On 7 March 2016, the Government submitted to the Chamber of Representatives a bill on the counterfeiting of medical products and similar crimes involving threats to public health (Wetsontwerp houdende instemming met het Verdrag van de Raad van Europa over de namaak van medische producten en soortgelijke misdrijven die een bedreiging vormen voor de volksgezondheid, gedaan te Moskou op 28 oktober 2011/Projet de loi portant assentiment à la Convention du Conseil de l'Europe sur la contrefaçon des produits médicaux et les infractions similaires menaçant la sécurité publique, fait à Moscou le 28 octobre 2011 – the "Bill").
The Bill, when adopted, will ratify the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (the "Medicrime Convention"). The Medicrime Convention is the first international criminal law instrument to oblige States to penalise the following offences:
- the manufacturing of counterfeit medical products (this term includes both medicinal products and medical devices);
- the supplying, offering to supply and trafficking in counterfeit medical products;
- the falsification of documents;
- the unauthorised manufacturing or supplying of medicinal products and the placing on the market of medical devices which do not comply with conformity requirements.
The Bill considers that Belgian law, and in particular the Medicines Law of 25 March 1964 (Wet op de geneesmiddelen/Loi sur les médicaments) and the Criminal Code, already contain provisions implementing the Medicrime Convention.
Article 16 of the Medicines Law penalises the counterfeiting and falsification of medicinal products and the intentional supply of counterfeit medicinal products. However, this provision does not apply to investigational medicinal products for human use or to medical devices. The explanatory note of the Bill indicates that this gap will have to be filled by making the relevant offences under Article 16 also applicable to investigational medicinal products for human use and to medical devices.
The Medicrime Convention further encourages national and international co-operation in order to combat the above offences. In this regard, the Bill considers that Belgium established a General Drugs Policy Cell (Cel Algemeen Drugsbeleid/Cellule générale de Politique Drogues) serving as a platform for cooperation among public services in the fight against counterfeiting and falsification of medicinal products. This cell has the task of centralising and updating information as well as providing advice and recommendations on policy harmonisation. With regard to international co-operation, the Special Investigation Unit attached to the Federal Agency of Medicines and Health Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/Agence fédérale des médicaments et des produits de santé) will act as a national contact point to receive requests of information and/or co-operation.
The Medicrime Convention also calls on the parties to take precautionary measures in the fight against the counterfeiting of medical products and similar offences. Such measures are foreseen at European level by harmonising national rules relating to medicines and medical devices. The EU rules are either directly applicable or were implemented into Belgian law. The requirements set out in the Medicrime Convention have thus been met.
Given the potentially serious consequences of counterfeiting of medical products and similar offences for victims, the Medicrime Convention requires Parties to guarantee the protection of the rights and interests of the victims through the implementation of specific measures such as compensation for victims. Belgian law does not provide for a special compensation fund for victims of offences covered by the Convention. However, the Law of 31 March 2010 relating to the compensation for damages resulting from healthcare (Wet betreffende de vergoeding van schade als gevolg van gezondheidszorg/Loi relative à l'indemnisation des dommages résultant de soins de santé) establishes a general medical accidents fund. The Bill notes that this law could apply if the intervention of a health care professional or a health care institution contributed to the injury of the victim.
The Bill is expected to be voted upon and then signed into law in the coming months.
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