European Union

Europe’s four most powerful men are in peril, fighting for their political lives in some choppy and unusual electoral waters. Whether this week in the case of Britain’s David Cameron or Spain’s Mariano Rajoy, or in the coming months with regard to Matteo Renzi and Francois Hollande, each one is nearing a career-defining reckoning with voters. The four cover opposite ends of the mainstream political spectrum, but share a common fear: being undone by primal anti-establishment forces. Such is the lot of Europe’s political princes.

David Cameron’s verdict There is a touch more optimism in Downing Street on the EU referendum. After a tumultuous week, poll momentum has swung back to Remain (as well as defections). Mr Cameron also delivered a solid TV performance on Sunday night, channelling his inner Winston according to the FT’s Henry Mance. Note the emphasis on this referendum being a no-turning-back decision on the EU – but not on Mr Cameron. His approval ratings have plummeted but he insists this vote is not a verdict on him. It appears he may try, against the odds, to hold on to power after a Brexit win. Given what it would do to his legacy, what does he have to lose?

Matteo Renzi’s star falls Once the golden-child of this political quartet, the restless Italian Socialist is facing a ballot-box revolt. The Five Star movement routed Mr Renzi in Rome’s municipal elections last night, making Virginia Raggi the eternal city’s first female mayor. In a big upset Turin was lost as well to a 31-year old Five Star insurgent, Chiara Appendino. Mr Renzi’s Democratic party did manage to draw the line there, hanging on to Milan and Bolgna, where it was facing a more traditional run-off with centre-right opponents. All eyes are now on the October referendum on constitutional reform that Mr Renzi said he would win or quit. His enemies are circling.

Yesterday was one of those days for Commissioner Andriukaitis; a day where he finds himself defending the Commission’s position on endocrine disrupters*(ED) in front of Members of the European Parliament (MEPs).

Yesterday was a little bit more special than usual though as he came with the long-awaited proposed ED criteria. Heated exchanges were expected. All the protagonists were in the room, ready to play their part. Mr. Poc for the S&D, Mrs. Grossetête for the EPP, Mrs. Girling for ERC and Mr. Eickhout for the Greens. They all came and told our Commissioner what they thought of his criteria. Spoiler alert! They are not happy.

And then something a little strange happened. Commissioner Andriukaitis told them he was “happy” – happy to see that no one really agreed with the Commission’s proposal. He saw the absence of consensus as the sign that we are all moving in the right direction.

Are we really?

I could not say from a scientific or safety perspective. I am no toxicologist or risk assessor. Yet, I would like to share a few observations on how we got and how, despite what he says, we may not be moving in the right direction as far as public decision making is concerned.

The EU relies on the capacity to reach compromises. All parties have to agree to make some sacrifices. In return they gain something, preferably more valuable than what they gave up. In a perfect world everyone is happy, to a certain extent at least.

Reality could not be more different when it comes to ED. Shortly after the publication of the proposal, reactions piled up. Industry, NGOs and Members of the European Parliament, all rapidly issued statements expressing their disappointment. Cefic and their partners regretted the absence of potency while NGOs such as ChemSec and HEAL – and a number of MEPs – blamed the Commission for disregarding the possibility to categorise ED and limiting the observation of adverse effects to human health. In short, NGOs blamed industry lobbying, industry blamed NGOs and both criticised the European Commission.

All this… for that? Years of debate (both at scientific and political level), a legal case brought before the European Court of Justice against the European Commission, and no one is happy.

Could things have been different? My answer is yes. A better outcome could have probably been reached provided all parties had behaved a bit differently.

Let’s start with industry. The chemical industry and its partners underestimated the political and emotional ramifications of this debate. Science is critical of course. Public decisions must rely on solid data and scientific knowledge. Still, as much as some may dislike it, values and in this case emotions also play a role in decision making. This is called politics. If you don’t play the game, get out of your comfort zone and engage, you cannot win. It does not mean one has to agree with all claims and allegations, but one must enter the debate, answer questions decision makers ask and prepare for a negotiation. It is all the more important when the agenda is set by your opponents, as it was the case here.

NGOs… Are we allowed to criticize them? I think so, in particular in this dossier. NGOs who engaged on ED played their role perfectly. They raised awareness, set the political agenda and turned an obscure scientific issue into a societal debate – as they should do. They may however have gone too far from time to time using (creating?) fears that make it all the more difficult for public authorities to take serene decisions.

Finally, a few words about the scientific community, both an actor and a tool in this debate. The “fight” between toxicologists and endocrinologists has certainly played an important role in this dossier. The first ones defended their own corner against the new kids on the block advocating for a new approach of toxicology. Eventually some consensus was found, in particular on the question of potency. Still, it took a long time and their opposition deeply shaped the debate I believe, also at policy level.

Put all these ingredients together and what do you get? A “dead end” debate, with everyone standing on its positions and making it almost impossible to reach a good compromise.

This is not the end of the story of course. The proposal will now go to the European Parliament and Member States. And if they oppose it (the Environment, Public Health and Food Safety committee will most likely do), the end is nowhere to be seen.

One can only hope that one day someone reminds everyone that the point of all this is to make a decision that would actually protect people’s health and the environment – not stick to stubborn positions of principle that make you look good.

I know, this is most likely wishful thinking. Well, hope springs eternal!

Pauline Tawil

*Endocrine-disrupting chemicals are substances that alter the functions of the hormonal system and consequently cause adverse effects to humans and/or to the environment. 

Monday 20 June 2016
Lisbon
11.30 Meeting with Prime Minister António Costa
12.45 Press conference
13.15 Working lunch
15.00 Meeting with President Marcelo Rebelo de Sousa

Tuesday 21 June 2016
10.00 Meeting with President of Israel Reuven Rivlin (photo opportunity - press statements ±11.00)
6-month badge/special accreditation will be required to access the Justus Lipsius VIP entrance
15.00 Meeting with Minister of Foreign Affairs of the Netherlands Bert Koenders

Wednesday 22 June 2016
15.30 Meeting with Federal Chancellor of Austria Christian Kern (photo opportunity)

Thursday 23 June 2016
12.45 Meeting with Palestinian President Mahmoud Abbas (photo opportunity - press statements ±13.15)
6-month badge/special accreditation will be required to access the Justus Lipsius VIP entrance

Friday 24 June 2016
10.30 Meeting with European Parliament President Martin Schulz, Prime Minister of the Netherlands Mark Rutte and European Commission President Jean-Claude Juncker (Berlaymont)

THE COUNCIL OF THE EUROPEAN UNION:

1.         RECALLS that major steps have been taken at unprecedented speed over the past years to establish the Banking Union. After a comprehensive assessment of all significant credit institutions in the Banking Union, the Single Supervisory Mechanism was fully established in 2014 and the Single Resolution Mechanism has become operational in 2016.

2.         Furthermore, RECALLS the fact that almost all Member States have transposed and implemented into national law the relevant legal provisions of the single rulebook. This has ensured more consistent regulation and high-quality supervision across the EU by: stronger prudential requirements for banks, introduced under the Capital requirements Directive and Regulation (CRDIV/CRR); a new recovery and resolution framework for banks, established under the Bank Recovery and Resolution Directive (BRRD); the functioning of national Deposit Guarantee Schemes (DGSs), enhanced by the Deposit Guarantee Scheme Directive (DGSD).

