Health Technology Assessment (Italian Edition)

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Health Technology Assessment and vaccine: Abstract Health Technology Assessment HTA can represent an innovative and effective approach to supply decisionmakers with a valid instrument to improve the allocation of resources in the field of vaccines. This approach could be of great interest when the decision making process involves choices regarding new vaccines.

We developed a HTA approach for assessing all of the aspects involved in the introduction of vaccines against HPV in Italy, considering the following issues: A HTA report on the new vaccine could represent an new important tool to support the choice of decision makers in order to better inform the allocation of economic resources and maximize healthcare services, since it takes into account not only the burden and the epidemiology of the disease, and the economic evaluation of different scenarios, but also the social, legal and bioethical aspects.

For HTA to support the introduction of new technologies, and new vaccines can be considered in this sense, there to utilise a process that is well defined, transparent and widely used. Menagement e economia sanitaria , FrancoAngeli Editore, vol. Technology Assessment Statistics Access and download statistics Corrections All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: See general information about how to correct material in RePEc.

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This allows to link your profile to this item. Where the Commission considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment the "List of Assessed Health Technologies" or the "List" at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.

Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report. The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline.

The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group.

Article 6, paragraphs 12 to 14 shall apply. Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies.

If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non-inclusion. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.

For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report on the IT platform referred to in Article 27 and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List. Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion.

That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article Article 9 Updates of Joint Clinical Assessments. The Coordination Group shall carry out updates of joint clinical assessments where: The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

Updates shall be carried out in accordance with the procedural rules established pursuant to Article 11 1 d. During the transitional period referred to in Article 33 1: The Commission shall develop, by means of implementing acts, procedural rules for: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30 2.

Article 12 Requests for Joint Scientific Consultations. Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning data and evidence likely to be required as part of a joint clinical assessment.

In such a case, it shall make that request at the time of submitting an application for scientific advice to the European Medicines Agency. In considering the request for joint scientific consultation, the Coordination Group shall take into account the following criteria: Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation.

Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2. Following the acceptance of a request for a joint scientific consultation in accordance with Article 12 and on the basis of its annual work programme, the Coordination Group shall designate a sub-group to oversee the preparation of the joint scientific consultation report on behalf of the Coordination Group.

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedural rules and documentation established pursuant to Articles 16 and The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation. The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation.

The assessor, with the assistance of the co-assessor, shall prepare the draft joint scientific consultation report. Where, at any stage in the preparation of the draft joint scientific consultation report, the assessor considers that additional evidence from a health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request the additional evidence from the health technology developer. The members of the designated sub-group shall provide their comments during the preparation of the draft joint scientific consultation report.

The assessor shall provide the draft joint scientific consultation report to the submitting health technology developer and set a time-frame in which the developer may submit comments. The designated sub-group shall ensure that stakeholders, including patients and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments. Following receipt and consideration of any comments provided in accordance with paragraphs 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments.

Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice. The assessor, with the assistance of the co-assessor, shall take into account the comments of the members of the designated sub-group and submit the final draft joint scientific consultation report to the Coordination Group. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple majority of Member States, at the latest days following the start of the preparation of the report referred to in paragraph 4.

Article 14 Joint Scientific Consultation Reports. The Coordination Group shall communicate the approved joint scientific consultation report to the requesting health technology developer at the latest 10 working days following its approval. The Coordination Group shall include anonymised summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology for which a joint scientific consultation has been initiated and where the contents of the request are the same as those covered by the joint scientific consultation.

The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning: Article 18 Identification of Emerging Health Technologies. The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems. In the preparation of the study, the Coordination Group shall consult: The conclusions of the study shall be summarised in the Coordination Group's annual report and shall be taken into account in the preparation of its annual work programmes.

Voluntary Cooperation on Health Technology Assessment. Article 19 Voluntary Cooperation. The Commission shall support cooperation and the exchange of scientific information among Member States on: The Coordination Group shall be used to facilitate the cooperation referred to in paragraph 1. The cooperation referred to in paragraph 1 points b and c may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and The cooperation referred to in paragraph 1 shall be included in the annual work programmes of the Coordination Group and the results of the cooperation shall be included in its annual reports and the IT platform referred to in Article Article 20 Harmonised Rules for Clinical Assessments.

