Health (Miscellaneous Provisions) Bill 2016: Second Stage (Resumed)

Question again proposed: "That the Bill be now read a Second Time."

I welcome the opportunity to speak on Second Stage of the Health (Miscellaneous Provisions) Bill 2016. Part 2 of the Bill seeks to amend the Irish Medicines Board Act 1995 to allow for the payment of fees to members of the Health Products Regulatory Authority, formerly known as the Irish Medicines Board. I fundamentally agree with the principle of a person being paid a fee for work done and, as such, I agree with the amendment. There will be no additional cost to the Exchequer as a result of it.

Part 3 will amend the Nursing Homes Support Scheme Act 2009, which we all know as the fair deal scheme. Again, I agree with the change, which will exempt payments made under certain schemes from the calculation of assessment for the fair deal. I am particularly pleased that the Lourdes Hospital Redress Board and the Lourdes hospital payment scheme are to be included in the amendment. I agree that the key principle underlying the legislation in that a person must not be disadvantaged because he or she has accepted a payment under an ex gratia scheme which has been approved by the Government.

Like many other Members of the House, I have made a large number of representations about the fair deal scheme. In general, the scheme works very well and takes a lot of worry away from families about how their loved ones are cared for in their later years. However, one issue that comes up time and again is the location of the nursing home in relation to where the family resides. For example, we could have a situation in which a family based in north county Louth, say in Carlingford, could have a family member cared for in a nursing home in Ardee. This is happening on a regular basis and is a source of ongoing worry and concern for families.

We need to address this situation in a more formal manner and perhaps to include it in legislation. We should consider introducing a system whereby those availing of the fair deal scheme are located in a nursing home not more than, for example, 10 km from the family home, once a suitable nursing home is available. This would alleviate the problem of families not being able to visit their loved ones in nursing homes on a more regular basis and this would benefit the person in care, who will have a better quality of life while in the nursing home.

Part 4 amends the Health (Pricing and Supply of Medical Goods) Act 2013. The amendment will ensure that over-the-counter products, which do not require a prescription, can continue to be available under the GMS and community drug schemes. This will ensure that over-the-counter products, including emergency contraception and nicotine replacement, continue to be reimbursed to medical card holders after May 2018. The amendment refers to the parallel importation of medical products from EU countries. I ask that the Minister also examine the effects of this change in light the UK's decision to leave the EU and whether it will impact on the legislation.

Part 5 seeks to amend certain sections of the Public Health (Standardised Packaging of Tobacco) Act 2015. The amendment will deal with the retail packaging of cigarettes, "roll your own" tobacco products and cigars. I spent a lot of time in the previous Dáil as a member of the health committee and discussed in detail the packaging of tobacco products. My personal view is that tobacco products have no place in society and every effort should be made to remove them. While this is not going to happen in the near future, I am happy that at least we are making moves to limit the sale of tobacco. I was brought up in an era when tobacco was seen as acceptable and advertising played a major role in that. Major sporting events were sponsored by tobacco companies and TV advertising glamorised smoking.

Thankfully, this no longer happens and people are more aware of the dangers of tobacco and its effects on their long-term health.

In order to rid society of tobacco entirely, we must educate our young people. We must start this education process in primary school and continue it during secondary school. I spent a great deal of time researching this issue during my time on the health committee and have no doubt that we need to take a more proactive approach in our schools.

The amendment under discussion will tackle the problem of tobacco packaging and the influence that it has on the sale and promotion of tobacco once and for all. I welcome the Bill and look forward to its passage through the Houses.

This important Bill makes significant amendments that afford the Minister additional ways of ensuring that no sum of money received by victims of medical misadventures in compensation as part of a new deal will be included in any assessment of means under the nursing homes support scheme. The scheme is expensive and has existed for a number of years and there are significant problems with it. For example, I receive complaints from people in nursing homes or their families to the effect that, although they agreed to an overall package before entering a home, many elements were not included. Clarity is needed as regards what is being offered and paid in these deals. A person signs a list of items when entering a nursing home, but homes often ask for extra money subsequently, which can eat into the small resources still in the pensioner's hands after paying for the fair deal. This has a significant and adverse impact on many pensioners. Pressure is placed on them to pay for additional items that should have been included in the deal and of which they may never be able to avail. For example, someone who is bed-bound because he or she cannot move a leg or arm due to a medical condition might have to pay for entertainment and other activities that he or she cannot even attend or participate in.

As the Acting Chairman knows, a question about home help has arisen in our constituency. In many cases, the home help system in County Louth is not working efficiently or well. I am still receiving complaints from people who have applied for home help services or whose home help hours have been cut. What is the point in cutting people's home help hours when the alternative is a nursing home at a much higher cost to the State and a significant reduction in the benefit derived by being supported to live independently in one's own home as best one can regardless of one's medical condition? This is a concern and I am not satisfied that the system is working to everyone's benefit. For example, I fail to see the advantage in offering an elderly person half an hour per day of home care over a week, which is often the case. By the time the person who comes to the home can get anything done, it is already time to go. In such a situation, the advantage that someone's carer might otherwise have - going out, taking a break, doing a bit of shopping, getting a breath of fresh air or having a little bit of a social life - is not available. This must be addressed in respect of people with significant adverse medical conditions. The transparency of decision making in the HSE concerns me. I have tried to communicate with the HSE and get a better understanding of what is happening within it as regards home help, but I have failed.

The question of respite care also arises in our constituency. Some people can get respite care from the HSE in institutions, but a significant number in our constituency cannot get any. This is because no spaces are available. They have intellectual disabilities and the respite care previously afforded them by the St. John of God services in Drumcar is no longer sufficiently available. I am concerned about this. We have held a number of meetings about it, including with the Minister, but the situation remains unresolved. The key benefit of respite care is that it keeps people out of long-term care and gives families an opportunity to do things that they would not otherwise be able to do. When adults suffering mental disabilities have nowhere to go, it is unacceptable that the funding provided to the St. John of God services cannot be broken down to identify how much of it is for respite care. This is an emerging need across the country, with a large number of families encountering problems in getting respite care because the congregated settings principle has ended. While I welcome the fact that funding is now going towards resourcing adequate and proper homes for long-term patients in the community, people who need respite care are not being considered and nothing is being made available to them.

I welcome other aspects of the legislation, but I wish to make a point about cataract operations in County Louth. A constituent told me this week that the private waiting list is four weeks long. If he could come up with the money, which he cannot, then he could have his cataracts dealt with in four weeks. Instead, he must wait 18-24 months to attend the Mater hospital. This is unacceptable. If he availed of the facility to go north of the Border, his operation would be almost twice as expensive as it would be in the South and he would be expected to pay the difference. The State covers £1,184, which is the listed price for a cataract operation, and the price in the North is £2,198. The State is obliged to ensure that people get their operations in time, but one must come up with the difference if one goes to the North or else suffer for a further 24 months.

