Poland has in place a system of guidelines for the evaluation of medical devices. The purpose of the guidelines is to indicate principles and acceptable methods for conducting the medical technology assessment process for medical devices, ensuring high quality analysis and reliability of the results.
The guidelines refer to the medical devices applied for in order to be covered by the guaranteed benefit status as defined in art. 15 par. 2 item 14 of the Polish Act on health care services financed from public funds (Journal of Laws 2020, item 1398, as amended), and which are processed in accordance with art. 25 of the Polish Act of 12 May 2011 on reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws 2020, item 357, as amended) and which meet all of the following criteria:
(a) are mass produced;
(b) are intended for use by an individual patient;
(c) are materially superior to products currently receiving public funding, the burden being on the applicant to demonstrate the claimed superiority;
(d) are therapeutic medical devices or are used for prophylaxis (they are not diagnostic medical devices).
When the medical device contains a drug product, the documentation should address the requirements described in the Health Technology Assessment Guidelines (Version 3.0) developed for drug technologies.
DEFINITION OF MEDICAL DEVICES AND MEDICAL TECHNOLOGY ASSESSMENT UNDER POLISH LAW
In January 2022 there have entered into force the provisions of the Polish law on special rules for the remuneration of persons performing tasks in the field of cyber security, which, among other things, provide for the creation of the Polish Cyber Security Fund, which will be used to finance salary supplements for persons engaged in cyber security.
HIGHER EARNINGS OF SPECIALISTS WORKING FOR MAJOR OFFICES IN POLAND
ICT benefit, which is a salary or emoluments allowance, is to be provided to persons performing tasks in a national level CSIRT; in cybersecurity authorities; persons who serve the Plenipotentiary for Cyber-security, as well as persons who perform tasks related to ensuring cyber-security in, among others, the Internal Security Agency, the Foreign Intelligence Agency, the Central Anti-Corruption Bureau, organizational units subordinate to the Prime Minister or to ministers, the Chancellery of the Prime Minister or in offices serving ministers, the Police or the State Protection Service.
The amount of remuneration for the work, including the ICT benefit, cannot exceed twenty-one times the base amount for members of the civil service corps specified in the Budget.
As for service procedure of documents in Poland until present, the common form was a paper letter that had to be sent with an acknowledgement of receipt. The changes introduced by the 2019-2021 amendments to the Polish administrative procedure, particularly the 2021 amendment on electronic service, are intended to effectively change the way parties are informed about the stages in the procedure. The changes move correspondence with government entities to an electronic level. From 5 October 2021, there have entered into force the changes which concern, among others, the principle of written documents (Article 14 of the Code of Administrative Procedure), provisions on the power of attorney (Article 33 of the Polish Code of Administrative Procedure ), time limits (Article 35 of the Polish Code of Administrative Procedure), reminders (Article 37 of the Code of Administrative Procedure), service (Articles 39-49 of the Code of Administrative Procedure), summons (Articles 50, 54 of the Code of Administrative Procedure), time limits (Article 57), or commencement of proceedings (Articles 61, 63 of the Code of Administrative Procedure).
On February 3, 2022 KIELTYKA GLADKOWSKI KG LEGAL will participate in the seminar organized by Proskauer on Nasdaq listings for European and Asian companies. The seminar will discuss the SEC process, disclosure requirements, corporate governance, ADRs and liability concerns.
The speaker will be Peter Castellon, Partner.
Due to large interest among our law firm’s clients in Nasdaq listing and related requirements, our corporate and regulatory team members will take advantage of the seminar by gaining practical information for our clients in relation to the listing process. The information will be of particular interest for KG Legal’s clients operating in technology and healthcare sector.
On 16 and 17 November 2021 KIELTYKA GLADKOWSKI will participate in Global Class Actions Symposium 2021 organised by ICLG.com. With 14 panel discussions across the two days, expert speakers will cover topics including:
Funding international collective proceedings
Settlements of global disputes
Planning Global Strategy
Class action for breach of data protection
Competition claims
ESG claims
Global trends in securities litigation
Consumer protection
Calculating damages in cross-border cases
Since class actions expertise, with heavy emphasis on cross border aspect, is one of the key specialisations of KIELTYKA GLADKOWSKI, the participation in the event will allow our lawyers to gain more insight into current trends and strategies within global class actions.