In Poland there has entered into force the Act of 12 March 2022 on assistance to Ukrainian citizens in connection with an armed conflict in the territory of that country (Journal of Laws of 2022, item 583).
The adopted special act regulates the issues of stay of Ukrainian citizens in Poland. It also assumes a number of solutions related to the labor market. The most important thing is to open access to the labor market for Ukrainian citizens.
Admitting Ukrainian citizens to work in Poland will not require a work permit or a declaration of entrusting work, as it has been so far. The only formal requirement is the obligation for the employer to notify employment offices about entrusting work for a citizen of Ukraine.
The employer has 14 days from the date of starting work by the Ukrainian citizen to fulfill this obligation. The notification shall be submitted via the praca.gov.pl portal. The solution applies only to Ukrainian citizens, not all foreigners. The special act also gives Ukrainian citizens the possibility of simplified registration – as unemployed and jobseekers – in poviat labor offices.
Activities in the area of Risk Management and Compliance have recently assumed exceptional importance. This is due not only to internal company regulations, but also to the constantly tightening regulations on transactions with related parties, including those from tax havens or from outside the EU, control of final beneficiaries or the obligation to verify the credibility of the counterparty. Not only for the purposes of security of receipt of payment, but also to ensure that VAT is correctly accounted for.
Real World Data (RWD) is data collected in the real world about patient health and healthcare delivery. This data can be collected routinely from a variety of sources including electronic health records, disease registries or patient generated and uploaded data. RWD allows for the collection of more data from actual users of medicinal substances. Real World Evidence (RWE) is clinical evidence that has been carried out on the basis of RWD analysis. They concern the benefits or risks of using a medicinal product. RWE is obtained from various studies and analyses such as randomised trials, including large simple trials, pragmatic trials or observational studies. They can be used to determine what action should be taken to reduce the risks and increase the benefits of a medicine for therapeutic purposes. RWE has been defined in Sec. 3022 (2) of the 21st Century Cures Act: ‘real world evidence’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials. Clinical trials are now at the heart of the process of bringing medicinal products and medical devices into use. For the most part, they are conducted even before a product is placed on the market, but the final, fourth phase takes place after the product is marketed. This phase consists of determining whether the marketed product is safe in all manufacturer’s indications and for all patient groups. Conclusions from previous phases are further verified in this phase. In the earlier phases, studies are conducted on a group of volunteers on whom the effects of the substance are tested. In the final phase, information is collected on adverse drug effects that have been reported. In this aspect, RWE and clinical trials are similar. However, there is one important difference that weighs in favour of RWE. In the case of clinical trials, data are collected only from patients who have reported adverse effects and the information about them has reached the manufacturer. RWD can be collected from all patients who reported an adverse reaction to a medicine and the adverse reaction was reported in their medical records. The number of people from whom data on the effects of medicines are derived is therefore much larger than in the case of clinical trials. Manufacturers of medicinal products and medical devices use RWD and RWE to support clinical trials, especially their final phase. They are therefore not mutually exclusive modes of research, but rather designed to support each other.
On August 2, 2021, Poland submitted to the European Commission an application for a derogation pursuant to Art. 395 of Council Directive 2006/112/EC on the common system of value added tax to authorize the application of a measure derogating from Art. 218 and 232 of that directive.
On 30 March 2022 the European Commission, based on the application, prepared and submitted to the EU Council a draft derogation decision authorizing Poland to implement the mandatory electronic invoicing system.
The Polish Ministry of Finance is working on the business and legal concept of the target National System of Electronic Invoicing. The assumption is the fullest possible use of the potential of electronic invoicing within the scope of consent granted to Poland by the EU institutions.