Roadmap Chapter 28

Roadmap Steps for preparing the opening of EU Accession Negotiations in Chapter 28 – Consumer and health protection

CHAPTER 28 CONSUMER AND HEALTH PROTECTION – ROADMAP, WITH CONCRETE AND TIMELY STEPS IN ORDER TO REACH THE NECESSARY PREPARATION FOR THE OPENING OF THE CHAPTER Tirana, 30/03/2021

This document is compiled by Aleksandar Andrija Pejović, international expert, with the financial assistance of the German Government, implemented by the “Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH”, in the frame of the project “Support to Accession Negotiations in Economic Chapters of the Acquis (SANECA)”. The views expressed herein are those of the consultant and therefore cannot in any way be taken to reflect the official opinion of GIZ.

Table of Contents I INTRODUCTION...............................................................................................................1 II STEPS LEADING TO THE OPENING OF CHAPTER 28 ..........................................................2 III. SCREENING PROCESS FOR CHAPTER 28 .........................................................................6 III.1. BILATERAL SCREENING ......................................................................................................................... 6 IV. NEGOTIATING POSITION DEVELOPMENT PROCESS .......................................................8 IV.1. TASKS RELATED TO THE NEGOTIATING POSITION .............................................................. 8 IV.2. SCHEMATIC PRESENTATION OF THE PROCESS OF FINALISING THE NATIONAL NEGOTIATION POSITION ............................................................................................................................... 10 IV.3. THE CONTENT OF THE NEGOTIATING POSITION ............................................................... 10 IV.4. SPECIFIC ADAPTATIONS AND NEGOTIATING REQUESTS .................................................................. 11 IV.5. DOCUMENTS TO BE USED FOR NEGOATIATING POSITION ................................................ 12 V. PROPOSAL OF THE STRUCTURE OF THE NEGOTIATING POSITION FOR CHAPTER 28............... 14 ANNEX 1 - DETAILED GUIDELINES ON THE PROPOSAL OF THE STRUCTURE AND CONTENT OF THE NEGOTIATING POSITION ..........................................................................................16 I - INTRODUCTORY DECLARATION (Part I of the negotiating position) ..............................16 II - PART II OF THE NEGOTIATING POSITION.....................................................................17 II.1. General Points ................................................................................................................. 17 II.2. Structure of the Overview................................................................................................ 18 II.2.1 Legislative framework and status of implementation and enforcement of the acquis .................. 19 II.2.2. Institutional framework/administrative capacities......................................................................... 20 II.2.3. Implementing measures taken and challenges ............................................................................... 20 III - PART III OF THE NEGOTIATING POSITION...................................................................21 III.1. General remarks ............................................................................................................. 21 III.2. The structure .................................................................................................................. 21 III.3. Specific Arrangements .................................................................................................... 23 III.4. Additional Documents and Addenda ............................................................................... 24 ANNEX 2 – TEMPLATE OF A NEGOTIATION POSITION – MODEL FOR.................................26 CHAPTER 28 – CONSUMER AND HEALTH PROTECTION.....................................................26

I INTRODUCTION According to the latest enlargement methodology, as devised in the documentt Enhancing the accession process - A credible EU perspective for the Western Balkans1, Chapter 28 shall be a part of the new system of cluster-based negotiations. Therefore, Chapter 28 - Consumer and Health Protection will be negotiated together with other eight chapters in the thematic Cluster No 2 – Internal Market (other chapters are: 1 – Free Movement of Goods; 2 - Freedom of movement for workers; 3 - Right of Establishment and the Freedom to Provide Services 4 - Free movement of capital; 6 - Company law; 7 - Intellectual property law; 8 - Competition policy and 9 - Financial services). Negotiations on each cluster will be opened as a whole – after fulfilling the opening benchmarks - rather than on an individual chapter basis. As a result of the screening process, carried out per cluster, priorities for accelerated integration and key reforms will be agreed between the EU and the candidate country. The underlining idea of the new methodology is to open Cluster 2 only after the first Cluster on the Fundamentals is opened. When these priorities have been sufficiently addressed, the cluster (covering all associated chapters) is opened without further conditions as a whole. In practice, this would mean that the work on Chapter 28 will have to be coordinated with the work on other eight chapters in order to open them en bloc. Once, they are opened, the closing benchmarks will be set for each chapter. Where important reforms will already have been implemented before opening, the timeframe between opening the cluster and closing individual chapters should be limited, so that the idea is to close them preferably within a year fully dependent on the progress of the reforms, with the focus on remaining measures needed to ensure full alignment. The EU accession process is an extremely complex and non-linear process that has many important points, decisions to be made, procedures to be respected and a sophisticated model of consultations. Therefore, it is not easy to represent the whole process in a linear way. Here, 33 different steps are presented to show how many distinctive levels a candidate country needs to pass in order to reach the opening of Chapter 28. Consequently, this document offers useful points and guidelines on the steps leading to the opening of Chapter 28. It specifies the necessary preparatory steps for the bilateral screening organisation that awaits Albania with various points that need to be considered. It also provides information on the development process of the negotiation position for Chapter 28 – the task related to the negotiation position, the content of it as well as the documents to be used when preparing the negotiation position. Also, the document offers the proposal of the structure of the negotiation position that might be used by the Albanian negotiation structure and the guidelines on how to prepare this important paper. The specific steps that are explained in more details in the text are of importance for the preparation and the good work of the Ministry of Finance and Economy of Albania. Therefore, the areas presented here are not exclusive of other obligations and tasks that may arise in the negotiation process. 1 https://ec.europa.eu/neighbourhood-enlargement/sites/near/files/enlargement-methodology_en.pdf 1

II STEPS LEADING TO THE OPENING OF CHAPTER 28 1. The pre-screening (explanatory screening) was conducted where the European Commission presented the acquis in Chapter 28 for Albania on 28-29 March 2019;  2. The European Council adopts its General Negotiating Framework defining the principles, essence, and procedures for negotiating; 3. The Council of Ministers of Albania adopts its own General Negotiation Framework; 4. The first intergovernmental conference is convened – marking the official start of the negotiations. The EU (headed by the Presidency of the Council Foreign Minister and the Enlargement Commissioner) and Albania (Head of the State Delegation) present their expectations regarding the negotiations based on their own General Negotiating Framework at the First intergovernmental conference; 5. The next stage of screening begins - (bilateral screening) where all the chapters, including Chapter 28 are presented. 6. In the preparation of the bilateral screening, the EC may ask from Albania further questions and clarifications, as well as provide guiding questions and directions for a better preparation of the bilateral presentation by the Albanian delegation. 7. A meeting of bilateral screening with Albania is organised to present its legislation, provide its evaluations of the alignment of its regulations with the acquis, and plans to achieve the complete alignment in Chapter 28. The aim is to observe the differences between Albanian regulations and the acquis in the subheadings of Chapter 28. 8. Once the bilateral screening is done, the European Commission will start preparing the screening report for Chapter 28. The report shall include the European Commission assessment on achieved level of the candidate state’s legal order alignment level with the acquis and the implementation level, as well as the assessment of the extent to which the plans for the future alignment are realistic. The screening report shall also present the views of the Commission on the administrative capacities and institutional framework; 9. When preparing this report, the documents and information provided by the candidate country both at the screening and after the screening are used. Therefore, once it starts drafting the report, the EC may ask for additional information and questions. 10. The European Commission provides Albania with the first two parts of the draft of the screening report for comments - without the third part which assesses Albania and provides potential benchmarks in Chapter 28; 11. Albanian negotiation structure for Chapter 28 coordinates its work on providing comments and sending the finalised comments document to the European Commission; 2