Notwithstanding the Bill's good elements, problems continue to exist in our health service. The HSE needs to be made more accountable, particularly to Members of the Oireachtas, in how it operates. My colleague, Deputy Fitzpatrick, referred to being a member of the health committee. I am not a member, although I have tried to become one. Unfortunately, I was turned down. Obviously, I do not qualify with my interest in health. I would love to make the HSE accountable on a regional level to Members of the Oireachtas. When an Oireachtas Member was a member of a health board, one attended its meeting every month and could raise and get an answer and action on any acute care or community care issue affecting one's county. Now, we cannot meet the people in question. They hide behind e-mails. Notwithstanding that, the HSE has a good communicator in Mr. Dermot Monaghan, who is exceptionally capable and helpful. However, it is impossible at times to contact other people further down the line. I would like the HSE to be accountable to Members on a two or three-county basis. It keeps reorganising itself and I do not know what dance it is doing in what counties at present, but it is not accountable. People run and hide from us and the public suffers as a result. I would like to see more accountability to the Oireachtas, notwithstanding the efforts of the health committee. Deputies and Senators would meet the HSE executives from each group of counties - I believe our group used to comprise Louth, Meath, Cavan and Monaghan - on a quarterly basis.

They would go through issues of concern for only those areas and I should make it very clear that it would not be about taking up issues outside the brief. They would have to give due notice of questions and copies of reports. That would make them much more accountable and much less likely to provide bad health care.

I am familiar with the case of a person who died a very tragic and appalling death while in care. The family feel the same. The inability of the HSE to provide an independent investigating team indicated the following problems. An investigation was established that did not include medical people so the family could not accept the result. A doctor who worked with the HSE met another specialist in a second investigation but the doctor resigned from the committee - I am told it was because of work pressures - and the investigation ceased. I am thankful that in the past two weeks an independent private company has begun to investigate this appalling death. I welcome the investigation, which will be professional, thorough, full and fair. Nevertheless, the HSE cannot and should not investigate itself and attempts for it to do so are wrong. The HSE needs a body separated from the executive in every respect, with a field of specialists available to investigate tragedies, health mismanagement and deaths that could bring serious concern to the public. The family I spoke of has been waiting four years for accountability in respect of the death of its relative. If such an separate and independent process could be put in place, such people would not have to wait that long. That process should be professional in doing its work. For families to get closure in the event of tragic deaths like this is very important for the people in question and the State. There should be independent analysis of what happened and how it can be prevented from happening again.

I welcome the changing of some previously prescription items to being available over the counter with a medical card. It is a very positive move that will alleviate medical problems for people who need creams or different products. Not every person with a medical card will need them but some will. If the product was not on the list in the past, they could not afford the medication. I welcome that change.

I am still amazed by the number of people who continue to smoke. Many of them are very young. I might see them walking across the street and I would say "Hey guys, you know that in 20 or 30 years you will probably be in your graves". That is what I say in my head and I do not actually say it do them. How can one miss all the health issues associated with smoking? Anything we can do to stamp out the evils of tobacco, with all the additional powers being vested in the Minister to make new and better regulations on tobacco packaging, should be welcomed.

I thank the Ceann Comhairle for the freedom to deal with a range of issues. I will deal another time with 900 complaints made to HIQA four years ago. I gave the information to the Garda and received a report on it recently. I probably do not have enough time to deal with it today. I welcome the Bill and the changes proposed. The Minister of State is listening and I hope the Department will hear what I say. We will raise these questions and issues again.

I welcome the Bill, which contains a number of miscellaneous provisions relating to the health area. I will comment on one or two of them but I will also suggest some areas not included in the Bill that require attention from the Department of Health in the very near future if not in this Bill.

We heard mention of an issue this morning on Leaders' Questions when Deputy Harty, on behalf of the Independent Alliance, spoke about rural services provision. He was speaking about post offices but he is probably better known for talking about GP services. He mentioned the phrase "no doctor, no village", which I have become familiar with in recent times. Although this may be associated with the western seaboard or quite rural areas, the issue is becoming apparent right around the country, with rural GP and health care services being eroded. The Department and the HSE have not been proactive in replacing these.

A particular issue arises when those who live in localities are very dependent on their community GPs. We heard, correctly, for many years about the need to move towards primary care as the first point of service provision so that as much as possible can be done at the first point of contact by bringing care into the community and the home in some cases. This is a very laudable and sensible approach. Unfortunately, however, it depends on individuals and, like many things, the practice of health is subject to market forces. It is of mixed nature as there is serious public intervention as well but we cannot control where individuals choose to practice. An issue arises when a GP provides a very valuable service to communities but decides not to continue servicing those communities because of economic reasons - it may be unviable - or, as in my own constituency of north Kildare, around Johnstown Bridge and its surroundings, a rural GP may retire. Retirement is a normal life event for everybody and a GP is absolutely entitled to do this but it can be very difficult to find a successor. There are 6,000 patients in the surgery in my area and they now have nowhere to attend. A locum is in place but it is restricted, down from 100 hours to 18 hours on an interim basis. This leaves a number of people in rural communities very exposed and it is a particular issue, as I have said, in Johnstown Bridge in north Kildare, although it is happening across the country. The more I investigate, the more I hear about it in other constituencies. It is an issue at national policy level that must be addressed. The HSE, the Department and, perhaps, the Minister must become more proactive in highlighting this. Forward planning plays a huge part in identifying where a GP is likely to be retiring and what steps can be taken to replace the GP in time.

As I have stated, it is a mixed market and there are elements of the general medical scheme and public patients attending practices along with private patients. The difficulty is one of one of economics as the public practice may not be enough on its own to sustain a GP practice, so a private element is needed. In Clare, Mayo and Kildare I have seen that the process of replacing a GP takes so long that the practice dissipates to the four winds and there is nothing to take over once three, six or 12 months have elapsed. I understand that this was addressed in the programme for Government and it was certainly the subject of talks relating to the formation of the current Administration. I am not sure how far that got but it is something that needs to be highlighted on a national level. I hope we can see movement on it, perhaps not in this Bill, but at a future stage. There is a need to be cognisant of the gaps arising in rural communities, where GPs are retiring - a natural life event - but not being replaced, as well as the health economics around that.

Measures such as the rural practice allowance were traditionally associated with practices with a large rural catchment area and General Medical Services scheme. In some cases that measure has been taken away and I understand it was replaced in the programme for Government. Regulations were updated but in many cases pared back. The net effect is that many places no longer have community GPs. Where there was a GP and he or she retires, the process of replacing him or her is so cumbersome and elongated, there is nothing left to take over in some cases. People then go to towns and primary care centres where that is possible but many elderly people in particular do not have the option. From a policy perspective, forward planning would not be terribly difficult as this manifest itself again and again. I hope I will still be in this House in a few years but I hope I will not be talking about this and it will have been addressed in the meantime. Right now we can examine the ages of GPs in rural areas across the country and when they can be expected to retire.

