AmCham Poland Advocacy Bulletin 2/2023

We are delighted to share with you our latest advocacy bulletin, summarizing our recent activities in the field of advocacy. As AmCham, we remain committed to promoting strong and fruitful relations between Poland and the United States, while supporting business development and fostering a stable and predictable legal environment to attract new investments and drive the growth of the Polish economy.

In this issue: 

1. Changes to the Pharmaceutical Law and threats to the pharmacy market in Poland

AmCham was active in the legislative process of amending the Pharmaceutical Law, which introduced significant changes to the operation of the entire pharmacy market in Poland.

This included a prohibition on taking control of entities operating public pharmacies. Simultaneously, Provincial Pharmaceutical Inspectors would be obligated to withdraw pharmacy permits for entities undergoing such changes in control. The novelization also mandated the imposition of financial penalties on entities assuming the control. There is a risk that these changes would eliminate the possibility of ownership changes in capital companies operating pharmacies, constituting a blatant violation of the freedom to conduct a business.

Considering this, AmCham has issued a position paper in which we emphasize the procedural aspect of the changes. The reason for this was the fact the amendments to the Pharmaceutical Law were introduced through the Act amending the Law on State-Guaranteed Export Insurance and certain other acts (Parliamentary Print No. 3458). However, the initial project submitted to the Sejm on July 3rd did not include these pharmacy-related changes. Only later, during the proceedings of the Parliamentary Committee on Public Finance and the Committee on Economy and Development, Amendment No. 3, which included the changes, was introduced.

Our position paper interlining both substantive and procedural reservation to the law changes was distributed to the members of the parliament and senators. In addition to that, AmCham representatives participated in the Senate Committee on National Economy and Innovation and met with representatives of the presidential palace.

The President has signed the current law on September 9, 2023. Upon feedback from business organizations, including AmCham, the law was referred to the Constitutional Tribunal to examine the compatibility of the new provisions with the Constitution. The new provisions are set to take effect on September 28^th, however, there is chance that the Constitutional Tribunal will invalidate the legal force of the provisions changing the Pharmaceutical Law.

AmCham’s position paper on the Pharmaceutical Law and threats to the pharmacy market in Poland is available here.

2. AmCham’s activity regarding the healthcare perspective

As many developments are underway to leverage the healthcare perspective both on the national and European level, AmCham continues to operate effectively in promoting the development of the business environment and investments focused on patient welfare, regulatory stability, and predictability in business operations.

Our activities include:  

• The recently processed reimbursement law, during which the AmCham Pharmaceutical Committee participated in a meeting organized by the Ministry of Health; in the Health Senate Committee session and collaborated with the US Embassy in Poland.
• The EU pharmaceutical strategy which represents the first comprehensive overhaul of EU pharmaceutical law in 20 years and the perspective of shaping the pharmaceutical and biotechnological market for decades. Together with industry organizations, AmCham presented a position paper to express a unified approach to this matter. While presenting its perspective, the Polish government should consider the conditions for conducting business in Poland. Thus, the dialogue should serve as the foundation for devising solutions that ensure competitiveness, pharmaceutical safety, access to cutting-edge drug technologies, and the economic development of Poland. Moreover,  during the Economic Forum in Karpacz, we also organized a breakfast dedicated to this topic, where we had the opportunity to present and discuss our point of view with our guests, including Deputy Minister Maciej Miłkowski, with a broad representation from the Department of Pharmaceutical Policy and Pharmacy; President of the Medical Research Agency Radosław Sierpiński; Deputy Chairman of the Health Committee of the Sejm Bolesław Piecha; former Deputy Minister Marcin Czech; and the representative from the Agency for Health Technology Assessment and Tariffication.
• The report containing recommendations for streamlining the process of making medicines available to patients in pharmaceutical programs, from the administrative decision to the actual use of the medicinal product published by the AmCham Pharmaceutical Committee. As part of this initiative, the Committee collaborated with other international chambers in Poland under the Coalition of Chambers for Health. Together, we organized an event titled “Pharmaceutical Programs – Real Access After Reimbursement Decisions,” featuring experts from the healthcare system and industry journalists.
• The 4th edition of the Healthy Legislation report which focuses on the legislative process regarding healthcare. The report examines the quality of consultations, government-imposed deadlines, and the stability and predictability of new laws. The conclusions and recommendations expressed in the report have also been considered by political parties in the preparation of their election programmes.

3. Employment of foreigners in Poland

 Since economic growth in Poland demands new employees, and most companies are affected by a lack of candidates and face difficulties when hiring non-EU citizens, AmCham continues its initiative aimed at simplifying the process of obtaining work permits. Candidates for work permits experience the longest wait in the Lower Silesia voivodeship, which is not only harmful to businesses but also increases the number of legal cases and financial penalties imposed against the voivodeship.

Together with the Association of Business Service Leaders (ABSL), we have submitted a letter to the Voivode of Lower Silesia outlining the difficulties in the procedures for granting work permits to non-EU citizens.

As a next step, we plan to organize a follow-up meeting with the Lower Silesian Voivode, which will include representatives from AmCham member companies operating in the Lower Silesia voivodeship and facing challenges related to the employment of foreigners.The entire document is available here.

4. Inquiry from the Ministry of Digitalization Regarding the Need to Enhance User Protection against Calls from Unknown Numbers

The Ministry of Digitalization has reached out to AmCham with a request to share best practices related to solutions that protect users from messages or calls originating from unknown numbers, including international numbers. The Ministry also requests that the response should include information on whether these solutions have default settings to protect users.

This request is motivated by the need to increase security against attempts at fraud, unwanted messages, and calls that could be avoided through the use of solutions that block connections from unknown users or numbers initially considered untrustworthy or solely intended for marketing purposes, or calls made from international numbers.

Responses should be directed to the address: [email protected] by September 27th.

5. The upcoming parliamentary elections: meeting with politicians and advocacy priorities

As the upcoming parliamentary elections approach, AmCham continues its meetings with candidates for the Polish Sejm and Senate. These meetings provide an opportunity to discuss election programs and present AmCham’s advocacy priorities to U.S. companies operating in Poland and the impact of AmCham member companies on Poland’s economy.

So far, we have had meetings with Adam Bodnar (Ombudsman for Human Rights in Poland from 2015 to 2021 and currently a candidate for the Senate) and Andrzej Domański (the Chief Economist of Instytut Obywatelski and a candidate for the Sejm).

Key discussion topics included:

• The importance of regulatory stability in the investment environment, especially in the context of the Rule of Law Index 2022 report prepared by the World Justice Project
• The development of the IT and New Tech sector in Poland, as a focus on skills, business transformation, and innovation is critical for resilience and competitiveness on a global scale, and this largely depends on Poland’s post-election policies and vision.
• Diversification and development of clean energy sources in Poland, matters of reporting on ESG, and providing access to green energy sources in the context of the Civic Coalition’s energy program announced on September 21st.
• Streamlining procedures and reducing processing times for issuing work permits to foreign nationals.
• Modern vocational education that aligns with the changing needs of employers and industries.

Reports from these meetings with politicians are available on AmCham’s social media channels.

Facebook, Linkedin

The entire document presenting AmCham’s advocacy priorities and postulates in the context of the upcoming parliamentary elections is available here.