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Joint Committee on Health debate -
Tuesday, 23 May 2017

Engagement with Mr. Vytenis Andriukaitis, European Commissioner for Health and Food Safety

Please note that these proceedings will be carried on Saorview, channel 22, Virgin Media, channel 207, Eir Vision, channel 504, and other channels, which I will not read out.

I warmly welcome our European Commissioner for Health and Food Safety, Mr. Vytenis Andriukaitis, to this meeting. It is an honour to have him here and I thank him very much for attending. The Commissioner is accompanied by Ms Vilija Sysaite, Mr. Marco Valletta, members of the Commissioner's cabinet, Mr. Gerry Kiely, head of the European Commission Representation in Ireland, and Ms Paola Colombo, director of DG SANTE, food and veterinary office. Members of the health committee are joined by some members of the Joint Committee on Agriculture, Food and the Marine and the Joint Committee on European Affairs. Midday is an unusual time for our meeting, so we hope our other members will arrive.

I invite Commissioner Andriukaitis to make his opening statement. We asked that he might address particular issues including EU procedures for the purchase of drugs and pharmaceuticals; arrangements for cross-border health care, particularly for Ireland in the aftermath of Brexit; medical research and developments in health care; and the European Commission position on the uptake of vaccinations. I understand the Commissioner may also speak about veterinary, agriculture and food matters.

Dr. Vytenis Andriukaitis

I thank the Chairman and Members of Parliament. Once again, we woke up to terrible news this morning. My heart and my thoughts are with the victims of the Manchester attack. We also think of the families of the victims in France. It breaks our hearts. It is very painful for all of us, but we will show our solidarity in the face of this terrible terror. Once again, we will be ready to come together and show our solidarity, especially in such a turbulent time.

I am very happy to be in this House for a second time. At the beginning of my mandate I started to visit national parliaments. I achieved my goal of visiting all the capitals in two and a half years. I visited all 28 member states, capitals, national parliaments and Governments. I took the opportunity to have discussions with non-governmental organisations, industry, unions and youth organisations, and I am happy to say that today I understand much more in terms of what is happening on the ground.

It is a pleasure for me to be with the members today. In two and a half years our work has been to promote jobs growth and Jean Claude Juncker's investment agenda. In that respect, I would like to raise again the question of the economy, especially, I am sorry to say, the health economy. I am very happy to have two portfolios, namely, public health issues and food safety, both of which help us to keep people as healthy as possible for as long as possible, guaranteeing the possibility to fight against risk factors, to reduce risk factors and to provide safe food. It might be much better to provide more healthy food, but we will discuss today our options in that regard.

I started with three Ps - promotion, prevention and protection, and of course promoting good health by encouraging health communication and physical activities, as well as supporting healthy living and working conditions.

I remind members of the common obligation to prolong our average life spans by two years and to have the goal of healthy ageing. Can one imagine achieving healthy ageing without the possibility of introducing evidence-based public health instruments and moving forward by keeping an eye on promotion, protection and prevention? This is evident from the first slide.

On the second slide, it is very important to see the relevant instruments. Today, the main risk factors are alcohol, tobacco, salt, sugar and trans fats. Of course, there are mental health factors and anti-stress measures to be considered. The slide refers to pricing policies and marketing policies and it alludes to how to reduce problems. Availability and consumer information, especially product labelling, are instrumental. It is a matter of how to provide evidence-based public awareness and school-based education. All these instruments are in our hands. I am very happy to learn, in having good debates with the members' Government, that it is providing such a Bill addressing alcohol and that it is making it possible to address childhood obesity and providing instruments to guarantee the possibility of fighting against tobacco. We are happy to support Ireland and promote its activities to help it achieve its ambitious goals.

May I consider tobacco? I know very well that Ireland is on the way towards fully transposing the tobacco products directive adopted in 2014, thanks to the Irish Presidency. In 2013, the Irish Presidency was very successful. There was keenness at that time to introduce a tobacco products directive. Today, there is a good opportunity for member states to decide how best to introduce the directive into their law. Ireland is championing this. Timely transposition of the directive was achieved and ambitious tobacco control measures were taken on plain packaging. I thank Ireland for this. It is a really good example. Today, three countries - France, the UK and Ireland - have introduced plain packaging. We know very well that 21% of Irish people smoke, which is below the EU average of 26%. Of course, it would be good to achieve much more. I very much welcome Ireland's proactive approach, for which I am thankful. I am ready to disseminate Ireland's good practices around all member states.

The second issue concerns obesity and alcohol. I acknowledge Ireland has many problems with binge drinking among young people. At age 15, some 16% of Irish boys and girls have been drunk at least once, with immediate negative health effects and a risk of future addiction. I, therefore, welcome Ireland's continued commitment in this area, such as the action plan on youth drinking.

We need a stronger approach to promote nutrition and physical activities. Obesity is increasing across the EU, and Ireland is no exception. More than one in three European schoolchildren are overweight or obese, putting them at great risk of type-2 diabetes or cardiovascular diseases late in life. Promoting healthy lifestyles and introducing preventive measures do not need to be expensive but they require political will.

Policy makers have an opportunity and responsibility to add important values in this respect. I am a big fan of supporting all Ireland's steps in this direction. Of course, I know very well that we had a good conversation with the Government about that to see how to move forward and achieve some new steps.

I draw attention to the health care system and sector. Today, I know that Ireland is on the way to presenting new primary health care reform, drawing attention to possibilities to improve primary health care and to see primary health care colleagues as gatekeepers in this very important area. Of course, the community-based approach is a very big one. We provided information about health at a glance in all 27 member states. Today, we are on the way to presenting a schematic of the analysis in the field of health and the state of health in the EU. We will, together with the Organisation for Economic Co-operation and Development, OECD, present such a report at the end of this year. It will be very useful for members of parliaments to read those reports and see how to improve our national health care systems. I know that the Oireachtas will see possibilities to strengthen financial management and also possibilities to introduce e-tools and use ICT platforms to encourage the health care system to be more efficient.

