by Helen Collis
BRUSSELS, Oct 14 (APM) - Europe’s drugs regulators may consider potentially harmonising the numerous early access schemes that are currently being introduced across the region, a medicines regulatory conference heard.
Speaking on Monday at the TOPRA conference in Brussels, Xavier de Cuyper, CEO of Belgium’s drugs regulator FAMHP, said it was something that was likely to be discussed at the next management board with the European Medicines Agency (EMA), before the end of the year.
Cuyper was responding to questioning from an industry representative on whether they could expect any uniform system in future given the multitude of new early access programmes that were evolving. The conference had just heard details of Belgium’s early access programme which was launched on July 1.
He said that at the last EMA management board meeting, UK colleagues raised a similar question, underlining that each regulator was busy working on similar projects at the same level of expertise, “so why don’t we work together on the same strategy since we have the same problems in Europe?” Cuyper quoted the UK colleagues as saying.
“I take note of your question - where can we work together? Maybe the next meeting when we see the first draft of the road map it will be an opportunity to discuss this question,” he said.
In the meantime, he said that work on early access, particularly in the last months, was an encouraging sign of how member states had adapted to the needs of patients.
“What’s important in my view is that what we have seen in the last months that on the basis of this question of medical need, we have found a better way or working together between licensing, HTA (health technology assessment) and reimbursement bodies and that’s important if you want to help the patient.”
From July, Brussels introduced its own early access scheme, known as early temporary authorisation (ETA) - the latest in a string of European regulators to implement a form of European adaptive licensing scheme.
Explaining how it works, Greet Musch, director general of pre-authorisations at Belgium’s drugs regulator FAMHP, said companies can apply for it under a compassionate use programme for products which have no licence, or under the medical need programme for licensed products to be used in a different indication.
The conditions are that clinical trials must be running for each type of programme, within the investigative indications. In addition, in Belgium, not only can companies apply for the early access programmes, but so can ministries of health and public affairs.
The country’s ethics committee will look at the justification for the application to decide if there are really no other alternative therapies. In addition, a list of diseases with unmet need was also being drawn up.
To date, Belgium has received five applications so far, she said.
The UK also introduced an early access to medicines scheme in the spring this year. To date, one application has been awarded ‘promising innovation’ status, a prerequisite for application for an early licence once relevant trial data has been collected.
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