History of the Institute
History of the State Institute for Drug Control is connected with the formation of Czechoslovakia as an independent state. The State Institute's for Drug Control immediate predecessor was "The Institute for Investigation of Medicines" established as early as in 1918 .The former Institute's laboratories were located in several buildings of Charles University Prague. In 1931, laboratories of the Institute were concentrated on the premises of the State Health Institute and the Institute's headquarters is situated there until today.
The Institute got its today's name in 1952 following its complete separation from the State Health Institute's organizational structure. On this occasion, the activities of the Institute were extended to control of "medical devices, in particular therapeutic and diagnostic aids and disinfectants or other devices/products". In 1969 all the Institute's workplaces were brought together in a new building.
So called "medicines control laboratories" charged with control of pharmacies, control of handling medicinal products supplied to health care centres and control of quality of raw materials distributed to pharmacies were incorporated in the Institute in 1992. Until then these laboratories formed a part of Pharmacy Services under the control of regional National Healthcare Centres. In 1992 the Institute took charge of the area of medical devices assessment including issuance of approval certificates for medical devices used in health care facilities.
Following the Minister of Health's decision of 1997 this activity was extended to all approvals of medical devices of any type. The Act on Pharmaceuticals no. 79/1997 Coll. laid down details of the Institute's activities in the area of medicines in 1997. In the sphere of medical devices, the scope of activities of the Institute was stipulated in particular by Act no. 123/2000 Coll., on Medical Devices, which focused SÚKL's operation in this area to safeguarding the safety of products already placed on the market. The process of approving medical devices was transferred to the Ministry of Health of the Czech Republic.
In compliance with Act no. 138/2002 Coll., amending the Act on Advertising Regulation, as of June 01 2002 SÚKL has become the competent authority responsible for surveillance over advertising of human medicinal products.
As of January 01 2008, pursuant to Act no. 48/1997 Coll., on Public Health Insurance, SÚKL has been given the competence to determine the maximum prices of medicinal products and to determine the level and conditions of reimbursement of medicinal products. As of the same date, SÚKL has been performing the price control of medicinal products, foods for special medical purposes, and medical devices.
Moreover, Act no. 296/2008 Coll., on Human Tissues and Cells, has also extended the scope of SÚKL's operation by assigning SÚKL with surveillance over the quality and safety of human tissues and cells intended for use in man.
The latest change in the scope of operation to date has been implemented by the amended Act no. 167/1998 Coll., on Dependency Producing Substances, which extended the surveillance activities also to the sphere of narcotic and psychotropic substances.
Directors of SÚKL (since 1952):
- From 1952 - Prof. PhDr. PhMr. Eduard Skarnitzl
- From 1959 – Ing. Jan Buriánek, CSc.
- From 1982 – doc. MUDr. Jiří Elis, DrSc.
- from August 31 1990 to February 25 1991 RNDr. Jan Mikeska, CSc was appointed acting director.
- From 1991 – doc. RNDr. Jiří Portych, CSc.
- From 1993 – RNDr. Jan Mikeska, CSc.
- From 1994 – MUDr. Milan Šmíd, CSc.
- from July 12 2006 to September 15 2006 MUDr. Michal Sojka was appointed acting director
- from September 16 2006 to December 31 2006 RNDr. Jitka Šabartová, CSc was appointed acting director.
- From 2007 – PharmDr. Martin Beneš
- From 2012 - MUDr. Pavel Březovský
- From 2014 - PharmDr. Zdeněk Blahuta
Today's position and activities of the Institute
The State Institute for Drug Control is an administration body established by the Act no. 79/1997 Coll. It falls under direct control of the Ministry of Health.
The scope of operation of the Institute is stipulated by legal regulations.
In order to safeguard its tasks, the Institute establishes regional workplaces located outside the headquarters of the Institute.
The Institute's mission is, in the interest of public health protection,
- to ensure that all human pharmaceuticals available on the Czech market meet appropriate standards of quality, safety and efficacy
- to take share in ensuring that only safe and functional medical devices are used in the Czech Republic, in addition, accompanied by reliable and appropriate information. Moreover, its role is to contribute to rational use and where appropriate, to responsible and ethical clinical trials of both medicinal products and medical devices.
- Regulatory procedures shall not result in unnecessary obstacles to availability of medicinal products and medical devices nor to introduction of new therapeutic procedures.
In the Czech Republic the Institute ensures the following activities:
State supervision of properties of human medicinal products in all areas of handling such products. Activities of the Institute relate to monitoring of quality, safety and efficacy of medicines in all stages of development and use. For this purpose the Institute uses a system of preliminary reporting, licensing/authorisation and registration procedures, inspections, laboratory controls and monitoring of practical use of medicines and gathers appropriate information. As of January 1 2008 the Institute performs price control of medicinal products, foods for special medical purposes and medical devices. As of the same date it has been authorised to issue, in administrative procedures, decisions on maximum prices of medicinal products or foods for special medical purposes, and on the amounts and conditions of their reimbursement from health insurance. The Institute is entitled to take action in case a risk to public health arises, to impose penalties, and to request necessary documentation.
- In the area of medical devices the Institute ensures control of health care providers, investigation of adverse incidents and control of clinical trials.
- Ensures sufficient information for health care professionals and lay public on the issues relating to its activities
Competences of the Institute in the area of medicines and medical devices regulation are laid down by legal regulations and international agreements, in particular (more Legislation)
Activity of SUKL
SUKL is a national administrative authority reporting to the Ministry of Health. It is lead by a director appointed and recalled by the minister of health, unless stipulated otherwise by special law.
The activities of SUKL regarding drugs are primarily defined by the Act no. 378/2007 Coll., on drugs and on amendment of certain related laws (the act on drugs). Other regulations defining the activities of SUKL include the Act no. 167/1998 Coll., on addictive substance and on amendment of certain laws, as amended, the Act no. 160/1992 Coll., on healthcare in non-governmental healthcare facilities, as amended, and the Act no. 40/1995 Coll., on regulation of advertising and on amendment of the Act no. 468/1991 Coll., on radio and television broadcasting, as amended.
The activities of SUKL in the area of prices and payment for drugs are defined by the Act no. 48/1997 Coll., on public health insurance and on amendment of certain related laws, as amended, the Act no. 265/1991 Coll., on competences of authorities of the Czech Republic in the area of pricing, as amended, and the Act no. 526/1990 Coll., on pricing, as amended.
The activities of SUKL in the area of human tissues and cells are defined by the Act no. 296/2008 Coll., on safeguarding quality and safety of human tissues and cells intended for human use and on amendment of the related laws (the act on human tissues and cells).
The activities of SUKL in the area of medical devices are defined by the Act no. 123/200 Coll., on medical devices and on amendment of certain related laws, as amended.
cz