Our aim is to develop expertise on performance assessments of health systems, to build country-specific and cross-country knowledge to help inform policies at national and European level. This is designed to inform and support and not to make recommendations because it is very clear that one must follow subsidiarity. Subsidiarity is to allow member states to provide their own instruments, but we are ready to assist, help, advise and propose good practice examples from different countries. This case is very important to draw attention to health technology assessment issues, because it is about access to more than treatment. It is about possibilities to help people achieve effective treatment. Also, as members of the committee know, it is also a possibility to co-operate in clinical trials, inviting researchers, industry and the pharmaceutical industry to gather and to see how to assess what innovation is, how it is caused, which economic and social consequences there are, which medical consequences there are, and how to see possibilities to achieve socially acceptable prices.

Pricing issues are very high on the agenda. We know very well that health technologies today cost more and more money. If one compares it to our phones, they are cheaper and cheaper. On the other hand, our medical equipment has higher and higher costs. How do we address those issues? We know very well it puts pressure on our public finances and the resilience of health care systems. We need to have a single way to co-operate, provide methodologies and to have instruments on how to assess those technologies and discuss issues about costs and economic effectiveness. We need to have a permanent mechanism at EU level for health technology assessment. As the members of the committee know, we have European Union co-operation on health technology assessment. Ireland is very active here. We see possibilities to move in such a direction and are ready to present our final results of the impact assessment at the end of this year. We will elaborate at a gathering of all member states on a concept of a permanent mechanism of health technology assessment.

Today, we have joint actions from time to time, but this co-operation is not stable. We need to move forward.

Another very important issue is the cross-border health care directive. I want to raise the possibility of using cross-border health care instruments. All countries must have national contact points. We all have problems with patient waiting lists and it would be good to raise awareness among patients. Yesterday, I had a meeting with some doctors who raised questions about this and why more people did not know about the cross-border health care directive, which is in place. The national contact points must provide information on, for example, how to reduce waiting lists by using the opportunities for treatment in different countries. I can only see one way to do this and that is for countries to co-operate. The European reference networks, which were launched in March this year, are a very good example. Here in Ireland, there are European reference centres which belong to 24 pathologists. It would be good to use the tools and e-technologies available to encourage governments to provide more European financial instruments so that by the end of 2018 the European reference network is a workable network.

We need to use the connecting Europe facility money, Structural Funds, and Horizon 2020, all these different resources, to encourage countries to co-operate and to find opportunities to present virtual consultation, virtual possibilities to provide diagnoses and treatment, and to use e-prescriptions, patients records and patients images. It is a very important area. It would be good to do our best to fulfil our obligations in practice by 2019. I am one of you - the members - and we are together in one team. We have a good opportunity to build new ties from 2017 and to build more coherent European networks, thereby guaranteeing that people with rare and low-prevalence diseases can achieve treatment in proper time. This is very important.

A very important question is that of antimicrobial resistance, AMR. Next month, we will finalise our new action plan using a one health approach and combining the agri, human, and environmental sectors. Our goal is to make the EU a best practice region on AMR, boosting research and innovation in AMR and shaping global activities on AMR. Last Friday and Saturday, I presented our activities to a meeting of the G20 in Berlin. The G20 adopted a common declaration on global health care, international health regulations, health care system resilience and AMR. We will see how we can encourage all 27 member states to follow those obligations and introduce them in practice.

The next issue relates to the circular economy package. This is about food waste, the agriculture sector and the possibility of introducing national action plans to tackle food waste. I had a meeting with Irish activists, FoodCloud people and slow food activists, in Ballymaloe. They are very active in the area of food waste. We waste 88 million tonnes of edible food every year.

In Ireland, approximately 1 million tonnes of edible food is wasted every year. It means we have a lot of problems in terms of reducing it. Our target is to halve food waste to 45 million tonnes by 2030. It is up to us but there are many possibilities to use our resources properly, feed our animals, provide food for those in need and, of course, to change regulations to reduce the regulatory burden and provide methodologies of how to measure food waste in all chains of food production. We are ready to move forward in this direction because we have established the European Union Platform on Food Losses and Food Waste. There is an obligation on us to measure and monitor food waste, provide guidelines to facilitate food donation, optimise safe use of food in feed and promote better understanding and use of date marking. We established the EU food platform last autumn and in June, there will be a second round of the food waste platform and we will discuss these issues with all the operators and NGOs. As the committee knows, we have obligations to achieve our sustainable development goals.

Let me stress a few points on a very important topic, which will be very high on the agenda here. Yesterday, we had meetings with the Minister of State at the Department of Agriculture, Food and the Marine, Deputy Andrew Doyle, and the Minister for Health, Deputy Simon Harris, and discussed these matters. Animal and plant health issues will be big in light of Brexit. We will have to deal with those questions because they are very complex and technical but we must find possibilities as to how to achieve a result.

As the committee knows, prevention is better than cure in this area. This is also true in respect of human life. We will be proactive in fighting crises and in implementation. The new animal health law adopted at the end of March 2016 will bring significant improvements to the existing European Union animal health legislation, contributing to long-term competitive sustainability. Implementation of the new law is a lengthy and complex task, requiring a series of Commission Acts detailing measures to better prevent and eradicate devastating animal diseases. These acts will also support the use of modern technology in disease surveillance and detection.

We also have a new plant health law, which helps us to ensure we are best prepared to deal with future outbreaks of plant pest and also that our territory remains properly protected from the entry of non-native pests. The new regulation will introduce more proactive rules for early detection and eradication and more tools and actions to allow the EU to adopt a more proactive policy against the entry of pests from other countries. It will harmonise the rules concerning certification of plants and plant products and specify the responsibility of producers to the EU legislation authorisation.

We have many important topics on our agenda. Health is a very difficult area in all political sectors. It is very difficult to encourage member states to fulfil their obligations. The Lisbon treaty asked us to be very comprehensive and to have a more holistic approach. It is very easy to use these words but it is very difficult to implement them in real life. I thank the committee.

Thank you Commissioner for that comprehensive overview. As I said to you earlier today, we are in the process of developing a report on the future of our health service. Our health service is quite fragmented. It is very inefficient, with long waiting lists for procedures, long waiting lists for outpatients appointments and difficulty in accessing diagnostics.

We are trying to move to a different focus in our health service, from a focus on hospital-centred services to community and primary care-centred services. We have looked at many European countries in terms of how they organise their health services and what their structures are. We seem to be out of line in that we do not have a universal single-tier service. In your experience across Europe, what is the effect of a universal single-tier service?

