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Medicines for Poland

M4PL

Medicines for Poland represents domestic producers of generic and biosimilar drugs.

Lobbying Activity

Response to Union prevention, preparedness, and response plan for health crises

27 Oct 2025

Good afternoon, I am enclosing the position statement of Medicines for Poland. Yours sincerely Grzegorz Rychwalski
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Response to General revision of the General Block Exemption Regulation

6 Oct 2025

Szanowni Państwo, W załączeniu stanowisko Polskiego Związku Pracodawców Przemysłu Farmaceutycznego - Krajowych Producentów Leków. Z poważaniem Grzegorz Rychwalski
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Response to Critical Medicines Act

5 May 2025

Dear Please find attached the position paper of Medicines for Poland. Yours sincerely
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Response to Critical Medicines Act

24 Feb 2025

Europe's growing dependence on the supply of raw materials necessary for pharmaceutical production from sources outside our continent has been the subject of debate at EU level for several years. The Critical Medicines Act, which has been announced for years and explicitly mentioned in the 'EU Competitiveness Compass' published at the end of January, aims to increase their production in Europe and reduce reliance on non-EU supplies. In order to be able to achieve these goals, a well-considered, holistic regulatory and financial framework is needed to bring pharmaceutical production back to Europe and to become independent from Asian suppliers. In recent years, the EU pharmaceutical industry has experienced a decline in competitiveness and relocation of production, jobs, clinical trials and R&D operations to Asia and the US. Over the last two decades, the investment gap between the US and the EU has grown from EUR 2 billion to a staggering EUR 25 billion, representing a thousand per cent increase in the disparity. Meanwhile, the EU remains the second largest pharmaceutical market in the world. It is therefore necessary to put in place mechanisms that will effectively encourage the launch and increase of the production of critical medicines and their ingredients in Europe. On behalf of Medicines for Poland, I am attaching a position paper to the CMA.
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Meeting with Adam Jarubas (Member of the European Parliament) and The Employers' Union of Innovative Pharmaceutical Companies

15 Mar 2024 · Pharmaceutical Package

Response to Review of the Health Emergency Preparedness and Response Authority (HERA)

16 Feb 2024

Szanowni Państwo, z zadowoleniem przyjmujemy inicjatywę Komisji Europejskiej dotyczącą przeglądu działań przeglądu realizacji działań Urzędu ds. Gotowości i Reagowania na wypadek Stanu Zagrożenia Zdrowia (Urząd bądź HERA) zgodnie z art. 8 decyzji Komisji (COM(2021) 6712) z dnia 16 września 2021 r. Związek jako reprezentant 17 wiodących krajowych producentów leków, członek organizacji Medicines For Europe, Konfederacji Lewiatan oraz Związku Przedsiębiorców iPracodawców pragnie wyrazić pełne poparcie dla dalszego rozwoju HERA i jej działań związanych z bezpieczeństwem zdrowotnym w całej UE. W załączonym materiale przekazujemy nasze stanowisko. Z poważaniem Grzegorz Rychwalski
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Meeting with Adam Jarubas (Member of the European Parliament)

4 Dec 2023 · Access to medicines in the EU

Response to Evaluation and revision of the general pharmaceutical legislation

31 Oct 2023

Medicines for Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe, effective and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive e to manufacturing and continuous innovation. Focusing on the provisions of the Regulation, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by rejecting the proposed transferable exclusivity vouchers for novel antimicrobials. The vouchers would lead to the extension of monopolies on the most profitable blockbuster drugs, thus breaking the founding principle of the relationship between innovation and reward, unduly delaying patient access to the more affordable off-patent products and dramatically increasing costs for healthcare budgets. To address the AMR challenge, instead of transferring the costs of funding antimicrobials to patients with already limited and unequitable access to blockbuster drugs, Europe should establish a Union multi-country pull incentive scheme to improve innovation, development and access to both novel and existing antibiotics, such as the revenue guarantee mentioned both in the December 2021 and June 2023 EPSCO Council Conclusions. 2. Establishing a clear European strategy to prevent and mitigate shortages. We support the proposed harmonised definitions of shortages and critical medicinal products, but are concerned about extending shortage notifications from 2 to 6 months which would lead to shortage false alarms as happened in Italy and Canada. Instead, a single digitalised and automated reporting system would allow marketing authorisation holders to report shortages as soon as they are aware, without placing an unnecessary burden on either them or the competent authorities. We support the introduction of shortage prevention plans with a risk-based approach, based on a single coherent list of critical medicines or essential medicines with no alternatives to avoid the generation of countless resource-intensive and unnecessary reports, instead allowing manufacturers to focus their resources on preventing and mitigating actual shortages. 3. Ensuring an efficient regulatory system that delivers on medicine availability. While the proposal already foresees several key provisions to optimise regulatory operations, including a shortened marketing authorisation (MA) procedure from 210 to 180 days, it would be critical to ensure the possibility for generic, hybrid and fixed dose combination products marketing authorisations applicants to choose between the centralised and the decentralised procedure. Moreover, removing the requirement for generic and biosimilar manufacturers to duplicate packaging and brand names for use patents by better adapting labelling to the use patent landscape and avoiding confusion among patients due to duplicate MA applications. We are ready to continue the dialogue with the co-legislators, the Commission, patients and other stakeholders to improve medicines availability, accessibility and affordability and achieve an open strategic autonomy in healthcare.
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Response to Evaluation and revision of the general pharmaceutical legislation

