statement on the european commission proposal to develop ... - IPPOSI

STATEMENT ON THE EUROPEAN COMMISSION PROPOSAL TO DEVELOP A REGULATION PROMOTING COOPERATION IN THE AREA OF HEALTH TECHNOLOGY ASSESSMENT

February 2018, DUBLIN: IPPOSI welcomes the proposal put forward by the European Commission (EC) on 31 January 2018 to develop a regulation around health technology assessment (HTA), and specifically to require the mandatory cooperation of member states in the area of joint clinical assessment1. We call on the European Parliament and Member States to adopt the EC proposal, and for Irish representatives to clearly advocate for its adoption through the legislative procedure. We believe that the proposed regulation will build upon and formalise the important, and until now, voluntary cooperation between Member States which has been underway for almost three decades. We also believe that only a permanent structure, independently supported by the EC, and implemented in a step-wise approach, can guarantee the long-term cooperation and sharing of scientific expertise and methods across Member State HTA agencies. Efficiency Mandatory joint clinical assessments should create a more efficient process, by reducing the existing duplication arising from 28 Member States engaging in individual assessments of the clinical value of a health technology. We call on the EC to set and adhere to clear timeframes and to ensure that the approval of joint clinical assessment reports, either at the Coordination Group or EC level, does not hamper the completion of national health technology assessments. In this regard, the proposal to coordinate the timing of joint clinical assessments with the timing of the central marketing authorisation procedure must be properly applied. Also, while national authorities should be given sufficient time to comment on draft joint assessments, care should be taken to ensure that Member States do not re-assess clinical domains which have already been assessed (efficacy, safety, relative effectiveness). Currently, national agencies use different methods and sources of data for HTA. By optimising capacities and pooling resources, this regulation will improve disparities in the quality of assessments and in the timing of the decision making.

1

http://europa.eu/rapid/press-release_IP-18-486_en.htm

Digital Office Centre, 12 Camden Row, Dublin 8 D08 R9CN T: 01-4790552 E: [email protected] W: www.ipposi.ie IPPOSI Board of Directors Martijn Akveld (Secretary), Ava Battles (Vice-Chair), Dr Tomás Carroll (Chair), Dr Catherine Darker, Colm Galligan, Colm Fahey, Prof Anne Marie Healy, Deirdre Hyland, Neil Johnson, Prof Jason Last, Dr Robert O’Connor, Karen O’Keeffe, Tom O’Leary, Susanne O’Reilly, Julie Power, Dr Jean Saunders, Prof Gaye Stephens (Treasurer), Philip Watt, Kevin Whelan Registered Company Number: 408258

CHY No: 17079

Transparency As a national competence, questions around how and when decisions are made, what evidence is used to inform decisions, and who is involved in decision-making processes have been traditionally levelled at the relevant national assessment agency. If responsibility for clinical assessment shifts to the European level, IPPOSI believes that patients in Member States will be better equipped to understand the scientific rationale behind the assessment of the added value of health technologies. Evidence-based The requirements laid down for the design of clinical assessments, the information required in dossiers, and the content of assessment reports and summary reports will ultimately determine the success of future cooperation in this area. We ask that the EC engage in a review of national assessment agency processes and select from the available best practice to ensure that clinical assessment standards increase as a result of cooperation. We request that the EC identify sustainable solutions to ongoing challenges faced by national assessment agencies, for example the assessment of health technologies which present with limited clinical evidence or ‘immature’ data, such as rare disease or advanced therapies. In these cases, early dialogue between the EC, manufacturers and patient representatives should be encouraged and assessment methods should be tailored to the special conditions presented by orphan medicines. Participation The joint clinical assessment process should view patients as partners, and we underline in the strongest terms that the new process must – as a priority – secure the confidence of patients and the public. As a first step, we encourage the EC to consult widely with patient communities in developing the tertiary legislation and procedural rules needed to guide the implementation of the regulation. On a more long-term basis, we urge the EC to incorporate the involvement of patients into both the joint clinical assessment and the joint scientific consultation processes. We welcome plans to set up a stakeholder network and to allow nominated representatives to observe the work of the Coordination Group, and we call for the criteria for selecting network members to be as inclusive as possible. We emphasise that patient observers must be afforded the same access to information (including to confidential information) as Coordination Group members, and we call on the EC to put in place the necessary confidentiality agreements to facilitate this. Finally, we support the EC’s vision to ensure that the work undertaken by various European projects informs the development of ground-breaking European legislation around health technology assessment. As the proposed regulation focuses solely on cooperation in the area of joint clinical


CHY No: 17079

assessments, we call for continued commitment to and support for initiatives which also seek to promote voluntary cooperation in other related fields, such as pre-market horizon scanning, early dialogues and post-market real world evidence generation.

IPPOSI – the Irish Platform for Patient Organisations, Science and Industry – is a patient-led organisation that works with patients, government, industry, science and academia to put patients at the heart of health policy and innovation. Learn more at www.ipposi.ie

For media queries, please contact: Ken ROGAN Communications Manager P: 086 317 9955 / +353 (1) 4793273 Irish Platform for Patients' Organisations, Science and Industry (IPPOSI) Digital Office Centre, 12 Camden Row, Dublin 8, D08 R9CN Email: [email protected] Website: www.ipposi.ie IPPOSI Newsletter: www.ipposi.ie/sign-up Twitter: @IPPOSI


CHY No: 17079