3.         As for the SRF, REITERATES that participating Member States agreed on 8 December 2015 on a harmonised Loan Facility Agreement with the Single Resolution Board (SRB), providing national credit lines to the SRB to support the national compartments of the SRF in case of possible funding shortfalls in that compartment following resolution cases of banks during the transition period. All Member States that have not yet signed the Loan Facility Agreement with the SRB  commit to do so as soon as possible, ultimately by September 2016.

4.         CONSIDERS that these achievements, combined with the ECB's measures as well as national measures, made a significant contribution to financial stability, reversing the fragmentation of financial markets, mitigating moral hazard and reducing the risk for the involvement of public financial means.

5.         Building on the important progress made, and in the context of the deepening of the Economic and Monetary Union, REAFFIRMS the importance of the Banking Union with a view of its completion.

6.         RECOGNIZES that, to this end,  further steps will be have to be taken  in terms of reducing and sharing risks in the financial sector, in the appropriate sequence, in order to address a number of remaining challenges.

7.         UNDERLINES the importance of the work being carried out by several institutions at Banking Union, EU28 and international level, in particular work by the Commission to:

a)             propose amendments to the legislative framework in view of implementing the Total Loss Absorbing Capacity (TLAC) standard and reviewing the minimum requirement for own funds and eligible liabilities (MREL). The Council will seek to ensure consistent rules and adequate amounts for the bail-inable buffers that contribute to an efficient and orderly resolution process in line with BRRD for all credit institutions for which bail-in would be the validated resolution strategy.

b)             put forward a proposal on a common approach to the bank creditor hierarchy, to enhance legal certainty in case of resolution.

c)             propose amendments to the CRR/CRDIV as part of an overall review exercise, which would result in:

i.   harmonisation or further specification of options and national discretions (ONDs) granted to MS, which could also contribute to the objective of reducing financial fragmentation;

ii.  implementing and finalising remaining Basel reforms including the introduction of a leverage ratio, possibly set higher than 3% for systemic banks, and the introduction of a net stable funding ratio;

d)            propose a legislative proposal for minimum harmonisation in the field of insolvency law in the context of the Capital Markets Union (CMU), which may also support efforts to reduce future levels of non-performing loans;

e)             conduct further work on examining whether and how harmonizing the rules and application of moratorium tools can contribute to the stabilisation by the relevant authorities of an institution in the period before, and possibly after, an intervention.

8.         In this context, UNDERLINES the following key steps:

a)             On the Commission´s banking proposals set out under paragraph 7, the Council invites the Commission to put forward the proposals as soon as possible and by no later than the end of 2016. On that basis, the Council will start technical work immediately in view of a swift implementation. The Council underlines the importance of considering European specificities when implementing global regulatory standards, including Basel standards, in the EU;

b)             On the common backstop for the Single Resolution Fund, the Council takes note of the intention of Member States to start work in September 2016 if and when all participating Member States have fully transposed the BRRD. In this context, the Council will also take stock of the establishment of the bridge financing arrangements, noting that participating Member States are committed to sign the Loan Facility Agreement by that time. They reaffirm the need to have the common backstop fully operational at the latest by the end of the transition period.  When the work is completed, it may be decided, in line with the risk reduction measures mentioned in paragraph (a), that the backstop may become operational ahead of the end of the transition period;[1]

c)             On the regulatory treatment of sovereign exposures, the Council agrees to await the outcomes of the Basel Committee. Following the work of the Basel Committee the Council will consider possible next steps in the European context;

d)            On a European Deposit Insurance Scheme (EDIS), the Council will continue constructive work at technical level. Negotiations at political level will start as soon as sufficient further progress has been made on the measures on risk reduction, as mentioned above. In this context, the Council takes note of the intention of Member States to have recourse to an IGA when political negotiations on EDIS start;

e)             The Council will assess annually the progress made on the above mentioned measures towards completing the Banking Union.

9.         REAFFIRMS that the discussions on measures relevant to all Member States continue to take place at the level of EU28 to ensure that the Banking Union remains open to all Member States and in view of preserving the single market within the EU.

 [1] Arrangements concerning the SRF backstop will be fiscally neutral over the medium term, ensure equivalent treatment across all Member states participating and incur no costs for Member states not participating in the Banking Union.

Not necessarily bad news? (Illustration: Michel Gaillard)

Not that anyone in Britain cares what the French think. As a matter of fact, even the French themselves don’t care that much. They have other ‘cats to whip’ as they say around here: social unrest, terrorist murders, drunk hooligans. There have been surprisingly little surveys in this normally poll-obsessed country, and while the British polls are quoted and analysed by some media, Le Monde recently simply shrugged their shoulders and drily noted that ‘In France, the Brexit provokes neither debate nor consensus‘. Others, like the financial monthly Capital, summarised the shoulder-shrugging differently: ‘Brexit? Not necessarily bad news!’.

In this context it is interesting to have a closer look at some data tables kindly provided by Céline Bracq and Gaël Sliman from the Odoxa polling institute. A poll they conducted earlier this spring for the daily newspaper Le Parisien highlights that a majority of French citizens would rather like the UK to remain in the European Union. The poll was very quickly and rather superficially quoted upon in the Financial Times, but did not seem to raise any eyebrows on the other side of the Channel. But then again: who cares in Britain what anybody else might think on the continent?

As could be expected, the data on the French attitude towards a potential Brexit reveal more about the French themselves than about the UK’s role in Europe. To no surprise they are deeply split both on UK membership, as they are on most EU matters.

One of the questions simply asked whether the Brexit referendum was ‘an important event for Europe’. It appears that the event is indeed considered important across all age groups (around 65%), but most of all among the over 65 years-old (79%). As for almost all things European, the higher the CSP or the revenues per household, the stronger the concern among respondents. More interestingly, although not too surprising for those who follow French attitudes towards Europe since the 2005 referendum, is the divergence between voters of traditional mainstream parties (they are over 80%, no matter left or right, to consider the event important) and those who find themselves close to the Front national or the extreme left-wing parties, where the scores are significantly lower.

The comparison with other European countries is also of interest. It appears that the French are less opposed to a Brexit than people in Italy, German or Spain (where between 65% and 76% of respondents declared themselves ‘favourable’ to British membership. In France only 54% have this attitude. It also seems that their patience is wearing out: in a similar poll in 2013, 58% of them were displeased with the prospect of a Brexit, today only 42% declare themselves ‘opposed’.

Finally, independently from the Brexit question, the poll also enquired about current attitudes toward the Euro. Bad news for the Front National: 68% of the French seem to be determined to keep the Euro. That’s a score that the ‘Remainers’ in a for the time being hypothetical ‘Frexit’ referendum would hardly achieve. Contradictory? Not in the French mind, it seems.

Albrecht Sonntag, EU-Asia Institute
at ESSCA School of Management.
Follow us on Twitter: @Essca_Eu_Asia

The post Brexit: what does France think? appeared first on Ideas on Europe.

Place:           European Convention Centre Luxembourg (ECCL)
Chair(s):      Sharon Dijksma, the Dutch Minister for the Environment 

All times are approximate and subject to change 

+/- 08.30
Arrivals (live streaming) 

+/- 09.25
Doorstep by Minister Dijksma

+/- 10.00 
Beginning of the meeting (roundtable)
Adoption of agenda
Adoption of non-legislative A items

+/- 10.10
Emissions trading system (ETS) (public session)

+/- 11.50
Paris agreement (public session) 

+/- 12.15
Air quality (NEC directive) (public session) 

+/- 13.15
Any other business: emissions by cars and endocrine disruptors 

+/- 15.30
EU action plan for circular economy (public session) 

+/- 16.30
EU action plan against wildlife trafficking (public session) 

+/- 16.55
Any other business 

+/- 18.00
Press conference (live streaming)

“Which debt relief agreement are you talking about?”

