AmCham Poland Advocacy Bulletin 2/2024

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.

IN THIS ISSUE: 

I.      Deregulation Bill
II.     Changes to the Cybersecurity Law
III.   Implementation of CSR Directive
IV.   Public procurement certification
V.    Copyright Law Amendment Act
VI.   Changes to the Reimbursement Law

I.               Deregulation Bill

At the Ministry of Development and Technology’s invitation, AmCham Poland took part in the consultations on the Deregulation Bill.

This long-awaited Deregulation Bill aims to simplify the laws regulating business in Poland. The bill applies to all entrepreneurs operating in Poland, but some of its provisions may be of special interest to foreign investors. In particular, the proposed act implements many of the postulates presented by AmCham in recent years, primarily in the area of standards for rule-making process and guarantees for regulatory stability.

The new law contains many loosely related amendments to 35 laws in economic and administrative law. Their common aim is to deregulate economic activity and simplify procedures. The most significant changes include:

• The introduction of the principle of balancing administrative obligations (one in, one out) into business law, according to which the removal of an equal number of obligations should balance the imposition of new obligations on entrepreneurs;
• Introducing the principle that laws defining business rules should have a vacatio legis of at least 6 months;
• Repeal of a provision of the Tax Code which allowed tax offices to extend the period for pursuing tax debts by instituting criminal tax proceedings against individuals acting in companies;
• Introduction of a requirement for inspectors to provide a preliminary list of expected information and documents before starting an inspection at a company;
• Deregulation of the process of setting up small wind power plants;
• Extension of the scope of the tax relief for research and development;
• Introduction of electronic bills of exchange;
• Easing the start-up of a business.

In a position paper submitted as part of the consultation, AmCham proposed changes to the R&D relief and construction of excise tax exemption on cars used for research purposes.

The full position is available here.

II.              Changes to the Cybersecurity Law

AmCham Poland has presented its position as part of the public consultations organized by the Ministry of Digital Affairs on amendments to the Cybersecurity Law. The aim of the new regulation is to strengthen the protection of citizens and institutions against growing threats in cyberspace and to adopt NIS2 Directive updating the EU cyber-security framework. This new regulation affects mostly key service operators and digital service providers.

The most important changes to the Cybersecurity Law include:

1. Expanding the catalogue of entities of the national cyber security system with new sectors of the economy, such as wastewater, ICT management, space activities, manufacturing, as well as production and distribution of chemicals and food;
2. Introducing new obligations regarding risk management on entities important in cybersecurity, concerning, in particular, the application of appropriate and proportionate technical, operational, and organizational measures;
3. Introducing accountability of the leadership of the critical entity or important entity for the performance of cybersecurity tasks;
4. Introducing the possibility of reporting incidents via the ICT system to the relevant sectoral CSIRT and national level CSIRT teams;
5. Strengthening the competence of supervisory cyber security authorities;
6. Introducing new fines for failure to comply with statutory obligations;
7. Establishing a National Plan for responding to large-scale cyber security incidents and emergencies;
8. Empowering the Government Plenipotentiary for Cyber Security by providing him with specific powers to offer recommendations to strengthen the level of cyber security;
9. Expanding the competencies of national-level CSIRT teams.

While AmCham Poland supports the general direction of the changes proposed in the bill, we have made comments based on the practice of operating U.S. technology companies in Poland.

We pointed out the need to:

• keep the Polish law in line with the NIS 2 Directive and regulations in other EU member states to prevent regulatory fragmentation of the common digital market;
• clarify certain statutory obligations and procedures and to maintain the proportionality of statutory enforcement and penalty mechanisms;
• exclude micro and small entrepreneurs from the scope of the law, who may not be able to cope with the burdens associated with the new obligations, and the introduction of a single point of contact for incident reporting.

The full position is available here.

III.            Implementation of CSR Directive

AmCham took part in the public consultations regarding implementation of the Corporate Sustainability Reporting (CSR) Directive into the Polish law. This implementation is made by the draft bill amending the Accounting Act, the Act on Statutory Auditors, Audit Firms, and Public Oversight, among other regulations and affects:

•  all large entities operating in Poland,
•  entities that are the parent company of a large group,
• small and medium-sized entities admitted to trading on a regulated market,
• certain subsidiaries and branches established in an EU Member State that are controlled by large parent entities.

The main focus of the proposed law is to establish a new non-financial reporting regime. Information on sustainability issues will be more detailed than before. The Bill also introduces mandatory application of European Sustainability Reporting Standards, digitalization of reporting and mandatory verification of sustainability reporting, including mandatory attestation of reported information by auditors.

The most crucial issue requiring clarification during the further rule-making process is that the proposed law should specify the deadlines for companies within a capital group to fulfill their sustainability reporting obligations, especially when their parent company is based outside the EU. This proposal aims to address the challenges posed by varying deadlines across EU member states, which can complicate compliance for Polish companies reporting through their parent company. The proposal suggests that such reporting should be considered compliant if the Polish company includes a declaration in its financial report specifying which company will publish the required sustainability report and when.

