Covid-19: Summary of New Measures Published by the Government and Important Legislative Amendments in December 2020
Under Government Decree No. 584/2020 (December 15)the pandemic preparedness period has been extended until June 18, 2021.
On December 9, 2020, the amendment of Government Decree No 488/2020. (November 11) on Measures for the Safe Supply of Medicinal Products entered into force. According to the amended provisions, to prevent the presumed or justified spread of the coronavirus disease (COVID-19), the pharmaceutical government body can permit the import of medicine that are permitted for application or placed on the market in the EEA member states and/or the United Kingdom.
On January 1, 2021, the amendment of rules in relation to the fines stipulated in Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products went into effect. Under the law, the government body for pharmaceuticals will have the power to impose fines upon the person having committed an infringement. Pursuant to the amendment, the amount of the fine imposed may be cumulative in case of multiple violations. The fine remains between one hundred thousand (HUF 100,000.00) and five hundred million (HUF 500,000,000.00).
On January 1, 2021 an amendment to Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products became effective. The amendment provides rules relating to the imposition of fines and their circumstances. The amount of the fine and the applied sanction will be determined with regard to the provisions of Act CXXV of 2017 on Sanctions of Administrative Infringements and all applicable circumstances, in particular, the scope and gravity of the injury caused to patients and persons qualified to prescribe or supply medicinal products and/or medical aids, and the duration of the illegal conduct, including repeat offenses where applicable, and patient care interests. In the case of multiple violations, the fines may be cumulative.
Pharmacy operators can be ordered to eliminate the discrepancies discovered as a result of an inspection of a pharmacy within the prescribed deadline. The operating permit together with the implementation permit can be withdrawn if the discrepancies were not eliminated within the prescribed deadline.
As of January 1, 2021, Government Decree No. 648/2020 (December 23) on Changes Regarding Medical Public Procurement governs the steps of public procurement proceedings relating to medical devices,disinfectants, and healthcare institutions providing hospital services went into effect. The rules of the Decree are no longer applicable to the medicines and medical devices if the public procurement proceeding of these products is carried out by the National Health Insurance Fund of Hungary. The central purchasing body cooperates with the National Medical Council during preparation and procedure of public procurement proceedings relating to medicines.
It is important to note, that as of January 1, 2021, the successor of the National Healthcare Service Center is the Public Procurement and Supply Directorate-General.
On February 1, 2021, the amendment to Act CXLIII of 2015 on Public Procurement will go into effect. The amendment was published on December 10, 2020, and aims to bring the national provisions in line with the corresponding EU directives and the decisions related to public procurement cases rendered by the European Court of Justice recently, simplify public procurement procedures, and ease administrative burdens. Under Section 12 of the amendment affiliated companies of contracting entities that are not required to conduct a public procurement procedure(s) can enter a contract with a third party covering a maximum 25% of the public service contract. If they intend to enter a contract covering more than 25% of the public service contract, it must conduct a public procurement procedure. The amendment no longer stipulates the above-mentioned limit thus affiliated companies must perform the contract and cannot require third parties..
SUSPENSION OF LOAN REPAYMENTS
On January 1, 2021, Government Decree No. 637/2020 (December 22) on the Introduction of Special Provisions related to Suspension of Loan Repayments went into effect. The debtor who did not exercise his right to the suspension of loan payments in relation to capital or interest payments or payments of charges in December must indicate its intention to suspend loan repayments in advance in writing or by electronic means determined by the creditor.
On December 12, 2020, the amendment to the Act CLV of 1997 on Consumer Protection and Act XLVII of 2008 on the Prohibition of Unfair Business-to-Consumer Commercial Practices went into force. The amendment allows the use of electronical means in the course of the procedure of the arbitration board, gives further details of aspects to be considered in case of violation against the law, and determines the maximum amount of the fine.
As of May 28, 2022, the term “product” will be replaced by the term “goods” and there will be additional amendments regarding the terms ‘misleading commercial practice’
Government Decree No. 604/2020 (December 18) went into force on December 19, 2020. The decree allows the deviation from the rules of the Act LXXXIII of 1997 on the Services of the Compulsory Health Insurance System during the state of danger thus the health insurance administration can terminate the financing contract during the state of danger by ordinary termination with a notice period of thirty (30) days. However, the health care service provider cannot terminate the financing contract by ordinary termination.