It seems that the process of recruitment and replacement only kicks in at that point. Surely it should be kicking in much earlier in order to enable forward planning. This is a serious issue in rural areas where people, particularly the elderly who cannot travel to other towns to avail of medical services, feel exposed and vulnerable. I ask the Minister to examine this issue. If provisions were included in this Bill, I would welcome them, especially around the rural practice allowance and other supports to maintain rural practices but perhaps that would be better done through another vehicle.

There are many provisions in this Bill related to pricing, how the system works and various pricing structures. Prescription charges are a cross to bear for many older people. While a €2.50 charge may seem like a small amount of money, it is a lot to some people, particularly pensioners who have very limited means and are living on a fixed income. Fianna Fáil believes that the prescription charge should be abolished entirely and I hope we will see some movement on that in next week's budget. There is nothing in this Bill that deals with the issue of prescription charges but I await next Tuesday's budget with great interest and expectation in that regard. Prescription charges are a burden on older people. I have spoken to many people at my clinics - as have many other Deputies no doubt - who have told me that they are afraid to fill their prescriptions because their income is so limited and they are afraid of what they might be left with at the end of the week. They are taking a chance and deciding to do without their medication because of the limited money in their pocket and the need to put bread on the table. The cumulative effect of this is that older people are exposed and more vulnerable. Fianna Fáil firmly believes that prescription charges should be abolished if at all possible. As I have said, I look forward to seeing if prescription charges are on the agenda next Tuesday.

The problem with rural GP practices must be addressed. I have seen in my own constituency and in many areas across the country that when rural GPs retire, they are not being replaced quickly. The process of replacing them takes so long that the practice is dissipated. People are left exposed and vulnerable and find themselves having to travel to see a GP, while some are not able to travel at all. The entire recruitment process must be overhauled. Supports for rural surgeries and practices also need to be overhauled. The rural practice allowance and other measures must be re-examined. Again, I hope to see movement on the issue of prescription charges which are a burden on elderly people.

The Health (Miscellaneous Provisions) Bill 2016 essentially tidies up a number of matters in four key areas. Part 2 of the Bill seeks to amend the Irish Medicines Board Act to give the Minister the power to pay a fee to all the board members of the Health Products Regulatory Authority. The Department of Health has indicated that this is proposed due to an inconsistency in legislation but will not cost the State anything. The authority itself will pay the fees which have been estimated to cost a total of €61,500 or €7,695 per board member. The members of the board do not have to accept this fee. Those board members who are already in receipt of a public sector salary will not be paid the fee. As a result, there will be no cost to the State from this provision. The provision mirrors those that apply in respect of other authorities, the members of which are paid for a certain amount of the work they do.

Part 3 of the Bill seeks to amend the Nursing Home Support Scheme Act of 2009. It appears that the provisions in this Part will allow certain payments from redress and similar schemes to be exempt from means testing for the fair deal nursing homes support scheme. I wish to raise an issue regarding the fair deal scheme, particularly for people with dementia. An enduring power of attorney is required, which is a long and costly process. Does this Bill provide that such legal costs, if incurred by any of those in redress and similar schemes, will be covered by the State? The Bill makes specific reference to several schemes for different groups of women who were treated brutally in our health services. One of the schemes referred to is the Lourdes Hospital redress scheme for former patients of Dr. Michael Neary at Our Lady of Lourdes Hospital in Drogheda, who number around 119 women. The Lourdes Hospital payment scheme is also included, which is a scheme for former patients of Dr. Neary who were excluded from the Lourdes Hospital Redress Scheme for reasons of age. The symphysiotomy payment scheme for women who underwent symphysiotomy in any hospital in this State between 1940 and 1990 is also included in this Part of the Bill. At the time that we debated that scheme in the House, we learned that approximately 400 women were affected although some of them have, tragically, passed on since then. The provisions in this Part also apply to those individuals who were disabled by thalidomide. I am not sure of the numbers involved but according to the Department of Health, the provisions will apply to approximately 520 people, mainly women, in total.

The explanatory memorandum to the Bill points out that the payments made under the various schemes acknowledge the hardship, pain and suffering which these individuals underwent. I will always remember the feeling of sadness and overwhelming shame at the way the State treated these people, particularly the women who underwent symphysiotomy and who had to campaign for so long for recognition of their situation. They underwent a brutal operation, involving the breaking of their pelvic bone, which was done without their permission. They were left in a dire situation, health wise, which was not recognised for many years. It badly affected the women and their families. Eventually the redress scheme was set up after much campaigning on the part of the women. I welcome the fact that their ex gratia payment will not be taken into consideration in the context of a means test for the fair deal nursing homes support scheme.

I have a question about one section of the explanatory memorandum which states that "the proposal will not give access to free nursing home care to the various groups, but it will merely mean that the awards/payments they receive will be ignored for the purpose of assessment under the NHSS". Do these women have to pay for nursing home care? I did not think that was the case but it seems, from the explanatory memorandum, that they do not have access to free nursing home care.

The Bill also deals with drug reimbursement and over-the-counter medicines. Part 4 of the Bill provides for the amendment of the Health (Pricing and Supply of Medical Goods) Act 2013. The relevant context for the proposed amendment is that at present, for certain eligible people, namely those with medical cards or long-term illness cards, the HSE covers the cost of their prescription medicines. The HSE maintains a reimbursement list, which is a list of products provided free of charge to eligible people. A pharmacist provides the medication and is later reimbursed by the HSE. The HSE does not cover the cost of non-prescription or over-the-counter drugs for the same people. The legislation provides that the drugs on the reimbursement list must be reviewed within three years. The amendments to the Bill would allow over-the-counter medicines to be put or kept on the reimbursement list if this is deemed to be in the interests of patient safety or public health.

A number of people have told me that they welcome the fact that certain over-the-counter medicines will be put on the medical card reimbursement list. However, I am surprised that more people have not cottoned on to the fact that the morning-after pill is to be put on the list.

