Michael Harty (Clare, Independent)
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It is proposed to leave housekeeping matters to our meeting on 18 April? Is that agreed? Agreed.

The purpose of this meeting is scrutiny of the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU with representatives of the Department of Health, the Health Information and Quality Authority and from the National Centre for Pharmacoeconomics. As we are obliged to vacate this room at 1.15 p.m. I ask members to put questions that are succinct.

On behalf of the committee, I welcome Dr. Kathleen MacLellan, Mr. Finian Judge and Ms Laura Nagle from the Department of Health; Dr Máirin Ryan and Dr. Conor Teljeur, from the Health Information and Quality Authority; and Dr. Lesley Tilson and Dr. Emer Fogarty from the National Centre of Pharmacoeconomics. Before we begin, I draw witnesses' attention to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, they are protected by absolute privilege in respect of the evidence they are to give to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person or an entity by name or in such a way as to make him, her or it identifiable. I also advise the witnesses that their opening statements may be published on the committee's website following this meeting. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official, either by name or in such a way as to make him or her identifiable.

Before I invite the witnesses to make their opening statements, I am aware that France and Poland consider that the proposed regulations do not comply with the principle of subsidiarity and that Germany has some concerns about the proposal. I now invite Dr. MacLellan to make her opening statement.

Dr. Kathleen MacLellan:

I thank the Chairman and the committee for the invitation to this meeting. I am accompanied by Mr. Finian Judge and Ms Laura Nagle from the Department of Health primary care division. I will endeavour to set out for the committee the importance placed on health technology assessments, HTAs, in Ireland, the processes we have in place for their delivery and some considerations with regard to the Commission's proposal.

From a policy perspective, the Department regards the availability of high quality, timely and cost-effective HTAs as an extremely important factor in the delivery of health services. HTAs can help provide answers as to whether medicines are a better treatment for a certain disease, whether a new scanner will lead to a better diagnosis or if innovative surgery will improve a patient's treatment. In summary, HTA is a procedure for assessing the added value of new medicines and medical devices. The importance of ensuring that resources are directed correctly within the health service to where they can provide the most benefit cannot be overstated. HTAs are, therefore, a key element in the ongoing evolution of the Irish health system and one of the vital inputs used to inform decision-makers when considering whether and when to commence using a particular new medical technique or treatment, or, on occasion, when it can be considered that a treatment has become obsolescent and can be withdrawn from use.

Currently in Ireland, HTAs are primarily conducted by two bodies, the Health Information and Quality Authority, HIQA, and the National Centre for Pharmacoeconomics, the NCPE, representatives of which are here today and will be able to provide further detail on the technical aspects of HTA and specific considerations that they may have with regard to the proposed EU regulation. The NCPE provides HTA advice to the HSE drugs group on drugs for reimbursement under the community drugs schemes. In addition to undertaking HTA on a national basis, Ireland has long been involved in international co-operation efforts. Currently, there are two EU HTA co-operation mechanisms, the European CommissionHealth Technology Assessment Network and the European network of HTA, known as EUnetHTA. The joint work proposed under the regulation will focus only on clinical aspects of health technology assessments. The assessment of more specific HTA domains, including economic, organisational, ethical and decision-making on pricing and reimbursement will remain a member state competence. Assessment of these domains could be carried out jointly by member states on a voluntary basis but this would lie outside the remit of the regulation.

I understand that the committee has particular queries on issues surrounding orphan drugs and drug pricing more generally. In this respect, the Department has received the committee's report on the evaluation of orphan drugs, which is welcome and currently under examination in the Department. The HSE has statutory responsibility for medicine pricing and reimbursement decisions under a number of publicly funded community drug schemes, including the general medical services, GMS, the long-term illness, LTI, scheme, the drug payment scheme, DPS, and the high tech arrangement in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In considering an application for reimbursement, the Act requires the HSE to consider detailed criteria when making decisions around reimbursement and pricing, including the health needs of the public, clinical need, cost effectiveness, potential or actual budget impacts, safety, efficacy, effectiveness and added therapeutic benefit versus standard therapies, availability and suitability, the level of clinical supervision and the resources available. The legislation, as passed by the Oireachtas in 2013, does not make separate provision for orphan drugs.

Likewise, there is no separate provision or distinct criteria for the assessment of orphan drugs.

HSE decisions are supported by HTAs which systematically assess whether a drug is both a clinically effective and a cost-effective health intervention. Most new medicines, including orphan medicines, undergo HTAs. The NCPE has a standardised process and criteria for the evaluation of pharmaceutical products, including orphan drugs. The final decision for reimbursement is made by the HSE drugs group or HSE leadership. I understand that one of the recommendations in the committee’s report is to change the process and criteria for the assessment of orphan drugs. As the committee has acknowledged, this would require legislative change.