If anyone had any doubts that Christine Lagarde, the managing director of the International Monetary Fund, doesn’t think much of the debt relief deal for Greece that was struck last month by the Eurogroup, these should have been firmly laid to rest by her comments at a press conference in Luxembourg on Thursday.

Asked about what she thought of the outcome of euro area finance ministers’ marathon meeting last month on Greece, which reached some tentative agreements on easing Athens’ massive debt burden, Ms Lagarde appeared to question whether it amounted to a meaningful breakthrough at all.

“Which debt relief agreement are you talking about?,” Lagarde said, before smiling conspiratorially. “I think you have my response in my question actually.”

The issue of debt relief has become central to the roll out of the €86bn euro area bailout of Greece that was agreed on by euro area leaders last summer. The IMF has refused to take part in the programme unless relief is granted, and has challenged what it says are over optimistic EU predictions for the recovery of the Greek economy.

Place: European Convention Centre Luxembourg (ECCL)
Chair: Federica Mogherini, High Representative for Foreign Affairs and Security Policy

All times are approximate and subject to change

from 08.00
Arrivals (live streaming)

+/- 09.20
Doorstep by High Representative Mogherini

+/- 09.30
Beginning of Foreign Affairs Council meeting (roundtable)
Adoption of the agenda
Adoption of A Items 

+/- 09.35
The Arctic
The Sahel
The former Yugoslav Republic of Macedonia  

+/- 13.00
Working lunch on Middle East Peace Process 

+/- 15.00
Visa liberalisation in the context of EU-Georgia relations
AOB

+/- 16:30
Press conference (live streaming)

17.30
Beginning of the meeting (roundtable)

(tbc) 19.30
Press conference (live streaming)

It’s a cliché, but time really does fly when you’re having fun. I arrived in Brussels last September, one of nine hopeful (and nervous) undergraduates embarking on a ten-month internship at FleishmanHillard. It’s been a year full of new experiences, big and small – everything from attending COP21 in Paris to getting lost (a little too often) in the corridors of the European Parliament. I’ve worked with some great people and learnt a lot about EU policy, public affairs and what it‘s like to live and work in the heart of the European project, Brussels.

My fellow interns and I are almost at the end of our time in Brussels, but for anyone considering doing a similar internship, here are five insights into the “Brussels Bubble” and EU public affairs to help you on your way.

1. Don’t be shy – Break into the Brussels Bubble. Brussels is a small place and the EU quarter where decisions take place is miniscule. In fact, within the EU sphere everyone knows pretty much everyone. I once heard someone compare the city’s EU quarter to a university campus, which is not far from the truth. To make the most of your time here, both professionally and socially, networking is key. Whether it’s at a work event or over Thursday drinks at ‘Plux’ (Place du Luxembourg), don’t forget your business cards, push past the awkwardness of introducing yourself to a total stranger, and get talking about that latest POLITICO article or whatever is going on in the Bubble at the moment.
2. To tweet or not to tweet? The answer is easy – tweet. Social media like Twitter and LinkedIn are big in Brussels and can be very helpful, especially if you work in communications. They are good sources of information and an easy way to connect with people. So, create a Twitter account and update your LinkedIn profile now because you’re going to need it. Also, think about how you want to present yourself – do you want to keep it personal or profile yourself professionally? Many EU public affairs professionals use their social media platforms to discuss their chosen policy area. Whether or not you do the same, it’s always good to have a clear idea of what you want to achieve with your digital presence.
3. Stick your neck out. There’s a lot of room for initiative and creativity in EU public affairs. Don’t be afraid to find your niche and voice your ideas. Public affairs professionals in Brussels are an open and dynamic bunch, ready to embrace new ideas (even from newbie interns). Take this opportunity to get the most out of your internship and learn about your strengths and weaknesses in the work place.
4. Embrace your inner nerd. Working in Brussels is a great opportunity to get bogged down in a particular policy area (energy, financial services, food and health etc.) or the intricacies of European politics. It’s a city full of knowledgeable people, so don’t be afraid to ask questions and develop your particular area of interest (even if your friends may tire of hearing you drone on about the Energy Union, the Juncker Plan or the intricacies of the European Parliamentary groups…).
5. Learn by doing. Having studied European politics at university was a great help for me when I started my internship. However, you quickly realise that many of the ins and outs of EU politics are best understood by experiencing them first-hand as well. If you’re an EU geek like me, who loves the academic side of EU studies, an internship is a great way to get practical knowledge to complement your education. Brussels life puts everything you’ve theorised about into perspective. For example, there is nothing like following a legislative dossier for months through the different institutions to really appreciate the dynamics of how the European Commission, Parliament and Council interact with each other. Working in public affairs in particular is a unique experience, in that it gives you a birds-eye view of EU policymaking while allowing you to take an active part in the process yourself. So, make the most of this opportunity and learn by doing!

By: Louise Olander

Westminster is in mourning. Campaigning is on hold. The grief over the murder of Jo Cox MP is raw and palpable. The implications for Britain at this historic juncture are hard to predict. Six days out from the referendum, in the midst of an angry and shrill campaign, politics has suddenly taken a different hue. This was a dark moment for democracy in Britain and an unbearable tragedy for one young family. Start your reading with Alex Massie of the Spectator on a day of infamy.

With last than a week to go until the EU referendum, the campaigns on both sides are now in overdrive. Since late January, we have been following the social media campaigns, particularly on Twitter, to understand better the messages that different groups are making, the way in which they frame and the extent to which their followers have been picking these up. In this post, we want to bring together our weekly analyses, to give the bigger picture. With almost 28,000 tweets from ten different groups, we have been able to draw a number of basic conclusions.

Leave dominate online

Throughout this campaign, Leave groups have been both more visible and more popular than their Remain opponents. In terms of followers, this is true whether we look at the two lead groups – Vote Leave and Stronger In – or the Conservative and Labour pairs, or indeed the camps as a whole. The reasons have been rehearsed in our earlier posts, but reflect the much longer establishment of eurosceptics online, plus the more visceral nature of their campaigning. Indicative of this is the dominance of Leave.EU, which even without securing the official designation, has maintained a clear lead over any other group, with 1.5 times as many Twitter followers as all the Remain groups in our sample. The pattern is also found on Facebook.

If we consider volumes of output, then the disparity is smaller, although in only two weeks in our sample period have the Remain camp tweeted more than Leave. While the last two weeks have seen a massive increase in tweeting by the two official groups, this has still seen Leave produce more content.

The campaign has not obviously caught the public’s attention

For several months now, we have been awaiting the break-through moment of this campaign, when the man or woman on the street really gets into the debate. This would be reflected in a number of markers, including increased numbers of followers and improved rates of retweeting groups’ content. However, this has not happened so far. While Twitter follower growth has strengthened in recent weeks, it has not approached the rates seen around the time of Cameron’s European Council deal. This suggests that the majority of those who are deeply engaged with the issue have been so for a long time and the it remains a marginal issue for the large majority of voters. Clearly, this has implications for turnout, which looks set to be a key consideration in the outcome of the referendum.

Likewise, when we consider our standardised measure for audience engagement – the average number of retweets per tweet per follower – then there is no clear movement either for groups as a whole or for individual groups. If there has been any pattern then it is that the more focused groups have a generally better rate of engagement than the broader ones. Of course, this measure masks the generally larger effect of engagement by Leave, driven by the much larger follower base.

