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5 months ago
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Despite its significant potential, Europe trails North America and the Asian Pacific in Advanced Therapy Medicinal Product (ATMP) development, clinical trials, and investment. Belgium however, boasts one of the highest densities of advanced therapy companies globally.
As a key hub for ATMP development, Belgium, alongside other European leaders such as Sweden, France, The Netherlands, and Germany, is making strides in the biotech field. According to data from the Boston Consulting Group, Belgium excels in attracting cell and gene therapy development, ranking second and third globally in trials per capita.
Its also home to approximately 9% of EU cell and gene therapy companies, underscoring its pivotal role in the sector. The strength of the Belgian ecosystem lies in its seamless integration of university-industry collaboration, bolstered by robust support from government and regulatory authorities.
Denis Dufrane, MD, PhD, CEO and Founder of Novadip Biosciences, emphasises Belgium’s dynamic ATMP ecosystem. “Belgium is a country with a lot of research and clinical activities in the field of ATMP development, both in academia and industry. In addition, Belgian authorities with the Federal Agency for Medicines and Health Products have developed a large expertise in this field,” Dufrane explained to Euractiv.
Novadip Biosciences is at the forefront of developing therapies for rare bone-related genetic diseases, offering hope to patients facing the dire prospect of limb amputation.
Europe-wide innovation framework
Dufrane advocates for a Europe-wide innovation framework that accelerates procedures and reduces authorisation times for medicines, ensuring they reach patients more swiftly. His company, located in Wallonia, thrives within a cell and gene therapy ecosystem, further enhanced by the Walloon government’s announcement of an €81 million investment at the onset of Belgium’s EU Presidency.
This commitment is mirrored in Flanders by notable grants to institutions like KU Leuven and significant investments by companies like UCB, Legend Biotech and Janssen, boosting Belgium’s dedication to pioneering ATMP innovation.
Europe lags in ATMP development
As data from the Alliance of Regenerative Medicine (ARM) shows, despite Europe’s significant efforts, it still lags behind North America and the Asian Pacific in advanced therapy development. With only 495 companies compared to 1,088 in North America and 859 in Asia Pacific, Europe faces a significant shortfall.
This gap extends to clinical trials, where Europe conducts only 358 ongoing trials, contrasting with 972 in North America and 790 in Asia Pacific. IQVIA Institute’s recent report ‘Strengthening Pathways for Cell and Gene Therapies: Current State and Future Scenarios’ further confirms Europe’s decline, with only 10% of industry and 7% of non-industry trials initiated in 2023 occurring in Europe.
Investment in Europe is also playing catch-up, with only €1.02 billion invested, compared to €6.89 billion in North America and €1.79 billion in the Asia Pacific.
This disparity poses a substantial challenge to Europe’s competitiveness in the field. The Alliance for Regenerative Medicine is expecting up to 17 potential approvals in 2024 in the US and EU combined, with 11 in the US and six in Europe.
Critical juncture
While the revision of the EU pharmaceutical legislation presents a critical juncture for policymakers to confront Europe’s lag in ATMPs, the question of whether it will effectively surmount challenges and propel Europe forward remains.
On 10 April, the plenary of the European Parliament adopted its position on the revised pharmaceutical legislation. The file will be taken up by the new Parliament after the European elections on 6-9 June.
The general association of the innovative Belgian pharmaceutical industry, pharma.be, told Euractiv that the reform might have a negative impact on the competitiveness of the biopharmaceutical sector in Europe compared to the rest of the world and certainly on Belgium.
Conventional medicine policy
The proposed changes to EU pharmaceutical legislation and the Health Technology Assessment (HTA) could potentially hinder advancements.
“In general, the pharmaceutical legislation is focused on conventional medicines rather than ATMPs, which is a disappointment given ATMPs’ potential to transform medicine. That said, the European Parliament has made some improvements,” the Brussels-based Alliance for Regenerative Medicine told Euractiv.
Despite these hurdles, there is a sense of optimism, with the European Parliament making notable improvements to the proposals, particularly in recognising the impracticality of launch conditionality provisions for ATMPs targeting rare diseases.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has expressed optimism about the Commission’s proposals, which aim to improve the regulatory landscape for ATMPs and novel therapies.
Dr Alexander Natz told Euractiv, “The introduction of the regulatory sandbox, streamlining of environmental risk assessments for GMO medicines during clinical trials, and the introduction of a robust framework for Platform Technologies will support the assessment of these therapies and competitiveness of the EU. These are all marked steps in the right direction to support innovation in Europe.”
However, he stressed that these provisions are only a part of the puzzle. Other changes in the pharmaceutical legislation and wider pharmaceutical ecosystem must also be considered when considering the sum of the EU’s global competitiveness in this field.
[By Nicole Verbeek, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]
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