12. The European Commission finalises the Screening Report on Chapter 28 and sends it to the Council; 13. The EU Council's Working Party on Enlargement and Countries Negotiating Accession to the Union (COELA) evaluates whether Albania has reached sufficient level of the alignment with the acquis in Chapter 28 – where each Member State provides its opinion and the final approval for the document. 14. The Member States in COELA can produce technical reservations on the screening report which can take any time from several weeks to several years under which they ask for more time in order to decide whether the screening report for any individual chapter for Albania is ready to be adopted. 15. Once COELA gathers all the positive opinions on the screening report, the decision is sent to COREPER II2 for the final approval. 16. If Council evaluates that Albania has not reached the required level of preparedness yet, it will most probably define opening benchmark(s) in Chapter 28 which should be met by Albania as a prerequisite for opening of negotiations within such chapter. The opening benchmarks under this chapters might take various forms. However, it should be noted that Croatia, Montenegro and Serbia have had no opening benchmarks for the Chapter! 17. Albania works on the fulfilment of the opening benchmark(s) in conjunction with the work of other eight chapters in Cluster 2. 18. In agreement with the European Commission, Albania recognises that it has fulfilled its opening benchmarks and informs by a letter the European Commission of it; 19. The European Commission prepares the Opening Benchmark Assessment Report (OBAR) specifying that Albania has fulfilled the opening benchmarks in Chapter 28 and is ready to open the chapter. 20. The European Commission in agreement with the EU Council Presidency sends OBAR on Chapter 28 to the Council. 21. The COELA evaluates the OBAR – each Member State provides its opinion and the final approval for the document; 22. The Member States in COELA can produce technical reservations on OBAR which can take any time from several weeks to several years under which they ask for more time in order to decide whether Albania is ready to be invited to present its negotiation position. 23. Once COELA gathers all the positive opinions on it, OBAR is sent to COREPER II for the final approval; 2 COREPER - Committee of the Permanent Representatives of the Governments of the Member States to the European Union. Coreper II is composed of each member states' permanent representatives. It is chaired by the permanent representative of the country holding the presidency of the General Affairs Council. 3

24. Once OBAR is approved and adopted, the Presidency of the Council of the EU sends the letter to Albania inviting it to submit its negotiation position for the chapter. 25. Once all the chapters of Cluster 2 are ready for the opening, Albania prepares its negotiation position on Chapter 28, adopts it at the government session and sends it through the Mission to the EU to the EU Council Presidency Mission. 26. The European Commission prepares the Draft Common Position (DCP). 27. The European Commission in agreement with the Presidency of the Council of the EU sends the DCP to the Council. 28. The COELA evaluates the DCP and the negotiation position of Albania – each Member State provides its opinion and the approval for the document. 29. The Member States in COELA can produce technical reservations on the DCP which can take any time from several weeks to several years under which they ask for more time in order to decide whether Albania is ready to open the chapter. 30. Once COELA gathers all the positive opinions on the DCP, the EU Common Position is sent to COREPER II for the final approval. 31. An Intergovernmental Conference is convened by the Presidency of the Council of the EU and the European Commission for the whole of Cluster 2, and the chapter is officially opened along with other eight chapters of this Cluster. 32. The EU3 will state that the level cannot ensure provisional closure of the chapter, and it will determine closing benchmark(s) Albania must meet before closing Chapter 28. In this case, Albania will be invited to work on the fulfilment of these benchmark(s). Here is a non-exhaustive list of possible closing benchmarks based on Croatia, Montenegro and Serbia experience: 1) Albania amends its Law on General Product Safety and the Law on Consumer Protection in order to further align its legislati- on in the field of consumer protection, particularly with Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards the better enforcement and modernisation of Union consumer protection rules and Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services, and demonstrates that adequate administrative structures and enforcement capacity will be in place to implement the legislation correctly by the time of accession. 3 The EU itself is presented by the Presidency of the Council of the EU and the European Commission at the IGC – so both parties will present the closing benchmarks that are written in teh EU Common Position. 4

2) Albania adopts and puts in force legislation transposing directive 2001/83/EC on the Community code related to medicinal products for human use as amended by directive 2004/27/EC and legislation transposing directive 2001/82/EC related to medicinal products for veterinary use - this includes establishing the authorisation process for medicinal products in both fields, as well as directive 89/105/EEC related to the pricing and reimbursement of medicinal products, in line with the principles of the jurisprudence of the European Court of Justice. 3) Albania demonstrates alignment with the EU communicable diseases acquis, and ensures that adequate institutional, technical and administrative capacity will be in place by the time of accession to implement it and to fulfill EU reporting and coordination obligations to deal with serious cross-border threats to health. 4) Albania adopts legislation aligning with the acquis on substances of human origin, especially with regard to organs, reproductive cells and reporting of serious adverse events and reactions as well as blood and blood components, traceability requirements and notification of serious adverse reactions and events and of a quality system for blood establishments. Albania demonstrates that it will have the adequate administrative capacity to properly implement and enforce the legislation in the area of blood, tissues, cells and organs by the time of accession. 5) Albania achieves substantial progress in transposing the EC tobacco control acquis particularly as regards health warnings, ban on misleading product descriptions, ingredients reporting, tobacco sponsorship and tobacco advertising in the information society services. 33. Albania starts working on the fulfilment of closing benchmark(s) 5

III. SCREENING PROCESS FOR CHAPTER 28 The negotiating process starts with the analytical overview and evaluation of alignment of national legislation with the acquis, known as the screening. The screening process is organised in two phases: Multilateral/explanatory screening, where the EU acquis is presented by the EC, which Albania already performed; and the bilateral screening, where Albania will be requested to present the degree of its alignment with the acquis for Chapter 28. During the bilateral screening, Albania will be expected to express its readiness to fully align the national legislation with the EU acquis or to, if possible, announce the areas where specific arrangements might be requested in Chapter 28. III.1. BILATERAL SCREENING When preparing for the bilateral screening, it is crucial to organise the work on time – early enough to be able to prepare everything before the bilateral screening, but also not too early which would make a problem for the IIWG to lose interest and focus. This especially holds true for the Albanian case where the explanatory and bilateral screenings are so far apart. A calendar of work for the chapters would be very useful in order to know how to meet the demands and plan accordingly. Use the following documents and sources during the process of the screening preparation: 1. The materials presented during the Explanatory Screening – they are the most essential basis for the preparation of the responses to the explanatory screening and giving a full picture about the situation in Albania when it comes to an individual chapter. 2. The questions that the EC sends to Albania before the bilateral screening – in some or most cases the EC might send specific questions that may assist with the preparation of the presentations to focus more on an area within the chapter. 3. Positions presented by the Government at meetings of the working bodies tasked with implementing the SAA - Working bodies tasked with implementing the SAA provide a forum for monitoring the progress of the country in the negotiations. All positions presented at the meetings and their conclusions, particularly at the meetings of the SAA Committee and subcommittees, must be embodied in the negotiating position and potential action plans, as commitments that the country has already undertaken. 4. Minutes and Recommendations of the SAA bodies meetings (SAA Council, Committee and Sub-Committees) – the minutes and recommendations of the EU on the progress of Albania in a specific chapter provide for a good basis to assess the situation and the current level of the preparedness of Albania to align and implement the Union acquis. 5. Country Report findings – represent an extremely important, though not very detailed, source of assessment of the preparedness of Albania for the Union acquis. Thus, it should be used as one of the most important directions how to present the national legislation of Albania in a specific chapter. 6. Legal and Institutional gap analysis / Impact assessments – for those chapters where they exist, these documents can be of great use for the comprehensive and exhaustive 6

