Participants

PETROVIČ Matej, PharmDr. PhDr. - General Director of Section of Pharmacy and drug politicians
SALTH Joseph, RNDr., CSc. - Director of Section of Pharmacy and drug politicians
JAĎUĎ Branislav, Mgr. MVDr. – Chairman of Categorisation committee for Medical devices
HRÚZIKOVÁ Liliana, Ing. Mgr. - Administrative Clerk for EU Affairs and International Cooperation

Content

Mr. Beat Egli introduced company Zimmer Biomet and its products (e.g. joint replacements, artistic hips and knees, trauma implants, spinal implants etc.). Mr. Egli mentioned Coreper and Council agreement with Proposal for Regulation on medical devices and in vitro diagnostic medical device.

Main topic of discussion was transition phase.

Mr. Egli was interested in transition phase after new Direct on MD is effective within new products and within products already placed on market.

New products Does certification process as during old regulation, when certificates were valid for 5 years, or there will be period shortered to 3 years? Are there extra clinical data required due to transition phase?

Products already placed on market There is new strict for high risk devices, by until when they should be available, as it is not clear in the text. Mr. Egli claimed that technology is on market and Wondered whether these products would need to be subject to additional clinical data? Given the fact clinical trials last for years in special cases.

Mr. Jaďud assured Mr. Egli, there is a high range of products and while answering his questions, characteristic of Zimmer Biomet products will be taken in account. We need to learn from past and be aware that time is crucial and safety needs to be well balanced.

Mr. Egli pointed out complexity of work load and additional requirements regarding EUDAMED database and he expects 20-30% more resources to be needed during transition phase.

Mr. Salty stressed that enforcement is still not hungle discussion, as there are still final approval steps of EU for these Regulations. Afterwards there will be discussion about enforcement of transition phase in September/October (transition criteria will be agreed). There is also Council meeting EPSCO in December on Ministry level, where the topic will be also Discussed.

19% tax on non-financial income to be paid by Health Care Professionals (HCPs) on training delivered by industry

Company Zimmer Biomet provides and requires training for proper use of their products for young physicals. As participants on training has to pay 19% tax on non-financial income, they are usually relative to Take part. This law may cause quality issues. Mr. Jaďud proposed Mr. Egli to get in touch with SK-MED. Mr. Petrovič agreed to coordinate this with Ministry of Finance.

Debts in Slovakian health care system - Outstanding Payments of 500+ days

Mr. Egli mentioned that big companies, as Zimmer Biomet is, can cope with delays in payments from state, however small and medium size cannot. The effective term of payment in the Slovakian health care system meters currently to 500 days in average and is increasing. Mr. Egli wondered if we could do something about it, with Mr. Jaďud dating, that SK-MED is active in This matter, however permanent solution of payments discipline requires wider structural changes in health care system in Slovakia.