Seanad Éireann díospóireacht -
Wednesday, 16 Dec 2020

Vol. 273 No. 10

Nithe i dtosach suíonna - Commencement Matters

Medicinal Products

Senator Fiona O'Loughlin

The issue I want to raise before the House, and it is not the first time that I have spoken about it here, is the area of hereditary amyloidosis. Like many Members, I would not have heard about this very debilitating and difficult disease if it had not affected somebody that I know very well. Pat Tinsley is a well known and well loved member of the Newbridge community whose life has been absolutely destroyed by this degenerative disease. This debilitating and fatal illness attacks the heart and nervous system of patients.

As it progresses, it causes loss of sensation, limb weakness and pain. The drug patisiran, which helps alleviate and manage symptoms, is available in the UK and the US but is not available here.

Pat is running out of time and desperately needs this drug, as do approximately 30 other people in Ireland. Thankfully, the Department secured a significantly enhanced budget with an extra €50 million for new medicines in 2021 but I have been informed that this budget allocation will be insufficient to cover the costs of all new medicines in 2021. I know that the HSE is committed to providing access to as many new medicines as possible from the resources provided and I urge it and the Minister to include patisiran in that list.

Some 4,000 of my constituents signed a petition calling for patisiran to be made available to Pat and the other sufferers of this disease and I am speaking on their behalf. I have submitted that petition to the Minister for Health, the chief executive of the HSE and the Chair of the Oireachtas Committee on Health. According to the HSE, the required National Centre for Pharmacoeconomics, NCPE, health technology assessment report was received by the HSE on 24 February 2020. At that point, under a different Government and regime, it was recommended that patisiran not be recommended for reimbursement unless cost effectiveness could be improved relative to existing treatments. Patisiran was then considered at a meeting of the drugs group in July 2020 and, unfortunately, no recommendation was made then.

The agenda of the December 2020 drugs group meeting was full and patisiran was added to the list of items for the next available meeting. Patisiran currently sits as the third item for consideration on the draft January drugs group agenda. The drugs group is expected to provide a recommendation to the HSE executive management team on the basis of all of the available evidence at that time.

I understand that the HSE executive management team is required to consider a range of criteria which include unmet need, clinical evidence, economic evidence, budget impact and the resources available. I urge the executive to remember that behind these statistics and criteria lie real people who desperately need this drug. Those with amyloidosis understand that other people are also waiting for drugs but there is a huge sense of urgency for sufferers of hereditary amyloidosis due to the rapid progression of the disease. I am pleading with the Minister of State and the HSE on their behalf. They absolutely need to have this drug and if they do not get it, the quality of their lives is at risk, and even their lives are at risk.

Minister of State at the Department of Health (Deputy Frankie Feighan)

I thank Senator O'Loughlin for raising this important issue and for giving me the opportunity, on behalf of the Minister, Deputy Stephen Donnelly, to speak on the reimbursement of patisiran for hATTR amyloidosis. I fully understand that access to potentially beneficial drug treatments is an extremely important issue for people with this condition.

As the Senator is aware, the HSE has statutory responsibility for medicine pricing and reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies certain criteria for decisions on the reimbursement of medicines which include unmet need, clinical evidence, the resources available to the HSE when making reimbursement decisions and budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the NCPE. It uses a decision framework to systematically assess whether a drug is cost effective as a health intervention.

The Minister is advised by the HSE that it received an application in December 2018 for the reimbursement of patisiran for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. In January 2019, a full health technology assessment, HTA, was commissioned by the HSE. In February 2020, following the HTA, the NCPE recommended that patisiran not be considered for reimbursement unless cost effectiveness could be improved relative to existing treatments.

In July 2020, the HTA report, the patient group submission received during the HTA process, and the outputs of commercial negotiations were reviewed by the HSE drugs group. The drugs group was unable to recommend in favour of patisiran at that time. The drugs group therefore sought additional patient and clinician engagement input via the rare diseases technology review committee, RDTRC, to assist the group in making its recommendation to the HSE executive management team.

In September 2020, the rare diseases technology review committee reviewed the clinical data previously submitted as part of the established pricing and reimbursement process and heard from consultants involved in the specialist management of patients with this illness. In November 2020, the committee convened again and continued its review of patisiran, which included patient input on the impact of this illness. Following these meetings, the committee finalised a statement summarising the clinician and patient engagement on patisiran, which was forwarded to the HSE drugs group for consideration.

