Slovakia: new drug classification laws

New laws on the classification of drugs came into effect on 1 December 2011, with further provisions taking effect from 1 January 2012.

The key aims of the legislation are to:

• provide detailed rules for determining the official price of drugs, medical devices and dietary foods, and for their reimbursement under public health insurance
• ensure greater cost-effectiveness of treatment reimbursed under public health insurance
• introduce more innovative ways of categorizing drugs to ensure that funds from public health insurance are used effectively and the system is financially stable
• enable faster marketing of new drugs and increase savings for public health insurance through the introduction of generic drugs
• make the processes of classification and price setting more transparent, and help move them online.

From 1 December 2011:

• lists of classified drugs will be published on the first day of each month, which gives 12 opportunities a year to assign new drugs to classifications (compared to four under the previous system)
• stricter conditions for price reductions when a generic drug is first introduced to the market. The generic drug must be at least 30% cheaper than the original drug (previously, it was 20%)
• marketing authorisation holders must ensure the availability in the market of sufficient quantities of the relevant drug for as long as it is on the classified list (ie enough to cover its estimated monthly consumption in the Slovak Republic)
• where sufficient quantities of a classified drug are not available in the market for 60 consecutive days, the Ministry of Health may remove the drug from the classified list (requiring a new application to get back on the list, along with proof that it has become available in sufficient quantities)
• all applications and other filings about the classification or official price of drugs must be made via the Ministry of Health’s electronic portal, with written communication only allowed where the electronic portal is unavailable (for reasons attributable to the Ministry)
• participants are treated as having received documents from the Ministry on the day after they are published on its website
• Ministry decisions will now be executed electronically, signed by secure electronic signature, and published on the 15th day of each month. This change does not seem to apply to other types of proceeding. This gives stability and predictability to the process of announcing decisions, rather than exposing regulated relationships to the possibility of having to react immediately to change on any given day

Law: Act No. 363/2011 Coll. on the scope and conditions of payment for drugs, medical devices and dietary foods under public health insurance and on amendments to certain acts