The full position is available here.

IV.            Public procurement certification

AmCham took part in the consultations on a draft bill on certification of public procurement contractors and amendments to certain other laws. The proposed law provides for introducing a certification system in public procurement procedures into Polish law and affects all investors operating in Poland that are parts of public contracts or willing to participate in public procurement procedure.

The bill will directly improve the situation for all entities seeking public procurement in Poland, including foreign investors, by reducing the administrative burden and lowering the cost of participation in procurement procedures.

The introduction of certification will allow a contractor to replace numerous documents or declarations with an appropriate certificate issued by an authorized certification body after the contractor’s verification process. Certificates will be awarded by entities accredited by the Polish Accreditation Center and posted in a publicly available and free database. Such a certificate, issued for one to three years, will allow contractors in Poland to participate in many different contract award procedures in Poland and other European Union countries without having to collect and submit other documents each time.

Certification for contractors will be voluntary. Its introduction is expected to promote the professionalization and transparency of the contractor verification process through the participation of professional certifiers and reduce the cost of involvement in the proceedings. The ministry also aims to increase the efficiency of the public procurement system by standardizing the requirements set by ordering entities as part of the conditions for participation in the proceedings.

The full position is available here.

V.             Copyright Law Amendment Act

AmCham took part in the consultations on the Copyright Law Amendment Act which implements the provisions of the Copyright in the Digital Single Market (DSM) Directive into Polish law.

The position paper we presented raising several key points, e.g. proposal for the removal of Article 5a of the Act on Collective Management of Copyright and Related Rights from the Draft, concerns regarding the exception for text and data mining and comments regarding additional remuneration.

One of the main concerns was cutting generative AI from the scope of the exception. Article 4 of the DSM Directive creates an exception regarding exploring texts and data. The first version of the Polish draft introduced this rule, however, with the additional reservation that the exception does not apply in the case of “creating generative models of artificial intelligence”. Influenced by the voices expressed during the consultations, the ministry dropped this provision.

AmCham Poland is also involved in a coalition opting to reconsider how to shape the regulation of royalties for works made available online.

The full position is available here.

VI.            Changes to the Reimbursement Law

AmCham Poland, together with the Pharma Committee, continues to work towards the development of the healthcare system in Poland. The Ministry of Health has completed the pre-consultation phase regarding amendments to the Reimbursement Act aimed at clarifying the regulation.

We have identified the following areas for urgent amendment:

1. Abandonment of the new rules for calculating minimum supply quantities specified in Article 25, point 4 of the Reimbursement Act, and reverting this provision to the wording that was in effect before November 1, 2023. This means returning to the practice where applicants declare supply quantities according to the actual demand of patients for a given drug and their logistical-production capabilities.
2. Revocation of provisions requiring the Ministry of Health to dismiss reimbursement proceedings if the applicant fails to supplement, within the deadline, analyses submitted with the application that, in the opinion of the President of Agency for Health Technology Assessment and Tariff System (AOTMiT), do not meet the requirements specified in the executive regulations, and documentation confirming the fulfillment of additional conditions recommended by the President of AOTMiT. These regulations could lead to premature dismissal of reimbursement proceedings, potentially delaying access to modern therapies.
3. Restoration of the previous wording of regulations governing the creation of limit groups and removal of provisions allowing changes to reimbursement decisions during their term based on discretionary criteria. This introduces unpredictability and undermines the principle of administrative decision stability, causing applicants to worry about the conditions of reimbursement during the decision period agreed upon during negotiations. This could destabilize the reimbursement system, affecting both applicants and patients, as the structure of the limit group determines the co-payment amount for reimbursed drugs in pharmacies.
4. Ensuring legal certainty for applicants by introducing a procedure to inform applicants of planned changes, combined with allowing them to apply for amendments to the risk-sharing instrument based on appropriate regulations. The right granted to the Ministry of Health by DNUR to unilaterally change the descriptions of drug programs continues to raise concerns among applicants about potential discrepancies between such changed descriptions and the agreements reflected in the risk-sharing instrument.
5. Revocation of the provision allowing agreements with any countries under which Poland would share sensitive information about effective prices or other details of risk-sharing instruments. Establishing new platforms for exchanging confidential information regarding the reimbursement conditions of specific products in Poland could pose a significant threat to the stability of operations conducted by pharmaceutical companies with an international or global reach.
6. Removal of the provision imposing criminal liability on individuals signing reimbursement applications for the accuracy of the data and information contained therein, as this liability is disproportionately severe compared to the actual ability of these individuals to verify the data. Each reimbursement application compiles data and information from various individuals often located in different countries, and those signing in Poland lack the ability to verify all the data.

One of the potential consequences of retaining the current regulations could be the reduced availability of modern therapies for patients due to the uncertainty surrounding the practical application of these regulations. This could reverse the recent trend in Poland of a dynamic increase in the number of reimbursed new therapies, sometimes making Poland one of the first countries in the European Union to do so.

The full position is available here.