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Vifor Pharma Management

Vifor Pharma Group, formerly Galenica Group, is a global pharmaceutical company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions.

Lobbying Activity

Response to Revision of the Union legislation on blood, tissues and cells

26 Aug 2022

CSL Vifor welcomes the European Commission’s proposal on Blood, Tissues and Cells. The existing Directives have done much to ensure the safety of blood and blood derived products. However, the consultations that the European Commission has carried out showed that the legislation has not done enough to manage the sustainability of red blood cells, blood derived product and plasma products. CSL Vifor welcomes the European Commission’s willingness to address issues relating to the sustainability of SoHO and to the resilience of the EU health systems, by encouraging Member States to develop strategies to ensure the sufficiency of supply. (“Member States shall make all reasonable efforts to promote public participation in SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected”). We believe that the European institutions, in addition to address sustainability of these products through supply measures, should also encourage initiatives on the demand side, by making sure that precious SoHO resources are used only where needed. Member States should be encouraged by the Regulation to consider implementing measures to monitor and protect recipients, programs to ensure sufficiency of supply of SoHOs, and strategies to optimise patient outcomes. Therefore, we would recommend that the proposal also includes an encouragement for Member States to develop strategies which can lead to the implementation of Patient Blood Management programs, with a thorough evaluation of the appropriateness of individual blood component demand - as recommended by the Patient Blood Management guides the European Commission has developed. This will lead to improved patient outcomes and a more rational use of blood, ensuring that this precious resource is saved for the patients who need it most, as required by the World Health Organization since 2010 and most recently in a Policy Paper on the Urgent Need to Implement Patient Blood Management . The COVID-19 pandemic has highlighted the underlying pressures on our blood supply and the dangers of shortages. Therefore, other solutions must be adopted to continue and/or resume care of patient population.
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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