From a policy perspective, we view the Commission’s proposal as in keeping with the approach that has been taken for the past several years, multiplying the relatively small HTA capacity which Ireland operates through uniting with other European agencies and gaining access to the assessments which our partners have completed. The financial support of the Commission for this HTA work is also noteworthy.

Ireland has been an active participant in these HTA co-operation mechanisms. The regulation has been brought forward by the European Commission due to the fact that the current arrangements will expire in the coming years and a revised approach will be required for the period beyond 2020. The proposal will see co-operation among member states on the production of joint relative effectiveness assessment reports, which are reports focused only on the clinical aspects of a particular technology. These reports would then be used by individual member states as the basis of their economic assessments, which in turn would inform decisions on pricing and reimbursement.

In our contacts with the Commission, including during the visit to the Department of Health last November, while outlining our general support for the regulation, we have emphasised the importance of ensuring the quality of assessments undertaken by the various national bodies are of a sufficient standard. The need for access to the relevant information from technology companies and for the HTA to be timely has also been expressed. Our understanding is that the process of undertaking HTA will continue to be driven by the member states, particularly those with experience of HTA. Methodologies and tools to be used by the agencies undertaking HTA will be agreed.

There are potential efficiencies and benefits within these proposals where a small country like Ireland will be able to access, participate in and lead HTAs across member states. This will, hopefully, minimise duplication and build a stronger HTA function across Europe. The Department of Health recognises that Ireland has a good reputation across member states on HTAs and indeed has played a leadership role in establishing strong standards for HTA assessment.

In conclusion, there are many benefits for Ireland with this proposal including early access to robust evaluation of clinical evidence. However, key to this is trust in the proposed joint working arrangements for HTAs across member states. That will require adherence to and monitoring of minimum quality assurance standards for HTAs.

I thank the Chairman for the opportunity to present this opening statement and we will endeavour, with our HIQA and NCPE colleagues, to address the committee’s considerations.

Dr. Máirín Ryan:

I thank the committee for the invitation to address it this afternoon. I am accompanied by HIQA’s chief scientist, Dr. Conor Teljeur. We were invited to the committee to discuss the proposed regulation on health technology assessment, published by the European Commission in January of this year. I will begin by defining health technology assessment, HTA, outlining HIQA’s role in HTA, describing HTA activity undertaken to date and detailing how efficiency is achieved through international collaboration. I will then describe the anticipated impact on HIQA of the proposed regulation on HTA.

HTA is a multidisciplinary, scientific, research-based activity that collates all of the information that decision-makers need to support evidence-based decisions. HIQA’s HTA process is independent, transparent, impartial and robust and aims to ensure maximum public confidence. Health technology assessment is a tool used to comprehensively assess new and existing technologies and ensure that relevant reimbursement, investment or disinvestment decisions are informed by the best available evidence. For the purposes of HTA, technologies include drugs, devices, procedures, diagnostics and public health interventions.

HIQA holds the statutory function for health technology assessment in accordance with the Health Act 2007. The purpose of HIQA’s HTAs is to develop independent, scientific advice in line with international best practice. The advice is then provided to the Minister for Health or the HSE to inform a decision on reimbursement or investment.

Currently HIQA conducts comprehensive HTAs to inform national health policy and health service decisions. HTAs typically address clinical aspects of the technology, cost-effectiveness and budget and resource impacts and also domains covering organisational, ethical, social or medico-legal issues. Demand for HTA advice from HIQA greatly exceeds capacity to deliver, thus a formal prioritisation process was implemented in 2014.

All HTAs are undertaken by HIQA staff, with occasional input from external experts as necessary. All HTAs are undertaken in compliance with a comprehensive quality assurance framework aligned to international best practice. An expert advisory group comprising representation from all relevant stakeholders, including, for example, clinicians, patients, decision-makers, HTA and international experts, is convened for each HTA to inform the assessment. Oversight is provided by the board of HIQA.

For HTAs on topics of public interest, a targeted and public consultation is undertaken prior to completion of the assessment. Technology providers are also invited to make submissions on their product, which may be used to inform the HTA.

The final draft report is approved by the board of HIQA and published on HIQA’s website within one week of approval. Examples of HTAs conducted to date at the request of the Minister for Health include BCG vaccination; smoking cessation interventions; and an ongoing HTA on the HPV vaccine for boys. Examples of HTAs conducted to date at the request of the HSE include HPV DNA as the primary screening test for cervical screening and mechanical thrombectomy for large vessel occlusive stroke.

