AmCham Poland Advocacy Bulletin 2/2025

AmCham Poland is continually active in the legislative process and legal environment in Poland. This AmCham Poland Advocacy Bulletin provides an update of our advocacy work in a variety of areas on behalf of our member companies. We also invite you to visit our website where we regularly publish the latest activities of AmCham and previous editions of the Advocacy Bulletin.

IN THIS ISSUE: 

I. Engagement with Public Officials and Policy Stakeholders
II. Cloud and AI Provisions in the Draft SAFE Regulation
III. Revision of the Cloud Computing Cyber Security Standards (SCCO)
IV. Updated Draft Bill on Artificial Intelligence Systems
V. Draft Bill Concerning the Protection of Minors from Harmful Online Content
VI. Amendment to the Reimbursement Act
VII. Medical Devices Regulation
VIII. Pharma Committee: Two Reports to Advance Patient Access

I. Engagement with Public Officials and Policy Stakeholders

The AmCham Legal & Public Policy team maintains an active role in parliamentary and regulatory processes, consistently advocating on behalf of U.S. investors in Poland. Recently, AmCham participated in meetings of the Parliamentary Committee on Economy and Development, where discussions focused on transatlantic trade relations and innovation within Poland’s automotive sector. During these engagements, we underscored the strategic importance of sustained EU-U.S. economic cooperation and emphasized the critical role of Standard Essential Patents (SEPs) in safeguarding innovation.

Following the visit of Brendan Nelson, Global President of Boeing, AmCham organized a high-level meeting with the Presidium of the Parliamentary National Defense Committee. The meeting aimed to enhance dialogue between defense industry stakeholders and policymakers, reinforcing the strategic commitment of U.S. Defense & Security investors in Poland and the significance of access to cutting-edge U.S. technologies.

AmCham continues to engage broadly with key public sector stakeholders. In recent weeks, we held discussions with MP Bożena Hołownia; Chair of the Parliamentary Committee on Economy and Development, Ryszard Petru; and Government Plenipotentiary for Deregulation, Mariusz Filipek. Additionally, AmCham met with Minister of Health Urszula Demkow and Director Konrad Korbiński at the Ministry of Health, as well as with representatives of the National Health Fund (NFZ).

II. Cloud and AI Provisions in the Draft SAFE Regulation

AmCham has submitted a position paper addressing key concerns in the draft Security Action for Europe (SAFE) Regulation, specifically regarding provisions related to the military use of cloud computing and artificial intelligence. The SAFE Regulation is intended to create a new EU-level instrument to finance joint defense investments by Member States. However, the current draft includes several technical provisions that could unintentionally weaken European defense capabilities and hinder NATO interoperability by limiting access to essential commercial technologies.

In our position paper, AmCham highlighted the following key issues:

1) Overly broad security clearance requirements

The draft imposes blanket security clearance obligations on all personnel managing classified data, which diverges from current NATO best practices and could impede access to qualified talent.

2) Misaligned AI component regulations

The proposed approach focuses on replacing physical components rather than regulating operational control – an approach inconsistent with how modern military AI systems are designed and deployed.

3) Lack of clarity on supplier classification criteria

The absence of transparent and objective criteria for classifying suppliers introduces legal uncertainty and may deter trusted commercial providers from participating in EU defense initiatives.

AmCham’s full position paper is available here.

III. Revision of the Cloud Computing Cyber Security Standards (SCCO)

AmCham Poland participated in the public consultation process regarding the updated Cloud Computing Cyber Security Standards (SCCO). While the SCCO is not a legally binding regulation, it remains the most influential set of guidelines governing cloud security standards for public administration in Poland.

In our submission, AmCham proposed several technical recommendations aimed at aligning the revised standards with current market realities. Key points raised in our position paper include:

1) Ensuring consistent terminology, particularly in the use of the terms “data” and “information”.

2) Recommendations to revise nomenclature and specific requirements within each tier of security classifications.

3) Concerns about vague or undefined concepts, such as “data sovereignty” and “control over technical personnel,” which may create ambiguity in implementation.

The full position paper is available here.

As a follow-up to the consultation, AmCham met with Mr. Marcin Wysocki, Deputy Director of the Cyber Security Department at the Ministry of Digital Affairs. In addition to cloud standards, the discussion addressed the implementation of the NIS 2 Directive and progress on the European Cloud Certification Scheme.