As a manufacturer working in innovative areas of medicines development and manufacturing, we support the Commission’s efforts to future-proof the EU’s general legislation and adapt to scientific and technological developments. The Commission’s IIA highlights the need to introduce elements of flexibility to this end. However, this does not imply that there is no need for standardisation – flexibility needs to be balanced to deliver regulatory efficiency and consistency. Nanomedicines, which fall under the category of Non-Biologic Complex Drugs (NBCDs) are medicinal products that have at least one dimension in the nanoscale range (1nm to 100nm), which allows for preferential crossing of specific barriers within the body therefore providing new therapeutic options for many diseases. Nanomedicines exhibit phenomena and properties attributable to size and morphology that are relevant to safety, effectiveness and quality. The complexity of nanomedicines does not allow for full physiochemical characterisation and nanomedicine “sameness” cannot be demonstrated in the same way as regular generics. This has potential implications for patient safety and efficacy as the smallest changes in composition can create different levels of biological activity. To ensure both safety and efficacy, it is essential that a robust regulatory process exists and that there is greater awareness of the underlying complexities. There are an increasing number of nanosimilars being developed, however uncertainty remains as to the best way of approving them. Currently they can go via CP, DCP, MRP or NP and in the past have been approved through the generic, hybrid and biosimilars pathways (Klein et al., The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations, 2019). There are examples of nanosimilars approved through the generic pathway which did not prove therapeutically equivalent to their originators (Rottembourg et al., Do two intravenous iron sucrose preparations have the same efficacy? 2011). The complexity of nanomedicines and the challenges posed by nanosimilars means that the current regulatory options are not well suited for this class of products – this has also been recognized by the Joint Research Centre REFINE White Paper (Anticipation of regulatory needs for nanotechnology-enabled health products, 2019) and the EMA 2025 Regulatory Strategy. The generic application procedure (Art. 10(1)Dir 2001/83/EC) is inappropriate, a fact that has previously been acknowledged by the EMA in different reflection papers (e.g. Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product, 2015; Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product; 2013). In addition, the biosimilar application procedure (Art. 10(4)) is not always an option, as many nanomedicines are not biologic. The hybrid application procedure (Art. 10(3)) has increasingly been used for these types of products, however this option lacks adequate guidance. The Commission should therefore use the opportunity presented by this evaluation and revision to: • Introduce a mandatory centralized procedure for nanomedicines and nanosimilars to avoid potential divergence in approaches by NCA. • Introduce a new, stand-alone application for nanosimilars to provide clarity on data requirements for introduction of new products on the European market. The EU has shown that regulatory clarity and consistency can lead to investments in innovation and benefits for patients. With its robust biosimilars regulation, the biologic medicines market has seen vast investments, driven by a clear approval process, definitions and guidelines. This regulatory clarity would see nanomedicines of the highest quality, safety and efficacy being developed and made available to patients in EU.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Vifor Pharma, as a manufacturer of nanomedicines, appreciates the opportunity to contribute to the evolution of an effective regulatory framework. As an organisation working in an innovative area of medicine, we support the European Commission’s efforts to reinforce the European pharmaceutical sector’s global competitiveness, and we are committed to providing patients with safe, state-of-the-art therapies. However, for patients to realise the full potential of nanomedicines and their follow-on products, nanosimilars, there is an urgent need for the development of a clearly defined regulatory pathway. Currently, nanomedicines and nanosimilars can be approved at national level, creating uncertainty due to different policies or interpretation of requirements per country. Due to their complex nature, it is difficult to demonstrate equivalence between originator nanomedicine product and its follow-on. Therefore, a nanosimilar “sameness” cannot be readily demonstrated with the same certainty as with highly characterisable small molecule generics. Indeed, there is clinical evidence demonstrating that nanomedicines and their similars are not equivalent, affecting both efficacy and patient safety. The complexity of these compounds warrants careful attention in the definition of approval pathways and regulatory science. The Pharmaceutical Strategy aligns with the Industrial Strategy, which stresses the need for Europe to take the lead in the next era of industry, and the Commission has stated that the intent of the Pharmaceutical Strategy is to develop a system that is future-proof. Vifor fully supports this, including adapting the regulatory framework surrounding nanomedicines to be equipped for current and future innovation. Core components of this future-proof system need to be approached for recognising innovation, and for safe evaluation of follow-on products as part of the life-cycle of health systems. There has already been some recognition of the need for improvement, with the Commission’s Joint Research Centre acknowledging that the complexity of nanosimilars ‘often does not allow a full comparability of physicochemical characteristics demonstrating the equivalence of products’ and adding that the framework for assessing biosimilars could be used as a basis for nanomedicines. In addition, the EMA’s Regulatory Science to 2025 states that, as part of the strategic goal of catalysing the integration of science and technology in medicines’ development, there is a need to develop a regulatory response to nanotechnology in pharmaceuticals. Potential safety or quality issues in the approval and regulation of one class of innovative technologies, nanomedicines, could risk weakening public trust in the system for other innovative frameworks. The Pharmaceutical strategy and regulatory framework must be robust across technology platforms and therapeutic areas to be successful. Furthermore, the roadmap indicates that there will be encouragement and support for EU manufacturing capacity of Active Pharmaceutical Ingredients (APIs), with reduced reliance on APIs from third countries. We believe that this is relevant to ensure high quality manufacturing of complex products such as nanomedicines. Products which are difficult or impossible to fully characterize at release are reliant on well regulated and carefully managed controlled manufacturing. In the nanomedicines field, the entire nanomedicine product is regarded as the API and, as with other areas of complex medicines, it is increasingly difficult to ensure API quality purely based on import and release specifications. It is essential that the pharmaceutical framework enables and provides incentive for innovators to build and maintain manufacturing capacity in the European economic region throughout the life-cycle of a medicinal product. The introduction of regulatory clarity would help increase patient access to efficacious and safe originator and follow-on nanomedicines.
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