(1)

The development of health technologies is a key driver of economic growth and innovation in the Union and is key to achieving the high level of health protection that health policies need to ensure for the benefit of all. Health technologies constitute an innovative sector of the economy and form part of an overall market for healthcare expenditure that accounts for 10 % of Union gross domestic product. Health technologies encompass medicinal products, medical devices, in vitro diagnostic medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

(2)

Health technology assessment (HTA) is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.

(3)

HTA is able to contribute to the promotion of innovation, which offers the best outcomes for patients and society as a whole, and is an important tool for ensuring proper application and use of health technologies.

(4)

HTA can cover both clinical and non-clinical aspects of a health technology, depending on the healthcare system. The Union’s co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current health technology, the examination of the technical characteristics of the health technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a health technology, and its ethical, organisational, social and legal aspects.

(5)

HTA can improve scientific evidence used to inform clinical decision-making and patient access to health technologies, including where a health technology becomes obsolete. The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems, and stimulate innovation that delivers better outcomes for patients.

(6)

The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment can result in health technology developers being confronted with multiple and divergent requests for data. It can also lead to both duplication and variation in outcomes, resulting from the specific national healthcare context.

(7)

While Member States have carried out some joint assessments within the framework of the EUnetHTA Joint Actions, the voluntary cooperation and production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. The use of the results of the EUnetHTA Joint Actions, including their joint clinical assessments, at Member State level has remained limited, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed. On the other hand, the main outcomes of the EUnetHTA Joint Actions should be considered when implementing this Regulation, in particular scientific output such as methodological and guidance documents as well as information technology (IT) tools to store and exchange information.

(8)

In its conclusions of 1 December 2014 on innovation for the benefit of patients (3), the Council acknowledged the key role that HTA has as a health policy tool to support evidence-based, sustainable and equitable choices in healthcare and health technologies for the benefit of patients. In those conclusions, the Council further called on the Commission to continue to support cooperation in a sustainable manner, and asked for joint work between Member States on HTA to be enhanced and for opportunities for cooperation on exchange of information between competent bodies to be explored. Furthermore, in its conclusions of 7 December 2015 on personalised medicine for patients (4), the Council invited Member States and the Commission to strengthen HTA methodologies applicable to personalised medicine, and the Council conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the European Union and its Member States (5) provided further evidence that Member States see clear added value in cooperation on HTA. The joint report of October 2016 of the Commission’s Directorate-General for Economic and Financial Affairs and the Economic Policy Committee further called for enhanced European cooperation on HTA. Finally, in its conclusions of 15 June 2021 on Access to medicines and medical devices for a Stronger and Resilient EU (6), the Council invited Member States and the Commission to explore the possibility of establishing an EU Real-World data collection and evidence generation action plan, which will promote better collaboration between ongoing national and cross-border initiatives and which could contribute to reducing evidence gaps in HTA and payer decisions.

(9)

The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines (7), called on the Commission to propose legislation on a European system for HTA as soon as possible and to harmonise transparent HTA criteria in order to assess the added therapeutic value and relative effectiveness of health technologies compared with the best available alternative, that takes into account the level of innovation and benefit for patients.

(10)

In its communication of 28 October 2015 on Upgrading the Single Market: more opportunities for people and business, the Commission declared its intention to introduce an initiative on HTA to increase coordination in order to avoid multiple assessments of a product in different Member States and improve the functioning of the Single Market for health technologies.

(11)

This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, medical devices and in vitro diagnostic medical devices. At the same time, this Regulation establishes a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies. Both objectives are being pursued simultaneously and, whilst inseparably linked, one is not secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation sets out the procedures and the rules for carrying out joint work and establishing a framework at Union level. As regards Article 168 TFEU, whilst aiming at providing a high level of health protection, this Regulation allows for cooperation between Member States on certain aspects of HTA.

(12)

Joint work should be produced following the principle of good administrative practice, and it should aim to achieve the highest level of quality, transparency and independence.

(13)

Health technology developers often face the difficulty of submitting the same information, data, analyses and other evidence to different Member States, and also at various points in time. The duplication of submissions and consideration of different timings for submission across Member States can constitute a significant administrative burden for health technology developers, in particular for smaller companies with limited resources, and might contribute to impeding and distorting market access, leading to a lack of business predictability, higher costs and, in the long run, negative effects on innovation. Thus, this Regulation should provide for a mechanism that ensures that any information, data, analyses and other evidence required for the joint clinical assessment should be submitted only once at Union level by the health technology developer.

