Pharmaceutical and medical operators First, should pay attention to Act dated 2 March 2020 „specific prevention, prevention and eradication solutions COVID-19, other infectious diseases and the resulting crisis situations" (Journal of Laws of 2020, item 374 of 7 March 2020), which co-creates the so-called Crisis Shield. It introduces a number of new regulations on operators operating in this sector.
The above Act maintains the list of refunded products and the decision to refund pending proceedings under the refund provisions. Notices of reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices applicable from 1 March 2020, remain valid until 31 August 2020, of which the period of validity of administrative decisions ending before the date 1 July 2020 is extended until 31 August 2020 Administrative decisions whose date of entry into force has also been set at 1 May 2020, is fixed per day 1 September 2020
Entities that have not yet been connected to the information system shall be obliged to connect to it and to start providing information
Changes in the distribution chain have been made.
In the event of a risk of a lack of availability of a medicinal product in the territory of the Republic of Poland, the Minister responsible for Health may, by means of a regulation, impose on entities who are required to provide information to the system, to enter all medicinal products on the market.
The health minister may also, by way of notice, reduce the number of these products per one Patient. Entities that have not yet been connected to the information system shall be obliged to connect to it and start providing information within a period of time. 24 hours since the imposition of this obligation.
With upload first information the entity reports simultaneously the individual opening balance, called ‘IBO’. This balance represents information on the stock of products to be reported to the system on the day on which they were sent first report.
According to the new regulations, pharmaceutical wholesalers are obliged to dispose of medicinal products, foodstuffs for particular nutritional uses and medical devices only to other pharmaceutical wholesalers, pharmacies, pharmacy outlets and establishments.
The Act stresses that manufacturers or importers of medical devices or foodstuffs for particular nutritional uses are obliged to dispose of the items or products specified in the list exclusively of pharmaceutical wholesalers. Where the list of these measures is published by the Minister responsible for Health by way of notice.
The law also provides for penalties for breaching these obligations or conditions. The Act states that entities that do not comply with these guidelines will be subject to a monetary penalty of between 10,000 PLN to 5,000,000 PLN.
The Act also introduces arrangements for maximum prices and margins for products and products which may be used for countering COVID-19. The conditions in this respect may be determined by means of a notice by the Minister responsible for Health.
These regulations concern products that may be used in connection with the prevention COVID-19 or in the event of a risk of their lack of availability in the territory of the Republic of Poland due to COVID-19, except for those products, products or measures the price of which is fixed in an administrative decision.
In this case, a monetary penalty shall be imposed on those who apply prices higher than those established. The penalty is a fine of up to 5,000 PLN to 5,000,000 PLN.
Author: Rafał Dąbrowski
Lawyer, tax adviser included on the list of National Tax Advisory Board and licensed restructuring adviser. At Russell Bedford responsible for the Department of Tax Advisory. Author of numerous tax-related articles published in the industry press.