Historical steps in the development of the Cooperation Agreement on Biosafety​

​Although Europe adopted a specific GMO regulatory framework in 1990​, it was not until several years later that the European Directives 90/219/EEC and 90/220/EEC were transposed into Belgian law. At the beginning of the 1990s, Belgium was undergoing extensive institutional changes. This period was marked by the transfer of various competences from the State to the Regions, notably in the area of environmental protection. With the transposition of the two Directives mentioned above into national law, there was a crossover of numerous competences, which could sometimes be regarded as federal and sometimes as regional.

The Directives also address matters that are important for the scientific research sector or that have potential economic consequences linked to the development and marketing of GMO-based agricultural, food or pharmaceutical products. It was therefore important to avoid that disparities between federal and regional rules, relating in particular to the deliberate release of GMOs, would result in creating unequal conditions of competition or barriers to the development and marketing of products containing such organisms.

In 1987, Belgium's Interministerial Conference for Science Policy followed up the publication of the OECD "Blue Book" by creating an ad hoc "Biotechnology Regulations" group. In 1989, this group proposed the creation of an "Interdepartmental Recombinant DNA Advisory Committee" (or "rDNA Committee") responsible for the evaluation of biosafety, in particular notifications introduced pursuant to the future Directive 90/220/EEC.

The early 1990s was marked by various uncoordinated initiatives in relation to the transposition of the GMO Directives. Firstly, the Flemish Region decided to transpose the two Directives in full into its environmental legislation (the VLAREM - "Vlaams Reglement betreffende de Milieuvergunning") for matters under its jurisdiction. Secondly, in October 1991 a Concertation Committee "National government - Regional executives" mandated the Regions and the Federal State to negotiate the transposition of Directive 90/220/EEC and the creation of an "rDNA Committee". At that time, it had already been suggested that this committee be supported by an "rDNA Secretariat" located within a department of Sciensano (then known as the "Institute of Hygiene and Epidemiology - IHE", until 1996). At the same time, discussions were taking place between the three Regions with the aim of harmonising the transposition of Directive 90/219/EEC and creating an "rDNA unit" within Sciensano, to provide scientific support to the Regions.

Sciensano, in particular Dr. William Moens, was directly involved in all of these discussions. In June 1992, the Institute organised a symposium bringing together the national and regional authorities, the industrial and academic sectors and other stakeholders. This symposium was an opportunity to review the progress of the transposition of Directives 90/219/EEC and 90/220/EEC in Belgium and highlight the importance of cooperation between the authorities concerned in this context.

Gradually, it became desirable for the authorities to settle once and for all, at the institutional level, the intervention of the Federal State and the Regions in matters covered by the above-mentioned Directives. To that end, a new legal tool was available, introduced previously by the Special Law on Institutional Reform of 8 August 1980 (Loi spéciale du 8 août 1980 de réformes institutionnelles / Bijzondere wet van 8 augustus 1980 tot hervorming der instellingen. Moniteur belge/Belgisch Staatsblad, 15.08.1980, p. 9434). Article 92 bis of this Law gives the State, the Communities and the Regions the possibility of concluding Cooperation Agreements, particularly on the joint creation and management of common services and institutions, the joint exercising of specific competences, and the development of joint initiatives.

In 1993, the negotiators agreed on the need to set up a single Cooperation Agreement covering all matters concerning biosafety, i.e. human health and environmental safety linked to the deliberate release of GMOs into the environment, but also to the contained use of genetically modified organisms and human pathogenic organisms. Thus they decided, through the adoption of this Cooperation Agreement, to cover the harmonised transposition and implementation between the different levels of competence of the two Directives 90/219/EEC and 90/220/EEC, also taking into account the provisions of Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. They also chose to set up a biosafety scientific evaluation system common to the Federal State and the Regions, so as to guarantee objective and harmonious treatment of biosafety dossiers vis-à-vis the notifiers, the general public, the European Commission and the other Member States.

After another period of negotiations, a draft of the Cooperation Agreement concerning biosafety was approved by the various authorities concerned on 16 May 1995. The text of the agreement was modified in view of the opinions of the Council of State, particularly to clarify the respective roles of the bodies constituting the common scientific evaluation system for biosafety.

On 25 April 1997, the final text of the Cooperation Agreement between the Federal State and the Regions on the administrative and scientific coordination concerning biosafety was adopted by all parties.

The Cooperation Agreement concerning biosafety is the central legal text that regulates the implementation and management of biosafety in Belgium. Although it was not formally adopted until 1997, its objectives and general principles were defined in the initial stages of the negotiations. It was on this basis that the Regional and Federal authorities successfully led, in parallel to the negotiations on the Cooperation Agreement, discussions aimed at implementing Directives 90/219/EEC and 90/220/EEC into Belgian law.