New health technologies are frequently considered for investment in many countries concurrently or within a similar timeframe. This offers the opportunity for joint production of HTA information, while economic models developed for one jurisdiction may be adapted to reflect health care delivery models in another. The conduct of HTA requires substantial staff resources, but equally many of the elements of a HTA are ideal for sharing across national borders. To minimise duplication of effort and to maximise our efficiency, almost all HTAs carried out by HIQA to date have leveraged off work conducted elsewhere by updating evidence reviews or adapting economic models. Equally, evidence reviews and models developed by HIQA have been used by other European agencies. Strong positive relationships with other HTA agencies enable this collaboration.

Since 2007, HIQA has represented Ireland on the EU-funded joint action projects on HTA conducted by the European network of HTA, EUnetHTA. The objective of EUnetHTA is to facilitate effective and sustainable HTA collaboration that brings added value at both the European and national levels. I am the chairperson of the assembly of EUnetHTA members and participate in the executive board. HIQA actively contributes to EUnetHTA’s work, for example, HIQA was the lead author of a European rapid assessment of endovascular therapy using mechanical thrombectomy devices for acute ischaemic stroke. I also represent Ireland on the Health Technology Assessment Network. This is a permanent network of HTA agencies established by the European Commission with the objective of fostering permanent strategic and scientific collaboration on HTA across the EU from 2020 onwards. European collaboration on HTA across Europe has culminated in the development of the proposal for a HTA regulation, which I will now discuss.

The proposed HTA regulation outlines four key outputs: joint assessments comprising the clinical HTA domains; joint scientific consultations for technology developers; horizon scanning to identify new and emerging technologies; and a framework to support collaborative working, for example, HTAs of other technologies such as public health programmes and HTAs addressing non-clinical joint assessments such as economic assessment.

The standardisation of methods and processes and the use of common tools required by the proposed regulation will build heavily on development work already conducted by EUnetHTA. Methods for systematic review of the clinical evidence base are already standardised internationally. The Irish national HTA guidelines developed by HIQA align with international best practice and EUnetHTA standard approaches. Work is already well under way in HIQA to standardise our methods and processes to the EUnetHTA framework, which will be a requirement of the regulation if implemented. Article 22 of the regulation requires the standardisation of national HTA procedures to guarantee that the scientific evidence is produced in a manner that espouses independence, transparency and stakeholder engagement. All of these principles are already embedded in the conduct of HTA by HIQA.

Joint production of assessments of medicines and high-risk medical devices will increase the availability of systematically produced reviews of the international evidence on clinical effectiveness and safety of relevant technologies.

The availability of joint clinical assessments will add to the efficiency of HIQA's processes by obviating the need for one of the key steps in the production of health technology assessment.

Scrutiny of the proposal for the regulation on health technology assessments by HIQA has raised several issues that will ideally be addressed or clarified before it enters into force. I have outlined the issues of concern in my written statement and I am happy to answer any questions committee members may have in this regard. I have provided an overview of how international collaboration is leveraged by HIQA to enhance the quality and efficiency of HTA. I have also outlined the implications for HIQA of the proposed regulation on HTA. I thank the committee for inviting us to speak and we are happy to take any questions committee members may have.

Michael Harty (Clare, Independent)
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Dr. Lesley Tilson will make an opening statement on behalf of the National Centre for Pharmaeconomics.

Dr. Lesley Tilson:

I thank the committee for the invitation to attend the meeting. I am joined by my colleague, Dr. Emer Fogarty, who is a senior health technology assessor at the NCPE. I will briefly outline the role of the NCPE and the centre's involvement in European initiatives and I will discuss the implications of the proposed European regulation promoting co-operation in the area of health technology assessment.

The NCPE conducts rigorous, evidence-based health technology assessments to inform decision-makers on the reimbursement of pharmaceuticals and vaccines in Ireland. The NCPE assessment considers the clinical effectiveness and health-related quality-of-life benefits and all relevant costs, including potential savings from reduced health care resource use like hospitalisation, which a new treatment may provide and whether the price requested by the manufacturer is justified. A budget impact analysis is also required in addition to the status of HTA in other jurisdictions. The NCPE process facilitates submissions by patient groups who wish to have their views taken into consideration. The NCPE will then advise the HSE on the clinical effectiveness, cost effectiveness and budget impact associated with specific pharmaceutical products. The final decision on reimbursement of any drug is made by the HSE following consideration of all relevant evidence and recommendations in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE process is well-established and standardised criteria are used for the evaluation of pharmaceutical products. All assessments are conducted in accordance with published general HTA guidelines produced by HIQA and internal NCPE assessment guidelines. The pharmacoeconomic process is outlined in the 2016 framework agreement on the supply and pricing of medicines.

