Date of meeting: 5.10.2016
Organizer: SFLP, MZ SR (meeting suggested by Medicines for Europe)
Participants: MZSR (Matej Petrovič, Jozef Slaný, Liliana Hrúziková)
Medicines for Europe (Sergio Napolitano, Beata Stepniewska, Michaela Palagyi, Martin Gaplovský)

Meeting minutes:

Main subject of meeting was introduction of Medicines for Europe to Ministry of Health.

Following questions were raised during meeting from Medicines for Europe representatives:

1. How does Ministry of Health of Slovakia see follow up on Dutch presidency?
2. What is intent of Ministry of Health in respect of Informal Council of Ministers? Is there any intend to stimulate discussions about timely access update and entry of generics& biosimilar?

Director General Matej Petrovič summarized all SK PRES events, where medicines shortages were discussed (Working Party on Public Health at Senior level on 15 July 2016 in Brussels, Informal Council of Ministers held 3- 4.10.2016 in Bratislava) and planned Conference “Shortages of Human Medicines in the European Union” 17 - 18 November 2016, Bratislava. Medicines for Europe proposed active participation on conference. Matej Petrovič gave also brief update about Amendment of Act. No. 362/2011 on Medicinal Products and Medical Devices that shall come in effect as of 1.1.2017, which should also improve timely access to medicines by preventing parallel trade.

There were several problematic areas that Medicines for Europe pointed out on meeting:

Beata Stepniewska was interested into law of reimbursement, indicating that Ministry of Health do not look coherently on generics& biosimilar as on originals despite the fact generics& biosimilar create 70% of products on market. According to Beata´s words, generics& biosimilar experience price cut and there are no actions to stipule volume. This situation leads to serious withdrawal of products. Beata Stepniewska suggested Ministry of Health to have a closer look on functioning of current price and reimbursement system, which is vulnerable because while in the beginning earnings are created to national budget, but in the end it creates unsustainability of health system.

Beata Stepniewska mentioned weak part in tendering system with one winner and in case something happens, we face problem of medicine shortage. Exceptional delivery is not regulated. Generic substitution would be suitable tool to cover missing generics. Beata Stepniewska suggested Ministry of Health to have more coherent horizontal view and would welcome more meetings with follow up discussions to tackle solutions. Lower constrains would lead to better system functioning.

Beata also mentioned weak spot in reimbursement part, where it takes 4 months to generic companies from registration to get reimbursement, whereas in other countries it takes less time.

Medicines for Europe as well as GENAS is eager to help Ministry of Health to help with building the case, that would help to deliver better service to all sides.

Follow up agreed: none

Meeting minutes elaborated by: Liliana Hrúziková

Approved by: Matej Petrovič