by Helen Collis at the EMA/TOPRA meeting
LONDON, Nov 21 (APM) - The European Medicines Agency has launched a pilot to include patients in discussions on the benefit-risk assessment of new drugs, a regulatory conference has heard.
Since its launch in September, so far one meeting of the EMA’s CHMP has included patients in its discussions, Isabelle Moulon, head of patients and healthcare professionals department at the EMA, told the TOPRA regulators/European Medicines Agency (EMA) meeting in London on Thursday.
She said: “The objective is not to just involve them because it’s politically correct, but when we need them to be involved in certain discussions.”
Moulon said the initial idea was to invite patients to be included in the oral discussion with the company, adding their involvement is decided on a case by case basis. “We hope that the need to involve them should be discussed as early as possible.”
She said that there were various ways patients could be involved in the CHMP discussions, but underlined that they would not be invited during the decision-making meetings, “as they have no voting rights”.
She said they proposed at least two patients to be involved, one who is experienced and who already acts as a patient expert for regulators, to guide the others. She also said they would be carefully vetted particularly for any conflict of interests.
What was not yet decided was whether “the patient needed to have any experience of the drugs or not”, she said.
Where the patients are in their disease life cycle was also an important consideration given the different views patients have at different stages of the disease, she noted.
Given this was still at the pilot phase, she said patients would only be eligible if they spoke English, as the agency did not have the resources to use translators and did not want to “disrupt” the committee’s work. This was something an audience member later criticised, but Moulon said she envisaged, later down the line, that other languages would be accepted.
“This is something we have in mind and we know we have this problem,” she said.
Moulon noted that the CHMP was the last of the major scientific committees within the EMA to bring patients to the table. They are already represented in committees for orphan drugs, paediatric medicines, advanced therapies and in the pharmacovigilance committee, PRAC.
So far, it looked like the CHMP pilot would last longer than planned, given the relatively slow progress, the conference heard.
An AstraZeneca delegate questioned whether it was acceptable to bring patients with them to their CHMP meetings and if so, what credibility would they have?
In response Moulon said: “The company can do whatever they want and who they bring - there’s no limitation but do they (patients) have credibility? I don’t think we can answer in general, it really depends on the contribution of the person.
“For patients, I think it’s exactly the same as any other experts. But for patients there’s always the a priori thinking that there’s some kind of manipulation of the patient on the part of the company. It’s up to the company to find ways of overcoming this perception from the committee but there’s no ‘yes’ or ‘no’ answer to bringing patients.
“It’s up to the company to identify the best way to convey the message they want.”
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