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Biogen Inc.

Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience.

Lobbying Activity

Response to Requirements for Artificial Intelligence

2 Aug 2021

We welcome the Commission’s first ever legal framework on AI and its goal to promote Europe’s innovation capacity in AI, which has the potential to speed drug development and improve healthcare outcomes across the continent. We support a risk-based approach to AI with an oversight proportionate to the intended use and led by defined risk categories. Biogen supports the Commission’s approach to regulate AI based on risk, overall acknowledging CE marking system for high-risk applications in healthcare which is already addressed by MDR/IVDR. We would welcome an alignment of the risk levels described in the proposal with MDR for consistency. Under a risk-based regulatory system and in consideration of the scope of use, some AI-driven software may be categorized as low or intermediate risk under the MDR, whereas the draft proposal appears to classify all such devices as high risk. The inclusion of AI software into the EU’s product compliance framework could also decrease the competitiveness on the market due to providers having difficulty in fulfilling market access regulations and therefore jeopardizing the uptake of AI-driven solutions by operators. AI has a broad application in the pharma supply chain including R&D, manufacturing, launch, post marketing surveillance and patient support. To incentivise the investments in AI solutions in Europe, we recommend a thorough assessment of the proposed requirements versus the support offered to providers to navigate through the new rules. In order to assure high quality AI solutions and to safeguard the EU’s competitiveness in the international AI marketplace, easy yet compliant access to a significant amount of high quality and representative data will be prerequisite to reducing bias, discrimination and ensuring highest levels of safety and robustness of AI. We support the mapping and “FAIR-ification” of existing databases to build up on existing sources and to make the machine-readable metadata findable for automated discovery. The Commission’s plans to create a EHDS promises to unlock the power of data for AI-enabled healthcare and a well-functioning EHDS should incentivise data sharing and harmonise applicable rules to remove barriers to the collective benefits across Europe. In order for all stakeholders, including providers and operators, to train, test, develop and apply a trustworthy, reliable AI system, clear rules on data access and processing should be laid out; and full benefit should be made of all measures in support of innovation such as AI regulatory “sandboxes” which may involve the further processing of personal data for a limited period of time and under well-defined conditions. Emerging AI methods involving the decentralised development of machine learning algorithms would enhance user and stakeholder privacy and should be investigated. In line with our health equity commitments, Biogen emphasizes the importance of access to not only high quality but diverse datasets to proactively counter the potential for bias in AI-base systems as an important protection for patients. We should avoid fragmented implementation. Therefore, we welcome the creation of a European AI Board tasked with coordination of collaboration on AI across the EU. We emphasise that the evolving positive ecosystem of AI must be built together. Biogen wishes to underline the importance of all key stakeholders being engaged in this initiative at the highest level and encourages early agreement on public-private platform to allow for structured dialogue with the Board. Finally, we call the EU policymakers to engage with international partners throughout the legislative process to take into consideration how the rules would apply internationally. Any regulation should ensure an equal playing field for both local and global players while not stepping away from core European values.
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Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

Biogen is one of the world’s leading biotechnology companies, with a focus on discovering, developing, and delivering worldwide innovative therapies for people living with serious neurological diseases. The planned initiative to evaluate the general pharmaceutical legislation is an opportunity to incorporate learnings into a future medicine regulatory framework that supports innovation and can accommodate rapid developments in scientific progress. We favour a regulatory system that stimulates research and innovation in areas of unmet medical need. Neurodegenerative conditions were highlighted in the EU Pharmaceutical Strategy as an area of significant unmet need and recent years have seen many companies move away from neuroscience due to challenges in research and high risk. Consequently, for areas where there are significant challenges to development either due to the nature of the disease (neurodegenerative conditions), lack of a viable market (AMR) or where the current framework has not yet covered all needs (OMP/paediatric indications), a holistic approach to incentivising medicine development should be considered. The rapid advancement of technology and innovation and the ability of regulatory science to keep pace is a challenge. As such, the creation of a progressive and adaptable regulatory system requires the legislation underpinning it to be based around high level principles which still allow for future policy adaptations in response to scientific, technological and societal developments without the need for further legislative revision. The potential for the medicine regulatory system to provide scientific advice along the development continuum and embracing novel manufacturing technologies is essential. Revision of the legislation in areas where it prevents the delivery of an efficient, expertise-driven assessment or limits the agility of the regulatory system to adapt to innovation is supported. There is already scope to modify the regulatory framework within the current legislation (the introduction of the EMA’s Priority Medicine Scheme being one example) and ensuring that any changes made to the legislation will allow flexibility in the future is crucial. This concept should apply beyond Directive 2001/83/EC and Regulation 726/2004 to other legislation that impacts on the medicine regulatory system e.g., the GMO legislation and the Variation Regulation (1234/2008) which requires modernisation to streamline the EU post-approval framework. All these aspects need to be considered in the context of a rapidly developing digital environment. As such, the mandatory requirement to provide printed package leaflets with medicinal products should be adapted. Also, expanding the role of the EMA in the assessment of drug-device/diagnostic combination products is supported. The potential use of digital clinical data in regulatory decision making extends beyond the initial marketing authorisation into post-marketing and it will be important to support the development of learning healthcare systems that are able to create standardised, high quality data repositories in the context of the developing regulatory framework. Finally, among the issues that the initiative aims to tackle, Biogen does not believe that changing the pharmaceutical legislation will solve concerns around access and affordability, which remain as national competencies. Whilst ensuring the delivery of treatments to patients remains Biogen’s primary goal, the situation across Member States is inherently complex and is likely to become even more so, with the development of personalised medicines and administration of complex therapies in specialised centres. Given this complexity, proposals to link incentives to access could negate their aim to promote research and development. This will require further consideration outside the pharmaceutical legislation with the Commission proposal for a Regulation on Health Technology Assessment as a starting point.
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Response to A European Health Data Space

