On 27 July 2015, the Minister for Social Affairs and Public Health, Maggie De Block ("the Minister"), and the pharmaceutical sector umbrella organisations pharma.be and FeBelGen entered into a "Pact for the Future" (Toekomstpact/Pacte d'avenir - the "Pact"). In the Pact, they agree on a significant number of measures in the pharmaceutical field for the period 2015-2018.
The Pact groups these measures under four main headings: (i) accessibility; (ii) growth and innovation; (iii) ethics; and (iv) budgetary durability and predictability.
The Pact's principal goal is to make innovative therapies easier and earlier accessible for patients. This goal should be achieved through the following measures:
Innovative medicines will become reimbursable as from the date of publication of the Minister's positive decision on the website of the National Institute for Sickness and Invalidity Insurance (Rijksinstituut voor Ziekte- en Invaliditeitsverzekering/Institut national d'assurance maladie-invalidité). According to the Pact, this will make new and innovative medication available at least two months earlier than is now the case. The assessment procedures will be accelerated by (i) shortening the applicable time frames where appropriate; and (ii) avoiding duplication of any work that has already been carried out at a different level, whether national or international. The prices to be paid by patients will decrease. The Minister will aim for closer cooperation at the European level in order to foster the development of, and patient access to, medicines for unmet medical needs and orphan medicines. Growth and innovation
The Pact identifies three policy priorities to stimulate growth and innovation:
The first priority is to create a stable, predictable and trustworthy environment for R&D in the pharmaceutical field. The Pact stresses the importance of financial, fiscal and legal certainty. It will be examined whether there is scope for introducing a biotechnology tax shelter for early phase developments. Moreover, a central contact point will be established to provide regulatory support to biotechnology spin-offs and start-ups. In addition, it will be made easier to use human body material for R&D purposes and a clear regulatory framework will be established to stimulate the development and production of advanced therapy medicinal products. The second priority is to monitor the competitive position of the Belgian pharmaceutical industry...