Women who have concerns about getting pregnant after having sex will be able to get the morning-after pill. It normally costs a woman approximately €20 to go in and buy it. Women can get it over the counter by using their medical cards. I am really concerned that they have to go to a doctor to get a prescription to actually get that over the counter. The Irish Pharmacy Union has said it is concerned about this. The earlier a woman has access to the morning-after pill, the fewer her health concerns. There are also concerns about discrimination against poorer women who have to go to a doctor to get a prescription before going to the pharmacist with a medical card to get the morning-after pill. According to the Irish Pharmacy Union, the emergency contraception pill is 95% effective if it is taken within 24 hours of having sex, 85% effective if it is taken within 24 to 48 hours of having sex and 58% effective if it is taken within 48 to 72 hours of having sex. It appears to me that the earlier a woman can access the emergency contraceptive pill, the better it is for her health. According to the briefing material we have received from the Library and Research Service, the Department has clarified:

This [the proposed amendment] does not mean that pharmacists can supply such products to medical card patients without a prescription. A number of policy issues would need to be considered before this could be contemplated, including the potential cost from loss of prescription charges, or otherwise.

I am not sure by whom this "loss" would be incurred. It seems that the pharmacists would have no problem with such an arrangement. They would not mind having to hand the emergency contraceptive pill over to people who do not have a prescription. I think that should be taken on board. We should look at ways of ensuring women do not have to go to their GPs to get prescriptions when they need the emergency contraceptive pill. As I have said, the current provisions in this regard are discriminatory because they made it more difficult for poorer women to access this form of contraception as quickly as possible.

Part 5 of this Bill seeks to amend various sections of the Public Health (Standardised Packaging of Tobacco) Act 2015. As I understand it, the purpose of the 2015 Act was to control the design and appearance of tobacco products and packaging and to contribute to improving public health by reducing the appeal of tobacco products to consumers. It was intended that this legislation would increase the effectiveness of health warnings on the packaging of tobacco products and reduce the ability of the packaging of such products to mislead consumers about the harmful effects of smoking. I take the point made by Deputy Lawless about seeing younger people smoking as they walk across the street. It must be remembered that it is very difficult to give up this serious addiction. It is said that in some cases, giving up tobacco is more difficult than trying to give up heroin and other hugely addictive drugs that people can get hooked on. Some people seem to think addicts can just stop, but that is not the case. I tried to stop smoking on eight occasions because I knew it did terrible harm to my body from a health point of view. It always proved difficult and I ended up going on and off the cigarettes again and again. I am vaping at the moment. I think the Government should be careful not to make it more difficult for people to access vaping products because they have played a role in my campaign to stop smoking and move onto alternatives with the intention of moving off them over a period of time.

We know that smoking is very dangerous. It causes huge health problems, including chronic illnesses and diseases, over a person's lifetime. It is good that plain packaging has been introduced because it is less attractive. The legislation before the House today provides for various ways of changing packaging to ensure no particular brand is mentioned on it and to make it as unpleasant as possible. As I have said previously, people who are addicted to cigarettes and tobacco tend to buy nice fancy containers to put their cigarettes into. They choose designs with their friends. I have seen them in the shops around Moore Street. People prefer to put their cigarettes into these containers, which have lovely designs, pictures, photographs and all types of things on them, rather than leaving them in boxes that look brutal. They will continue on in that way.

I would like to see more evidence of the actual impact that plain packaging is having on smoking levels. I know that when plain packaging was introduced in Australia, a cigarette company took a court case on the basis that its profits were being affected. This should be a big concern that sends an alarm to people in this country and elsewhere in Europe, especially in the context of the TTIP and CETA trade agreements, which could allow tobacco companies to challenge in secret courts public sector wage increases or anything else that they consider might have an impact on their profits. I do not think it is really known out in the ether of general society that these trade agreements, unlike normal trade agreements, contain such provisions. Philip Morris has brought Australia and another country - I cannot remember which - to court and that process is continuing. Any measure that can assist people who are trying to give up cigarettes would be good. It looks like a very plain type of packaging will be provided for. It will include the word "cigarette", small calibration marks, some text indicating the contact details of the manufacturer and a statement of what is contained in a packet of cigarettes. They will be very plain and therefore will not attract more people. As I have said, those who smoke do not carry these packets around with them. They get a nice little box to put their cigarettes into. They choose something they can carry in their bags and put on the table in front of them when they smoking in a pub or hotel on a night out.

As I have said, it does not appear that the various areas covered by this Bill will lead to increased costs or have an effect on the State's coffers. All of them seem to be self-funding. Obviously, the manufacturing companies will have to dip into their pockets to meet the plain packaging rules. It does not seem that the changes in prescription costs will have an impact on the State's coffers. Many of these provisions are welcome. In general, I support them. I ask the Minister to answer the questions I asked about legal costs that may be incurred when the power of attorney process is invoked and whether nursing home help care is being paid for. I will leave it at that.

I would like to look at a couple of sections of the Bill. Section 8 refers to payments made under schemes for individuals disabled following the thalidomide tragedy that took place in the 1960s. The Health Products Regulatory Authority has a role in this context. Thalidomide was marketed as a sleeping pill and morning sickness cure in the late 1950s and early 1960s. It led to the deaths of tens of thousands of babies who were born with malformed limbs worldwide. Only 50% of affected babies survived. This horrible outcome led to an overhaul of the regulation of medication in the west and the aggressive marketing of the pharmaceutical industry was reined in. That was the plan, anyway. Three major steps were taken. First, new drug development was rewarded with product rather than process patents.

In other words, the idea was to ensure that the regulators could target the company responsible for making a given drug and hold it responsible if anything went wrong. Second, new drugs were made available on a prescription-only basis. The system had pluses but, as we know now, it created different problems and it has been a licence to print money for some. Third, proof was required that new drugs worked through controlled trials before they could be marketed.

This all sounds like a good idea but issues have been identified by a very knowledgeable individual called Dr. David Healy, who was born in Raheny in Dublin. He is currently professor of psychiatry at Bangor University in the United Kingdom. He is a psychiatrist, a psychopharmacologist - it is difficult to say that word - and a scientist. In any event, he is, by all accounts, a brilliant individual. Dr. Healy has documented in detail how the aims of these innovations have been circumvented by people in the pharmaceutical industry to advance their aims. His comments are worth putting on the record: "... increasing numbers of pregnant women who religiously steer clear of alcohol, tobacco, soft cheeses, or anything that might harm their unborn child, but who are nonetheless being urged by their doctors to take drugs like the antidepressants – now the most commonly prescribed drugs in pregnancy – even as the evidence accumulates that these drugs cause birth defects, double the rate of miscarriages, and cause mental handicap in children born to mothers who have been taking them".

The efforts to protect ourselves from a recurrence of the thalidomide disaster have been a disaster. Product patents give an incentive to pharmaceutical companies to produce drugs that are so valuable to them and their survival that the incentives to breach regulations and hide any safety data that might be inconvenient for the companies are extraordinary. Entire trials are hidden. Almost all trials are ghost-written to ensure the data looks right. No one, not even the US Food and Drug Administration, has access to the data.

