Belgium has become a focal point in Europe’s biotech debate after the biotech company Galapagos halted development of its advanced cell therapy programme. The move follows similar withdrawals by Takeda and Novo Nordisk, both of which ended their cell therapy operations to refocus on core areas.
When asked about the reasons behind the decision, a Galapagos spokesperson said the company could not yet comment as “consultations with the works councils are still ongoing.”
As the EU Biotech Act, Life Sciences Strategy, and Pharmaceutical Package all aim to turn Europe’s scientific excellence into patient access, the Belgian biotech’s decision highlights the persistent obstacles that keep promising therapies from reaching patients.
Ward Rommel, an expert in cancer care at the Belgian NGO ‘Stand Up to Cancer’, told Euractiv that to address the issue, a publicly funded development path alongside commercial models is required.
“Galapagos’ decision can be seen as a symptom of a deeper structural problem within the European and Belgian ecosystem for advanced therapies (ATMPs). Although Europe is strong in fundamental research and innovation, the commercial translation of these therapies proves difficult to achieve,” he explained.
Access hurdles
Research by the Belgian Health Care Knowledge Centre (KCE), commissioned by Stand Up to Cancer, shows that about one-third of commercial ATMPs with a European marketing authorisation are withdrawn from the market, mostly for commercial reasons or due to disappointing results. Less than half of the authorised ATMPs are actually available in Belgium.
The high development and production costs for a too-small patient population and the high risks involved often discourage the industry from further development. As a result, patients miss out on innovative and potentially life-saving treatments.
“The commercial development of cell therapies is primarily driven by return on investment, not solely by the goal of addressing unmet medical needs,” Rommel said.
This leads to structural limitations and market failure, especially for rare and personalised treatments. “Therapies for rare diseases often turn out not to be commercially viable, despite their potential to save lives,” he argued.
The public route
As Rommel pointed out, “That is why academic and non-profit initiatives advocate for local production and alternative development models to significantly reduce costs.”
“A complementary, non-commercial pathway is essential to ensure affordable access and sustainable solutions for niche needs,” he added.
That non-commercial pathway for ATMPs should be “a publicly funded, complementary route that enables academic and non-profit institutions to develop therapies for rare, personalised, and pediatric conditions that are often ignored by industry,” Rommel explained. It would require adapted regulation, infrastructure, and financing, with a more accessible and affordable authorisation process through the EMA.
“The Hospital Exemption should be maintained as a complementary option, but made more accessible and harmonised across Europe,” he remarked.
At the national level, structural government funding is needed for clinical studies so that “promising therapies can continue to be investigated without dependence on commercial investors.” “University hospitals can collaborate to establish safe, high-quality production facilities for cell and gene therapies. Early collaboration between academics, regulators, and payers is essential, supported by a shared knowledge platform and joint GMP production capacity,” he pointed out.
The National Institute for Health and Disability Insurance (NIHDI) and the Special Solidarity Fund should reimburse non-commercial therapies, while HTA methods and reimbursement procedures must be adapted to the unique characteristics of ATMPs.
“Finally, there should be a single central access point at the government level, where researchers can receive early guidance on regulation, authorisation, reimbursement, and possibilities such as the hospital exemption,” he argued.
Sustainable system
Rommel argues that making ATMP development in Belgium and Europe sustainable is to ensure that future generations of patients gain rapid access to innovative treatments at prices that remain affordable for social security systems.
“That requires close cooperation between academic institutions, government, and industry, with not only technological but also societal objectives at the centre.”
Therapies largely developed with public or non-profit funding must also benefit the public.
“Therefore, we advocate for clear societal conditions to be attached to public funding and licensing agreements. For example, we can include anti-shelving clauses that prevent a company from simply halting development or commercialisation. In such cases, the patent owner, for instance, the university, should have the option to continue the work with another partner,” he explained.
In addition, Rommel pointed out, “socially responsible licensing clauses are important to ensure that companies granted a license bring the product to market at fair and socially acceptable prices.”
Valuable therapies
The results of these therapies were particularly promising, he said.
“As Prof. Dr Sébastien Anguille of UZA pointed out, in patients who had run out of treatment options, we saw that the cancer stayed away for months, even years. Those are results we could hardly have imagined until recently,” he added.
Moreover, for patients who have already been treated, there is fortunately no immediate threat. “In most cases, one treatment is sufficient, as the cultured cells remain in the body and continue to provide protection against relapse.”
“But for new patients who would still have qualified for this therapy, the door now closes. And that is particularly painful,” he warned.
“This is not about figures or markets, but about people for whom this could be a matter of life and death. It is therefore deeply disappointing that commercial considerations weigh more heavily than the interest of the patient.”
[VA, BM]
