               EUROPEAN COMMISSION
            Brussels, 2.6.2021
            COM(2021) 502 final
            Recommendation for a
            COUNCIL RECOMMENDATION
            delivering a Council opinion on the 2021 Convergence Programme of Bulgaria
            {SWD(2021) 501}

               Recommendation for a

               COUNCIL RECOMMENDATION

               delivering a Council opinion on the 2021 Convergence Programme of Bulgaria

               THE COUNCIL OF THE EUROPEAN UNION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies
                  1
               , and in particular 9(2) thereof,

               Having regard to the Recommendation of the European Commission,

               Having regard to the resolutions of the European Parliament,

               After consulting the Economic and Financial Committee,

               Whereas:

               (1)On 20 March 2020, the Commission adopted a Communication on the activation of the general escape clause
                  2
                of the Stability and Growth Pact.
                  3
                In its Communication, the Commission set out its view that, given the expected severe economic downturn resulting from the COVID-19 outbreak, the conditions to activate the general escape clause were met. On 23 March 2020, the Ministers of Finance of the Member States agreed with the assessment of the Commission. The general escape clause has granted Member States budgetary flexibility to deal with the crisis. It has facilitated the coordination of budgetary policies in times of severe economic downturn. Its activation allows for a temporary departure from the adjustment path towards the medium-term budgetary objective of each Member State, provided this does not endanger fiscal sustainability in the medium term. On 17 September 2020, in its Annual Sustainable Growth Strategy, the Commission announced that the general escape clause would remain active in 2021.
                  4

               (2)On 20 July 2020, the Council recommended Bulgaria
                  5
                to take all necessary measures, in line with the general escape clause, to effectively address the pandemic, sustain the economy and support the ensuing recovery. It also recommended Bulgaria to pursue, when economic conditions allow, fiscal policies aimed at achieving prudent medium-term fiscal positions and ensuring debt sustainability, while enhancing investment.

               (3)Next Generation EU, including the Recovery and Resilience Facility, will ensure a sustainable, inclusive and fair recovery. Regulation (EU) 2021/241 establishing the Recovery and Resilience Facility
                  6
                came into force on 19 February 2021. This Facility will provide financial support for the implementation of reforms and investment, entailing a fiscal impulse financed by the EU. It will contribute to the economic recovery, to the implementation of sustainable and growth-enhancing reforms and investment, notably to promote the green and digital transitions, and it will strengthen the economies’ resilience and potential growth. In turn, it will also help public finances to return to more favourable positions in the near term and will contribute to strengthening sustainable public finances, growth and job creation in the medium and long term.

               (4)On 3 March 2021, the Commission adopted a Communication providing further policy orientations to facilitate the coordination of fiscal policies and the preparation of Member States’ Stability and Convergence Programmes.
                  7
                The overall fiscal stance, taking into account national budgets and the Recovery and Resilience Facility, should remain supportive in 2021 and 2022. At the same time, given the expectation of economic activity gradually normalising in the second half of 2021, Member States’ fiscal policies should become more differentiated in 2022. Member States’ fiscal policies should take into account the state of the recovery, fiscal sustainability and the need to reduce economic, social and territorial divergences. In view of the need to support a sustainable recovery for the EU, Member States with low sustainability risks should gear their budgets towards maintaining a supportive fiscal policy in 2022, taking into account the impact of the Recovery and Resilience Facility. Member States with high debt levels should pursue prudent fiscal policies, while preserving nationally financed investment and making use of grants under the Recovery and Resilience Facility to fund additional high-quality investment projects and structural reforms. For the period beyond 2022, fiscal policies should continue to take into account the strength of the recovery, the degree of economic uncertainty and fiscal sustainability considerations. A refocusing of fiscal policies towards achieving prudent medium-term fiscal positions, including by phasing out support measures in due course, will contribute to ensuring fiscal sustainability in the medium term.

               (5)The Communication of 3 March 2021 also announced the Commission’s view that the decision on the deactivation or continued application of the general escape clause should be taken as an overall assessment of the state of the economy, with the level of economic activity in the EU or euro area compared to pre-crisis levels (end-2019) as key quantitative criterion. On the basis of the Commission’s 2021 spring forecast, on 2 June the Commission considered that the conditions to continue to apply the general escape clause in 2022 and to deactivate it as of 2023 were met. Country-specific situations will continue to be taken into account after the deactivation of the general escape clause.
                  8

               (6)On 5 May 2021, Bulgaria submitted its 2021 Convergence Programme, beyond the deadline established in Article 8 of Regulation (EC) No 1466/97.

               (7)In 2020, based on data validated by Eurostat, Bulgaria’s general government deficit was 3.4% of GDP, while general government debt increased to 25% of GDP. The annual change in the primary budget balance amounted to -5.5% of GDP, including discretionary budgetary measures of 3.2% of GDP in support of the economy and the operation of automatic stabilisers.

               On 2 June 2021, the Commission issued a report under Article 126(3) TFEU. This report discusses the budgetary situation of Bulgaria, as its general government deficit in 2020 exceeded the 3% of GDP Treaty reference value. The report concluded that the deficit criterion was fulfilled.

               (8)The macroeconomic scenario underpinning the budgetary projections is cautious in 2021 and 2022, since it does not take into account funding under the Recovery and Resilience Facility. Consequently, the presented baseline is not directly comparable with the Commission forecast. Moreover, the Commission forecast expects a stronger growth rate in exports, based on more favourable assumptions for foreign demand.

               (9)In its 2021 Convergence Programme, the government plans an increase of the general government deficit from 3.4% of GDP in 2020 to 5.6% of GDP in 2021, while the debt ratio is planned to increase to 27.4% of GDP in 2021. According to the programme, the change in the primary budget balance in 2021 compared with the pre-crisis level (2019) is set to amount to -7.8% of GDP. The drivers of the projected increases in the nominal and primary general government deficit and consequently debt are not explained in detail in the Convergence Programme and occur despite the expiration of some of the discretionary budgetary measures. These projections are above the Commission’s 2021 spring forecast. According to the Commission’s 2021 spring forecast, the deficit is expected to decrease to 3.2% of GDP in 2021 and the debt ratio is expected to decrease to 24.5% of GDP in 2021. The main source of difference is the projection of other revenue, which according to the Convergence Programme is expected to decrease by 2.5 percentage points of GDP in 2021, well below historical levels. The drivers of this reduction are not explained in the Convergence Programme.

