# Presentation: 923484

## First Experience with New Roles and Responsibilities & Outlook into the Future 

**Martin Benes**

## SÚKL regulatory activities

|  | till the end of 2007 |  | as of January 2008 |  |
| --- | --- | --- | --- | --- |
| marketing authorisation | SÚKL | administrative proceeedings | SÚKL | administrative proceedings |
| maximum ex-factory price | MoF | admin. proc. / price order | SÚKL | administrative proceedings |
| reimbursement | MoH | decree | SÚKL | administrative proceedings |
| price control | MoF | administrative proceedings | SÚKL | administrative proceedings |

## Administrative proceedings

**Party to proceedings**
_**Marketing authorisation holder**_** – medicinal products**
**Producer/ importer – food for special medical purposes**
**Health insurance companies**
**Administrative body**
**SÚKL (employees + experts) ****	****– authority**
**Ministry of Health ****	****	****	****– appeal**
**Administrative court – final instance **

## What happens from January

**Act No. 48/1997 Coll., on Public Health Insurance **
**MoH Price Order No. 01/2008 **
**MoH Decree No. 384/2007 Coll., on Reference Group of Medicinal Products**

## Regulations under preparation

**Missing implementing legislation to Act 48/1997 Coll. **
**Price Basket of Reference Countries**
**Classification of Levels and Conditions of Reimbursement**
**Conditions of Application Form**
**Administrative proceedings are ongoing**

## Overview 

**Number of ****applied administrative ****proceedings **
**Reimbursement**** ****	****– ****	****       ****   ****67**** **
**Price+reimbursement**** ****	****– ****	****     ****     ****19**
**Cancelation**** of ****previous ****P/R****	****– ****	****     ****     ****21**
**Total****	****–**** ****	****        107**
**Number of Suspended AP**
**Reimbursement**** ****	****– ****	****       ****   ****12**
**Price+reimbursement**** ****	****– ****	****       ****   ****  2**

## Application forms on web from 2008 January 1th 

## Differences of Admin.Proc.

_**Act on Pharmaceuticals**_
**Pre-consultations for applicants**
**Process is started after application assembly**
**Consultations are allowed**

_**Act on PHI**_
**No consultations for applicants**
**Process is started upon submission of application **
**Basic information to applicants only**

## Difficulties of Admin.Proc.

_**Act on PHI**_
**applicant not entitled to apply (legitimate)**
**MAH differs from applicants !**
**absent authorization to apply for price/reimbursement**
**Applicants can be legal persons under Section 39f (2) and (3) of Act 48/1997 Coll.**

## SUKL Acts in Admin. Proc. 

**Application delivery = start of AP **
**Notification to other parties to proceedings**
**Validation of application**
**Data gathering**
**Notice to applicants – pre****-****decision statement **
**Taking measure with applicants objections**
**Issuance of decision including justification**

## Party to Proceedings Acts

**Application submission = start of AP **
**Data gathering (30 days)**
**Documents inspections**
**Raising objections to SUKL pre****-****decision statement **
**Appeals against SUKL statements and decisions **
**Withdrawal of **
**application**
**appeal **

## TOP 10 Chart

**PHI **
**UHI**
**..**
**Consequences**
**frequent documents inspections**
**extension of several AP time-limits**
**complaints filed against SUKL acts**
**conservation of former principles**
**unnecessary hindering of the AP**

## Demands on SÚKL

**Well managed system of documents – IS and workflow**
**Uncertainty caused by delayed legal acts**
**Demands on staff**
**1⁄2 of workload targeted on parties to proceedings measures**
**Short terms**
**Communication with experts**
**Communication with patient organizations**

## TRANSPARENCY

**Extreme administrative workload on applicants, other parties to administrative proceedings, SUKL**
_**Communication with parties to proceedings based on platform of transparency/**__**translucency**_
_**Resistance to privileged individual interest of „the most important“ stakeholder,  for a „superdrug“ or „important diagnose“**_

## Outlook to the near future

**First decisions of SUKL – approx. in 3 weeks**
**First published decisions, are expected to be in force – April 1****th**** **
**Brand new list of medicinal products and foods for special medical purposes - data structure published on SUKL web**

## Outlook to the distant future

**e-Communication (applicants vs. SUKL vs. IC)**
**Revision of MoH Pricing order**
**Clarification of unclearness/unreadeabilities of Act No. 48/1997 Coll. (annex 2, ...)**
**...**
**Revision of the Act (01.01.2009)**