preparation of documents. Legislative framework – Constitution, laws and bylaws present the main framework for the assessment of the chapter and its content in relation on where Albania stands to it. Information on institutional framework and administrative capacities - When preparing for the bilateral screening check on the situation on how the current level of alignment is implemented in the administrative framework of Albania, as well as the reform plans for the future. 7. National Programme for European Integration (NPEI) - The NPEI represents the Government’s strategic document setting out a plan for achieving full compliance with the acquis within the envisaged timeframe. The NPEI outlines fundamental positions and plans of the Government. The positions presented in the NPEI are considered in the preparation of the negotiating position as a basis that can be further elaborated and/or specified. After a negotiating position is adopted and the chapter opened, the NPEI should in its next revision be modified so as to align it with commitments taken in the negotiating position. After a chapter is opened, the NPEI becomes the main instrument for monitoring the implementation of the negotiating position. 8. National strategic documents in a given area - Current national strategic documents provide the basis for further alignment plans. Given that screening presentations and the NPEI plans have been developed on the basis of the current strategic documents, they have therefore already been incorporated at the above stages. However, before preparing a negotiating position, one should first consult the strategic document regulating the area, as in most cases these documents will specify in more detail the next steps and requirements to be taken in the alignment process. Any inconsistencies found between the positions presented at the screening, in the NPEI and in the strategic documents should be removed, so the negotiating position contains the final position of the Republic of Albania in the given area. Take note that strategic documents often represent opening benchmarks and in some cases the closing ones. 9. Other sources such as international organisations’ reports as well as the Member States positions – need to be assessed in order to see how the current state of play in Albania is seen by these stakeholders. The EU often uses these reports in the course of accession process. Use the template for the presentations – there should be only one for all the chapters and all the power points in Chapter 28 possible the same as for all other chapters. In this way the Negotiation Structure would ensure uniformity in expression and presentation. This would present Albania as a serious and organised negotiator. The power point presentations need to be shared early enough to be able get the opinion and comments of the responsible negotiation structures. In this way you ensure timely verification of the materials to be presented especially since you may be asked by the EC to send these presentations some time before the bilateral screening (usually two weeks). The EC might also send additional questions after it receives the power point presentation to clarify some issues more, as well as after the bilateral screening. Note that you may get the demands from the EC to send them translations of the draft laws, tables and other materials after the bilateral screening!

IV. NEGOTIATING POSITION DEVELOPMENT PROCESS IV.1. TASKS RELATED TO THE NEGOTIATING POSITION 1. The IIWG shall prepare a draft of the negotiating position for Chapter 28 within the deadlines and in the manner established by the Negotiating Group, considering the European Commission screening report and other relevant documents. 2. The IIWG should follow the guidelines and deadline set by the Chief negotiator while preparing and drafting the negotiating position. 3. Special guidelines for the assessment of the financial effects of the negotiating position, considering the specific nature of this type of assessment, shall be prepared by the European Integration Secretariat in cooperation with the Ministry of Finance and Economy and the Negotiating Group. 4. The Head of the IIWG / Member of the Negotiating Group responsible for Chapter 28 can inform the Chief Negotiator or the member of the Government (Minister) responsible for Chapter 28 and the Head of the State Delegation on any open issues incurred during the procedure of the preparation of negotiating positions. 5. During the preparation of negotiating positions, the IIWG shall consult the public concerned using the Partnership Platform of European Integration (PPEI), in accordance with the Premier Minister Order on the organisation and functioning of the PPEI, as well as the regulations and international agreements governing the protection of classified information and access to classified information. 6. The IIWG shall prepare the draft negotiating position for the negotiations on Chapter 28 and forward it to the Negotiating Group (Member responsible for Chapter 28). 7. The Negotiating Group Member responsible for Chapter 28 shall review the draft negotiation position. 8. The Negotiating Group Member responsible for Chapter 28 shall submit4 the draft negotiating position prepared by the IIWG to the Negotiating Group for discussion and assessment. 9. The Chief Negotiator shall submit the draft negotiating position on Chapter 28 developed by the relevant inter-institutional working group, for the opinion of the National European Integration Council. 10. The Chief Negotiator shall submit the draft negotiating position on Chapter 28 developed by the relevant inter-institutional working group, along with the opinion of the National European Integration Council, for review to the State Committee for European Integration. 11. The State Committee for European Integration shall provide guidance to the Minister in charge for the specific field of state responsibility for Chapter 28 and the Chief Negotiator 4 The European Integration Secretariat is present all the way through the process of work on the negotiation positions. It is tasked to collect and process the draft proposals on negotiation positions for each chapter of European Union “acquis”, in accordance with the draft proposals and negotiating positions prepared by each inter- institutional working group as provided in section VIII of this decision; as well as to coordinate the interaction and exchange of negotiating positions and relevant documentation between the State European Integration Committee, the State Delegation, the negotiating Group and Chief Negotiator with inter-institutional working groups.

on the draft negotiating position that is to be submitted for approval to the Council of Ministers. 12. The Minister in charge presents the negotiating position to the Council of Ministers. 13. The Council of Ministers shall approve the negotiating position for Chapter 28. 14. The Chief Negotiator shall, through the Republic of Albania Mission to the European Union, submit the negotiating position on each chapter and any supporting documentation after getting an approval by the Council of Ministers. 15. The Mission of the Republic of Albania to the European Union shall submit the official version of the negotiating position to the Council Secretariat and the Mission of the Country holding the Presidency of the Council of the EU. 16. It might also be necessary to prepare an amendment to the negotiating position or in the case of re-opening a negotiating chapter with regard to the preparation of adequate acts, in which case the Chief Negotiator shall coordinate this task with the European Integration Secretariat. 17. It might also be necessary to prepare a corrigendum to the negotiating position; in which case it would be necessary that the Chief Negotiator coordinates this task with the European Integration Secretariat. 18. If in the course of negotiations, a need for further clarification of negotiating positions arises, the Council of Ministers shall adopt the required clarifications in order to communicate them to the European Union. 19. The negotiating positions that the Republic of Albania is to adopt in the course of the accession negotiations for each individual negotiating chapter shall be afforded \"LIMITE\" security classification level in accordance with regulations on information classification. Exceptionally, parts of the negotiating position may be afforded the security classification level \"CONFIDENTIAL\". 20. The negotiating positions shall retain security classification level \"LIMITE\" or \"CONFIDENTIAL\" until the Government decides to remove the classification in question. 21. Translation and expert proof-reading of the translation into English of the adopted negotiating position and the accompanying documents shall be performed by the ministries, Government agencies, or authorities or organizations within the scope of activities of the negotiating Group, in accordance with the nomo-technical rules and terminology prescribed in special acts of the Government and the Albanian terminology base. 22. The IIWG shall perform technical and expert revision of the negotiating position and the accompanying documents in English.

