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The 5 major changes in Belgian pharma law of 2023
Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.
1. Export ban on critical medicines facing shortage
The Royal Decree of 19 January 2023 has implemented how and when the Minister of Health (MoH) may impose temporary export bans on wholesalers (including a full-line wholesaler) of ‘unavailable’ medicines.
The MoH’s authority has been delegated to the Administrator-General of the Federal Agency for Medicines and Health Products (FAMHP), who is authorised to make the export of medicines intended for the Belgian market conditional upon a prior authorisation if the following conditions are met:
- the drug’s unavailability has been notified to, or observed by, the FAMHP;
- the drug’s unavailability is likely or certain for at least one month;
- the drug’s administration is urgent and necessary, either immediately or within a few days, as the lack of an urgent diagnosis or treatment with this medicine might lead to acute or chronic physical or mental health deterioration; and
- the drug’s unavailability cannot (sufficiently) be remedied by other authorised drugs with the same therapeutic effect.
When the export of a medicine has been subjected to such prior authorisation, wholesalers need to submit a request for export authorisation through the FAMHP’s website. The MoH or Administrator-General of the FAMHP will take a decision within five working days, in the absence of which the export is authorised.
2. New public procurement rules for biological products
The Royal Decree of 13 September 2023 has imposed specific rules on hospitals regarding the public procurement of biological products.
First, hospitals must award a public contract for the purchase of biological products no later than nine months after the first biosimilar is reimbursed and made available in Belgium.
Second, all public contracts for biological medicines concluded since 2 October 2023 onwards must include a clause providing for the contract’s termination if a new public contract is to be awarded in accordance with the Royal Decree.
Third, the duration of a public contract for biological products is limited to 24 months, which can consecutively be extended twice by 12 months if no biosimilar is reimbursed and available in Belgium before the end of these periods.
Finally, a number of criteria are now prohibited from being taken into account when awarding public contracts for biosimilars. This includes criteria requiring that the biological has already been marketed for a certain period of time or criteria related to their efficacy, safety or quality profile.
3. Stricter rules for off-label prescription of GLP-1 analogues to treat excess weight
GLP-1 (glucagon-like peptide-1) analogues are a class of medications used in the treatment of type 2 diabetes. GLP-1 is a hormone that stimulates insulin secretion in response to meals, reduces glucagon secretion (which helps lower blood sugar levels), slows down gastric emptying, and promotes a feeling of fullness. Their availability is internationally at risk due to a strong increase in demand, including for off-label prescription for weight loss.
To avoid unavailability for patients that need these medicines the most, the Royal Decree of 9 November 2023 has tightened the prescription conditions for GLP-1 analogues. Bydureon®, Ozempic®, Rybelsus®, Trulicity®, and Victoza® are caught by this measure and so these medicines may only be prescribed to:
- Patients suffering from type 2 diabetes mellitus; or
- Patients suffering from a serious form of obesity; or
- Patients relying on these medicines as part of a clinical trial.
4. New draft law on raw materials used by pharmacists
On 10 July 2023, Belgium notified the European Commission of a draft Law on raw materials (active substances and excipients) used by pharmacists to prepare magistral and officinal preparations.
The draft Law would govern the way in which a raw material may be manufactured, marketed and used, as well as the obligations of the various market players, namely the manufacturer, the distributor and the pharmacist. It is thus meant to update the currently applicable Royal Decree of 19 December 1997 on the control and analysis of raw materials used by officinal pharmacists.
More specifically, the draft Law redefines, clarifies and harmonises requirements, quality and control standards to offer patients raw material of the highest possible quality, on the basis of which the pharmacist will prepare the magistral or officinal preparation for them.
5. Reform of Belgian reimbursement rules
The Belgian government has proposed a revamp of its medicines policy to ensure sustainable and future-proof accessibility to valuable medicines for patients. At the MoH’s request, the National Institute for Health and Disability Insurance (NIHDI) has developed a number of spearheads to assist in this reform, in collaboration with stakeholders.
With the Act of 6 November 2023, the reference reimbursement system has been amended regarding the impact on patent and regulatory data protection disputes as follows:
- The reference reimbursement system will be suspended if the NIHDI is notified in time that summary proceedings or accelerated proceedings on the merits (not regular proceedings on the merits) are pending concerning a patent or regulatory data protection dispute regarding the medicine triggering the reference reimbursement system. If the commercialisation of the generic product is authorised by a decision with res iudicata, then the pharma company of the original medicine can be asked to compensate for the additional expenses resulting from such suspension.
- If the medicine triggering the reference reimbursement system becomes unavailable (whether or not as a result of such a dispute) either within 20 days before, or within 24 months after, the application of the reimbursement system, then the reimbursement basis of the original product can be restored to its earlier level. This provision applies to all products that have been clustered since 1 January 2023.
Additionally, a future spearhead of the reform concerns the modernisation of reimbursement procedures, which includes:
- A change in the composition of the Commission for the Reimbursement of Medicines (CRM), which advises the MoH on reimbursement applications. This body is currently composed of academics, representatives from the insurance institutions, doctors and pharmacists, industry and the relevant Ministers; a new effective and substitute advisory member will join the CRM to represent the voice of patients.
- For all pharmaceutical specialties reimbursed through a managed entry agreement (MEA), a public clause will be added providing that the agreement may be reviewed while still in force if an alternative for that specialty is reimbursed.
- The CRM will be able to formulate a proposal for a public agreement with binding (contractual) reimbursement conditions. The commitment would be signed in the same manner as the current confidential MEAs, but the public agreements would be simple and standardised, designed only to deal with budgetary uncertainties, and would last for a maximum of five years.
- The total term of MEAs would be six years, starting with a “Term 1” lasting no more than three years, which, after an evaluation by the MEA working group, may be extended once for a “Term 2” with a maximum duration of another three years. At the same time, the minimum duration of MEAs and the possibility of a transition year would be abolished, encouraging the applicant to submit a new dossier to the CRM for Term 2 at least 18 months before the end date of the Term 1 MEA.
If you would like any further information, please contact Kirian Claeyé or Bart Junior Bollen.