Ipsen Pharma
Ipsen is a leading biopharmaceutical group dedicated to improving lives through innovative medicines in oncology, neuroscience and rare diseases.
ID: 84295189159-07
Lobbying Activity
Meeting with Oliver Schenk (Member of the European Parliament)
21 Nov 2024 · Health priorities and rare diseases in the EU
Meeting with Pascal Arimont (Member of the European Parliament)
14 Oct 2024 · Tackling rare diseases in Europe
Meeting with Laurent Castillo (Member of the European Parliament) and RPP Group and Servier
1 Oct 2024 · Europe de la Santé
Meeting with Ondřej Knotek (Member of the European Parliament)
1 Feb 2024 · Pharmaceutical package
Response to Evaluation and revision of the general pharmaceutical legislation
6 Nov 2023
Ipsen, a global biopharmaceutical company committed to improving patients' lives through breakthrough innovations, focuses on unmet medical needs, particularly in oncology, rare diseases and neuroscience. We support the objectives of the reform but urge more ambition to foster innovation for people with rare diseases and improve Europes competitiveness and attractiveness. The path to developing therapies for rare diseases is characterised by major scientific and clinical challenges, so that investment is often hardly worthwhile economically. Nevertheless, we believe it is fair to drive innovation in the field of rare diseases. The proposals could seriously harm innovation and people with rare diseases. A recent study* assessing the European Commission's proposed changes suggests that they could lead to a 12% drop in innovation. This could deny around 1.5 million European patients with rare diseases access to innovative treatments and lead to a further 4.5 billion drop in research and development (R&D) spending in Europe. Such a loss, even a fraction, would be a major setback that runs counter to the Commission's goal of expanding therapeutic options for patients with rare diseases and maintaining the Union's industrial competitiveness. Incentives are a powerful driver of innovation. Before 2000, only 8 orphan drugs were available to patients. The introduction of the OMP Regulation in 2000 was a turning point, resulting in 146 orphan medicines having an active marketing authorisation in Europe by February 2023. However, despite these remarkable achievements, the proposals aim to cut incentives for R&D in the field of rare diseases rather than expand them. We should learn from the valuable lessons of our past and current successes and continue to create a thriving environment for progress. Legislation should be a driving force for investment. There are more than 30 million people living with rare diseases in Europe, but only 5% of the more than 7,000 known rare diseases have treatment options. Introducing concepts such as a "high" unmet medical need or a narrowly defined UMN could discourage future investment due to the inherent ambiguity of these terms and their potential impact on IP protection. This definition could lead to discriminatory and unethical treatment of patients unless it takes into account the views of all stakeholders, including patients, authorities, scientists and industry. Confirmation of significant benefit is also a barrier to the development of OMPs and makes it unnecessary given the evolution of HTA procedures at national level in the past 20 years. The legal framework should reduce the burden during the authorisation process by removing the re-evaluation of significant benefit for orphan designation. Modulation of incentives will not improve access. The problems of unavailability and delayed access to innovations for patients are multifactorial and cannot be solved by IP alone. Insufficient national resources allocated by governments, a smaller share of GDP spent on healthcare and medicines and very long waiting times for national authorities to consider reimbursement claims are major barriers to patient access across Europe**. We therefore call on the EU institutions to increase support for R&D in the field of rare diseases and to reduce the burden of developing treatments for people with rare diseases as part of the reform, while working with national authorities to address the root causes of patient access in Europe. Rare disease patients have a right to the promise of health, and we are committed to making that promise a reality. Ipsen is a member of EFPIA and EuropaBio and we fully support the associations respective contribution to this public consultation. *https://dolon.com/wp-content/uploads/2023/09/Impact-of-changes-to-Orphan-Regulation-Dolon-Report.pdf?x83136 **https://www.efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
Read full responseMeeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and Teva Pharmaceuticals Europe BV
14 Jul 2022 · Medicines
Meeting with Barry Andrews (Member of the European Parliament)
29 Jun 2022 · Health policy and pharmaceuticals
Response to Revision of the EU legislation on medicines for children and rare diseases
6 Jan 2021
As a global specialty-driven biopharmaceutical company committed to discovering new solutions for debilitating rare and ultra-rare diseases and improving quality of life for patients suffering from these diseases, Ipsen welcomes the opportunity to comment on the inception impact assessment.
The Orphan Medicinal Product Regulation (EC) No 141/2000 and the Paediatric Regulation (EC) No 1901/2006 aim to address areas of high unmet need by incentivizing the development of solutions for children and people with rare diseases and we believe the EU should remain an innovator and world leader in this field by continuing to support more innovation, not less.
