Fresenius Kabi Deutschland GmbH
All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations.
ID: 130305227617-65
Lobbying Activity
Meeting with András Tivadar Kulja (Member of the European Parliament)
22 Oct 2024 · European Pharmaceutical Industry
Meeting with Andreas Glück (Member of the European Parliament)
22 Oct 2024 · Health
Response to Evaluation and revision of the general pharmaceutical legislation
8 Nov 2023
As part of the globally active Fresenius Group, headquartered in Bad Homburg, Germany. Fresenius Kabi corporate philosophy is caring for life. Our generics and biosimilars play a crucial role in ensuring access to medicines with 15,000 employees in Europe alone and our production facilities in France, Germany, Austria, Italy, Sweden, and other countries, we contribute to Europe's health sovereignty. to ensure fair access to medicines for all Member States, we supports a shift from market to data protection. This would provide the needed certainty for generic and biosimilar medicines to enter the market once protections expire. It is therefore essential to guard against the misuse of the modulated protection system that could create legal uncertainty and delay competition from generic and biosimilar medicines. To enable generic and biosimilar medicine developers to effectively contribute to closing access gaps, the criteria for granting conditional exclusivities must prioritise predictability and legal certainty. This is one reason why Fresenius Kabi is in disagreement with the latest legislative proposal (e.g., extending data exclusivity to 9 years), resulting in a cumulative data protection period of 13,5 years (or 14,5 years when considering the TEV). 1.2 Transferable Exclusivity Vouchers (Art. 40a, Recitals 78a, 78c) Considering the abovementioned reasons, Fresenius Kabi expressly rejects the idea of a Transferable Exclusivity Voucher TEV presented by the European Commission as an incentive for the development of new antibiotics. Given the importance of new antibiotics, we suggest considering alternatives such as guaranteed revenues, market entry rewards, and the use of regulatory leeway to reduce development costs and cut red tape. 1.3 The Vital Role of the Bolar Exemption in the European Pharmaceutical Legislation (D Ch VII Art. 85) Therefore, Fresenius Kabi welcomes the intentions of the proposal (Recitals 63 and 64) to support the market entry of generics on day 1 after patent expiration. To outline the utmost importance of the Bolar for the generic industry, we would like to outline the main reasons to include it in the pharmaceutical legislation. 1. The Bolar Exem. facilitates fair competition in the pharmaceutical sector. By enabling generic drug manufacturers like us to conduct essential research and development activities without patent infringement concerns, which encourages competition. This, in turn, benefits patients by making medicines more affordable and accessible. 2. The Bolar Exemption expedites the research and development process, allowing innovative treatments to reach patients sooner. 3. Generic and biosimilar drug competition not only benefits patients but also contributes to cost savings in healthcare systems and health insurance. 1.4 Unitary SPC As part of the generic industry, Fresenius Kabi advocates that the unitary SPC should not expand the geographical scope of protection, potentially hindering access when the original product is not marketed in a specific member state. Furthermore, when the SPC expires in the register, a clear prohibition of patent linkage should be included to prevent potential abuse. Double SPC protection (national and unitary) should be avoided. 1.5 Union list of Critical medicinal products (Reg. Art. 131) Fresenius Kabi advocates for establishing a Union list of essential medicines that demand unified action at supranational level. The current proposal lacks a harmonised approach, as it encourages Member States to determine essential medicines, potentially resulting in various national lists. Instead, Fresenius Kabi proposes prioritising a Union List of Essential Medicines, avoiding redundant and confusing national lists that weaken the regulatory system's coherence. Therefore, the establishment of a harmonised list of critical medicines is urgently needed as a starting point for all further efforts. Electronic product information supported, only ePIL and as soon as p
Read full responseResponse to Extension of the transition period for medical devices
18 Jan 2023
We are in favor and welcome the extension of the transition period for the MDR implementation in order to maintain uninterrupted supply to European markets. We want to highlight two aspects 1. A design freeze (see article 1b of the proposal extension of the transition period, second bulletin point) during the transitional period till 2027 respective 2028 remains a challenge based on the fact that ECHA continues to sunset the use of various substances with relevance for medical devices. DEHP is one prominent example with a sunset date of 27. of May 2025. The resulting substitution of substances forces manufacturers to implement material- and thus design changes in order to maintain uninterrupted supply to the market. But according to article 1b significant changes are not allowed to be done during the transitional period. In conclusion the supply of medical devices is at risk in these cases. We therefor propose to update and synchronize the ECHA sunset dates, e.g. for DEHP, according to the new MDR due dates, in reference to REACH, recital 6 of 2021/2045. Additionally the MDR proposal could be updated in the sense that in cases where material changes are forced by obsolescence or ECHA use restrictions than significant changes are allowed in order to maintain supply. 2. It remains a high priority a find a regulation for orphan devices in order to maintain supply. Otherwise many of these low volume devices may not be offered anymore after their MDD certificates expire and simply disappear from the market. This can lead to severe lacks in treating critically ill patients in the near future. Pediatric devices are a prominent example for orphan devices that cause a lot of concern.
