EMA pilot brings outside regulators into committee work

A new collaborative initiative is bringing the perspective of non-European Union regulators into the evaluation process for vaccines and therapeutics to combat COVID-19.
 
The pilot program, dubbed OPEN, debuted in December 2020. On Thursday, the European Medicines Agency (EMA) published a series of questions and answers (Q and A) fleshing out how the collaboration is working.
 
“The pilot will foster better understanding of regulatory outcomes, while retaining scientific and regulatory independence of the participating authorities,” wrote EMA. Regulators participating in the OPEN pilot include Health Canada, Japan Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Swissmedic, Australia’s Therapeutic Goods Administration (TGA) and the World Health Organization (WHO).
 
The extra-EU regulators are contributing to EMA’s COVID-19 pandemic task force, as well its human medicines committee (CHMP); OPEN pilot participation is ordinarily capped at two outside members per authority, though exceptions could be made, said EMA.
 
WHO may only have its own staff participate through the OPEN program, though it may have a total four outside observers from non-EU regulatory authorities. Other EMA scientific committees are explicitly excluded from participation in the pilot. OPEN experts should have their names and affiliations listed in committee-generated scientific documents, while WHO observers should not be listed.
 
As a policy matter, such international cooperative efforts increase overall transparency, noted EMA in the introduction to the Q and A. Additionally, the initiative is meant to boost timely patient access to care, increase regulatory expertise in decision-making and simplify compliance for sponsors of therapies and vaccines.
 
In the usual course of committee work, OPEN experts “should be able to present the compiled scientific evaluation and overall assessment of their authority,” according to the Q and A. “The experts can also discuss and report back within their authority (e.g. to their product team) on the discussions taking place at EMA.”
 
Though OPEN experts are expected to be active participants in discussion and deliberation, they are not voting members, clarified EMA. However, they can receive “necessary outputs” from a committee, such as rapporteurs’ assessments, joint assessment reports, and interim and final opinions. “Opinion-making remains the sole competence of the Committee and its members,” according to the Q and A.
 
Should OPEN experts identify a scientific issue that the committee or its rapporteurs had not spotted, the issue should be raised and reported upon, but individual attribution of the opinion is not necessary, according to EMA. “For the sake of clarity, there is no obligation for the Committee to agree with the views of an OPEN expert, but in terms of Good Scientific Practice, transparency of debate about scientific views leads to better quality of assessment,” wrote EMA.
 
Experts from outside EMA who are contributing to CHMP and COVID task force work via the OPEN pilot are nominated by the relevant external authority and appointed by EMA. Participants must provide a curriculum vitae and be registered in EMA’s database of experts; they must also complete a declaration of interests and sign an individual confidentiality agreement.
 
EMA’s conflicts of interest requirements also apply to OPEN pilot participants, “in particular with respect to medicine procurement or purchase decisions” for CHMP members, said the regulator.
 
The Q and A provides boilerplate language to be included in assessment reports and formal European public assessment reports (EPARs) to indicate which non-EU authorities contributed to discussions and to clarify that these authorities did not weigh in on final benefit-risk determinations.
 
Currently, international regulator participation is seen as time-limited to the duration of the crisis of the COVID-19 pandemic; an analysis is planned after the pilot ends.
 
EMA