Belgium creates a new legal exemption for unauthorised medicines

Belgium has recently advanced its efforts in addressing the critical unavailability of certain drugs by introducing a new legal provision in the decree of 14 December 2006 regulating medicinal products for human use. Effective from 1 November 2024, a newly added Article 105/1 allows for the import and distribution of unauthorised medicines under specific circumstances.

Building on the European named patient use rule set out in the EU Community Code for medicinal products which is currently being revised, this new provision is designed to address the pressing issue of critical shortage of certain medicinal products.

Article 105/1 core elements

The framework established by the new provision is intended to facilitate the marketing of unauthorised drugs in Belgium if they address special needs arising from critical unavailability. It allows a wholesale distributor to place an unauthorised product on the Belgian market if the medicine meets those needs and unavailability criteria. The imported medicine should be from another European Economic Area (EEA) state where the medicine is authorised, provided that the conditions set out in the article are met.

The main principles of Article 105/1 include a requirement for the wholesale distributor to notify the Belgian healthcare regulator, the FAMHP, of their intention to import and distribute the unauthorised medicinal product. The FAMHP has the authority to oppose the importation, including if the regulatory conditions are not met.

Assessing critical unavailability

Critical unavailability, for the purpose of the new legislation, refers to situations where the absence of a medicine on the Belgian market poses significant risks to patient health.

The FAMHP determines whether a shortage is critical based on specific criteria, including the necessity of the medicine for the prevention, diagnosis, or treatment of acute or chronic conditions, the treatment of vulnerable patient groups, or the implementation of national health programmes. Additionally, the unavailability must result in an interruption of treatment that compromises the patient's prognosis or significantly reduces the likelihood of a less severe disease progression. There must also be no appropriate alternative available on the Belgian market.

Scrutiny and concerns

The legislative comments accompanying the royal decree of 12 September 2024 which incorporates the new Article 105/1 have raised doubts and criticisms regarding the adoption of this provision from a legalistic standpoint.

One of the main concerns is the compatibility of the provision with the European named patient use (NPU) exemption as outlined in Article 5, paragraph 1, of the EU Community Code.

A key question raised by the Belgian Council of State is whether the system of notification, rather than prior authorisation, aligns with European law. The European NPU exemption allows to derogate from the requirement of marketing authorisation for medicines provided in response to a bona fide unsolicited order formulated in accordance with the specifications of an authorised healthcare professional for use by an individual patient under their direct personal responsibility. The Council expressed doubts about whether the new, broader Belgian system meets EU law's intent to ensure that such derogations are strictly controlled and justified on a case-by-case basis.

Further concerns were raised by the Council of State about the potential for market saturation with unauthorised medicines if the provision is not carefully controlled. Without a stringent prior authorisation process, there is a risk that the market could be flooded with unauthorised medicines, leading to potential safety and efficacy issues.

Additionally, the Council criticised the limited scope of the provision, which only addresses the shortage of authorised medicines and does not cover situations where no authorised medicine exists. It was suggested that the provision should be expanded to include such cases to fully address the needs of patients.

Differentiating from compassionate use

The new exemption under Article 105/1 differs from the Compassionate Use Programme (CUP) mechanism. While both systems allow for the use of unauthorised medicines, they serve distinct purposes and operate under different conditions.

The new NPU exemption introduced in Belgium is designed to address critical unavailability of authorised medicines on the local market by allowing the importation of unauthorised medicines from other EEA states. It is a reactive measure that responds to specific shortages and is intended to ensure continuity of care for patients who cannot be treated with available authorised medicines.

In contrast, CUPs are proactive measures that allow patients with serious or life-threatening conditions to access unauthorised medicines that are still in clinical development. CUPs are typically for medicines that have not yet received marketing authorisation but have shown promising results in clinical trials. They are intended to provide early access to potentially life-saving treatments for patients who have no other therapeutic options.

FAMHP process

The procedure for obtaining approval to import and distribute an unauthorised medicine under Article 105/1 involves several steps. The wholesale distributor must submit a notification to the famhp using a form available online. The notification must include detailed information about the medicine to be imported, the quantity, the unavailable medicine it will replace, and the period of distribution. Any changes to the information provided must be promptly notified.

The FAMHP may request additional data to evaluate the quality, safety, and efficacy of the unauthorised medicine. The wholesale distributor can proceed with the importation if the famhp does not oppose it within ten business days of receiving a complete notification. It must ensure that the imported medicine is authorised in another EEA member state and that it meets the criteria for therapeutic equivalence or valid alternative to the unavailable medicine.

Osborne Clarke comment

By introducing Article 105/1 in the pharma decree of 14 December 2006, Belgium takes a new step towards combatting the shortage of essential medicines. By allowing the importation of unauthorised drugs from other EEA member states, the provision aims to address urgent patient needs and prevent interruptions in treatment.

However, the questions raised by the Council of State during the legislative process have once again highlighted the delicate balance between EU directives – such as the Community Code – and the national laws of Member States intended to implement them. This scrutiny underscores the challenges faced in ensuring that national provisions align with the overarching objectives and stringent requirements of EU laws. The concerns about the compatibility of Article 105/1 with the European NPU exemption illustrate the complexities involved in translating EU directives into effective national legal frameworks that both address local needs and maintain compliance with broader regional standards.

Engaging with regulatory authorities and staying informed about any updates or changes to the regulatory framework will allow business to navigate the complexities of the new system and to adapt their practices accordingly. Pharmaceutical companies should also be mindful of the detailed