European Council

The greatness of a country is not determined by its area, the greatness of a country is not determined by its population. Today we speak of Slovakian greatness not by measuring it in square kilometres, nor based on demographic statistics, but by evaluating the results of your work, your determination, patience and wisdom.

You have demonstrated these attributes since the beginning of your indeed challenging history. You have built your independence with patience and wisdom, and with equally great determination you have built your position in Europe. You have shown everyone what it means to be proud. You asked no alms of anyone. You didn't want anything for free. You demanded only respect and understanding for your ambitions. Great, but justified ambitions. And today you quite rightly enjoy the respect and recognition of all of Europe, all of the international community.

You have also proved that despite difficult historical and political circumstances you are able to build good relations with all your neighbours. I appreciate this ability of yours not only as the President of the European Council, but also as a Pole. In tough times for Europe, your responsibility, resourcefulness and common sense can set an example for others.

That is why I am happy that it is Slovakia that for the first time takes up the EU presidency. From this moment on, a great responsibility lies with you, both for the daily management of Europe for the next six months as well as for the process of revitalisation of our community. It is Bratislava that in September will host the 27 European leaders who will be debating the future of post-Brexit Europe.

Looking at how much you have achieved over the past years, and how you are coping in this critical moment for Europe, I have to say that the EU couldn't wish for a better presidency.

(The speech was delivered in Slovak.)

Monday 4 July 2016
13.00 Meeting with President of Argentina Mauricio Macri (photo opportunity)

Tuesday 5 July 2016
Strasbourg
09.15 Report to the European Parliament on the European Council of 28 June and the informal meeting of 27 EU leaders on 29 June 2016

Friday 8 July 2016
Warsaw
EU-US leaders' meeting

EU-NATO cooperation event

NATO SUMMIT
14.30 Welcome by NATO Secretary-General Jens Stoltenberg and President of Poland Andrzej Duda
15.15 Family photo
20.30 Intervention at the North Atlantic Council working dinner hosted by President of Poland Andrzej Duda and chaired by NATO Secretary-General Jens Stoltenberg

Saturday 9 July 2016
Warsaw
NATO SUMMIT
09.00 Intervention at the summit meeting on Afghanistan
12.00 North Atlantic Council meeting

On 30 June 2016 the Council and the European Parliament reached a provisional agreement on a directive to reduce emissions of air pollutants. This so-called new NEC Directive sets stricter national limits from 2020 to 2029 and from 2030 onwards. 

"With this directive we will combat air pollution, a killer that annually causes over 400 000 premature deaths. The reduction of emissions of certain pollutants will ensure substantial health benefits. I am very pleased that after years of negotiations we were able to reach this agreement on the last day of the Dutch presidency, for all the people in Europe".

Sharon Dijksma, Dutch Minister for the Environment and president of the Council

The aim of this directive is to further address the health risks and environmental impact of air pollution. It is also meant to align EU law with international commitments (following the revision of the Gothenburg Protocol in 2012).

The new directive set national limits for the emissions of five pollutants: sulphur dioxide, nitrogen oxides, non-methane volatile organic compounds, ammonia and fine particulate matter.

The national emission limits for each pollutant from 2020 to 2029 are identical to those to which the member states are already committed  in the revised Gothenburg protocol. New stricter reductions from 2030 have now been agreed.

With the new commitments, the health impact of air pollution is estimated to be reduced by about 50% in 2030 (compared to 2005).

Indicative emission levels for 2025 will be identified for each member state.  They will be determined on the basis of  a linear trajectory towards the emission limits that will apply from 2030. However, member states will have the possibility to follow a non-linear trajectory if this is more efficient.

If member states deviate from the trajectory planned, they will need to give the reasons and explain the actions they intend to take  in order to get back on track.

Some flexibility to comply with the limits is foreseen, under certain circumstances. For instance, if one year a member state cannot fulfil its commitment due to an exceptionally cold winter or dry summer, this country will have the possibility to average out annual emissions with those of the preceding and subsequent year.

