Health (Miscellaneous Provisions) Bill 2016: Committee Stage

This meeting has been convened to consider the Health (Miscellaneous Provisions) Bill 2016, the purpose of which is to amend the Irish Medicines Board Act 1995, the Nursing Homes Support Scheme Act 2009, the Health (Pricing and Supply of Medical Goods) Act 2013 and the Public Health (Standardised Packaging of Tobacco) Act 2015, and to provide for related matters.

On behalf of the committee, I welcome the Minister of State, Deputy Corcoran Kennedy, and her officials to the meeting. The Minister of State would like to make an opening statement.

I am pleased to resume the legislative process of the Health (Miscellaneous Provisions) Bill, which was published in January. I thank the Chairman for allowing me to make some introductory remarks to outline the legislative proposal for the members of the committee.

The Bill is entitled an Act to amend the Irish Medicines Board Act 1995, the Nursing Homes Support Scheme Act 2009, the Health (Pricing and Supply of Medical Goods) Act 2013 and the Public Health (Standardised Packaging of Tobacco) Act 2015; and to provide for related matters. It has four main purposes: to amend the 1995 Act to allow for the payment of fees to members of the Health Products Regulatory Authority, HPRA, formerly the Irish Medicines Board, as such fees are payable to the members of other boards; to amend the 2009 Act in order to exclude certain ex gratia payments that have been or will in future be made to individuals under specific schemes approved by Government for the purpose of assessment of means under that Act; and to amend the 2013 Act so that over-the-counter medicinal products, including emergency contraception and nicotine replacement products, can continue to be reimbursed to medical card holders after June 2018. Otherwise, medical card patients will have no way to access such products without charge other than the prescription charge.

The Bill's purpose is also to amend sections 2, 7, 9, 10, 13 and 14 of the 2015 Act to provide by way of regulation for a number of elements relating to the appearance of tobacco packaging. The regulation of the appearance of the packaging is intended to contribute to improving public health by reducing the appeal of tobacco products to consumers; increasing the effectiveness of health warnings on the retail packaging of tobacco products; and reducing the ability of the packaging of tobacco products to mislead consumers about the harmful effects of smoking. The Bill's amendments to the 2015 Act set out further provisions relating to retail packaging of tobacco products, some of which are of a technical and practical nature and some of which seek to provide basic information to the consumer.

The Bill has five Parts and 16 sections. Part 1 sets out the Title of the Bill and all Parts will be commenced on enactment. Part 2 amends the 1995 Act to allow for the payment of fees to members of the HPRA. Under section 8(7) of the 1995 Act, as amended, only the chairman of the authority is entitled to a fee. There is an onerous responsibility and a significant time commitment placed on members of the authority and we wish to attract the highest calibre of people to apply to be members of such boards. Some people may be self-employed and, without the modest fee that will be paid under this amendment, it would be difficult for them to give the time commitment involved. There is no additional cost to the Exchequer relating to paying board members of the authority, as it is mainly self-funding. The fee approved for payment to each board member, in keeping with the guidelines issued by the Department of Public Expenditure and Reform, is €7,695 per annum. The additional cost to the authority will be up to approximately €61,560 per annum. However, some members may choose to waive their fees and the one person one salary policy will also apply to members who are in receipt of a salary from the public service.

Part 3 aims to amend the 2009 Act in order to exclude certain ex gratia payments that have been or will in future be made to individuals under specific schemes approved by Government for the purpose of assessment of means under the Act, also known as the fair deal scheme. A number of groups within the State have been in receipt of, or will receive, ex gratia payments as a result of Government decisions that acknowledge the hardship, pain and suffering that these individuals underwent. The schemes being covered in this legislation are the Lourdes Hospital Redress Board, involving 119 women; the Lourdes hospital payment scheme, which compensated women who were excluded from the redress board on age grounds alone, which relates to 47 women; the surgical symphysiotomy payment scheme, which has made awards to approximately 400 women; and payments made either by the Government or the German Contergan Foundation to 32 Irish survivors of thalidomide. The Bill will also amend section 36 of the 2009 Act, giving regulation-making power to the Minister to allow for an exemption for other similar groups that may receive ex gratia payments from being taken into consideration for support under the nursing homes support scheme, provided such schemes have been approved by the Government. This is the way that such exemptions under various social welfare schemes are managed by the Department of Social Protection.

The key principle underlying this legislation is that a person should not be disadvantaged because of acceptance of a payment under an ex gratia scheme that has been approved by the Government. Applications under the Nursing Homes Support Scheme Act 2009 are means tested and the individuals or their partners could be over the income threshold for availing of Nursing Homes Support Scheme supports due to receipt of their ex gratia awards. The proposal will not give access to free nursing home care to the various groups. Rather, the awards or payments that they receive under Government-approved ex gratia schemes will be excluded from the financial assessment for supports under the fair deal.