Looking at the engagement measure over time, if we compare the period before the official campaign began in mid-April with that since, then we see that rates for different type of framing generally are lower, with the partial exception of negative arguments, although this is not a significant difference.

Campaigns have become less positive over time

A long-standing discussion on this blog has concerned whether negative campaigning is as successful as it has been suggested for other elections. We discuss this below, but a more general observation is that both sides have become more negative in their framing over time. This has also been true of the three main groups: Stronger In , Vote Leave and Leave.EU.

As we noted last week, the advent of the TV debates has contributed to this very substantially, given the scope for immediate critiquing of opponents, but the trend long predates these events. Our analysis does not yet offer up a convincing explanation for why this occurs, but it will one of the avenues that we will explore in more depth in the coming months. One possibility is that there has been a shift from generic arguments to more specific reaction to events, which produces a similar type of effect to that found with the TV debates.

This shift has also resulted in a clear growth in the use of negative comments about other groups. All of the big three have seen this, again with the TV debates providing rich pickings.

Negative campaigning might work

If there has been a growth in negative framing, then it has not been an unambiguous benefit to groups. Taking our sample as a whole, we do not find that negative framings clearly out-perform positive ones on our engagement measure. Positive arguments and negative comments about other groups are neck and neck, while negative arguments and positive mentions of one’s own group trail a bit behind. Even when we break this up by weeks, there is still not a clear pattern: of particular note would be the last fortnight, which contained the TV debates, but does not show any improvement for negative frames.

The campaigns have been (mostly) consistent in their approach to twitter

Our analysis shows that there has been some notable consistency in the way the groups have used twitter throughout the course of the campaign. This is demonstrated in the 7 days snapshots of tweets for key time periods during the campaign, shown below.

In terms of issues, Leave EU’s message has been dominated by tweets about: 1) politics; 2) criticism of the EU; and 3) business, trade and the economy. We also see a drop off in the number of tweets related to their own campaign after the announcement of the designated groups on the 15th April.

Stronger In’s twitter campaign has been built primarily around business, trade and the economy, with spikes in other issues at certain times. For example, at the beginning of June there is a significant jump in the number of tweets related to domestic issues. Overall, the campaign has builts its message around a core message on business and the economy and the actions of the other campaign.

Vote Leave has conducted a very different social media campaign to Stronger In. It has used twitter to promote its own campaign efforts, rather than engaging the opposing campaign, or to focus on specific issues. Rather, the campaign has focused consistently on a range of issues – politics; domestic issues; immigration; business, trade and the economy; security – but none of these have come to dominate the campaign’s message on twitter. This is a contrast to Stronger In’s predominate focus on business, trade and the economy over other issues.

For this most recent week we have seen a jump in tweets about the opposing campaign from both the designated campaign groups. With Stronger In dedicating almost 30% of their tweets to the leave campaign, and Vote Leave just over 20%. This is in part, likely to reflect the nature of the TV debates in the last week, which formed a significant proportion of the tweets from the campaigns this week and accounts, in part, for the significant increase in the number of tweets generated (see discussion above). In contrast, the number of tweets dedicated to the other campaigns by Leave EU has been significantly lower, at around 2.5%.

The post What the EU referendum campaigns say on social media appeared first on Ideas on Europe.

"The Council of the European Union

1.             RECALLS that under Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities, that Union action, which shall complement national policies, shall be directed towards improving public health, that the Union shall encourage cooperation between the Member States in the field of public health and, if necessary, lend support to their action, and fully respect the responsibilities of the Member States for the organization and delivery of health services and medical care and allocation of the resources to them;

2.             RECALLS that under Article 168(4)(c) of the Treaty on the Functioning of the European Union, the European Parliament and the Council can, in order to meet common safety concerns, adopt measures setting high standards of quality and safety for medicinal products and devices for medical use;

3.             RECALLS that under Article 4(3) of the Treaty on European Union, the Union and the Member States shall assist each other in carrying out tasks which flow from the Treaties, pursuant to the principle of sincere cooperation;

4.             RECALLS that under Article 5(2) of the Treaty on European Union, the Union shall act only within the limits of the competences conferred upon it by the Member States in the Treaties to attain the objectives set out therein and that competences not conferred upon the Union in the Treaties remain with the Member States;

5.             RECALLS that under Article 3(1)(b) of the Treaty on the Functioning of the European Union, the Union has exclusive competence in relation to the competition rules necessary for the functioning of the internal market for medicinal products;

6.             STRESSES that it is fully Member States' competence and responsibility to decide which medicinal products are reimbursed and at what price and that any voluntary cooperation on pricing and reimbursement between Member States should remain Member States driven;

7.             RECOGNISES that a balanced and strong, functioning and effective intellectual property environment, that is line with international commitments of the European Union, is important for supporting and promoting access to innovative, safe, effective and quality medicinal products in the European Union;

8.             NOTES that the pharmaceutical sector in the European Union has the potential to be a major contributor to innovation and the health and life sciences sector, through the development of new medicinal products;

9.             RECOGNISES that new medicinal products however may also pose new challenges to individuals patients and public health systems, in particular regarding the assessment of their added value, the consequences for pricing and reimbursement, the financial sustainability of health systems, their post-market surveillance and patient access and affordability;

10.           UNDERLINES that Health Technology Assessment is an important tool in achieving sustainable health care systems and to promote innovation that delivers better outcomes for patients and society as a whole and RECOGNISES that EU cooperation in line with the Strategy for EU cooperation on Health Technology Assessment and the adopted work programme of EUnetHTA can support the decision-making of Member States, while acknowledging the potential added value of health technology assessments in the context of national health systems;

11.           TAKES NOTE that the EU pharmaceutical legislation provides harmonised regulatory standards for the authorisation and supervision of medicinal products for human use and lays down certain regulatory schemes for the earlier marketing authorisation of medicines with less comprehensive data, such as the conditional marketing authorization or the authorisation under "exceptional circumstances";

12.           RECOGNISES that the exact conditions for the inclusion of innovative and specialised medicinal products in the existing schemes of early marketing authorisation could be further clarified in order to improve transparency, to ensure a continuous positive benefit risk balance of medicinal products put on the market under special conditions and to focus on medicinal products of major therapeutic interest for public health or to meet unmet medical needs of patients;

13.           BEARING IN MIND that specific legislation has been put in place promoting the development and marketing authorisation of medicinal products targeting - inter alia - products to treat patients suffering from rare diseases commonly known as orphan medicinal products, paediatric medicinal products and advanced therapy medicinal products, incorporating specific incentives, including supplementary protection certificates, data exclusivity or market exclusivity and protocol assistance for orphan medicinal products;

14.           BEARING IN MIND that the incentives in this specific legislation need to be proportionate to the goal of encouraging innovation, improving patients' access to innovative medicines with therapeutic added value and budgetary impact, and it should be avoided that circumstances are created that might encourage inappropriate market behaviour of some manufacturers and/or hamper the emergence of new or generic medicinal products and in this way potentially limit patients' access to new medicines for unmet medical needs and that can affect the sustainability of health systems;

15.           NOTES that there are indications that the post-market compliance with certain obligations for marketing authorization holders is not always optimal, which may cause that independent research data and information from patient registries are not structurally generated, collected and made available for research and proof of effectiveness and safety;