The Commission presented its proposal as part of the 'Air quality package' in December 2013. This file follows the ordinary legislative procedure. The European Parliament voted its position on the proposed directive in October 2015. The Council agreed on a general approach in December 2015. This directive needs qualified majority to be adopted by the Council.

In June 2016 a compromise text proposed by the presidency of the Council was supported by Coreper. On 30 June the text was in principle accepted by the European Parliament.

The European Parliament is expected to vote it in the autumn. Then the text will be submitted to the Council for final adoption at first reading.

On 30 June 2016 the Council and the European Parliament agreed on revised rules for the fishing of deep sea species in the EU and CECAF waters.

The agreed draft regulation aims to ensure the sustainable exploitation of deep sea stocks while reducing the environmental impact of these fisheries.

The agreement, successfully concluded under the Netherlands Presidency, comes after four years of intense political and technical work, and is still subject to the approval of the Council's Permanent Representatives Committee (Coreper) and the European Parliament's committee on fisheries (PECH).

"The agreement reached today on the protection of deep-sea habitats includes a general ban on deep sea fishing with bottom trawls from 800 meters depth and a system for the protection of vulnerable marine ecosystems in areas where fishing under certain conditions is still allowed. This deal therefore strikes a good balance between the need to protect deep-sea habitats and a responsible exploitation by fishermen", said Martijn van Dam, minister for agriculture of the Netherlands and president of the Council.

The EU deep sea fishing regime regulates which operators are allowed to target deep sea species and sets the conditions under which member states can issue fishing authorisations for deep sea fisheries.

The agreement on revised rules strikes an ambitious balance between the commercial exploitation of certain deep water fish populations and their sustainability.

It does this through the introduction of innovative tools to manage the stocks such as:

• a 800 meter depth limit below which it will not be possible to fish with bottom trawls
• the setting of a geographical footprint based on historical criteria by which vessels will only be able to fish in those areas where they have done so during the reference period
• special protection measures for vulnerable marine eco-systems which apply to operations with bottom gears below a depth of 400 m
• boosted control measures based on the system applied by the management plans
• additional targeted data collection obligations aimed at ensuring a better picture of deep-sea stocks. Among these, of particular importance is an observer coverage of 20% applicable to EU vessels fishing with bottom trawls and bottom set gillnets in both EU and NEAFC waters

The Coreper will be invited to endorse the agreement, while the European Parliament is expected to vote on the compromise text at a future meeting of its PECH committee. Further steps will then be the formal adoption of the Council's position at first reading, reflecting the political agreement, and Parliament's identical second reading position in autumn.

This should enable the entry into force of the new legislation by the end of 2016.

The Fishery Committee for the Eastern Central Atlantic (CECAF) is the competent organisation responsible for recommending fisheries management measures for the international waters of the Eastern Central Atlantic to its Contracting Parties.

The purpose of the Committee is to promote the sustainable utilisation of the living marine resources within its area of competence by the proper management and development of the fisheries and fishing operations.

The North East Atlantic Fisheries Commission (NEAFC) is the competent organisation responsible for recommending fisheries management measures for the international waters of the North East Atlantic to its contracting parties. The latter include Denmark (in respect of the Faroe Islands and Greenland), the European Union, Iceland, Norway, and the Russian Federation. The objective of NEAFC is to ensure the long-term conservation and optimum utilisation of the fishery resources in its convention area, providing sustainable economic, environmental and social benefits.

On 30 June 2016 the Permanent Representatives Committee approved, on behalf of the Council, an agreement with the European Parliament concerning goods that can be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment. 

The agreement will enable regulation 1236/2005 to be amended in the light of developments since it entered into force in 2006. It provides for amendments to the rules on export controls, new controls on brokering services and technical assistance, and a ban on advertising of certain goods. The aim is to prevent EU exports from contributing to human rights violations in third countries.

The new regulation amending regulation 1236/2005  is due to be approved by the Parliament in September, and will then be submitted to the Council for adoption. Political agreement with the Parliament was reached on 24 May 2016.