The HSE has advised that patisiran currently sits as the third item for consideration on the January drugs group draft agenda. The statement from the rare diseases technology review committee will be considered by the drugs group along with the health technology assessment and the outcomes from commercial negotiations.

As the Senator will be aware, additional funding of €50 million was provided for new medicines in budget 2021. This funding will allow the HSE to approve medicines which have been recommended by the HSE drugs group on the basis of efficacy and value for money in line with the 2013 Health Act. The application for patisiran remains under consideration with the HSE and the reimbursement of this medicine will be considered in this context.

Senator Fiona O'Loughlin

I have listened closely to what the Minister of State has said and I accept that last February and July, a decision was made in the negative on patisiran but things have changed rapidly. The fact that an extra €50 million was included in the budget in order to treat rare diseases is important and an absolute game changer. I accept, of course, that there has to be criteria for the spending of public money on medicines. However, the 30 people who we are speaking about are lucky that we know that there is a drug that can absolutely help to support them with their difficult symptoms. That is hugely important. I accept that the whole reality of trying to negotiate with commercial pharmaceutical firms is something that we need to do. We need to have that negotiation. I hope that the Minister of State will intervene to ensure that those 30 people, including my friend Pat, will have the opportunity to access patisiran in early 2021.

Deputy Frankie Feighan

The Minister, Deputy Stephen Donnelly, has received a number of representations on this matter from patients and concerned family members. I fully appreciate that this is a worrying time for patients, families and carers, and I hope the Senator's friend Pat and any other people who want this drug will get a good result. The Minister and I hope that this process comes to a satisfactory conclusion for all concerned. It is important to note that the HSE executive management team is the decision-making body for the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. It will, on receipt of the outcome of the drugs group's deliberation, make the decision as to whether patisiran will be reimbursed.

The Senator is absolutely right that the additional funding for new medicines provided in budget 2021 will allow the HSE to provide access to evidence-based, cost-effective medicines, and ultimately to provide more medicines to Irish citizens. This item is third for consideration on the draft January drugs group meeting agenda, and hopefully there will be a positive outcome. The decision on this issue is made by the HSE executive management team, on receipt of the outcome of the meeting of the drugs group.

Employment Rights

Senator Paul Gavan

I wish to raise a serious issue today, namely, the work of social media content moderators. These people carry out a new form of work which is horrific in nature but regrettably is essential. On a daily basis, these workers will view and filter out the worst acts of humanity posted online in order that they do not appear on our screens. This is done through social media platforms such as Facebook, Twitter and Instagram. It may come as a surprise to the Minister of State that approximately 2,000 workers in Dublin are working in these horrific jobs. The positions are outsourced, insecure and low-paid. They are doing the worst of work to protect us, but unfortunately, this comes at a cost to their own mental health. They are subject to serious psychological damage and injury due to being exposed to explicit content during the course of their everyday work.

We need to address the problems of these workers, as we now know this is causing post-traumatic stress disorder, PTSD, and other psychological damage to many of those workers exposed to this type of content. A month ago, an open letter was published from more than 200 Facebook moderators, including well over 100 workers based in Dublin, that was addressed to the CEO of Facebook, as well as the chief executives of the recruitment company CPL and of Accenture. In this letter, Facebook content moderators wrote to "express our dismay at your decision to risk our lives - and the lives of our colleagues and loved ones - to maintain Facebook's profits during the pandemic". Another line from that letter stated the moderators did:

Facebook’s most brutal job. We waded through violence and child abuse for hours on end. Moderators working on child abuse content had targets increased during the pandemic, with no additional support.

The Tánaiste and Minister for Enterprise, Trade and Employment, Deputy Varadkar, said in the Dáil last month that this work is essential and he recognised that it has to be done. He stated that if there is any problem, employees should contact the Health and Safety Authority, HSA, and that he believed no such complaints had been made. To be frank, this is not good enough. It suggests that no problem exists, when in fact, we know that major problems exist. The reality is that these are agency workers on low pay, and in making complaints, they could see themselves risking their jobs.

Earlier this year a reported settlement of €52 million was made in a court case in which it was alleged that Facebook failed to protect workers tasked with moderating disturbing content from the grave mental health aspects of the job. More than 11,000 people who have worked as moderators for Facebook in the US will qualify for compensation under the settlement agreement. A 2019 report from The Verge found that workers were paid as little as $28,000 per year, and I can tell the House that the rate of pay in Ireland is just €14.36 per hour. That is what these workers get paid for watching thousands of horrific videos each day, with very little mental health support.