Part 4 of the Bill amends the Health (Pricing and Supply of Medical Goods) Act 2013, Part 1 of Schedule 3. This amendment is required to ensure that over-the-counter products that do not require a prescription can continue to be available under the general medical services, GMS, and community drug schemes if so required. This will ensure that over-the-counter medicinal products, including emergency contraception and nicotine replacement products, can continue to be reimbursed to medical card holders after June 2018. The amendment will allow the HSE to disapply the criterion regarding prescription-only medicines when considered appropriate in the interests of patient safety or public health.

Another amendment proposed is to paragraph 1(e) of Part 1 of Schedule 3 of the Health (Pricing and Supply of Medical Goods) Act 2013, which specifies that medicinal products must have a marketing authorisation referred to in paragraph (a) of the definition of "authorisation holder" in section 2(1) of the Act. The reference to paragraph (a) is unintentionally restrictive, as it excludes products that are authorised by the European Medicines Agency and parallel imports. Parallel importation is the importation from an EU member state or a country within the EEA of a medicinal product that is essentially similar to a product already authorised in Ireland by an importer who is someone other than the importer appointed by the marketing authorisation holder of the product on the Irish market. The parallel trade of medicinal products is based on the principle of the free movement of goods within the internal market of the EU under Articles 28 to 30, inclusive, of the EC treaty. It was never the intention to exclude such products and any such inference would be contrary to free trade principles.

The Bill's explanatory memorandum noted that allowing "reimbursement of certain over-the-counter medicines under the GMS and community drug schemes will give rise to some additional cost from loss of prescription charges over time, but this is not expected to be significant." However, this is not correct. My officials have confirmed that there are in fact no additional costs arising from the amendments proposed in Part 4. The explanatory memorandum also notes that over-the-counter medicines will not be available for reimbursement under the schemes after June 2016. However, the Minister for Health granted an extension of this period under section 18 of the 2013 Act until June 2018.

Part 5 of the Bill seeks to amend sections 2, 7, 9, 10, 13 and 14 of the Public Health (Standardised Packaging of Tobacco) Act 2015. Section 2 of that Act sets out the definitions used in it, section 7 deals with retail packaging of cigarettes, section 9 with roll-your-own tobacco products, other tobacco products, including cigars are dealt with in section 10, presentation of tobacco products in section 13 and features of retail packaging in section 14.

The Act provides for a number of elements to be prescribed by the Minister, including the colour of the outer and inner surfaces of tobacco packaging, the form and manner of bar codes and the manner in which a name may be printed on tobacco products. The amendments to the 2015 Act proposed in this Bill are to provide by way of regulation for a number of other matters relating to the appearance of tobacco packaging. Some of these matters are of a technical and practical nature and some seek to provide basic information to the consumer.

These amendments will permit the following elements to be included on tobacco retail packaging: text to indicate the type and weight or number of tobacco products contained in the packet; the inclusion of a tab to allow consumers to reseal the pack, excluding cigarette packs; the inclusion of a calibration mark, which may be necessary for the automated production of the packaging; contact details of the manufacturer; and additional information on cigar bands.

I intend to bring forward an amendment to the Bill on Report Stage. It relates to Part 5 and the amendment of the Public Health (Standardised Packaging of Tobacco) Act 2015 in the context of the transitional times outlined in section 6. The reason for it relates to the lapse of a substantial period of time since the Health (Miscellaneous Provisions) Bill was first initiated in the Houses. The Bill serves to make important changes to four Acts in the interests of equity or, in some cases, patient safety. Of course, tobacco legislation is to help to protect public health. I hope Deputies will give their full support to the Bill.

As there is only one amendment, the issue of groupings does not arise. The amendment is to section 9.

Sections 1 to 8, inclusive, agreed to.
SECTION 9

I move amendment No. 1:

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

“(c) 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.”.”.

I am moving the amendment on behalf of Deputy Clare Daly and know that there has been some correspondence on the issue with the Department. I urge that it be looked at it again. Deputy Clare Daly reserves her right to retable the amendment on Report Stage. I ask the Minister of State to comment on the purpose of the amendment and indicate whether there is a possibility the particular issue will be addressed because there is an anomaly.

I have examined the amendment proposed by Deputy Clare Daly and there are a number of points I wish to make in outlining the background to the section.

The purpose of section 9 is to allow the HSE to consider the inclusion of over-the-counter products in the list of reimbursable items, where appropriate. The section, as I have proposed it, corrects an anomaly in existing legislation in which current rules only allow medicines that are prescription-only to be supplied under the community drug schemes. This 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 legislation gives a temporary reprieve in supplying over-the-counter medicines until 2018. The amendment, as I have proposed it, will make this permanent. The effect will be that some very useful medicines such as emergency contraception and nicotine replacements will continue to be available under the drug payment scheme, the medical card scheme and other schemes. Patients will still need a doctor's prescription to obtain an approved over-the-counter product under the various schemes. This applies to all schemes and both over-the-counter and prescription-only items. This is a very important control, both clinically and for the financial operation and governance of the schemes.