IV.2. SCHEMATIC PRESENTATION OF THE PROCESS OF FINALISING THE NATIONAL NEGOTIATION POSITION The IIWG prepares the draft of The State European Integration The minister in charge presents negotiating position and forwards Committee provides guidance to the draft negotiation position to it to the Negotiating Group the minister in charge and the the Council of Ministers (Member responsbile for Ch). Chief Negotiator on the proposal The Council of Ministers approves The Negotiating Group Member for the negotiating position the negotiating position reviews the draft negotiation position proposal. The Chief Negotiator submits the negotiating position along with the opinion of the National European Integration Council, for review to the State Committee for European Integration. The Negotiating Group Member The Chief Negotiator submits the The Chief Negotiator, through the submits the draft negotiating negotiating position for the Republic of Albania Mission to the position to the Negotiating Group opinion of the National European European Union, submits the for discussion and assessment. Integration Council. negotiating position IV.3. THE CONTENT OF THE NEGOTIATING POSITION The negotiation process essentially means the process of the alignment of both parties shall be made in the communication between competent EU institutions and those of the candidate state. Formally the negotiations on individual chapters will be opened and temporarily closed within the intergovernmental conference meeting. A significant negotiation principle shall be that all of the chapters shall be closed provisionally i. e. \"nothing is agreed until everything is agreed\". In its negotiation position for individual chapter, the candidate state shall present the achieved alignment level with the acquis, the remaining alignment scheme, and the overview of the existing and future administrative capacities for the implementation. In addition, in its negotiation position, the candidate state shall also define the requirements for the transition periods and/or exemptions (permanent derogations) within those segments where it deems that, due to reasonable grounds, it will not be able to fully transfer the EU legal order within the national framework at the time of the anticipated accession to the EU. The candidate state may, during the negotiations, submit the EU the supplement and/or change of the negotiation positions.

The negotiating positions also constitute Albania’s commitment. Therefore, the preparation of a negotiating position (and planning of resources for delivering commitments made under the negotiating position) should be guided by the following principles: 1. Promise only what is realistic and feasible in the given time frames. It should be remembered that negotiating positions are the highest form of commitment given by a country and that their implementation will serve as a basis for assessing the credibility and readiness of the country to become an EU member state; 2. Clearly assess what is financially realistic; 3. Avoid additional commitments that are not necessary for achieving full compliance with the acquis, i.e. that are not necessary for closing the chapter; 4. Maximise the use of EU funds and remove obstacles (‘bottlenecks’) for infrastructure investment by planning administrative capacities; 5. In planning the resources, focus on the implementation of the EU acquis (allocation of the current financial and human resources and their focusing on objectives that ensure better progress in negotiations comparing to other priorities). It should be noted that the European Commission, on behalf of EU member states, constantly checks whether Albania honours its commitments during the negotiations but also even after the negotiations are closed (the last report on the readiness for membership is submitted by the European Commission three to six months before the date of accession). Fulfilment of the commitments taken brings to the candidate country the credibility needed to close the accession negotiations. This is of outmost importance since negotiations are closed at the time when the country is not yet fully compliant with the EU requirements, on the basis of a promise that the country (Albania in this case) will be fully prepared by the time of accession to the EU, given the track record how the commitments have been fulfilled thus far. IV.4. SPECIFIC ADAPTATIONS AND NEGOTIATING REQUESTS Albania’s acceptance of the rights and obligations arising from the acquis may necessitate specific adaptations to the acquis and may, exceptionally, give rise to transitional measures which must be defined during the accession negotiations. The adaptation most commonly requested takes the form of various specific arrangements from certain regimes or from a specific requirement of EU legislation, such as: 1. transitional periods, 2. transitional measures, 3. temporary exemptions, 4. permanent derogations. However, as the Negotiating Framework indicates, specific adaptation to the acquis is not exhausted in requests for transitional periods only nor is it related to obligations only but also to certain rights arising from membership. In addition, a request for a transitional period can be brought forward in various forms. Finally, the content of the acquis in various negotiating chapters, specific expectations and the administrative philosophy of relevant institutions of the

European Commission may require flexibility in preparing a negotiating position and the negotiating requests it contains. For this reason, the Guidelines are also flexible and they leave room for negotiation in formulating the negotiating requests (Part 3 of the negotiating position structure) so as to cover a variety of situations emerging in negotiations that require various forms of negotiating request (transitional periods, temporary exemptions, permanent exemptions, specific arrangements, introduction of certain rights or specific adaptations into secondary sources of EU law, that are all reflections of specific circumstances connected with Albania and do not question the EU policies concerned). Having in mind that the final formulation of a negotiating request will be determined within the national negotiating structure, mainly by the Negotiating Group, this approach is justified and provides the opportunity, through exchange of opinions between key participants in the negotiations, to determine the best possible form of request that would not be prejudiced by the Guidelines. Note that the success of the negotiations is not reflected in the number of requested and/or granted transitional arrangements but in securing the best possible preparedness of Albania and its economy for membership. When defining a specific request that Albania wishes to put forward in negotiations, it should be borne in mind that only what is really necessary should be requested. All requests must be thoroughly justified and supported by a financial rationale as to why Albania will not be able to adapt by the time of accession but would have to request a transitional arrangement. IV.5. DOCUMENTS TO BE USED FOR NEGOATIATING POSITION When preparing a negotiating position, one should start from strategic documents and then work down to documents related to a specific chapter. One should be familiar with the following documents: 1. Positions presented by the Government at the bilateral screening - When preparing a negotiating position and any action plans for meeting the opening benchmarks, positions presented at the bilateral screening should be taken into account. It is on the basis of these positions that the EU adopted the screening report and assessed the degree of compliance with the EU acquis. 2. Screening report - The EU describes the current state of affairs in a given area and the achieved degree of compliance in a screening report. It also provides a gap analysis of the national legislation vis-à-vis the EU 3. Screening outcome - In case the country has not achieved a satisfactory degree of compliance, the EU will determine the opening benchmarks that will be communicated in a screening outcome. In that case, the country should first meet the defined benchmarks so it can start preparing the negotiating position. In case a benchmark requires elaboration of an action plan for alignment of the legislation with the EU acquis, the negotiating position should fully incorporate the plans outlined in that action plan. 4. Positions presented by the Government at meetings of the working bodies tasked with implementing the SAA - Working bodies tasked with implementing the SAA provide a forum for monitoring the progress of the country in the negotiations. All

