Member Article

Since the publication of our legal update on COVID-19 Legal Challenges for Pharmaceutical Companies on 31 March 2020, new important measures were adopted or announced on both national and EU level.

Extraordinary Measures in Healthcare

On 3 April 2020, the Slovak Parliament adopted the Act on Extraordinary Measures Relating to Outbreak of the Dangerous Contagious Disease COVID-19 in Healthcare, which will enter into force immediately after publication in the collection of laws, expected in the upcoming days. The most important measures introduced by the act are:

• The Ministry of Health will have new powers applicable for the duration of the crisis situation:
  • to prohibit export of OTC medicinal products or medicinal products not included in the list or reimbursed medicinal products (export of reimbursed medicinal products is already prohibited by law, save for certain exceptions), medical devices, in vitro diagnostic medical devices, or dietary foods;
  • restrict or regulate dispensation of medicinal products, medical devices, in vitro diagnostic devices, or reimbursed dietary foods;
  • regulate prescription of medicinal products, medical devices, in vitro diagnostic devices, or dietary foods;
    
    

Breach of a decision issued under the new emergency powers may be sanctioned by a fine of up to EUR 25,000;

• COVID-19 measures as a circumstance discharging from administrative liability: Persons subject to obligations from laws in the healthcare sector, breach of which is an administrative offence, may be discharged from liability if they prove they could not meet the obligations as a result of application of laws, decisions of the authorities, and extraordinary measures adopted in relation to crisis situation caused by SARS-CoV-2 virus. This rule may be relevant for pharmaceutical companies and their obligations to ensure availability of medicinal products, or to supply reimbursed medicinal products through the emergency channel;
  
  
• During the crisis situation, it is prohibited to sell or otherwise transfer FFP2 and FFP3 filtration face half masks to persons other than Slovak healthcare providers, Slovak healthcare professionals, state and self-government authorities, persons or entities obliged to provide for personal protection devices based on health and safety at work laws, persons or entities performing body examinations, funeral services, employees of certain authorities, persons with health reasons, and resellers to these persons. Breach of this obligation may be sanctioned by a fine of up to EUR 10,000;
  
  
• Definition of duly (lege artis) provided healthcare is amended to include care in which the minimum personal, material and technical requirements for healthcare facilities could not be met as a result of the crisis situation;
  
  
• Numerous obligations under public health laws are postponed to after the crisis situation.
  
  

COVID-19 Treatment

The Ministry of Health has issued and published its first decisions permitting use of non-authorised medicinal products, or off-label use of authorised medicinal products, for COVID-19 (the decisions are available under this link, in Slovak language only). The decisions are only a regulatory pre-requisite for lawful administration of the products to the patients, and do not constitute any supply obligation of marketing authorisation holders or address any conditions or supply and delivery. These conditions are negotiated individually between the Ministry of Health and the respective pharmaceutical company.

In the meantime, the State Institute for Drug Control has issued a recommendation on potential possibilities of COVID-19 treatment, mentioning ongoing clinical trials involving remdesivir, lopinavir / ritonavir combination, chloroquine and hydroxychloroquine, systemic interferons, in particular beta interferons, and monoclonal antibodies.

Clinical Trials

The State Institute for Drug Control adopted measures to expedite the authorisation of medicinal products for COVID-19, and the approval of clinical trials related to COVID-19. The State Institute published an e-mail address for communication on the availability of accelerated authorisation procedure and clinical trials approvals, with declared 24-hour response time.

Following the EMA guidelines on ongoing clinical trials, the State Institute for Drug Control published national guidelines, addressing provision of healthcare to clinical trial participants, provision of investigative medicinal products, and trial monitoring.

Medical Devices Regulation

The European Commission announced that work on a proposal to postpone the date of application for the Medical Devices Regulation for one year is ongoing. The European Commission is working to submit this proposal in early April for the European Parliament and the European Council to adopt it quickly as the date of application is the end of May.

Subsequently, the Slovak Act on Medicinal Products and Medical Devices will likely have to be amended, since the new provisions reflecting the Medical Devices Regulation are already in the legislation, with effectiveness postponed until 26 May 2020. An amendment further postponing these provisions will be necessary.

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We follow current legislative developments and we will continuously publish relevant updates on the above information (and also on other legislative changes and interesting legal topics). This legal alert was prepared on 6 April 2020.