31 Oct 2023

Medicines for Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and affordable medicines, through better competition, an efficient regulatory system and a framework conducive to manufacturing and continuous innovation. Focusing on the Directive, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by: a) clarifying the Bolar provision to allow immediate day-1 competition after IP expiry, through the inclusion of the supply of EU produced APIs for obtaining marketing authorisations (API supply, offer, export, manufacturing) and all necessary regulatory and administrative steps (MA/P&R list/tender bids); b) modulating market protection rather than data protection, to ensure that in case the originator manufacturer does not supply the product to all EU markets, generic or biosimilar medicines would be approved in time to supply the underserved markets; c) ensuring the cumulative data and market protection period does not exceed the current 11-year cap. 2. Establishing a clear European strategy to prevent and mitigate shortages, by: a) increasing the visibility and transparency of the supply chain through a single interoperable reporting system, leveraging existing data sources like the European Medicines Verification System; b) allowing faster pan-European implementation of electronic product information, starting with hospital products, thus enabling faster reallocation of medicines across Member States. 3. Ensuring an efficient regulatory system that delivers on medicine availability. The proposal already foresees several key provisions to optimise regulatory operations but we still see areas where optimisation can go further to ensure faster patient access to affordable treatments by: a) avoiding limiting the mutual recognition procedure within a year of MA granting b) offering a pragmatic path for the national competent authorities to opt-in national procedures by allowing them to recognise for public health reasons the MA procedure within 5 days after the procedure has been closed c) ensuring a greater flexibility in choosing the marketing authorisation route d) adjusting the ownership of the ASMF to the legal entity that has ultimate responsibility for the ASMF. 4. Adopting a science-driven and risk-based environmental risk assessment (ERA) to reduce the environmental footprint while safeguarding patient access. We support the development of a streamlined process for referencing originator ERA for generic, biosimilar and fixed-dose combination products in order to avoid unnecessary duplication of efforts and delays in access to medicines. In addition, we recommend: a) ensuring that post-MA ERA condition is sufficient for authorisation of products where ERA is not (yet) available b) adopting AMR-related measures for products with a confirmed high risk of developing resistance. 5. Supporting affordable innovation to address patient needs via a clear pathway for value added medicines. The proposal recognises the importance of repurposed value added medicines with a non-cumulative 4-year data protection. We recommend including in the scope all relevant changes which deliver significant benefit to patients, such as repositioning, reformulation and complex combinations, while ensuring the article is not misused for evergreening practices. We are ready to continue the dialogue with the co-legislators, the Commission, patients and other stakeholders to improve medicines availability, accessibility and affordability and achieve an open strategic autonomy in healthcare.
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Response to A New European Innovation Agenda

9 May 2022

Please find attached the position of Medicines for Poland for public consultation on the New European Innovation Agenda initiative by the European Commission.
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Response to Single Market Emergency Instrument (SMEI)

9 May 2022

Please find attached the position of Medicines for Poland for public consultation on a new EU instrument guaranteeing the functioning of the Single Market in emergency situations by the European Commission.
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Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