A ban on torture and ill-treatment is enshrined in United Nations conventions on human rights. At EU level, the Charter of Fundamental Rights prohibits capital punishment and provides that "no one shall be subjected to torture or to inhuman or degrading treatment or punishment". The EU also promotes respect for fundamental rights around the world. 

Regulation 1236/2005 bans the export and import of equipment/goods that can only be used for torture or capital punishment. Such goods are listed in annex II to the regulation. 

The regulation requires specific licences for exports of equipment/goods that could have such uses but which also have legitimate applications. Such goods are subject to a case-by-case assessment and are listed in annexes III and IIIA to the regulation. 

In December 2011, the regulation was amended to control the export of drugs that could be used in executions by lethal injection. 

The new regulation imposes a ban on the brokering of equipment that is subject to a ban and listed in annex II, so as to cover transfers of goods that are not located in the EU. It additionally bans the provision of brokering services by any broker who is aware that goods listed in annex III or IIIA may be used for torture or capital punishment. 

The draft also bans the supply of technical assistance (concerning goods listed in annex III or IIIA) by anyone who is aware that the equipment in question may be used for torture or capital punishment. 

It furthermore provides for an urgency procedure in case rapid amendment of the regulation's annexes is necessary when new goods enter the market. 

Under the agreement with the European Parliament, the agreed text: 

• introduces a prior authorisation regime for brokering services and technical assistance for annex III and IIIA goods, in place of the prohibition proposed by the Commission;
• prohibits the transit of goods listed in annex II and, if the transporter knows that the goods will be used for torture or capital punishment, for annex III and IIIA goods;
• prohibits the advertising and promotion at exhibitions and trade fairs of goods listed in annex II;
• establishes a coordination group, which will serve as a platform for member state experts and the Commission to exchange information on administrative practices. The group will also discuss questions of interpretation, developments and implementation of the regulation.

On 30 June 2016 the Permanent Representatives Committee approved, on behalf of the Council, an agreement with the European Parliament on institutions for occupational retirement provision (IORPs).

The draft directive is aimed at facilitating the development of IORPs and better protecting pension scheme members and beneficiaries.

The directive will improve the governance and transparency of IORPs and facilitate their cross-border activity. It revises directive 2003/41/EC on the activities and supervision of IORPs.

IORPs manage collective schemes for employers that provide retirement benefits for their employees. The revision of directive 2003/41/EC will reinforce their role as institutional investors and help channel long-term savings to growth-enhancing investments.

The directive has four objectives:

• clarifying cross-border activities of IORPs;
• ensuring good governance and risk management;
• providing clear and relevant information to members and beneficiaries;
• ensuring that supervisors have the necessary tools to effectively supervise IORPs.

Member states will have two years to transpose the directive into their national laws and regulations.

Provisional agreement with the European Parliament was reached on 15 June 2016. The directive is expected to be approved by the Parliament at first reading. It will then be submitted to the Council for adoption.

The fourth meeting of the Accession Conference with Montenegro at Deputy level was held today in Brussels to open two negotiating chapters: Chapter 12 - Food safety, veterinary and phytosanitary policy, and chapter 13 - Fisheries.

The European Union delegation was led by Ambassador Pieter de Gooijer, Permanent Representative of the Netherlands to the EU. The Montenegrin delegation was led by Ambassador Aleksandar Andrija Pejović, State Secretary for European Integration and Chief Negotiator for Negotiations on Accession of Montenegro to the European Union.

With today's conference, out of a total of 35 negotiating chapters, 24 chapters have now been opened for negotiations of which 2 chapters have already been provisionally closed.

The EU considered that some benchmarks were required to provisionally close both chapters. These include legislative amendments as well as the administrative capacity to implement and enforce the relevant acquis in the respective chapters.

