European Council

"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.

Good evening and welcome to this press conference. During our meeting we heard the sad news of the passing away of Mrs Jo Cox in the United Kingdom, and we observed a moment of silence in our meeting out of respect for her. Our thoughts are with her loved ones and all those who were touched by her life and political work for the UK. The United Kingdom is a beacon for peaceful politics and we hope that the British public, the people of the UK, can make their democratic choices serenely and in a safe way next week.

Today we've welcomed Christine Lagarde, who presented the article IV review of the euro zone. The IMF sees the euro area cyclical recovery on track, despite turbulence in the global economy. This good news follows on from the achievements of the euro area in recent years including rebalancing and reforms at national level and strengthening of institutions throughout the eurozone, for the eurozone. We have built a banking union, set up new institutions, created a single rulebook, the SSM and the SRB, all of which are all up and running. And the work will continue on the strengthening of our banking system. Structural reforms remain high on our agenda and will continue to be discussed in depth in the Eurogroup, and it will also be on the agenda of tomorrow's Ecofin in the context of the European Semester and the country specific recommendations.

At the same time, we concurred with IMF that we need to make our economies more resilient, certainly viewing any future economic shocks that may occur. This means using the opportunities that we have at the moment, for example low interest rates, trying to address budgetary issues, starting to reduce deleveraging and reducing debt levels throughout the eurozone. It also means continued work on the banking union, reforming our economies to make them more flexible, to help them adjust faster.

The Fund has provided us with number of recommendations and ideas on how we can support growth further at the European level, including fiscal policies and structural policies, and we will continue to work on that. One of the ways we do that is by discussing in depth structural reforms, the design, the principles and the benchmarks for reforms, which is something that is on the agenda of the Eurogroup on the regular basis.

Today specifically, we discussed common principles for pension reforms in the Eurogroup, one of our regular thematic discussions. We have designed four common principles, which will improve the effectiveness of pension reforms (the statement will be provided to you on those principles), making our pension systems more sustainable, safeguarded against demographic and macroeconomic risks, but also designing flanking policies to extend the working lives of people and to boost retirement incomes.

We will periodically in the Eurogroup monitor developments in this field, the way we've done on other issues of structural reforms, and return to those, creating benchmarks for our work on structural reforms.

Also today we discussed, as we do on a regular basis, inflation and exchange rate developments, and we agreed with the Commission and the ECB's assessment of recent development in this area. We noted that the IMF also considers that the ECB's comprehensive package of measures is yielding positive effects. Inflation rates are expected to pick up later this year and increase further gradually in 2017. Now let me first give the floor to Christine, who would like to brief us further on their work on the eurozone

"THE COUNCIL OF THE EUROPEAN UNION

RECALLS

1.             Article 168 of the Treaty on the Functioning of the European Union (TFEU)[1], which states that a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities and which provides that the Union shall encourage cooperation between the Member States in the field of public health and, if necessary, support their action.
Article 26 TFEU, which states that the internal market shall comprise an area without internal frontiers in which the free movement of goods is ensured.

2.             The Council conclusions of 6 December 2007 on the Commission White Paper on a strategy for Europe on nutrition, overweight and obesity-related health issues[2], which, in the context of an integrated approach to tackle nutritional challenges, called upon Member States to support activities aimed at reformulating foods to reduce levels of salt, saturated fat, trans-fatty acids, added sugar and energy density, given the role these elements play in the development of non-communicable diseases, overweight and obesity.

3.             The Council conclusions of 8 June 2010 on action to reduce population salt intake for better health[3], which called upon Member States to strengthen or develop coordinated and sustainable national nutritional policies, including salt reduction programmes, to reduce salt consumption to an appropriate level.

4.             The EU Framework for National Initiatives on Selected Nutrients[4], established in 2011 following the positive results of the EU Framework for National Salt Initiatives[5], to which were added, in 2012, Annex I on saturated fat[6] and, in 2015, Annex II on added sugars[7], providing political guidance for action.

5.             The Council conclusions of 20 June 2014 on nutrition and physical activity[8], and the Action Plan on Childhood Obesity, recognising the beneficial impact of disease prevention on both citizens and health systems and the importance of healthy diet in reducing the risk of chronic conditions and non-communicable diseases, which invited the Member States to continue to make healthy diet a top priority, thus contributing to better health and quality of life of EU citizens and the sustainability of the health systems.

6.             EU Member States' support for the World Health Organisation's (WHO) global action plan for the prevention and control of NCDs 2013-2020, of 27 May 2013[9], which called for a reduction in the preventable and avoidable burden of morbidity, mortality and disability due to non-communicable diseases by means of multisectoral collaboration and cooperation at national, regional and global levels, so that populations reach the highest attainable standards of health and productivity at every age and those diseases are no longer a barrier to well-being or socioeconomic development.

7.             The conclusions of the report from the Commission to the European Parliament and the Council regarding trans fats in foods and in the overall diet of the Union population[10].

8.             The Conference on Food Product Improvement, organised by the Presidency, in Amsterdam, on 22 and 23 February 2016[11], where a roadmap for action on food product improvement[12], to develop more concerted action to move step by step towards a healthier product offer, was endorsed by the majority of the Member States and by Norway and Switzerland as well as by food business operators and health-related non-governmental organisations.

