The European Medicines Agency has hosted a workshop bringing together regulators, the continent's  health technology assessment bodies and the pharmaceutical industry to improve access to approved drugs.

The EMA-HTA workshop on parallel scientific advice was held earlier this week, building on pilot projects that have been running since 2010. The process allows drug developers to receive simultaneous feedback from both regulators and HTA bodies on their development plans for new medicines.
The EMA says that with the support of the European medicines regulatory network, it has so far conducted 25 parallel scientific advice procedures with several HTA bodies and a further six procedures are expected to start in 2014. A guidance is being developed which will detail "the timelines and actions" for feedback.

In addition, HTA bodies have initiated the Shaping European Early Dialogues for health technologies (SEED) consortium, financed by the European Commission, "to explore a number of scenarios for conducting early dialogues". The EMA will also take part in the dialogues.

The EMA highlights the problem that many new medicines authorised by the European Commission fail to be reimbursed and/or used as expected. "There is a clear need to initiate early dialogue between medicines developers, the EMA and HTA bodies to discuss and agree on a development plan that generates data that both parties can use to determine a medicine's benefit-risk balance and value", the agency says.

Tomas Salmonson, chair of the EMA’s Committee for Medicinal Products for Human Use said the guidance "can be a major tool for medicines development, which will help new medicines with a positive benefit-risk balance and expected added value to reach patients in a faster and more transparent way." He added that this simultaneous feedback "will ultimately lead to better advice for companies, to help them meet the requirements of all stakeholders and consequently increase predictability".

The workshop brought together over 280 representatives, including attendees from the European Commission, European regulators, HTA bodies from 12 European Union countries and  the pharmaceutical industry, as well as patient groups and academics. A report and video from the workshop will be published in early 2014.