On 12 November 2015, the policy document on Social Affairs and Healthcare was presented by Minster Maggie De Block to the Belgian Chamber of Representatives. This policy document clarifies various issues that are relevant for the Pharmaceutical and Associated Industries.
In line with the governmental agreement to get more involvement from the patient, several associations have become full member of the managing council of the Belgian Health Care Knowledge Centre (KCE). From 2016 on they will also be represented in the modernised Medicines Commission of the Federal Agency for Medicines and Healthcare Products (FAMHP).
Evidence based medicine and evidence based practice will be the cornerstone of the decision process setting the goals of public healthcare policy. The main goal of the Pact agreed in 2015 with the pharmaceutical industry is to ensure a long-term strategy whereby the patient gets access to the most innovative therapies. A deontological framework has been established together with the industry and at last there is a stable multi-year budegetary framework for medicine expenditures. The Pact will result by 2018 in € 60 million savings for the patient. On an annual basis € 350 million will be invested in innovation and the goverment should be able to realise € 236 millions of savings.
The patent cliff will come into operation in March 2016: at expiry of the patent and as soon as a generic alternative comes on the market, the price of the innovator product will drop by 54.35% for medicines reimbursed in category B. There will be a price cut of 60.73% for category A medicines. The patient's contribution is limited to € 5.
The patent cliff approach is expected to be an administrative simplification and offer improved transparancy. A stimulating effect on industrial innovation is also anticipated; it is in the interest of the pharmaceutical industry to have a full R&D pipeline that will compensate for the steep decline in revenues at expiry of their patents.
On 1 January 2016 a convenant comes into opeation that should promote the use of biosimilars. The increased use of biosimilars is expected to lead to substantial savings for the Belgian healthcare budget.
Earlier access to innovative medicines will be facilitated by the "unmet medical need" procedure still to be finalised by the KCE.; under certain conditions, partial reimbursement could be possible up to 6 months before the obtention of the marketing authorisation.
Also very important is the planned revision of the royal decree describing the procedures for reimbursement applications for medicinal products. Procedures will be improved, more external experts will be involved in the decsion making process. Reimbursement for additional indications will be done according to a methodology that is expected to be innovation stimulating. The administrative handling of certain applications will be simplified. Reimbursement decisions will be published faster on the RIZIV/INAMI/NIHDI website.
Orphan medicinal products will receive special attention. The Orphan Drug Committee will be involved in individual reimbursement decisions only in those cases where simplified electronic approvals are not possible. Medicinal products which after 10 years of exclusivity still meet the conditions for their orphan status will continue to benefit from tax exemptions.
It is considered essential that Belgium also in the future will retain its prominent position as a clinical trial friendly European member state. The FAMHP is to optimise its collaboration with the various national ethics committees so that the legal timelines for evaluation of clinical trial proposals are respected.
For (implantable) medical devices, focus will be laid on auto-control by the industry.