Specifically regarding access to emergency hormonal contraception, there are a number of issues I have considered carefully. Medical card holders already have access to emergency contraception which is currently available free under the general medical services, GMS, scheme to medical card patients provided they obtain a prescription first. It is also available as an over-the-counter treatment. Therefore, anybody can go into a pharmacy and buy it without a prescription. The most up-to-date figures show that in the 12 months to August this year, just under 13,000 emergency hormonal contraceptive prescriptions were dispensed across all schemes, of which more than 12,000 were under the medical card scheme. The barrier, therefore, for medical card patients in obtaining emergency hormonal contraceptives as soon as possible is not access. More than 12,000 people a year go to their doctor and then the pharmacy. The issue arises when people need emergency hormonal contraception but cannot obtain a prescription in time to receive treatment. It might be the weekend and they cannot get an urgent appointment or they might not be able to afford to buy it. I share Deputy Clare Daly's concern about timely access to treatment for medical card holders and fully accept that there should not be unnecessary barriers to receiving this treatment. However, while I agree with the principle of the Deputy's amendment, I do not propose to accept it for the following reasons. The Minister for Health has instructed officials to remove this requirement as a matter of urgency.

Work on the development of services and clinical structures is under way. A minor ailments pilot scheme was run over the summer, allowing pharmacies to treat medical card patients with over-the-counter medicines for minor conditions without a doctor's prescription. Much of the IT infrastructure needed has been trialled under the minor ailments pilot scheme. In line with the Minister's instructions, the HSE is developing the operational structures to implement this service safely and effectively, including the clinical standards required to ensure patient safety; procedures for identifying pharmacies in compliance with these standards as for the vaccination programmes; and the infrastructure required to provide a secure claiming and verification process. Service development will be built on work already done, including the Pharmaceutical Society of Ireland's professional practice guidelines for dispensing over-the-counter emergency hormonal contraception and existing structures for providing specific services in pharmacies such as the vaccination programme.

The amendment is not legally necessary. There is no legal barrier to the proposal other than that being corrected in section 9. The amendment which prescribes the supply of a single treatment in a specific manner through primary legislation raises a number of challenges, including that it could undermine the requirement placed on the HSE to provide treatment in line with patient safety and cost constraints, for example, to get the best price or refuse individual products. Crucially, it might remove the ability of pharmacists to make clinical judgments and decisions, in particular, a decision not to supply where it may be unsafe for a patient for clinical reasons. This is a professional clinical service set out by the Pharmaceutical Society of Ireland which the amendment does not reflect and which would make it unsafe.

Discussions will be required with the Irish Pharmaceutical Union on implementation and officials will pursue this aspect. The Irish Pharmaceutical Union has previously indicated a willingness to expand into this type of professional service and was involved in the minor ailments pilot scheme for over-the-counter products. The Pharmaceutical Society of Ireland has issued professional practice guidelines on dispensing emergency hormonal contraception and advising patients. Deputy Clare Daly and other members of the committee will appreciate that significant steps have been taken to remove barriers to timely treatment for medical card holders in the case of both emergency contraception and over-the-counter products in general. The principle behind the amendment is worthwhile. I thank the Deputy for raising the issue and Deputy Billy Kelleher for raising it in her stead. The amendment makes a valuable contribution but is actually not necessary in addressing this health need. In fact, it could have unintended consequences. In addition, given the operational challenges to be addressed, it would not speed up implementation which is already under way.

There are other issues that have been raised about cases in which pharmacists would not provide treatment. They may not have been able to provide treatment or may have had personal reasons for not wishing to do so. The statutory code of conduct for pharmacists requires that, where they are unable to provide a service, they take reasonable action to ensure the patient's care is not jeopardised. In practice, the patient should be referred to another pharmacist, pharmacy or health service. All pharmacists must subscribe to this code. If a patient is unhappy with the conduct of a pharmacy or a pharmacist in this or any other matter, he or she should contact the Pharmaceutical Society of Ireland which regulates the profession.

I withdraw the amendment, but Deputy Clare Daly retains the right to reintroduce it on Report Stage for further consideration.

Amendment, by leave, withdrawn.
Section 9 agreed to.
Sections 10 to 16, inclusive, agreed to.
Title agreed to.

The Bill is a timely reminder of some of the sadder episodes in medical history, some of which were referred to by the Minister of State.

It is no harm to reflect on them now and hope the necessary remedial action has been taken. The episodes are a sufficient warning to us all to ensure we do not repeat them.

I thank the Minister of State, Deputy Marcella Corcoran Kennedy, and her officials for attending. I thank members for considering the Bill.

Bill reported without amendment.