For chapter 12, the benchmarks to be met are the following:

• Montenegro submits to the Commission an approved national programme for the upgrading of establishments for products of animal origin, including establishments for animal by-products. As regards the milk sector, the national programme should also include a strategy for the use of non-compliant raw milk.
• Montenegro provides to the Commission guarantees for the  establishment of an EU-compliant system for official controls of live animals and animal products, including its funding.
• Montenegro continues to set up and develop, in accordance with the acquis, the relevant administrative structures, in particular as regards food safety controls, and to further increase its administrative capacities and infrastructures. Montenegro demonstrates that it will have sufficient administrative capacity to correctly implement and apply all the acquis covered by this chapter upon accession.

 For chapter 13, the benchmarks to be met are the following:

• Montenegro adopts legislation that provides a substantial degree of alignment with the EU acquis for fisheries and ensures that Montenegro will be able to fully apply the Common Fisheries Policy upon accession.
• Montenegro substantially strengthens the administrative, inspection and control capacity required by the Common Fisheries Policy and ensures that EU requirements will be fully met at the date of accession, in particular as regards inspection and control.

The EU also underlined that it would devote particular attention to monitoring all specific issues mentioned in its common positions, with a view to ensuring Montenegro's administrative capacity and its   capacity to complete the legal alignment in the relevant areas.

Monitoring of progress in the alignment with and implementation of the acquis will continue throughout the negotiations. A final assessment of the conformity of Montenegro's legislation with the acquis and of its implementation capacity can be made only at a later stage of the negotiations. The Conference will have to return to these chapters at an appropriate moment.

                                                                       ***

The next Accession Conference is planned under the Slovak Presidency in order to take the process forward.

The twelfth meeting of the Accession Conference with Turkey at Ministerial level was held today in Brussels. The European Union delegation was headed by Bert Koenders, Minister of Foreign Affairs of Netherlands, on behalf of the Netherlands Presidency of the Council of the European Union. The European Commission was represented by Johannes Hahn, Commissioner for European Neighbourhood Policy and Enlargement Negotiations. The Turkish delegation was led by Ömer Çelik, Minister for EU Affairs and Chief Negotiator, accompanied by Mevlüt Çavuşoğlu, Minister of Foreign Affairs, and Naci Ağbal, Minister of Finance.

The Conference opened negotiations on Chapter 33 - Financial and budgetary provisions. This chapter covers the rules concerning the financial resources necessary for the funding of the EU budget ('own resources'). These resources are made up mainly from so-called traditional own resources from customs and agricultural duties and sugar levies, which are levied by the Member States on behalf of the EU; furthermore a resource based on value-added tax; and finally, a resource based on each Member State's gross national income. Member States must have appropriate administrative capacity to adequately co-ordinate and ensure the correct calculation, collection, payment and control of own resources. The acquis in this area is directly binding and does not require transposition into national law.

During the Conference, the EU extended condolences and reiterated its solidarity with Turkey following the terrorist attack in Istanbul last Tuesday, reaffirming its pledge to support fighting terrorism. The European Union also reiterated the importance it attaches to the close relations between the EU and Turkey, noting the close cooperation in a number of important areas of common interest, such as migration, counter-terrorism, energy, economy and trade. In line with the outcome of the EU-Turkey Leaders' meeting on 29 November 2015, and the EU-Turkey Statement of 18 March 2016, the EU welcomed a re-energizing of the accession process and confirmed its willingness to support Turkey in its reform efforts.  In this regard, the EU reiterated the need for swift reform efforts, particularly in the areas of rule of law and fundamental rights. In addition, the EU recalled that Turkey can accelerate the pace of negotiations by advancing in the fulfilment of benchmarks, by meeting the requirements of the Negotiating Framework, and by respecting its contractual obligations towards the EU.

Since the start of the accession negotiations on 3 October 2005, sixteen chapters have been opened, of which one has been provisionally closed.