Dr. Vytenis Andriukaitis

May I draw the committee's attention to the experience of Finland? Finland decided to very actively combine its efforts in social care and health care, uniting its budgets, uniting its instruments and discussing how to guarantee community-based approaches at local level and how to create teams. The patient is in the middle. Secondary health care providers and management teams are at another level. They use IT tools. The Finns invested a lot in eHealth instruments. They have joined social care budgets, local community instruments and budgets and health care budgets and have created community-based models and networks. They are innovative and have pilot projects. This required changes in the constitution, of course. They decided to centralise slightly their health care facilities, especially at regional level because they have a lot of hospitals at community level. They tried to go from community hospital care to primary care centres, which are community-based instruments, and of course to combine with regional hospitals. This took three years and was very difficult. They are now on their way to adopting final legislation. I would happily recommend looking at the Finnish experience at the moment.

Spain and Germany, of course, are federal states, but in Spain there are also some states which have introduced community-based principles and methodologies. Some countries, in central and eastern Europe, have so-called systematic connections between primary, secondary and tertiary care. They innovate to improve IT instruments and platforms and eHealth instruments and this helps them to reduce the number of hospital beds. Of course, it is very difficult and painful. I mention centralising regional capacities, especially in tertiary, high-level specialised medicine and monitoring. Only Finland decided to join social budgets and social instruments with health care budgets and it would be a good example to look at in more detail.

We are ready to assist you and to analyse and provide information. We would be more than happy to co-operate with you and to draw attention to some pilot projects that might help you achieve results.

What are the main funding models for health services across Europe? Is there a big variation?

Dr. Vytenis Andriukaitis

Today we have mostly mixed models, which are all very much interconnected. At the moment, there are five big classic models: the Bismarck model; the Beveridge model; the Mediterranean model; the Scandinavian model; and the central and eastern European financial model. Some combine a state insurance composition with budgetary instruments. Such mixed models are more successful.

Sometimes one hears about many social problems, with some social groups who cannot be insured. In some areas, one must guarantee stable financial flow. If there is no sustainability, there is no chance to monitor services. I would draw the committee's attention to the Lithuanian model, which is an example of a successful mixed model and which was assessed by the World Health Organization/Europe. The Finnish model is a very important step forward and it combines compositions from the insurance side and the budgetary side. For a smaller country, it is much better to have a mixture and to see how to achieve better results. This is because one can never be sure about the coverage of insurance or about the need to have the possibility of providing public financial flow in areas to guarantee sustainability.

Thank you Commissioner.

I welcome the Commissioner and his delegation to Ireland. It is good to see Commissioners touring member states. There was a reluctance to do this some years ago but I am delighted to see it is a growing trend and long may that continue. I have a few questions. How does the Commissioner feel about the possibility of having an EU-wide health regime where basic fundamentals would apply in all countries? This is the case in the United States, for instance, and I am not making a direct comparison, but there are some rules that apply across every state in the United States while others do not, thankfully. How well could the Commissioner see something like that working?

My other question is on animal health and the issue of pharmaceutical residuals in animals. To what extent has that been curtailed effectively? Have we got to the stage where antibiotics are being carefully used so that their use does not in any way jeopardise human health? To what extent does the Commissioner see improvements taking place in that area, with the view to ensuring that Europe's animal health is the best globally? Its traceability is, I presume, the best and will continue to be so. Does the Commissioner see any threats to that?

On the issue of human health, I notice that Ireland is about half way down the good side of most of the graphs the Commissioner showed us today. How does he see the use of antibiotics and other medicines across Europe affecting people's health in the future? Have adequate steps been taken to ensure that we do not have overprescribing or overdosing and that we do not inherit the worst aspects of what can follow as a result?

The Commissioner also mentioned the environment, which is, of course, very important to all of us. How does he see Europe marrying the objectives of high quality food production and attaining high quality health standards with complying with environmental requirements around greenhouse gases, etc.? I do not want to ignite the debate, which can get quite flammable from time to time, but we all have to eat, no matter where we are. Some people will always have dramatic responses, such as telling us to stop eating or stop producing food. We cannot do that. Does the Commissioner see the European Union reaching best practice in terms of the environmental balance?

The buying power of the Single Market has been mentioned at this committee on numerous occasions in respect of various drugs, both new drugs and existing drugs that have gone off patent under the eight-year patent rule. Does the Commissioner see the European Union, across all the member states, getting the best value for money for these drugs and for new technology in the whole area of drug production?

Commissioner, there were five main topics there. Perhaps you would like to start with the first one, which was the European-wide health service.

Dr. Vytenis Andriukaitis

These five topics could take five hours to answer but I only have a few minutes. First, I will address the question about the harmonisation of basics around the EU. The Lisbon treaty was very clear on subsidiarity, that it was up to member states to decide on their health care and on the basic standards to be covered by national health care systems. We do however have the cross-border health care directive and the European Court of Justice decision in the case of Kohll v. Luxemburg. This was a very important decision on cross-border health care that ruled that the rights of patients to access treatment in different countries must be respected. This helped us to start the cross-border health care directive.

The directive in turn raises questions as to how to reimburse services from one country to another. If patients are going from Ireland to Lithuania this means that there must be a reimbursement agreement between the two countries. Such principles of the reimbursement of basics are enshrined in the health care directive. When we ask countries to dedicate some public money guaranteeing payments for patients going from one country to another, they must be ready to guarantee financial coverage of their costs.

We have a very good example of cross-border health care directive co-operation between France and Belgium, which decided to adopt some areas in which cross-border health care is achievable. They provide ID numbers to people in particular cities along the border in France who then have free access to go to the other side in Belgium and have medical treatment and services there. This is then automatically entered into accounts for the national reimbursement system which are then calculated between France and Belgium without involving the patients. This is a brilliant example of how IT tools such as electronic identification and signatures can be used in an absolutely secure manner to guarantee access to treatment. This means that the countries involved have to discuss a lot of reimbursement compositions and issues and technically speaking this is very time-consuming. They have done it however, and from 40 km either side of the border people are taking the opportunity to use each other's facilities. This means that, step by step, we are moving closer and closer on some basics and on possibilities to understand different financial mechanisms which will provide some instruments to help us guarantee access to modern treatment.