positions presented at the meetings and their conclusions, particularly at the meetings of the SAA Committee and subcommittees, must be embodied in the negotiating position and potential action plans, as commitments that the country has already undertaken. At these meetings, after a chapter is opened, the EU monitors progress in implementing the negotiating position, indicates delays and proposes measures to address these delays. 5. Legal and institutional gap analysis / Impact assessment – for those chapters where they exist, these documents can be of great use for the comprehensive and exhaustive preparation of documents. 6. National Programme for EU Integration (NPEI) - The NPEI represents the Government’s strategic document setting out a plan for achieving full compliance with the acquis within the envisaged timeframe. The NPEI outlines fundamental positions and plans of the Government. The positions presented in the NPEI are considered in the preparation of the negotiating position as a basis that can be further elaborated and/or specified. After a negotiating position is adopted and the chapter opened, the NPEI should in its next revision be modified so as to align it with commitments taken in the negotiating position. After a chapter is opened, the NPEI becomes the main instrument for monitoring the implementation of the negotiating position. 7. National strategic documents in a given area - Current national strategic documents provide the basis for further alignment plans. Given that screening presentations and the NPEI plans have been developed on the basis of the current strategic documents, they have therefore already been incorporated at the above stages. However, before preparing a negotiating position, one should first consult the strategic document regulating the area, as in most cases these documents will specify in more detail the next steps and requirements to be taken in the alignment process. Any inconsistencies found between the positions presented at the screening, in the NPEI and in the strategic documents should be removed, so the negotiating position contains the final position of the Republic of Albania in the given area. 8. Positions presented at screenings in related negotiating chapters - Many chapters will deal with the same subject matter from various angles (Chapter 8: State Aid and Chapter 20: Enterprise and Industrial Policy) or they together create one large field (Chapters 11, 12 and 13: Agriculture). When preparing a negotiating position, the positions presented at screenings for given chapters should be checked so the data are consistent. If different data were presented at various screenings, than such inconsistencies should be justified. 9. Positions presented in negotiating positions for related chapters - When preparing negotiating positions in related chapters, positions should be checked with the related II WG so as to avoid bringing forward conflicting requests or presenting data that can benefit the country in one chapter but could damage its interests in another. In case of conflicting requests, the Negotiating Group or even the Government should take a position or adopt a political decision on what is more in the country’s interest and then act consistently in all related chapters. 10. Peer review mission report - can be very helpful in drafting the negotiation position for a specific chapter since they help with very detailed information and an expert view.

V. PROPOSAL OF THE STRUCTURE OF THE NEGOTIATING POSITION FOR CHAPTER 28 The negotiating position consists of the following parts (bold text marks the title of chapters, the text in brackets is the explanation): I. Introductory declaration – Part I of the negotiating position, statement of acceptance of the Union acquis and noting of the specific arrangements; II. Legislative and institutional framework (Overview of status of alignment, institutional framework and administrative capacities – Part II of the negotiating position); III. Plans for alignment of the legislative and institutional framework with the acquis (Plans for full alignment, institutional framework and administrative with the Union acquis and justification of the specific arrangements demanded – Part III of the negotiating position)5. Part I - of the negotiating position outlines Albania’s general negotiating position concerning the acquis under the negotiating chapter. It provides a summary of the negotiating position that is presented in other parts, as well as Albania’s acceptance of obligations arising from membership providing a clear overview of all negotiating requests (request by request) if any. Part I of the negotiating position presupposes the explanations given in the parts II and III, and specifies the negotiation requests that derogate from the general position, i.e. that Albania accepts the acquis in its entirety as it stands on the date indicated in the negotiating position. Part II - of the negotiating position gives an overview of the actual status of alignment (status regarding the transposition, implementation and enforcement of the acquis), which in addition to formal alignment of legislation also includes an overview of the status of institutional capacities, administrative capacities and any measures taken. Part II can also provide a brief overview of the most significant challenges concerning the implementation of the acquis, particularly those economic and financial in nature. Part III - of the negotiating position provides a precise and clear overview of steps, stages, measures, activities and timeframes of the plan for achieving full compliance. This part of the position follows naturally from Part II of the negotiating position, which has presented the status regarding the transposition, implementation and enforcement of the acquis as well as the most significant challenges. This part of the Negotiating Position is the most difficult to draft since it calls for a lot of planning, strategic thinking and commitments to be presented. If the status overview in Part II suggests that there is full compliance with the entire or some part of the negotiating chapter, that should be highlighted, indicating, potentially, activities to ensure that this remains so (e.g. secured financing, extension of continuous activities etc.). For instance, if the screening report, the Commission’s report on the fulfilment of opening benchmarks, Commission peer reports etc. already show that Albania is ready to take on, fully 5 Detailed guidelines on the content and structure of the negotiating position in Annex 1.

or in part, the obligations under the negotiating chapter, it is logical that this will have an effect on the negotiating position. Also, Albania will ensure that its subsequent measures do not hinder the achieved degree of compliance so as to prevent the risk of re-opening the negotiating chapter. Part III of the negotiating position also outlines the steps for overcoming the challenges identified in Part II, and relevant timeframes. It will also provide reasons and justifications for any negotiating requests for specific adaptations i.e. - a) permanent derogations or b) transitional measures: transitional arrangements, exemptions, introduction of certain rights or specific adaptations into the secondary sources of EU law, which are a reflection of specific circumstances connected with Albania and are without prejudice to EU policies, etc.).6 6 Template of a negotiating position – model of Ch 28 Consumer and Health Protection is attached to this document in Annex 2.

ANNEX 1 - DETAILED GUIDELINES ON THE PROPOSAL OF THE STRUCTURE AND CONTENT OF THE NEGOTIATING POSITION The presented Detailed Guidelines on the parts of the negotiating position are not mandatory but serve as guidance as to how to present information, the number of paragraphs related to particular information etc. The content, type and level of detail depend on the expectations of the European Commission i.e. the competent General Directorate, and member states in certain negotiating chapters. Please note that in this regard, deviation from the Guidelines is possible. I - INTRODUCTORY DECLARATION (Part I of the negotiating position) Part I of the negotiating position provides a summary of the document. It declares Albania’s general position vis-a-vis full acceptance of commitments arising from the negotiating chapter, in a precise and clear manner. The text of the summary is a reflection of the content of the negotiating position that is essentially outlined in three following sections, i.e. current status (Part II of the negotiating position), plans for achieving full compliance (Part III of the negotiating position) and negotiation requests (if any) (Part III of the negotiating position). Therefore, the text of the introductory declaration in the negotiating position depends on whether Albania fully accepts the acquis in the negotiating chapter without special negotiating requests or it accepts it fully with derogations defined in the negotiating requests. Also, as Albania cannot influence the content of amendments to the acquis after submitting the negotiating position, the introductory declaration will contain a general clause that its acceptance of the acquis (and any negotiating requests) relates only to the acquis as it stands on the day indicated in the negotiating position. Therefore, if Albania has no special negotiating requests in a negotiating chapter, then the text of the introductory declaration in the negotiating position may be formulated in the following way: 1. “The Republic of Albania accepts the European Union acquis covered by Chapter 28 Consumer and Health Protection in effect as of (date of the submission of the negotiating position) and is ready to achieve its full implementation by the date of the EU accession.” 2. “The Republic of Albania does not request specific adaptations under this Chapter.” If Albania plans to present its negotiating requests in Part III of the negotiation position, then the text of the introductory declaration of the negotiating position may be formulated in the following way: 1. Albania accepts the European Union acquis covered by Chapter 28 Consumer and Health Protection in effect as of (date of the submission of the negotiating position) and is ready to achieve its full implementation by the date of the EU accession, with the exception of the Council Regulation/Directive year/number/EU…. for which Albania is requesting a transitional period for full alignment, and the Council Regulation/Directive year/number/EC… for which Albania is requesting exemptions from full application.

