EMA seeks greater engagement with industry to connect silos
Speaking to Outsourcing-Pharma at DIA Euromeeting in Denmark, Guido Rasi, executive director at the European Medicines Agency (EMA), said better communication between regulators, patients and industry is needed to modernise pharmaceutical oversight. The EMA is currently focussing on doing just that.
However, he said the initiative’s success requires industry to step-up its involvement in the formation of the regulatory process. “The only stakeholder that is not now in the agency is the industry, but we do have a forum where we can discuss with them and include them,” he said.
“All the other stakeholders are really in the agency: the patient, the professionals, the commission representative from parliament – we have all the stakeholders potentially.”
He added that he feels “the time is now for a higher level of engagement”.
Know your place
The backbone of the EMA’s new efforts to change the regulatory process is ensuring each player understands its role within the process.
Martin Harvey, head of communications for the EMA, told us the body is starting by taking a good hard look at itself.
He said: “What the EMA wants to achieve is a better understanding about the regulators’ role in the chain.
“Quite often we feel like we’re in unconnected boxes. Health payers there, industry there, patients there.
“The question we’re asking ourselves at the moment is what information is needed from the regulators and what is needed from the pharma industry, and how do we join all of this together?”
He added that in the EMA’s new paradigm, everyone is the process is equally important, “the question is: how do you involve everybody?”
