New Price Regulations in the Area of the Price Regulation of Medicinal Products

Just before Christmas, the Ministry of Health published, in its Bulletin, three new regulations that were passed on 10 December 2019: Price Regulation No. 1/2020/CAU, on the regulation of the prices of medicinal products and food for special medical purposes, Price Regulation No. 2/2020/CAU, on the regulation of the prices of provided medical services, the stipulation of the maximum prices of medical services provided by dentists and covered by public health insurance, and of specific medical procedures, and finally Price Regulation No. 3/2020/CAU, on the regulation of the prices of individually prepared medicinal products containing hemp for medical purposes (“Price Regulation – Medical Hemp I”). 

Travel bans and quarantine: COVID-19 updated for the Czech Republic

The Czech Republic has declared a nationwide quarantine in its entire territory. The government has decided to impose a two-week quarantine in the country until 6 am local time on March 24, 2020. The restrictions, prohibiting travel from the Czech Republic, apply to citizens of the Czech Republic and persons with permanent or temporary residence over 90 days. Find out more about operational changes. 

Public Contracts: Abolition of the Fee for a Motion Filed with the Office for the Protection of Competition Can Be Considered as Appropriate

In November 2019, the Constitutional Court abolished the fee for a motion to initiate proceedings at the Office for the Protection of Competition. This step was even nominated in the current year of the Act of the Year survey. What were the most negative aspects of this controversial fee? What was its actual impact in practice? And what are the other pitfalls in relation to public contracts? 

Extending the Group of Obliged Entities in Real Estate

Combating the legalisation of proceeds of crime (anti-money laundering or AML) and terrorist financing has continuously been a vibrant area at the both international and local levels, which is largely reflected in regularly changing legislation that sets increasingly more obligations and, above all, affects increasingly more entities. 

Employment of Employees in Debt from the Perspective of Employer

Employees against whom is enforced a decision of state authorities by a certified enforcement administrator (in Czech: exekutor) or who are insolvent are not only worried themselves, but it also means extra work for their employers who pay their salary as they are subject to a considerable administrative burden and obligations imposed upon them by Czech law. If this is the case, do you know what you have to do as an employer? What sanctions do you face if you fail to perform any of the required actions? And how do you actually calculate the amount of salary deductions you have to perform? 

E-shop Must Pay Compensation to a Client for a Login Data Breach

In the case of a user who sued a Czech e-shop provider for a login and identification data breach, the Court reached a judgement and awarded financial compensation to the plaintiff. Would you like to find out more? Read the December issue of our TechLaw Newsletter. In the field of personal data protection, we further analyse the draft methodology of the Czech Office for Personal Data Protection regarding the correct conduct of the data protection impact assessment. Furthermore, we discuss an important European case law concerning the limits of employee monitoring. 

Latest Developments in the Area of Medical Devices: A New Act Is On Its Way to a Legislative Process

On Monday 6 January 2020, the government approved a bill reflecting the European Medical Devices Regulation (“MDR”), effective from 26 May 2020, and partly also the European Regulation on In Vitro Diagnostic Medical Devices, effective from 26 May 2022, in the national legislation. The legislative package also includes fundamental changes in the area of regulation of medical device advertising. 

What Does the RTS on SCA Bring with Regard to Statutory Audits?

Regulatory technical standards for strong customer authentication (the “RTS to SCA”), which entered into force on 14 September 2019, brought about a number of new obligations to payment service providers, including banks and payment institutions. Although the media mention, in particular, new obligations related to the requirements for strong customer authentication, in particular when initiating electronic payments (whether it is card payments in the store, the purchase of goods in an e-shop, entering an order in online banking or other acts), which must newly be a two-factor one (i.e. consisting of a combination of two or more elements from the category of ‘knowledge’, ‘possession’ and ‘inherence’), the above regulation also brings about new obligations of a purely internal nature. Specifically, the obligation to carry out internal audits, namely the audit of security measures (“audit of security measures”) as well as an audit of the way in which the so-called transaction risk analysis (“TRA audit”) is carried out. What are these two types of audits about and what is their substance? 

Personal Data Processing News

This time we focus on the most important findings from the published information regarding inspections and decisions of the Office for Personal Data Protection in the first half of 2019. We are also reporting on further development concerning codes of conduct and certifications, on the procedure in the event of a security breach and procedure for informing customers about personal data processing, on an important decision related to cookies, and on an effort to unify the procedure for issuing penalties in Germany, and possibly the whole EU.