There is another key issue here that must be addressed. Why are these jobs being outsourced? Facebook is the second or third most valuable and profitable company in the world. Yet it has chosen to outsource these essential roles to agencies and to pay the workers a distinctly low rate of pay for the horrific work that they do. From what I can see, they are effectively being treated as yellow-pack workers. Someone in the Government must recognise that this is not right. This is fundamentally wrong. I dread to imagine how horrific this work is. Indeed, one of these workers had to go home and explain to their families that they could not discuss their work with them. As this will be a "Prime Time" exposé in years to come, the response of the Minister of State to this issue will be very important. I ask him not to provide a regular Civil Service response. I ask him to tell us what the Government will do to actively engage on this issue to protect these vulnerable workers and to ensure that something changes fundamentally for them.

Deputy Frankie Feighan

I thank the Senator for raising this matter. First, I wish to state there is a strong legislative regime in Ireland to protect all workers in respect of their working conditions, including work-related health and safety. On the issue of general working conditions, there is a comprehensive body of employment rights legislation for which the Workplace Relations Commission, WRC, is mandated to secure compliance. This legislation protects all employees who are legally employed on a contract of service basis. Where an individual believes he or she is being deprived of employment rights applicable to employees, that individual may refer a complaint to the WRC where the matter can be dealt with by way of mediation or adjudication leading to a decision, enforceable through the District Court. WRC inspectors can also be asked to investigate certain breaches. Complaints can be made on a single online complaint form available on the WRC's website, www.workplacerelations.ie.

In respect of the health and safety of workers specifically, we have a suite of workplace health and safety legislation designed to prevent and mitigate against work-related accidents and injuries. In this regard, social media content moderators should be treated by an employer in the same way as any other worker who is potentially exposed to hazards. The employer must ensure that appropriate training is provided and must carry out a risk assessment with a particular focus on potential hazards for the worker and must prepare a safety statement based on this risk assessment. A written safety statement should include an assessment of all hazards and risks and should set out how the safety and health of all employees will be protected. Proper risk assessment, along with mitigation measures, is the foundation for all workplace health and safety.

The HSA has an extensive range of advisory and guidance material available to employers to assist them in identifying and managing specific workplace hazards and risks. In addition, any content moderator concerned about his or her health and safety arising from the manner in which his or her work is organised can contact the authority, in confidence, for advice.

The Senator asked what protections are available for those working as content moderators. Where a social media company outsources work such as content moderation to another company, that company is responsible for the totality of the employment relationship with the employees that do the content moderation work. This means that the company has the same employer obligations under both employment rights and health and safety legislation as any other employer. Also, content moderators have access to the services of State bodies, such as the WRC and the HSA.

Senator Paul Gavan

I am genuinely very disappointed by that response. I am a former trade union official and the Minister of State has spent the last four minutes reciting the current employment law protections. Respectfully, I am aware of them. The problem is that the protections in place are not working in respect of these content moderators. There is no right to collective bargaining in this country, which undermines much of the collective protections that are currently in law.

Another line from the workers' letter that was published states:

The current crisis highlights that at the core of Facebook’s business lies a deep hypocrisy. By outsourcing our jobs, Facebook implies that the 35,000 of us [2,000 in Dublin] who work in moderation are somehow peripheral to social media. Yet we are so integral to Facebook’s viability that we must risk our lives to come into work.

The simple call of these workers is for the practice of outsourcing to be ended.

The Government needs to engage on this issue. What is happening in our city at the moment is nothing short of scandalous. I ask the Minister of State to at least give a commitment that the Government will immediately engage with Facebook, and bring in the company to ask it why it is outsourcing these positions. It is fundamentally wrong and it is immoral.

Deputy Frankie Feighan

First, I again note there is a strong legislative regime in place in Ireland to protect all workers in respect of their working conditions, including work-related health and safety. However, I urge these employees to engage, in the first instance, with their employer to see how their concerns can be resolved at workplace level.

Second, my colleague, the Minister for Media, Tourism, Arts, Culture, Sport and the Gaeltacht, who is responsible for media policy, including online safety legislation, is currently advancing a regulatory framework that will deal with online safety.

Lastly, the Tánaiste stated, in response to a priority question on Tuesday, 20 November, that "content moderators working for social media platforms play an important role in preventing the wider distribution of explicit content on these platforms". He has said that he is willing to meet these workers and-or their representatives to hear first hand any particular health and safety concerns they might have associated with the work they carry out.

