Grading the regulator
When SUKL was given responsibility for maximum price and reimbursement evaluation in 2008, the Czech pharma market changed
considerably. Pavel Březovký, the body's director, was appointed on the 1st of May of 2012—and he has immediately contended
with a dissatisfied base.
The first hundred days
Astellas' Luboš Chadim articulates the industry's misgivings about such consolidation of power within a single entity. According
to Chadim, "The system was simpler in the past, and, in principle, the Ministry of Finance dealt with prices, while the Ministry
of Health (MOH) would set reimbursement levels. The authorities changed this, and delegated pricing and reimbursement decisions
to a single body: SUKL.
"On one hand, the MOH creates legislation, and passes it to SUKL for implementation. On the other hand, SUKL does not have
the capacity to implement. The agency has a tremendous backlog, and is encumbered by complex procedural requirements."
Chadim believes that from a budgeting perspective, the reorganization of SUKL was beneficial. "However," he notes, "the negative
consequences we saw from the creation of this body ensured that many products were not launched on the market."
SUKL has a daunting task, and many believe that it does not have the manpower to perform adequately. Glenmark CR head Jiří
Havránek has seen a disconcerting outcome emerge: "There is not enough capacity within SUKL. Sometimes, we find a very confusing
situation, wherein products enter the market with a different reimbursement level than similar drugs already on the market.
The reason behind this is that there are so many INNs, and so many molecules, that the regulator is not able to manage the
environment given their current capabilities."
Havránek affirms, "The challenge for SUKL is huge, and they are simple unable to deliver on time."
Březovký, a man with close ties to the industry, aims to make improvements. "My goal," he says, "is to be more proactive with
the registration of drugs. New drugs can change treatment paradigms and change the approach that doctors take to treatment
and diagnosis. Outcomes can become more economically viable or effective for patients. Hence: my first goal is to shorten
the registration period. The industry will benefit a great deal from this."