Prescription-only status has made doctors the conduit for prescription drugs. Company marketing can concentrate on these few consumers and understand them better than they understand themselves. Doctors claim to be shielded from company marketing by guidelines and evidence-based medicine, seemingly unaware that pharmaceutical companies are now the most enthusiastic advocates of guidelines and evidence-based medicine.

Clinical trials were introduced as the eye of the needle through which the financial camel that is the pharmaceutical industry would have to squeeze if it wanted to get drugs on the market and make money. These trials would establish whether drugs worked and would lead to a clear recognition of their hazards. Despite this, we have been led badly astray. The most extraordinary example of how badly is the fact that the one drug that has been through a controlled trial before it was marketed and which had been shown to be safe and effective was thalidomide. This is the system on which we now depend to avoid future drug disasters. Once trials were put in place, industry took over the running of them. More than 90% of all clinical trials are now run by private companies. They organise ethical approval through other private companies and outsource the trials to parts of the world where oversight is at a minimum. The results, sometimes stemming from patients who do not exist, are fed back to the parent companies. They are coded in a manner that often causes problems to vanish. These trials and the results that suit company marketing agendas are then written up by ghost-writers and published in leading medical journals, even though the editors know what is happening and that they are putting lives at risk by publishing these articles. If something goes wrong with a drug, the industry claims that no one can link the drug to the problem unless a clinical trial has shown there is a statistically significant link. Everyone buys this such that even when serious problems arise with a drug, clear up when the drug is stopped and reappear if the drug is reintroduced, industry players can deny a link and can expect regulators and academics to line up behind them.

The function of Part 3 is to allow for expense fees to be paid to the board members of the Health Products Regulatory Authority because of an expansion in the functions of the organisation. There is "an onerous responsibility and significant time commitment placed on the members of the Authority". It sounds as if they may be overworked and understaffed - I do not know. The HPRA does valuable work but there is a limit to what the authority can do, as Dr. Healy has shown. There is an element of corporate capture in the regulation and approval of pharmaceutical products. Has the HPRA conducted independent trials into the eight most widely prescribed selective serotonin re-uptake inhibitors used to treat depression in Ireland or is the authority box-ticking the results of trials carried out by the private sector, the manufacturers or companies with business ties to the manufacturers? I am raising this because of growing concern around the links between antidepressants in the form of SSRIs and self-harm, depression, violence and suicide.

The former assistant state pathologist, Dr. Declan Gilsenan, and Dr. David Healy raised these issues with the former Minister of State with responsibility for mental health issues, Kathleen Lynch. Dr. Gilsenan argued that in his 30 years of experience carrying out post-mortems he had seen too many suicides after people had been taking SSRIs and called for a national survey of suicides to see how many people had begun taking SSRIs shortly before taking their lives. The former Minister for State commended Dr. Gilsenan for speaking out about the connection between SSRIs and suicide and stated, "When someone of this stature speaks out, we have to take notice". She continued:

GPs have found themselves in a position where there is nothing else to do but prescribe pills. There needs to be alternatives for people. It can’t just be medication, and we need a system where people are reviewed on a continuous basis.

This was a very good statement on the part of the then Minister of State. I agree that there needs to be more contact and monitoring of a patient's progress, especially when on these medications, but GPs and the drugs themselves have to be monitored as well. What if a GP is over-prescribing? Does the GP have the skills to help people come off the drugs? Does the GP give the proper warnings, furnished to her by the HPRA, to the people to whom she has prescribed the drugs? Do the doctors respond properly to complaints about the drugs and unexpected side-effects or do they continue with the prescription? Do GPs refer these complaints to the HPRA? Does the HPRA add these side-effects to the information leaflet it provides to GPs and other professionals? Does the HPRA review the efficacy of these drugs in light of these complaints?

Part 4 allows for certain over-the-counter medicines to be made available free of charge for medical card holders, for example, the morning-after pill. While this is a welcome measure and should make this treatment more accessible financially, there is an issue with the fact that in order to obtain the morning-after pill on a medical card, it will now be necessary for the patient to get a prescription. In 2011, the Irish Medicines Board approved the morning-after pill as an over-the-counter medicine in response to growing demand. The earlier this pill is taken, the more effective it is. Given the time-sensitive nature of taking this medication, reintroducing a delay for those with medical cards is completely unfair.

Ireland takes a medieval stance on women's reproductive rights. There is already a two-tier system in place. There are those who can afford to travel abroad for abortions and those who cannot. Introducing an extra barrier in obtaining emergency contraception is simply another way in which the State can interfere with the reproductive rights of women.

Requiring people to go to their general practitioner to obtain a prescription for products that usually do not require prescriptions seems like a waste of time and resources. Will the State have to foot the bill for these additional GP consultations? Will GPs be required to spend their time in consultations for products that are already available over the counter? Considering the recent findings of the National Association of General Practitioners that the average waiting time for a GP appointment is 34 hours it would be counterintuitive to add unnecessary consultations into the mix. If there is a need to safeguard against people taking advantage of the new system, for example, by stocking up, the responsibility for assessing whether someone needs the morning after pill should remain with the pharmacist.

I have concerns in respect of Part 5 of the Bill that the looming provisional application of the Comprehensive Economic and Trade Agreement, CETA, between Europe and Canada and the impact it will have on this kind of legislation is being ignored. The investor-state dispute settlement, ISDS, mechanism that is built into CETA will shortly give corporations with bases in Canada the legal right to punish Ireland for this Bill which is designed to protect the wellbeing of Irish people. I and others have raised this issue numerous times, never to have it adequately addressed. There does not seem to be a very serious appetite in this institution for dealing with the Transatlantic Trade and Investment Partnership, TTIP, or CETA, which is very worrying. There are very serious concerns for the Irish people that are not being addressed and it would be a terrible shame if we did not address them properly and inform people about what is really involved because there is a serious lack of information around it, a lot of secrecy and there is a certain element of education to be engaged in on the part of the State. It is only fair that people should know what is going on, what is involved, what it means and what it will result in because the implications are enormous.

At the start of July, Deputy Pringle asked the Minister for Jobs, Enterprise and Innovation 11 very specific questions about the ISDS mechanism that is contained in CETA. The Minister grouped the questions and made no reference to ISDS in her answer. Instead, she simply copied and pasted the official advertisement for CETA. That is not very good. Investor-state dispute settlements, dispute resolution mechanisms, the investor court system, regulatory cooperation and the text of the trade deals make clear that these elements of CETA and TTIP create a situation where corporations get privileged advance warning of upcoming legislation that will affect their profits so that they can start changing and influencing legislation before it is voted on. Failing that, if existing or newly implemented legislation impacts profits, real or potential, they can sue national governments for loss of profit. Most worrying is that CETA is about to become provisionally applied after a European Council vote on 18 October, which under the Treaty on the Functioning of the European Union means that it will come into full force and even if subsequently our national Parliament, the European Parliament or the Council of Ministers vote against it, it will remain in place for three years.