(14)

In accordance with Article 168(7) TFEU, the Member States are responsible for the definition of their health policy and for the organisation and delivery of health services and medical care. Those responsibilities include the management of health services and medical care and especially the allocation of the resources assigned to them. It is necessary therefore that Union action is limited to those aspects of HTA that relate to the joint clinical assessment of a health technology and to ensure in particular that there are no value judgements in joint clinical assessments in order to respect the responsibilities of Member States pursuant to Article 168(7) TFEU. In that regard, the joint clinical assessments provided for by this Regulation constitute a scientific analysis of the relative effects of the health technology as assessed on the health outcomes against the chosen parameters which are based on the assessment scope. The scientific analysis will further include consideration of the degree of certainty of the relative effects, taking into account the strengths and limitations of the available evidence. The outcome of joint clinical assessments should therefore not affect the discretion of Member States to carry out assessments on the clinical added value of the health technologies concerned or predetermine subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement decisions, which could depend on both clinical and non-clinical considerations individually, or together, and which remain solely a matter of national competence.

(15)

Member States should be able to perform complementary clinical analyses, which are necessary for their overall national HTA process, on the health technologies for which a joint clinical assessment report is available. In particular, Member States should be able to perform complementary clinical analyses relating, inter alia, to patient groups, comparators or health outcomes other than those included in the joint clinical assessment report, or using a different methodology if that methodology would be required in the overall national HTA process of the Member State concerned. If additional information, data, analyses and other evidence is needed for complementary clinical analyses, Member States should be able to ask the health technology developers to submit the necessary information, data, analyses and other evidence. This Regulation should not restrict in any way Member States’ rights to perform non-clinical assessments on the same health technology prior to, during the preparation of, or after the publication of a joint clinical assessment report.

(16)

In order to guarantee the highest quality of joint clinical assessments, ensure a wide acceptance and enable pooling of expertise and resources across national HTA authorities and bodies, it is appropriate to follow a stepwise approach, starting with a small number of jointly assessed medicinal products and only at a later stage requiring joint clinical assessments to be carried out for other medicinal products undergoing the centralised marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council (8) and where those medicinal products are subsequently authorised for a new therapeutic indication.

(17)

Joint clinical assessments should also be carried out on certain medical devices as defined in Regulation (EU) 2017/745 of the European Parliament and of the Council (9) which are in the highest risk classes and for which the relevant expert panels referred to in Article 106(1) of that Regulation have provided their opinions or views, as well as on in vitro diagnostic medical devices classified as class D pursuant to Regulation (EU) 2017/746 of the European Parliament and of the Council (10).

(18)

Taking into consideration the complexity of certain medical devices and in vitro diagnostic medical devices, and the expertise required to assess them, Member States should be able, where they see an added value, to undertake voluntary cooperation on HTA on medical devices classified as class IIb or III pursuant to Article 51 of Regulation (EU) 2017/745 and in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 which are software and which do not fall within the scope of joint clinical assessments under this Regulation.

(19)

In order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant, of high quality and based on the best scientific evidence available at any given time, it is appropriate to establish conditions for updating those assessments, in particular where additional data that becomes available subsequent to the initial assessment has the potential to increase the accuracy and quality of the assessment.

(20)

A Member State Coordination Group on Health Technology Assessment (the ‘Coordination Group’) composed of Member States’ representatives, in particular from HTA authorities and bodies, should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work within the scope of this Regulation. In order to ensure a Member State-led approach to joint clinical assessments and joint scientific consultations, Member States should designate the members of the Coordination Group. Those members should be designated with the goal of ensuring a high level of competence in the Coordination Group. Members of the Coordination Group should designate HTA authorities and bodies to the subgroups, which provide adequate technical expertise for carrying out joint clinical assessments and joint scientific consultations, taking into account the need to provide expertise on the HTA of medicinal products, medical devices and in vitro diagnostic medical devices.

(21)

To reflect the scientific nature of the cooperation and ensure that decisions taken by the Coordination Group meet the objectives of guaranteeing joint work of the highest scientific quality and impartiality, the Coordination Group should use its best endeavours to reach a consensus. If such a consensus cannot be reached, and in order to ensure a smooth decision-making mechanism in the Coordination Group, decisions of a technical and scientific nature should be taken on a simple majority basis where one vote is given to each Member State irrespective of the number of members of the Coordination Group from any given Member State. By way of exception, and given its different nature, decisions on the adoption of the annual work programme, the annual report and the strategic direction for the work of the subgroups should be taken on a qualified majority basis.

(22)

The Commission should not take part in votes on joint clinical assessments or comment on the content of joint clinical assessment reports.