NOTES WITH CONCERN THAT

9.             The prevalence of overweight, obesity and other diet-related non-communicable diseases in the European population is too high and is still rising. This has a negative impact on life expectancy, reducing Union citizens' quality of life and affecting society, for example by threatening the availability of a healthy and sustainable workforce and inducing high healthcare costs which may affect the sustainability of the healthcare systems. It thus also imposes an economic burden on the Union and its Member States.

10.         In particular, the high prevalence and rise of overweight and obesity among children is a serious concern, calling for strong concerted action, as already addressed at the level of the Member States, the Union and the World Health Organisation (WHO)[13].

11.         Nutrition plays an important role in this context, alongside other lifestyle-related matters: the diet of many Europeans contains too much salt, saturated fats, sugars and energy value, mostly through consumption of processed or prepared foods, whilst at the same time most people do not consume enough fruits, vegetables and wholegrain products. In some Member States, people are still exposed to high amounts of trans fatty acids.

RECOGNISES THAT

12.         For people's diet to improve, the healthy choice should be the easy choice.
To achieve such an objective, a holistic approach is needed: physical and social environments that support and encourage healthy patterns of food consumption as well as objective nutrition information and public-health driven education are key for policies and actions at national and local level.
Food product improvement, by reducing among others the levels of salt, saturated fats, added sugars[14] and energy value, as well as improving the availability of small and/or reduced portion sizes[15], is an important tool to make the healthy choice easy. In general such reduction should not lead to an increase in energy value[16] and should not decrease the quality and safety of the products.

13.         To reach the majority of the population, in particular children and vulnerable groups, more action is needed on mainstream products that are consumed by the majority of the European population on a daily basis.

14.         Accessible and affordable improved food products can contribute to the goal of decreasing health inequalities, as vulnerable groups, for whom it might be difficult to make healthy choices, could more easily opt for improved products as they become more widely available.

15.         Governments have the responsibility for setting public health objectives, which should, subsequently, be achieved in cooperation with food business operators and other relevant stakeholders. Food business operators[17] throughout the food chain have a responsibility towards improving the products and meals they offer and, by doing so, contribute to making the healthy choice the easy choice. Guidelines on the composition of foods to be provided by public bodies (such as hospitals, schools and residences for elderly people or students), including through public procurement, can also play a major role in supporting these objectives.

16.         The point of departure varies between Member States, some of which already have a history in food product improvement, for example by setting compositional criteria for products, criteria for school meals and other food provided via public procurement, - validating the proposals of food business operators - criteria relating to labelling or to the marketing of food products to children, and criteria for portion sizes.

17.         Cultural differences in preferences and dietary patterns can partly determine the approach, the pace of reduction of salt, saturated fat, added sugars and the final results. Every approach should acknowledge those cultural differences and dietary patterns. Local and traditional foods, including geographical indications[18], intrinsically tied to a country's culture and heritage, could be subject to special consideration, taking into account the national situation, for example their contribution to the overall dietary intake.

18.         Salt, saturated fats and added sugars should be reduced in food gradually, to enable consumer acceptance of improved products. Food for infants and children deserves specific attention, to develop broad tastes, including for fruits and vegetables, and avoid early development of taste preference for high-sugar and high-salt foods.

19.         Food is extensively traded across borders within the internal market; therefore, food product improvement calls for cross-border cooperation in order to be effective from the public health and industry points of view, thus ensuring a high level of consumer and health protection and better functioning of the internal market.

20.         Small and medium-sized enterprises (SMEs) which would like to participate in food product improvement initiatives may lack the necessary resources or skills to work on food product improvement; raising awareness among SMEs and encouraging support and attention for SMEs through the voluntary sharing of knowledge and best practices is important in view of their market share.

21.         The improvement of the composition of food products opens up great possibilities for innovation and business opportunities and can lead to a market advantage. Within companies, increased coherence between the development of improved food products and marketing investment is desirable and expected in order to promote the healthiest options in the portfolio of companies and make the healthy choice easy.

22.         Including companies' nutrition and health activities specifically related to food product improvement in auditing initiatives concerning corporate social responsibility could be a valuable incentive.

23.         Research provides the necessary information for a solid approach to food product improvement; in general, the necessary know-how for the first important steps in improvement is available, but such information could be better distributed and exploited.

24.         Data on current consumption and product composition help to make it possible for actions to be targeted at the most relevant product groups. The transparency and accessibility of such data facilitate the adoption of good practices.

25.         Regular, transparent, credible and independent monitoring of product composition is essential for insight into the market situation and into the results of actions undertaken.

26.         Other factors, such as technological possibilities, food safety and sustainability goals, may influence results in food product improvement.

CALLS UPON THE MEMBER STATES TO

27.         Have a national plan for food product improvement in place by the end of 2017, either as a new plan or integrated into an existing plan, in cooperation with the relevant stakeholders, to make the healthy choice easier for consumers by 2020, through an increased availability of food with lower levels of salt, saturated fats, added sugars, energy value and, where appropriate, through reduced portion sizes and to provide information on the nutritional composition of processed foods. Local and traditional foods, including geographical indications [19], intrinsically tied to a country's culture and heritage, could be subject to special consideration, taking into account the national situation, for example their contribution to the overall dietary intake.