2. The Republic of Albania requests (special adaptations, exclusion, permanent exemptions) in the area concerning ................(Regulation/Directive XX/XX/XX) 3. The Republic of Albania accepts the European Union (EU) acquis under Chapter 28 Consumer and Health Protection, in force (the date indicated in the negotiating position), and it is ready to achieve its full implementation before its accession to the EU, with the following exceptions and requests: 4. The Republic of Albania will have implemented any outstanding acquis, i.e. the acquis adopted after (the date indicated in the negotiating position) by the date of accession to the European Union subject to the outcome of the negotiations under this chapter.’ As has been indicated in the Introduction, the text of the negotiating requests in Part III of the negotiating position in each negotiating chapter will be agreed on through the national negotiating structure. Therefore, the proposed text of the introductory declaration can be adapted depending on the nature of the negotiating requests presented under Part III of the negotiating position and on the agreement in the Albanian negotiating structure. II - PART II OF THE NEGOTIATING POSITION II.1. General Points The goal of the negotiating process in any negotiating chapter is to close it. In the second part of the position Albania starts providing the information and data of the situation in the field. Accession entails acceptance of rights and obligations on which the Union was founded, and its institutional framework known as ‘the Union acquis’. Albania will have to apply this framework as it stands at the time of accession. Thus, an overview of the achieved level of development is provided in Albania’s negotiating position with respect to the degree of compliance of legislation, to the institutional framework and to the capacities for its effective implementation and enforcement. More specifically, the dynamics of opening and provisional closure of a negotiating chapter will be determined on the basis of proper transposition of the acquis into the Albanian legal system, how it is implemented, and how effectively enforced through the appropriate administrative and judicial structures. Therefore, for the purposes of the Negotiating Framework and these Guidelines, alignment with the EU acquis entails proper and full transposition of legislation and sufficiently strengthened institutional frame, and the administrative capacities (management, administrative and judicial) for effective implementation and enforcement of the acquis under a negotiating chapter. In that regard, this part of the negotiating position should describe the progress achieved in transposing the acquis under the negotiating chapter, institutional structure and administrative capacities responsible for the implementation of the relevant EU legislation (including, where relevant, the municipal institutional capacities), as well as judicial capacities and their suitability for effective implementation and enforcement. The overview should realistically, clearly and concisely reflect the achieved degree of compliance of the legislation with the acquis, adequacy of institutional capacities and administrative practices, in relation to criteria from the acquis, no more no less. For this reason, any too extensive reasoning, exaggeration or underestimating the progress achieved should be avoided. The

criteria for assessing the progress achieved are those contained in the requirements of EU legislation. The account should be taken of the assessments made by the European Commission contained in the relevant documents (screening report, report on the fulfilment of the opening benchmarks for chapters, progress report, SAP Council conclusions, subcommittee minutes, etc.). II.2. Structure of the Overview The structure of the overview should follow the structure of the acquis covered by the negotiating chapter the way it was presented in the screening report. The focus should be on the EU legislation presented at the explanatory screening and on issues indicated in the European Commission’s Screening Report and Opening Benchmark Assessment Report or at meeting of the SAA implementation bodies. When describing the status of legislative and institutional capacities, account should be taken of the European Commission’s replies to questions Albania asked at the explanatory screening, of the screening outcome and presentations, as well as of written and oral replies provided or sent by Albania to the European Commission during bilateral screening, comments given in the framework of implementation of the SAA, etc. In addition, given that a certain amount of time can pass from the end of the bilateral screening to the Council’s call on Albania to submit its negotiating position, the overview of the situation will also cover the progress made in harmonising with the acquis in the meantime. In that regard, special account should be taken of the content of strategies and action plans or other measures Albania adopted in order to meet the opening benchmarks, including the measures and activities implemented in the meantime. Where relevant, or where the expectations of the European Commission suggest it, progress achieved in implementation and enforcement should also be presented using quantitative data and official statistics reflecting the alignment status, as well as trends, primarily in the implementation and enforcement (e.g. infrastructure coverage in Albania required by the acquis, number of issued permits compliant with EU acquis requirements, supervisions conducted, statistics concerning administrative measures taken, court decisions, etc.) Data can also be presented in tables, graphs and similar. Also, for reasons of text economy, references to information already submitted to the Commission (e.g. in action plans, NPI etc.) can be used. The status is presented through the following segments: 1. legislative framework (overview of the status of formal alignment from the Constitution, through the laws to bylaws); 2. institutional framework/administrative capacities (overview of institutions authorised for the implementation of the EU acquis, adequacy of the achieved level of capacities); 3. Technical issues such as digitalisation or information-systems; 4. implementing measures taken and challenges.

In more complex negotiating chapters, the overview of the status provided in the above segments can be presented in subchapters (it can follow the structure of the Commission’s screening report). II.2.1 Legislative framework and status of implementation and enforcement of the acquis It is necessary to show the status of the transposition of key EU directives under a negotiating chapter and of the degree of compliance with regulations and decisions. The focus should be on the acquis that the European Commission presented at the screening. It is also necessary to include information on the status of the transposition of amendments to the acquis under the negotiating chapter that have occurred following the screening. The overview can be given in the following way: A short summary should be given of status of alignment of the Albanian legislation with key legislation (the acquis presented at the screening and indicated in the screening report, together with its latest amendments) under the given chapter/subchapter. The overview should focus on the transposition of the key acquis being transposed in Albanian legislation, which the European Commission presented at the explanatory screening and in the screening report. The following terms should be used to indicate the status of alignment with EU regulations and decisions: aligned/partially aligned/not aligned, whereas for directives, ‘transposed’ or ‘partially transposed’ can be used. If appropriate, there should also be a short description of reasons for nonalignment/incomplete transposition or, in positive terms, in what aspect alignment/transposition has already been achieved. If a chapter has more than one subchapter, a general overview of the degree of compliance of the Albanian legislation should be provided for each subchapter. • The paragraph should cite the relevant piece(s) of national legislation transposing the specific Union acquis. International agreements may be indicated if the accession to such agreements is relevant to a given negotiating chapter. • When referring to a legislative act, it is necessary to indicate the date of adoption and the number of the Official Journal; Example: This area is regulated by the Law on ... adopted on …(date)… (Official Journal of the Republic of Albania). If the law had several amendments, it is necessary to indicate when it was first passed and the date of the most recent amendment. • When referring to EU legislation, it is necessary to cite the official name of the document as adopted in the EU. • If a given piece of EU legislation is also addressed in another negotiating chapter, the position should clearly indicate that chapter in a footnote or within the brackets and ensure coherence of information in the negotiating positions.