16.           NOTES WITH CONCERN an increasing number of examples of market failure in a number of Member States, where patients access to effective and affordable essential medicines is endangered by very high and unsustainable price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic strategies and that individual governments have sometimes limited influence in such circumstances;

17.           NOTES the increasing trend of marketing authorisation of new medicinal products for small indications, including, in some cases, the authorisation of a single product for 'segmented' patient groups within a disease area and the authorisation of one substance for several rare diseases and in this respect NOTES WITH CONCERN that companies may seek very high prices while the added value of some of these products is not always clear;

18.           RECOGNISES that special attention should be given to the access to medicines for patients in smaller Member States;

19.           UNDERLINES the importance of timely availability of generics and biosimilars in order to facilitate patients' access to pharmaceutical therapies and to improve the sustainability of national health systems;

20.           STRESSES that both public and private investments are essential for the research and development of innovative medicinal products. In those cases where public investment has played a major role in the development of certain innovative medicinal products, a fair share of the return on investment in such products should preferably be used for further innovative research in the public health interest for example through agreements made on benefit sharing during the research phase;

21.           STRESSES that the functioning of the pharmaceutical system in the EU and its Member States depends on a delicate balance and a complex set of interactions between marketing authorisation and measures to promote innovation, the pharmaceutical market, and national approaches on pricing, reimbursement and assessment of medicinal products and that several Member States expressed concerns that this system may be imbalanced and that it may not always promote the best possible outcome for patients and society;

22.           RECALLS the Council Conclusions on the reflection process on modern, responsive and sustainable health systems adopted on 10 December 2013[1], the Council Conclusions on the economic crisis and healthcare adopted on 20 June 2014[2], the Council Conclusions on innovation for the benefit of patients adopted on 1 December 2014[3] and the Council Conclusions on personalised medicine for patients adopted on 7 December 2015[4];

23.           RECALLS the discussion at the Informal Meeting of Ministers of Health in Amsterdam on 18 April 2016 on “Innovative and Affordable Medicines” which highlighted the important role of the life sciences industry in Europe, in particular, in developing effective new treatments for patients with high unmet medical needs. At the same time challenges in the pharmaceutical system in the EU and its Member States were noted and that several Member States may wish to cooperate and take action on a voluntary basis to face common challenges identified by those several Member States to the sustainability of national healthcare systems, which may be linked to a number of potential factors, for example the affordability of medicinal products related to high prices, possible unintended or adverse consequences of incentives and the lack of leverage of individual Member States in negotiations with industry;

24.           WELCOMES the discussion during the informal meetings of relevant high level representatives of the Member States responsible for pharmaceutical policy on 11 December 2015 and 26 April 2016, who met for the first time and recognised the added value of an informal reflection and exchange of views on strategic policy level between Member States;

25.           RECOGNISES that a number of Member States have expressed interest in pursuing voluntary cooperation between two or more Member States in the field of Health Technology Assessment as well as in exploring voluntary cooperation in different areas, for example on issues related to pricing and reimbursement of medicinal products, activities aimed at 'horizon scanning', the exchange of information and knowledge, the collection and exchange of price data such as the EURIPID collaboration, and in some cases by bringing together of facilities and resources as well as instruments for joint price negotiations and the conducting of early dialogue with companies developing new products; all these activities should remain to be voluntary, focused on clear added value, shared interests and objectives;

26.           RECOGNISES that further analysis to examine the current functioning of the pharmaceutical system in the EU and its Member States would be useful, in particular in relation to the impact of certain incentives in EU pharmaceutical legislation, the use thereof by economic operators and the consequences for the innovation, availability, accessibility and affordability of medicinal products for the benefit of patients including as regards innovative treatment solutions to common diseases that cause a heavy burden for individuals and health systems;

27.           RECALLS also the relevant findings of the European Commission's 2009 Pharmaceutical Sector Inquiry Report[5], which stressed that a healthy and competitive market for medicinal products benefits from vigilant competition law scrutiny;

28.           UNDERLINES the importance of a continuing open and constructive multi-stakeholder dialogue with pharmaceutical industry, patient organizations and other stakeholders, which is necessary in order to ensure future developments of new and innovative medicinal products as well as the sustainability of the pharmaceutical system in the EU and its Member States, while reinforcing, at the same time, public health interests and guaranteeing the sustainability of the EU Member States health systems;

29.           RECOGNISES that the pharmaceutical system in the EU and its Member States, which is characterised by a division of competences between Member States and the EU level, can benefit from dialogue and a more holistic approach regarding pharmaceutical policy, by enhancing voluntary cooperation between Member States aimed at greater transparency, to safeguard common interests, ensuring access of patients to safe, effective and affordable medicinal products as well as the sustainability of national health systems;

30.           RECALLS the Report on the implementation of the EMA-EUnetHTA three-year work plan 2012-2015 [6] published by the European Medicines Agency and EUnetHTA;

31.           RECOGNISES potential benefits of the exchange of information across Member States on implementation and application of Managed Entry Agreements;

32.           RECOGNISES that while these Council conclusions mainly refer to medicinal products, given the specific nature of the sector, the same concerns regarding sustainability and affordability, as well as considerations regarding research and development and HTA, are also applicable to medical devices and in-vitro diagnostic medical devices.

INVITES THE MEMBER STATES TO:

33.           Consider further development of exclusively Member States driven voluntary cooperation between relevant authorities and payers from Member States, including cooperation within groups of Member States, that share common interests in relation to pricing and reimbursement of medicinal products and to explore possible areas in which such voluntary cooperation can contribute to higher affordability and better access to medicinal products. Where relevant and appropriate, groups of Member States that would like to explore cooperation on a voluntary basis, may also make use of international expertise, with full respect of Member States' competences. This voluntary cooperation could include activities such as:

• Assessment of future introduction of new medicinal products with a possibly significant financial impact on health systems at an early stage through so called 'joint horizon scanning', which entails a forward looking scan of emerging trends and future developments in pharmaceutical research and development aimed at better anticipating the arrival of new, expensive, innovative medicinal products that might potentially affect current policy and practice;
• Pro-active exchange of information between Member States (e.g. national pricing and reimbursement authorities), particularly in the pre-launch phase, with due respect for existing national rules and frameworks, e.g. in relation to business confidentiality;
• Exploring possible strategies on voluntary joint price negotiations in coalitions of Member States, that have expressed interest to do so;
• Consider reinforcing existing cooperation schemes and initiatives to foster agreement on approaches to address unavailability of medicinal products and market failure situations.

34.           Exchange HTA-methodologies and assessment outcomes through EUnetHTA and the HTA Network as already foreseen under the Joint Action EUnetHTA, while recognizing that financial impact and pricing must be addressed separately from the HTA, and that the applicability of HTA results need to be assessed by national health systems.

35.           Without prejudice to existing cooperation in the context of EUnetHTA, and where appropriate, further explore closer voluntary cooperation on HTA between two or more Member States as a Member States' initiative, such as mutual recognition of HTA reports and/or joint HTA reports.

36.            Consider organising during each EU Presidency an informal meeting of relevant high level representatives from the Member States responsible for pharmaceutical policy (e.g. national directors of pharmaceutical policy), encouraging strategic reflection and discussion on current and future developments in the pharmaceutical system in the EU and its Member States, thereby avoiding duplication and respecting the division of competences. These discussions are purely informal and, where relevant and appropriate, can be used as an input for further reflection in the appropriate EU fora, in particular the Working Party on Pharmaceuticals and Medical Devices when areas of EU competence are concerned.