28.         Make full use of all existing structures and tools, including the online tools of the EU Health Policy Platform[20], for sharing experiences on new initiatives and actions, as well as best practices, aimed at promoting food product improvement.

CALLS UPON THE MEMBER STATES AND THE COMMISSION TO

29.         Report regularly, at least every two years, on progress achieved in food product improvement initiatives, and share benchmarks, where available, best practices of implementation and results, within the framework of the High Level Group (HLG) on Nutrition and Physical Activity[21].

30.         Integrate the multidimensionality of food product improvement by involving representatives responsible for the areas of health, agriculture, food, economy and distribution, innovation, research and the internal market in the actions undertaken.

31.         Support technological and research projects in the field of food product improvement aimed at developing and applying sound and up-to-date scientific knowledge.

32.         Raise awareness and facilitate involvement of SMEs, e.g. by supporting research projects aimed at improving food composition, disseminating information on food product improvement techniques and applying criteria relating to food product improvement to relevant structural funds, thus providing affordable solutions for SMEs when improving food products.

CALLS UPON THE COMMISSION TO

33.         Assess existing benchmarks for the reduction of salt and saturated fats in the context of the EU Frameworks for National Salt Initiatives and National Initiatives on Selected Nutrients and support the development of new possible benchmarks within the context of the HLG within a clear timeframe.

34.         While respecting Member States' competence, continue to involve the stakeholders concerned at Union level, including food business operators, in the food product improvement process, by:

a)             continuing to support coordination and cooperation between the HLG on Nutrition and Physical Activity and the EU Platform for Action on Diet, Physical Activity and Health[22], for more focused discussions and exchanges of information on food product improvement;

b)             establishing working groups with experts from both Member States and stakeholders within the EU Platform for Action on Diet, Physical Activity and Health:

• to work on improving the methodology, quality and share the results of monitoring activities[23];
• to suggest possible criteria regarding salt, saturated fats, added sugars and, where appropriate, portion sizes for food categories throughout the food chain;
• to look for other possible ways to increase the availability of healthy choices, particularly by also increasing beneficial nutritional elements that are recommended to be consumed and in general are not sufficiently consumed.

c)       supporting clear, transparent and flexible working procedures (e.g. exchange of information by electronic means and guidance for public-private cooperation) and making the progress achieved and results attained by the working groups publicly available, for example via the online EU Health Policy Platform, to optimise the work of the groups.

35.         Continue to support the improvement of the scientific basis, monitoring and data collection and sharing at EU level regarding improved products, consumption and new production methods.
Monitoring of progress to be outlined with the Joint Action on Nutrition and Physical Activity (JANPA)[24] coordinated by France and to be seen in the light of the work of ongoing activities of WHO Europe, the European Commission and the Joint Research Centre (JRC).

36.         Invite the JRC to participate in the autonomous verification and monitoring of EU Platform commitments with regard to food product improvement, which should be measurable, comparable and monitored in a sound and transparent way.

37.         Increase coordination and alignment of research activities and open research data to underpin the development of improved food products through the Joint Programming Initiative: Healthy Diet for a Healthy Life.

38.         Where possible, closely coordinate all new activities with regard to food product improvement with existing groups and actions, such as the JANPA and the WHO European Salt Action Network (ESAN, coordinated by Switzerland).

39.         Facilitate the exchange of best practices, in particular through the following actions:

a)             setting up special pages on food product improvement on the online multi-stakeholder EU Health Policy Platform, with links to existing databases where possible, where all stakeholders involved can share experiences, challenges, knowledge, showcase results, identify obstacles in the EU internal market and share possible solutions to these obstacles;

b)             updating all stakeholders on planned and implemented actions at the regular meetings of the HLG and the EU Platform for Action on Diet, Physical Activity and Health."

