EMA looks to sharpen HTA data output
pharmafile | November 20, 2013 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | ABPI, EMA, NICE, hta, transparency
The European Medicines Agency (EMA) has deepened its partnership with the European network for Health Technology Assessment (EUnetHTA) as it looks to do more with its trial data.
In order to help pharma incorporate both clinical and cost-effectiveness into its documents, the EMA and the EUnetHTA have published a joint three-year work plan outlining key areas of collaboration.
Building on the two groups’ collaboration that began in 2010, the key areas for the next three years include:
- scientific advice/early dialogue with sponsors, involving medicines regulators and health-technology assessment (HTA) bodies
- exchange on the development of scientific and methodological guidelines to facilitate clinical-trial design that can generate data relevant for both benefit-risk and relative effectiveness assessments
- developing approaches for collection of post-authorisation data to support activities of both medicines regulatory authorities and HTA bodies
- orphan medicinal products, exploring ways of sharing information for the common benefit of patients affected by rare diseases and the financial sustainability of the healthcare systems.
The collaboration between the EMA and EUnetHTA aims to address recommendations by the Pharmaceutical Forum – a high-level group of European policy makers – to improve the way data published by EU regulators as part of their benefit-risk assessment contribute to relative effectiveness assessments by HTA organisations.
The EMA and EUnetHTA started a project in 2010 that looked specifically into how the information on the benefits and risks of a medicine contained in European public assessment reports (EPARs), could better address the needs of HTA organisations.
The project has resulted in a series of improvements to the EPAR template, and the EMA and EUnetHTA said they are in the “process of publishing the outcome of this project in more detail”.
Trial transparency
Meanwhile, the UK government this week published its thoughts on European data transparency, and said it agrees with the EMA that there should be more access to clinical trial data.
It said in a statement: “Transparency is important for patients, the public, researchers and the NHS, and can be achieved through ensuring that all clinical trials are registered on a public database such as the EU Clinical Trials Register. This means that everybody can see what trials are ongoing, the results of all clinical trials are published, and data from all clinical trials are made available.”
This comes as the European Commission calls for a publically accessible EU database, as currently the EUDRACT database can only be seen by pharma and the regulator.
The new public database will contain details of all trials submitted for authorisation in the EU and summaries of their results within one year, after they have ended. The UK government said it is ‘supportive of these proposals’.
“The government also agrees with the European Parliament that once a regulatory decision has been made, the data in clinical study reports should not be considered commercially confidential” it added.
Ben Adams
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