prescription, that only applies to those who can afford €35. The What's Left survey by the Irish League of Credit Unions found that 483,000 people have no money left at the end of the month. Many of them are people with medical cards. The income of a single woman living alone or with friends would have to be €184 or less per week to qualify. Therefore, €35 would be more than one fifth of one's weekly income. It is clear that there is an unarguable case for this amendment. It needs to be taken on board and implemented next year.

I support this amendment. Emergency hormonal contraception, or the morning-after pill, as it is more commonly known, is an important addition to the range of available birth control measures in Ireland, from oral contraception to medical and surgical abortion.

To further the development of reproductive health care services, it is important that the morning after pill be easily available from local pharmacies without prescription and without charge to GMS patients. Emergency contraception provides relief from worry about an unwanted pregnancy and an opportunity to reassess contraception arrangements as a contraception method may fail. The considering of other options is facilitated by a consultation with a doctor or a nurse, if required, on such occasions. Emergency hormonal contraception is an important part of reproductive health care services and should be available without prescription or charge to GMS patients. I urge Deputies to support the amendment.

I thank the Deputies for their contributions. I will convey Deputy Clare Daly's thanks to the Minister for Health, Deputy Simon Harris.

The purpose of section 9 is to allow the HSE to consider including over-the-counter products in the list of reimbursable items, where appropriate. This provision corrects an anomaly in the existing legislation. Under the 2013 Act, only prescription medicines can be supplied under community drug schemes. This anomaly affects a number of products that were prescription-only but are now over-the-counter, as well as some over-the-counter items that have long been available under the schemes. The 2013 Act gives a temporary reprieve in supplying over-the-counter medicines under the community drug schemes until 2018. The provisions included in the Bill will make the reprieve permanent and allow some useful medicines such as emergency contraception and nicotine replacements to remain available under the drugs payment, medical card and other schemes. However, patients will still need a doctor's prescription to obtain an approved item under the schemes, be it an over-the-counter or prescription-only item. This is an important control clinically and for the financial operation and governance of the schemes.

I wish to make a number of important points about access to emergency hormonal contraception. It is important to note that medical card holders already have access to emergency contraception which is free under the GMS scheme with a prescription. Emergency contraception is also an over-the-counter treatment; therefore, any person can enter a pharmacy and buy it without a prescription. In the 12 months to August this year, there were just under 13,000 emergency hormonal contraception prescriptions dispensed under all schemes, of which more than 12,000 were to medical card holders. Timely access is not an issue for the more than 12,000 people per year who present to their doctors and then their pharmacists for emergency contraception, rather the issue is for people who need emergency contraception but who cannot get a prescription in time, for example, at the weekend or if they are unable to obtain an urgent appointment with a GP and cannot afford to buy the product. I share the concerns raised about timely access to emergency hormonal contraception for medical card holders and accept that there should not be unnecessary barriers to women receiving this treatment.

I agree with the principle of the amendment proposed by Deputies Ruth Coppinger, Clare Daly, Mick Barry and Paul Murphy, but I do not propose to accept the amendment for the following important reasons. The Minister has already instructed officials to remove the prescription requirement for emergency hormonal contraception as a matter of urgency. Work on the development of service and clinical structures to do this is under way.

Following consultation with the Irish Pharmacy Union, IPU, last year, officials identified the challenges involved and are addressing them. Since Committee Stage they have engaged further with the HSE on the process required. Section 9 will remove the major legislative barrier to supplying over-the-counter medicines in general, including emergency contraception. Many of the IT and service processes needed were trialled in the minor ailments pilot scheme this year under which pharmacies treated patients directly for six minor conditions with over-the-counter medicines and without prescriptions.

In line with the Minister's instructions, the HSE is developing operational structures to provide an over-the-counter emergency hormonal contraception service for GMS patients professionally, safely and effectively, including clinical standards to ensure patient safety, pharmacy compliance with these standards, as with the vaccination programmes, secure claiming and verification processes. Development will continue to build on the work already done, including the IPU's professional practice guidelines for dispensing over-the-counter emergency hormonal contraception and existing structures for specific pharmacy services such as the vaccination programme.

The proposed amendment is not necessary to address any operational challenge that may arise. Furthermore, it would prescribe the supply of a single treatment in a specific manner in primary legislation. This raises potential difficulties in a number of areas, including the requirement on the HSE under the 2013 Act to provide treatment in line with patient safety and cost constraints, for example, to get the best price or refuse individual products on the basis of suitability or safety. It also raises potential difficulties in a pharmacist's use of clinical judgment, in particular, not to supply a product where it may be unsafe for a patient for clinical reasons. Supply of emergency hormonal contraception is a professional clinical service set out by the Pharmaceutical Society of Ireland which the amendment does not reflect. Further discussion will be required with the IPU on service design and Department of Health officials will pursue the matter. The IPU has previously indicated its willingness to provide this as a professional service and the Pharmaceutical Society of Ireland has issued professional practice guidelines on dispensing emergency hormonal contraception and advising patients.

It is evident that significant progress has been made to remove barriers to timely treatment for medical card holders through the use of over-the-counter products in general and, in particular, emergency contraception. I thank the Deputies for raising the issue again on Report Stage and the valuable contributions they have made in doing so. The principle behind the amendment is worthwhile and being acted on. However, the amendment is not necessary in addressing this health need and could have unintended consequences. In addition, while implementation is under way, the remaining operational challenges must be addressed before emergency hormonal contraception will be available over the counter to medical card holders. The Bill's progress was delayed by the fall of the previous Government and the delay in forming the new one. There is an upcoming discussion with the IPU on section 9 and there should be no further legal barriers. While the Deputies' amendment is well intentioned, it would not make what they want to happen happen any faster. Therefore, while I thank the Deputies for tabling it, I do not propose to accept the amendment.

