Belgium’s New Pharma Approval System

by Odelle Technology

Belgium’s drug reimbursement system has become increasingly lengthy and complex, compromising patient access to innovative medicines. The roadmap recently presented by the Minister of Health and the Belgian National Institute for Health and Disability Insurance (INAMI) proposes a series of measures to speed up access, limit the duration of reimbursement contracts, increase transparency and foster patient involvement.

A Slow and Flawed System

In Belgium, the drug reimbursement process has become more and more elaborate and implies a lengthy approval procedure that must go through both the Commission for the Reimbursement of Medicines (CRM) and the minister of social affairs and can take 180 days. The system’s deficiencies were recognized by the Minister of Health, Frank Vandenbroucke, who last year commissioned the INAMI to begin a consultation process with several stakeholders, including the pharmaceutical industry, representatives of the patient community, insurers, and the Federal Public Service Economy. “It was time for an in-depth reform,” he claimed.

Belgium, a European leader in terms of clinical trials, spent EUR 5.5 billion on R&D in 2021. Not surprisingly, the Belgian pharma industry also complained of the system’s shortcomings and their impact on access. “If the significant efforts in R&D, clinical trials and production do not lead to better access for Belgian patients, Belgium’s strong position as a pharmaceutical hub could be compromised in the future,” said, the association that represents pharmaceutical innovators active in Belgium, in a statement.

The consultation process took some 20 months and has resulted in a series of measures recently presented by the minister and the INAMI’s deputy general administrator, Pedro Façon. If validated by the government, the roadmap will lead to widespread reform.

Faster Access

If the presented roadmap is approved, reimbursement procedures will be streamlined and as a result, patients will gain access to innovative drugs sooner. For an innovative medicine it currently takes 180 days to complete the reimbursement procedure in Belgium whereas under the proposed reform that period would be reduced to four months by allowing a drug’s manufacturer to submit a request for reimbursement as soon as it obtains approval from the European Medicines Agency (EMA).

Moreover, for drugs that have shown “promising potential” but are not yet approved, the duration of the procedure would be reduced to just two months.

Limited Reimbursement Contracts

The goal is not to drive prices down endlessly. My paradigm is the right price based on the real added value of the medicine.

Frank Vandenbroucke, Minister of Health

One of the more drastic proposals on the INAMI’s roster of propositions is to limit the duration of reimbursement contracts to three years, renewable only once for an additional period of three years, when there is no current limit for the duration of contracts. “It is advisable to prevent drugs from remaining under contract for too long,” commented Façon.

The CRM may exceptionally add three additional years, but one year before the expiration of a drug’s protection period, a call will be launched to generic and biosimilars makers to see if they want to submit a reimbursement file. These manufacturers will receive information relating to the reimbursement foreseen by the CRM at the expiration of the contract with the original drug. “This should allow for healthier competition and better market dynamics”, façon added.

“The goal is not to drive prices down endlessly. My paradigm is the right price based on the real added value of the medicine,” said Vandenbroucke on Twitter.

The industry, however, is worried about the impact on pricing. “The main concern for is the correct assessment of the value of a medicine. The qualitative assessment process to determine the value of medicines should be strengthened to go beyond the cost of a medicine and to appreciate its impact on the patient, his quality of life and society,” said the pharma association in a statement.

Increased transparency

Another objective of the proposed reforms is to increase transparency. At present, contracts negotiated with the pharmaceutical industry for innovative drugs allegedly contain what are known as “secret clauses” that make it possible to negotiate discounts. While the new policies do not aim to reveal the content of these clauses, they propose to make contracts public on the INAMI website, revealing compensation mechanisms, but without citing actual amounts or percentages.

The monitoring of evidence on the real value of medicines is also set to be reinforced with an independent “Real World Evidence” platform that will monitor the use and effectiveness of drugs under contract. “We want the decision to reimburse a medicine to be based more on scientific knowledge and accurate and up-to-date data. Companies themselves should also make more efforts to scientifically clarify the beneficial effect of their medicine,” stated façon.

Patient involvement

Beyond the more specific reforms that aim to impact access to medicines, the INAMI’s proposal also contemplates increased patient participation in the drug reimbursement approval process. “We want to actively involve patients in CRM. Today, insurance companies are the voice of patients. In the future, we will also work with patient associations,” façon claimed. To this effect, the creation of a Patient Council with its representatives sitting on the CRM has been proposed.

The Minister underlined that the motivation of the reforms is not only reducing public spending but making better use of that spending. The industry revealed its disappointment about the extent of its dialogue with the government as well as its hopes for the reform: “Although the Minister of Health did not respect the philosophy of a pact with industry on the proposed reforms, as mentioned in the government agreement, is convinced that by continuing the dialogue with industry and by forging a common understanding of the issues, this roadmap can be the basis for a lasting reform and even strengthen the strong footprint of our industry in Belgium. therefore wishes to be involved as a discussion partner in the further development of the proposals. Belgium is internationally recognized for its excellent biopharmaceutical ecosystem. Appropriate reforms will enable us to strengthen this position,” said pharma. BE’s CEO Caroline Ven.

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