The decision to let European parliaments vote on the trade deal is meaningless if the Council of Ministers gives it a qualified majority vote. This point was raised by Deputy Maureen O’Sullivan with the Taoiseach and by me with the Minister for Jobs, Enterprise and Innovation on the last day of the Dáil term before the summer recess. In both cases the point was not addressed or appreciated but was glossed over with talk about TTIP and quotes from flawed research about projected future growth in gross domestic product, GDP, even though the questions were about CETA. The Government has repeatedly refused to engage with the real dangers of these trade agreements. It completely ignores them to the extent that it is almost certain that the Taoiseach will vote to apply CETA provisionally come 16 October.

In 2010, in just one of the thousands of ISDS cases that corporations have taken against states attempting to regulate in the public interest, Philip Morris, the tobacco company, sued Uruguay over its plain packaging laws for tobacco. The case went on for years but eventually collapsed on a technicality to do with the subsidiary Philip Morris used to bring the case. Philip Morris, Imperial Tobacco and Japan Tobacco Limited all sent letters to the Irish Government threatening to challenge legally the plain packaging legislation we introduced in 2015.

There is also opposition to the legislation put forward here today on the basis of infringements of property rights and free trade. The Taoiseach will go to Brussels in two weeks effectively to hand over to the tobacco giants the right to sue us successfully in respect of these objections. In essence, the Government is proposing legislation and the leader of that Government is acting against the spirit of the legislation. Most people who understand how the system works would be of the view that the influence and power of big business has probably never been greater in the history of the planet. The potential for states to hold it to account is diminishing because its influence is so great. The Nice and Lisbon treaties played a part in that. For example, a bypass is being built at New Ross in County Wexford. We are not allowed to borrow money at 1% which the Government could do because according to EU rules it would go on our books and break our 3% rule and we would be in different trouble. We have to go to a public private partnership, PPP, where at a minimum the money is costing in the region of 15%. We are paying 15 times more for the money to build the bypass at New Ross than we should be paying. That is only one example. We are building schools under PPPs. The money is costing 15 times more than it should. Where is the rationale behind that? How can the Commission say that it is legislating in the best interests of the people of Europe if it is driving the states and governments of Europe into the hands of the private sector to be used and abused because that sector has a licence to make crazy money off the European states because of the rules and regulations it has introduced. On our own little patch in Ireland if the full light of day ever shines on the workings of the National Asset Management Agency, NAMA, it will show how we do business and it is rotten to the core.

Sections 6 to 8 of this Bill refer to the payments made to women who suffered unnecessary symphysiotomies, those who received payments through the Our Lady of Lourdes Hospital redress scheme and those who suffered as a result of Thalidomide. Another group of people who are unfairly assessed in respect of the nursing home support scheme, the fair deal scheme, is farmers. If they need to go into nursing home care the farm is taken into account in an assessment of their income and assets. Normally, 80% of a person’s income is taken into account and the person’s home. For farmers, however, the entire farm is taken into account in the assessment of assets.

It is viewed as money in the bank. A farm might be worth €500,000 or €600,000. Its income generating capacity could be €20,000 or €25,000, but the full value of the farm is taken into account in assessing their assets. In that regard, farmers are often liable for the entire cost of their nursing home care. That is unfair. I will be seeking, certainly in this budget if it is possible, to have the value of a farm assessed not at 100% of its value but perhaps at 10% of its value. That would still involve a farmer's offspring making a contribution towards his or her nursing care but would not cripple the farm.

Also, if a farm is transferred to a relative five years or more at the time of a patient requiring to go into a nursing home, there is no liability on the land. However, if the parent goes into a nursing home within five years of transferring the property to a son, daughter, preferred nephew or whoever it might be, the entire asset value of the farm is taken into account. The Minister might consider reducing that five year rule to a three year rule.

There is a difficulty with regard to drugs and appliances. The morning after pill was referred to earlier. However, there are other drugs which should be available on the General Medical Services, GMS, scheme but which are not. One is a drug called Macushield. It is prescribed by ophthalmologists for the treatment of macular retinal degeneration, which is a life-threatening eye condition. It is a vitamin preparation which has been removed from the GMS reimbursement scheme. It costs about €30, yet it is being prescribed to GMS patients who have to fund the full cost of that. It was refundable through the hardship scheme, but it has been removed from the list of drugs that are refunded through that scheme. It is a drug the Minister of State might consider adding to the list of reimbursable drugs.

The morning after pill is available across the counter to anybody. Unfortunately, if someone wishes to get it through the GMS scheme they have to submit a GMS prescription. It is open to the patient to buy the drug in an emergency, and the morning after pill requirement is for emergencies. It is available, but it is not free unless one has a GMS prescription.

In terms of the morning after pill provision, there is an added benefit in someone going to see their general practitioner. They may need counselling on the use of the morning after pill. They may need to be on the contraceptive pill, which would mean they would not have to take the morning after pill. There is an opportunity to counsel people if they attend their GP, which is a positive aspect.

With regard to drugs and appliances, there are many dressings which are required for the treatment of people with leg ulcers or bed sores or people who are incontinent. Many of those dressings are not available through the GMS. They were available through the hardship scheme but that has also been discontinued. It is necessary now for those patients to see a consultant to approve the requirement for those dressings, and we all know how long it can take to see a consultant to get a letter stating one should be getting the dressings, which previously were available to one prior to their removal from the scheme. That is a huge problem for public health nurses who visit these patients but who do not have the dressings or the appliances to treat them properly. The Minister of State might consider that question also.

On the packaging of cigarettes, anything that can be done to diminish the consumption of cigarettes is welcome. If changing the packaging will make a difference, which is questionable, it should be introduced. However, what is more important is the prevention of smoking. As the Minister with responsibility for health promotion, she will understand that education is far more important than drug packaging. Getting children in primary and secondary school to consider the health, social and cost aspects of smoking is far more important and will have a lifelong effect on them. Getting that message to children in primary and secondary education is very important. Also, if children hear about the bad aspects of cigarettes, they apply pressure on their parents to give them up. That, too, is an important intervention in regard to smoking.

Deputy James Lawless referred earlier to medical manpower and the No Doctor No Village campaign, of which I was a part. As the Minister may have heard this week, there are huge problems in terms of medical manpower, not only in hospitals but particularly in general practitioner services. Thirty-three per cent of GPs are over the age of 55 and 20% are over the age of 60; I qualify on both counts. There is a manpower crisis coming down the line because young GPs are not coming in to general practice. The contract is so unpalatable they will not take it up. A new contract with GPs must be negotiated urgently and put in place, which hopefully would redress the emigration of young GPs or the failure of young GPs to take up GMS contracts.

