Hot topics that economic efficiency assessments raise in daily legal practice

Defining the criteria for economic efficiency assessment of medicines is essential. This is one of the conclusions of the Conference held on 8 May 2013 in Madrid, where various experts have discussed about these matters.

The Conference has been organized by the Department of Economy of Medicines of the University Carlos III in Madrid, in collaboration with Abbvie. The scientific program of included a presentation by Jordi Faus on “Hot topics that economic efficiency assessments raise in daily legal practice”.

In his presentation, Jordi Faus stressed the importance of respecting the principles of modern administrative law, including transparency and the need to secure procedural guarantees. As it happens with biological products, where the product is closely linked to its manufacturing process; in administrative procedures the rules of the process are essential to secure the quality of the final product.

Jordi Faus indicated how important it is that all Healthcare industry has been aligned to support its involvement in health technology assessment, and that partnering with agencies, while respecting their independence, can surely report advantages for all parties involved.

Jordi Faus has also referred to the issues which are more commonly raised by companies seeking legal advice when dealing with pricing and reimbursement procedures in Spain. Among others, these include the duration of the procedures, the position that companies may take in the event of failure to act by the authorities, the criteria which are used to decide on these matters, the existence of administrative barriers that make access to market difficult in some regions, and the use of alleged therapeutic equivalence as a tool to bring prices down specially in public tenders for medicines in Spain. Jordi Faus has also pointed out to some regions or hospitals sponsoring off-label use of some products or in-situ compounding or manufacturing as areas of concern.