3 Feb 2021

Biogen is one of the world’s leading biotechnology companies, with a focus on discovering, developing, and delivering innovative therapies and digital solutions for people living with serious neurological diseases. We welcome the proposal to create sectoral and horizontal legislative frameworks to unlock the value of data, support the use, re-use and exchange of health data, foster harmonization of digital standards at the EU level, address safety and liability-related aspects of AI to ensure a high-quality healthcare and reduce inequalities. We also welcome the Commission’s intention to ensure coherence between the different pieces of legislation. It is critical that the biopharmaceutical industry and the drug development process are included within the definition of the health data ecosystem. Medicines developers will play an increasingly crucial role in the digital economy of health data through decentralized virtual trials and the use of mobile technologies by patients both in clinical trials and in the real world (registries). Digital data can power a learning health care system that merges the world of clinical research with the health care system to improve prevention, screening, diagnosis and treatment options as well as data for decision-making. Agreement on any policy by the EU and Member States should promote data sharing and harmonize applicable rules. Clear guidance on how each stakeholder may gain access to health data and for what purpose, needs to be transparently articulated and understood by all data partners within this data ecosystem. The associated processes to obtain and maintain access need to be clearly defined. We welcome the proposal in the draft Data Governance Act to establish competent bodies who may act as a gateway to national data resources. Sectoral bodies dealing with secondary use of data, including data altruism, should be set up. We believe that the actions of such bodies should be substantially harmonized at EU level to avoid complexity and duplication of groups at Member State level, charged with data access requests, particularly regarding the secondary use. We consider that it is important that any consent form (as proposed in the Act), as well as providing for subjects to exercise specific control over the use of their data, should also permit individuals to grant consent to very broad categories of use (e.g., health research), both for primary and secondary use. The GDPR assigns a special regime to scientific research, intended to foster innovation. However, in the clinical trials space, there is great fragmentation between Member States on privacy issues. Renewed efforts to clarify and harmonise the rules would be valuable. We agree with the need to further review an individual’s ability to exercise their data portability rights and to invest in building public understanding and trust in how health data is used in research. We support EFPIA’s commitment to work with the Commission to develop Codes of Conduct for the sector that would harmonize the rules across Europe, ensuring equal rights of citizens between countries and reducing the complexity of cross-border projects. Investment in an interoperable data infrastructure is a prerequisite to facilitate processing and analysis of different data sources. Data should not have to be physically pooled into one repository in a single format, but instead can sit as distributed data networks provided appropriate safeguarding mechanism are in place. A positive European health data space will scale up existing health data networks to connect them and ensure the system operates at scale across Member States. Standardised outcome measures as well as expansion of common data models and quality standards are fundamental in consolidating multiple datasets and overcoming differences between the sources, while at the same time ensuring a high level of data protection and generation of credible insights for research.
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Response to Revision of the EU legislation on medicines for children and rare diseases