1 Apr 2022

Medicines for Poland has a negative opinion on the plans to implement the Unitary Supplementary Protection Certificate (SPC) system. The same view is also shared by Medicines for Europe. In the discussion on the possible introduction of a single SPC, the following issues should not be overlooked: • A unitary SPC system would actually increase the geographic scope of protection: Currently, SPCs are not registered in 8 out of the 27 Member States. In these countries, generic/ biosimilar medicines may be brought to market earlier than in countries with SPC protection. In the case of a unitary SPC regime, protection may extend to all countries covered by the SPC agreement, potentially delaying access to treatments in countries where this protection does not exist at the moment. This is important for therapies for which the degree of availability increases significantly after a generic or biosimilar medicine is launched on the market. • A unitary SPC system should not prevent equal access to treatment: The absence of SPC protection in some EU Member States is due to the fact that there are markets where innovative products are not launched. In a scenario where the SPC covers countries with no protection, the unitary SPC would inevitably delay access to treatment in markets where the innovator product is not marketed, while at the same time generic/biosimilar products could not enter the market due to the unitary SPC protection regime
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Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry. The legislation should ban patent linkage – a major cause of generic/biosimilar entry delays, which the EC considers anti-competitive and “unlawful”. While incentives have generated some success, they should not go beyond their legally defined public objective and abuses/misuses that delay generic/biosimilar competition should be tackled. To encourage competition, access and sustainable innovation, there should be incentives and regulatory reforms to encourage the development of follow-on orphans and off-patent paediatric products. In addressing AMR, there should be market reforms to ensure the availability of critical older off-patent antibiotics and encourage value added innovation. Value added medicines (VAM) are an opportunity for continuous innovation on off-patent molecules for unmet medical needs, e.g. reformulation of off-patent antibiotics to tackle AMR, repurposing in oncology. To encourage this innovation, the pharmaceutical legislation should recognise VAM as a separate category of innovation with proportionate incentives. The regulatory system needs to be updated to keep a resilient off-patent sector by: • The use of telematics tools for regulatory efficiency • short and predictable timelines • adapting to new digital or technological developments Single global development is a key enabler of efficient generic drug development and the unethical duplication of studies in humans. It is important to tailor regulatory pathways for maintenance, approvals and regulatory learnings as well as enabling multi-source competition at loss of exclusivity of the reference drug. Amendments to the Variations Regulation and Variations Classification guidelines are needed to reflect the science and telematics tools to optimise the regulatory process, avoid duplication and enable a faster reaction to shortages or emergencies (via Target Operating Model). Current limitations to broader use of the CP, DP and RUP should be removed. To prevent continued consolidation of the market and manufacturing, supply chain resilience should be strengthened via procurement reform that includes criteria other than price and encourages multiple manufacturers to supply the market. Imposing stronger obligations to supply and subsequent penalties will increase demands on manufacturers with no reward thus increasing consolidation. Any stockpiling of medicinal products must be done rationally: clear demand, financing and management of the stockpile, preventing strain on manufacturing capacities and potential wasteful disposal of unused medicines. Uncoordinated national stockpiling demands should be rejected as this will fragment the internal market, increase costs and undermine EU solidarity. To address the environmental impact of medicines manufacturing and disposal, policies should look at the life cycle of the medicine. Establishing a central EMA ERA database containing all available ERA data submitted by MAHs can identify missing environmental data gaps considering science and risks, and prevent unnecessary duplication. Beyond medicines manufacturing, introduction of e-Pi would bring not only environmental benefits but also greater supply flexibility in a crisis.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

