A Belgian policy framework for best-value biological medicines

Biological medicines (biologicals) represent a growing share of all medicines worldwide. Biologicals are complex molecules produced out of cultures of living cells. Biologicals are becoming increasingly important in the treatment of diverse complex, life-threatening disorders, and chronic illnesses. However, due to the complex and costly manufacturing process, biologicals are in general very expensive. The success of biological therapies has therefore put significant pressure on healthcare budgets. Following the expiry of exclusivity on originator biologicals, the market has opened up for follow-on versions with the same efficacy and safety. These similar biologicals are called biosimilars. The uptake of biosimilars is essential to introduce price competition in the off-patent biologicals market.

Despite the Belgian government taking actions encouraging the use of biosimilars, market access and competition/uptake is currently rather limited. The problem seems to be multi-facetted: lack of knowledge about biologicals and biosimilars in particular, unclarities about health care practitioners’ prescribing drivers and legal uncertainties related to IP strategies integrated in companies’ business models. Competition in the market requires a sustainable policy that addresses all aspects and all players in the market. 

This PhD program will contribute to the development of a sustainable, balanced and transparent policy framework suitable for best-value biologicals in Belgium, by studying which aspects are in particular relevant for a competitive market in Belgium. Several studies will be conducted with the following aims: 

1. Gain a deeper understanding of the functioning of the off-patent biologicals market in Belgium, including reference biologicals, biosimilars, second-generation products, competing products of the same or other therapeutic classes. 

2. Formulate proposals for communication and education strategies towards patients fostering a balanced and transparent market environment for best-value biologicals in Belgium and Europe. 

3. Identify factors influencing the prescribing behavior of physicians in the context of biological medicines.

4. Propose incentives (like gainsharing, quota’s) in support of a sustainable environment for best-value biologicals in Belgium.

5. Formulate proposals for a Belgian legal and policy framework to support a sustainable, balanced and transparent environment for best-value biologicals in Belgium.

The PhD project will be carried out from a multidisciplinary perspective, requiring collaboration with diverse health care providers, regulators, health care payers, pharmaceutical industry, hospitals, and patient organisations. The research will include quantitative studies (literature reviews, surveys, analysis of data) as well as qualitative studies (semi-structured interviews, expert panels, focus group discussion)