For this chapter, the Union has closely examined Turkey's general state of preparedness. Taking into account Turkey's present state of preparations, and in line with the Council conclusions on 11 December 2006, 16 December 2014, 18 March 2016, other relevant Council conclusions and the Negotiating Framework, as confirmed by the European Council, the EU notes - as well as on the understanding that Turkey will continue to make progress in alignment with and implementation of the acquis - the EU communicated that the chapter may only be provisionally closed once agreement has been reached with regard to Turkey's request for “transitional financial corrective measures including compensation and assistance” as regards the EU Budget, and the main issues related to the closing benchmarks have been met by Turkey, including that:

• Turkey has fulfilled its obligations of full, non-discriminatory implementation of the Additional Protocol to the Association Agreement towards all Member States.
• Turkey increases its administrative capacity and coordination structure and to this end adopts an action plan in order to sufficiently prepare and introduce procedural rules to ensure that it will be able, from accession, to correctly calculate, forecast, account for, collect, pay, control and report to the EU on own resources in line with the acquis.

The EU also underlined that it would devote particular attention to monitoring all specific issues mentioned in its position with a view to ensuring Turkey's administrative capacity to ensure the correct calculation, forecast, collection, payment and control of own resources and reporting to the EU for implementation of the own resources rules.

On 1 July 2016, the Council prolonged the economic sanctions targeting specific sectors of the  Russian economy until 31 January 2017. 

These measures were introduced on 31 July 2014 initially for one year in response to Russia's actions destabilising the situation in Ukraine. They were reinforced in September 2014. They target  the financial, energy and defence sectors, and the area of dual-use goods. 

On 19 March 2015, the European Council agreed to link the duration of the sanctions to the complete implementation of the Minsk agreements, which was foreseen to take place by 31 December 2015.

Since the Minsk agreements were not fully implemented by 31 December 2015, the Council extended the sanctions until 31 July 2016. Having assessed the implementation of the Minsk agreements, the Council decided to renew the sanctions for a further six months, until 31 January 2017.

The economic sanctions prolonged with the decision notably: 

• limit access to EU primary and secondary capital markets for 5 major Russian majority state-owned financial institutions and their majority-owned subsidiaries established outside of the EU, as well as three major Russian energy and three defence companies;
• impose an export and import ban on trade in arms;
• establish an export ban for dual-use goods for military use or military end users in Russia;
• curtail Russian access to certain sensitive technologies and services  that can be used for oil production and exploration.

In addition to these economic sanctions, several EU measures are in place in response to the crisis in Ukraine including: 

• targeted individual restrictive measures, namely a visa ban and an asset freeze, currently against 146 people and 37 entities until 15 September 2016;
• restrictive measures in response to the illegal annexation of Crimea and Sevastopol, limited to the territory of Crimea and Sevastopol, currently in place until 23 June 2017.

The decision was adopted by written procedure and as it is the rule for all decisions on prolongation of restrictive measures, unanimously.

On 29 June 2016 the Council led by the Netherlands Presidency and the European Parliament reached a political agreement on a regulation amending the long-term plan for cod stocks from 2008, the so-called cod plan.

The agreed draft regulation discontinues the effort regime, recognising this is a main obstacle to introducing in full the landing obligation in the areas of the cod plan, and thereby granting more flexibility to fishermen. Furthermore in the agreed text the rules on allowable catch limits (TACs) are largely simplified, while the co-legislators await the Commission's proposal of a reform-based multiannual plan for the North Sea, which is expected to contain a chapter on specific targets and safeguards in this respect. Finally as regards the landing obligation, the Council and European Parliament underlined the importance of maintaining selectivity and discard reduction measures that were developed under the cod plan. Maintaining or further developing these measures should facilitate the phasing-in of the landing obligation in demersal fisheries which started in 2016.

The proposal for a new amended regulation establishing a long-term plan for cod stocks from 2008 was presented by the Commission in September 2012. The aim of the proposal was to amend the effort regime in the cod plan, modify the rules for setting TACs for data-poor stocks, and strengthen measures top address discards.

The European Parliament adopted a position at first reading on 11 June 2013 and a revised negotiating position on 7 June 2016 following the Court judgement on Joined Cases C 124/13 and C 125/13. On 22 June 2016 the Permanent Representatives Committee (Coreper) gave a revised mandate to the Presidency to enter into negotiations with the European Parliament.