Our campaign, No Doctor No Village, is attempting to highlight that issue. Witnesses who come before the Committee on the Future of Healthcare outline how chronic multi-morbidity care in the community is the only way forward for our health service. If elderly people and those with chronic multiple illnesses end up in hospital unnecessarily, which is an extremely expensive way to care for people, our health service cannot sustain that cost. We need to keep people at home. We need to have chronic disease management in primary care and in general practice, but to do that we need to double the number of GPs. We have approximately 2,400 GPs. If free care is to be given to the entire population, and if there is a transfer of care from secondary to primary care, we will need twice that number of GPs. The likelihood is that in the next ten years we will lose one third of GPs. I do not know how that will be squared, but we need a huge investment in GP manpower. We need a new contract, and we need to attract back the many graduates who have emigrated.

The assessment of farmers' land for the fair deal scheme is very unfair. I am not sure whether the stock on the land would be valued as well and thrown into the mix. This issue is creating stress and concern for the son or whoever is taking charge of the farm in that they might be landed with this unreasonable cost. It is unfair. It is their asset for generating income. In many cases it has been handed down from father to son going back years. If this rule is applied, some young farmers will not be able to continue to farm or make ends meet.

I was made aware of a problem facing a publican who lived in the pub. His wife needed to go into a nursing home but they encountered the same problem. The same problem is being faced by publicans and small shopkeepers who live over their shops or in the premises from which they operate their business. That is not fair. We need to address this problem for people applying for the fair deal scheme as soon as possible because it is very serious and is causing great concern to many people.

I do not believe the plain packaging of cigarettes will be of any benefit or use because as all Members are aware, cigarettes are an addiction.

It does not make any difference whether it is in a mug or a box, people will get a cigarette when they really need it. The shape or colour of that box will not prevent them from buying it.

However, I believe the battle is being lost. There is a lovely congregation of youngsters in the Gallery who should hear this point. It appears to me that more youngsters than ever are smoking. I can understand that in the case of people gone by or who now are moving on in years, there were no Government warnings or health warnings when they started smoking. However, I am very disappointed the youngsters do not appear to be heeding the health warnings at present. I am worried because as all Members are aware, they have caused many people to depart this life long before they should have. The issue must be addressed with some other type of campaign because sadly, the youngsters do not appear to be heeding the health warnings they have been getting.

I must raise a few important matters in respect of health. Health is wealth and it is not good enough that in a hospital like Cork University Hospital, people must wait for four weeks for surgery to get a triple or quadruple bypass after having a heart attack. The reason is no beds were available for the patient's recovery after the surgery and that is not good enough. Can the Minister of State imagine the distress one man's family endured for almost four weeks while waiting for a badly-needed operation? This cannot be allowed to continue. I am familiar with another case in which another person is waiting in a primary care centre at present to get a bed and to be operated upon. The reason the operation is delayed is because no bed is available for the patient after the operation. This is not good enough. Many people approach me in my clinics or contact me on the telephone in respect of cataract operations, which are at a standstill in County Kerry. It is sad to think of a man I met a couple of weeks ago who only has 20% vision left in his second eye but who has been told he must wait for another two years. That man is almost stone blind and is afraid to go out. He lives in a town but cannot go down the street. He is a prisoner, marooned inside his house. That is not good enough and I ask the Minister of State to relay the message that this must be dealt with and treated as being extremely urgent. As for orthodontic treatment, youngsters in County Kerry are told they must wait for three or four years. This is not good enough because their gums then will become too strong, the treatment will not be as effective and they probably will have lost teeth by the time they are treated. Such matters must be a priority in the budget. I do not know whether it is a matter of money or whatever but it must be seen to and dealt with and I ask the Government to do just that. On home help, I was told that County Kerry was to receive €900,000 for home help out of the funding of €40 million the Minister made available to improve health services nationwide. This week, however, an 89 year old woman born in 1927 had two hours of home help per week cut to one hour, which I cannot understand.

The sad part is I can see no accountability. If a question is asked at the regional health forum in the county buildings in Cork, one is told they will write to the Minister or Department of Health. In the Dáil, the answer invariably is the Minister will contact the Health Service Executive. That is not good enough and this system must be changed in order that someone is accountable to someone else. Members are accountable to the people who elect us; they will not elect us unless we do what they ask of us. In the same way, those who are responsible for delivering the health service should be accountable to the Minister, the Government or the elected representatives because I cannot see them doing what the people want or what is needed and urgent matters are being held up. People are being held up because they only have a medical card. Can the Minister of State imagine telling an 83 year old man he must wait for a year and a half or for two years before having a hip operation? That man stays awake every night until he is worn out. He does not fall asleep until some time around 6 a.m. or 7 a.m. and he hears the clock striking every hour throughout the night. It is wrong to leave elderly people to suffer in pain after what they have given to the country over the years. It is no way to treat elderly people and the same is true of knee operations. Such people are obliged to wait too long and are enduring too much pain. I reiterate to the Minister of State that the HSE must be made more accountable to the Department, the Minister and the elected representatives.

First, I am delighted to have the opportunity to speak on the Health (Miscellaneous Provisions) Bill. I welcome this Bill and its various provisions, which I believe are for the common good, especially those designed to combat tobacco smoking. I believe a progressive Legislature sometimes should be ahead of public opinion in enacting progressive measures that modify behaviour, eventually change attitudes resulting in the common good for all. I believe changing attitudes towards tobacco smoking will be effected by plain packaging. For far too long, this poisonous carcinogenic drug has been socially acceptable as part of everyday life in such a way as to have become normal. The scenario in which children in their buggies were being pushed into shops in which displays of advertising for this killer substance were the norm thankfully now is in the past and this is the time to adopt the same treatment for the packaging. Over a single year, between 5,000 and 6,000 people die in this State from smoking related diseases. Nicotine addiction should be treated with the seriousness it merits. It is fatal and still is too socially acceptable. From when children are very young, they should be learning that smoking is no rite of passage into adulthood but instead that to fall into nicotine addiction is a terrible thing to happen to anyone. There is not a single good feature of nicotine addiction, despite the brainwashing in which the tobacco companies engage. It is dangerous, often fatal, dirty and expensive and any talk of stress relief or enjoyment simply is pure rubbish, as is the case with any addictive substance. I also am glad the provisions in this Bill are bringing closer the day when smoking tobacco becomes socially unacceptable and are bringing us to a smoke-free Ireland as soon as possible.