The NCPE is involved in several European initiatives. The NCPE is committed to, and heavily involved in, European co-operation by participating in various collaborations, including the European Medicines Agency joint scientific advice process, numerous Innovative Medicines Initiative-funded initiatives and the EUnetHTA collaboration in health technology assessment. The NCPE is a full partner to the current and final EUnetHTA joint action and is involved in the four main work packages. These involve co-operation in the following areas: early scientific advice to manufacturers and post-market evidence generation; production of joint relative effectiveness assessments; guidelines on development and quality assurance; and implementation. The NCPE provides meaningful contributions to many EUnetHTA outputs, such as the prioritisation of work tasks for Joint Action 3 across work packages and companion guides for the conduct of HTA. The centre is currently co-authoring the topic identification, selection and prioritisation horizon scanning programme for current and future models of co-operation. Furthermore, the NCPE has provided expert advice to the Department of Health regarding collaborative pricing and reimbursement initiatives at European level, including the Valletta and Beneluxa initiatives. Overall, the NCPE has invested significant resources in co-operation on European projects in recent years and the centre welcomes the publication of the Commission proposal on the regulation of HTA.

On 31 January 2018, the European Commission put forward a proposal to develop a regulation around HTA. Specifically, the proposal requires mandatory co-operation of member states in the area of joint clinical assessment. The Commission has described the intention and scope of the proposed regulation. The purpose is to address impediments to market access between member states, avoid duplication of work for HTA bodies and overcome the challenges of voluntary HTA co-operation by creating permanent infrastructure and funding to support joint activity. Specifically, the proposal focuses on joint work on clinical aspects of HTA while the assessment of more context-specific economic issues and decision-making on pricing and reimbursement will remain at member state level. Member states will continue to draw conclusions on the overall added value of the assessed health technology based on the joint clinical assessment report and the assessment of non-clinical aspects of the technology.

The NCPE welcomes the proposal and consider that there is potential for efficiency gains for our organisation and potentially the broader health service, if implemented in a timely manner. However, the NCPE considers that there are several important issues that require detailed clarification before these potential efficiency gains could be realised. These include whether it will be mandatory for pharmaceutical companies to submit evidence as part of this process. As much of the relevant clinical evidence is held by the companies, their participation is considered to be critical. Another factor is the co-ordination of the publication of the joint clinical assessments and the product launch date in Ireland. Product launches and reimbursement applications are often made in Ireland some time after receipt of EU marketing authorisation. Efficiency gains may be lost if the product launch is later than the date of marketing authorisation and reassessment is required due to the availability of new clinical evidence. Furthermore, efficiency gains may not be realised if the primary language of the new body is not English.

The NCPE understands that these clarifications may not be available until after the proposed regulation comes into force and are produced as part of the secondary legislation process. Thus, at this point it is not possible for the NCPE to confidently assume that the process will yield significant efficiency gains in the assessment of clinical effectiveness of new drugs.

The committee has specifically requested information on how the proposed regulation may affect the approval of orphan drug products in Ireland and the likely impact on drug pricing in member states. The draft regulation does not distinguish orphan drugs or propose any specific processes for orphan drugs. In its current format, the draft is unlikely to affect the approval process for orphan drug products in any way. Drug pricing and reimbursement is outside the scope of the proposed regulation, which contains no reference to formal co-operation in this area. The NCPE considers that the proposed regulation should not prevent or impede international co-operation on pricing and reimbursement. I thank the committee for the invitation to speak today.

Michael Harty (Clare, Independent)
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I thank Dr. Tilson. We will now open the discussion to our members. Given the time constraints, members should make their observations and then we will get the replies. The order of speakers is Deputy Louise O'Reilly, Deputy Kate O'Connell, Deputy Bernard Durkan and Senator Colm Burke.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I thank the Chairman. I will be as quick as I can. I thank the deputations for attending. By way of a general point, it seems that everything functions reasonably well and everyone seems to be fairly happy. I am a little lost as to why we particularly need this measure. Dr. MacLellan has advised that Ireland has outlined its general support for the regulation and emphasised the importance of ensuring that the quality of assessment undertaken by the various national bodies is of a sufficient standard. Is Dr. MacLellan satisfied that the concerns or questions raised have in fact been answered sufficiently?