37.             The Presidency-trio (the Netherlands, Slovakia and Malta) is invited to identify with the Member States a set of mutual experienced concerns and challenges which could be considered and/or modified by the future Presidencies in the period from 2017-2020, with full respect for Member States' and EU level competences.

38.             Where appropriate, these common concerns and challenges will be followed up concretely through dialogue, exchange and (international) cooperation as well as through information exchange, monitoring and research at Member States and EU level in the appropriate fora and, in particular, when EU competences are concerned, through the Working Party on Pharmaceuticals and Medical Devices, with the input from Member States, existing technical and policy fora and, where relevant, the European Commission.

INVITES THE MEMBER STATES AND THE COMMISSION TO:

39.             Explore possible synergies between the work of regulatory bodies, HTA bodies and payers, whilst respecting their specific responsibilities in the pharmaceutical chain and fully respecting Member States competences, in order to ensure timely and affordable access of patients to innovative medicinal products that reach the market especially through EU regulatory tools of accelerated assessment, marketing authorisation in exceptional circumstances and conditional marketing authorisation while also analysing the effectiveness of these tools and examining possible clear and enforceable (pre-) conditions and exit options for the products that enter the market through these mechanisms in order to ensure high level of quality, efficacy and safety of the respective medicinal product. These products will therefore continue to be appropriately evaluated and examined with regard to their benefits and risks and appropriateness to be included in these tools.

40.             Foster enhanced cooperation between Member States under the 3rd Joint Action of the European Network for Health Technology Assessment (EUnetHTA) as adopted and to reflect about the future of HTA cooperation at European level for the period beyond 2020 when the current Joint Action comes to an end.

41.             Improve and strengthen existing dialogue and cooperation between Member States and at EU level, in particular through and within existing fora and technical working bodies and by continuing investment in and facilitating the work of the Network of Competent Authorities on Pricing and Reimbursement (NCAPR), the Pharmaceutical Committee and the Expert Group on Safe and Timely Access to Medicines for Patients (STAMP).

42.             Assess the relevance and functioning of the various technical bodies operating at EU level within the EU pharmaceutical framework, including those operating under the auspices of the European Commission, to clarify and confirm existing tasks, roles and mandates with the aim to avoid duplication and fragmentation of work, and to give Member States a better insight and overview of ongoing developments and discussions in these fora.

43.            Consider further investments at national and EU level in the availability of registries and in the developments of methods to assess the effectiveness of pharmaceuticals including through the use of relevant digital means. The implementation of means to inform on post-marketing effectiveness of medicines should allow exchange of information between Member States although in full respect of individual competences, applicable legislation on data protection and other legislation.

44.            Consider further investments at national and EU level in the development of innovative medicines for clearly defined unmet medical needs, in particular also through Horizon 2020 and the Innovative Medicines Initiative (IMI) and with the involvement of the European Medicines Agency, whilst promoting open access to research data while fully respecting applicable legislation on data protection and, where applicable, the information that is considered commercially confidential, and considering conditions such as equitable licensing to ensure a fair return on investment for publicly funded research that delivered a major contribution to the development of successful medicinal products.

45.             Explore obstacles for deploying existing methods and consider new solutions to address market failure, in particular also in small markets, when established products become unavailable or new products are not introduced to national markets, for example for business economic reasons.

INVITES THE EUROPEAN COMMISSION TO:

46.             Pursue the ongoing activities to streamline the implementation of the current legislation on orphan medicinal products and to ascertain correct application of the current rules and fair distribution of incentives and rewards and if necessary consider revision of the regulatory framework on orphan medicinal products without discouraging the development of medicinal products needed for the treatment of rare diseases.

47.             Prepare as soon as possible and with the close involvement of the Member States, while fully respecting Member States competences, the following:

a.              an overview of the current EU legislative instruments and related incentives that aim to facilitate the investment in the development of medicinal products and the marketing authorization of medicinal products given to the holders of a marketing authorisation as implemented within the EU: Supplementary Protection Certificates (Regulation EC 469/2009), medicinal products for human use (Directive 2001/83/EC and Regulation EC 726/2004), orphan medicinal products (Regulation EC 141/2000) and paediatrics (Regulation EC 1901/2006);

b.             an evidence based analysis of the impact of the incentives in these EU legislative instruments, as implemented, on innovation, as well as on the availability, inter alia supply shortages and deferred or missed market launches, and accessibility of medicinal products, including high priced essential medicinal products for conditions that pose a high burden for patients and health systems as well as availability of generic medicinal products. Among those incentives, particular attention should be given to the purpose of supplementary protection certificates as defined in the relevant EU legislative instrument and the use of the “Bolar” patent exemption[7], the data exclusivity for medicinal products and the market exclusivity for orphan medicinal products.

Where relevant, the analysis of impacts should also address - inter alia - the development of medicinal products and the effects of the pricing strategies of industry in relation to these incentives.

The Commission will conduct the analysis on the basis of the information that is made available or gathered, including from the Member States and other relevant sources.

To this end, the Commission should prepare by the end of 2016 a timetable and methodology for conducting the analysis as mentioned in this paragraph.

48.             Continue and where possible intensify, including through a report on recent competition cases following the pharma sector inquiry of 2008/ 2009, the merger enforcement pursuant to the EC Merger Regulation (Regulation 139/2004) and the monitoring, methods development and investigation - in cooperation with national competition authorities in the European Competition Network (ECN) - of potential cases of market abuse, excessive pricing as well as other market restrictions specifically relevant to the pharmaceutical companies operating within the EU, such in accordance with Articles 101 and 102 of the Treaty on Functioning of the European Union.

49.             Based on the above mentioned overview, analysis and report in paragraphs 39 and 40, and taking into account the international commitments of the EU and - inter alia- also the needs of the patient, health systems and the competitiveness of the EU based pharmaceutical sector, discuss the outcome and possible solutions proposed by the Commission in the Working Party on Pharmaceuticals and Medical Devices and, when public health issues are concerned, the Working Party on Public Health at Senior Level." 

[1]        OJ C 376, 21.12.2013, p. 3, with Corrigendum in OJ C 36, 7.2.2014, p.6
[2]        OJ C 217, 10.7.2014, p.2
[3]        OJ C 438, 6.12.2014, p.12
[4]        OJ C 421, 17.12.2015, p. 2
[5]        12097/09 + ADD1 + ADD2
[6]         http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/04/WC500204828.pdf
[7]        Article 10.6 of the Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use.

"The Council of the European Union

1.             RECALLS the Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine[1] and the reports of December 2005, April 2010 from the Commission to the Council on its implementation[2] and the Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections[3] and the reports of November 2012 and June 2014 from the Commission to the Council on its implementation[4].

2.             RECALLS the Council conclusions of 10 June 2008 on antimicrobial resistance (AMR)[5], the Council conclusions of 1 December 2009 on innovative incentives for effective antibiotics[6], the Council conclusions of 22 June 2012 on the impact of antimicrobial resistance in the human health sector and in the veterinary sector - a 'One Health' perspective[7] and the Council conclusions of 1 December 2014 on patient safety and quality of care, including the prevention and control of healthcare associated infections and antimicrobial resistance[8].

3.             RECALLS the European Parliament Resolution of 12 May 2011 on antibiotic resistance[9], the European Parliament Resolution of 27 October 2011 on the public health threat of antimicrobial resistance[10], the European Parliament Resolution of 11 December 2012 on the Microbial Challenges - Rising Threats from AMR[11] and the European Parliament Resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance[12].

