Avicenna Alliance
The Avicenna Alliance is a global non-profit organization advocating for the adoption and regulation of Computer Model and Simulation (CM&S, also known as In Silico medicine).
ID: 217362043770-33
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
6 Nov 2023
The Avicenna Alliance represents a collaborative effort among stakeholders committed to advancing in silico medicine. This initiative harnesses the power of computer modelling and simulation to revolutionize the development and delivery of innovative medical treatments. By using virtual patient interactions, in silico medicine significantly reduces the risks involved in the initial stages of product development, consequently leading to reduced costs and shorter times to market for new drugs or medical devices. This transformative approach is underpinned by the utilization of computer simulations that can accurately predict how a new treatment may interact with the human body. It allows for comprehensive assessments without the need for real-world testing, ultimately ensuring a much safer and more cost-effective route in drug development. The Avicenna Alliance is advocating for the integration of these in silico methods into existing pharmaceutical legislation. The primary focus of this integration lies in emphasizing patient safety, cost-efficiency, and the enhancement of the drug development process. This forward-thinking initiative aligns with the current regulatory landscape in the European Union, albeit necessitating modifications to adapt to the rapidly evolving technological advancements that define the field of in silico medicine. The integration of predictive medicine within regulatory frameworks represents a pivotal moment in the future of medical treatment. It not only promises enhanced patient safety but also holds the potential to significantly reduce the expenses entailed in developing new treatments. Additionally, aligning with the 3R principles, this approach aims to minimize reliance on animal testing, prioritizing ethical and responsible scientific progress. Simulation serves as a linchpin in the integration of in silico medicine. It ensures informed decision-making across the spectrum of drug development while upholding stringent patient safety standards. This progressive approach extends beyond mere integration by proposing the creation of regulatory "sandboxes" and the incorporation of Artificial Intelligence (AI) into these methods. This innovative step forward is geared towards refining risk management and fostering responsible innovation in the healthcare sector.
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
6 Nov 2023
The Avicenna Alliance represents a collaborative effort among stakeholders committed to advancing in silico medicine. This initiative harnesses the power of computer modelling and simulation to revolutionize the development and delivery of innovative medical treatments. By using virtual patient interactions, in silico medicine significantly reduces the risks involved in the initial stages of product development, consequently leading to reduced costs and shorter times to market for new drugs or medical devices. This transformative approach is underpinned by the utilization of computer simulations that can accurately predict how a new treatment may interact with the human body. It allows for comprehensive assessments without the need for real-world testing, ultimately ensuring a much safer and more cost-effective route in drug development. The Avicenna Alliance is advocating for the integration of these in silico methods into existing pharmaceutical legislation. The primary focus of this integration lies in emphasizing patient safety, cost-efficiency, and the enhancement of the drug development process. This forward-thinking initiative aligns with the current regulatory landscape in the European Union, albeit necessitating modifications to adapt to the rapidly evolving technological advancements that define the field of in silico medicine. The integration of predictive medicine within regulatory frameworks represents a pivotal moment in the future of medical treatment. It not only promises enhanced patient safety but also holds the potential to significantly reduce the expenses entailed in developing new treatments. Additionally, aligning with the 3R principles, this approach aims to minimize reliance on animal testing, prioritizing ethical and responsible scientific progress. Simulation serves as a linchpin in the integration of in silico medicine. It ensures informed decision-making across the spectrum of drug development while upholding stringent patient safety standards. This progressive approach extends beyond mere integration by proposing the creation of regulatory "sandboxes" and the incorporation of Artificial Intelligence (AI) into these methods. This innovative step forward is geared towards refining risk management and fostering responsible innovation in the healthcare sector.
Read full responseMeeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and
23 Oct 2023 · Pharmaceutical Package (Regulation)
Meeting with Stelios Kympouropoulos (Member of the European Parliament)
18 Oct 2023 · discussion on the General Pharmaceutical Package revision
Response to A European Health Data Space
28 Jul 2022
The Avicenna Alliance welcomes the proposal for the EHDS. The Alliance is a multistakeholder group with the mission of accelerating medical innovation and its practical implementation to ensure safe, affordable and cost-effective health care through the large-scale adoption of in silico medicine and computer modelling and simulation (CM&S). The exchange of and secondary access to good quality health data is particularly important to the Alliance because of its potential to support scientific research and innovation, including in CM&S. There is a distinct need to boost data-driven R&D and innovation to address health challenges which are currently limited by a lack of clear and harmonised data access regulation.
While the Alliance largely welcomes the EHDS proposal, we would like to draw attention to certain aspects of the proposal that may require clarification to fully achieve its intended goals.
To address the lack of legal clarity, there is a need to better define the interplay between pre-existing and sectoral legislation with the EHDS, particularly the MDR, IVDR, upcoming AI Act and GDPR. The EHDS should ease the current difficulties and incongruencies regarding technical definitions and policy inclusion/application, and thus must clarify which policies apply at which points to ensure effective use of resources as well as avoid limiting research and innovation potential.
The regulation and data interoperability should not be focused exclusively on the EU, as there are existing rules from international organisations that foster global health research. This is especially prevalent for fields such as rare or pediatric diseases for which limited data is available and the largest, highest quality data sets possible are necessary.
The proposal also fails to directly mention the synthetic data that may be produced via innovative techniques including in silico medicine. In addition to the Commission's cautious approach to regulating the use of AI-based tools, there is a need to accept or adopt digital evidence produced by these new techniques. The Alliance recommends the Commission consider how Good Simulation Practice (GSP) could offer the regulatory guidance that industry and researchers need, as well as how to incorporate this into the EHDS legislation beyond the recognition in Article 34, paragraph 1.(g) that data can be processed for secondary use where the intended purpose is for the “training, testing and evaluating of algorithms.”
In terms of implementation, the Alliance calls on the Commission to ensure adequate representation of all stakeholders in the EHDS governing board as well as connectivity between pre-existing boards. The Alliance additionally calls on the Commission to highlight how it will support the implementation of the EHDS infrastructure such that it does not result in a bottleneck limiting data access for crucial research while data access bodies are created.
Finally, as a multistakeholder organization composed of both academia and industry, the Alliance would like to highlight the need for increased clarity regarding fees to obtain secondary data access. The unspecified fees in Article 42 must not disadvantage certain groups, such as academic and research institutions, in their ability to access high-quality data for research because of significant financial constraints.
The Avicenna Alliance believes that the EHDS is a necessary next step to support individuals’ rights as well as foster health research and innovation in the EU. It welcomes the aim of supporting research including that tied to in silico medicine, but highlights that certain points within the proposal must provide more legal clarity to avoid creating a patchwork of legislation relating to data usage, AI, clinical trials and medical innovations. The best possible access and quality as well as the largest data sets will be crucial elements to enable the rollout of in silico methods and thus achieve the many benefits that follow.
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