My next question is for the NCPE. Dr. Tilson said clarification might not be available until after the regulation comes into force. There is an element of the unknown about it. Is there any role for the committee in communicating with the Commission to seek answers? Are these small issues or matters of concern for the NCPE? Can the NCPE outline its thinking in this regard?

My questions for HIQA are in the same vein. The HIQA submission referred to strong positive relationships that exist already. It strikes me that a good deal of co-operation exists as does considerable information sharing. Moreover, much work is already getting done. Can the HIQA deputation outline how the regulations will help to improve what seems to be a reasonably good procedure as it stands?

With regard to the concerns that were expressed, do any of the witnesses think the committee has a role in addressing those with the Commission?

Kate O'Connell (Dublin Bay South, Fine Gael)
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I welcome the sharing of clinical information and joint clinical assessment, leading to efficiency. In the case of a recent drug, Orkambi, as far as I know it did not get through the normal approval process and there was an intervention after the assessment. I believe the approval of the drug was a combination of the process along with Ireland's unique relationship with the cystic fibrosis condition. In the case of another condition or illness that might be specific to a certain group or population, is there a facility for those groups within the combined model? Where countries have high scale manufacturing of drugs, is it built into the system that such countries would not favour their products over other countries' products?

My understanding is that the entire budget is together. Last week or the week before that this committee asked about the total drugs spend. Although the drugs spend is still very high, despite reference pricing and the arrival of generics, it appears that the savings on regular drugs have been taken up with the spend on high tech and orphan drugs. Would there be any benefit in separating these budgets, so it is clear where we are making savings and where is the spend? I am not sure if having a budget ceiling on spending on orphan drugs is the way to go. There is almost a target or limit for what can be spent. What happens if the money is all spent and an orphan drug emerges that we really want to approve? How will we deal with that? I take on board Dr. Lesley Tilson's comment that the research has to be in English as the first language. It is of no use if one cannot interpret it.

We are under time pressure so I will conclude with that.

Bernard Durkan (Kildare North, Fine Gael)
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There are great potential benefits from standardisation, provided the highest standards are met. That is obvious. There are three issues - the possibility of reduced costs, increased efficiency and standardisation to the highest standard. If those three conditions can be met within the proposal, my question is whether it runs foul of subsidiarity as present. However, so do a number of other things that we were led to believe were the exclusive rights of the member states, corporation tax being one of them. Some of our colleagues have decided to find a way around that and to encroach on that territory. An issue arises there. I strongly believe in standardisation and getting the benefits of EU population numbers in terms of assessment of costs and avoiding duplication. It is and should be possible. Does it augur in any way for Irish pharmaceutical manufacturers in terms of their access, remuneration or whatever the case may be?

There is no sense in introducing something that does not deal with the entire spectrum of drugs. Given that orphan drugs, for example, are not going to be part of the parcel at this stage, one has to ask why they cannot be and when that can happen. That is one of the issues we urgently require to be dealt with at present.

I strongly support the European assessment, as I have said previously at these meetings, provided we achieve the highest standards. It would be a good exercise in democracy if our national standard bearers were to become part of that European assessment bloc so we would have national representation there as well, similar to the way the ECB has representation from the national central banks as well. If that were done we could have the benefits of high standards, efficiency and lower costs.

Colm Burke (Fine Gael)
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I thank the witnesses for their presentations. My apologies for being late. I had to be in the Seanad. The problem I am encountering is that the pharmaceutical companies are expressing their frustration to us with the process here. In our report on orphan drugs we referred to what occurred in Scotland. It was having the same problem and it set up a new process for dealing with it. With regard to co-ordination with other member states, have we examined, for argument's sake, aligning ourselves with another member state as regards the processes, rather than acting independently? I realise that we rely on the European Medicines Agency and what is happening at European level, but we still seem to have a totally separate process. Many of the pharmaceutical companies that are based here spend a huge amount of money on research and development, but when they come through process here they find it frustrating. I was talking to a representative of one company recently that had invested €149 million here. After making that investment, the company found that dealing with the process was very tedious and difficult compared with other member states. The report we produced set out a number of recommendations and I note the witnesses are suggesting a change in legislation. Can we do something to fast track the decision making process here and make it as efficient as possible? If companies get a negative answer that is fine, but at least they know they are getting an answer. Instead it appears to be review after review. Can we examine that issue?

