Pharmeca.cz

S účinností od 1. 9. 2023 z důvodu snadnější orientace účastníků řízení v procesních krocích Ústavu přistoupil Ústav ke sjednocení informací zveřejněných na webových stránkách Ústavu týkajících se postupu po vydání hodnotící zprávy. Níže uvedený dokument tedy nahrazuje předchozí informace vztahující se k průběhu individuálního správního řízení, včetně postupu při předkládání smluv. 

 Ústav dále uvádí, že v souladu s ustanovením § 2 odst. 4 zákona č. 500/2004 Sb., správní řád, dbá ve všech procesních krocích na to, aby přijaté řešení v řízeních o stanovení nebo změně úhrady LP/PZLÚ bylo v souladu s veřejným zájmem a aby odpovídalo okolnostem daného případu, jakož i na to, aby při rozhodování skutkově shodných nebo podobných případů nevznikaly nedůvodné rozdíly. 

 Toto sdělení má tedy za cíl v typově stejných řízeních: 

• nastínit procesní kroky Ústavu tak, aby se předešlo pochybnostem na straně účastníků řízení 
• zvýšit transparentnost 
• zvýšit předvídatelnost procesních kroků 
• zlepšit procesní ekonomii 
• doporučit účastníkům řízení, jak mají v řízení optimálně postupovat v obdobných případech

a to v individuálních správních řízení („ISŘ“) o úhradě dle části VI. zákona č. 48/1997 Sb., o veřejném zdravotním pojištění a o změně a doplnění některých souvisejících zákonů, ve znění pozdějších předpisů („zákon o veřejném zdravotním pojištění“) se zákonnou lhůtou pro vydání rozhodnutí 75, respektive 165 dní.

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.

More information: MZCR.cz.

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.

More information: MZCR.cz.

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.

More information: MZCR.cz.

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.
  

More information: MZCR.cz.

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.

More information: MZCR.cz.

Pharmeca a.s. provides services in the areas defined by this legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.  

Implementing legislations:  

• Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
  
• Decree No  384/2007 Coll., on the list of reference groups, as amended,
  
• Decree No  385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
• Decree No. 618/2006 Coll., which issues framework agreements, as amended,
  
• Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
• Decree No. 527/2021 Coll., on determination of the amount of reimbursement of expenses for professional acts and the method of determination of the amount of compensation of expenses for professional consultations carried out by the State Institute for Drug Control under the Public Health Insurance Act, as amended,
  
• Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year,
• Government Regulation No. 307/2012 Coll., on local and temporal availability of health services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Implementing legislations:  

• Decree No. 351/2022 Coll., on the transmission of data on the consumption of medicinal products by insured persons of the public health insurance when changing the health insurance company, as amended

Act No. 526/1990  Coll., on Prices, as amended.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing legislations:  

• Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,  
• Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
• Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
• Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
  
• Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
  
• Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
  
• Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended,
• Decree No. 463/2021 Coll., on the detailed conditions for conducting a clinical trial of medicinal products for human use, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing legislations:

• Decree No. 53/2014 Coll., on forms under the Addictive Substances Act, as amended,
• Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
• Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
• Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended,
• Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
• Decree No 53/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.
  

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended. 

Implementing legislations:

• Decree No 377/2022 Coll., on the implementation of certain provisions of the Act on medical devices and in vitro diagnostic medical devices, as amended, 
• Decree No 379/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 
  

Act No 376/2022 Coll. amending certain acts in connection with the adoption of the Act on medical devices and in vitro diagnostic medical devices, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended.

Act No. 89/2021 Coll., on medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Act on pharmaceuticals), as amended.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.  

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.  

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 40/1995 Coll., on the regulation of advertising and on amending and supplementing Act No. 468/1991 Coll., on the operation of radio and television broadcasting, as amended. 

Act No 242/2022 Coll., on the services of video sharing platforms and amending certain related acts (Act on the services of video sharing platforms), as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.

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.
  

More information: MZCR.cz.