Marcella Corcoran Kennedy (Offaly, Fine Gael) | Oireachtas source

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 gratiapayments 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 gratiapayments 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 gratiapayments 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 gratiapayments 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 gratiascheme 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 gratiaawards. 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 gratiaschemes 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.