The common procedural rules and methodology established in accordance with Article 22 and the requirements established in accordance with Article 23 shall apply to: Article 21 Clinical Assessment Reports. Where a clinical assessment is carried out by a Member State, that Member State shall provide the Commission with the clinical assessment report and summary report at the latest 30 working days after the completion of the health technology assessment.

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The Commission shall publish the summary reports referred to in paragraph 1 in the IT platform referred to in Article 27 and make the clinical assessment reports available to other Member States through that IT platform. Article 22 Common Procedural Rules and Methodology. The Commission shall adopt implementing acts concerning: Implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 30 2.

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Article 24 Union Funding. The financing of the work of the Coordination Group and its sub-groups and activities in support of that work involving its cooperation with the Commission, with the European Medicines Agency, and with the stakeholder network referred to in Article 26 shall be ensured by the Union. The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations. Assessor and co-assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.

Article 25 Commission Support for the Coordination Group. The Commission shall support the work of the Coordination Group. In particular the Commission shall: Article 26 Stakeholder Network. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications.

The Commission shall publish the list of stakeholder organisations included in the stakeholder network. The Commission shall organise ad-hoc meetings between the stakeholder network and the Coordination Group in order to: On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.

On the request of the Coordination Group, the stakeholder network shall support the Coordination Group in the identification of patient and clinical expertise for the work of its sub-groups. Article 27 IT Platform. The Commission shall develop and maintain an IT platform containing information on: The Commission shall ensure appropriate levels of access to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public.

Article 28 Implementation Report. No later than two years after the end of the transitional period referred to in Article 33 1 , the Commission shall report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter. Article 29 Evaluation and Monitoring.

No later than five years after the publication of the report referred to in Article 28, the Commission shall carry out an evaluation of this Regulation, and report on its conclusions. By … [ insert date one year after the date of application ] at the latest, the Commission shall establish a programme for monitoring the implementation of this Regulation. The monitoring programme shall set out the means by which and the intervals at which the data and other necessary evidence will be collected.

The monitoring programme shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence. The annual reports of the Coordination Group shall be used as part of the monitoring programme. Article 30 Committee Procedure. The Commission shall be assisted by a committee. Article 31 Exercise of the Delegation. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from … [insert date of entry into force of this Regulation ]. The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision.

It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.

That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 32 Preparation of Implementing and Delegated Acts. The Commission shall adopt the implementing and delegated acts referred to in Articles 11, 16, 17, 22, and 23, at the latest by the date of application of this Regulation.

When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors. Article 33 Transitional Provisions. Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until Member States shall notify the Commission where they intend to make use of the transitional period set out in paragraph 1 at the latest one year before the date of application of this Regulation.

Member States which have delayed their participation in accordance with paragraph 1 may begin participating with effect from the next financial year after having notified the Commission at least three months before the beginning of that financial year. Article 34 Safeguard Clause. Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

Member States shall notify the Commission of their intention to carry out a clinical assessment using other means together with the justifications for doing so. The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States.

In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved. References to the deleted Article shall be construed as references to this Regulation. Article 36 Entry into Force and Date of Application. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from [insert date 3 years after date of entry into force]. This Regulation shall be binding in its entirety and directly applicable in all Member States.

Duration and financial impact. Management mode s planned. Monitoring and reporting rules. Management and control system. Measures to prevent fraud and irregularities. Heading s of the multiannual financial framework and expenditure budget line s affected. Estimated impact on expenditure. Summary of estimated impact on expenditure. Estimated impact on operational appropriations. Estimated impact on appropriations of an administrative nature.