4.             RECALLS the 2001 Community Strategy against AMR[13] and the European Commission Communication of 15 November 2011 on an action plan against the rising threats from Antimicrobial Resistance[14] and the outcome of the evaluation of the 5 years action plan of the European Commission.

5.             WELCOMES the Global Action Plan (GAP) on Antimicrobial Resistance[15] developed by the World Health Organisation (WHO) with the contribution of the Food and Agricultural Organization (FAO) and the World Organization for Animal Health (OIE) and unanimously adopted in May 2015 by the 68th World Health Assembly, calling all Member States of the World Health Organization to put in place national action plans against AMR by mid-2017.

6.             WELCOMES the Resolution on Antimicrobial Resistance adopted in June 2015 by the 39th Conference of the FAO and the Resolution combating Antimicrobial Resistance and promoting the prudent use of antimicrobial agents in animals in May 2015 at the World Assembly of Delegates of the OIE.

7.             WELCOMES the Codex Alimentarius Commission[16] initiative with regard to the need to review and update standards, codes and guidelines related to AMR.

8.             WELCOMES other international and regional initiatives such as the declaration by the G7 on Antimicrobial Resistance[17] and the decision to put antimicrobial resistance on the agenda of the G20.

9.             RECALLS that regarding human health, the Union's action is defined by Article 168 of the Treaty on the Functioning of the European Union.

10.           RECALLS that antimicrobial resistance is a cross-border health threat that cannot be sufficiently addressed by one Member State alone and cannot be confined to a geographical region or a Member State and hence needs intensive cooperation and coordination between Member States, as stated in the Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health[18].

11.           RECALLS that in the veterinary sector a number of legislative and non-legislative measures have already been taken and are taken at EU level to coordinate and ensure a common EU approach reducing the risk of AMR. These measures include  especially those set out in the Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition[19], prohibiting the use of antibiotics as growth promoters, Commission Implementing Decision 2013/652/EU on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria[20], Commission Decisions following referral procedures under Directive 2001/82/EC, resulting in modifications of marketing authorisations for products containing critically important antimicrobials in order to reflect specific measures against development of AMR and in the Guidelines for the prudent use of antimicrobials in veterinary medicine (2015/C 299/04)[21].

12.         WELCOMES the ongoing work of the Organisation for Economic Co-operation and Development (OECD) and the World Bank on the economic impact of AMR.

13.         EXPRESSES ITS CONCERN regarding  the data provided by OECD, according to which, it is estimated that about 700 000 deaths may be caused globally each year by AMR. Compared to a world with no AMR, the economic impact associated with current rates of AMR may reach about 0.03% of GDP in 2020 in OECD countries, 0.07% in 2030 and 0.16% in 2050. This would result in cumulative losses of about USD 2.9 trillion by 2050[22].

14.         ACKNOWLEDGES the Scientific Opinions and reports on antimicrobial resistance published by the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA).

15.         RECOGNISES that due to the complexity of the problem, its cross-border dimension and the high economic burden, the impact of antimicrobial resistance goes beyond its severe consequences for human and animal health and has become a global public health concern that affects the whole of society and requires urgent and coordinated intersectoral action, where necessary based on the precautionary principle[23].

16.         UNDERLINES that in order to stimulate the development of new antimicrobials, alternative therapies and (rapid) diagnostics, EU and global coordination and cooperation on research programmes and incentives are needed and RECOGNISES the work done by the Innovative Medicines Initiative (IMI) project DRIVE-AB (Driving reinvestment in research and development and responsible antibiotic use), the proposals of the Antimicrobial Resistance Review team[24] and the Joint Programming Initiative on Antimicrobial Resistance[25] among others.

17.         STRESSES that more cooperation between Member States and with the Commission and pharmaceutical industry is crucial regarding the reduced availability including possible withdrawals from the market of antimicrobials that may lead to shortages in antimicrobials and inadequate replacement therapy.

18.         HIGHLIGHTS that to make progress in the fight against AMR, the new EU Action Plan should contain measurable (clearly defined quantitative or qualitative) goals, benchmarks and effective measures to achieve these goals.

19.         HIGHLIGHTS that the success of the fight against antimicrobial resistance relies heavily on the commitment and willingness of governments to take actions to ensure the implementation of the initiatives under the One Health approach involving all relevant sectors and on the will of the EU Member States to cooperate within the EU and at an international level.

20.         WELCOMES the EU Ministerial One Health Conference on AMR[26] held in Amsterdam on 9 and 10 February 2016, at which the political will to tackle the AMR problem, by means of a One Health approach was expressed, including among others, enhanced cooperation between the Member States through a EU One Health Network on AMR. The EU One Health Network will not be a new governance structure, but it will work through joint meetings of existing groups or bodies in the human health, food and veterinary field, such as the AMR working group and the Health Security Committee. The EU One Health Network will be used on a regular basis, to discuss AMR related issues from a one health perspective, i.a. the exchange of information between Member States about the progress made on the implementation of the National Action Plans against AMR and the development and implementation of the EU Action Plan.

21.         CALLS UPON THE MEMBER STATES TO:

1.             have in place before mid-2017 a national action plan against Antimicrobial Resistance, based on the One Health approach and in line with the objectives of the WHO Global Action Plan. The national action plan, adapted to the national situation, should:

a)             ensure that measures and actions in the different domains take into account the public health concerns of AMR;

b)             be developed and implemented in cooperation between all relevant ministries and the relevant stakeholders in the public and private sector;

c)              include measurable goals to reduce infections in humans and animals, the use of antimicrobials in the human and veterinary sector and antimicrobial resistance in all domains. These goals could be qualitative and/or quantitative and should be addressed through effective measures adapted to the Member States' national situations;

d)             include measures to reduce the risk of AMR and strengthen the prudent use of antimicrobials in veterinary medicine, according to EU[27] and national guidelines, including actions to avoid the routine preventive use of veterinary antimicrobials and actions to restrict the use in animals of antimicrobials that are of critical importance to human health (e.g. use on the basis of antimicrobial susceptibility testing);

e)             include measures to reduce the risk of AMR and strengthen the prudent use of antimicrobials in human medicine including actions to improve prescribing practices and prudent use of antimicrobials that are of critical importance to human health (e.g. use on the basis of antimicrobial susceptibility testing);

f)              include the mechanism for implementation of national action plans and monitoring of their progress, including the way to further strengthen surveillance and to improve the quality and comparability of the data reported to ECDC, EFSA and EMA on the use of antimicrobials and on resistance in humans, animals, the food chain and possibly the environment;

g)             include the way enforcement of legislation relevant to AMR is organised and ensured in the Member State;

h)             include education programmes, where appropriate,  and targeted campaigns to raise awareness among consumers, animal keepers and relevant professionals;

2.              within the EU One Health Network, present their national action plans and share best practices, discuss policy options, ways to better coordinate responses and keep each other updated on the progress made on the implementation of the action plans;

3.              support dialogue with the pharmaceutical industry in order to keep existing effective antimicrobials used in human and veterinary medicine on the market, and explore alternative solutions to ensure availability of these antimicrobials on the market;

4.              join or strengthen their commitment to the existing Joint Programming Initiative on AMR[28];

5.              promote and facilitate the implementation of measures to prevent infections in animals such as the use of vaccines and biosecurity measures in order to reduce infection pressure and therefore the need to use antibiotics;

6.              promote the use of diagnostic tools including rapid tests and their uptake in the human and veterinary sector as means to improve the prescription of antimicrobials.