Dr. Kathleen MacLellan:

I will start with Deputy O'Reilly's question about the confidence the Department would have in the quality of assessment and whether the assessments would be of sufficient standard. The Department's view of standardisation is that it is critical that those standards are met. What is proposed is building on the current work and our current work across the various EU HTA networks. The regulation proposes the use of common tools and common standards, which we would welcome. We were very clear when the Commission visited the Department in December that this was a red line for us, and that it would be problematic if standards are seen to be diminished around HTA assessment. There are articles within the regulation which require standardisation, so as the regulation is further developed we will have to engage with, track and monitor that to ensure we are satisfied that the requirements in the regulation will continue to allow us to have the confidence in the standards that would be expected around HTAs across the member states.

I will briefly comment on Deputy Durkan's reference to subsidiarity. I am responding on the issues to which I can respond before handing over to my colleagues. With regard to the subsidiarity principle, we have been considering this as the proposed regulation offers potential benefits and efficiencies to a small country such as this. It is probably small countries that will benefit most from this type of collaboration. We are already engaged in collaboration on a voluntary basis. The regulation is proposing to put a regulatory and legal framework behind that. At this stage and as it is developing we see many positive benefits for us. It gives us the opportunity to leverage the clinical assessments that are being carried out internationally and to prevent duplication. We believe that will be useful.

It will be important that we can continue to manage the aspects that are sensitive to our own national public interests and matters relating to economic, ethical and organisational elements. From that point of view, we hope that, as a country, we can contribute quite strongly to a stronger European health technology assessment, HTA, function. We are very confident that we have two bodies here that have exceptional expertise in HTA and that is already recognised at EU level. We can see by the fact that Dr. Máirín Ryan is actually chairperson of EUnetHTA that this is recognised and that this regulation will provide us with the opportunity to lead on and participate in HTAs. We are confident on that aspect. I might ask my colleagues to address other aspects raised. Mr. Finian Judge might want to take the question on the Department's role then we might potentially move to the Health Information and Quality Authority, HIQA, and National Centre for Pharmacoeconomics, NCPE.

Mr. Finian Judge:

I will try to take the end questions on policy and the Department's role in the order that they were asked. Deputy O'Reilly asked about the committee's role, which is a very good question. We have the committee's report and we are also aware that a Private Members' Bill has been published on the area. With regard to how we can take on board what the committee has to say and how to reflect it with regard to the Commission's thinking, we will examine the committee's report in detail. As we sit in council over the next 12 months, debating this proposal line for line, we will certainly take on board what the committee has to say in its report. That has very much been an involvement of the committee in our thinking for the next 12 months. We will relay to the Commission, at the council groups, precisely what the committee has said in its report.

Deputy O'Connell raised this issue of Orkambi. The answer to her question is that yes, there is a facility for the HSE, if resources are substantial, to make a submission to the Department and to the Minister in that regard. The Minister and his colleague, the Minister for Finance, are involved in the process. The Deputy also raised the issue of countries favouring their own products. In that respect, as we have discussed this proposal at council, we will ensure that there is no undue influence by any one company or manufacturer in that entire process. Deputy O'Connell spoke about the drugs spend and breaking it down between high-tech and orphan. In recent days, we gave a letter to the Chair of the committee where we broke down the spend between the different community drug schemes. We can certainly work more on that if the committee wishes to see a more detailed breakdown. We are restricted by the data collected by the primary care reimbursement service, PCRS, in the HSE. Deputy O'Connell's other point was on a separate process for orphan drugs. As we all know, there is not a separate rule set in the Act as laid down by the Oireachtas for orphan drugs. Having said that, the HSE is always mindful of the particular challenges posed by orphan drugs. It is under active consideration. A new committee has been established under the national rare disease plan. There is a likelihood that that new committee will look at the feasibility or the merit in establishing new entry and exit criteria for orphan drugs. It is up for consideration.

Deputy Durkan spoke about piloting a separate rule set for orphan drugs. I think I have answered that. Deputy Durkan made a point that we should look to our EU partners and grow collaboration with them. This is precisely the point that the Taoiseach and Minister have been making quite a lot. We are already involved in the Valletta collaboration. The Minister only very recently wrote to his colleagues in Belgium, the Netherlands, Luxembourg and Austria, seeking to join what is known as the BeNeLuxA collaboration. We are trying to do as much as we can to build on the experience and power of getting into the space of joint pricing.

Senator Colm Burke talked about the pharmaceutical company frustration in the process. There is no doubt that, post the HTA process, there can be delays in final decision-making. Much of that delay is down to the fact that a decision from the NCPE, even one to say that it does not stand up, is a decision that it does not stand up at the price submitted. That is a catalyst for the process to begin at the HSE level to go back to the companies involved and renegotiate price etc. Much of the delay is because commercial negotiations are reopened and the HSE is seeking to attain the best price possible for the drug. The Senator also raised the issue of collaboration, which I have mentioned. I think I have covered most of the issues that were put to the Department.