21 Dec 2020

Biogen discovers, develops, and delivers innovative therapies for people living with serious neurological and neurodegenerative diseases, including rare conditions – an area to which we are strongly committed to. Biogen developed the first approved treatment for spinal muscular atrophy (SMA), which changed the life of thousands of patients worldwide, and is currently investigating a range of treatments for rare diseases (RD) with great unmet medical need, such as Choroideremia, Trigeminal Neuralgia and Amyotrophic Lateral Sclerosis. Children and RD patients have greatly benefited from the progress achieved through the Orphan & Paediatric Regulations. The Orphan Regulation has incentivised the pharmaceutical sector to deliver treatments for up to 6,3 million patients. After years of lagging behind other regions of the world, the regulation created an environment that has fostered investment and innovation specifically in Europe. The Paediatric Regulation is meeting best-case expectations from its impact assessment conducted in 2004. With this response, we want to express our concerns towards the Commission’s broad approach, which is influenced primarily by considerations around access and affordability, and which may result in a curtailing of incentives for the development of medicines for rare diseases and children. While we acknowledge the importance of equitable access and are ready to work together to develop appropriate solutions, changing the OMP and paediatric legislation is unlikely to solve them, while it will affect companies’ capacity to invest in these areas. All options the Commission puts forward require a clear and consistent definition of unmet medical needs agreed across multiple stakeholders, particularly patients. While crucial, the absence of any treatment is not the only element to identify an unmet need, i.e. disease severity or the patients and care givers quality of life are also essential elements. Reducing rewards for fulfilling the PIP obligations or reducing incentives to focus only on ultra-rare diseases where no treatment exists or on first in class innovation fail to reflect the scientific developments that drive biopharmaceutical research. Such measures will not redirect R&D into areas of needs but will affect the attractiveness of Europe as a region for innovation. Limiting the RD-designation criteria to less prevalent diseases and risks excluding significant numbers of pathologies and patients; reducing prevalence thresholds or using a cumulative prevalence criterion fails to recognise the importance of follow-on innovation to achieve meaningful patient outcomes. Developing medicines for children and RD patients only provides a very marginal economic case, which is why these areas are not attractive to generic and biosimilar developers. We welcome the Commission’s intention to keep pace with scientific and technological developments and to ensure that procedures remain efficient. Regulatory authorities should be entrusted to ensure that the system works and keeps up with these advances. Key scientific and procedural developments can be consolidated in guidance, i.e. on issues such as biomarker-defined conditions or class waivers for paediatric development. Biogen is committed to tackling significant diseases in challenging areas and ensuring that available treatments reach all European patients, and we demonstrate this through continued investments in R&D and broad availability of our therapies. We also believe there is room for improvement in the current system, e.g. through increased acceptance of Real-World Evidence, closer European collaboration on the Health Technology Assessment, closer alignment on requirements from EMA committees, and facilitate conduct of PIPs. We call on the Commission to consider all options through a thorough impact assessment, including those identified as ‘baseline’, and consider further engagement with stakeholders to address the above-mentioned issues.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. We are proud of the role we have played in advancing the field of biotechnology and helping patients since our foundation — and are building on this legacy of great science and discovery as we pursue innovation in all that we do. We welcome the Commission’s recognition of the importance of our sector and we believe the EU Pharmaceutical Strategy has the potential to support Europe’s medical research eco-system and contribute to address our continent’s health challenges, such as those related to ageing population and chronic diseases. Unfortunately, we believe the Roadmap does not contain the necessary drivers of innovation to realize its own ambition of supporting the pharmaceutical industry in Europe to be a world leader. Europe needs a research and manufacturing infrastructure that delivers the next generation of vaccines and treatments. That means developing clinical trial networks, biobanks and data banks, seizing the opportunities offered by digital technologies, such as through decentralized virtual trials and the use of mobile technologies by patients, building a European health data space, delivering public-private collaboration mechanisms to accelerate bringing health solutions to patients and encouraging innovative manufacturing. To place the EU at the forefront of pharmaceutical innovation, Europe needs a world-class IP framework to attract investment into the development of future treatments for the benefit of patients, including for patients with rare and paediatric diseases. Developing incentives to further address unmet medical needs and seize advances in science is critical to tackling issues like Alzheimer’s Disease and other neurodegenerative diseases. SPC harmonisation and strong IP systems can increase certainty and predictability for innovators and investors alike. Europe needs a regulatory framework that is stable but adaptable, fast, effective and globally competitive. We need development support and regulatory approval times on par with other regions, EU regulators delivering world class scientific expertise in collaboration with global partners, simplification of the EU regulatory network, and connected regulatory oversight of drug-device/diagnostic combinations. To be able to deliver on its related 2025 regulatory science strategy, the EMA needs further strengthening. Faster, more equitable access to medicines for citizens is a goal that we share. We can only address this issue by working together through a High-Level Forum on Better Access to Health Innovation as suggested by EFPIA and several stakeholders. Also, we would like to emphasis the urgency to positively conclude the HTA Regulation negotiations in order to address the misalignment on evidence between industry, regulators and HTA bodies; one of the most prominent and complex delays to access. We stand ready to provide more information at your request.
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Meeting with Grzegorz Radziejewski (Cabinet of Vice-President Jyrki Katainen) and CELGENE

27 Nov 2015 · Biopharmaceutical industry's contribution to jobs and growth