II.2.2. Institutional framework/administrative capacities This part should describe the institutional framework and the capacities relevant for transposition, implementation and enforcement of the acquis. In that regard, it is recommended: • to indicate the competent institution or institutions (where relevant, indicate the judicial authorities also) responsible for the implementation and enforcement of the EU legislation (including municipal level, where relevant); • to provide a short description of their functions and responsibilities for the implementation of the acquis. If responsibility for enforcement is shared, a short explanation should be provided of interrelations between those institutions, division of responsibilities and coordination mechanisms, if any; • if it is relevant in terms of supporting Albanian statement on the achieved degree of compliance, more details should be provided concerning the date of establishment, activities implemented, reorganisation plans, the strengthening of technical and administrative capacities, supervisory inspection, financing mechanisms established, etc.; • there should be an indication of the number of staff effectively dealing with issues under a given chapter and a general assessment of their adequacy in relation to the requirements of the acquis; • there should be a short assessment at the end of the paragraph on whether the institutional structure and capacity to implement the EU legislation is in place and an assessment of their adequacy. II.2.3. Implementing measures taken and challenges • Key activities implemented, taken or initiated in relation to strategies or action plans adopted for the purpose of opening and closing a negotiating chapter. • If the nature of the substance of a given negotiating chapter requires so (and if that supports the negotiating position by confirming the adequacy of the institutional capacities), this part of the position can provide a short summary of key measures and activities, implemented or ongoing, that are relevant for implementation and enforcement of the acquis requirements and reflecting the achieved level of efficiency of the institutions (e.g. adopted plans, financing mechanisms established, infrastructure developed, capacity established for the absorption of EU funds, etc.). • The level of the implementation achieved can be illustrated using statistics that may be shown in tables, graphs or in another convenient manner. • Also, if there are challenges related to implementation, in particular those that would require a negotiating request, they should be described through key points.

III - PART III OF THE NEGOTIATING POSITION III.1. General remarks This is the central and the most difficult part of the negotiating position as it defines Albania’s position regarding the Union acquis, i.e. how and when it plans to be fully ready to take on the obligations under the negotiating chapter. In other words, this part of the negotiating position provides key answers as to how and when Albania will address any shortcomings in order to close a negotiating chapter. At the same time, Albania here commits to implementing obligations taken in the positions as to avoid re-opening a negotiating chapter after its temporary closure. The dynamics of the temporary closure of a negotiating chapter depends on how convincing the plans for full alignment are. Part III and Part II of the negotiating position need to complement each other. The activities envisaged and measures listed in Part III are a natural consequence of the status of alignment with the EU acquis and of the level of implementation and enforcement presented in Part II through the information communicated by Albania at the screening stage and, where relevant, through fulfilling the opening benchmarks for the negotiating chapter. In preparing the position it should be considered that Albania is called upon, in certain negotiating chapters, to present its negotiating position after it has fulfilled the opening benchmarks. The opening benchmark usually would be a strategy or an action plan for transposition, implementation and enforcement of the acquis, which includes its financial component. This is why the content of the negotiating position will largely be dependent on the content of the document that was the condition for opening a given chapter. On the other hand, in areas where compliance has been already achieved according to assessments in Part II (based also on reports adopted by the EU), in particular regarding the institutional aspects, Part III of the negotiating position has to confirm Albania’s readiness to continue fully respecting its commitments. III.2. The structure The structure of the part III should follow the structure of the acquis the way it was presented in the screening report. The focus should be on EU legislation presented at the explanatory screening and on issues indicated in the Screening Report (Title III - Assessment of the degree of compliance and implementing capacities) as well as in the Opening Benchmark Assessment Report – OBAR in the case there was an opening benchmark for the chapter. The plans for full compliance are presented in the following integral parts: 1. Plans for alignment of legislation with the EU acquis, 2. Plans for alignment of institutional frameworks/administrative capacities with the EU acquis, 3. Measures and activities envisaged to achieve full compliance with the EU acquis and justification for the negotiating requests.

The content of Part III should be presented on the basis of the structure of Part II (which follows the structure of the acquis used in the screening report). Information on plans for alignment of the legislative framework and information on the degree of compliance presented in Part II of the negotiating position should be complementary. In more complex negotiating chapters, the overview of plans in the above-mentioned integral parts should be given using subchapters (the structure of the Commission’s screening report should be followed). Plans for alignment of the legislative framework with the acquis If the relevant acquis is not fully transposed, a clear overview of the plan for transposing the key directives (or alignment with key regulations and decisions) should be provided having in mind the target date for the closure of the negotiations (the point of departure is the positions presented at the bilateral screening, in the NPEI adopted and in the action plans and sector strategies adopted to meet the opening or closing benchmarks for the negotiating chapter). Based on any previous situation reports/assessment of administrative capacities, there should be an indication of whether the required capacities are in place or whether they need strengthening. A concise and clear overview should be provided of key activities/measures/steps started, taken or planned in order to establish or strengthen the institutional framework needed to close the negotiating chapter (the point of departure is the positions presented at the bilateral screening, in the NPEI and in action plans and sector strategies adopted in order to meet the opening or closing benchmarks for the negotiating chapter). There should be an indication of the key activities initiated and/or to be initiated and completed. If some of the activities are already finished (as stated in Part II) they can be briefly mentioned and/or it can be referred to the relevant part of the negotiating position in Part II. Some negotiating chapters should also include activities intended for strengthening administrative capacities at the municipal level. The text should focus on measures and timeframes for rectifying the shortcomings found in the screening report adopted by the Council and in the Opening Benchmark Assessment Report. Relevant conclusions of the body tasked with SAA implementation should also be taken into account. Account should also be taken of all other relevant assessments and recommendations (both those clearly stated or communicated implicitly) of the European Union and a position should be taken in that regard in the negotiating position. Connections of certain fields in a chapter with other chapters, which is usually indicated in the screening report, should be taken into account. In this case, these fields should be touched upon, substance of connected positions and addenda should be compared so as to ensure coherence. Unless there is a specific request from the European Commission, it will suffice to list the key steps, for instance by summarising the most important measures set out in strategies and action plans adopted in order to open or close a negotiating chapter.