               (10)In response to the COVID-19 pandemic and related economic downturn, Bulgaria has adopted budgetary measures to strengthen the capacity of its health system, contain the pandemic and provide relief to those individuals and sectors that have been particularly affected. This forceful policy response has cushioned the contraction in GDP, which, in turn, curtailed the increase in government deficit and public debt. Fiscal measures should maximise support to the recovery without pre-empting future fiscal trajectories. Therefore, measures should avoid creating a permanent burden on public finances. When Member States introduce permanent measures, they should properly fund them to ensure budgetary neutrality in the medium term. The measures taken by Bulgaria in 2020 and 2021 have been in line with the Council Recommendation of 20 July 2020. The discretionary measures adopted by the government in 2020 and 2021 are temporary or matched by offsetting measures.

               (11)The 2021 Convergence Programme assumes investment and reforms financed by grants under the Recovery and Resilience Facility amounting to 0.02% of GDP in 2020, 0.3% in 2021, 0.8% in 2022, 1.4% in 2023, 1.7% in 2024, 2.6% in 2025 and 1.8% in 2026. The Commission’s spring forecast includes these grants in its budgetary projections.

               (12)The established indicators of fiscal adjustment set out in Regulation (EC) No 1466/97 need to be considered in the context of the current circumstances. First, there is significant uncertainty surrounding output gap estimates. Second, there is a need for fiscal policy to stand ready to rapidly adapt to the evolution of the pandemic, shifting from emergency relief to more targeted measures once health risks diminish. Third, the current context is characterised by a significant policy response to support economic activity. In the presence of sizeable transfers from the EU budget (such as those from the Recovery and Resilience Facility), the established indicators do not capture the full impulse provided by fiscal policies to the economy. Against this background, the structural balance does not appear adequate in the current circumstances. The expenditure benchmark, in turn, needs to be adapted
                  9
                and complemented with additional information in order to fully gauge the fiscal policy orientation.

               First, and similarly to the approach pursed in the assessment of the 2021 Draft Budgetary Plans, temporary emergency measures have been excluded from the expenditure aggregate. These crisis-related temporary emergency measures support health systems and compensate workers and firms for the losses in income due to lockdowns and supply chain disruptions; their reversal by the public authorities is contingent on the return of the public health and economic situation to normality.

               Second, to assess the overall fiscal stance at the current juncture, the sizeable transfers from the EU budget (such as those from the Recovery and Resilience Facility) should be included in the relevant expenditure aggregate.

               Therefore, the fiscal stance is then measured by the change in primary expenditure (net of discretionary revenue measures and excluding crisis-related temporary emergency measures) including expenditure financed by grants under the Recovery and Resilience Facility and other EU funds.

               Going beyond the overall fiscal stance, the analysis also aims at assessing whether national fiscal policy is prudent and its composition is conducive to a sustainable recovery consistent with the green and digital transitions. For that reason, particular attention is paid to the evolution of nationally financed primary current expenditure and investment.

               (13)In its 2021 Convergence Programme, Bulgaria’s general government deficit is planned to decrease to 2.7% of GDP in 2022, mainly due to a discontinuation of the temporary support measures adopted in 2020 and 2021. The general government debt ratio is planned to increase to 28.6% of GDP in 2022. The projections are above the Commission’s 2021 spring forecast.

               Based on the Commission’s forecast, the overall fiscal stance as defined above  – also including the impact on aggregate demand in 2022 from investment financed by both the national and the EU budgets, notably the Recovery and Resilience Facility – is estimated at -1.4% of GDP
                  10
               . The positive contribution of expenditure financed by Recovery and Resilience Facility grants and other EU funds is projected to increase by 0.8 percentage points of GDP. Nationally financed investment is projected to provide a contractionary contribution of 0.4 percentage points of GDP.
                  11
                Nationally financed primary current expenditure (net of discretionary revenue measures) is projected to provide an expansionary contribution of 1 percentage point of GDP.

               (14)The quality of Member States’ budgetary measures appear particularly important. Fiscal structural reforms aimed at improving the composition of national budgets can support potential growth, create much-needed fiscal space and help ensuring fiscal sustainability over the longer term, including in view of climate change and health challenges. On the revenue side, the COVID-19 crisis has reinforced the importance of reforms for more efficient and fairer public revenue systems. On the expenditure side, it has made even more crucial to increase the level and quality of sustainable and growth-enhancing investments, consistent with serving the objectives of enhancing growth potential, economic and social resilience, and the green and digital twin transition. The Recovery and Resilience Plans will allow to improve the composition of national budgets.

               (15)According to the programme’s medium-term budgetary plans, the general government deficit is planned to increase to 3.1% of GDP in 2023. No information on 2024 is provided in the Convergence Programme.

               Based on the programme, the overall fiscal stance as defined above – also including the impact on aggregate demand from investment financed by both the national and the EU budgets, notably the Recovery and Resilience Facility – is estimated at -0.6% of GDP in 2023. The positive contribution of expenditure financed by Recovery and Resilience Facility grants and other EU funds is projected to increase by 0.6 percentage points of GDP in 2023. Nationally financed investment is projected to provide an expansionary contribution of 0.4 percentage points of GDP in 2023.
                  12
                Nationally financed primary current expenditure (net of discretionary revenue measures) is projected to provide a contractionary contribution of 0.4 percentage points of GDP.

               The current estimate of the 10-year average nominal potential growth is 5%.
                  13
                However, this estimate does not include the impact of the reforms that are part of the Recovery and Resilience Plan and can boost Bulgaria’s potential growth.

               (16)The general government debt ratio is planned to increase to 29.3% of GDP in 2023. There is no information on 2024 in Bulgaria’s Convergence Programme. Bulgaria is considered to face low fiscal sustainability risks over the medium term, as per the latest debt sustainability analysis.
                  14

               (17)In view of the currently still exceptionally high degree of uncertainty, the fiscal policy guidance should remain predominantly qualitative. More precise quantified guidance for the later years should be provided in 2022, if the degree of uncertainty has sufficiently declined by then.

               The Council has assessed the 2021 Convergence Programme and the follow-up by the Bulgaria to the Council Recommendation of 20 July 2020.

               HEREBY RECOMMENDS BULGARIA TO:

               1.In 2022, pursue a supportive fiscal stance, including the impulse provided by the Recovery and Resilience Facility, and preserve nationally financed investment. Keep the growth of nationally financed current expenditure under control.

