by Catherine Featherston
BERLIN, Sep 29 (APM) - A European Network for HTA (EUnetHTA) equal in stature to the European Medicines Agency (EMA) but fully independent is needed in order to solicit better heath technology assessment (HTA) data quality, said the head of pharmaceuticals at Germany's higher HTA body G-BA.
"We HTA bodies have to move on an EU level to get into a better position concerning the needs for clinical evidence," said Thomas Mueller at the Forum-Institut für Management conference on HTA in Germany and the EU in Berlin on Thursday.
"It's very clear that we need EMA and EUnetHTA to be equal partners," he added.
Mueller was speaking in a session about the German political perspective on European harmonisation.
Germany is strongly opposed to the idea of joint production of HTA reports, Mueller said but he does see a centralised procedure for evidence requirements as very possible.
"G-BA has learned that studies will not be designed according to national demands," he said.
"The pharma companies think globally and they don't have the financial power or time to make studies for every market," he added.
Regulatory and HTA agreement
Beyond the need for EU countries to work together on establishing common HTA evidence requirements, the process must be closely aligned with regulatory procedures from the EMA, Mueller said."EUnetHTA and EMA will be independent, but the protocol that you get as a company in the form of scientific advice will be binding on the subsequent national assessments," Mueller said.
In particular, it is important that the two bodies come to some agreement on endpoints, surrogates, biomarkers and populations, he said.
For example, he said EMA and EUnetHTA have very different approaches on populations.
"EMA is looking at very clinically pure populations and HTA [bodies ] normally are looking for more realistic populations," he said.
Ultimately, study design is a compromise between various needs and interests, Mueller said, and it is a strategic decision on the company's part. "We will not make the decision for you."
Legal backing for HTA data
Mueller acknowledged that providing joint advice on clinical evidence is only reasonable and sensible if the company can rely on the resulting protocol being taken into consideration and accepted in subsequent assessments.To that end, there must be some kind of legal backing for HTA data, he said.
A potential solution for providing these data with a legal framework would be to add HTA-type endpoints into early discussions with the EMA, a conference attendee suggested.
Because the regulatory procedure including the selection of endpoints leads to licensing, regulatory endpoints are by their nature part of a legal framework, he said. Mueller agreed with this point.
"That's the goal," said Mueller. "We need a legal framework for the EUnetHTA position."
Mueller said the European Commission is working on a first draft of legislation to provide HTA data with a legal framework, and it expects to have a first draft by the end of 2017. But new legislation will take time, he concluded.
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