In a meeting held in the European Parliament on 5 June, the Patient Access Partnership (PACT) welcomed the Commission’s proposal regarding the future of EU cooperation on HTA and its potential to improve access to innovative health technologies for patients across the EU. This meeting, hosted by the Parliament’s Interest Group on Patient Access to Healthcare, aimed to gather health stakeholders’ perspectives on this proposal before the consideration of the Parliament’s draft report in the ENVI Committee on 7 June.
The event, jointly chaired by the Co-Chairs of the Interest Group on Access to Healthcare and PACT’s Secretary-General Stanimir Hasardzhiev, was attended by all Interest Group’s co-chairs and some 100 key health stakeholders.
Speaking in the event, DG SANTE’s Anna-Eva Ampelas presented the proposed HTA Regulation, underlining that better cooperation can result in effective, innovative health tools reaching patients faster as ‘this initiative will lead to a better and more effective use of Member States’ resources, exchange of expertise and will avoid duplication of efforts’.
Representing the current and upcoming EU Presidencies, Prof. Ilko Getov (Bulgarian Ministry of Health, HTA Committee Chair) and Philipp Tillich (Health Attaché, Permanent Representation of Austria to the EU) both underlined the sensitive nature of the Commission proposal. While the need for a more formal cooperation on HTA is clearly recognised after 28 years of voluntary cooperation, there are elements in the proposal – e.g. the fact that cooperation will be mandatory – that will need careful deliberation and discussion. However, both representatives expressed their country’s intention to find positive solutions.
European Parliament Rapporteur Soledad Cabezon Ruiz (S&D, Spain) welcomed the Commission’s proposal as ‘timely’ and underlined its added value as ‘it represents a further step towards closer EU integration in the health arena’. She argued that ‘Europe needs more and better clinical evidence, to determine the efficacy and therapeutic advantage of medicines…any policies regulating health and healthcare provision must have the aim of guaranteeing access to medicines for patients’. Trust, quality and scientific evidence are key concepts if European cooperation in the field of HTA is to be a success.
Kaisa Immonen, speaking on behalf of the European Patients’ Forum, underlined EPF’s commitment to work closely with the European legislators ‘towards a sustainable European framework for HTA where patients are actively and meaningfully involved as partners and which ensures timely and equitable access for patients to medical technologies that add value and improve their lives’.
François Houÿez, representing EURORDIS, also welcomed the Regulation, as ‘it will help patients across the EU to know on which scientific grounds health technologies are reimbursed or not’. He also emphasised the need for meaningful and equitable involvement of patients in the HTA process and governing bodies.
MEPs present emphasised the need for cooperation in the field of HTA; the current fragmented situation, with different methodologies, timelines and conclusions needs to be amended as a matter of urgency. They welcomed the Commission proposal as it has ‘the clear potential to address health inequalities and ensure better health outcomes’.
Stakeholders intervening in the audience debate generally welcomed the Commission′s proposal, emphasising the need to address the current fragmented situation and pooling of precious resources. Remarks were made about the need to include a sense of proportionality when referring to medical devices and to include stakeholders in the ongoing deliberations, also at Council level.
The report from the meeting is available below:
1. The Patient Access Partnership on Equity of Access to Quality Healthcare (PACT) was officially launched in 2014 to tackle the issue of health inequalities from the perspective of patients. This patient-led network brings together the patients, the medical community, the industry and the European policy-makers to ensure equal access to quality healthcare is a priority of the EU institutions too as Member States alone cannot tackle this problem. Besides this, a genuine involvement of all stakeholders engaged with healthcare is vital to find workable solutions to fit real-life needs.
2. The Interest Group on Patient Access to Healthcare: officially launched on 27 January 2015 the European Parliament Interest Group aims to tackle health inequalities and enhance proper access to high-quality healthcare for all patients. The main objective of the Group is to play a major role in providing a platform for discussion and concrete action, in cooperation with patients and the healthcare community. It will also promote synergies and knowledge-sharing regarding disease specific initiatives in the EP relating to access, and other thematic interest groups to ensure maximum effectiveness. The secretariat is being provided by the PACT.
3. The proposed Regulation on health technology assessment covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas. Member States will be able to use common HTA tools, methodologies and procedures across the EU, working together in four main areas:
1) on joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
2) on joint scientific consultations whereby developers can seek advice from HTA authorities;
3) on identification of emerging health technologies to identify promising technologies early;
4) on continuing voluntary cooperation in other areas. Individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.
4. The proposed Regulation can be found here