Galapagos NV
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action.
ID: 262498239347-21
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
Galapagos is a pioneering European biotech dedicated to improving patients' lives. We focus our R&D on areas of high unmet need. We believe Europe can be a hub for innovation.
The COVID-19 pandemic has once more shown how vital the European biotechnology sector is for Europe and the world. To ensure continued competitiveness of the European biotechnology sector, Galapagos welcomes the timing and initiative of the consultation on revision of the General Pharmaceutical Legislation. Galapagos calls on policymakers to prioritize development of a new Pharmaceutical and Biotech Strategy at EU level integrating a focus on supporting biotech companies.
A strong array of incentives is necessary to ensure the European biotechnology companies can compete at global scale. Galapagos proposes the following solutions to enable ambitious European biopharmaceutical companies to keep developing innovative solutions for patients.
Simplify legislation and create regulatory attractiveness
• Simplification is welcomed and of highest importance, but without compromising the quality of regulatory efforts.
• Regulators and policymakers should prioritize efforts aimed at global regulatory convergence, in particular between the EMA and FDA, to align on regulatory timelines and data requirements, and support patient access to innovative medicines.
• Clinical trials assessment and authorization frameworks should be further harmonized, simplified and shortened going beyond what has been introduced by the EU Clinical Trials Regulation, to eradicate duplication, drive more agile development of innovative medicines, and enable continued investment in R&D in Europe.
Revise the system of incentives
• Mechanisms to provide expedited pathways with earlier interactions with developers, early assurance of accelerated assessment and decreased regulatory burden could prove an effective incentive.
• Incentives must not be linked to an obligation to launch: market launch depends on the structure and requirements of each individual Member State. For smaller and midsize companies, it is particularly difficult to navigate the different systems in a given time frame due to their operational and financial restrictions.
• Linking incentives to more transparency of R&D costs might prove extremely challenging: developing products is a complex process with a high failure rate, and methodologies are unlikely to capture the true R&D costs and investments. Consequently, linking the incentives system to the beforementioned obligations might put additional strain on companies and could potentially weaken the EU’s ability to attract investments in innovation.
Accelerate product development and authorisation
• Early regulatory consultation and advice, and early assessment are crucial for companies like ours. We value the role of continued dialogue with the regulators to enhance the development processes of medicines and ensure mutual understanding aimed at bringing innovative medicines to patients in a safe and timely manner.
• We call for a more adaptive approach to uncertainty in risk-benefit evaluations to be applicable to treatments for chronic diseases, and for patients’ perspectives to be incorporated into the regulatory process and design.
Generic/biosimilar competition
• Any efforts to bring generics and biosimilars to the market faster must not put the balanced system of regulatory incentives and IP rights at risk. It is also of paramount importance to ensure that patients can access the most appropriate and effective treatment option for them, not only the most economically advantageous.
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