[1]           OJ C 326, 26.10.2012, p.47 (consolidated version).
[2]           15612/07.
[3]           OJ C 305, 11.11.2010, p. 3.
[4]           http://ec.europa.eu/health/nutrition_physical_activity/docs/euframework_national_nutrients_en.pdf
[5]           http://ec.europa.eu/health/archive/ph_determinants/life_style/nutrition/documents/salt_initiative.pdf
[6]           http://ec.europa.eu/health/nutrition_physical_activity/docs/satured_fat_eufnisn_en.pdf
[7]           http://ec.europa.eu/health/nutrition_physical_activity/docs/added_sugars_en.pdf
[8]           OJ C 213, 8.7.2014, p. 1.
[9]           http://apps.who.int/iris/bitstream/10665/94384/1/9789241506236_eng.pdf
[10]         http://ec.europa.eu/food/safety/docs/fs_labelling-nutrition_trans-fats-report_en.pdf
[11]         http://english.eu2016.nl/events/2016/02/22/thematic-conference-on-product-improvement
[12]         https://www.rijksoverheid.nl/documenten/formulieren/2016/02/22/roadmap-for-action-on-food-product-improvement
[13]         Non-exhaustive list: EU Strategy on Nutrition, Overweight and Obesity-Related Health Issues 2007; Political Declaration of the High-level Meeting of the General Assembly (of the United Nations) on the Prevention and Control of Non-communicable Diseases" of 2011; WHO European Food and Nutrition Action Plan 2015-2020; Vienna Declaration on Nutrition and Non-Communicable Diseases in the Context of Health 2020; EU Action Plan on Childhood Obesity 2014 - 2020.
[14]          In the sense used in Annex II to the EU framework for national initiatives on selected nutrients (http://ec.europa.eu/health/nutrition_physical_activity/docs/added sugars_en.pdf) 'added sugars' refers to sucrose, fructose, glucose, starch hydrolysates (glucose syrup, high-fructose syrup) and other isolated sugar preparations used as such or added during food preparation and manufacturing, as well as sugars present in honey, syrups and fruit juices and fruit-juice concentrates.
[15]          A number of foods are packed (biscuits, chocolate bars, milk drinks, yogurts, nuts, salads, preserves, etc.) or sold (hamburgers, dishes in canteens, etc.) in portions designed to be consumed immediately or once open. There are no unified 'sizes' for such portions, but it is clear that the size chosen by the producer is a clear invitation to consumption, as people avoid wasting food. Smaller portions offer more flexibility for the consumer, as a second portion will only be eaten through an active decision.
[16]          However, even if the energy value remains unchanged, reductions of saturated fats or added sugars can be encouraged through an increase of recommended nutritional components that are not generally consumed in sufficient amounts (e.g. fibre, fruits and vegetables).[17]          This includes, among others, manufacturers, retailers, caterers, bars, restaurants and other providers of food.
[18]          http://ec.europa.eu/trade/policy/accessing-markets/intellectual-property/geographical-indications/
[19]          http://ec.europa.eu/trade/policy/accessing-markets/intellectual-property/geographical-indications/
[20]          http://ec.europa.eu/health/interest_groups/policy_platform/index_en.htm
[21]          http://ec.europa.eu/health/nutrition_physical_activity/high_level_group/index_en.htm
[22]          http://ec.europa.eu/health/nutrition_physical_activity/platform/index_en.htm
[23]          For monitoring purposes the focus should be on total sugars instead of added sugars, since (currently) only total sugars can be analysed.
[24]          http://www.janpa.eu/

The Eurogroup endorses, in the context of its thematic discussions on growth and jobs, a set of common principles for strengthening the sustainability of pension systems in the euro area.

The Eurogroup considers that significant progress has been achieved in improving pension sustainability in the euro area. However, it also acknowledges that considerable risks remain in many Member States, especially over the medium term. In particular, pension expenditure projections are sensitive to the underlying macroeconomic and demographic assumptions. Against this background, further policy action is needed to strengthen the resilience of public pension systems to adverse demographic and macroeconomic developments and to guard against the risk of reform reversal.

The Eurogroup underlines that in times of high public debt, the importance of pension sustainability for the euro area from a financial, economic and social point of view renders developments in this field a matter of common concern in the euro area. In the context of interlinkages in the monetary union, adverse cross-border spill-overs may arise from unsustainable national pension systems. Developing common principles for pension reforms in the euro area is therefore beneficial, while recognising that country specificities influence the features of national pension systems.

Overall, the Eurogroup considers that the sustainability of pension systems, while safeguarding the adequacy of old-age incomes, is a clear policy priority for euro area Member States.

The Eurogroup thus endorses the following common principles, which should guide Member States when implementing reforms in this field: 

• Safeguard against demographic and macroeconomic risks: reforms should focus on systematically increasing the resilience of public pension systems against risks from demographic change or macroeconomic shocks. In particular, the introduction of automatic mechanisms appropriately designed at Member State level has been shown to be an effective tool for dealing with the effects of demographic change, specifically the slow-moving but significant increases in life expectancy.

• Flanking policies: pension reform should be complemented by flanking policies so as to improve the sustainability of the pension system, while ensuring the adequacy of pensions. These policies should seek to extend working lives and thereby boost retirement incomes, through measures to increase older people's employability as well as restricting early pathways out of the labour force. The provision of complementary means of savings for retirement should also be explored.

• Broader reforms to strengthen growth and employment: longer working lives should be accommodated without higher expenditure on non-pension benefits. Effective policies need to be enacted to ensure that the entire work force is put to the fullest possible use. Workplaces should adapt to maximise the productivity of a heterogeneous workforce, while policies to boost productivity and potential growth should support the impact of pension reforms on sustainability more broadly.

• Anchoring political and societal support: the implementation of pension reforms has far-reaching consequences for individuals as well as the macro-economy and has implications for intergenerational equity. Societal and political support is essential for the lasting success of reforms. In this context, it is particularly important to establish a common understanding of the challenges pension systems face, as well as a constructive dialogue and involvement of the relevant stakeholders, and an appropriate phasing in of the reforms.

The Eurogroup also approves these common principles as a reference point for reviewing national reform efforts to strengthen the sustainability of pension systems for euro area Member States. The Eurogroup thus invites the Commission to assess developments in this field within its usual surveillance processes, with a view to allowing periodic monitoring by the Eurogroup. The Eurogroup also invites its preparatory committees and the Commission to explore the development of appropriate benchmarks based on these common principles, and report back to the Eurogroup in the first half of 2017.

European Council meeting will take place on 28-29 June 2016 in Justus Lipsius building in Brussels. 

Now open for last-minute accreditation requests (online only)
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For more details on the European Council meeting, see the meeting page.

