by Peter O'Donnell
BRUSSELS, May 25 (APM) - Flora Giorgio, the European Commission official responsible for health technology assessment, steered a delicate path through the problems besetting the projected new European system for coordinating this work when she addressed the EUnetHTA Forum in Cologne on Friday.
The Commission draft text released in January (APMHE 56684
) has generated tensions over aspects that are seen as "problematic", she acknowledged, highlighting the concerns raised by several member states over what they see as EU intrusion into their own national prerogatives of a mandatory system of cooperation.
"These criticisms that the text is too prescriptive on mandatory use of output, and too close to national competence, will still be highly debated," she said, acknowledging some of the lively discussions already taking place at the level of diplomats and officials at the level of the EU Council.
"We do not believe that the proposal presents any challenge to subsidiarity".
On the contrary, she insisted that the process will be driven by member states operating as a coordination group, and that the negative interpretations of the draft are the result of misunderstanding.
"There is no intention to have any Commission official drafting a report on joint clinical assessment," she said, suggesting that this was an area where technical issues had taken on a political resonance.
"Some of our wording was perhaps not clear enough," she accepted. "But it is national bodies that will do the work, and the Commission's role will be in support."
The "support", she went on, would be related to issues such as logistics, IT and scientific support.
However, the Commission would also be responsible for publication of the joint assessments created by member states - and that would impose its own specific requirements, Giorgio went on.
She said that the aim was to avoid duplication, rather than "mandatory compliance". There will be a chance for input, but once agreement is reached on an assessment then "there is no going back".
With the Commission publishing the final version of a joint assessment, "at that point the Commission is liable for the document".
"The Commission must be able to respond to any legal challenges - and because of that it will accompany the process of drafting the assessments, to ensure quality standards and due procedure."
And if the Commission judges that an assessment does not match up to those requirements, "it can send it back to the coordination group for a second look".
But she pointed out that so far the work that EUnetHTA has done on joint assessments has not suffered from quality concerns. The main problems have been related to timing.
To allay the concerns that the new system will impact on national decisions on pricing and reimbursement, Giorgio also underlined that the focus of the draft regulation will be clinical, not economic.
This is a practical objective that can be achieved among member states, rather than the more challenging task of a joint comparative appraisal or an economic evaluation.
"It's a joint scientific assessment of clinical aspects," she emphasised. Solutions can be found to give added value to joint assessment while leaving appraisal to national bodies.
The European Parliament is now beginning its work on examining the proposal with "an ambitious agenda", said Giorgio.
MEPs have been appointed to lead the discussion, and the parliament's health committee is planning to discuss the first draft of a report in June, with adoption foreseen in September and a vote in plenary session in October.
Meanwhile, Health Commissioner Vytenis Andriukaitis has been holding bilateral meetings with different stakeholder groups to hear their views: the final meeting in this series, with the pharmaceutical industry, is due to take place within weeks, she said.
Giorgio encouraged vigorous input from all parties at this stage of the process. "The Commission is keen to continue discussion with all stakeholders", she said.
"It is important that you communicate your views to your national officials and your local MEPs, particularly on the problematic elements," she said, adding that Commission officials "are always available to clarify the proposal."
If the proposal is - "maybe, perhaps" - adopted, she remarked, the phase-in is envisaged to take 10 years, so that it would be fully in force by 2027.
"We cannot commit to continue our support to joint HTA if our proposal is not adopted," she said.