Plans for strengthening institutional capacities should be realistic and sustainable and should not go beyond what is required for the implementation of the EU legislation. If the existing capacities are suitable, committing to establishing new institutions or to recruiting new staff should be avoided. Training, equipment and similar may be enough to achieve the objective. If the institutional capacities are inadequate, then there should only be an indication of those activities and measures (e.g. establishing new institutions or new employment) that are required for an effective implementation of the acquis, no more, no less. In addition to establishing an institutional framework, certain EU legislation may require qualitative or quantitative results in the field (e.g. coverage of agglomerations by certain infrastructure, achievement of a certain level of recycling of the total mass of packaging waste, ensuring that certain operations are performed by operators with permits compliant with requirements of EU legislation, qualification of food production facilities, etc.). Some requirements may entail a step by step approach or a long period of adaptation. This part should indicate the key activities, plans, stages (and, where relevant, sources of financing) that will be implemented in order to achieve those results. There should be an indication of obligations arising from EU membership that are intended to be implemented after accession to the EU (the name and provision of the EU legislation whose implementation requires a transitional period or other specific adaptation should be indicated). This is where requests are indicated for transitional periods after the accession to the EU or any other negotiation requests that may be defined, together with justification for transitional periods, with implementation plans (by indicating key implementation stages), statistical and financial indicators and analysis. If the justification is accompanied by implementation plans, statistical and financial indicators or larger analyses (exceeding 3 pages), they will be given in an addendum that will contain a clear reference to the part of the position that they clarify, and the text of the position will provide a summary of the main reasons for requesting a transitional period and key stages towards achieving full compliance. If there are requests for specific adaptation (transitional arrangements, permanent exceptions, introduction of certain rights into the EU acquis etc.), considering Albanian specificities, they should be accompanied by a detailed justification for requesting the specific amendment of the EU legislation. III.3. Specific Arrangements The purpose of this part is to state Albania’s position, namely that it accepts the EU acquis as it stands on the date indicated in the negotiating position with certain derogations that are listed in the form of a negotiating request. They should be indicated precisely and concisely (request by request). Negotiating requests represent various forms of specific adaptations of Albania to the EU acquis that respect its specificities or specific circumstances. Negotiating requests cannot ask for changes in principles, criteria and parameters embodied in the EU acquis.

Transitional periods are approved exceptionally and only if the request is well founded. Permanent derogations from the EU acquis regime referred to in the SAA will not be automatically transposed into the accession agreement. Every individual request for adaptation is a separate subject of the accession negotiations. A formula for accepting the acquis with negotiating requests can read as follows: o For transition period The Republic of Albania requires transition period for application of …. for ….. and … until date in order to create conditions for its abolishment, or replacement by …. Explanation. Reasons why the Republic of Albania is requesting a transition period for application of zero rate in …. o for permanent derogation The Republic of Albania requires to continue to apply … exemption for the …, as provided in item … Annex X Section X of the Regulation/Directive year/number/EC, as long as such exemption is applied in any of the Member States, in line with the conditions to be applied as of the day of its accession. Or The Republic of Albania requires a derogation for full implementation of the Directive year/number/EC as regards to the application of … for … so that it can maintain the….. Explanation: These are the reasons for which we believe that keeping the … for the abovementioned is of key importance for … and by doing so the overall sustainability of the system in Albania. III.4. Additional Documents and Addenda Addendum Where they exist and where required, any statistical and financial indicators, analyses and other data of larger volume supporting the statements given in the negotiating position, primarily regarding the requested transitional periods, will be indicated in the addendum of the position. There should be a clear indication of the part of the position to which the addendum is related. Data may also be presented in the text of the position if this is found to be more appropriate.

How large the justifications will be and where they will be indicated can be decided in consultation with the Negotiating Group. Corrigendum If any changes are to be made after the submission of the negotiation position, the new document in the form of Corrigendum is to be sent to the secretariat of the Intergovernmental Conference (Council of the EU and the EU mission of the presiding country of the Council) through MEFA and the Albanian Mission in Brussels to replace the previous negotiation position.

ANNEX 2 – TEMPLATE OF A NEGOTIATION POSITION – MODEL FOR CHAPTER 28 – CONSUMER AND HEALTH PROTECTION7 Government of Albania NEGOTIATING POSITION OF ALBANIA FOR THE INTERGOVERNMENTAL CONFERENCE ON ACCESSION OF ALBANIA TO THE EUROPEAN UNION CHAPTER 28 – CONSUMER AND HEALTH PROTECTION TIRANA, DATE 7 The model of the Negotiation Position has been made based on the examples of Montenegro and Serbia and the explanatory screening for Albania and North Macedonia. The structure of the Negotiation Position of Albania may vary from this example pending the bilateral screening topics and the requests of the European Commission for specific areas to be reported upon.

I SUMMARY OF THE NEGOTIATING POSITION Albania accepts the European Union acquis covered by Chapter 28 – Consumer and Health Protection in effect as of (date of the submission of the negotiating position) and is and is ready to realise its full application until the accession to the EU, with the exception of the Directive … of the European Parliament and of the Council on the …., for the full application of which Albania requests a transitional period. II LEGISLATIVE AND INSTITUTIONAL FRAMEWORK II.a. Consumer protection Legislative framework Horizontal aspects General Product Safety Non-safety issues/protection of consumers’ economic interests Institutional framework and administrative capacities System for consumer protection Non-governmental organisations for consumer protection II.b. Public Health Horizontal aspects Legislative framework Medicinal products (for human and veterinary use) Cosmetic products Medical devices Tobacco control Communicable diseases (Surveillance and reporting; Prevention and control; Health security) Non Communicable diseases Cancer Mental Health Rare diseases Blood, tissues, cells and organs Patients` rights in cross-border healthcare eHealth Social and environmental determinants of health Health inequality/Roma integration Prevention of injury and promotion of safety Healthy lifestyle

- Nutrition - Prevention of alcohol and drugs abuse - Health workforce - Health information (statistics on health) Institutional framework and administrative capacities III ALIGNMENT OF THE LEGISLATIVE AND INSTITUTIONAL FRAMEWORK WITH THE EU ACQUIS IF YOU HAVE A SPECIAL REQURIEMENT (SPECIFIC ARRANGEMET) FOR AN AREA, YOU EXPLAIN IT HERE UNDER THE FIELD: Given the expected difficulties in the transposition and enforcement of the EU acquis in the Albanian legislation, Albania is putting in a request for a transitional period for full implementation of Directive …. on the …., which would end on xx xx ….year (HERE YOU PUT THE DATE UNTIL ALBANIA WILL BE READY TO IMPLEMENT FULLY THE ACQUIS AND TERMINATE THE TRANSITIONAL PERIOD). Rationale: …. Legislative framework General product safety Non-safety issues / protection of consumers' economic interests Institutional framework and administrative capacity III. b. Public health Tobacco control Communicable diseases Blood, tissue, cells and organs Patients' rights in cross-border healthcare Mental health, prevention of drug abuse, health inequalities, nutrition, reduction of harmful effects caused by the use of alcohol, cancer screenings, healthy environment, promotion of safety including prevention of injuries, European action in the field of rare diseases and active and healthy ageing. Mental health Prevention of drug abuse Health inequalities Nutrition Cancer screening Healthy environments, including prevention of injury, promotion of safety, European action in the field of rare diseases, and active and healthy ageing

Institutional framework and administrative capacities Health information

Project: Suppport to Accession Negotiations in Economic Chapters of Acquis (SANECA) Addresss: Str. Ismail Qemali, Nr.3, 2nd Floor, Tirana, ALbania T +355 4 2273424/2234365