               2.When economic conditions allow, pursue a fiscal policy aimed at achieving prudent medium-term fiscal positions and ensuring fiscal sustainability in the medium term. At the same time, enhance investment to boost growth potential.

               3.Pay particular attention to the composition of public finances, both on the revenue and expenditure sides of the budget, and to the quality of budgetary measures, to ensure a sustainable and inclusive recovery. Prioritise sustainable and growth-enhancing investment, notably supporting the green and digital transition. Give priority to fiscal structural reforms that will help provide financing for public policy priorities and contribute to the long-term sustainability of public finances, including by strengthening the coverage, adequacy, and sustainability of health and social protection systems for all.

               Done at Brussels, 2.6.2021

                     For the Council

                     The President

                     (1)

                        OJ L 209, 2.8.1997, p. 1.

                     (2)

                        The clause, as set out in Articles 5(1), 6(3), 9(1) and 10(3) of Regulation (EC) 1466/97 and Articles 3(5) and 5(2) of Regulation (EC) 1467/97, facilitates the coordination of budgetary policies in times of severe economic downturn.

                     (3)

                        Communication from the Commission to the Council on the activation of the general escape clause of   the Stability and Growth Pact, Brussels, 20.3.2020, COM(2020) 123 final.

                     (4)

                        Communication from the Commission on Annual Sustainable Growth Strategy 2021, Brussels, 17.9.2020, COM(2020) 575 final.

                     (5)

                        Council Recommendation of 20 July 2020 on the National Reform Programme of Bulgaria and delivering a Council opinion on the 2020 Convergence Programme of Bulgaria, OJ C 282, 26.8.2020, p. 8.

                     (6)

                  OJ
                   L57, 18.2.2021, p.17.

                     (7)

                        Communication from the Commission to the Council on one year since the outbreak of COVID-19: fiscal policy response, Brussels, 3.3.2021, COM(2021) 105 final.

                     (8)

                        Communication from the Commission on Economic policy coordination in 2021: overcoming COVID-19, supporting the recovery and modernising our economy, Brussels, 2.6.2021, COM(2021)500 final.

                     (9)

                        In particular, the 4-year smoothing of investment used in the expenditure benchmark does not allow assessing properly the fiscal support to the recovery provided by nationally financed investments.

                     (10)

                        A negative sign of the indicator corresponds to an excess of the primary expenditure growth compared with medium-term economic growth, which indicates an expansionary fiscal policy.

                     (11)

                        Other nationally financed capital expenditure is projected to provide a contractionary contribution of 0.1 percentage points of GDP.

                     (12)

                        Other nationally financed capital expenditure is projected to provide an expansionary contribution of 0.1 percentage points of GDP.

                     (13)

                        Estimated by the Commission, following the commonly agreed methodology.

                     (14)

                        See Commission Staff Working Document – Statistical Annex providing background data relevant for the assessment of the 2021 Stability and Convergence Programmes.


               EUROPEAN COMMISSION
            Brussels, 8.7.2021
            COM(2021) 374 final
            Recommendation for a
            COUNCIL DECISION
            authorising the opening of negotiations to amend the International Coffee Agreement 2007

               EXPLANATORY MEMORANDUM

               The present recommendation concerns a Decision authorising the Commission to engage on behalf of the Union in the negotiations to partially review the International Coffee Agreement 2007 (ICA) that the International Coffee Council (ICC) decided to launch.

               1.CONTEXT OF THE RECOMMENDATION

               •The International Coffee Agreement 2007

                  The European Union is a Contracting Party to the ICA.

                  The International Coffee Agreement 2007 (ICA or ‘the Agreement’) aims to ensure enhanced international cooperation in connection with world coffee matters and related issues, provide a forum for intergovernmental consultations on coffee and on ways to improve the world coffee economy, to facilitate trade by collecting and providing information on the world coffee market and to encourage increased demand for coffee globally. A core objective of the Agreement is to encourage Contracting Parties to develop a sustainable coffee sector in economic, social and environmental terms.

                  The Agreement was signed in 2007 and entered into force on 2 February 2011 for a period of ten years; then extended for one year (until 1 February 2022). If necessary, the Agreement can be extended for a maximum of eight years.

               •The International Coffee Organization and the International Coffee Council

                  Article 6 of the ICA states that the International Coffee Organization (ICO or ‘the Organization’), established under the International Coffee Agreement 1962, administers the provisions and supervises the operation of the Agreement.

                  As per Article 9 of the ICA, the International Coffee Council (ICC or ‘the Council’) is the responsible body for the performance of all functions necessary to carry out the provisions of the Agreement, as the highest authority of the Organization. The Council consists of all the Members of the Organization (Article 8 of the ICA).

                  Pursuant to Article 49 of the ICA, the ICC may propose amendments to the Agreement and communicate them to all Contracting Parties. Article 14 of the ICA stipulates that all decisions of the ICC, including amendments to the Agreement shall be taken in principle by consensus. If consensus cannot be reached, the ICC shall take decisions and make recommendations by a distributed majority vote of 70% or more of exporting Members present and voting, and 70% or more of importing Members, present and voting, counted separately.

                  According to Article 12 of the ICA, Members of the ICC hold 2000 votes in total. Each Member of the ICC holds a specified number of votes, which is annually adjusted by the Council following criteria defined by the ICA. The distribution of votes also determines a Member’s contribution (Article 20(2) of the ICA). Currently, the Union is the largest contributor to the ICO.

               •The review of the International Coffee Agreement

               A partial review to reform the ICA is necessary and is clearly in the interest of the Union to further align it with the practices the Union fosters in other international commodity boards, and to take developments in the global coffee market since 2007 into consideration. This has been regularly outlined during the last ICC sessions in 2019-2020 .

               In 2019, at the request of the ICC, the ICO established a Working Group on the revision of the ICA.

               The main changes to be proposed in a revision of the ICA concern the governance of the Organization, a possible review of the voting and contribution system and the participation of the private sector and civil society in the work of the Organization.

               The overall objectives of the Agreement, as outlined in Article 1 of the ICA, are not intended to change.

                  The Commission guidelines to recommended changes are set out in the Annex.

