Healthcare has been impacted heavily in connection with the COVID-19 pandemic, and the situation is constantly evolving. We have prepared an overview of legal implications of COVID-19 on this sector.
A steep rise in prices is among the issues that have arisen in connection with the current high demand for medical devices and medicinal products.
Maximum price of respirators. The Ministry of Finance issued a cap regarding the prices for FFP3 class respirators. The maximum price of for those respirators manufactured in the EU was set at CZK 175, while the maximum price for respirators manufactured outside the EU was set at CZK 350.
Excessive prices. During the state of emergency, the Czech Office for the Protection of Competition (Office) will focus on cases of excessive pricing, especially regarding goods with supply shortages (e.g. facemasks and other medical devices, or basic food items). The Office will further focus on manipulations of public tenders or market sharing.
Changes in legislation on medical devices
Postponement of implementation of the regulation on medical devices and regulation on in vitro diagnostic medical devices. The European Union promised to delay implementation of new legislation regulating medical devices, i.e. regulation on medical devices and regulation on in vitro diagnostic medical devices. The reason is that all stakeholders working on implementation of the regulations are now focussing on tackling the pandemic. The European Commission promised to postpone the date of force of these regulations by one year.
Harmonised standards. The European Commission adopted a decision setting simplified harmonised standards for facemasks, surgical drapes, gowns and suits, washer-disinfectors and sterilisation. These standards should bring a faster and cheaper conformity assessment procedure. Using these standards grants conformity with the directives on medical devices.
Use of unregistered medicinal products
Specific treatment programme. In case of an extraordinary need when no registered medicinal product is available for effective patient treatment, prophylaxis and the prevention of infectious diseases, there is a possibility to allow the use, distribution and sale of an unregistered medicinal product within a specific treatment programme. A specific treatment programme can be conducted with prior approval of the Ministry of Health based on an application stating a description of the programme, including group f patients concerned, means of monitoring or the facility where the programme should be conducted.
Temporary approval of distribution, sale and use of an unregistered medicinal product. In case of an expected or confirmed spread of a cause of a disease (i.e. also in case of a pandemic), the Ministry of Health can, based on an expert opinion of the State Institute for Drug Control (SÚKL), allow the distribution, sale and use of an unregistered humane medicinal product. In such a case, the marketing authorisation holder, manufacturer and healthcare providers cannot be held liable for the consequences of such use of the medicinal product.
Prescription by a doctor. An attending doctor can prescribe or use an unregistered medicinal product with the goal of providing optimal healthcare, under the condition that a registered medicinal product is not available on the Czech market and the product to be used is already registered in another state; further, the use is sufficiently based on scientific knowledge and the medicinal product does not contain genetically modified organism.
New clinical studies. The State Institute for Drug Control in a statement strongly recommended not starting clinical trials and placing subjects of assessment to clinical trials. This concerns especially clinical trials dealing with a treatment affecting the immunity system. This further concerns placement of patients / trial subjects to ongoing clinical trials and conducting clinical trials with the participation of healthy volunteers or “healthy patients”, i.e. clinical trials that do not have a treatment benefit for assessment of the subject placed in such trial.
An exception would be clinical trials focused on treatment of the prevention of COVID-19.
Ensuring the safety of trial subjects while maintaining the quality of the clinical trial is the responsibility of the sponsor; the safety of the trial subjects is the responsibility of the investigator or main investigator who is responsible for the whole team.
Ban on export of medicinal products and medical devices
Disinfectants. By an extraordinary measure of the Ministry of Health from 5 March 2020, the export of all products of personal hygiene for hand disinfection has been banned indefinitely.
Medical devices. By an extraordinary measure of the Ministry of Healthcare from 6 March 2020, the sale of all personal protection devices of class FFP3 to entities other than the Czech Republic and its units and distributors has been banned indefinitely.
Further, it is by a decision of the European Commission not allowed to export protective equipment (protective glasses, facemasks, protective suits, etc.) outside of the EU without export authorisation.
Medicinal products. By an ordinance of the Czech government from 17 March 2020, the supply of registered medicinal products intended for the market of the Czech Republic to EU member states and export of these products to other countries than EU member states has been banned. The ordinance is in force for the duration of the state of emergency. Whether the medicinal product is intended for the Czech market is assessed based on the language of the label; in case of more languages, the marketing authorisation holder shall make a declaration to the customs office stating which market the product is intended for.
Entering into agreements
Entering into agreements over distance. Written form is upheld also in the case of electronic written communication as long as it is possible to identify the acting (signing) person. If parties agree on it, an agreement can be concluded even via an email. In order to ensure a higher level of certainty of both parties, we recommend using an electronic signature. An electronic signature needs to be obtained personally?
Agreements with public authorities. When concluding or amending agreements with public entities, a qualified electronic signature (requiring certificate to be stored on a token – e.g. a chip card or a USB disc) is necessary.
New public tenders. It is to be assumed under the current circumstances that the supply of certain goods will require hasty execution, and formal proceedings in accordance with the Act on Public Procurement could cause irreparable harm. The main issue in question is especially the fast delivery of facemasks, respirators and disinfection supplies to the units of the integrated emergency system (police, healthcare emergency or fire brigade). The following exceptions may be used according to a statement of the Office for the Protection of Competition (ÚOHS) as well as the Ministry for Regional Development.
Negotiated procedure without prior publication (jednací řízení bez uveřejnění or JŘBU, in Czech) may be applied where necessary because of an extreme urgency that was unforeseeable by and not attributable to the contracting authority and other forms of simplified procedure cannot be used. In accordance with the ÚOHS statement, this urgency occurs in case of purchase of goods necessary for management of the COVID-19 threat. It should be noted that some requirements of the Act on Public Procurement still apply in case of JŘBÚ. To these requirements belong for example evidencing basic qualifications or the beneficial owner(s).
In consequence of the extraordinary security measures, it is not in many cases possible to conduct a standard public procurement procedure. If there is an urgent need of the supply for managing the current situation (typically facemasks, medicinal products or medical devices), it is possible to execute the supply without the public procurement procedure. It is essential that the contracting authority differentiates between these extraordinary supplies from common purchases unconnected to the state of emergency (e.g. office supplies or planned construction works).
Existing public contracts. The current situation might qualify as a change of circumstances that could not have been predicted by the contracting authority. Such a change might allow a significant change of the public contract. If necessary, it should be possible to increase the volume of supply or change delivery deadlines. We also recommend a review of contracts to assess possibilities of contract termination in case of eventual delays, impossibility to perform or other disruption of supply that might occur.
If you are dealing with any of the above stated issues or have any other questions connected to the current situation, please do not hesitate to contact us. We remain at your disposal.
JUDr. Barbora Dubanská, LL.M., MHA, Ph.D.
Partner, Taylor Wessing Czech Republic
Co-Head Life Sciences CEE
Mgr. Patrick Boháček
Associate, Taylor Wessing Czech Republic