Taking the lessons learned from COVID-19, Medicines for Poland has two main reflection points on the proposal. 1. We highlight the important challenges of using joint procurement (JP) for generic multisource medicines. The joint procurement of ICU medicines during the pandemic was not an efficient way to secure medicines supply. The JP lacked transparency and offered little-to-no commitment to purchase from the countries and the EC. Companies awarded were forced to hold stock to fulfil the framework agreement while some of the participating countries organized parallel tenders for the same products generating additional stress to the supply capacity and demand volatility. Result: inventory blocked and unused instead of serving patients needs at risk of causing shortages. We echo that JP is not a suitable method to procure generic medicines. Based on the ICU medicines JP, we believe that there are 6 core lessons: i) Implementation of an ‘exclusivity clause’: countries participating the JP should be prevented from procuring the same products concurrently nationally. Pre-existing national supply agreements must supersede the JP. ii) Clear award criteria: tender award criteria and specifications should be discussed before launching the procurement process in an open competitive manner, involving the relevant trade associations and prospective manufacturers. Thus, ensuring they are workable and avoiding unnecessary delays. This would allow the implementation of smart procurement criteria and the process would have been faster with prior consultation of the industry on the criteria which were a source of confusion for procurers and companies. It is incorrect to claim that this was not possible due to the urgency of the situation as the ICU tender took 3 months from launch to award. iii) Transparent call for tender and results: the EC and MS must ensure that all companies authorized to market medicines in Europe are able to participate in the call for tender. Additionally, the EC should provide a full account JP procedure to allow its proper evaluation ahead of launching additional calls for tender. iv) Packaging flexibility: when procuring generic medicines that are mostly nationally licenced (DCP, MRP, NP), there should be flexibility and clarity on the packaging, labelling, possibly FMD serialisation, to make it quicker to manufacture and package large volumes. v) Volume commitments: volumes jointly procured must be accurately estimated and have volume commitments for bidders to prevent waste. vi) Healthcare Crisis Focus only: JP should only be carried for the purpose of addressing patient needs during a health crisis and following the Directive 2014/24/EU to prevent any disruptions to the normal functioning of the internal market. 2. We understand the need to buildup an EU reserve of critical medicines. We stress the value of a balanced and coordinated approach to avoid creating a large inventory of medicines at waste risk and potential short-term supply issues. To ensure a functional European reserve of critical medicines, some aspects that must be included: i) Agree on a list of essential medicines for the reserve, based on identified needs in a risk assessment. ii) Establish a transparent process to purchase these medicines, identifying who will place orders, purchase the goods, hold the reserve, call off deliveries and under which conditions these medicines can be used. The process should clarify the tasks to be managed at a country and EU levels, involving the relevant supply chain actors. iii) Establish clear responsibility for the costs associated with ordering, purchasing, logistics, storage and distribution of these medicines. Logistics should take into account the product characteristics (eg shelf-life) as well as the ownership of the financial risks of obsolescence and destruction. iv) Avoid the wasteful destruction of medicines (only needed in an emergency) by using best practice from across Europe regarding rolli
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

Medicines for Poland welcomes the reform of the mandate of the European Centre for Disease Control (ECDC) especially in light of its response to the first wave of the COVID-19 pandemic in Europe when it struggled to collect data from member states and to provide forecasts of the progression of the virus. Medicines for Europe, along with other stakeholders in the field of the pharmaceutical industry, regularly requested dialogues and information from the ECDC to plan manufacturing and supply capacities for therapeutics such as medicines used at intensive care units, vaccines, etc. across Europe. However, we did not receive any useable information from the agency for the purpose of production planning even though this is clearly its main mission (to help the EU with the epidemiology of infections). We believe that the COVID-19 outbreak showed the need to reinforce the surveillance systems and subsequent coordination between the Member States, EU Institutions, relevant European agencies (such as European Medicines Agency) and stakeholders. Special attention should be paid to strengthening the external communication of the ECDC towards the Member States. In our opinion, the mandate of the ECDC is more than a question of more funding. The agency’s role in providing information to the pharmaceutical industry is also critical as surges in patient demand for medicines (emergency medicines, anti-infectives, anti-virals, vaccines) will almost certainly be a feature of future crises. We underline that during the first wave of the Covid-19 pandemic, the pharmaceutical industry in a project led by Medicines for Europe and EFPIA had to conduct its own epidemiological research on the progression disease and on the medicines needed to treat patients. What is the point of funding an agency of epidemiological experts for Europe if, in the end, the industry must do this data collection and epidemiological calculation on its own? We understand that it is challenging to provide epidemiological projections to fit an industrial planning timeframe of 2-4 months but that is where epidemiological predictions can serve a public purpose. Medicines for Europe is prepared to work with the Commission and ECDC to share its experience on how this future work could be developed to avoid this scenario repeating itself in the future.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

