Participants
PETROVIČ Matej, PharmDr. PhDr. - General Director of
Section of Pharmacy and drug politics
SLANÝ Jozef, RNDr., CSc. - Director of Section of Pharmacy and drug
politics
JAĎUĎ Branislav, Mgr. MVDr. – Chairman of Categorization 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, artificial 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
devices.
Main topic of discussion was transition phase.
Mr. Egli was interested in transition phase after new
Directive on MD is effective within new products and within products already
placed on market.
New products – Does certification process work as
during old regulation, when certificates were valid for 5 years, or there will
be period shortened to 3 years? Are there extra clinical data required due to
transition phase?
Products already placed on market – There is new
scrutiny 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 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. Slaný stressed that enforcement is still not hugely
discussed, as there are still final approval steps of EÚ 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 (HCP’s) on training delivered by industry
Company Zimmer Biomet provides and requires training for
proper usage of their products for young physicians. As participants on training
has to pay 19% tax on non-financial income, they are usually reluctant 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
amounts currently to 500 days in average and is increasing. Mr. Egli wondered if
we could do something about it, with Mr. Jaďud stating, that SK-MED is active in
this matter, however permanent solution of payments discipline requires wider
structural changes in health care system in Slovakia.