A further issue concerns the European reference network. If I am here in Dublin and have a very rare disease - there are now 6,000 diseases on our list - I have the possibility of being treated in Warsaw in Poland. This means that we need common treatment technologies which will be acceptable to medical doctors and medical societies. We then have to consider how we can guarantee payment from both sides. As we move forward, step by step, we will see possibilities to destroy the silo mentality in every country and in this way achieve more and more in practical ways.

The third question concerned cross-border health care threats. It means pandemics and vaccines and, of course, possibilities to buy vaccines together and to harmonise countries' vaccination calendars. Again, it means money. Today there are more than 30 million people working in different countries with their families, which is very challenging. For young families moving from Italy to Poland, for example, they have one vaccination calendar in Italy and another in Poland and their children fall in between. We ask member states, say, France, to realise in practice how they can harmonise vaccination calendars so as to keep children vaccinated. They are not citizens in the countries in question, but they are living there with their parents and need to be covered by vaccines. I again ask Ministers of the member states to discuss vaccination calendars and how to move forward to avoid such silo mentalities. In the Single Market we have common goods, common movement and a lot of infectious diseases. If we are not ready to understand we are obliged to address these issues from Lisbon to Helsinki, it will be a disaster. There are 4,000 cases of measles in Romania, for example. There are also cases in Spain because the movement of people is very intensive; it is not like what it was 20 years ago when the Schengen agreement was not in place. We need to change the silo mentality and step by step see more harmonisation. This is not because it is legally binding but because of the reality in which we will address these issues together.

I will ask my team to say something about the position on animal health because they are very much involved in dealing with the matter. The director of our food and veterinary department is Ms Paola Colombo.

Ms Paola Colombo

I am indeed the director of the audit service of the Commission. We are in charge of auditing and inspecting the control system on food safety, animal health, plant health and also human health and medical devices. We carry out these activities both in member states and non-EU countries. The general position on animal health in Europe is quite good. We also have some emergencies, but we are containing them very well.

The Deputy's question was about the general use of antimicrobials. I am a veterinarian and my view is that we are dealing with these issues very seriously. At European level, we have legislation prohibiting the use of antibiotics as growth promoters. We have on the table important legislation dealing with veterinary medicines and medicated animal feed.

This legislation is unfortunately not progressing as quickly as we had expected. This is, however, probably the only missing link in effectively fighting antimicrobial resistance. Overall, we are already very much ahead internationally compared to other trade partners in fighting antimicrobial resistance in animals and in the veterinary field. We could do even better if this proposal were to be adopted.

Dr. Vytenis Andriukaitis

Let me add a little bit. We have two guidelines on the proper use of antibiotics in the veterinary field. Those guidelines are tabled. Next, I do not know if we are finished or not but we are on the way to finishing guidelines on the proper use of veterinary antibiotics in the human field. It will be covered in a proposal to be made to all 28 member states. Second, this new legislation requires that some antibiotics may only be used in humans. This will reduce the use of antibiotics in the veterinary field. We will see how to encourage our veterinarians and medical doctors to co-operate in understanding that some antibiotics must be dedicated solely to human treatment.

We also have big problems when dealing with out trade partners, the third countries, where residues of antibiotics in meat is the main challenge. We will detect those residues, and if they are present we will reject those goods from the European Union market. Of course we always raise questions about antimicrobial resistance and other treatment issues when we make bilateral deals with the US, China, Brazil or India. It is always on our agenda. Of course, it is a very difficult question. We propose, for example, that our trade partners introduce common obligations to reduce use of antibiotics, hormones or growth-promoters in their food industries. There has not been significant progress but it is on the table. We will discuss those issues between the EU and Mercosur countries. Of course the committee knows very well that our audits detected residues in pork in Brazil for example. We do not allow Brazil to export pork to the EU because of ractopamine, which is banned in the EU. We will not allow Brazil to send such pork meat to the EU. I have a lot of tensions and problems on my table in the area of residues. When we speak about animal treatment, there are very strict rules about which animals are allowed in the food chain and which are not. They must quarantine piglets for six months or more to guarantee that residues of medicines are not in animal blood. We allow our control institutions to be very tough on those issues.

The Deputy raised questions about food providers, food reformulation and the possibilities to reduce food waste. He also spoke about healthy food and how to change our behaviour and encourage people to eat more healthy food, not just safe food. Sometimes we have very safe food but with a lot of sugar, salt, trans-fats, additives, different preservatives and flavourings.

Such products are good for staying on the shelf. There is long chain of food production. How can the food chain be reduced? How do we guarantee the shortest journey from the farm to our tables? How do we provide assistance to different operators to avoid such a production chain and deliver fresh food to our tables? We also must look at food waste issues in those production chains and encourage the use of more fresh, healthy food, for example, through schemes for milk, fruit and vegetables. Those schemes are a very good example. They are financed by EU instruments. Children in our schools have the right to have fresh vegetables, fruit, milk and milk products, using Structural Funds. I encourage members to be active in those areas because public procurement rules will be changed to allow for effective actions in this area. In the same line, we have a common voluntary agreement with our food industry to reduce the amount of sugar, salt and trans fats, but that is the industry's obligation. We signed such an agreement in Amsterdam to reduce the number of those risk factors in our food during the Netherlands' presidency of the Council of the European Union.

There was a question about new treatments and incentives to create new business models, especially in the area of rare diseases, new anti-microbials and new medical devices. I am very happy that today we have good instruments in our hands in the innovative medicines initiative. It has provided more than €1 billion to industry, health researchers and clinicians to organise seven clusters. They are dealing with rapid diagnostic tests. This year, we awarded funding to an excellent diagnostic tool which helps to diagnose upper respiratory tract issues. Using markers, it can determine whether they are caused by a virus or a microbe. It is very effective. If it achieves mass production, it will also be good for our primary care facilities as they will be able to immediately diagnose whether it is a virus or not and avoid prescribing unnecessary antibiotics. It is a very excellent opportunity. Of course we provide a lot of new incentives. We started an initiative called adaptive pathways with the European Medicines Agency, EMA, to ease registration of new effective drugs, especially in the area of orphan diseases. Have I covered all five issues?