(23)

The Coordination Group should ensure that the scientific joint work as well as the procedures and methodology for the preparation of joint clinical assessment reports and joint scientific consultation outcome documents guarantee the highest quality, are prepared in a timely manner, and reflect the state of the art of medical science at the time of their preparation.

(24)

Methodologies for performing joint clinical assessments and joint scientific consultations should be adapted to include specificities of new health technologies for which some data may not be readily available. This may be the case for, inter alia, orphan medicinal products, vaccines and advanced therapy medicinal products.

(25)

The assessment scope for joint clinical assessments should be inclusive and should reflect all Member States’ needs in terms of data and analyses to be submitted by the health technology developer.

(26)

Where joint clinical assessments are used to prepare subsequent administrative decisions at Member State level, they constitute one of several preparatory steps in a multi-step procedure. Member States remain the sole entity responsible for national HTA processes, for the conclusions on the value of a health technology and for the decisions resulting from HTAs. Member States should be able to determine at which step of their HTA process, and by which authority or body, the joint clinical assessment reports should be considered.

(27)

The Coordination Group should make all efforts to endorse the joint clinical assessment report by consensus. Where a consensus cannot be reached, and with a view to ensuring the finalisation of joint clinical assessment reports within the timeframe set, divergent scientific opinions should be included in those reports. To ensure the integrity of the system of joint clinical assessments and the aim for consensus, the inclusion of divergent scientific opinions should be limited to those opinions which are fully justified on scientific grounds, and therefore should be considered as an exceptional measure.

(28)

Member States should remain responsible for drawing conclusions at national level on the clinical added value of a health technology, as such conclusions depend on the specific healthcare context in any given Member State, and on the relevance of individual analyses included in the joint clinical assessment report (for example, several comparators could be included in the joint clinical assessment report, of which only a selection is relevant to a given Member State). The joint clinical assessment report should include a description of the relative effects observed for the health outcomes analysed, including numerical results and confidence intervals, and an analysis of scientific uncertainty and strengths and limitations of the evidence (for example, internal and external validity). The joint clinical assessment report should be factual and should not contain any value judgement, ranking of health outcomes, conclusions on the overall benefit or clinical added value of the assessed health technology, any position on the target population in which the health technology should be used, or any position on the place the health technology should have in the therapeutic, diagnostic or preventive strategy.

(29)

Transparency and public awareness of the process is essential. Where there is confidential data for commercial reasons, the reasons for confidentiality need to be clearly set out and justified and the confidential data well delimitated and protected.

(30)

Where Member States conduct HTAs at national or regional level for health technologies that have been assessed at Union level, they should consider the joint clinical assessment reports at that level. In that regard, especially taking into account that different timing can apply for national HTA decisions, Member States should be able to take into account information, data, analyses and other evidence that were not part of the joint clinical assessment at Union level. The HTA conducted at national or regional level on a health technology that has been assessed at Union level should be made available to the Coordination Group.

(31)

In the context of this Regulation, the term ‘give due consideration’, when applied to a joint clinical assessment report, means that the report should be part of the documentation of authorities or bodies involved in HTA activities at Member State or regional level and should be considered for any HTA at Member State level. If the joint clinical assessment report is available, it should be part of the documentation that supports the national HTA process. However, the content of the joint clinical assessment report is scientific in nature and should not be binding on those authorities or bodies or on Member States. If a joint clinical assessment report is not available at the time when the national HTA is finalised, this should not delay any subsequent process at Member State level. A joint clinical assessment report should have no external impact on applicants and other parties other than the Member States.

(32)

The obligation on Member States not to request at national level any information, data, analyses or other evidence which has been submitted by health technology developers at Union level reduces, where health technology developers comply with information submission requirements laid down pursuant to this Regulation, the administrative and financial burden on them which would result from being confronted with multiple and divergent requests for information, data, analyses or other evidence at Member State level. That obligation should however not exclude the possibility of Member States asking health technology developers for clarification about the submitted information, data, analyses or other evidence.

(33)

The obligation on Member States not to request at national level the same information, data, analyses or other evidence that has been already submitted by health technology developers at Union level should not encompass requests of information, data, analyses or other evidence within the scope of early access programmes at Member State level. Such early access programmes at Member State level aim to provide patient access to medicinal products in situations of high unmet medical needs before a centralised marketing authorisation has been granted.

(34)

Health technology developers should not submit any information, data, analyses or other evidence at national level that has been already submitted at Union level. This ensures that Member States can only request information, data, analyses and other evidence from health technology developers at Member State level that are not already available at Union level.

