The Puzzle Master: EMA's Guido Rasi - Pharmaceutical Executive


The Puzzle Master: EMA's Guido Rasi

Pharmaceutical Executive

Safety savior

The flip side of transparency is risk: and all medicines can be dangerous. The consequences for public health of a product crisis are multiplied when information is inaccessible, hard to interpret, or missing entirely. Politicians and parliamentarians recognized this in approving in December 2010 EU Regulation 1235/2010, which put the EMA in charge of coordinating a new European-wide structure for monitoring the safety of medicines on the market in the 27 EU members and three affiliated EEA states (Iceland, Norway, and Lichtenstein). This has proved to be a huge assignment, extending the agency's purview to ensuring safe use of medicines authorized by some 40 different national authorities through the de-centralized procedure, in addition to drugs approved by the EMA.

At the heart of the program is a new reporting network—EudraVigilance—designed to quickly detect side-effect/adverse reaction problems with marketed medicines, and to coordinate the execution of appropriate control measures to safeguard public health. Responsibility is a shared effort, with national regulatory authorities assigned by the EMA to monitor a list of specific active substances approved in more than one EU member country through the national, decentralized, or mutual recognition procedures. In essence, it means that national authorities will take on a broader leadership role in certifying drug safety for selected medicines outside their own jurisdictions. "Europe is moving toward a genuinely region-wide approach to the key growth area in drug regulation over the next decade—post-marketing surveillance," Ansis Helmanis, principal at the DC-based advisory firm RegLink Associates, told Pharm Exec.

The reporting requirement is being implemented without any significant increase in funding. Much of the burden of compliance is placed on individual companies, who already provide approximately 80 percent of the EMA budget through fees paid to support evaluation of the initial registration dossier. A new data entry tool devised by the agency to facilitate reporting has received mixed reviews from companies.

Looking forward—the adapted license?

The EMA's diffuse mandate gives it more flexibility than its counterparts in considering how it should do business with industry. An interesting example is the proposal in its 2012 work plan to initiate a debate on alternatives to the standard "magic moment," where one decision to authorize lasts for the entire lifecycle of the product. The EMA calls the idea "staggered approval" or "adaptive licensing," in which an approved drug could be reevaluated and its license "adapted"—or perhaps revoked—to conform to new evidence, advances in science, or changes in clinical practice.

In March the management board endorsed testing this approach through a pilot project for completion by year end, pursued in alignment with all stakeholders, including industry. However, no action has been taken to date. Nevertheless, EFPIA Director Bergstrom told Pharm Exec he agrees with this and other efforts to make the regulatory system "more fit for purpose." "The ideas coming from EMA staff on adaptive licensing are very encouraging."

William Looney is Pharm Exec's Editor-in-Chier. He can be reached at


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