In its decision,
the Ministry of Health confirms the possibility of ensuring patients’
right to free (i.e., fully reimbursed) medicinal products from the groups
listed in Annex No. 2 to Act No. 48/1997 Coll., even through products
that are not available on the Czech market at the time of the SÚKL decision,
as long as it is certain that such products will be available in
sufficient quantitiesat the time the administrative decision becomes
enforceable.
This typically
applies to contractual arrangements between marketing authorization
holders and health insurance companies, which include a binding
commitment to ensure availability of the respective medicinal
products.
On the other hand, the
right to free medicinal products cannot be ensured through products that
are not present on the Czech market or are available only in
negligible quantities.
Furthermore,
according to the Ministry of Health of the Czech Republic, SÚKL is
not obliged to verify whether a product has been reported as temporarily
unavailable on the domestic market, since such a temporary
unavailability concerns only a transitional period, unlike permanent
discontinuation of supply.
A continuously
updated overview of decisions issued by SÚKL and the Ministry of Health in the
field of pricing and reimbursement is available on the Pharmeca a.s. website.
The text was translated using ChatGPT 4o.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
According to the Ministry of Health
(MZ), even a single health insurance company can demonstrate that the presented
budget impact exceeds the current financial capacity of its fund, even if
this applies only to that specific insurer.
Rejecting
the statement of one insurance company solely because other insurers remain
silent or their statements are less convincing (or not sufficiently
substantiated) is, in the Ministry’s view, irrational. If the presented budget
impact poses an economic risk to even one health insurance company, this is
clearly a factor indicating the unacceptability of the proposed budget impact.
The
requirement by SÚKL for statements from all health insurance companies
regarding the acceptability of the budget impact has no legal basis, according
to the Ministry of Health.
A continuously
updated overview of decisions issued by SÚKL and the Ministry of Health in the
field of pricing and reimbursement is available on the Pharmeca a.s. website.
The text was translated using ChatGPT 4o.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant sanofi-aventis, s.r.o., against the decision of the State Institute for Drug Control from 23. 3. 2021, under the no. SUKLS172396/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant sanofi-aventis, s.r.o. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 9. 4. 2021, under the no. SUKLS182256/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 12. 4. 2021, under the no. SUKLS182359/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 10. 8. 2022, under the no. SUKLS85858/2022:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 15. 3. 2021, under the no. SUKLS246602/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Ipsen Pharma S.A.S., against the decision of the State Institute for Drug Control from 12. 3. 2021, under the no. SUKLS306733/2020:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Ipsen Pharma S.A.S. - the decision is reversed and the issue is referred back for reappraisal.