22.         CALLS UPON THE MEMBER STATES AND THE COMMISSION TO:

1.             develop together, while respecting Member States competencies, a new and comprehensive EU Action Plan on Antimicrobial Resistance based on the One Health approach, taking into account the evaluation of the current Action Plan, the discussion at the EU Ministerial One Health Conference on AMR of 10 February 2016 and the WHO Global Action Plan. The new EU Action Plan should include the following measures and measurable[29] goals:

a)             measures to prevent infections and to ensure prudent use of antimicrobials in human and veterinary medicine;

b)             measures to combat illegal practices related to the trade and use of antimicrobials, in human and veterinary medicine;

c)             align surveillance on AMR in humans, food, animals and environment at EU level;

d)             decrease, over the period of the new EU Action Plan, antimicrobial resistance in humans, animals and in the environment in the EU;

e)             decrease, over the period of the new EU Action Plan, the differences between Member States, in use of antimicrobials in both human and animal health, whereas Member States with a relatively low use should also try to further pursue prudent use of antimicrobials;

f)              decrease, over the period of the new EU Action Plan, healthcare associated infections in the EU;

g)             develop indicators to assess the progress made on addressing AMR and on the implementation of the EU Action Plan.

2.             strengthen coordination and cooperation between Member States, between Member States and the Commission, and between human, food, veterinary, environmental, research and other relevant sectors and actively participate in the joint discussions of the EU One Health Network as defined in paragraph 20;

3.             within the One Health Network, discuss the development, progress and implementation of the EU Action Plan;

4.             strive for ambitious legislative measures that address the public health risk of AMR, in the areas where there is competence to do it, for example in the area of veterinary medicinal products and medicated feed;

5.             develop European Union guidelines on prudent use of antimicrobials in human medicine to support national guidelines and recommendations;

6.             set up a voluntary country-to-country peer review system in which representatives from one or several Member States evaluate each other's national action plan, reflect about policy options and provide recommendations to support Member States to improve measures taken. This country-to-country peer review system is complementary to other existing assessment tools or audit activities (e.g. ECDC, Directorate on Health and Food Audits and Analysis[30] or WHO);

7.             ensure that the EU has a common approach in the global discussions on AMR, especially on the implementation of the GAP of the WHO, the FAO and the OIE Resolutions on AMR and on the implementation and updating the intergovernmental standards related to AMR published by Codex Alimentarius and the OIE;

8.             in the framework of the One Health Network on AMR align strategic research agendas of existing EU R&D initiatives on new antibiotics, alternatives and diagnostics, set priorities  based on societal needs in the field of public health, animal health and the environment, taking into account the gaps analysis in this domain;

9.             actively engage in initiatives and proposals to implement a new business model to bring new antibiotics to the market, including models in which investment costs or revenues are de-linked from sales volumes;

10.           encourage all relevant partners, including national regulatory authorities to launch a reflection, within the existing appropriate fora (e.g. the One Health Network), regarding the regulatory framework with regards to antibiotics in order to stimulate research and development and to facilitate marketing authorization procedure for new antimicrobials;

11.           encourage the use of alternative treatment and prevention options including vaccines and the development and use of affordable diagnostics tests in human and veterinary medicine;

12.           support in close cooperation between the Member States and the Commission, the proposals to put AMR on the agenda of the United Nations General Assembly in September 2016, as mandated by the WHO GAP and the FAO Resolutions on AMR, in order to raise awareness of the issue at the highest political level, involving all Heads of State and all relevant UN organisations and aim for ambitious outcomes.

23.         CALLS UPON THE COMMISSION TO:

1.             facilitate and support Member States in the development, assessment and implementation of national action plans against AMR, including support to strengthen monitoring and surveillance systems and consider financial support within existing frameworks;

2.             facilitate and support the regular meetings of the EU One Health Network on AMR as defined in paragraph 20;

3.             report to the Council at least once a year on the activities of the One Health Network including the developments in the area of the implementation of the EU Action Plan against AMR;

4.             establish a harmonised approach to prevent introduction and spread of emerging antimicrobial resistance in animal husbandry and the food chain with potential impact in public health (e.g. carbapenem resistance);

5.             develop as a matter of priority specific acts under the Regulation on transmissible animal diseases ('Animal Health Law')[31] including infection prevention measures, good management practices in animal husbandry and harmonised surveillance systems of relevant animal pathogens;

6.             actively promote and defend in multilateral and bilateral dialogues and agreements between the EU and its counterparts the EU standards and EU policies on AMR, especially:

a)             the importance of infection prevention, prudent use of antimicrobials and strengthening the awareness of the risks of AMR in human and veterinary medicine;

b)             the ban on the use of antibiotics as growth promoters in livestock farming;

c)             the avoidance of the routine preventive use of antimicrobials in veterinary practice;

d)             the restrictions on the use in veterinary practice of antimicrobials that are not authorised or which use has been restricted in the EU due to the fact that they are critically important for the prevention and treatment of life-threatening infections in humans;

e)             the EU requirements for the import of live animals and products thereof;

f)              the concept of the precautionary principle[32].

7.             promote economic impact studies in the human and animal sector to assess the cost of AMR." 

[1]           OJ L 34, 5.2.2002, p.13
[2]           5427/06 [COM(2005)684 final] and 8493/10 [COM(2010)141 final]
[3]           OJ C 151, 3.7.2009, p.1
[4]           COM(2012)0658 and COM(2014)0371
[5]           9637/08
[6]           OJ C 302, 12.12.2009, p. 10
[7]           OJ C 2011, 18.7.2012, p. 2
[8]           OJ C 438, 6.12.2014, p. 7
[9]           P7_TA(2011)0238
[10]         P7_TA(2011)0473
[11]         2012/2041 (INI)
[12]         2014/2207(INI)
[13]         COM/2001/0333 final Volume I.
[14]         16939/11 [COM(2011)748]
[15]          http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_ACONF1Rev1-en.pdf?ua=1
[16]          CAC 39-CL2015/21
[17]          https://www.g7germany.de/Content/EN/Artikel/2015/06_en/g7-gipfel-dokumente_en.html
[18]          OJ L 293, 5.11.2013, p.1-15
[19]          OJ L268, 18.10.2003, p. 29
[20]          OJ L 303, 14.11.2013, p. 26
[21]          OJ C 299, 11.9.2015, p. 7
[22]          http://www.oecd.org/els/health-systems/Antimicrobial-Resistance-in-G7-Countries-and-Beyond.pdf ;
                 NB: in the quoted report the amount "trillion" means 1012
[23]          Communication from the Commission on the precautionary principle (COM(2000) 1 final of 2 February 2000).
[24]          Lead by J. O'Neill (http://amr-review.org/)
[25]          http://www.jpiamr.eu/
[26]          http://english.eu2016.nl/events/2016/02/10/ministerial-conference-on-amr
[27]          Commission Guidelines for the prudent use of antimicrobials in veterinary medicine (2015/C 299/04)
                 http://ec.europa.eu/health/antimicrobial_resistance/docs/2015_prudent_use_guidelines_en.pdf
[28]          http://www.jpiamr.eu/
[29]          See paragraph 18.
[30]          The Directorate on Health and Food Audits and Analysis of the European Commission's Directorate-General for Health and Food  Safety, formerly the "Food and Veterinary Office".
[31]          Regulation (EU) No 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law') (OJ L 84, 31.3.2016, p. 1).
[32]          See also paragraph 15.