National Planning Framework

Acting Chairman (Senator Marie Sherlock)

I welcome the Minister of State, Deputy Peter Burke. Has it been communicated to him that someone else will ask Senator McGahon's question?

Deputy Peter Burke

No.

Acting Chairman (Senator Marie Sherlock)

Senator Keogan is next as Senator McGahon cannot be here.

Senator Sharon Keogan

I sincerely thank the Cathaoirleach for selecting my Commencement matter and welcome the Minister of State who has come here to respond to my question.

I previously served as a county councillor in Meath and, therefore, realise how vitally important clarity is for everyone in the formation and execution of housing policy and development plans. I seek clarity for the public who need housing, for the elected councillors and for the chief executives of the 31 local authorities that form and execute housing policy in their respective local authority areas.

Undoubtedly, there is a clear and pressing need for more housing to cater for the people who currently live in Ireland and those who emigrate to Ireland. Increasing supply, apart from anything else, could have a dampening effect on increasing house prices and alleviate affordability to some extent. What is not known is precisely how many housing units will be needed over the coming decades and whether there are ceilings or strict parameters on the number of units that each local authority may build. Reliable, accurate data on population trends and demographics is vital for ensuring that the number, type and location of housing units suit the evolving needs of our growing population. There does seem to be conflicting data and estimates as to the exact number of housing units that will be needed to meet demand over the coming years and decades until 2040.

The national planning framework states, "Annual housing output will need to increase to 30,000 to 35,000 homes per annum in the years to 2027", and will be subject to monitoring and review. I welcome the publication of the report by the Economic and Social Research Institute, ESRI, entitled Regional Demographics and Structural Housing Demand at a County Level. The report contains expert opinions on the trends that feed into the targets of housing units that will be needed. Section 5.6 of the report is interesting in light of the implications of the Covid-19 pandemic. Between 18,000 and 20,000 units only will be completed this year on account of the cessation of construction during lockdown. However, the report notes that the pandemic could ease pressure on housing demand.

A particular concern of mine is the Dublin region and surrounding counties known as the commuter belt. The ESRI report outlines different scenarios of population growth. Its baseline scenario predicts that regions of the east and midlands are expected to experience the fastest population growth and will capture the majority of the total expected population growth over the period from 2016 to 2040 of 55.6% or 500,000 people. This evidence points towards the need for more housing to be built in the east and midlands. Contrary to this urgent need, I am aware that some local authorities have dezoned lands that were zoned for residential development, and that includes Meath and Kildare. This includes the so-called post-2019 land. Such dezoning has been done contrary to the policy contained in the spatial strategy whereby land zoned for development would not be subsequently dezoned. Can the Minister of State comment on the matter? Can he call on local authorities to ensure that they do not dezone land that will be needed to meet demand in the future?

On 1 December the Minister of State, or another Minister of State from his Department, was present to discuss the national planning framework when it was clearly stated that "the national planning framework does not either remove one-off local needs planning for rural houses or impose rezoning or de-zoning population caps". It seems that local authorities have received conflicting information on the number of housing units to be delivered in the future. I hope that the Minister of State's answer to my question will eliminate uncertainty about these policy matters.

Minister of State at the Department of Housing, Local Government and Heritage (Deputy Peter Burke)

I thank the Senator for raising this matter and providing an opportunity for me to clarify this very important position.

As the Senator is aware, there is an urgent need to increase national housing supply to meet existing housing demand to the greatest extent possible in the shortest time possible, while also accommodating projected national housing demand likely to arise as a result of future population growth. Anticipated population growth is projected to be around 1 million people by 2040. The national planning framework, NPF, sets out a spatial strategy to accommodate that level of population and related housing growth over the next 20 years. In particular, the NPF seeks to ensure more balanced regional development led by the growth of Ireland's five cities and five identified regional and cross-Border drivers. It also aims to ensure that a greater proportion of housing demand arising in Ireland's cities and towns can be accommodated within and close to those cities and towns and thereby avoid sprawl into surrounding counties. The NPF is explicit that, rather than focus on seeking additional housing development in locations that have been subject to rapid development and require infrastructure and services to further catch up, some locations should include planning for a greater focus on deficits, such as targeting greater employment and the needs of existing communities, as well as housing.