Thank you Commissioner. I think you have covered them all, and in less than five hours too.

I welcome the Commissioner and thank him for his presentation. Many of my questions follow on from those of Deputy Durkan. I am a pharmacist by profession so my view might be a little bit skewed and biased. I would like to follow on from the Commissioner's comments on antibiotics in pig meat. For a long time I have had an issue with powdered antibiotics being put into feeds for chickens and pigs in Ireland, in what to my knowledge has been a fairly unregulated manner. One of the issues I have is that oral medicines in Ireland, including oral antibiotics, are subject to a 0% rate of VAT while injectable medicines are subject to a 23% rate of VAT. For me, there is something wrong when a product such as a bulk antibiotic is not subject to VAT but a vaccine is subject to 23% VAT. I have inquired about it and I have been told that how we apply our VAT rate to products is decided at EU level.

Does the witness have any thoughts on that? It seems to me bizarre that it is almost incentiving a product by not having VAT on it. Perhaps I am looking at this from a naive perspective, but if there was VAT on oral or powdered antibiotics for bulk feeds, there would be a better method of tracking how much is being used. If it was per kilo or whatever, one would be able to quantify how much is actually being used in the market. Does the witness have any views on that?

The witness covered the antibiotic resistance issues quite well in response to Deputy Durkan's questions. There is no need for me to repeat any of that.

I have a family member who is a vet and I was born in rural Ireland. Therefore, I have quite an interest in agriculture. Another thing I have an issue with in light of Brexit is hormone beef coming from Brazil and Argentina, which seem to be the main countries producing high-level hormone beef. In light of Brexit, one of my concerns recently was that a UK supermarket had on its shelves only British beef. One of my concerns is how to get a message to the public. If a supermarket says that this beef is cheaper, to the consumer that is a good thing because naturally people do not want to spend as much money. I have an issue with the fact that perhaps we are not getting out the message that just because it is cheaper does not mean it is as good. There is a complete difference between hormone beef and the effect it has once ingested and assimilated and non-hormone beef. Has the witness any plans for marketing to the consumer within the EU states that cheap is not always best? Some of us know about this, but I think there is an issue in disseminating that information down to the person pushing the shopping trolley around the supermarket.

My second train of thought this morning is in regard to vaccination. Again, the witness covered it very well. It is something that is quite prevalent in Ireland at the moment. We have a serious problem in Ireland with anti-vaccine groups with online agendas. They are gaining a lot of momentum. We had the ex-Dr. Wakefield from the UK touring Ireland recently with his anti-vaccine agenda. It has caused a lot of damage. I am sure the witness is aware of our falling vaccination rates, from about 95% for the MMR down to about 92% now. We have a huge issue with our HPV vaccine rates in Ireland. Can the witness, given the EU context, give us any advice on how to counteract that? Are we in Ireland specifically exposed to this sort of "fake news", for want of a better term, or are other countries experiencing the same sort of negative campaigning against vaccines, which is clearly very serious? I have said it here many times. People on trolleys and waiting lists will be the least of our worries if there is a measles outbreak like there has been in Romania and in some of the Iberian area of Europe.

Regarding antibiotic resistance and the over-use of antibiotics, is the witness monitoring the excretion of antibiotics through urine, human or animal, into the water supply? Is he monitoring what sort of levels we have? In Ireland, we are all moving a little more towards rainwater harvesting. We are trying to deal with our waste on our own site Is the witness looking at the levels of antibiotics that are excreted by humans into our clean water supply?

It is the same with pork and chicken. Are we making our consumers aware of the complete difference between a chicken that is pumped full of hormones or chlorine and a chicken that has not had that sort of a life?

To sum up, my questions are really about disseminating the information from an EU context to the person pushing the shopping trolley around the supermarket. Has the witness any advice on how we can deal with the negative vaccine campaigns? There is also the issue of the VAT rate on oral antibiotics.

With regard to orphan drugs, we have had a lot of difficulty in this country. I do not think that anybody can deny that it is the issue coming down the track for us. The witness knows as well as I do that the orphan drug issue was not relevant in the past because there was not the seed capital to get the research going initially. However, people are now coming together globally, getting the data together and producing the orphan drugs. States can be held to ransom to some extent for a very high-price drug. Has the witness thought about this? Has he any views on what might be done to curtail the drug spend? I understand Orkambi is going to cost this State €300 million annually. We have a unique relationship in this country with cystic fibrosis. I am fully supportive of Orkambi being given. However, if there were ten drugs like Orkambi, we would be in a very serious financial situation where the annual price of a drug could be the same price as building a hospital or whatever. These are major pressures on Ireland's finances and obviously on European finances. I ask the witness to give me a little bit of information on that. If he does not have the answers here, I am willing to follow up for answers.

Dr. Vytenis Andriukaitis

May I ask Ms Paola Colombo to react to the questions on chicken and on antibiotics? I will cover the questions on online anti-vaccine campaigns, hormone treated beef, HTB, market environment and orphan drugs.

Ms Paola Colombo

Antibiotics and hormones?

Dr. Vytenis Andriukaitis

Especially in chicken and poultry.

Ms Paola Colombo

Yes. The first question was on taxation. Unfortunately, I am not aware of this situation but we can look into it and perhaps come back to the Deputy.

I will cover the second question as well on hormones and getting information to the consumer. With regard to the Deputy's question about the possibility of having hormone treated beef from non-EU countries, it is not a possibility. It is prohibited. We do not allow importation of meat derived from animals that have been treated with-----

I know that, but my question is in light of Brexit. It will perhaps be more than likely available on the shelves in UK supermarkets. Is that going to happen or do the witnesses know yet? That is my concern. Is hormone beef going to be located in the UK between Ireland and the rest of Europe? I am aware that we do not have hormone beef in Europe.

Ms Paola Colombo

Unfortunately we cannot predict that. In Europe, one of the things we do not question is the prohibition of using hormones in meat. When we do our audits in countries like Brazil or Argentina, where this practice is authorised, to carefully check which guarantee they can offer us. We allow the split system and a completely separate way of tracing back animals that have not been treated with hormones. In Europe, I would be surprised if it was brought into question by any one. It is a sort of a credo. It is something we are no longer discussing.