               2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

               •Legal basis

               Article 218(3) of the Treaty on the Functioning of the European Union (TFEU) provides for authorising the opening of negotiations and, depending on the subject of the agreement envisaged, nominating the Union negotiator or the head of the Union's negotiating team.

               Article 218(4) TFEU provides for the Council to address directives to the negotiator and designate a special committee in consultation with which the negotiations must be conducted.

               The envisaged negotiating directives should give the negotiator on behalf of the Union the means to achieve the overall objectives as set out under the point 1. They are outlined in the Annex.

                  Therefore, the procedural legal basis for the proposed recommendation is Article 218(3) and 218(4) TFEU.

               •Subsidiarity (for non-exclusive competence)

               The Union is a Contracting Party to the ICA and is represented by the Commission in the ICC. EU Member States are not separate Contracting Parties to the ICA. The Union's negotiation of the partial review of the ICA pertains to the exclusive competence of the Union.

               •Proportionality

               Reviewing the ICA in order to achieve an improved treaty leading to the modernisation of the Agreement is in the interest of the Union. Currently, the EU's participation in the ICO is beneficial both to the Union and to other ICO Members. Modernising the Agreement is expected to attract more interest in the ICO, potentially attracting new Members as well as increasing the relevance of its work.

               3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

               •Stakeholder consultations

                  The Union is a Contracting Party to the ICA and its membership is generally supported since 2007 by the coffee sector in the EU as well as by most EU Member States. It is not deemed necessary to engage in stakeholder consultations regarding a process, which merely aims to continue the Union's membership of the ICO, albeit under a set of rules that are in line with those of other international commodity bodies of which the EU is a member.

               •Impact assessment

                  A full-fledged impact assessment is not necessary, since the measure is not likely to have significant economic, environmental or social impacts. The successful amendment of the ICA would result in a reformed governance considered as a key starting point for the modernisation of the ICA and should also result in a more active participation in the ICO by its Members.

               4.BUDGETARY IMPLICATIONS

                  The opening of negotiations is not deemed to have a budgetary impact.

               Recommendation for a

               COUNCIL DECISION

               authorising the opening of negotiations to amend the International Coffee Agreement 2007

               THE COUNCIL OF THE EUROPEAN UNION,

               Having regard to the Treaty on the Functioning of the European Union, and in particular Article 218(3) and (4) thereof,

               Having regard to the recommendation from the European Commission,

               Whereas:

               (1)The Union is a Contracting Party to the International Coffee Agreement 2007 (‘the Agreement’) and a member of the International Coffee Organization (‘ICO’). The Agreement was concluded by the Union by Council Decision 2008/579/EC
                  1
                and it entered into force on 2 February 2011.

               (2)Pursuant to Article 9 of the Agreement, the International Coffee Council (‘ICC’) is the responsible body for the performance of all functions necessary to carry out the provisions of the Agreement, as the highest authority of the ICO.

               (3)Pursuant to Article 49 of the Agreement, the ICC may propose an amendment to the Agreement to be decided by the Members. Article 14 of the Agreement stipulates that all decisions of the ICC, in principle, are to be taken by consensus. In the absence of consensus, the ICC shall take decisions by a distributed majority vote of 70% or more of exporting Members present and voting, and 70% or more of importing Members, present and voting, counted separately.

               (4)At the request of the ICC, a Working Group on the revision of the Agreement has been established. This Working Group identified the governance of the ICO, the voting and contribution system and the participation of the private sector and civil society in the work of the ICO as the three main issues for partial review of the Agreement. In this respect, the Working group is drafting proposals of amendments of the Agreement subject to approval of the ICC.

               (5)It is in the interest of the Union to reform the Agreement in order to align it with the practices the Union fosters in other international commodity boards, as well as with developments in the global coffee market since 2007.

               (6)It is therefore appropriate that the Commission be authorised to engage in negotiations for the partial review of the Agreement.

               HAS ADOPTED THIS DECISION:

               Article 1

               The Commission is hereby authorised to negotiate, on behalf of the Union, amendments to the International Coffee Agreement 2007.

               Article 2

               The negotiating directives are set out in the Annex.

               Article 3

               The negotiations shall be conducted in consultation with the Working Party on Commodities.

               Article 4

               This Decision is addressed to the Commission.

               Done at Brussels,

                     For the Council

                     The President

                     (1)

                        Council Decision 2008/579/EC of 16 June 2008 on the signing and conclusion on behalf of the European Community of the International Coffee Agreement 2007 (OJ L 186, 15.7.2008, p. 12).

    ---documentbreak---

               EUROPEAN COMMISSION
            Brussels, 8.7.2021
            COM(2021) 374 final
            ANNEX
            to the
            Recommendation for a Council Decision
            authorising the opening of negotiations to amend the International Coffee Agreement 2007

               ANNEX

               Negotiating directives on the International Coffee Agreement 2007

               The Commission may enter into negotiations with the other Contracting Parties to the International Coffee Agreement 2007 (‘the Agreement’) within the International Coffee Organization (‘ICO’) with a view to modernising the Agreement, taking into account the evolution in the coffee sector.

               The review of the Agreement should improve the ICO governance, assess the balance of the voting and the contribution systems and address the integration of the private sector and civil society into the work of the ICO.

               The Union is a member of the ICO Working Group for the Future of the Agreement (‘WGFA’), which is currently working on recommendations for changes to be introduced into the ICA 2007 and which will follow the objectives put forward by Union Member States in International Commodity Bodies (‘ICBs’).

               The negotiating directives should take into account the objectives of simplification and streamlining of the agreement while maintaining the intergovernmental role of ICO for which ICO Members have pledged.

               1.Governance

               International Coffee Council (ICC)

               As regards the periodicity of ICC meetings, the current system of two meetings a year should be maintained. One of the meetings could be a virtual one.

               The ICC Chair and Vice-Chair should have a one-year mandate to facilitate the participation of all ICO members to decision process. The Vice-Chair could have a reinforced role in the ICC. To benefit from the experience gained, the Vice-Chair may express to the Council his/her interest to become Chair after the first year. The Council may express its acceptance if the Vice-Chair has proven to be suitable.

               ICO Committees

               If relevant in their work, the merging of ICO committees should be encouraged as a part of the streamlining of the ICO. A larger participation of the Members in the committee work should be encouraged.

               World Coffee Conference (‘WCC’)

               The current periodicity of a high-level WCC every four or five years should be kept, but with flexibility to adapt to specific circumstances or a particular situation (e.g. change in the coffee market situation, external event having an effect on the coffee sector, etc.)

