Legal aspects

The issues concerned with legal aspects of trials in general - including non-interventional studies in the Czech Republic and Slovakia - are closely linked to the European legislation.

 

Czech legislation

Act No. 378/2007 Coll. (Act on Pharmaceuticals) is the main legal act for clinical trials in the Czech Republic. This Act was amended by Act No. 70/2013 Coll., and changes apply to non-interventional clinical trials as well.

Non-interventional post-authorisation study

According to the Czech legislation, a non-interventional post-authorisation study is defined as follows:

“Non-interventional post-authorisation study of a medicinal product for human use shall mean any study in which an authorised medicinal product for human use is prescribed in the usual manner in accordance with the terms of the marketing authorisation and in which the assignment of the patient to a particular therapeutic strategy is not decided in advance by a study protocol but falls within current practice and the prescription of the medicine by the attending physician is clearly separated from the decision to include the patient in the study, while no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data; non-interventional post-authorisation studies include epidemiological, pharmacoeconomic and research studies.” (§ 3a par. 2)

The same legal norm also defines who is the investigator of a non-interventional clinical trial, and what are his/her obligations:

Section 59a of the Act on Pharmaceuticals stipulates that the investigator of a non-interventional post-authorisation study may be the marketing authorisation holder, contracted research organisation, medical doctor, healthcare service provider, expert medical society, medical faculty or pharmaceutical faculty. The investigator shall be obliged to notify the State Institute for Drug Control (SUKL) of the commencement and termination of the non-interventional post-authorisation study and, within 180 days of termination of that study, submit a final report to SUKL.

Non-interventional post-authorisation safety study

The above-mentioned paragraph does not apply to non-interventional post-authorisation safety studies, which might be carried out by the marketing authorisation holder. Non-interventional post-authorisation safety studies must comply to rules stipulated by the Section 93j of Act No. 70/2013 Coll. The PHV-3 guideline issued by SUKL provides a detailed description of terms, governs the conditions for performing the non-interventional post-authorisation safety studies. The PHV-3 guideline is available on the SUKL website.

Post-authorisation safety study (Article 3a (1) of AoP)

Post-authorisation safety study of a medicinal product for human use shall mean any study relating to an authorised medicinal product for human use conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

Non-interventional post-authorisation study (Article 3a (2) of AoP)

Non-interventional post-authorisation safety study of a medicinal product for human use shall mean any study in which an authorised medicinal product for human use is prescribed in the usual manner in accordance with the terms of the marketing authorisation and in which the assignment of the patient to a particular therapeutic strategy is not decided in advance by a study protocol but falls within current practice and the prescription of the medicine by the attending physician is clearly separated from the decision to include the patient in the study, while no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data; non-interventional post-authorisation studies include epidemiological, pharmaco-economic and research studies.

Non-interventional post-authorization safety study

It is a subset of post-authorisation safety studies covered by this guideline. The term "non-interventional post-authorisation safety study" is reserved only for a study that meets all the following conditions:

  1. The study is conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.
  2. The studies shall not be performed where the act of conducting the study promotes the use of a medicinal product.
  3. Payments to healthcare professionals for participating in non-interventional post-authorisation safety studies shall be restricted to the compensation for time and expenses incurred.
  4. Only authorised medicinal products in accordance with the terms of the marketing authorisation are used in the study.
  5. Medicinal products in the study are used in accordance with the current effective SmPC. Any changes to the SmPC or other regulatory actions regarding the safe use of the products must be immediately taken into consideration in the performed studies.
  6. Medicinal products used in the study have to be already marketed in the Czech Republic and available in the usual distribution network.
  7. Medicinal products in the study are prescribed and dispensed in the usual way, i.e. prescribed by a physician and dispensed by a pharmacist based on a prescription. No promotional samples can be used.
  8. Medicinal products in the study shall not be provided for free or at discount compared to their current availability in the market. This also applies to the additional payments in pharmacy.
  9. The selection of patients assigned in the study shall not be affected in advance and must depend solely on the decision of the attending physician as a part of the current practice. The participating physician should comply with the approved protocol of the study and the approved SmPC during the study.
  10. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods are used for the analysis of collected data. All diagnostic and therapeutic procedures that are applied to the patients included in the study shall be reimbursed in the usual manner, i.e. without any support from the organizer of the study. Some exceptions are situations where diagnostic procedures recommended in the SmPC are not sufficiently performed in current practice and these procedures are necessary for drug safety monitoring.

Studies that do not meet all 10 conditions may not be described as "non-interventional post-authorisation safety studies".

Protection of personal data

Non-interventional post-authorisation studies must also be in accordance with Act No. 101/2000 Coll., on the Protection of Personal Data.

Note: External links lead to the website of the Czech Ministry of Interior (available in Czech language only). We are not responsible for the content of external Internet sites.

 

European legislation

Directives 2001/20 and 2005/28 are the basic legal EU norms dealing with clinical trials. These directions are further transposed into national law or other local norms.

Directive 2001/20/EC of the European Parliament and of the Council (32001L0020) of 4 April 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, involves the following selected parts:

Commission Directive 2005/28/EC (32005L0028) of 8 April 2005, laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (also called the Good Clinical Practice Directive), involves the following chapters:

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. Based in London, the EMA was born after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products. The European Medicines Agency operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. More specifically, it coordinates the evaluation and monitoring of centrally authorised products and national referrals, developing technical guidance and providing scientific advice to sponsors. The Board includes one representative of each of the 27 Member States, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patients’ organisations, one representative of doctors’ organisations and one representative of veterinarians’ organisations.

The protection of personal data is enshrined in the Charter of Fundamental Rights of the European Union. These rights are further elaborated in the Directive 95/46/EC of the European Parliament and of the Council (31995L0046) of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Data Protection Directive). This directive also regulates transfers of data to third countries, stipulating that Member States shall neither restrict nor prohibit the free flow of personal data between Member States.