On 27 May 2016, the Council adopted Council Decision (CFSP) 2016/849[1] concerning restrictive measures against the Democratic People's Republic of Korea.

The Council Decision adopted additional restrictive measures against the Democratic People's Republic of Korea (DPRK) by prohibiting the supply, sale or transfer to the DPRK of further items, materials and equipment relating to dual-use goods and technology. In addition, it prohibits transfers of funds to and from DPRK unless specifically authorised in advance.

Furthermore, the Council Decision prohibits any aircraft operated by DPRK carriers or originating from DPRK from landing in, taking off from or overflying Member States' territory as well as any vessel that is owned, operated or crewed by DPRK from entering into Member States' ports. It introduces a prohibition on the import of luxury goods from DPRK, as well as prohibitions on all investment by the DPRK in the EU and the provision of financial support for trade with DPRK.

The Candidate Countries the former Yugoslav Republic of Macedonia*, Montenegro* and Serbia*, the country of the Stabilisation and Association Process and potential candidate Bosnia and Herzegovina, and the EFTA countries Iceland, Liechtenstein and Norway, members of the European Economic Area, as well as the Republic of Moldova and Armenia align themselves with this Council Decision.

They will ensure that their national policies conform to this Council Decision.

The European Union takes note of this commitment and welcomes it.

[1] Published on 28.5.2016 in the Official Journal of the European Union no. L 141, p. 79.

* - The former Yugoslav Republic of Macedonia, Montenegro and Serbia continue to be part of the Stabilisation and Association Process.

   

Good afternoon, I am delighted to be here in Helsinki. Let me start by thanking Prime Minister Juha Sipilä for his great hospitality.

We have just ended a good and fruitful meeting, the first part of our meeting, during which we discussed some of the most pressing issues for both Finland and Europe as a whole.

These are truly testing times for the European Union with many existential threats and challenges confronting us: the massive influx of refugees and migrants, terrorism, an aggressive Russian foreign policy, the continuing global economic challenges, and last but not least, the risk of “brexit”. The European Union is not and cannot be a fair-weather project. It is also made for rainy days, like here today, which we are demonstrating through our concerted efforts to tackle our common problems, one by one, together.

On the migration and refugee crisis we have managed to close the Western Balkan route, by starting to re-apply our common Schengen rules and by cooperating with Turkey. We have moved from almost 7.000 daily arrivals from Turkey to the Greek islands in October last year, to less than 50 per day in the last month. It shows that our strategy delivers. The June European Council will focus on how to return the economic migrants coming from Africa to Europe via the Central Mediterranean. Let me in this context recognise Finland as a front-runner in terms of relocating people. You have already fulfilled around a third of your national commitment and deserve credit for that. Likewise, other Member States need to step up and honour their commitments and follow Finland's example.

On Russia's violation of Ukraine's territorial integrity and sovereignty, we have stayed the course, keeping our unity despite systematic attempts to undermine it. Our principle political message has been heard throughout the neighbourhood and beyond. Sanctions on Russia continue to be linked to the complete implementation of the Minsk Agreements.

We are also working to broaden and deepen our security agenda with NATO. In the run-up to the NATO Warsaw summit, we are working to take our EU-NATO cooperation to a new level of ambition, in very practical ways. EU Member States and NATO Allies face the same challenges, and our responses need to be synchronised. I would like to thank Finland for being so forthcoming, even enthusiastic, in these discussions, including on stepped up action to tackle hybrid and cyber threats.

On the economic and financial crisis Europe has responded over the last years by supporting the efforts of the most affected countries to reform their economies. At the same time, institutional changes such as the banking union have made us more resilient. However we need to work harder to strengthen Europe's competitiveness and growth prospects and thank you for your support in this context . The Single Market, in particular the Digital Single Market, offer huge, still unexploited sources of durable growth. We need swift and determined progress on these issues. Therefore a strong message to this effect should be coming out of the June European Council. I know I have Juha's full support in this endeavour. I hope it will be effective.

And lastly on the question of the UK referendum. History has taught us that we were always defeated when divided. And that we always won when we stood united. Europe without the United Kingdom will be distinctly weaker. This is obvious. Equally obvious is that the UK outside the EU will be distinctly weaker too. Instead of seven years of political limbo and uncertainty in our relations, which will be the inevitable and direct result of “brexit”, we can have a fast and lasting less than one year implementation of the new settlement for the UK in the EU, negotiated by David Cameron. The UK has achieved a position of a key state in the EU, whose voice is respected. Today more than ever before. Many of the British ideas about the EU are gaining support all over Europe. There are so many things we can do together. Leaving now doesn't make any sense. Thank you.

The EU has agreed on a framework to stop the financing of armed groups through trade in conflict minerals, after negotiations between the Commission, Council and Parliament. It aims for EU companies to source tin, tantalum, tungsten and gold responsibly. These minerals are typically used in everyday products such as mobile phones, cars and jewellery.

"The EU is committed to preventing international trade in minerals from financing warlords, criminals and the human rights abusers", said Lilianne Ploumen, the Minister for Foreign Trade and Development Cooperation of the Netherlands, on behalf of the Council of the European Union. Along with the Chairman of the European Parliament's INTA Committee, Bernd Lange, INTA Rapporteur Iuliu Winkler, and the EU Trade Commissioner Cecilia Malmström, a political understanding was reached on a framework for an EU Regulation to stop profits from trading minerals being used to fund armed conflicts.

