Static winching tests were carried out in order to determine the mechanical resistance of Maritime pine to overturning. The tested stands were selected according to podzolic soil conditions: "wet Lande", characterised by a shallow ground water table and a hard pan horizon, and "dry Lande", with a deeper ground water table and a hard pan absent or broken up. As this soil horizon limits the vertical growth of tree roots, anchorage resistance was investigated with regards to the presence or absence of a hard pan underneath each tree. To determine if mechanical behaviour differed within a stand, trees from inside the stand and edge trees at the border exposed to prevailing winds were also tested. The critical turning moment (TM crit,total ) at the base of the stem was positively related to the variable (H × DBH 2 ) (H, total tree height; DBH, tree diameter). Linear regression analyses between TM crit,total and (H × DBH 2 ) showed that the presence of a hard pan had no significant effect on anchorage resistance in uprooted trees. Stem failure occurred for 82% of trees on dry Lande when (H × DBH 2 ) < 1 m 3 . Moreover, stem failure type on dry Lande indicated that trees were better anchored. On soil with a hard pan, edge trees were found to be 20% more resistant to overturning than inner trees. Edge trees differed from inner trees in that the soil-root plate was two times larger and also possessed a larger surface area on the windward side.

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An orphan disease is a disease with a very low prevalence. Although there are 5000-7000 orphan diseases, only 50 orphan drugs (i.e. drugs developed to treat orphan diseases) were marketed in the EU by the end of 2008. In 2000, the EU implemented policies specifically designed to stimulate the development of orphan drugs. While decisions on orphan designation and the marketing authorization of orphan drugs are made at the EU level, decisions on drug reimbursement are made at the member state level. The specific features of orphan diseases and orphan drugs make them a high-priority issue for policy makers. The aim of this article is to identify and discuss several issues surrounding orphan disease and drug policies in Europe. The present system of orphan designation allows for drugs for non-orphan diseases to be designated as orphan drugs. The economic factors underlying orphan designation can be questioned in some cases, as a low prevalence of a certain indication does not equal a low return on investment for the drug across its indications. High-quality evidence about the clinical added value of orphan drugs is rarely available at the time of marketing authorization, due to the low number of patients. A balance must be struck between ethical and economic concerns. To this effect, there is a need to initiate a societal dialogue on this issue, to clarify what society wants and accepts in terms of ethical and economic consequences. The growing budgetary impact of orphan drugs puts pressure on drug expenditure. Indications can be extended for an orphan drug and the total prevalence across indications is not considered. Finally, cooperation needs to be fostered in the EU, particularly through a standardized approach to the creation and use of registries. These issues require further attention from researchers, policy makers, health professionals, patients, pharmaceutical companies and other stakeholders with a view to optimizing orphan disease and drug policies in Europe.

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This static analysis measured orphan drug costs only, assuming that other components of health expenditure do not change over time. The analysis showed that the budget impact of orphan drugs in Belgium is substantial and rising, thereby putting pressure on total drug expenditure. Policy options to address the rising budget impact include pricing linked to return on investment, risk-sharing arrangements and re-appraisal of orphan drug status if additional indications are approved.

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In addition to the official criteria, other negotiable factors, such as price adjustments and employment incentives, may play a role in Belgian reimbursement decisions of orphan drugs. Some differences have also been noted between the clinical evidence reported in EMA documents and the evidence included in Belgian reimbursement dossiers of orphan drugs. There appears to be a need for further standardization of Belgian reimbursement applications and for European cooperation in sharing clinical evidence of orphan drugs.

No abstract