Harmonization of approval standards is an important policy objective for the industry. Can you cite examples of cooperation
with the FDA to ease conflicting decisions in the registration process?
Rasi: We are pleased with progress of the Transatlantic Simplification Initiative, which serves as a clearing house for joint
rule-making activities with FDA. There are regularly scheduled teleconferences to share insights and move projects forward.
We just had a very good outcome from one such project, to harmonize the orphan drug designation process. Continued progress
on harmonization is also politically astute. Regulators want to respond appropriately when patients ask awkward questions
about why the same medicine is available and benefiting patients in the US, and not here.
Pharm Exec: The flip side of cooperation is duplication of effort. A pressing concern for industry in Europe is the erosion of the traditional
"red line" between the basic market authorization decisions you make and access, pricing, and reimbursement activities at
the national level. An example of this is overlapping—and often contradictory—information requests from the EMA and local
agencies that conduct health technology assessment [HTA] studies on cost effectiveness. How is the EMA aligning its methods
with the HTA community to reduce the burden on companies?
Rasi: We offer companies a structured stakeholder consultation called parallel scientific advice. That advice is geared to helping
companies identify, at an early stage in the drug development process, what information will facilitate prompt review by us
as well as the national HTA authorities. What we offer, quite simply, is a roof under which all questions can be vetted in
advance. Some 17 parallel advice sessions have been conducted with companies to date; in addition to the EMA, the participants
include some of the key HTA authorities in the region, including NICE in the UK, Germany's IQWiG, HAS in France, AIFA in Italy,
the Dutch ZVZ, and the Swedish MPA.
Pharm Exec: Is this "red line" going to disappear entirely at some point in the future?
Rasi: Yes, I think the "red line" will become pink, at least as regards the basic decision on whether to reimburse a drug. We
will be more involved in supporting that decision at the national level. Pricing is not as clear; it's another step after
reimbursement, and here logic assumes the payer must be in the driver's seat.
Pharm Exec: Last year, the EMA assumed a huge new responsibility, to administer a coordinated region-wide umbrella network of pharmacovigilance
on product safety and side effects. How is it working so far?
Rasi: Implementation is going well; so far, we have met all the deadlines set by the 2010 EU Regulation. Our stakeholders are
pleased with the way we are interpreting the mandate. The question now is managing a complex signaling and detection system
that depends heavily on the performance of high-grade data gathering, integration, and interpretation software we have put
in place with the member states. The signals we derive from the system must be definitive and clean to avoid any unwarranted
alarms. More than 250,000 coded data points on marketed products have already been loaded into the system, and this is just
the beginning. It is also important to note that the responsibility we have assumed is funded by cross-subsidization with
the member states. No new money has been allocated. This is a major challenge, as we can rely on the current funding approach
to maintain the system only for a limited time.
Pharm Exec: What would you define as the major achievement of your first year?
Rasi: In addition to building trust through increased transparency, I would say it is the launch of our scientific coordination
board. Many people thought initially this would just be another layer of bureaucracy, but instead there is a broad recognition
that understanding issues around broad therapeutic areas—rather than individual products—delivers real insights on patient
welfare and makes for better decision-making overall.
Pharm Exec: Finally, how do you think the role of the regulator will have changed by the end of your mandate in 2016?
Rasi: Progress in science is running ahead of the ability of the regulator to understand it and weigh the implications. Thus,
we will see the expertise that we bring to our role expand to encompass other, complementary functions; we can't just be physicians,
chemists, and pharmacists. Molecular biologists, ethicists, and technology experts who can aggregate and interpret "big data"
are needed. HTA analytics will play a more prominent role too. In addition, to stay relevant, we have to build a much more
global orientation and presence. It is where industry is already. This is particularly important in the area of drug inspections—I
know the FDA shares our view that this area is vastly under resourced. A worldwide agenda of proactive cooperation is necessary
to minimize harm to patients.