Grading the regulator

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.

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."