Contracts including performance and management of uncertainty

• Published in: Annales pharmaceutiques françaises Vol. 71; no. 5; p. 338
• Main Authors: Duru, G, Garassus, P, Auray, J-P
• Format: Journal Article
• Language: French
• Published: France 01-09-2013
• Subjects: Biomedical Research; Contracts; Data Interpretation, Statistical; Diffusion of Innovation; Drug Industry - economics; Drug Industry - organization & administration; Drug Therapy - standards; France; Humans; Uncertainty; France; Médicament; Prévision; Uncertainty; Incertitude; Contrats; Medicine; Agreement; Remboursement; Price; Volume; Forecast; Prix; Reimbursement; Performance
• ISSN: 0003-4509
• DOI: 10.1016/j.pharma.2013.08.008

Since many decades in France, the most important part of ambulatory health care expenditure is represented by drug consumption. By the fact, French patient is indeed the greatest world consumer of pharmaceuticals treatments. Therefore, the regulation authorities by successive strategies, attempt to limit or even restrict market access for new drugs in the health care sector secured by public social insurance coverage. Common objectives are to assess the reimbursement to scientific studies and to fix the price of therapeutics at an acceptable level for both industries and government. New trends try then to determine recently the drug price in a dual approach, as a component of global and effective contract, including performance and outcome. The first diffusion authorization is diffusion concerned, but this concept takes into account the eventual success of new produces in long-term survey. Signed for a fixed period as reciprocal partnership between regulation authorities and pharmaceutics industries, the contract integrates two dimensions of incertitude. The first one is represented by the strategy of new treatments development according to efficacy and adapted price, and the second one is linked to the result of diffusion and determines adapted rules if eventual non-respects of the previous engagement are registered. This paper discusses problems related to this new dimension of incertitude affected by conditional drug prices in market access strategy and the adapted follow-up of new treatment diffusion fixed by "outcome" contract between French regulation administration and pharmaceutics industries in our recent economic context.