About this initiative

Full title

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU

Directorate-General for Health and Food Safety
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Feedback period
1 February 2018 - 2 April 2018
Feedback status: Closed

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Recent feedback

  • European Organisation for Rare Diseases (France)
    30 March 2018 Non-governmental organisation (NGO)
    European Organisation for Rare Diseases (France)

    Transparency and Health Technology Assessment cooperation as proposed by the Regulation are the only real antidote to secrecy and political games Why EURORDIS supports the proposal for a Regulation on Health Technology Assessment (HTA) Cooperation in Europe 30 March 2018, Paris – EURORDIS-Rare Diseases Europe, an alliance of 798 rare disease patient organisations from 69 countries, calls on the European Parliament and Member States to adopt...

  • EFPIA (Belgium)
    30 March 2018 Business association
    EFPIA (Belgium)

    EFPIA welcomes the Commission’s proposal for a Regulation on HTA. This proposal presents a unique opportunity to ensure a degree of harmonisation throughout the European Union, thereby leading to faster patient access to new innovative medicines and synergies in clinical evidence generation needs and assessment by Member States. The proposal clearly states that one of its core objectives is to remove existing divergences in the internal market...

  • COCIR (Poland)
    30 March 2018 Business association
    COCIR (Poland)

    COCIR welcomes the EC proposal on HTA cooperation in the European Union, adopted on 31 January 2018, in which the majority of the concerns highlighted in COCIR contribution to the European Commission public consultation on strengthening of the EU cooperation on HTA are considered. COCIR believes the current EC proposal is an important step towards more harmonized, sustainable and timely joint therapeutic value assessments, which should help...

  • Johnson & Johnson (Belgium)
    29 March 2018 Company/business organisation
    Johnson & Johnson (Belgium)

    Johnson & Johnson (JnJ) welcomes the opportunity to comment on the proposed HTA Regulation. Our companies provide innovative technologies across the Pharmaceutical, Medical Device and Diagnostic sectors, advancing the health and well-being of people around the world. A significant proportion of our technologies are therefore in scope of the Regulation. We have supported early collaborative efforts, such as the EUnetHTA Joint Actions, and...

  • BEUC (Belgium)
    28 March 2018 Consumer organisation
    BEUC (Belgium)

    BEUC comments to European Commission’s proposal Regulation Health Technology Assessment The European Consumers Organization (BEUC) welcomes the European Commission’s proposal on Health Technology Assessment (HTA). Too many new drugs or medical devices do not make a real difference compared to those already on the market but are nonetheless reimbursed by healthcare systems. In addition, an increasing number of medicines are authorised on the...

  • Bundesverband der Arzneimittel-Hersteller e.V. (Germany)
    26 März 2018 Business association
    Bundesverband der Arzneimittel-Hersteller e.V. (Germany)

    Arzneimittel-Hersteller können von einem einheitlichen europäischen HTA-Prozess profitieren, da die unterschiedlichen nationalen und regionalen Anforderungen die Unternehmen vor große Herausforderungen stellen. So variieren der Startzeitpunkt und die Dauer des HTA-Prozesses sowie die klinischen Anforderungen innerhalb der EU-Mitgliedstaaten. Diese teilweise sehr unterschiedlichen nationalen Herangehensweisen bewirken unterschiedliche Resultate...

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