Belgium ranks among the European leaders in pharmaceutical research, patents, exports and jobs. Yet only half of the innovative medicines approved at the European level between 2021 and 2024 are available to Belgian patients, and those that do arrive take on average a year and a half.
That paradox dominated a recent marathon hearing in the Belgian Chamber’s Health Committee, where MPs questioned the health insurance agency INAMI-RIZIV, doctors, patient organisations and industry federation pharma.be on the price of medicines, in a debate triggered by the public controversy over the cancer immunotherapy Keytruda.
“There are drugs produced in Belgium on one side of the street, but not available to patients on the other side of the street. We can’t explain that, can we?” Pharma.be chief economist Geert Steurs told the committee.
16th in Europe
The figures came from EFPIA’s annual W.A.I.T. indicator. Belgium ranks 16th in Europe: of 168 medicines centrally authorised between 2021 and 2024, 82 were available in January 2026, after an average wait of 552 days, just above the European median of 532 and far behind Germany’s 56.
Belgium trails all its neighbours except France, as well as Denmark, a country Pharma.be singled out as comparable in biopharmaceutical footprint. Across the continent, the share of new medicines fully available on public reimbursement lists has fallen from 42% in 2019 to 28%.
Anatomy of a 552-day wait
But who owns the delay? Under questioning, Pharma.be’s account turned out to be more nuanced than the headline number. The 552 days, the federation acknowledged, includes the months companies themselves wait before filing a reimbursement dossier, the procedural “clock-stops” companies request, and around 120 days of confidential contract negotiation that falls outside the formal procedure. The 180-day decision deadline is a European obligation, and one that most countries exceed, not just Belgium.
The breakdown of the missing half is equally telling. According to Pharma.be’s medical and political director, Patricia Van Dijck, noted that of the roughly 50% of new medicines unavailable in Belgium, half were assessed negatively by the reimbursement commission (CTG/CRM), and half were never submitted by the companies at all.
The dossiers that never come
Why would a company not even ask? Mainly pricing, Van Dijck explained. Firms know in advance that Belgium will benchmark their product against comparators they consider far too cheap, so the price “will probably never be accepted”.
The second reason is the process itself. “It is not always predictable how the added value will be determined. It is not always predictable how the medical need will be defined,” she said, adding that companies can get a completely different approach from one dossier to the next, which also drives the clock-stop requests.
MPs did not let the industry’s framing pass unchallenged. One member noted that companies wait, on average, around 370 days before submitting a reimbursement application and asked whether part of the solution lay in better, more complete dossiers from the companies themselves, rather than faster Belgian procedures.
Van Dijck did not engage with that figure. Companies wait “about 3-4 months”, she replied, speaking only of the products that are eventually filed in Belgium. The suggestion that dossier quality might be part of the problem went unaddressed. In her account, the obstacles sit on the Belgian side, in price benchmarking and in assessment requirements that shift unpredictably from one file to the next.
The fix she pointed to was the government’s own: she read MPs the coalition agreement’s commitment to “a standardised approach within the CTG”, with more harmonisation and predictability, reforms Pharma.be says it is discussing with INAMI-RIZIV.
The government’s new “early and fast access” procedure, designed to shorten the path for innovative medicines, drew cautious optimism. Pharma.be called it “a step in the right direction”, noting that several companies have already filed under it, while warning that the conditions are stringent and the risks rest mainly with the firms.
Red lights on the dashboard
Behind the procedural debate lies a harder commercial one. Sector employment fell in 2024 for the first time in years, and nearly all of Pharma.be’s performance indicators have since turned red. “Nine out of ten of the respondents in our survey expect a negative to very negative impact on the launch of new drugs in Belgium in 2026,” Steurs said.
The unspoken consequence: if drugs are not reimbursed in Belgium, companies will think twice about running clinical trials here, currently, patients’ fastest route to innovation.
The shadow of Washington
Hanging over the entire hearing was Washington. INAMI/RIZIV’s head of pharmaceutical policy, Francis Arickx, warned that the US ‘Most Favoured Nation’ pricing policy, import tariff threats and China’s rise in drug development could mean new medicines reaching Europe later, or not at all.
EFPIA director general Nathalie Moll made the same point at the W.A.I.T. launch: “It is unrealistic to expect greater investment into Europe and faster access to new treatments for Europeans if Member States also demand the lowest possible prices and highest government clawback rates. We need to make a choice.”
For Belgium, that choice is sharper than for most. The sector directly employs some 45,000 people and claims around 40% of all private R&D investment in the country. MPs across the spectrum acknowledged the dilemma, with several warning that a policy focused solely on price pressure could resolve the expensive-medicines problem in the worst possible way: patients simply losing access altogether.
The committee has requested written answers from INAMI-RIZIV on how many innovative medicines were refused over price in the past five years, answers that may show how close Belgium already is to that scenario.
[VA, BM]
Source:
www.euractiv.com