Dr. Vytenis Andriukaitis

I will continue.

It is important that members listen to those who are directly responsible. I hear many rumours that people can buy beef with hormones in the EU market. That is fake news and it should not be disseminated. There were big attacks against me when we discussed TTIP issues between the European Union and the United States. Many NGOs opposed me and Commissioner Hogan because they were blaming us, saying we were ready to diminish our food safety standards. Nothing will happen with food safety standards because they are clear. The committee must understand we do not have a one-way approach but two ways. I have pictures on my phone of restaurants in New York, for example. We are not using beef laced with hormones, antibiotics or GMO feeds. This is about EU standards which are acceptable in Brazil and the United States. It means that we can be proud to say our food safety standards are being applied around the globe. Producers are keen because consumer information is a much more powerful instrument. We are sending our audit teams. For example, we do not allow beef to be sent from Brazil, except from 20 establishments. Beef from four of the biggest has been stopped because of food fraud. We have figures and the volume of beef coming to Europe decreased very much in one month because of our restrictive measures. Reference was made to chicken. It will be good to once again assess the situation on the ground here because nobody can use antibiotics as growth promoters in the European Union. It would be a disaster for producers. It is a rumour. We immediately send teams to carry out audits because it is against the law. It is a big problem because there are legal consequences.

When members speak about AMR, I refer to veterinary medicine and medicated feed. There are two Bills on the table at the Agriculture Council and I ask Ireland to be active on them because we need to finalise adoption between the Parliament, the Council and the Commission. The Commission's proposal is to stop the use of antibiotics in medicated feed because of the possibility of using antibiotics in feeding animals. It means that only in treatment and only if there are indications from a veterinary point of view they should be used. Beef with hormones is not allowed into the European Union and we will ask our services directorate to provide additional information.

On vaccination and the anti-vaccine movement, I encourage my colleagues, the medical doctors, to be ambassadors for vaccination and vaccinate themselves. I vaccinate myself every year, together with Ministers. Last year the Polish Minister and I vaccinated ourselves against influenza to set an example.

We are ready to do the same again and we disseminated photographs through social media and so on. I have asked our scientists to be more vocal and to provide knowledge to all in society because there are so many rumours opposing vaccination.

The anti-vaccine movement uses strange messages relating to autism, which are terrible. They are responsible for the deaths of children in Spain, Romania and Berlin. It is painful to understand that today we are not even in touching distance of a measles-free Europe. Shame on us and shame on me. I will do my best and ask all members to stay strong and come together to promote scientific-based arguments to all society, otherwise it will be a disaster. We are, of course, using awareness campaigns with the WHO and Margaret Chan. It is important to see how different countries behave. Anti-vaccines in Brazil are weak because of the Zika virus, yellow fever and death. Old people ask us to provide new vaccinations. Brazil is measles free.

It was the same with Ebola. I was in Liberia, Sierra Leone and Guinea when the Ebola outbreak started. People asked us to help and provide a vaccination but at that moment we had no tools. We provided money and today we have vaccination. We dedicated €46 million to create vaccines against Zika.

Reference was made to antimicrobials in water, which is an important issue. We are in the final stages before presenting a new action plan. We have taken a topic about the environmental composition of monitoring of antibiotics. Nobody knows how many people use antibiotics in Dublin and monitors residuals to see which are going out. No one is controlling the antimicrobials in sewage and water and we have no understanding.

There are problems in big cities not only because of animals but because of people using antibiotics. There is a concentration of large farms, factories, hospitals, and cities and we must draw attention to water, sewage, the environment and how to detect situations. We establish a so-called consortium of laboratories. More than 30 laboratories have joined up and we asked them to monitor soil, water and environmental issues and to report the picture to us because at the moment we have no clear evidence. We have enshrined it in our new action plan and we have asked the European Environment Agency to be responsible for creating a monitoring system for water, soil and the environment. Big harbours and airports also have AMR bacteria. We must control ways of transmission, otherwise it will be a disaster because the EU is open, particularly in respect of trade. We need a system of monitoring ways of transmission and the Deputy's points are high on the agenda.

Orphan drugs is another issue. Today we have many instruments.

As the committee will know, there is paediatric medicines regulation which helps us to introduce more business models to help the industry to provide new treatments. Why? Let us say there are 10,000 people suffering from very rare diseases. Can one imagine how many industries would be keen to produce medicines if there were no market incentives or strategy? The provision of innovative medicine initiatives incentivises industries to join forces with academia and clinicians. There are more than 400 hospitals that deal with rare diseases. The instruments encourage the establishment of consortiums.

It is important to draw attention to pricing. In stimulating smaller countries one can get them to sign and use and put money into joint procurement agreements to use scale of economy to buy orphan medicines together. More than 18 countries are ready to co-operate, especially in the area of hormone treated beef, HTB, and vaccination in which we have found success. We have a very detailed plan to help them to use joint procurement agreements to buy modern vaccines. Of course, they are very costly and it is especially very difficult to tackle hepatitis C, but we will use our resources in only one way. We need to encourage countries to work together because scale of economy helps to reduce prices. Cyprus, Malta and Lithuania have no chance of covering all of the costs involved. There is, therefore, only one way to succeed. Ireland must co-operate with other countries in that regard. Today we have a strange picture. There are 28 markets, which is fruitful for the industry. Interestingly, having one single market is much more powerful when there is tête-à-tête. One can play the game and make a profit. My advice to everyone is, please, co-operate. We are ready to help Ireland. We can teach it how to deal with the industry because we can advise from our side. Countries, especially smaller ones, need to work together. For me, the answer is crystal clear.

I thank the Commissioner.

I thank the Commissioner for his presentation. I know that it is a great challenge to deal with health care issues across the European Union because there are various traditions and ways of dealing with issues. I wish to talk about a cross-border health care issue. I was a Member of the European Parliament from 2007 to 2009. I headed up the European People's Party group on the Committee on the Internal Market and Consumer Protection. I am, therefore, very familiar with this topic and I am greatly concerned about Brexit. There is cross-border health care provision between Ireland and the United Kingdom. Our biggest issue when the United Kingdom leaves the European Union will be trying to build the same connections with other countries in Europe. Has this issue been considered? As Dr. Andriukaitis is a heart surgeon, he will know that every year more and more there is sub-specialisation. It applies no matter what area of medicine one considers, whether it be orthopaedics or heart surgery. Has this issue been assessed to see how we can improve co-ordination in accessing health services, especially for those in smaller countries with rare medical conditions?

