Regulating non-therapeutic human experimentation: a new legal framework in Belgium

The new provision and its material scope of application

The legislative change emanates from the Federal Council of Ministers that adopted a pre-draft law on 14 July 2023, providing for the insertion of a new paragraph in Article 2 of the Act of 24 January 1977 concerning consumer health protection in relation to foodstuffs and other products (Parliamentary Documents, Chamber of Representatives, Nr 55 3804/001). 

The proposed paragraph, which was adopted by the Parliament without a change despite some debate (Parliamentary Documents, Chamber of Representatives, Nr 55 3804/003), is as follows: 

“The King may, by means of a decree deliberated in the Council of Ministers, enact rules on experimentation on humans of certain foodstuffs or other products that He designates, after consulting the Committee of Bio-ethics. These experimentations consist of trials, studies or investigations carried out on volunteers without therapeutic objectives. These provisions may relate to the products, the protection of participants, the conditions and procedures of the experimentation, liability and administrative obligations.” 

Fundamentally, this provision provides for a broad delegation of authority to the King to regulate human experimentation for specific foods or other product types. The government’s primary objective, which initiated the legislative process resulting in the new paragraph’s inclusion, is to provide regulation primarily for food supplements and cosmetic products. However, technically, the legal provision empowers the King to define new regulations for experimentation with all product types within the scope of application of the Act of 1977. This includes for instance food contact materials, detergents, tobacco products, and tattoo inks.

The experimentations in scope

The experimentations considered under the new provision include trials, studies, or investigations carried out on healthy volunteers to enhance understanding about a product. The enacted legal provision explicitly states that it targets experimentations devoid of therapeutic objectives. These experimentations cannot be employed to establish the safety of a product.

Addressing a regulatory void

The government’s draft proposed a legal basis for the regulation of non-therapeutic experimentation. The proposal emerged from the identified necessity to address a regulatory void. Experimentation that is intended to develop knowledge relevant to healthcare professions is governed by the Act of 7 May 2004, which is the Belgian transposition of the Clinical Trials Directive (Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001), now replaced by the Clinical Trials Regulation (Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014). 

By contrast, industry practices of conducting tests on products that are not encompassed by the legislation on clinical trials proceed without a legally binding framework, owing to the absence of a harmonised approach within the EU on the subject. The newly drafted proposal seeks to bridge this regulatory gap.

Targeted experimentations and participant protection 

The experimentations targeted by the new legal provisions are for instance those aiming at the generation of data for health claim authorisations or sunscreen solar protection factor testing. The underlying objective of the new law is ascertaining participant health protection is ensured. 

The impact assessment of the proposal highlights the potential for ethical adherence through regulatory oversight. This could mandate participant information on health consequences, operator coverage of medical costs, and adherence to hygiene-standard protocols. It could also limit participant numbers to prevent over-enrollment. The upcoming regulations, to be adopted on the basis of the new legal provision, could regulate informed consent procedures and define exclusion criteria for sensitive groups, such as the ill or infants.

Parliamentary debate and future clarifications 

During the parliamentary debate on the proposed legislation, several concerns, echoing the remarks made by the Council of State on the draft of text (Opinion of the Council of State Nr 74.272/1/V dated 22 September 2023), were raised about the initiative and its scope. It was flagged in particular that it was unclear whether the King, when enacting a Decree regulating experimentations on certain products, would decide by product category and not by individual product (Parliamentary Documents, Chamber of Representatives, Nr 55 3804/003). The text was also considered as requiring some clarification as regards the very definition of ‘experiment’, a notion that will indeed need to be defined by the Royal Decree implementing the new provision, given that the adopted text does not provide for such definition.   

While the new provision outlines the executive power’s operational framework and regulatory parameters, it is not self-sufficient and has no immediate effect. The content of the Royal Decree that will implement the new provision will thus significantly influence the new regime’s actual impact on food business operators in the Belgian market. 

Final observations

The newly adopted law, designed to regulate experimentations, does not inherently define new product requirements or market access rules. 

Experiment-conducting operators will however likely face declaration and reporting obligations to ensure compliance with experimentation regulations in addition to the other relevant legislation they already apply, such as the GDPR. The extent of ethics committees’ involvement in the forthcoming regime and their role remains uncertain.

It is unclear whether the future rules will effectively improve participant protection in experiments, or if the additional operator burden will discourage the conduct of experimentation in Belgium and encourage experimentation in other territories. A EU-harmonised approach on the subject would be beneficial to the emergence of a level playing field that balances all stakeholders’ interests. 

The new law’s enactment signifies a substantial progression towards increased human experimentation regulation in Belgium for food supplements and cosmetic products, and potentially other products. However, it raises several questions and concerns that must be addressed upon the adoption of the regulatory provisions implementing this new provision. As the implementation progresses, it is essential for stakeholders to maintain constructive dialogue with lawmakers to ensure the final legislation’s effectiveness, fairness, and compliance with European law.