Medicines for Poland, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity. We would like to see a proposal for a robust harmonized digital reporting system for shortages in Europe by all EU national competent authorities (NCAs), which would be built on a common definition of medicines shortage and based on common data fields. The system should be primarily based on collecting data on the national level, where the MAHs would report into the shortage reporting database. With data collected in harmonised fields, the EMA could receive aggregated data from national databases to monitor any potential cross-border shortages and to effectively intervene to mitigate or even prevent the possible consequences of such a shortage for patients. For such a system to be truly functional, the electronic form and data submitted should be compliant with ISO IDMP standards for the identification of human medicines and be based on a harmonised data template and with interoperability with SPOR data. This would allow EMA, national agencies and industry to identify medicines by using the standard and process with the benefit of reducing the duplication of manual data filling and risk of human error as it is today, avoiding redundant notifications of the same shortages, and improve data-sharing. The advantage of this approach is also its scalability as most reporting only concerns national markets. This approach would avoid the creation of massive data sets of little or no relevance to the EU level and allow the EU, member states and industry to focus their resources on where it matters most. To be able to respond adequately to any emergent large-scale crisis, there is a need to quickly identify critical medicines to secure their supply chain in the affected Members States. This should be done in collaboration with the manufacturers. Medicines for Europe and EFPIA led a project on this for ICU medicine supplies and it is imperative that the EU consider reusing this approach (Commission Decision, Competition law comfort letter, oversight by DG SANTE jointly with DG Competition) as only the industry can engage in production scale up to meet demand surges. Related to this, there should be a clear mandate in the regulation that the EMA and national medicines agencies should actively collaborate with the manufacturers of the medicines to avoid duplication of work, under the coordination of the European Commission. This coordination is needed in times of major cross-border health crisis and two-way communication should be maintained more generally. The industry is able to support the regulatory bodies in securing the supply chains and allocation of medicines in states with elevated demand for the benefit of the patients. The COVID-19 also crisis showed us, that there is a need for greater regulatory flexibility, and this should be clearly stated in the regulation – for both EMA and national agencies. We should also underline that the industry dialogue with the Health and Industry Commissioners was important to rapidly solve the numerous problems that arose during the COVID-19 Pandemic.
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Response to Intellectual Property Action Plan

6 Aug 2020

Please find attached the position of Medicines for Poland on the Intellectual property action plan.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

1 Jul 2020

Medicines for Poland supports the initiative to develop a European Union pharmaceutical strategy. The pandemic has shown how important it is to have a strong European and national pharmaceutical industry. The EU's dependence on the supply of pharmaceutical products from outside Europe, long supply chains and loss of manufacturing competence have threatened the security of EU. EU solidarity has proven to be very important, but it needs to be based on a strong foundation: the capacities and competences of MSs. It is therefore necessary to support the building of national production capacities that will contribute to EU health security which is as important as the energy or military security. The UE pharma sector uses more than 60% of the raw materials from Asia. EU manufacturers are unable to compete on price with Asian companies. In Poland, only a few companies manufacture active ingredients for the production of medicines (APIs), which they use to make medicines and export them to the US, Japan or Korea. One of the capital groups, which manufactures drugs in Poland for the local market and for export, uses for all its products APIs manufactured in the EU, USA and Japan. Other domestic drug manufacturers, who until a few years ago produced APIs in Poland decided to stop doing so for economic reasons and are trying to diversify their supply sources. A barrier to the development of new production capacity in Poland is limited investment support. The launch of API factories requires huge financial outlays and is time consuming. It should be remembered that, depending on the type of API, different production technologies with dedicated synthesis lines must be implemented and all processes are subject to validation. Targeted, long-term investment programmes should therefore be put in place to allow the production of key APIs in Europe and ensure a long-term return on investment. Increasing the volume of APIs produced in the EU will reduce their production costs and increase competitiveness with Asian producers. Poland, which has a long tradition in pharmaceutical production and access to highly qualified personnel can play a significant role in this. However, it is necessary to implement instruments to support domestic drug manufacturers. Recommendations: 1. Development plans prepared by the EC should be based on the potential of the already existing pharmaceutical industry, and the planned actions should focus on its advancement and shaping new competences. This requires implementation of a stable economic, industrial and regulatory policy. 2. Investments in the production of APIs, excipients and medicines in EU require support from national governments and the EU. The possibility of EU support for API and pharmaceuticals production at all stages of the production cycle through mechanisms modelled on the Common Agricultural Policy should be considered. Such production is associated with huge capital expenditures due to environmental standards, high electricity and water consumption. This will offset the higher production costs in Europe which are the price of building EU drug safety. 3. While deciding on the location of these investments, it is important to maintain balanced geographical distribution and ensure uninterrupted supply chains. 4. It is necessary to have a flexible registration process that makes use of digitisation and to shorten the registration. 5. Non-legislative measures should be implemented to recommend that the national authorities responsible for reimbursement policies give preference to products manufactured in the EU or using intermediates and APIs produced in Europe and move away from the lowest price criterion used so far, which gives an advantage to Asian manufacturers. 6. Increasing access to medicines and closing the gap between EU MSs should be an important pillar of the strategy. 7. The objectives of the strategy should be complementary to the objectives of current and future EU funding.
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