Michael Harty (Clare, Independent)
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I thank Mr. Judge. I call Senator Colm Burke.

Colm Burke (Fine Gael)
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On the orphan drug issue, the frustration I am talking about is that on average - therefore sometimes it takes longer than this - it takes 23 months for a decision to be made. This is a process the pharmaceutical companies finds frustrating since an assessment had already been done in other countries yet we are then going through the process again. It takes 23 months before any answer is received and that is the source of their frustration at present. It is not the process afterwards. I accept what the witnesses are saying about the process afterwards and the high costs. The Department is right in negotiating down costs. The process there to negotiate down costs is correct but it is in the process before we get to that stage that the companies find frustration.

Dr. Lesley Tilson:

Could I answer on the HTA process and the timelines for it? Our assessments are completed on similar timelines to the Scottish Medicines Consortium in many instances. An aspect that often is not highlighted is that in Scotland, all drugs are assessed through the full process whereas we have a rapid review process. For example, last year, we had 80 assessments of which 64 were done as rapid review assessments, which take on average four weeks at the NCPE. Only 16 products went on to a full health technology assessment. We prioritise very efficiently which drugs are assessed in a very detailed way and we try to reserve our resources so that happens.

Bernard Durkan (Kildare North, Fine Gael)
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Why is it necessary that there generally are two assessments?

Dr. Lesley Tilson:

The first is an initial screening. It is a rapid process to look and establish the requirement for a full pharmacoeconomic evaluation.

Bernard Durkan (Kildare North, Fine Gael)
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Does every country have that initial screening and a second one?

Dr. Lesley Tilson:

No, but it is favoured by the industry because it considers it as being a very practical solution for a small country to assess all medicines.

Bernard Durkan (Kildare North, Fine Gael)
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Why is it necessary for us to associate with a number of countries, albeit small countries? Why do we not associate our assessment system with all countries, thereby getting the benefit of the Single Market, which I have often referred to in this context? The Single Market is supposed to be available throughout all disciplines, not just with regard to travel or something like that, but this as well.

Mr. Finian Judge:

The statutory responsibility has been vested in the HSE. The criteria in the Act to which the HSE must adhere have been laid down by the Oireachtas. Different countries have different criteria. For example, the notion of cost-effectiveness could vary quite significantly from one jurisdiction to the next. We have very defined criteria to which we must adhere with regard to our assessment for drugs. We are looking at regional collaborations in Valletta and BeNeLuxA to see how we can collaborate on drug pricing and supply. If one looks at this proposal from the Commission, it could be seen as a first step to try to bring it under one EU roof. It starts with the process of clinical assessment.

Bernard Durkan (Kildare North, Fine Gael)
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There are several other areas where we come in under one EU roof. Why is this particular area exclusive and why does it come up again and again? I cannot understand it and I will never understand it if I live to be 100 - I am heading that way at the moment.

If we are to gain the benefits and efficiencies that one would expect to gain from being part of a bigger population, there are rules within the European Union which apply in that regard. I asked earlier if we know how the pharmaceutical sector in Ireland will be affected by having a central agency, to which we would make a contribution and which would meet the criteria relating to subsidiarity. Those criteria would, in turn, apply across Europe. I do not understand why we cannot do it. There are already variations in cost between member states.

Michael Harty (Clare, Independent)
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Does Dr. Ryan wish to contribute? We will conclude reasonably quickly after her remarks.

Dr. Máirín Ryan:

Deputy O'Reilly asked when we have a lot of work already ongoing and everything appears to be operating successfully, why do we need the regulation? The work we have done already has been about piloting joint assessments. The EC Health Technology Assessment Network and the European network of HTA, EUnetHTA, has conducted 18 non-drug assessments to date, I think, to which HIQA has contributed to eight, and ten drug assessments. This is about having a system where all drugs that come to the market or have a new indication, as well as all high risk medical devices would be subject to joint clinical assessment once it is ramped up. That means approximately 100 assessments annually. The regulation is about bringing the efficiency to ramp up production.

Deputy O'Connell asked about particular sub-groups. When the assessments are undertaken, each country will have the opportunity to contribute to deciding how the assessment will be undertaken including highlighting factors such as particular subgroups or particular comparators that are in the national context so that they might be taken into account. On mitigating the bias towards products produced in our own jurisdiction, each assessment team will probably consist of an average of ten countries which will contribute. There will be a joint assessor and the rest will be reviewers. There is oversight in terms of mitigating any bias that might creep into the process. On the assessments being conducted through English, to date all the EUnetHTA work has been conducted through English. Many of the European agencies publish their assessments in English and we hope that English will be the common language but that is yet to be determined.

