by Belen Diego
MADRID, Nov 28 (APM) - With a new health minister expected to be appointed on Wednesday following Ana Mato’s resignation (APMMA 40597) branded and generic manufacturers operating in Spain have said they hope the change will not affect new pricing regulation, the first draft of which is set for release before year end.
In October, the Spanish ministry of health introduced pricing talks with players before it publishes the draft of a new pricing and reimbursement regulation. It was a switch from its historical approach of publishing and then negotiating with interested parties (APMMA 40233) which has been welcomed by pharma.
Now, after months of meetings with the ministry, pharma and generic manufacturers have said this work appears to be in jeopardy because they do not know whether the new minister will carry on with the regulation or take a new path.
Speaking at a meeting with media on Friday Humberto Arnés, lobby group Farmaindustria’s director general, said new regulation should take into account the value of innovative drugs, with prices closer to those of other EU members.
Value-based evaluation is a key instrument Farmaindustria has presented during its meetings with the ministry (APMMA 33367) (APMMA 39757).
Lourdes Fraguas, Farmaindustria’s secretary general, also a speaker at the meeting, said there is uncertainty concerning pricing regulation. “With current regulation, incomplete in a number of aspects, there is a wide range for interpretation. What we think would be best for the industry is detailed pricing procedures, that would help create a more homogeneous, stable legal frame for pharma”, she said.
Emili Esteve, director of Farmaindustria’s technical division, also at the meeting, said it is crucial that new regulation unifies criteria. As an example, Esteve said guidance on how to use a drug, known as therapeutic positioning reports (IPTs) should carry two separate evaluations, one focused on healthcare results and a second one based on economic issues.
The latest IPTs published by the ministry, the ones for Gilead's Sovaldi (sofosbuvir) and Janssen's Olysio (simeprevir), did not include economic evaluation (APMMA 40497).
Spanish generic manufacturers association AESEG's director general, Ángel Luis Rodríguez de la Cuerda, said the best case scenario is the new minister maintains Mato’s team line of work.
“There has been a fluent dialogue with the ministry while she was in office. The whole team has acknowledged the importance of generics as a strategic product which contributes to the healthcare system’s sustainability”, he said in a telephone interview on Thursday.
“Ana Mato’s resignation had really nothing to do with her work at the ministry. We hope this change does not affect the process of approval of new pricing regulation we have been working on for months now”, he said.
It is likely that the new minister will soon get acquainted with the members of the pricing commission. On December 3, two of its members, representatives of Spanish autonomous regions, will be replaced during the meeting of the council of regions, which gathers health chiefs from autonomous regions to co-ordinate health policies with the ministry.
Spanish medical association OMC said there have been “lights and shadows” concerning Mato’s work at the ministry, with some fruitful initiatives and others still ongoing.
OMC said it offered to co-operate with the new minister in order to accurately evaluate healthcare technologies so that the more cost-efficient one are utilised.
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