               2.Votes and contributions

               Exporting and importing members

               The division between exporting and importing members should be retained as a relevant basic principle for the decision process in many ICBs.

               Method of calculation for votes and contribution

               The current arrangement based on exported or imported coffee volumes seems to constitute the easiest and the most reliable system for calculating the voting rights and the financial contributions of each Member to the Administrative Budget of the ICO. However, the relevance of other systems (e.g. value of exports/ imports, mixed systems, etc.) used in other ICBs could be explored with indications of the consequences of their use for the ICO.

               3.Participation of private sector and civil society

               The private sector and civil society should be better integrated in the working process within the ICO. Different formulas should be explored to find the best way to make them participate more closely in the context of a modernised agreement.

               As regards the eligibility of the private sector, the Agreement should recognise its diversity, from small producers to large multinational company, and their respective potential roles within the ICO.

               It would be preferable to foster the participation of trade/professional associations, but if the participation of individual corporations to the ICO was proposed, specific legal safeguards should be explored to ensure the independence of the ICO.

               The approval process for participation of the private sector and civil society in the case of national companies or organisations should go through the ICO Member concerned.

               Any move for better integrating the private sector should nevertheless preserve the intergovernmental character of the ICO.


               EUROPEAN COMMISSION
            Brussels, 1.12.2021
            COM(2021) 766 final/2

            DOWNGRADED on 6.12.2021
            Recommendation for a
            COUNCIL DECISION
            authorising the opening of negotiations on behalf of the European Union for the conclusion of an international agreement on pandemic preparedness and response as well as for the negotiations of complementary amendments to the International Health Regulations (2005)

               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE RECOMMENDATION

               •Reasons for and objectives of the recommendation

                  Multilateral cooperation is essential to fighting pandemics that by definition know no borders and require collective action. The COVID-19 pandemic has however brought to light the persistent vulnerabilities of the international health system and of global cooperation.

                  Before the COVID-19 pandemic, the reviews and evaluations following the Severe Acute Respiratory Syndrome (SARS-CoV), the H1N1 influenza pandemics and the Ebola outbreak in West Africa had already highlighted shortcomings in the global capacity to prepare for and respond to outbreaks, and have made numerous and specific recommendations to address these shortcomings. To some extent, those recommendations have resulted in important improvements, such as the revision in 2005 of the International Health Regulations (IHR) and the establishment in 2016, after the Ebola outbreak, of the World Health Organization (WHO) Health Emergencies Programme and of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme (IOAC).

                  In the light of the enormous challenges posed by the COVID-19 pandemic, the need to be better prepared at global level to predict, prevent, detect, assess and effectively respond to pandemics has however become clear. Based on its mandate, WHO has a central role to play in this process, as the leading and coordinating authority in addressing global health challenges, including preparedness for, prevention and detection of, and response to outbreaks.

                  In the course of the past months, several independent review committees and panels
                     1
                   have pointed to the urgent need for a stronger international regime to confront pandemics, as well as for the strengthening of the independence, authority and financing of WHO. This creates a unique momentum to reinforce global health security in light of lessons learnt from the COVID-19 pandemic.

                  Since the outbreak of the COVID-19 pandemic, the European Union has made a major contribution to the global pandemic response. The Union has been a driving force in supporting the leadership role of WHO and advancing the WHO reform process. The Union’s role in strengthening WHO has been reflected in various documents, including Council Conclusions
                     2
                   of November 2020 and a Statement
                     3
                   of the Members of the European Council in February 2021.

                  In this vein, the Union and its Member States, for the second year in a row, spearheaded a resolution at the 74th session of the World Health Assembly in May 2021 to strengthen WHO preparedness and response to health emergencies. This resulted in the set-up of a Working Group of WHO Member States on strengthening WHO preparedness and response (hereafter referred to as “the WHO Member States Working Group”) to consider the findings and recommendations of the independent review committees and panels and to report to the World Health Assembly in May 2022.

                  In the run-up to the 74th session of the World Health Assembly, the Union and a broad-based group of supporting countries from all WHO regions have also pushed to establish a process towards an international treaty on pandemic preparedness and response. In March 2021, 25 Heads of State and Government from around the world joined the President of the European Council Charles Michel and the Director-General of the World Health Organisation, Dr. Tedros Adhanom Ghebreyesus, in an Op-ed calling for an international treaty on pandemics, drawing from the lessons learnt during the COVID-19 pandemic
                     4
                  .

                  On 20 May 2021, the Council adopted the position to be taken on the Union’s behalf in the 74th session of the World Health Assembly
                     5
                  . This Decision clearly set out the Union support for the establishment of a WHO process for a new Framework Convention on Pandemic Preparedness and Response. It also indicated that the Union must be allowed to participate in the negotiating process, in view of the Union’s possible accession to such a treaty. The Union’s commitment to working towards an international treaty on pandemics within the framework of WHO has also been reflected in the Statement of the members of the European Council of February 2021 and in the European Council Conclusions of June 2021
                     6
                  .

                  On 21 May 2021, the European Commission and Italy, as chair of the G20, co-hosted the Global Health Summit, where the leaders of G20 and other States, in the presence of the heads of international and regional organisations, adopted the “Rome Declaration”
                     7
                  . The principles set out in this declaration provide common guidance for the prevention and preparation to future pandemics and are of particular relevance in view of the discussions on an international treaty on pandemics.

                  At the World Health Assembly in May 2021, the Union together with the Group of Friends (the co-signatories of the Op-ed) worked to establish a negotiating mandate for an international treaty on pandemics. This could not be achieved due to lack of consensus. As a way forward, the World Health Assembly adopted a decision asking the WHO Member States Working Group to consider the potential benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response. It was also decided to convene a special session of the World Health Assembly from 29 November to 1 December 2021 devoted to this issue and with a view to starting the formal negotiation process immediately thereafter.

                  The WHO Member States Working Group held five meetings between July and November 2021, as well as several intersessional meetings.