"This political understanding on conflict minerals will help trade to work for peace and prosperity, in communities and areas around the globe affected by armed conflict," said EU Trade Commissioner Cecilia Malmström. Chairman Lange agrees "we need to step up to our responsibilities and finally break the vicious cycle between the trade in minerals and the financing of conflict". The EU approach will build upon the OECD Due Diligence Guidance for responsible mineral sourcing.

"This framework paves the way for an effective and workable EU Regulation that will make a real impact on the ground", said Rapporteur Iuliu Winkler. The agreed framework carries clear obligations for the critical 'upstream' part of the conflict minerals supply chain, including smelters and refiners, to source responsibly. The vast majority of metals and minerals imported to the EU will be covered, while exempting small volume importers from these obligations.

In addition, the Commission will carry out a number of other measures - including the development of reporting tools - to further boost supply chain due diligence by large and smaller EU 'downstream' companies, i.e. those companies that use these metals and minerals as components in goods.

Today's political understanding sets the Regulation on track for technical work and final adoption in the coming months.

On 17 June 2016, the Council extended the restrictive measures in response to the illegal annexation of Crimea and Sevastopol by Russia until 23 June 2017.

The measures apply to EU persons and EU based companies. They are limited to the territory of Crimea and Sevastopol. The sanctions include prohibitions on:

• imports of products originating in Crimea or Sevastopol into the EU;
• investment in Crimea or Sevastopol, meaning that no Europeans nor EU-based companies can buy real estate or entities in Crimea, finance Crimean companies or supply related services; 
• tourism services in Crimea or Sevastopol, in particular, European cruise ships cannot call at ports in the Crimean peninsula, except in case of emergency;  
• exports of certain goods and technologies to Crimean companies or for use in Crimea in the transport, telecommunications and energy sectors and related to the prospection, exploration and production of oil, gas and mineral resources. Technical assistance, brokering, construction or engineering services related to infrastructure in these sectors must not be provided either.

As stated in the declaration by the High Representative for Foreign Affairs And Security Policy on behalf of the EU on 13 March 2016, the EU continues to condemn the illegal annexation of Crimea and Sevastopol by the Russian Federation and remains committed to fully implement its non-recognition policy.

Thursday 23 June
Justus Lipsius building - Brussels

12.45 Arrival of Palestinian President Mahmoud Abbas
Welcome by the President of the European Council Donald Tusk
(VIP entrance, level 02 - photo/TV opportunity)

+/- 13.15  Press statements
(VIP entrance, level 02 - photo/TV opportunity)

Access to the VIP entrance (level 02) for the photo opportunity and the press statements will be granted to all journalists holding a 6-month badge.

Journalists without the above badge must send a written request by mail - deadline Friday 17 June 2016, 17.00 - to press.centre@consilium.europa.eu, with a copy of their ID, press card (if available), or a signed letter from their media confirming their professional status and that they are assigned to cover this event.

Important: If you have never attended a summit organised by the Council, you must provide a signed letter from your media even if you hold a press card.

Original documents need to be produced when collecting the badge.

Photos and video coverage of the event will be available for preview and download on http://tvnewsroom.consilium.europa.eu
Livestream on http://video.consilium.europa.eu

On 15 June 2016, the Council's Permanent Representatives Committee endorsed the agreement reached with the European Parliament on 25 May on the new medical devices regulations. The Commission stated that it can also support the agreement reached between the two co-legislators. 

If the agreement is confirmed by the Parliament's ENVI committee the Council will approve the agreement at ministers' level. This is planned for September, once the draft regulations have been translated into all official languages. Following their legal-linguistic review the two draft regulations will be adopted by the Council and the Parliament, probably at the end of the year. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices. 

"The new EU rules have a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe, while allowing patients to benefit from innovative health care solutions in a timely manner. They also contribute to promote growth and create jobs in the EU by offering manufacturers the right legal framework to produce the devices that patients ask for", said Edith Schippers, Minister of Health of the Netherlands and President of the Council.

Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests. 

The new EU regulations: 

• strengthen the rules on placing devices on the market and reinforce surveillance once they are available; this will help toensure that medical devices and in vitro diagnostic medical devices are safe
• establish explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to act swiftly when concerns arise and help them to improve their devices continuously on the basis of actual data
• improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; this will allow fast and effective measures in case of safety problems
• set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions

 

 On Sunday morning we learned with deep sadness of the horrifying tragedy in Orlando, Florida that has claimed some 50 lives and has left indelible scars on so many more.  This was an attack on all Americans who share the values of equality and freedom; this was an attack on the very way of life which we treasure on both sides of the Atlantic. 

We express our deepest condolences to the families, friends and community of the victims as well as to the population of Orlando and all those further afield affected by this terrible event.

The United States and Europe have during the last months repeatedly been attacked. But each time we have stood up again and reached out to each other in solidarity, as true allies. In these challenging times we would like to assure you, Mr President, of the European Union's continued support, assistance and cooperation in combatting those who seek to challenge the common values we hold dear.

