The European Medicines Agency (EMA) hosted a one-day workshop on Nov. 26, 2013, which brought together regulators, health-technology-assessment (HTA) bodies and the pharmaceutical industry to discuss how to generate evidence in drug development and improve medicines access. Some new drugs approved in the EU do not get reimbursed because they fail to meet the requirements of HTA bodies. This issue indicates the need for drug developers to have early communications with EMA and HTA bodies and form on a drug development plan that generates the required benefit-to-risk balance and value data.
The workshop builds on pilot projects that have been running since 2010. The process enables drug developers to receive simultaneous feedback from regulators and HTA bodies on their drug development plan.
Guido Rasi, executive director of the EMA, emphasized during the workshop that “a strong interaction between regulators and HTAs is critical to enable innovation to reach patients, and ultimately for the benefit of public health.” He added that “this is the first workshop where we have tried to bridge these two worlds together to share views.
In a press release, EMA said that together with the European medicines regulatory network, the agency has to date, conducted 25 parallel scientific advice procedures with several HTA bodies taking part in this pilot project. Six more procedures are expected to commence in 2014.
Guidance for EMA–HTA parallel scientific advice based on stakeholders’ experience will be developed and published following the workshop. It will provide details on timelines and actions in which applicants can seek simultaneous feedback from regulators and HTA bodies on their drug development plans. The guidance will be opened to public consultation in early 2014. The final guidance will take into account feedback from all stakeholders.
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. EMA is associated with the consortium and will take part in the dialogues.
The workshop was attended by more than 280 representatives from the European Commission, European regulators, HTA bodies from 12 European Union countries, EUnetHTA, the pharmaceutical industry, payers, patients, healthcare professionals and academics, as well as representatives from the CHMP, the Pharmacovigilance Risk Assessment Committee, the Paediatric Committee, the Committee for Advanced Therapies, the Committee for Orphan Medicinal Products and the Agency’s Scientific Advice Working Party.
EMA will publish a workshop report and video in early 2014.