(35)

For medicinal products, directly comparative clinical studies which are randomised, blinded and include a control group, the methodology of which conforms to international standards of evidence-based medicine, should be preferentially considered when conducting a joint clinical assessment. That approach should however not per se exclude observational studies, including those based on real world data, when such studies are accessible.

(36)

The timeframe for joint clinical assessments for medicinal products should be fixed, as far as possible, by reference to the timeframe applicable to the completion of the centralised marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure that joint clinical assessments could effectively facilitate market access and contribute to the timely availability of innovative health technologies for patients. Health technology developers should therefore respect the deadlines established pursuant to this Regulation when submitting the requested information, data, analyses and other evidence.

(37)

The establishment of a timeframe for the joint clinical assessments for medical devices and in vitro diagnostic medical devices should take into account the highly decentralised market access pathway for those devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after the medical device or the in vitro diagnostic medical device has been placed on the market, and in order to allow for their selection for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place after their placing on the market.

(38)

In all cases, the joint work carried out under this Regulation, in particular the joint clinical assessments, should aim to produce high-quality and timely results, and foster greater collaboration between Member States on HTA for medical devices and in vitro diagnostic medical devices and should not delay or interfere with the CE marking of medical devices or in vitro diagnostic medical devices, or delay their market access. This work should be separate and distinct from the regulatory assessments conducted pursuant to Regulations (EU) 2017/745 and (EU) 2017/746 and should have no impact on decisions taken in accordance with those Regulations.

(39)

In order to facilitate the process of preparing joint clinical assessments, health technology developers should, in appropriate cases, be afforded the opportunity to engage in joint scientific consultations with the Coordination Group in order to obtain guidance on the information, data, analyses and other evidence that are likely to be required from clinical studies. Clinical studies comprise clinical trials of medicinal products, clinical investigations required for the clinical evaluation of medical devices and performance studies required for performance evaluations of in vitro diagnostic medical devices. Given the preliminary nature of the consultation, any guidance offered should not be legally binding either on the health technology developers or on HTA authorities and bodies. Such guidance, however, should reflect the state of the art of medical science at the time of the joint scientific consultation, in particular in the interest of patients.

(40)

Where joint scientific consultations are carried out in parallel with the preparation of scientific advice on medicinal products provided for under Regulation (EC) No 726/2004 or in parallel with the consultation on medical devices provided for in Regulation (EU) 2017/745, those parallel processes, including information exchange between the subgroups and the European Medicines Agency or the expert panels on medical devices, should be carried out with a view to ensuring that the generation of evidence fulfils the needs of the respective frameworks, while preserving the separation of their respective remits.

(41)

Joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of joint clinical assessments and joint scientific consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary that any information made public about the results of joint scientific consultations is presented in an anonymised format with the removal of any information of a commercially sensitive nature.

(42)

In order to ensure the efficient use of available resources, it is appropriate to provide for a ‘horizon scanning’ exercise, to allow the early identification of emerging health technologies that are likely to have a major impact on patients, public health and healthcare systems, as well as to inform research. Such horizon scanning could be used to support the Coordination Group in planning its work, in particular in relation to joint clinical assessments and joint scientific consultations, and could also provide information for long term planning purposes at both Union and national levels.

(43)

The Union should continue to support voluntary cooperation on HTA between Member States in areas such as the development and implementation of vaccination programmes and the capacity building of national HTA systems. Such voluntary cooperation should also facilitate synergies with initiatives under the digital single market strategy in relevant digital and data-driven healthcare areas with a view to providing additional real world evidence relevant for HTA. The voluntary cooperation on HTA can also cover areas such as diagnostics used to supplement treatment, surgical procedures, prevention, screening and health promotion programmes, information and communications technology tools and integrated care processes. Different demands are involved in assessing different health technologies, depending on their specific features, meaning that a cohesive approach which can cater for those different health technologies is needed in the field of HTA.

(44)

In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with stakeholder organisations with an interest in Union cooperation on HTA, including patient organisations, healthcare professional organisations, clinical and learned societies, health technology developer associations, consumer organisations and other relevant non-governmental organisations in the field of health. A stakeholder network should be set up to facilitate dialogue between stakeholder organisations and the Coordination Group.