In smaller countries it is unviable to have someone that has sub-specialised. Let us say four people have a particular complaint in this country and, therefore, it would be unfeasible for the expert to operate out of Ireland.

I wish to talk about co-ordinated medical training. Ireland is very much tied to the UK in terms of medical training. The UK has been very dominant in terms of medical training in, for example, Nigeria, Pakistan and the Sudan. As a result a number of doctors from those countries work here because their medical training is very much tied to the UK model. Has a unified medical code and training process in Europe been considered?

I wish to discuss the European Union's working time directive. I have received complaints from medical practitioners, particularly from those who work in hospitals. As much as 90% of trainee doctors comply with the working time directive. Many of them have complained that they have not gained the expertise that they require as a result. Let us say a person starts his or her shift at 8 p.m. He or she will be busy for the first three or four hours but he or she will not gain experience in the remaining hours. The hours must also be worked over a shorter period. Four or five years ago people worked 60 or 70 hours a week but might literally not work in real terms. They were a presence in hospitals but they did not have real work due to everything being in order. What is Dr. Andriukaitis's understanding of the working time directive in EU countries? How do trainee doctors acquire the necessary skills if they do not put in the hours?

I would like to discuss co-ordinated research. As much as 70% of the people who conduct research, especially people from outside of the European Union, end up working in the US. Europe does not seem to have a co-ordinated approach to medical research. The 28 member states should get their own people to conduct research and bring in external experts. We allow an awful lot of research to be based in the US and, in turn, the US dictates the market and everything else. Has this matter been considered?

I wish to comment on the final topic mentioned by Dr. Andriukaitis. Are we likely to see countries, especially smaller ones, grouping together to get cheaper prices for drugs? Will such a policy be implemented fairly fast? Larger countries like Germany and France are well able to negotiate better prices with the big pharma companies. Smaller countries, like Dr. Andriukaitis's home country of Lithuania, Ireland and other smaller countries do not have the same bargaining position.

Dr. Vytenis Andriukaitis

Let me start by discussing specialised medicines and the possibility of helping Ireland cope with Brexit. I agree with what the Senator has said. We will need to share common themes and have concrete discussions because I worry about Brexit issues.

Today, frankly, nobody knows what the reality will be because the reality is not on the ground. Nobody knows what the concept will be on the UK side. If it will be a hard Brexit, there will be one tactic from our side. We need to address the issue, but I cannot imagine the possibility without a transitional period. In my portfolio I have many problems and many questions but there are no answers at present.

Animal health was mentioned. Today, Ireland and Northern Ireland are one island. People are producing on one side, processing on the other and then selling into the UK. Can one imagine a hard Brexit with customs and so forth? I do not know how to deal with food safety standards because it is up to the UK to say which standard it will keep on its market. At present, there are the same standards. It is the same when speaking about the cross-border health care directive. It helps us. We will address how to do it. On one side we will see how to help Ireland achieve treatments in our European centres more frequently. The UK is very close and language, culture and tradition all play a role. We know that very well. We must have the discussions in this way. Of course, I will be more than happy to communicate with the committee. If some problems start we will see all the hot potatoes on the table and we can look at them together. The main teams must be the same teams. I, Dublin and Brussels must be one team. Otherwise, there is no way.

On the other hand, we have a good opportunity to trigger and push possibilities to use European reference networks. We must encourage countries to use the Connecting Europe Facility instrument, building IT infrastructure in reality and workability between hospitals and around all 27 member states to guarantee tele-medicine, guaranteeing immediate treatment, advice, consultations, virtual debates, virtual clinical assessment and possibilities to keep people here but consulting from different angles. It means the Connecting Europe Facility must be on the agenda. We need to build a workable infrastructure with IT platforms, connectors, communicators, the same electronic signatures, patient registries and data. We need to have those issues in 2019. This is 2017. A lot of people in governments do not understand what this will mean, I am sorry to say, but we will address those issues only in this way - on the one hand strengthening links between Ireland and the Continent and on the other dealing with the UK in a more proper way together. However, all things will be clear after June when the new parliament will be elected in the UK. Then we will see their concept of the positions. Politically, today we hear a great deal about hard Brexit, but nobody knows. However, then we will start to do practical things immediately, addressing the issues together.

About training problems, the member's idea is excellent. First, I wish to draw attention to the lack of medical doctors in primary care. There is a need for 6 million doctors at present. There is a deficit of 6 million doctors.

Second, the average age of primary care medical doctors is 57 years in one country and 62 years in another. After five years, they will be retired. Who will replace them? It is nobody's care. It is like a slow tsunami. There is a deficit of 13 million nurses.

People refer to Pakistan and elsewhere. The richest countries are playing a game and one sees a real mess in different countries. There is training, of course. The country which is the best has five high schools which are able to produce excellent nurses with good experience. The nurses are very welcome in countries but it is a budgetary cost. On the other hand we will ask member states if it is possible to co-operate on training issues and to understand that health care workforce planning, recruitment and retainment issues must be discussed at Council level. I am so unhappy that we are so involved in our national problems while the tsunami is around us. Of course, e-health is another matter to address immediately but shortages of staff cannot be addressed immediately because six, nine and 11 years of education are required, followed by training.

I agree that it is a painful topic, but mainly it is in the hands of member states, and mainly it is up to subsidiarity. We will only have joint action by discussing health care workforce planning, training and of course the working time directive. However, that is not in my hands. Commissioner Marianne Thyssen is responsible for the working time directive. I am not deeply involved in those questions. Generally, however, our medical staff are exempt from that directive. The working time directive does not apply to medical doctors and nurses generally, but I do not know the details. I have to ask my colleagues from the DG for Employment, Social Affairs & Inclusion. It is not in my hands. Perhaps I will send the committee a written reply on the working time directive because I am not sure. Generally, I know it does not cover medical doctors.

