Changes to Make EMA more Efficient and Transparent, Agency Says

The European Medicines Agency (EMA) has released the full text of its 2013 planned activities, part of what it referred to in December 2012 as a massive reorganization of its operations, processes and offices.

In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations."

A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee for Advanced Therapies (CAT) and others-with the aim of better allowing them to reach "high-quality, consistent opinions."

Why the changes? "We have a lot of new legislation and changes coming through in the next year," EMA spokesman Martin Harvey told Regulatory Focus. "The new changes are about doing more with less while maintaining the Committee's workload. We are absolutely not saying that the committees are doing a bad job. They were designed a long time ago, and these changes are meant to improve their efficiency."

But at the time of EMA's announcement, one thing in particular was lacking: details.

Though the agency communicated that its staff could be less available than usual as a result of the reorganizations, the agency was generally vague about its eventual effects.

Details Emerge

Now those details are emerging in full. EMA will undergo changes in four main areas, according to its "2013 Work Programme."

Two of the biggest changes EMA says it's planning for are the implementation of the "Falsified Medicines" legislation, which sets stricter standards for the import of Active Pharmaceutical Ingredients into the EU, and the revision of the EU veterinary medicines legislation, which is being conducted by the European Commission.

Regulators will also be grappling with the continued implementation of the recent pharmacovigilance legislation, which came into effect in 2012. Executive Director Guido Rasi noted that not all of the law's provisions have been implemented, particularly in regards to national authorities. He said EMA would be prioritizing remaining activities in order to best protect public health before moving on to transparency measures meant to make the law's provisions more accessible to the general public.

Transparency and Efficiency

Transparency efforts and operational efficiencies constitute the bulk of the other work, Rasi said.

"It is our objective to explain better how decisions are made with respect to all our opinions, and to provide more quantitative data in documents accompanying our opinions, where this helps to promote understanding," he said. This will reportedly entail giving consumers more information regarding the benefit:risk paradigm used to approve or reject products, as well as the overall qualitative rationale used to justify the decision.

"This sharing of information and knowledge will benefit the scientific community and various bodies working in the field of medicines," including health technology assessment and other reimbursement bodies, Rasi added.

From an operational efficiencies perspective, Rasi noted that the agency is "running numerous initiatives aimed at optimizing the use of resources, which will increase the effectiveness of our work in the related domains."

Those efficiencies are intended to ease budgetary demands on other programs. While EMA's budget increased in 2013, it was generally due to an increase in inflation-adjusted dollars, and not for any new activities. "At the same time," EMA wrote, "the agency needs to find compensation for services that do not generate revenue and to finance new legislative tasks."

How or what form that "compensation" would take is not explained in the work programme document, but the document does indicate that user fees and charges have constituted an increasing percentage of EMA's budget in recent years, from 80.1% in 2011 to 82.3% in 2013. That trend could well continue into the near future, allowing EMA to find that "compensation for services."