In its Coalition Agreement of 9 October 2014, the Belgian Government listed different measures it will implement in the health sector during this legislature, which are important from a life sciences perspective.
They can be divided in two main categories:
- measures concerning the price/reimbursement of medicinal products, implants and medical devices; and
- measures promoting new medicinal products, innovative treatments and R&D activities in the pharmaceutical sector in Belgium.
The proposed legislative initiatives at price/reimbursement level can be summarised as follows:
- more transparency on cost pricing of medicinal products and medical materials;
- the reimbursement of implants and medical devices will be further aligned with the reimbursement of medicinal products;
- measures aiming at obtaining lower prices for patients and the social security, such as generating more competition on the off-patent market and the possibility to review the reimbursement conditions of patented medicinal products on the basis of therapeutic value and cost efficiency arguments.
The new government also wants to create important incentives for the development of new medicinal products, innovative treatments and R&D activities in the pharmaceutical sector in Belgium. The following measures are set forth:
- particular interest will be paid to “unmet medical need” programs making available medicinal products for innovative treatment of patients with a seriously debilitating disease or whose disease is considered to be life threatening and who cannot be treated satisfactorily by an authorised medicinal product, even in case such medicinal products are not yet authorised at EU-level or before authorisation of a new indication for which exists a medical need that has not yet been met by an already authorised medicinal product;
- concerning clinical trials: a faster procedure for approval, making the inclusion of patients easier; simplifying the system evaluation by the national health authority (FAGG-AFMPS) and ethical committees;
- continuing to improve the existing administrative procedures to obtain a marketing authorisation for new medicinal products which are already approved on the basis of the centralised or mutual recognition procedure (e.g. by shortening the time-limits for the authorities to take a decision on applications and by avoiding duplication of work (i.e. work that has already been done by EU or national competent authorities));
- the “Biopharma R&D consultation platform” that has been set up in the past between the Belgian pharmaceutical sector and the government in order to create a well-established legal framework for R&D activities in the pharmaceutical industry, will continue its work.
The policy of the new Belgian Government, although ambitious, is clearly to promote innovation in the pharmaceutical sector, on the one hand, and, to further expand the market of “cheaper” medicinal products, on the other hand. The next months and years should therefore be very important for pharmaceutical and other companies in the health sector in Belgium.