The EU Orphan Medicinal Products (OMP) Regulation has been an undoubted success. It has had a significant impact on the area of rare diseases by stimulating the development of new treatments for patients living with previously untreatable rare diseases. It has been a great driver for innovation for patients with rare diseases and a genuine example of how this EU legislation has added significant value for patients as shown in recent publications. The number of medicines in development for rare conditions has increased consistently with 8% year on year growth until 2015; 6,3 million patients have found therapies for their diseases in Europe; and more than 107 therapies have been approved by 2017, more than half of which couldn’t have been developed without the current incentive framework of this regulation.
Ipsen recognizes challenges still remain, such as: finding solutions for the 95% of rare diseases without treatment and incentivizing research in these areas, maintaining Europe’s rare diseases research ecosystem competitiveness in the context of an increased international competitive landscape and improving accessibility and availability. As outlined by the European Commission, accessibility and availability of medicines for rare and ultra-rare diseases is best addressed elsewhere and we believe further work is needed to better understand root causes of limitations to access and their implications in order to facilitate the identification of appropriate solutions.
We welcome the Commission’s intention to keep pace with scientific and technological developments and principle to ensure that procedures and regulations remain efficient and fit for purpose. In Ipsen’s view, additional options to implement the necessary changes, including non-legislative options, could be explored to ensure that these regulations continue supporting a conducive environment for research on the treatments and cures of tomorrow.
We stand ready to work with all stakeholders to develop collaborative solutions to ensure we meet the needs of patients across Europe and as a member of EFPIA and EuropaBio we support their position.
Read full responseResponse to Pharmaceutical Strategy - Timely patient access to affordable medicines
7 Jul 2020
The life sciences & biotechnology sector has a major role to play in the EU’s ambition to strengthen the continent’s competitiveness globally, notably through innovation. However, Ipsen believes the Roadmap is missing drivers of innovation necessary to create a regulatory and policy environment that would live up to the EU’s ambition.
Between 1990-2018, R&D investment in Europe grew x4.5 versus over x9 in the US. In this increasingly competitive environment, Ipsen considers the new Pharmaceutical Strategy should aim for a robust and stable regulatory framework that encourages innovation, while improving patients’ timely access to safe and effective innovations, notably in areas of unmet medical needs.
Ipsen shares the concern over inequalities of access to new treatments across Europe. Faster, more equitable access for citizens is a shared goal. The root causes of these issues are multi-factorial (e.g. delayed market access assessment, heterogenous P&R policies, duplicative evidence requirements). These can only be addressed through multi-stakeholder cooperation to identify solutions that can broaden access, reduce delays and mitigate the impact of shortages. These shared goals cannot be achieved by diminishing the existing European regulatory and incentives framework.
Ipsen supports regulatory and administrative simplification (e.g. use of electronic product information & multilingual packs) to the benefit of patients. The regulatory flexibilities introduced for COVID-19 medicines under development proved to be efficient and could be applied to innovations addressing unmet medical needs (e.g. faster approval, rolling reviews, global cooperation). Ahead of future health crises, cooperation between national regulatory authorities should be strengthened and standardized to ensure efficient coordination and centralization of requests for companies (e.g. through the EMA).
A world-class IP and incentives framework is essential to protect and encourage the high-risk, complex and lengthy R&D of new treatments, especially to address high unmet medical needs such as in rare and paediatric diseases. In addition, harmonized and strengthened supplementary protection certificates (SPC) and patent systems (e.g. unitary SPC, tied to eventual adoption of unitary EP patents and a unified patent court, or a single grant mechanism with a unified appeal process) will contribute to increasing certainty and predictability for innovators.
The COVID-19 pandemic stressed the importance of speeding up digitalization. To reach the full potential of digitalization in the field of health, a secured and collaborative digital ecosystem should be put in place (incl. a European Health Data Space) that guarantees timely access to and use of data sets while safeguarding data privacy (e.g. for digital inspections).
The Pharmaceutical Strategy should facilitate investments for the European industry to manufacture and export high-value life science products, while supporting the green transition for Europe. Ipsen shares the goal of reducing the industry’s environmental footprint and has been proactively implementing an ambitious 2030 EHS Strategy. Greener manufacturing processes should be encouraged and incentivized at the EU level to ensure harmonization and predictability, notably for SMEs with limited resources.
Some Member States are adopting local measures, with specific goals, timelines and actions (e.g. France’s bill on circular economy & investments to reshore drug manufacturing; Germany’s encouragement of parallel imports and rebate policies). Ipsen is concerned these measures may conflict with the common approach and harmonization the EU is aiming for. The COVID-19 pandemic showed how detrimental unilateral measures enforced by Member States (export restrictions, closed borders, travel restrictions) can be for the access to medicinal products and medical equipment, and stressed the need for a better coordination at the EU level to tackle health crises.
Read full responseMeeting with Vytenis Andriukaitis (Commissioner) and
29 Nov 2017 · Pharmaceutical incentives, antimicrobial resistance