Read full responseMeeting with Dolors Montserrat (Member of the European Parliament)
1 Sept 2022 · Revision of the Pharmaceutical Legislation
Meeting with Sara Cerdas (Member of the European Parliament)
30 Jun 2022 · Nutritional Support in Hospitals
Meeting with Margaritis Schinas (Vice-President) and
16 Jun 2021 · Supply chains for medicines
Response to Intellectual Property Action Plan
14 Aug 2020
Fresenius Kabi welcomes the EU’s initiative to further develop the existing Intellectual Property framework of the EU, and we would like to comment in more detail on three points:
One important aspect of a strong and fair system for IP protection is its ability to promote early legal certainty for all parties involved. We observed that the practice of abusing the EPC’s rules to file unlimited divisional applications during the lifetime of a patent results in fact in legal uncertainty for up to 20 years after the first filing. Divisional applications per se are an important tool to adequately protect inventions, but the inflationary filing of divisional applications for strategic purposes has the unwanted effect of creating legal uncertainty up to the end of the patent’s lifetime. Today, creating legal uncertainty by filing of divisional applications has become a common tool to delay generic entry by the pharmaceutical industry. With great concern we also observe an increase in the numbers of pharmaceutical originators which abuse the existing system by withdrawing a granted patent shortly before a (potentially negative) decision in opposition or appeal proceedings would be achieved and instead uphold legal uncertainty by continuing the same subject matter with a divisional application (examples see attachment). Generic entry usually lowers the price for pharmaceuticals, so there is a public interest to set a clear legal frame for reviewing validity of second line patents, not only, but especially in the pharmaceutical sector. We therefore request to add the review of the divisional filing system at the European Patent Office to the Intellectual Property Action Plan. It clearly addresses the first problem mentioned in the roadmap as this system renders patent proceedings complex and costly.
The second topic we would like to address is the Commission’s focus on the introduction of the EU’s IP system including stronger IP enforcement rules into Non-EU countries, named as “global fair play”. The EU which is home to many originator pharmaceutical companies supported the inclusion of the TRIPs-plus provisions into the IP chapters of FTAs. As a consequence, FTA partners were expected to implement, in their domestic legislation, a level of IP protection similar to that applied in the EU member states. Proliferating bilateral negotiations of FTAs thereby result in an increasing level of IP protection in these countries. These delay the entry of generic and biosimilar products into the market and thereby prevent access to medicines for a number of patients and have the potential to prevent generic and biosimilar competition as such, with negative effects on the industries in these countries. We therefore ask the Commission to focus on other measures beyond IP aspects that foster incentives for the Pharmaceutical industry by enhancing competition and easing the regulatory burden in these countries.
Thirdly, we would like to bring the EU Commission’s attention to the impact of IP on the initiative of “Bringing the Supply Chain back home”. To avoid medical dependency in the future it was suggested to enable the manufacturing of medicines within Europe by bringing the whole supply chain back. One significant factor hindering the Generics Industry from producing in Europe however is the extraordinary longer IP protection in EU member states due to the introduction of SPCs. As long as the IP protection in a Non-EU country is shorter, the site of manufacturing had to be selected outside of the EU in order to compete for sale in the EU at Day 1 after SPC expiry. To balance these diverging interests recently the SPC Manufacturing waiver was introduced into the IP framework. However, it only provides for a period of 6 months during which the production is exempted from infringement. This time window is too short, especially when producing biosimilars. We therefore recommend to extend this period to 18 months rather than 6 months.
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