Wednesday, 1 February 2017
Health (Miscellaneous Provisions) Bill 2016: Second Stage
I am very pleased to have the opportunity to address the House on Second Stage of the Health (Miscellaneous Provisions) Bill, which was passed on 6 December last by Dáil Éireann. The Bill includes some provisions which relate specifically to my health promotion portfolio. When it comes to health promotion and encouraging behavioural change in relation to tobacco, alcohol and unhealthy diets, what we need is a whole of government and a whole of society approach. This is crucial if we are to be successful in stemming the tide of non-communicable diseases and their impact on our population.
Healthy Ireland, the national framework, aims to make it easier for more people to stay healthy, stay out of hospital and make positive changes that will enhance their lives. Part 5 of this Bill aims to progress the Healthy Ireland agenda by making amendments to the legislation that introduces standardised packaging of tobacco. Standardised packaging is just one of the many important public health measures we are introducing in order to reduce the number of deaths of Irish people from non-communicable diseases. The Bill has five Parts, with 16 sections. Part 1 sets out the Title to the Bill. 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. This is in line with the practice of other similar boards, where fees are paid to board members in order to attract individuals of the highest calibre and expertise to apply for board membership, for example, to the Medical Council and the Pharmaceutical Society of Ireland. 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. Some people may be self-employed and, without the modest 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 approximately €61,560 per annum. However, some members may choose to waive their fee and the one person, one salary system will also apply to members who are in receipt of a salary from the public service.
Part 3 of this Bill proposes to amend the Nursing Homes Support Scheme Act 2009 in order to exclude certain ex gratiapayments which have, or will in the future, be made to individuals under specific schemes approved by Government for the purposes of assessment of means under the nursing homes support scheme, commonly known as the fair deal scheme. The fair deal scheme is a very important scheme that provides financial support for those assessed as needing long-term nursing home care. Participants contribute to the cost of their care according to their means while the State pays the balance of the cost. The scheme aims to ensure that long-term nursing home care is accessible and affordable to everyone and that people are cared for in the most appropriate settings. All applicants to the scheme must undergo a financial assessment which is carried out by the HSE to determine how much a participant in the scheme will contribute to the cost of care. The scheme has a number of important safeguards built into the financial assessment to ensure that nobody will pay more than the actual cost of care and to ensure that an applicant will keep a personal allowance of 20% of his or her income or 20% of the maximum rate of the State pension, whichever is greater.
This proposed amendment to the Nursing Homes Support Scheme Act is a critically important provision for many of our senior citizens, as it will exempt payments made to persons under ex gratiaschemes approved by Government from being included in the assessment for State support under the fair deal scheme. This provision applies to persons who have received awards under four schemes: the surgical symphysiotomy payment scheme, which has made awards to around 400 women; 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 and relates to 47 women; and payments made either by the Government or by the German Contergan Foundation to 32 Irish survivors of thalidomide.
I am also particularly pleased that the Bill proposes to amend section 36 of the 2009 Act to provide for the Minister to make regulations to allow an exemption for other similar groups that may in the future receive ex gratiaawards, provided that the Government has approved the scheme. This future-proofing is an important and significant feature of this part of the legislation. For any individual who has received an ex gratiapayment under a Government-approved scheme, it is a very important principle that, on reaching a more senior stage of their life, people should not be in any way disadvantaged financially when it comes to making an application under the fair deal scheme. In summary, the proposed amendments to the Health (Miscellaneous Provisions) Bill are key, age-related provisions for people who have received an ex gratiaaward and who now in their older years are seeking supports under the nursing homes support scheme.
Part 4 of the Bill amends Part 1 of Schedule 3 to the Health (Pricing and Supply of Medical Goods) Act 2013. The purpose of this proposed amendment is to allow the HSE to consider reimbursing over-the-counter products, where appropriate. The amendment corrects an anomaly in existing legislation, where current rules only allow medicines that are prescription-only to be supplied in the community drugs schemes. This anomaly affects a number of products that were prescription only and are now over the counter, as well as some over-the-counter items that have long been available in the schemes. The 2013 Act gives a temporary reprieve on supplying over-the-counter medicines until 2018 and the amendment I have proposed will make this permanent. This means that some very useful medicines, such as emergency contraception and nicotine replacement, will continue to be available on the drug payment scheme, medical card scheme and other schemes. Patients will, however, still need an authorisation to get an approved over-the-counter product under the various schemes. This applies to all schemes and to 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 important points that have been carefully considered by the Department. First, it is important to note that medical card holders already have access to emergency contraception. It is currently available free to medical card patients, provided they get a prescription first. It is also available as an over-the-counter treatment, so any person can go into a pharmacy and buy it without a prescription. In the 12 months to August 2016, just under 13,000 emergency hormonal contraceptive prescriptions were dispensed across all the schemes, and over 12,000 of these were on the medical card scheme. The barrier, therefore, for medical card patients in getting emergency contraceptive as soon as possible is not access, as over 12,000 people per year go to their doctor and then to the pharmacy.