Another issue I wish to mention is the exclusion of the ex gratia payments to the victims of symphisiotomy and other such payments from the means testing of fair deal payments, which also is welcome. These people, along with those who have been otherwise mistreated by agents of the State, should not then be penalised by other State bodies for having received deserved compensation for their suffering. We also should be moving toward a scenario, as was mentioned earlier, in which the family farm is equally discounted. There are all sorts of incentives for farmers to sign over their farm to the next generation but there are many reasons some elderly farmers do not wish to so do. Sometimes, other issues such as dementia or whatever else, may be present. When such people are in need of nursing home care and wish to avail of the fair deal scheme, they find their entire holding is taken into account in the calculation of the means payment. There is a case for only the dwelling being accounted, as would be the case for a non-farmer. The portion which is taken by the State for the care of the elderly relative can seriously diminish the value on the family farm's earnings and thus affect its viability. In most parts of the country and in the west in particular, family farm income is low at present.

In County Leitrim, it is below €11,000 per annum for every farmer. It is a serious situation that the family farm would be taken into account. I hope this is something that can be rectified soon.

While the Bill in many ways is as much about keeping people well as about health care, the serious issue that needs to be dealt with is investment in the entire health service. A big part of that, as was mentioned by others, is investment in services, such as home help for the elderly, more nurses and more beds in hospitals, home care packages and community services. Mental health services, in particular, have been greatly disadvantaged over the years and need greater investment.

I welcome the Bill and all the provisions in it and I hope the other issues which have been mentioned by many Deputies here will be taken seriously and dealt with.

I thank the Deputies for all their contributions to the Second Stage debate on the Health (Miscellaneous Provisions) Bill.

The provisions in the Bill will allay the fears of recipients of ex gratia awards which have been approved by Government and which place them over the threshold for supports under the nursing homes support scheme. It would be most unfair if individuals who have endured more than enough pain and suffering were to be disadvantaged in their financial assessment for support under the nursing home support scheme as result of receiving an award from a Government-approved scheme. The usual financial assessment criteria will apply. This is a question that some Deputies raised. I hope this decision will give some peace of mind to the individuals concerned and their families.

There was also a question about enduring power of attorney. This is not covered by this legislation or the scheme specifically.

While not directly relevant to the Bill, issues were raised in the debate about the fair deal scheme, in particular as it applies to farmers. A programme for a partnership Government has committed to reviewing fair deal to remove any discrimination against small business and family farms. Any significant changes to the scheme deemed necessary will require legislation and will be addressed at the end of the review implementation process.

The Minister, Deputy Harris, and the Minister of State, Deputy McEntee, have met the Irish Farmers Association, IFA, and invited it to present its submission at the next meeting of the working group that was established to progress recommendations from the report of the review of the nursing home support scheme. The next meeting of the group is this month. Many Deputies will welcome that news.

Deputies also referred to the provision of home care services. These are critical to supporting older people to stay in their homes and communities. We can agree all on that because we want them to maintain their independence for as long as possible. I assure the House that the Government is committed to improving the resourcing of home care services as a priority in the period ahead. This year, €373 million is available to home supports, of which €338 million is available for home help and home care packages. This includes the addition of €40 million provided in June to address the increased demand for services. This year the HSE will provide 10.57 million home help hours and 15,800 home care packages.

The Minister of State, Deputy McEntee, is also considering how the service can be optimally structured to meet the needs of clients in as consistent and transparent a way as possible within the resources available at any given time. In this context the Health Research Board has been asked to carry out an evidence review to examine the regulation and funding of home care services in comparable jurisdictions. This should be completed by the end of the year and will inform future decisions about the structure and governance of home care services.

As Minister of State with responsibility for health promotion, I am particularly interested in the provisions of the Bill which seek to amend the Public Health (Standardised Packaging of Tobacco) Act 2015. Evidence indicates that tobacco packaging is a critical form of promotion. This is more relevant in Ireland where we have comprehensive advertising and marketing restrictions. We know that branding works, especially on children. If the tobacco sector did not get our children addicted, its industry would disappear within a generation. Given that 78% of smokers in a survey stated that they started smoking when they were under the age of 18, it is clear that our children are targeted to replace those customers who die or quit. It is critical, therefore, to reduce the appeal of tobacco products to consumers and increase the impact of health warnings. Standardised packaging of tobacco achieves this, as one of the measures and recommendations in our policy document, Tobacco Free Ireland. The policy includes education, media campaigns, pricing etc. In fact, in 2010, 12% of those aged ten to 17 years smoked, whereas 8% did in 2014, which I think the House will agree is a significant reduction. We have the potential to see quite soon a generation who will never smoke.

In relation to the Transatlantic Trade and Investment Partnership, TTIP, agreement, which may not be concluded for some time yet, the Department of Health has indicated that the agreement should not undermine existing public health measures. We will work to ensure any agreement will not prevent or deter Ireland from introducing new public health measures, for example, measures aimed at reducing tobacco or alcohol consumption. I thank the Deputies for their support for this public health measure. The amendments set out in the Bill will enable Ireland to proceed with the introduction of standardised packaging of tobacco products.

The provision in the Bill to amend the Health (Pricing and Supply of Medical Goods) Act 2013 is also intended to benefit the health of the population. It provides that, when considered appropriate in the interests of patient safety or public health, over-the-counter medicines can continue to be reimbursed on the medical card scheme and on the other community drug schemes after May 2018. This means that products such as nicotine replacement products and emergency contraception can continue to be provided under the medical card scheme. Currently, medical card patients can access emergency hormonal contraception by obtaining a prescription from a GP. If they must access this medication directly from a pharmacist, they would be required to pay for it. It is noted that there is an inequality of access to emergency hormonal contraception for women on the General Medical Service, GMS, scheme compared with private patients, and officials in the Department are examining this matter in detail.

If a pharmacist is not satisfied that the supply of the medicine or service to the patient is clinically appropriate or if the pharmacist is unable to supply a medicine such as emergency hormonal contraception to a patient on the grounds of conscientious objection, the pharmacist must take reasonable action to refer the patient to another health care professional, service or organisation who can provide those medicines and services in order that the patient's care is not jeopardised. This is provided for under the statutory Code of Conduct for Pharmacists and all pharmacists must subscribe to this code.

On the reimbursement for products, the HSE has statutory responsibility for decisions on pricing of and reimbursement for medicine under the community drugs scheme, including the medical card schemes. Prior to deciding whether to reimburse for a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

The proposed amendment to the Irish Medicines Board Act will allow the payment of fees to members of the Health Products Regulatory Authority. This is in line with the practice of other similar boards, where fees are paid to members of the board to continue to attract individuals of the highest calibre and expertise to apply for board membership. There will be no additional cost to the Exchequer as the authority is mainly self-financing, and any fees paid will be strictly in accordance with Department of Public Expenditure and Reform guidelines, which include the principle of one person, one salary for those who are already in receipt of a salary from the public service.

I thank Deputies for contributing to the Second Stage debate. I look forward to further constructive examination of the Bill on Committee Stage. It has been a thought-provoking and considered debate from all the Deputies who contributed. I commend the Bill to the House.

Question put and agreed to.