Regarding Deputy Durkan's comments, quality assurance is paramount when it comes to health technology assessment. We were very strong in influencing the work content of joint action 3, which is going on now, in that it would incorporate the development of a quality assurance framework in the context that if the regulation comes through that, the quality assurance framework will then be fit for purpose. On subsidiarity, we see efficiencies in the clinical assessments being available to use across the countries. There is obviously an efficiency there, but the regulation requires each country to adopt a common methodology which will offer further opportunities for co-operation in future. There is also a mechanism to support voluntary co-operation so the regulation is around mandatory co-operation for clinical assessment but there is also a framework to support voluntary co-operation in other assessments. For example, if Valetta and BeNeLuxA are trying to co-operate on the economic domains, the regulation provides a framework that will also support that work, but it is voluntary rather than mandatory.

Colm Burke (Fine Gael)
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Is it possible to get information on the number of applications that have gone through in recent years? From the committee's perspective, we are being constantly contacted by the pharmaceutical companies and it would be helpful for us if we had those figures and the length of time it took to process applications.

Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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I apologise if my questions have already been asked. I had to speak in the Chamber earlier. The HTA is to be set up across the EU by 2020. Do entities such as HIQA currently report to any authority in Europe now or does such a body exist?

I note that non-clinical aspects such as cost will remain a function for member states. Does Dr. Ryan feel there should be uniformity in the area of costs as well as other factors. How will the sharing of information be protected within states?

Dr. Máirín Ryan:

On work in the European network of HTA, we are a full partner in the collaboration which is currently ongoing. So far, it has been about piloting the joint clinical assessments. When we produce joint clinical assessments, they are validated by the UNnetHTA process. UNnetHTA is a voluntary collaboration across 81 HTA agencies and institutional producers of HTA across the 28 states.

On standardisation of costs, the regulation is concerned with joint clinical assessment. There are difficulties when it comes to economic collaboration. For example, the economic model can be potentially shared across different countries but a state may need to adapt it to its own setting. That is because it is not only about the cost of drugs or technologies differing, it is because the economic model considers all the other costs associated with the use of the therapy and also the impacts of the therapy. If the drug reduces the incidence of strokes, for example, then we have to consider the saving associated with the reduced incidence of strokes. The cost of managing stroke in Ireland is very different to what it is in Poland, for example, and also in Denmark because the different health care systems are set up differently and costs are different. That is where some of the difficulty arises on cost.

Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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It is difficult to make it uniform.

Dr. Máirín Ryan:

It is difficult. There are some aspects that are common and there can often be commonalities in the model. The information in respect of the clinical effectiveness is based on the international literature base, which is generally common, although sometimes one has to tweak it for one's own population. However, on the costs of health care systems, the main difference comes into play because they are organised differently in different countries.

Michael Harty (Clare, Independent)
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I thank Dr. Ryan. While the meeting is still in public session, will members indicate whether they are satisfied with COM (2018) 51, which is the proposal for a regulation of the European Parliament and of the Council on Health Technology Assessments amending Directive 2011/24/EU?

Bernard Durkan (Kildare North, Fine Gael)
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We do, subject to the concerns we raised.

Michael Harty (Clare, Independent)
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In that case, there is another option. If we want to make a political contribution on matters other than subsidiarity and proportionality, we can agree that at the next meeting.

Bernard Durkan (Kildare North, Fine Gael)
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Agreed.

Michael Harty (Clare, Independent)
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So the Deputy wishes to make a political contribution?

Bernard Durkan (Kildare North, Fine Gael)
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Yes, along the lines we discussed.

Michael Harty (Clare, Independent)
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We will draw up the wording for that and have it available for our next meeting. Is that agreed? Agreed.

I thank the representatives of the Department of Health, HIQA and the National Centre for Pharmacoeconomics for coming in to give the committee their expert advice and opinion.

Colm Burke (Fine Gael)
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I want to raise the issue of the report on orphan drugs. Has the committee formally written to the Minister sending him that report?

Michael Harty (Clare, Independent)
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Yes, it has been accepted and sent.

Colm Burke (Fine Gael)
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Has it been formally sent to the Minster rather than the Department? It is important that we correspond with the Minister.

Michael Harty (Clare, Independent)
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We will check that.

Colm Burke (Fine Gael)
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I thank the Chairman.