Belgium's prowess in advanced therapy medicinal products (ATMPs) offers a promising blueprint for Europe's pharmaceutical innovation. With a robust university-industry collaboration and strong governmental support, Belgium stands out in the global ATMP landscape.
Despite its potential, Europe trails North America and the Asia Pacific in Advanced Therapy Medicinal Product (ATMP) development, clinical trials, and investment. However, Belgium boasts one of the highest densities of advanced therapy companies globally.
According to the data from Boston Consulting Group, Belgium excels in attracting cell and gene therapy development, ranking second and third globally in trials per capita. Indeed, it's home to approximately 9% of EU cell and gene therapy companies, underscoring its pivotal role in the sector.
The dynamism of Belgium's ATMP ecosystem is attributed to its seamless integration of university-industry collaboration, supported by proactive government and regulatory frameworks. Denis Dufrane, CEO of Novadip Biosciences, lauds Belgium's vibrant ATMP landscape, citing the country's rich research and clinical activities alongside adept regulatory oversight.
Novadip Biosciences exemplifies Belgium's ATMP prowess, pioneering therapies for rare bone-related genetic diseases, offering a lifeline to patients facing limb amputation.
Europe-wide innovation framework
Dufrane advocates for a Europe-wide innovation framework to expedite procedures and reduce authorization times for medicines, ensuring swift access for patients. 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.
Pharmaceutical legislation
While the EU's revision marks a crucial juncture, obstacles persist in Europe's progression within ATMPs. The European Parliament's endorsement of its stance on the revamped pharmaceutical legislation lays the groundwork for forthcoming discussions. Enhancements have been made by the European Parliament, especially concerning launch conditions for ATMPs addressing rare diseases.
Dr. Alexander Natz from the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) expresses confidence in the Commission’s propositions, aimed at enhancing the regulatory framework for ATMPs and innovative therapies. Nonetheless, he underscores the need for broader alterations in pharmaceutical legislation and the ecosystem to bolster the EU's global competitiveness in this realm.