                  In the course of the discussions, the number of countries speaking in favour of an international treaty has increased. Based on the discussions held in the WHO Member States Working Group and as stated in its report adopted on 15 November
                     8
                  , a number of potential benefits of a new instrument for strengthening pandemic preparedness and response have been identified, including:

               (a)promoting high-level political commitment and whole government, whole society approach, which could strengthen cross-sectoral coherence and mobilisation;

               (b)providing an opportunity to enhance, update and strengthen the leading and coordinating role of WHO and its function to act as the directing and coordinating authority on international health work;

               (c)creating constituency support for the new instrument and its goals for pandemic preparedness and response;

               (d)fostering confidence by State Parties to mutual high-level commitments to pandemic preparedness and response;

               (e)anchoring all the principles found in the WHO Constitution (Preamble), including the principle of non-discrimination and the right to the enjoyment of the highest attainable standard of health;

               (f)addressing equitable access to countermeasures such as vaccines, therapeutics and diagnostics; a new agreement would be the most appropriate global process to consider and agree how to improve equity in the future and this could be done by including a framework for concrete measures and long-term mechanisms to develop, manufacture and scale up new countermeasures, and improve equitable access to existing countermeasures, including through increasing local production and strengthening regulatory systems;

               (g)sharing of data, samples technology and benefits; this should be included in a multilateral framework for sharing surveillance and monitoring data, genetic data and pathogens, with an agreement on how the benefits derived therefrom should be shared; this includes mechanisms to facilitate research and rapid sharing of technology to ramp up regional production and distribution of countermeasures, cognisant of ongoing discussions and negotiations in other fora;

               (h)reducing the risks posed by emerging diseases of zoonotic origin in the future and enhancing the ‘One Health’ approach, including targeted elements specifically aimed at reducing the risks posed by zoonotic diseases in future, strengthening existing platforms and surveillance, furthering multi-sectoral partnerships (human, animal and environmental health sectors), and promoting specific countermeasures in line with the ‘One Health’ approach; as well as

               (i)strengthening health systems and their resilience, through strengthening primary health care service, healthcare workers and achieving universal health coverage.

                  In addition, an important number of Member States have also expressed their support to strengthen the IHR, including through implementation, compliance, and potential targeted amendments without re-opening the entire instrument for negotiations.

                  On this basis, the WHO Member States Working Group concluded, in its report to the special session of the World Health Assembly, that “the way forward should include a process or processes for: i) developing a WHO Convention, Agreement or other international instrument on pandemic preparedness and response, and ii) strengthening IHR (2005), including implementation, compliance support for IHR core capacities and potential targeted amendments to the IHR”. The negotiation process would thus include both the negotiation of a legally-binding agreement on pandemic preparedness and response, as well as a set of complementary amendments to the IHR.

                  The present recommendation is therefore addressed to the Council in connection with the special session of the World Health Assembly of 29 November to 1 December 2021.

               •Consistency with existing policy provisions in the policy area

                  The proposed recommendation is in line with the existing Union legal framework on serious cross-border health threats, as currently set out under Decision No 1082/2013/EU
                     9
                  .

                  In addition, from the outset of the COVID-19 pandemic, the Union has put in place a set of measures and coordination to support Union Member States in tackling the pandemic and to strengthen the resilience of their health systems. The proposed recommendation is in line with the following measures taken at Union level and aims at complementing them by establishing a strong international framework for cross-border threats with pandemic potential:

               ·In June 2020, the Commission presented a common EU Vaccines Strategy
                  10
               , which enables the support and speeding up of development and manufacturing at scale. This approach has ensured access to COVID-19 vaccines for all Union Member States, as well as exports to more than one hundred fifty countries worldwide.

               ·On 11 November 2020, the Commission laid the building blocks of a European Health Union by adopting a proposal for a regulation on serious cross-border threats to health, a proposal to extend the mandate of the European Medicines Agency and a proposal to extend the mandate of the European Centre for Disease Prevention and Control
                  11
               . Drawing on the lessons learned from the current crisis, these proposals aim to strengthen the Union’s resilience to health threats and to ensure enhanced preparedness and response during the current and future health crisis.

               ·Adopted on 25 November 2020, the Pharmaceutical Strategy for Europe
                  12
                also builds on the weaknesses exposed by the COVID-19 pandemic and presents appropriate actions to adapt the EU pharmaceuticals system in the years to come. It aims at creating a future proof regulatory framework and at supporting industry in promoting research and technologies that reach patients in order to fulfil their therapeutic needs while addressing market failures.

               ·On 6 May 2021, the Commission adopted a Union Strategy for the development and availability of COVID-19 therapeutics
                  13
               , which complements the EU Vaccines Strategy. The Union Strategy for the development and availability of COVID-19 therapeutics covers the full lifecycle of medicines, from research, development and manufacturing to procurement and deployment. It includes clear actions and targets, including authorising at least three new therapeutics by the end of 2021.

               ·On 16 September 2021, the Commission launched the new European Health Emergency Preparedness and Response Authority
                  14
                to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures.

               In addition, the proposed recommendation is in line with the following general objectives of the EU4Health Programme, the new Programme for the Union’s action in the field of health for the period 2021-2027, as set out under Article 3(b) and (c) of Regulation (EU) 2021/522 of the European Parliament and of the Council
                  15
               :

               ·“protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States in order to cope with serious cross-border threats to health;

               ·Improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supporting innovation regarding such products.”

               Close synergies between EU4Health and the Neighbourhood, Development and International Cooperation Instrument
                  16
               , as well as the Union Civil Protection Mechanism
                  17
                are essential in this regard.

               •Consistency with other Union policies

                  The proposed recommendation is also in line with the following Union policies and actions:

               ·Climate and environment policies, for the prevention and management of zoonotic risks as part of a “One Health” approach;

                  ·Development and cooperation policies:

               –The Union is providing support to Union neighbouring regions to strengthen their public health systems preparedness and resilience in case of cross-border health threats;

               –The Union worked to establish and support the tools to share vaccines with lower and middle-income countries, the Access to COVID-19 Tools
                  18
                - Accelerator (ACT-A) and COVAX, its vaccines pillar. Team Europe, which involves the European Union, its Member States and financial institutions, remains one of the biggest donors of COVAX, having committed over EUR 3 billion;

               –The Union works with its industrial partners to make vaccines available for low and middle-income countries in 2021 and 2022, and Member States are sharing their vaccines via COVAX, but also on a bilateral basis;

               –The Union offers humanitarian assistance
                  19
                to populations affected by health crises, including disease outbreaks, through field operations and to countries in need of assistance under the Union Civil Protection Mechanism by bringing medical supplies to people in hard-to-reach areas. The Union also supports partners by contributing to vaccination strategies, the procurement and the distribution of supplies;

               –The European Commission, in cooperation with several Member States is pursuing an initiative with African partners to develop the production and access to vaccines, medicines and health technologies in Africa
                  20
               .