IV. Updated Draft Bill on Artificial Intelligence Systems

In response to the second round of public consultations on the draft bill concerning artificial intelligence systems, AmCham Poland has submitted a position paper addressing the latest version of the proposed legislation. The bill is intended to facilitate the implementation of the EU AI Act in Poland – an initiative of critical importance to U.S. investors offering cutting-edge AI-based technologies.

While the Ministry of Digital Affairs has incorporated many of the recommendations AmCham submitted during the first consultation round, the revised draft still raises several important concerns. In our position paper, we outlined the following key issues:

1) Insufficient safeguards for protecting information obtained by the Commission.

2) Unclear and potentially problematic funding model for the Commission’s operations.

3) Ambiguity regarding the material and territorial scope of the bill’s application.

4) Unrealistic timelines imposed by some of the deadlines proposed in the updated draft.

AmCham’s full position paper is available here.

V. Draft Bill Concerning the Protection of Minors from Harmful Online Content

The American Chamber of Commerce in Poland has submitted a position paper in response to the public consultation on the draft bill aimed at protecting minors from access to harmful online content. We recognize the initiative of the Ministry of Digital Affairs as a potentially important step toward more effectively preventing minors’ exposure to pornographic content.

At the same time, AmCham highlights several areas of concern where the proposed legislation could lead to conflicts with European Union law or significantly reduce legal certainty for digital service providers.

Key points addressed in our position paper include:

1) Legal uncertainty surrounding the proposed mechanism for website blocking

2) Potential conflicts with EU regulations, particularly the Digital Services Act (DSA)

3) Concerns about the introduction of the undefined and subjective term “harmful content” into national legislation

These concerns were also voiced by AmCham during the public hearing on the draft bill held on March 12 at the Ministry of Digital Affairs.

AmCham’s full position paper is available here.

VI. Amendment to the Reimbursement Act

The Reimbursement Act is a cornerstone of Poland’s pharmaceutical policy, governing the public funding of medicinal products and medical devices. It plays a vital role in ensuring patient access to reimbursed therapies and supporting the financial sustainability of the healthcare system.

A draft amendment to the Reimbursement Act has been published for public consultation, with stakeholders invited to submit feedback by June 21, 2025.

Many of the proposed changes align with the priorities outlined in the government’s legislative agenda released in January 2025. The draft introduces over 100 amendments to the reimbursement framework—several of which aim to simplify existing procedures established under DNUR and implement a range of patient-friendly solutions.

Most of the provisions are scheduled to come into effect on January 1, 2026.

AmCham has been invited by the Ministry of Health to participate in a dedicated consultation meeting. We are currently analyzing the proposed legislation and preparing our position to be submitted as part of the ongoing consultation process.

VII. Medical Devices Regulation

AmCham continues to play an active role in the dialogue surrounding the EU Medical Devices Regulation (MDR). Most recently, our Committee on Innovative Medical Devices held discussions with MEP Adam Jarubas, Chair of the European Parliament’s Public Health Committee, to address the ongoing challenges in the implementation of the MDR.

While the regulation is designed to enhance patient safety, prolonged certification timelines, high compliance costs, and inconsistent interpretations across Member States have posed significant barriers. These challenges risk delaying or limiting patient access to innovative and life-saving technologies in Europe.

AmCham is advocating for targeted reforms, including the extension of certificate validity, the establishment of streamlined pathways for breakthrough technologies, increased cost transparency, and enhanced collaboration with notified bodies. Following the European Parliament’s October 2024 resolution calling for a comprehensive review of the MDR framework, AmCham remains committed to fostering a regulatory environment that supports efficiency, innovation, and patient-centered care.

VIII. Pharma Committee: Two Reports to Advance Patient Access

The AmCham Pharma Committee has released two strategic reports aimed at enhancing access to innovative therapies in Poland.

The first report, “Optimized Diagnostic Pathway Model for Lung Cancer”, developed in collaboration with Dr. Andrzej Tysarowski and leading medical experts, demonstrates that targeted improvements—such as conditional referrals—could reduce lung cancer diagnostic times by up to 50%.

The second report, an updated edition of a 2023 publication prepared in partnership with Prof. Andrzej Śliwczyński, addresses administrative delays in the implementation of drug programs following reimbursement approvals. It provides clear, actionable recommendations to accelerate patient access to newly reimbursed therapies.

Both reports reflect AmCham’s commitment to evidence-based, patient-centered policy work and our ongoing collaboration with the Ministry of Health.