The issue is when women need emergency contraception but cannot get a prescription in time to get the treatment, for example, it might be at the weekend, they cannot get an urgent appointment with their GP or they cannot afford to buy the product. The Minister, Deputy Harris, and I share the concerns that have been raised by some Deputies in the Dáil over timely access to treatment for medical card holders. I fully accept that there should not be unnecessary barriers to women getting this treatment and this is being addressed. The Minister for Health has instructed officials to change the process for supplying emergency hormonal contraception to medical card holders as a matter of urgency and work on the development of service and clinical structures is under way.
Much of the IT infrastructure needed was trialled in the recent minor ailments pilot, in which pharmacies treated medical card patients with over-the-counter medicines for minor conditions, without needing to see a GP. In line with the Minister’s instructions, the HSE is developing the operational structures to implement this service safely and effectively, including procedures for identifying pharmacies in compliance with the Pharmaceutical Society of Ireland’s professional practice guidelines for dispensing over-the-counter emergency contraception, as is done for the vaccination programmes and also secure claiming and verification processes.It is expected that the measures for emergency contraception will be in place in the second quarter of this year.
Senators will appreciate that significant steps have already been taken to remove barriers to timely treatment for medical card holders for both emergency contraception and over-the-counter products in general.
Concerns also have been raised about the availability of emergency contraception to women where a pharmacist may not be able to provide the treatment or may have 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, pharmacists 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 pharmacist in this or any other matter, he or she should contact the Pharmaceutical Society of Ireland, which regulates the profession.
There is also provision in the Bill to remove the unintentionally restrictive provision referred to in paragraph (a), which excludes products authorised by the European Medicines Agency and parallel imports from the medical card and community drugs schemes. 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. It was never the intention to exclude such products and any such inference would be contrary to free trade principles.
For the information of the Senators I would point out that the explanatory memorandum which accompanied the Bill 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.
Part 5 of this Bill holds a particular interest for me in my capacity as Minister of State with responsibility for health promotion. It seeks to amend the Public Health (Standardised Packaging of Tobacco) Act 2015, which is a significant tobacco control measure. I acknowledge the tremendous work of the former Minister for Health, now Senator, James Reilly in enacting this important public health legislation. I know that introducing this legislation is of great importance to Senator Reilly and I assure him and all the Senators of my commitment and that of the Minister, Deputy Harris, to ensuring this legislation is commenced fully in the near future.
The aim of the legislation is to make all tobacco packs look less attractive to consumers; make health warnings more prominent and prevent packaging from misleading consumers about the harmful effects of tobacco. It gives effect to Ireland's obligations under the World Health Organization Framework Convention on Tobacco Control. Standardised packaging of tobacco is Ireland's next step towards creating a tobacco-free Ireland. Evidence indicates that tobacco packaging is a critically important form of promotion. This is more relevant in Ireland, where we have comprehensive advertising and marketing restrictions. We know that branding works, particularly on children. If the tobacco industry did not addict our children, its industry would disappear within a generation. Given that 78% of smokers in a survey said they started smoking before they reached the age of 18, it is clear that our children are targeted to replace those consumers who die or quit.
The amendments to the 2015 Act put forward in this Bill 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. The amendments also set out new transitional times to reflect the time that has elapsed since this Bill was initiated in the Dáil. The original timeframe for the manufacture of the new standardised packaging from 20 May 2016 has now passed. The approach taken in the Bill is in line with the original intention of the Public Health (Standardised Packaging of Tobacco) Act 2015. It is my intention to give key stakeholders, including the tobacco industry, adequate notice of the commencement date referred to in the Bill. The amendments set out in this Bill will enable Ireland to proceed with the introduction of standardised packaging of tobacco products. The objective of this measure and many other tobacco control measures is of course to dissuade people from starting to smoke, to encourage current smokers to quit and ultimately to save lives. It is the combination of past, present and future tobacco control measures that will reduce tobacco consumption in Ireland and not one measure in isolation. All of the measures outlined in our tobacco policy, Tobacco Free Ireland, will have a role in reducing the prevalence of smoking in Ireland.
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 hope Senators will give their support to the Bill. I therefore commend this Bill to the House.