On the matter of research co-ordination, I see big possibilities and opportunities if we join our research technology development, DG RTD, with DG GROW, DG SANTE and DG ENV and if we are capable of establishing the digital Single Market, invest in infrastructure, build possibilities to have big data and invite our research consultants, our industries and our countries to pool resources and guarantee venture capital for our research. We must have a sustainable economic model for the development of research clusters that will be very compatible. Otherwise, the United States is in a much better position. It has excellent financial possibilities. Venture capital instruments are developed at a very high level in the United States.

We lack incentives and venture capital. Of course, the European Fund for Strategic Investments, EFSI, has a role in the risk management of projects to be leveraged between private and public capital. The EFSI is a really brilliant instrument. Once again, we need to know the worth of co-operation, co-ordination and responsibility, which are not empty words. Today all are ready to sign memorandums on co-operation and co-ordination, but it is true that nobody likes to be co-ordinated.

Throughout Europe there is a shortage of doctors, particularly in isolated and rural areas. It is probably the most sensitive issue in medicine and it has a knock-on effect on the level of out-of-hours cover. We are now proposing to build a health service which will be built on the foundation of primary and community care, but we will have significant difficulties in populating these services because there is such a shortage of primary care professionals, GPs, nurses and therapists. It is a significant problem that many governments do not recognise, even though they want to transfer to a more community based system. They have no realisation of the shortage of personnel.

Dr. Vytenis Andriukaitis

I hear the Chairman's comment and ask him to draw attention to the problem. It is good to discuss the issue with the academics in universities. The thinking of those in the younger generation who have decided to study medicine is to specialise. They do not like the idea of being general practitioners.

Some of the entry courses to study medicine are directing and exposing people to primary care in their undergraduate education for half a year of their four year course. Also if graduates from rural areas were identified and given opportunities to train to gain particular expertise required when working in rural areas, that would give a much better return than a general education and hoping for the best.

Will the Commissioner comment on the social determinants of health? We concentrate on medicine, but there are so many social determinants such as education, housing and transport which feed into the health of a society. How are they being addressed across Europe?

Dr. Vytenis Andriukaitis

Frankly, if one looks at the money being dedicated to dealing with public health issues and addressing social determinants, one will see a strange picture. During times of austerity there are cuts, especially in public instruments, because the approach of accountants is to cut. Only approximately 3% of public spending in all 27 member states is dedicated to addressing social determinants. At a glance that shows that the difference in the level of access of low income and higher income groups to health care has been growing in the past five years. The same applies when encouraging counties to use Structural Funds to invest in the public sphere to address social determinants. Countries are mainly investing in road provision.

It is an excellent example of countries using Structural Funds on big buildings and big roads, and the reason is very simple. One needs to understand how difficult it is to join small actors, especially to build social industry, which are capable of addressing social determinants. One needs experts and the political will to build some clusters or platforms which invite small actors to stay and to apply for Structural Funds and to use those funds in a more effective way to solve problems related to social determinants. Such social determinants are in real territories, in rural communities and smaller cities and regions which are depressed because of austerity and the destruction of industry in those countries. One sees a strange picture. It is much easier to invest in road infrastructure than solve social problems. It is more difficult to achieve progress, but we have social instruments at EU level. Translating it into real action is very difficult, however. Social determinants are a major and painful issue for all of us.

The Michael Marmot report is an excellent report. Every member has a chance to read it and I ask the Parliament and the Government to consider what action is needed on the ground on how to use the Social Funds and Structural Funds to address social determinants. Otherwise one has no chance because there is not enough national public money.

We have a substantial housing crisis in Ireland. Some 7,000 people are living in emergency accommodation or in hotels. More than 2,500 children are living in emergency accommodation. We have difficulty in drawing down funds from Europe on the balance sheet and also off the balance sheet. We are limited in the amount of funds we can draw from Europe in relation to our housing crisis because of fiscal rules which mean the funds have to be included on the balance sheet. We are limited in how we can do that. Is that a problem across Europe?

Dr. Vytenis Andriukaitis

Yes, it is a problem across Europe. I am more than happy to send that message to my colleagues Commissioner Corina Creu, who has responsibility for Structural Funds, and Commissioner Marianne Thyssen, who is responsible for Employment, Social Affairs & Inclusion and manages the Social Fund. The Commissioners responsible for energy union, Commissioners Maroš Šefovi and Miguel Arias Cañete, speak a great deal about housing and the energy efficiency of houses, and it would be good to discuss those issues with other member states. With the help of the European Investment Bank, it should be possible to use such European advice when discussing issues together. We have a health programme but it deals with behavioural issues such as consumption of tobacco, alcohol, drug users and so on. I would be happy to activate a discussion on social determinants.

I will allow Deputy Durkan one last question.

I do not want an answer, but I think the difficulty we have is not drawing down the money, as we have the money, but that we are not allowed to spend it. That is the problem.

Mr. Gerry Kiely

It is a question of priorities.

We have our priorities, we want to spend the money on housing.

On behalf of the committee I thank Commissioner Andriukaitis for his attendance today and for covering a range of topics. We could spend hours speaking about them.

The Commissioner spoke about healthy ageing. End of life issues are very significant, not only in Ireland but across Europe. Discussion is centring on advance directives and how people want to be managed in their later years because medical technology has moved on to such an extent that people can be over-treated and almost heroic efforts can be made to keep them alive. We need to start conversations about how we address end-of-life issues and how we deal with them in the health sector but also in a social context. Does the Commissioner have a view on that?

Dr. Vytenis Andriukaitis

It is a very sensitive issue and from an ethical point of view, it is very complex. Most of my colleagues would say that it is for national Governments to regulate in this area. It is a big issue, from my point of view. We must consider it and have a set of ethical discussions at EU level also. We cannot shy away from it but must seek to be part of the debate. It is a very controversial area but I will actively engage in any discussions. We must discuss these issues because they are very serious.

I thank the Commissioner for his time and for addressing all of the issues raised. I also thank his staff Mr. Marco Valletta, Mr. Gerry Kiely, Mr. Paola Colombo and Ms Vilija Sysaite for attending today.

The joint committee adjourned at 1.55 p.m. until 9 a.m. on Thursday, 25 May 2017.
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