               2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

               •Legal basis

                  The procedural legal basis for the proposed decision is Article 218(3) and (4) of the Treaty on the Functioning of the European Union (TFEU).

                  Article 218(3) of the TFEU provides that the Commission shall submit recommendations to the Council, which shall adopt a decision authorising the opening of negotiations and nominating the Union negotiator. According to Article 218(4) of the TFEU, the Council may address directives to the negotiator and designate a special committee in consultation with which the negotiations must be concluded.

                  The substantive legal basis will be considered at a later stage once more information is available: i) on the scope and content of the international agreement on pandemic preparedness and response, and ii) on the scope and content of the complementary amendments to the IHR.

               •Subsidiarity (for non-exclusive competence)

                  Although its exact scope is not yet known, the envisaged international agreement is intended to address serious cross-border health threats with pandemic potential. It will therefore have an impact on the exercise of Union competences, and on Union legislation in areas such as health, environment, trade, free movement, data protection, internal market, development cooperation, all of which might become relevant under the envisaged agreement.

                  Although there is no decision yet on the provisions of the IHR that may be amended, it is likely that such amendments would have an impact on the EU legal framework on cross-border health threats, as set out under Decision 1082/2013.

                  In view of the above and the likely affectation of the existing Union legislation in different areas of the Union’s action, it is essential that the participation of the Union in the future negotiations and resulting international agreement is assured.

               •Proportionality

                  Strengthening health systems and the international preparedness for – and response to – future pandemics is a top priority for the EU and is clearly in the interest of the Union.

                  A Council Decision is necessary to authorise the opening of negotiations by the Union on an international agreement on pandemic preparedness and response, as well as on complementary amendments to the IHR if so is decided.

                  The proposed recommendation does not go beyond what is necessary for achieving the objectives pursued, in accordance with Article 5(4) of the Treaty on European Union.

               •Choice of the instrument

                  The choice of the instrument is stipulated in Article 218(3) and 218(4) of the TFEU.

               3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

               •Ex-post evaluations/fitness checks of existing legislation

                  Not applicable

               •Stakeholder consultations

                  Not applicable

               •Collection and use of expertise

                  Not applicable

               •Impact assessment

                  Not applicable

               •Regulatory fitness and simplification

                  Not applicable

               •Fundamental rights

                  According to Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all the Union’s policies and activities.

                  The proposed recommendation seeks authorisation for the opening of negotiations with a view to strengthening health systems and the international preparedness for and response to future pandemics. This would positively impact the right for a high level of human health protection, as enshrined in Article 35 of the Charter of Fundamental Rights of the European Union.

               4.BUDGETARY IMPLICATIONS

                  The opening of negotiations for an international agreement on pandemic preparedness and response and the possible complementary amendments to the IHR are not deemed to have a budgetary impact.

               5.OTHER ELEMENTS

               •Implementation plans and monitoring, evaluation and reporting arrangements

                  Preparatory work and negotiations are expected to start soon after the special session of the World Health Assembly of 29 November to 1 December 2021. A preliminary phase may be envisaged.

               •Detailed explanation of the specific provisions of the recommendation

                  The Commission recommends that:

               ·The Council authorise the Commission to open and conduct negotiations for the conclusion of a new international agreement on pandemic preparedness and response, as well as on complementary amendments to the IHR if so is decided;

               ·The Commission be nominated as Union negotiator;

               ·The Commission conduct the negotiations in consultation with the special committee if designated by the Council in accordance with Article 218(4) TFEU;

               ·The Council approve the negotiating directives annexed to this recommendation.

               Recommendation for a

               COUNCIL DECISION

               authorising the opening of negotiations on behalf of the European Union for the conclusion of an international agreement on pandemic preparedness and response as well as for the negotiations of complementary amendments to the International Health Regulations (2005)

               THE COUNCIL OF THE EUROPEAN UNION,

               Having regard to the Treaty in the Functioning of the European Union, and in particular Article 218(3) and (4) thereof,

               Having regard to the recommendation from the European Commission,

               Whereas:

               (1)The special session of the World Health Assembly of 29 November to 1 December 2021 was called by the World Health Organization (WHO) Decision WHA74(16) of 31 May 2021 to consider the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response with a view towards the establishment of an intergovernmental process to draft and negotiate such a convention, agreement or other international instrument on pandemic preparedness and response,

               (2)The Union, should participate in the negotiations on such convention, agreement or other international instrument, as well as on complementary amendments to the International Health Regulations (2005) (IHR),

               (3)The negotiations will take place in the context of the WHO,

               HAS ADOPTED THIS DECISION:

               Article 1

               The Commission is hereby authorised to negotiate on behalf of the Union an international agreement on pandemic preparedness and response, as well as complementary amendments to the IHR within the framework of the decisions taken during the special session of the World Health Assembly of 29 November to 1 December 2021.

               Article 2

               The negotiating directives are set out in the Annex.

               Article 3

               The negotiations shall be conducted in consultation with the [name of the special committee to be inserted by the Council].

               Article 4

               This Decision is addressed to the Commission.

               Done at Brussels, 1.12.2021

                     For the Council

                     The President

                     (1)

                        In particular, the Independent Panel for Pandemic Preparedness and Response, the Review Committee on the functioning of the International Health Regulations (2005) during the COVID-19 response and the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme.

                     (2)

                  https://data.consilium.europa.eu/doc/document/ST-12276-2020-INIT/en/pdf
                  .

                     (3)

                  Statement of the members of the European Council, 25-26 February 2021 - Consilium (europa.eu)
                  .

                     (4)

                  https://www.who.int/news-room/commentaries/detail/op-ed---covid-19-shows-why-united-action-is-needed-for-more-robust-international-health-architecture
                  . The Op-ed was signed by Heads of State/Governments of: Fiji, Thailand, Portugal, Italy, Romania, United Kingdom, Rwanda, Kenya, France, Germany, Greece, Republic of Korea, Chile, Costa Rica, Albania, South Africa, Trinidad and Tobago, Netherlands, Tunisia, Senegal, Spain, Norway, Serbia, Indonesia, and Ukraine.