On 14 June 2016, the Council extended the mandate of the EU rule of law mission (EULEX) in Kosovo until 14 June 2018. The Council also approved a combined budget for the mission of EUR 63.6 million providing for the period 15 June 2016 - 14 December 2016 for its operations in Kosovo and until 14 June 2017 for the specialist chambers and the specialist prosecutor office. 

The budget approved will cover the expenditure of EULEX KOSOVO for the implementation of its mandate in Kosovo at a level of EUR 34.5 million. EUR 29.1 million will support the specialist chambers and the specialist prosecutor office. 

The central aim of the civilian mission EULEX Kosovo is to assist and support the Kosovo authorities in the rule of law area, specifically in the police, judiciary and customs areas. 

EULEX Kosovo was launched in 2008. The headquarters of the mission are located in Prishtinë/Priština, Kosovo.

Tuesday 21 June 2016
Justus Lipsius building - Brussels

10.00 
Arrival of the President of Israel Reuven Rivlin
Welcome by the President of the European Council Donald Tusk
(VIP entrance, level 02 - photo/TV opportunity)

+/-11.00 
Press Statements
(VIP entrance, level 02)

Access to the VIP entrance (level 02) for the photo opportunity and the press statement will be granted to all journalists holding a 6-month badge.

Journalists without the above badge must send a written request by mail - deadline Wednesday 15 June 2016, 17.00 - to press.centre@consilium.europa.eu, with an advance copy of their ID, press card (if available), or a signed letter from their media confirming their professional status and that they are assigned to cover this event.

Important: If you have never attended a summit organized by the Council, you must provide a signed letter from your media even if you hold a press card.

Original documents need to be produced when collecting the badge. 

Tuesday 14 June 2016
11.00 Meeting with UN Secretary-General Ban Ki-moon (photo opportunity)
13.00 Meeting with European Commission President Jean-Claude Juncker (Berlaymont)
17.00 Meeting with President of Central African Republic Faustin Touadera (photo opportunity)

Wednesday 15 June 2016
10.30 Meeting with Prime Minister of Timor Leste Rui Maria de Araújo (photo opportunity)
13.30 Meeting with President of Burkina Faso Roch Marc Kabore (photo opportunity)
14.15 Meeting with Prime Minister of Ethiopia Hailemariam Desalegn (photo opportunity)
16.45 Meeting with President of the World Bank Group Jim Yong Kim

Thursday 16 June 2016
Helsinki
12.00 Meeting with Prime Minister Juha Sipilä
13.00 Press conference
13.30 Working lunch
15.00 Meeting with President Sauli Niinistö

On 10 June 2016, the Council agreed its negotiating position on the proposal for a directive on control of the acquisition and possession of weapons, which reviews and completes existing directive 91/477/EEC. On the basis of this mandate, the presidency will start negotiations with the European Parliament as soon as the latter has adopted its position. 

Ard van Der Steur, Minister for Security and Justice of the Netherlands and President of the Council said: “After the tragic terrorist attacks in Paris and Brussels the Justice and Home Affairs Ministers asked for a swift adoption of the directive. With this new directive the Netherlands Presidency has achieved a just and fair balance between an internal market for allowed firearms on the one hand and enhancing the security of EU citizens on the other.” 

The revised directive aims at addressing certain weaknesses in the existing legislation that have been identified especially in the aftermath  of the  series of terrorists attacks that took place in Europe. The amendments which address risks for public safety and security focus on: 

• improved control of the traffic in firearms; 
• enhanced traceability of firearms; 
• measures on deactivation and reactivation or conversion of firearms; 
• stricter rules for the acquisition and possession of the most dangerous firearms; 
• banning civilian use of the most dangerous firearms; 
• improving the exchange of relevant information  between member states. 

The directive sets out minimum rules and does not prevent member states from adopting and applying stricter rules. 

 

Background  

Council directive 91/477/EEC on control of the acquisition and possession of weapons was originally designed as a measure to balance internal market objectives and security imperatives regarding "civil" firearms.  

The amending proposal was submitted by the European Commission on 18 November 2015 against the backdrop of a series of terrorist acts that took place in Europe and which brought to light  gaps in the implementation of the directive.  The current review is a continuation of the 2008 revision and also alignes EU legislation with the provisions on the UN Protocol against the Illicit Manufacturing of and Trafficking in Firearms. 

On 9 June, EU Justice ministers discussed further improvements to criminal justice in cyberspace. They adopted two sets of conclusions which set out practical measures to improve cooperation, as well as a timeline for further action. 

Minister van der Steur, from the Netherlands presidency, said : "Making progress in these areas will contribute to securing and obtaining e-evidence more effectively, which is of utmost importance to step up the fight against terrorism and other criminal activities in or through the use of cyberspace." 

Council conclusions on improving criminal justice in cyberspace

The conclusions on improving criminal justice in cyberspace set out concrete measures for future follow-up and action in three main areas of work: 

• streamlining mutual legal assistance (MLA) proceedings and, where applicable, mutual recognition related to cyberspace, through the use of standardised electronic forms and tools.

• improving cooperation with service providers, through the development of a common framework (e.g. use of aligned forms and tools) with them to request specific categories of data; and

• launching a reflection process on possible connecting factors for enforcement jurisdiction in cyberspace. 