Compatibility with the current multiannual financial framework. Estimated impact on revenue. The Commission's strategic objectives targeted by this proposal are: The specific objectives of the proposal are: Expected result s and impact. Furthermore, focusing joint assessments on clinical data makes them relevant to all decision-makers, without affecting national competences on pricing and reimbursement decisions. HTA bodies in the EU will be able to specialise in different topics e.

Additionally, the publication of the joint clinical assessment reports will also increase the transparency of decision-making in relation to the availability of health technologies. For industry the proposal has a clear potential to improve business predictability and provide for savings.

It may also have a potential positive impact on time to market and it will reduce duplication of work through harmonisation of tools and methodologies. The proposal takes into account the more decentralised market access pathway for medical devices and does not link the timing of the joint clinical assessments to the timing of the conformity assessment, thus avoiding putting an additional burden on the manufacturers at market launch.

Health technology assessment in Italy.

Overall, a predictable HTA system is expected to re-direct medical device industry resources towards the development of and investment in health technologies which would for instance address unmet medical needs and lead to the improvement of health outcomes for patients. Indicators of results and impact. Requirement s to be met in the short or long term. The proposal addresses the shortcomings of the current model of EU cooperation on HTA impeded and distorted market access for health technologies due to various HTA processes and methodologies across the EU, duplication of work for national HTA bodies and industry, unsustainability of the current cooperation by providing a long-term sustainable solution which enables Member States' HTA authorities and bodies to use their HTA resources more efficiently.

It promotes convergence of HTA tools, procedures and methodologies, reduces duplication of efforts for HTA bodies and industry, and ensures the adequate uptake of joint outputs in Member States. Added value of EU involvement. The diversity and multitude of approaches to HTA across the Member States means that, due to their scale and effect, only action at Union level can eliminate the obstacles described.

Without action at EU level it is unlikely that national rules on how HTAs are carried out would be harmonised and thus the current fragmentation of the internal market would persist. Lessons learned from similar experiences in the past. As proven by the public consultation, the existing EU cooperation on HTA including the HTA Network the strategic arm and the EUnetHTA Joint Action as the scientific and technical arm has been useful for building trust between HTA bodies and stakeholders, for increasing knowledge of working procedures and methodologies in Member States, and for the sharing of best practices and capacity building.

The public consultations also confirmed the existence of important shortcomings which cannot be addressed by the current cooperation model e. While this proposal builds on the tools, methodologies and experience from the EUnetHTA Joint Actions, it addresses the abovementioned shortcomings, taking into account not only the needs of the Member States authorities but also those of industry, healthcare professionals and patients See section 1.

Compatibility and possible synergy with other appropriate instruments. The proposal constitutes a coherent approach, well in line with the EU's overarching objectives, including a smooth functioning of the internal market, sustainable health systems and an ambitious research and innovation agenda. In addition to coherence with these EU policy objectives, the proposal is compatible, coherent and complementary to existing EU legislation related to medicinal products and medical devices. For example, there are opportunities for mutual information-sharing and better alignment of the timing of procedures between the joint clinical assessment and the centralised marketing authorisation for medicinal products.

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Synergies are also expected between joint clinical assessments for medical devices and some of the provisions foreseen by the new EU Regulations for medical devices and in vitro diagnostics e. Moreover, the joint scientific consultations foreseen in this proposal will contribute to the objectives of related EU legislation on clinical trials to ensure that the evidence generated in clinical studies is robust and benefits patients and public health.

The proposal could also provide useful input to and synergies with the Digital Single Market agenda by encouraging innovation and research of high-tech health technologies and by supporting the development of a European IT infrastructure supporting EU cooperation on HTA. The Commission intends to ensure the provision of the services concerned via centralised direct management through its own services, including technical, scientific and logistic support. The Coordination Group and sub-groups will provide a regular platform to discuss issues related to the implementation of the new regulatory framework.

Monitoring of the implementation will also be facilitated by the IT Platform to be set up. No later than two years after the end of the transitional period foreseen by this proposal, the Commission will report on the implementation of the scope and support framework. The proposal also lays down a requirement for regular monitoring and reporting by the Commission on the implementation of the Regulation.

Information concerning the internal control system set up.