(45)

In order to ensure that joint work is of the highest scientific quality and reflects the state of the art, external experts with relevant in-depth specialised expertise should provide input on joint clinical assessments and joint scientific consultations. Such experts should include clinical experts in the therapeutic area concerned, patients affected by the disease, and other relevant experts on, for example, the type of health technology concerned or issues related to clinical study design. European Reference Networks could also be used as source to identify those experts and access relevant knowledge in specific therapeutic areas. Patients, clinical experts and other relevant experts should be selected for their subject matter expertise and act in individual capacity rather than representing any particular organisation, institution or Member State. In order to preserve the scientific integrity of the joint clinical assessments and joint scientific consultations, rules should be developed to ensure the independence and impartiality of patients, clinical experts and other relevant experts involved, and avoid conflicts of interest.

(46)

Cooperation in the field of HTA plays an important role throughout the health technology lifecycle from the early developmental stage, through horizon scanning and joint scientific consultation, and later once the health technology is on the market through a joint clinical assessment and its update.

(47)

In order to ensure a uniform and Member State-driven approach to the joint work provided for in this Regulation, the Coordination Group should develop its detailed procedural steps and the timeframe for joint clinical assessments, updates of joint clinical assessments and joint scientific consultations. Where appropriate, and taking into account the results of the work undertaken in the EUnetHTA Joint Actions, the Coordination Group should develop distinct rules for medicinal products, medical devices and in vitro diagnostic medical devices.

(48)

The Coordination Group should develop methodological guidance on the joint work provided for in this Regulation, following international standards of evidence-based medicine. The assessment process should rely on relevant, up-to-date and high quality clinical evidence. The Coordination Group should also develop guidance on the appointment of assessors and co-assessors for joint clinical assessments and joint scientific consultations, including on the scientific expertise required to implement the joint work set out in this Regulation.

(49)

In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers should be conferred on the Commission to decide that, where certain conditions are met, other medicinal products should be subject to joint clinical assessments at a date prior to that established in this Regulation, to select certain medical devices and in vitro diagnostic medical devices to be subject to joint clinical assessments, and to establish detailed procedural rules related to certain aspects of joint clinical assessments and joint scientific consultations, general procedural rules regarding certain aspects of joint clinical assessments, and the format and the templates of submission and report documents. Where appropriate, distinct rules should be developed for medicinal products, medical devices and in vitro diagnostic medical devices. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11).

(50)

When preparing the implementing acts referred to in this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including with the Coordination Group and at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (12).

(51)

In order to ensure that sufficient resources are available for the joint work provided for under this Regulation, the Union should seek to provide stable and permanent financing for the joint work and voluntary cooperation, and for the framework to support those activities. The financing should cover in particular the costs of producing joint clinical assessment and joint scientific consultation reports. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group.

(52)

In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should build on databases and functionalities developed under the EUnetHTA Joint Actions for the exchange of information and evidence, and aim to ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA, such as registries and databases related to real world data. In developing such an IT platform, the opportunities offered by the future European Health Data Space should be also explored.

(53)

In order to ensure the smooth establishment and operation of Union-level joint clinical assessments, as well as to safeguard their quality, it is appropriate to start with a small number of joint clinical assessments. As from three years after the date of application of this Regulation, a progressive expansion of the number of joint clinical assessments should take place.

(54)

In order to ensure that the support framework continues to be as efficient and cost-effective as possible, the Commission should report to the European Parliament and to the Council on the application of this Regulation no later than three years after its date of application. The report should focus on reviewing the added value of the joint work for the Member States. In particular, the report should consider whether there is a need to introduce a fee-paying mechanism, which would ensure the independence of the Coordination Group, through which health technology developers would also contribute to the financing of joint scientific consultations. In addition, the report should review the effect of the non-duplication of the request of information, data, analyses and other evidence for joint clinical assessment in terms of reducing the administrative burden for the Member States and health technology developers, facilitating market access for new and innovative products and reducing costs. The report could trigger an assessment on the progress made regarding patient access to innovative health technologies, the sustainability of health systems and the HTA capacity at Member State level.

(55)

No later than two years after the beginning of assessing medicinal products that fall under the scope of this Regulation, Member States should report to the Commission on the application of this Regulation and, in particular, on their assessment of the added value of the joint clinical assessment reports in their national HTA processes and the workload of the Coordination Group.

(56)

In order to adjust the list of information to be submitted by health technology developers, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in view of amending Annexes I and II. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(57)

Directive 2011/24/EU of the European Parliament and of the Council (13) provides that the Union is to support and facilitate the cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for HTA designated by the Member States. As those matters are governed by this Regulation, Directive 2011/24/EU should be amended accordingly.

(58)

Since the objective of this Regulation, namely to establish a framework of joint clinical assessments of health technologies that fall under the scope of this Regulation at Union level, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,