Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I move: "That the Bill be now read a Second Time."

I am very pleased to have the opportunity to address the House on the Second Stage of the Health (Miscellaneous Provisions) Bill, which was published in January this year. The Bill has five Parts, with 16 sections. Part 1 sets out the Title of the Bill and all Parts will be commenced on enactment.

Part 2 amends the Irish Medicines Board Act 1995 to allow for the payment of fees to members of the Health Products Regulatory Authority, formerly the Irish Medicines Board, as such fees are payable to the members of other boards. Currently, under section 8(7) of the Irish Medicines Board Act 1995, 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 fee that will be paid under this amendment, it would be very 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 fee and the one person one salary principle will also apply to members who are in receipt of a salary from the public service.

Part 3 aims to amend the Nursing Homes Support Scheme Act 2009, otherwise known as the fair deal scheme, to exclude certain ex gratiapayments which have been or will be made to people under specific schemes approved by Government for the purpose of assessment of means under fair deal. This is a very important amendment. Several groups within the State have been in receipt of, or will receive, ex gratiapayments as a result of Government decisions which acknowledge the hardship, pain and suffering which the people affected 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, involving 47 women; the surgical symphysiotomy payment scheme, which has made awards to around 400 women; and payments made either by the Government or by 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 fair deal, provided such schemes have been approved by Government. This is the way that such exemptions under various social welfare schemes are managed also 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 which has been approved by Government. Fair deal applications are means tested and the people themselves or their partners could be over the income threshold for availing of fair deal supports because of receipt of their ex gratiaawards. The proposal will not give access to free nursing home care to the various groups, but it will mean that the payments they receive under Government-approved ex gratiaschemes will be not be considered as part of their income for the purpose of assessment under fair deal.

Part 4 amends the Health (Pricing and Supply of Medical Goods) Act 2013, Part 1 of Schedule 3. This amendment is required to ensure over-the-counter products which do not require a prescription can continue to be available under the General Medical Service, GMS, and community drug schemes if so required. This will ensure over-the-counter medicinal products, including emergency contraception and nicotine replacement products, can continue to be reimbursed to medical card holders after May 2018. The amendment proposed will allow the HSE not to apply 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 currently 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 which are authorised by the European Medicines Agency and parallel imports. Parallel importation is the importation from a European Union, EU, member state or a country within the European Economic Area, EEA, of a medicinal product, which 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, Articles 28 to 30 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 explanatory memorandum which accompanies the Bill notes 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 now confirmed that there are in fact no additional costs arising from the amendments proposed in Part 4. My Department will ensure this is clarified in any further briefing on the draft legislation.

Part 5 seeks to amend sections 2, 7, 9, 10, 13 and 14 of the Public Health (Standardised Packaging of Tobacco) Act 2015. Section 2 of the Act sets out the definitions used in the Act, 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 regulation of the appearance of tobacco 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 retail packaging and reducing the ability of the packaging of tobacco products to mislead consumers about the harmful effects of smoking. This country has led the way through successive Governments in respect of tobacco control and moving towards a tobacco-free Ireland.

The Act currently 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 barcodes and the manner in which a name may be printed on tobacco products. The amendments to the 2015 Act put forward in this Bill are to provide, by way of regulations, 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 package; the inclusion of a calibration mark, which may be necessary for the automated production of the packaging; the contact details of the manufacturer; and additional information on cigar bands.

This Health (Miscellaneous Provisions) Bill serves to make important changes to four Acts in the interests of equity or, in some cases, patient safety, and of course the tobacco legislation is to help protect public health. I look forward to the passage of the Bill so that we can get on with making the improvements regarding the fair deal scheme, which is being led by my colleague, the Minister of State, Deputy Helen McEntee, and the job of introducing the standardised packaging for tobacco being led by my colleague, the Minister of State, Deputy Marcella Corcoran Kennedy, which is the next important step in terms of our move towards a tobacco-free Ireland.

I commend the Bill to the House. I hope Members on all sides can agree to support the legislation and have it passed as quickly as possible by the Oireachtas so that we can get on with making these important improvements.

See this speech in context