The Coreper will be invited to endorse the agreement, while the European Parliament is expected to vote on the compromise text at a future meeting of its Fisheries committee (PECH), probably mid July. Further steps will then be the formal adoption of the Council's position at first reading, reflecting the political agreement, and Parliament's identical second reading position in autumn. The amendment is planned to be published in late autumn 2016, and to come into force at 1 January 2017.

The President of the European Council, Donald Tusk received the letters of credentials of the following Ambassadors:

H.E. Mrs Pema CHODEN, Ambassador, Head of the Mission of the Kingdom of Bhutan to the European Union
H.E. Mr Francisco TILMAN CEPEDA, Ambassador, Head of the Mission of the Democratic Republic of Timor-Leste to the European Union
H.E. Mr Mario Raúl VERÓN GUERRA, Ambassador, Head of the Mission of the Argentine Republic to the European Union

On 30 June, the Permanent Representatives Committee (Coreper) confirmed, on behalf of the Council, the agreement with the European Parliament on the directive on the right to legal aid for citizens suspected or accused of a criminal offence and for those subject to a European arrest warrant.  

The proposed directive lays down minimum rules concerning the right to legal aid for suspects or accused persons in criminal proceedings who are deprived of liberty, and in certain other situations. It also ensures that legal aid is made available in European arrest warrant proceedings, upon the arrest of the requested person in the executing State.

Minister van der Steur from the Netherlands presidency said : "I am very pleased that a political agreement has been reached during our Presidency. Furthermore, I want to thank the rapporteur, Mr De Jong, for the excellent cooperation which was instrumental in achieving this compromise. The directive will contribute to mutual trust between Member States. And I firmly belief that this trust will in turn lead to improved European cooperation in criminal cases."

The two institutions agreed on certain modifications to the proposal submitted by the Commission, so as to enhance the rights for citizens and make the text clearer, in particular with regards to: 

• the scope of application of the directive, which has been broadened to include a right to ordinary legal aid and not only to provisional legal aid. The ordinary legal aid includes  support at all stages of the criminal justice process, under the conditions set out in the directive, while the right to provisional legal aid was meant to cover only the initial stage of criminal proceedings before a final decision on legal aid is taken; 
• the inclusion of a means test and a merits test, which may be used to determine whether a person is eligible for legal aid. A "means test" aims at assessing whether the person effectively lacks sufficient resources to pay for legal assistance, while a "merits test" allows to assess whether the provision of legal aid would be in the interest of justice in the light of the circumstances of the case.  

The agreed text will now go through revision by lawyer-linguists before being finally adopted by the Council and Parliament towards the end of this year. 

The Directive includes a transposition delay of 30 months. 

The UK and Ireland decided not to "opt in" while Denmark has an “opt out” by default from justice and home affairs legislation. 

This directive is the last legal text foreseen as part the roadmap for strengthening procedural rights of suspected or accused persons in criminal proceedings adopted by the Council in November 2009. 

The objective of the roadmap was to ensure that any citizen involved in criminal proceedings in a Member State would benefit from certain minimum procedural rights across the European Union. This should also enhance mutual trust between judicial authorities in the European Union, and so encourage the application of instruments such as the European arrest warrant.  

Five other measures have already been adopted on the basis of the roadmap: 

•    the right to interpretation and translation (Directive 2010/64);
•    the right to information (Directive 2012/13);
•    the right of access to a lawyer (Directive 2013/48);
•    the presumption of innocence (Directive 2016/343); and
•    special safeguards for children (Directive (EU) 2016/800).

We, the Heads of State or Government of 27 Member States, as well as the Presidents of the European Council and the European Commission, deeply regret the outcome of the referendum in the UK but we respect the will expressed by a majority of the British people. Until the UK leaves the EU, EU law continues to apply to and within the UK, both when it comes to rights and obligations.