It is important that this issue has been discussed on every Stage. I will not labour the points made previously, but it is not rocket science. Pharmacists already dispense this treatment without a prescription. They dispense it to those who can access it privately and no training is needed. Systems are already in place to deal with other items and medicines dispensed under the community drug schemes and so on. Other unified claim forms carrying, for example, the patient's medical card number signed by the pharmacist could be easily provided. This has been ongoing for a long time. I appreciate that work has started and that we are trying, but when will we succeed? I take it from the Minister of State's answer that there has been no dialogue with the IPU since Committee Stage, but perhaps I picked her up wrong. The HSE has discussed the matter, but a discussion has not been held with the IPU. Given that it was to the fore in facilitating the discussion, that is where it needs to be held. I see no reason for a delay. When the Minister of State replies, will she assure the House that there is no issue with cost?

There is sincere engagement with the officials. The intention is to progress the matter as quickly as possible. It is affordable for the HSE; therefore, it is not down to cost. There is still some IT architecture to design which we believe will take approximately three months to complete. I hope we will have made some progress on the matter by then. I hope I have given the Deputy the answer she required.

Amendment, by leave, withdrawn.

I move amendment No. 2:

In page 8, between lines 16 and 17, to insert the following:

“Amendment of section 6 of Act of 2015

12. Section 6 of the Act of 2015 is amended--

(a) in subsection (1), by the substitution of “Subject to subsection (3), this Act” for “This Act”, and

(b) by the insertion of the following subsections after subsection (2):

“(3) A specified provision of this Act shall not apply to the sale of tobacco products manufactured or released for circulation before the date of commencement of that provision, until the first anniversary of that date, provided that on the date of their sale those tobacco products comply with the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016).

(4) In subsection (3), “specified provision of this Act” means any of the following provisions of this Act:

(a) subsections (1) to (5) and (7) to (12) of section 7;

(b) section 8;

(c) subsections (1) to (5) and (7) to (12) of section 9;

(d) section 10;

(e) section 11;

(f) section 14.”.”.

As indicated on Committee Stage, I proposed to bring an amendment forward today to the Health (Miscellaneous Provisions) Bill. This amendment is to Part 5 of the Bill and proposes to insert a new section 12. The amendment seeks to amend section 6 of the Public Health (Standardised Packaging of Tobacco) Act 2015. The section deals with transitional provisions. New transitional times are now required given the significant period of time which has elapsed since the Health (Miscellaneous Provisions) Bill was initiated in January 2016. The original timeframe for the manufacture of the new standardised packaging from 20 May 2016 has now passed. I assure Deputies that while this means that the introduction of standardised packaging has been delayed somewhat the Minister, Deputy Harris, and I remain committed to ensuring that this important public health measure is introduced as soon as is practical.

The amendment proposes the insertion of new subsections (3) and (4) into section 6 of the Act of 2015. Section 6(3) states that specified provisions in the 2015 Act shall not apply to the sale of tobacco products which were manufactured before the date of commencement of that specified provision. Such products are permitted to be on sale for a 12-month period. Section 6(4) lists the relevant provisions of the Act of 2015.

The specified provisions mentioned in the amendment are the requirements of standardised packaging. The ban on the use of logos and trademarks, the use of a prescribed colour and the requirements for the appearance of cigarettes are some examples of the requirements. What the amendment means in practice is that once the specified provisions are commenced, all tobacco products manufactured from that commencement date must comply with the standardised packaging requirements. This date will be set taking into consideration the time it takes for the Health (Miscellaneous Provisions) Bill to complete its legislative journey and the notification of the technical requirements to industry for preparation. Tobacco products manufactured before that commencement date will be permitted to be sold for a period of 12 months. That is in line with the 12-month wash-through period set out in the original Act. I commend the amendment to the House.

I do not know whether the Minister of State's attention has been brought to the starter packs that are now on sale, which include some cigarettes and loose tobacco for a person to roll his or her own cigarettes. They are packaged in a typical cigarette pack. I will furnish the details to the Minister of State, although I accept it is a bit late to address the issue in the context of the Bill. However, it is something that must be addressed. We have talked about becoming a tobacco-free society in the near future and I am very supportive of all the measures being introduced but there are still areas that remain to be addressed. This is a nefarious, insidious industry at the best of times and it targets cohorts of young people in particular in order to get them addicted to tobacco. While the starter packs to which I referred will not come under the remit of this legislation it is something of which the Minister of State should be aware and if amending legislation is required then the Minister might look at that in a positive light.

I thank Deputy Kelleher for bringing the matter to my attention. It is certainly not something of which I was aware and it warrants further consideration because we are very serious about continuing the work towards having a tobacco-free society by 2025.

Amendment agreed to.
Bill, as amended, received for final consideration.

When is it proposed to take Fifth Stage?

Question proposed: "That the Bill do now pass."

I thank all Deputies who contributed to the debate on the Bill. This Bill serves to make important changes to four Acts in the interests of equity, or, in some cases, patient safety. The tobacco legislation is to help protect public health.

Question put and agreed to.

A message shall be sent to the Seanad acquainting it accordingly.