                     (5)

                        OJ L 238, 6.7.2021, p. 79.

                     (6)

                     European Council conclusions, 24-25 June 2021 - Consilium (europa.eu)

                  .

                     (7)

                        https://global-health-summit.europa.eu/rome-declaration_en.

                     (8)

                  Report of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies to the special session of the World Health Assembly

                     (9)

                        Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC, OJ L 293, 5.11.2013, p. 1

                     (10)

                        COM/2020/245 final, 17.6.2020.

                     (11)

                        COM/2020/727 final, COM/2020/726 final, COM/2020/725 final, 11 November 2020.

                     (12)

                        COM/2020/761 final, 25.11.2020.

                     (13)

                        COM/2021/355 final/2, 6.5.2021.

                     (14)

                        OJ C 393I, 29.9.2021, p. 3-8.

                     (15)

                        Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014, OJ L 107, 26.3.2021, p.1-29.

                     (16)

                        Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009, OJ L 209, 14.6.2021, p. 1-78.

                     (17)

                        Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism, OJ L 347, 20.12.2013, p. 924.

                     (18)

                        https://www.who.int/initiatives/act-accelerator.

                     (19)

                        European Consensus on Humanitarian Aid (2008/C 25/01) and Council Regulation (EC) No 1257/96 on humanitarian aid, OJ L 163, 2.7.1996, p. 1 – 6.

                     (20)

                        Press release of 21 May 2021, “

                     €1 billion Team Europe initiative in Africa (europa.eu)

                  ”.

    ---documentbreak---

               EUROPEAN COMMISSION
            Brussels, 1.12.2021
            COM(2021) 766 final/2

            DOWNGRADED on 6.12.2021
            ANNEX
            to the
            Recommendation for a Council Decision
            authorising the opening of negotiations on behalf of the European Union for the conclusion of an international agreement on pandemic preparedness and response as well as for the negotiations of complementary amendments to the International Health Regulations (2005)

               ANNEX

               Directives for the Negotiation of an International Agreement on Pandemic Preparedness and Response as well as for the Negotiation of complementary amendments to the International Health Regulations (2005)

               Within the framework of the intergovernmental process set out in the Decision SSA2/CONF./1Rev.1 of the Special session of the World Health Assembly (WHA) of 29 November to 1 December 2021, which provides a globally inclusive negotiating forum, the Commission will aim at negotiating an international agreement on pandemic preparedness and response
                  1
                (hereinafter “Pandemic Agreement”). The Commission, on behalf of the European Union, shall endeavour to achieve a comprehensive negotiated outcome, which encompasses the objectives and principles outlined below, drawing on the lessons learnt during the COVID-19 pandemic, and in view of preparedness for possible public health emergencies in the future.

               The Pandemic Agreement, which should complement the International Health Regulations (2005) (hereafter referred as IHR), will set out substantive, legally-binding obligations for its Parties aimed primarily at:

               –preventing and controlling;

               –detecting and reporting; and

               –preparing for, and responding to pandemic threats.

               The substantive obligations should be framed, including in the Pandemic Agreement’s preamble, by a series of general objectives and principles, such as the right to enjoyment of the highest attainable standard of health, international solidarity, equitable access to pandemic countermeasures (e.g. personal protective equipment, access to vaccination, therapeutics and diagnostics, medical and social care services), “One Health” approach, the need to address the close links between human, animal and environmental health, and the centrality of multilateral cooperation and the WHO in the global health governance.

               The Pandemic Agreement should also include provisions setting out:

               –the institutional framework;

               –rules on further rule-making;

               –monitoring and accountability mechanisms;

               –“whole of government”/cross sectorial preparedness approaches leading to better mobilisation of all competencies and resources and coherence in pandemic prevention and response; and

               –technical assistance and capacity building for implementation.

               In particular, an effective Pandemic Agreement will require significant investment in implementation support. This should include:

               –Strengthening WHO’s ability to support national and regional core health system capacities for pandemic prevention, preparedness, detection and response;

               –Strong technical assistance and capacity building for low and lower middle income countries aimed at:

               ·the effective implementation of Pandemic Agreement and related IHR commitments;

               ·the improvement of national and regional mechanisms for pandemic prevention, detection, preparedness, and response (including inter-agency and inter-sectoral coordination mechanisms); and

               ·the improvement of the health systems capabilities in the area of pandemic preparedness and response, including by increasing health and social care workforce capabilities to prevent, detect and respond to public health emergencies with pandemic potential, as well as developing and deploying digital health and social care tools.

               The Pandemic Agreement should aim at laying down substantive provisions and commitments especially in the key areas indicated above, while also charting the course for future negotiations, including by means of supplementary protocols. Legally binding provisions may be complemented by non-binding provisions (such as guidelines, standards and declarations).

               All United Nations Member States and regional (economic) integration organisations should be allowed to become parties of the Pandemic Agreement or any of its protocols. Specific arrangements for cooperation with relevant international organisations and non-governmental stakeholders should also be set out.

               In the light of the urgency of the subject matter of the Pandemic Agreement, the possibility of its provisional application, pending ratifications, should be envisaged so as to initiate implementation of the Pandemic Agreement’s provisions as early as possible.

               Transitional periods for implementation by low and lower middle-income countries and related implementation support should also be provided for.

               The objectives of pandemic preparedness and response pursued thorough the Pandemic Agreement may require complementary amendments to the IHR. Such amendments should aim at clarifying and strengthening existing IHR provisions and increasing their effective implementation, while ensuring complementarity and compatibility between such amendments and the provisions of the Pandemic Agreement.

               The Commission will represent the Union in the inter-governmental negotiating body in charge of developing a Pandemic Agreement, as set out in the WHA Decision SSA2/CONF./1Rev.1, and any preparatory or related body, as well as in the work of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies related to the development of IHR complementary amendments to strengthen the IHR, and their subsequent negotiation.

               The Commission should endeavour to ensure that the Pandemic Agreement and any possible complementary amendments to the IHR are consistent with relevant Union legislation and policies, as well as the Union’s commitments under other relevant multilateral agreements.

               The Commission should conduct negotiations in accordance with relevant Union legislation in force.

                     (1)

                        This designation denotes an agreement within the meaning of Article 2.1(a) of the Vienna Convention on the Law of Treaties and is without prejudice of the name that the agreement signatories will ultimately chose, e.g. convention, treaty or agreement.