Good afternoon. Today 27 EU leaders discussed the consequences of the British referendum for Europe. It was a calm and serious discussion, as it is a serious moment in our common history. Certainly one issue is clear from our debate. Leaders are absolutely determined to remain united and work closely together as 27.

We reconfirmed that Britain's withdrawal from the European Union must be orderly and there will be no negotiations of any kind until the UK formally notifies its intention to withdraw. We hope to have the UK as a close partner in the future. It is up to the British government to notify the European Council of the UK intentions to withdraw from the EU. Leaders made it crystal clear today that access to the single market requires acceptance of all four freedoms, including the freedom of movement. There will be no single market "à la carte".

We also discussed the fact that too many people in Europe are unhappy with the current state of affairs and who expect us to do better. Many recalled that for decades Europe was bringing hope and that we have a responsibility to return to that.

As you know it was a first exchange of 27 leaders after the British referendum and so it would be too early to draw conclusions. This is why we have started a political reflection on the future of EU with 27 states and will meet on 16 September in Bratislava to continue talks. Thank you.

Before anything else, let me express my deepest condolences to the families and loved ones of the victims of tonight's attacks at Ataturk International Airport in Istanbul. In times like these we should all be united.  

As you can imagine this was very much a British European Council. And not only because of Brexit. Most of the other issues discussed were also "British".

Leaders took important decisions on the single market, the digital market, the capital markets union, on stemming irregular migration and on closer cooperation with NATO.

We agreed to step up work with African countries on returns of irregular migrants, and on measures that would stabilise the situation in Libya. EU- NATO co-operation was discussed in the presence of Jens Stoltenberg ahead of the Warsaw Summit and we agreed to enhance our relationship given unprecedented challenges from the South and East. We decided on steps to deepen the Single Market further, especially when it comes to the digital market. We will also continue to develop the capital markets union despite the recent turmoil.

Most importantly, Prime Minister Cameron outlined the results of Thursday's referendum. Respecting the will of the British people, we all recognized that a process of orderly exit was in everyone's, and especially, in the UK's interest. Prime Minister Cameron undertook that the decision to trigger Article 50 of the Treaty on European Union be taken by the new leadership in Britain. Our discussions were calm and measured. Leaders understand that some time is now needed to allow the dust to settle in the UK. But they also expect the intentions of the UK government to be specified as soon as possible. This was a very clear message which I believe Prime Minister Cameron will take back to London.

We also considered the post-Brexit economic situation in the presence of the European Central Bank President, who reassured us about the good and constant cooperation of central banks. However, it was also made clear that Brexit means substantially lower growth in the UK, with a possible negative spillover all over the world.

Finally, let me thank Prime Minister Rutte, who is finalising his presidency. Mark, thank you for your professional and hard work on migration and particularly on our deal with Turkey, but also for your key role in making the single market move forward. Talking about referendums and the Netherlands I would like to mention that the European Council also discussed the ratification of the DCFTA (Deep and Comprehensive Free Trade Area) for Ukraine. Leaders agreed to do their best to find a legally-binding solution that would allow Prime Minister Rutte to proceed with this ratification.

Tomorrow we will launch a discussion, in fact, a reflection process to give an impulse on the future of the EU. It will be our first informal meeting without the UK, among the 27 States. Thank you.

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

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

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

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

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

THE COUNCIL OF THE EUROPEAN UNION:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

All times are approximate and subject to change 

+/- 08.30
Arrivals (live streaming) 

+/- 09.25
Doorstep by Minister Dijksma

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

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

+/- 11.50
Paris agreement (public session) 

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

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

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

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

+/- 16.55
Any other business 

+/- 18.00
Press conference (live streaming)

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

All times are approximate and subject to change

from 08.00
Arrivals (live streaming)

+/- 09.20
Doorstep by High Representative Mogherini

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

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

+/- 13.00
Working lunch on Middle East Peace Process 

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

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

17.30
Beginning of the meeting (roundtable)

(tbc) 19.30
Press conference (live streaming)

"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.