While some of the measures identified in the conclusions could be implemented right away, others need further reflection and political guidance. For this reason, Ministers held a policy debate on two specific issues, namely: 

• the possible grounds for enforcement jurisdiction that could be applied in cyberspace, e.g. grounds on which the relevant authorities can undertake an investigative measure in cyberspace,  when existing frameworks are not enough, such as cases where relevant e-evidence is hidden or moves quickly between jurisdictions; and

• a differentiated treatment of specific categories of data in criminal proceedings - i.e. how a differentiated approach - between non-content (subscriber or traffic) and content data or between real time and stored data - would affect their national legal framework, what elements would be relevant for a common EU approach and what measures could be considered in this respect.

The Council requested the Commission to present deliverables on the three work streams by June 2017. 

Council conclusions on the European Judicial Cybercrime Network

The conclusions formalise and enhance the network of judicial authorities and experts in the field of cybercrime, supported by Eurojust. 

The objective of the network is to facilitate the exchange of expertise, best practices and other relevant knowledge and experience on the investigation and prosecution of cybercrime. 

 Background

Ministers expressed political support in December 2015, and at the informal meeting of the Ministers of 26 January 2016 in Amsterdam, to develop solutions enabling effective investigations in cyberspace. Following the terrorist attacks in Brussels on 22 March 2016, the Ministers of Justice and Home affairs jointly emphasised the need to address these issues as a matter of priority.

On 9 June 2016, 18 member states reached a general approach on two regulations aimed at determining the rules applicable to property regimes for married couples or registered partners in cross-border situations (i.e. couples of different EU nationalities and/or who own properties in a another EU member state).

The regulations aim to determine which court will have jurisdiction and which law will be applicable in matters of matrimonial property regimes and the property consequences of registered partnerships. They will also facilitate the recognition and enforcement of decisions in cross-border situations on these matters. They will establish clear rules on applicable law in case of divorce or death, bringing greater legal certainty and putting an end to parallel and possibly conflicting proceedings in various member states.

The eighteen member states participating in the enhanced cooperation are Belgium, Bulgaria, Cyprus, the Czech Republic, Germany, Greece, Spain, France, Croatia, Italia, Luxembourg, Malta, Netherlands, Austria, Portugal, Slovenia, Finland and Sweden. Other member states are free to join at any time after its adoption. In this respect, Estonia announced its intention to take part in the cooperation after its adoption. 

Dutch minister Van der Steur, on behalf of the Netherlands presidency, said : "The Netherlands Presidency is very pleased that the Council has made a lot of progress, very swiftly,  to overcome the deadlock in this file, by means of enhanced cooperation. Already 18 member states are on board. The Commission, European Parliament and Council have been working hard on this file during this semester and we hope that, after the adoption of the proposals, other member states will join the enhanced cooperation as well."

The regulations leave untouched the underlying institutions of marriages and partnerships, which remain matters that are defined by the national laws of the member states. They also include a series of safeguards in order to respect national legal systems. For example, nothing obliges participating member states whose law does not recognise the institution of registered partnership to provide for it, nor to assume jurisdiction for such partnerships.

The Council also adopted today, without discussion, the decision authorising the enhanced cooperation itself. In accordance with the rules on enhanced cooperation, all Member States took part in that vote.

The enhanced cooperation was proposed after the Council concluded, at its meeting of 3 December 2015, that it would not be possible, within a reasonable period of time, to reach an EU-wide unanimous agreement on the original Commission proposals on these matters presented in 2011.

Next steps

Following the adoption of this general approach, the European Parliament will give its opinion on the texts in the course of the month. Consequently, the regulations will be formally adopted by the 18 participating member states. This formal adoption is expected at the end of June 2016.

Background

In 2011, the European Commission estimated that there are about 16 million couples in the European Union who live in a cross border situation.

It gives me great pleasure to again welcome the President of Georgia, Giorgi Margvelashvili, here in Brussels. 

Overall we are seeing good progress in our bilateral relations. And the strong pro-European stance of the Georgian people is a solid base for Georgia's continued progress in implementing reforms and strengthening democracy and the rule of law.

I am pleased to note that the EU-Georgia Association Agreement will fully enter into force on the 1st of July, and I look forward to working together to reap maximum benefits from it.

We spoke about Georgia's parliamentary elections, due to take place in October. Recent reports about violence against opposition politicians and members of the parliament are of real concern to me. I welcome the fact that the perpetrators have now been charged. Obviously, all steps must now be taken to prevent such incidents in the future. Thank you Mister President for your very clear and tough assessment of these events. What I have heard is really promising.

These elections will be an important test to the strength and resilience of Georgia's democracy. It is our expectation that the Georgian authorities will make every effort to guarantee a respectful, inclusive, and orderly election environment. Free and pluralistic media is an essential precondition for that. I noted with satisfaction the planned involvement of election observers.

I also reiterated to the President the EU's support for Georgia's sovereignty and territorial integrity within its internationally recognised borders. I underlined our firm commitment to conflict resolution and the policy of non-recognition and engagement. The EU Special Representative and the EU Monitoring Mission underscore this commitment.

Finally, we touched upon Georgia's visa-free aspirations. As you know, last December the European Commission confirmed that Georgia had achieved all the required benchmarks for a positive final decision, which I trust will be forthcoming soon. The Commission's proposal to grant Georgian citizens visa-free travel to the Schengen area is currently being discussed by the Council and the European Parliament.