The role of Polish Agency for Health Technology Assessment and related reimbursement of medicinal products
1. Introduction
In December 2021, Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ EU L 458, 2021, p. 1; hereinafter referred to as the Joint Clinical Assessment Regulation or the Regulation) was adopted. In turn, less than half a year ago, Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 was adopted, establishing, in accordance with Regulation (EU) 2021/2282 on health technology assessment, procedural rules on interactions during the preparation and updating of joint clinical assessments, the exchange of information on the preparation and updating of joint clinical assessments and the participation in the preparation and updating at Union level of joint clinical assessments for medicinal products for human use, and establishing document templates for those joint clinical assessments (OJ EU L 2024; hereinafter referred to as the Implementing Regulation).
Both of these regulations will soon become legally binding, which will lead to fundamental changes in the pharmaceutical market of the European Union Member States, including Poland. A joint clinical assessment will be introduced, as a result of which the clinical assessment of medicines and medical devices introduced to the Polish market will no longer be carried out at the national administration level by the Agency for Health Technology Assessment and Tariff System.
KIELTYKA GLADKOWSKI KG LEGAL was invited to participate in a survey that contributes to UNCITRAL CROSS BORDER INSOLVENCY PRACTICE GUIDE.
The United Nations Commission on International Trade Law (UNCITRAL) (French: Commission des Nations Unies pour le droit commercial international (CNUDCI)) is a subsidiary body of the U.N. General Assembly (UNGA) responsible for helping to facilitate international trade and investment.
UNCITRAL is currently working on an updated version of the 2009 UNCITRAL Cross-Border Insolvency Practice Guide. The UNCITRAL Practice Guide collects experience and practical aspects of cooperation and communication in cross-border insolvency cases and cross-border insolvency agreements. The initiative is supported by a team of approximately 25 insolvency judges, practitioners, academics, and other professionals from across the globe.
The survey aims to obtain information on the most relevant cases, practices and tools used in cross-border insolvency cooperation since 2009 to be included in an updated version of the UNCITRAL Practice Guide.
KIELTYKA GLADKOWSKI KG LEGAL, whose lawyers are active members of the American Bankruptcy Institute, provided practical input on cross border aspects of insolvency and enforcement cases handled by our law firm.
We are proud to share the news that KIELTYKA GLADKOWSKI KG LEGAL will take an active part in Life Science Open Space Summit 2024.
This is a flagship business and conference event organized annually for over a decade by the largest organization in the health and environmental protection market in Poland, LIFE SCIENCE CLUSTER POLAND, with the status of a KEY NATIONAL CLUSTER, founded by both leaders among Polish biotechnology companies (e.g. SELVITA) and by educational institutions of higher education (Jagiellonian University).
KIELTYKA GLADKOWSKI KG LEGAL is a proud member of the Life Science Cluster.
On behalf of KIELTYKA GLADKOWSKI KG LEGAL, the lecture will be delivered by Zaid Jaber, Pharmacy BSc and IP specialist within pharma patents. Zaid cooperates with KIELTYKA GLADKOWSKI KG LEGAL in connection with his activities at the Jagiellonian University within New Technologies and IP law.
KIELTYKA GLADKOWSKI KG LEGAL highly values its international environment of cooperation and has aspirations to become the platform for specialists within international law and life sciences sector.
Publication date: November 04, 2024, by Łukasz Chwałkowski
In the face of dynamic technological development, the legal profession is encountering new opportunities that could significantly alter the way legal services are provided. The computerization of legal work, using artificial intelligence (AI) and new technologies, not only increases efficiency but can also contribute to a more transparent and fairer justice system. Implementing AI in legal practice can offer various benefits:
We are very pleased to inform that, next to the specialists from the German jurisdiction (Mannheim) and the jurisdiction of the Cayman Islands and Canada, lawyers from KIELTYKA GLADKOWSKI KG LEGAL had the privilege of having their text included in the American Bankruptcy Institute, International Committee. The text discusses a critical assessment of the use of the instrument of division of a capital company utilizing a controversial valuation of shares to create a loss center and a profit center. The place of publication is the bulletin of the American Bankruptcy Institute, an organization with nearly 11,000 members. The American Bankruptcy Institute (ABI) is the largest multi-disciplinary, non-partisan organization dedicated to research and education on matters related to insolvency. Founded in 1982 to provide Congress and the public with unbiased analysis of bankruptcy issues, ABI is the premier professional organization in the field. Members span the entire spectrum of professionals and include attorneys, accountants, auctioneers, judges, lenders, academics, turnaround specialists, credit professionals and many others. Our lawyers are proud members of ABI in Polish jurisdiction.
