French Constitutional Council censors National Assembly’s ‘historic’ amendment on transparency

Eveline Van Keymeulen

On 20 December 2019, the French Constitutional Council issued a decision to censor, among other things, a historic amendment to the 2020 Social Security Financing Bill on transparency of medicinal product pricing and public contribution in research and development (R&D). Accordingly, the amendments requiring pharmaceutical companies to publicly disclose any public R&D contributions they have Read More

Belgium – FAMHP issues updated guidance document for clinical trial sponsors

Kaat Van Delm

On 19 December 2019, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued updated guidance for clinical trials sponsors. This document (and each of its previous versions) was adopted in the context of a pilot project that aims to prescribe the procedures and rules for the collaboration between the FAMHP, the Belgian Clinical Read More

Belgium – PharmaStatus: new online platform on availability of medicines

Tine Carmeliet

The Federal Agency for Medicines and Health Products (FAMHP) has launched PharmaStatuts a new online platform that collects and publicly discloses information about the availability of medicines in Belgium. The platform aims at reducing the impact of unavailable medicines on patients. In addition, it aims to facilitate the flow of information between all parties involved Read More

Belgium: New nomenclature for incidents with medical devices

Kaat Van Delm

A group of the International Medical Device Regulators Forum (IMDRF) has recently developed a new nomenclature for the reporting of incidents with medical devices, which will become applicable in 2020. The newly introduced codes will be used primarily to complete medical device reports (MDRs). They will therefore already form part of the new incident report Read More

Belgium launches International Horizon Scanning Initiative to negotiate better prices for medicines

Kaat Van Delm

The Belgian Minister of Health has announced in a press release that nine countries have decided to join forces to prepare for the arrival of new and expensive medicines, via the creation of the International Horizon Scanning Initiative (IHSI). The initiative was driven by the current debates concerning prices of medicines which are being perceived Read More