More broadly, there is a need to encourage increased housing output nationally to meet NPF targeted population growth in the years ahead, especially over the next decade. To assist in the preparation of individual city or county development plans over six-year timelines, an NPF roadmap circular was issued to all planning authorities in 2018, setting out targeted population growth for each county to 2026 and 2031. These targets remain valid. To build on this work, earlier this year my Department commissioned the Economic and Social Research Institute, ESRI, to carry out independent research into structural housing demand in Ireland to 2040. The ESRI research report was published earlier this week and further develops the population projection model that was used for the NPF. What the ESRI work is telling us is that factoring in existing housing demand, together with future projected demand, will require annual average national demand for just over 33,000 new households per annum to be met over the next decade. To meet this average over the period means that there is a requirement to substantially increase national housing output from the current estimated 2020 level of 18,000 homes to 20,000 homes.

Achieving projected levels of population and housing growth in accordance with the NPF will require an increase in annual average housing output in almost every local authority area in Ireland, also recognising that there are some local authorities where recent levels of housing supply are close to or exceed annual average NPF targets. These mainly comprise commuter counties adjoining Dublin, as articulated by the Senator, and are currently meeting a proportion of the very high levels of housing demand arising in Dublin, which is not being met by new housing within the existing city area.

To facilitate convergence with the NPF development scenario, we will enhance the alignment of public investment with NPF objectives to stimulate urban brownfield and public transport-led housing development at scale in Dublin and the other cities, including measures to encourage accelerated regional city growth and balanced regional development.

In the coming days, the senior Minister, Deputy Darragh O'Brien, will issue a circular to all 31 local authorities with guidance required for NPF targets and new ministerial guidelines that describe a housing supply target methodology for development planning, to be issued under section 28 of the Planning and Development Act, as amended. This circular and guidance will reflect the balanced approach necessary to ensure the six-year local authority planning cycles, while converging towards the preferred NPF scenario, can also reflect both the capacities to increase housing delivery and actual levels of housing output on the ground in the near term. It is also critical to meeting national housing supply targets during the next phase of activity and output and will form an essential part of Ireland's economic recovery from the Covid-19 pandemic.

Acting Chairman (Senator Marie Sherlock)

I thank the Minister of State. The Senator has one minute to respond.

Senator Sharon Keogan

I thank the Minister for his response and I will try to respond in one minute. The original projections of the ESRI for the population were developed using best practice. The input assumptions of the adjustments made by the Department for policy-based intervention are questionable. It should be noted that the migration assumptions used were and continue to be far below the historical data as observed by the CSO since 2016. The ESRI baseline assumed a net inward migration figure of 8,000 people per annum from 2016 to 2021, rising to 12,500 people thereafter. The reality has been of the order of three or four times that figure over the period to 2020. In the past four years, a minimum of 85,000 people do not seem to have been accounted for. There is a discrepancy in the ESRI report and the press release issued over the weekend in the media, which referred to a figure of 33,000.

I welcome the Minister of State’s acknowledgement that the national planning framework will require an increase in annual average housing output in every local authority. Will he clarify to which cities he is referring? Do they include Drogheda in County Louth, which has been seeking city status for the past five years? I welcome the circular the senior Minister will send out to local authority chief executives in the coming days. They certainly need to know exactly what is happening as unfortunately there is no certainty in that regard at this time.

Acting Chairman (Senator Marie Sherlock)

I ask the Minister of State to provide the Senator with a copy of his contribution.

Deputy Peter Burke

I will certainly do that. I thank Senator Keogan again for her response.

The national planning framework was underpinned by the key actors in terms of the methodology in devising population growth and the ESRI was central to that. The NPF is a roadmap for the delivery of planning and sustainable growth in our country over the next number of decades. Central to that, and this is clearly mapped out and articulated in the NPF, are our five cities and growth centres. There is significant capacity for growth in the regions, with 50% of growth to take place outside the Eastern and Midland Regional Assembly, ERMA, region. There have been significant pressures, as the Senator noted, in the greater Dublin area. We will immediately - I hope to do so this week - clarify the ESRI report through the circular that will issue to all 31 local authorities, which will make the pathway very clear.

It is clear that we need high-quality homes but we also need them in the right places. That is key to the work we are doing in the Department.

Acting Chairman (Senator Marie Sherlock)

My apologies to the Minister of State. I understand his contribution is available to Members. I thank him for coming to the House. I also thank Senator Keogan.

Sitting suspended at 11.17 a.m. and resumed at 11.30 a.m.