Effects of Supplementary Protection Mechanisms for Pharmaceutical Products

Rapport over beschermingsmechanismen op het gebied van intellectueel eigendom met betrekking tot medicijnen

Do Current Incentive Models for Biologicals and Pharmaceuticals (patent term extensions, data and market exclusivities), Pediatrics and Orphan Drugs Deliver on the Promise in Return for Which They are Granted, and Do We Need Other Incentives for Those and Other Drugs such as Antibiotics?

The life sciences sector is one of the most regulated in the world, and innovation requires in a fair amount of cases huge investments. That also means that for life science companies, an effective term of protection from competition is seen as indispensable for the continuation of their business model. To that effect, the life science industry cannot only avail itself of patent protection and patent term extensions, but it has also a rather extensive range of rewards and exclusivities at its disposal (paediatric extension, market exclusivity, data exclusivity, orphan drug designation and related market exclusivity if a marketing authorization is obtained, reduced fees for regulatory processes, variety of systems of tax benefits, etc, to name only the most common ones), more so than any other sector of technology. We see that the importance of some of these incentives, in particular data and market exclusivity, has grown rapidly, and they are today a crucial tool in any product lifecycle strategy. The question is now whether some of these incentives, which are granted with a specific innovation goal in mind, are now in fact leading to the innovation in those areas where it was supposed to be promised, and/or whether the existence of those incentives becomes part of the mix of possibilities to optimize profits. Research has shown that at least for some of these incentives, there is no conclusive evidence that they have led to the expected results. It has at the same been established that some of these incentives have become a useful tool in profit optimization for blockbuster drugs, whilst the intended goal of the incentives has played a less than prominent role. It seems appropriate to develop a more critical approach to the plethora of systems, and preserve and improve what works, and change what does not provide the expected effects

Do Current Incentive Models for Biologicals and Pharmaceuticals (patent term extensions, data and market exclusivities), Pediatrics and Orphan Drugs Deliver on the Promise in Return for Which They are Granted, and Do We Need Other Incentives for Those and Other Drugs such as Antibiotics?

The life sciences sector is one of the most regulated in the world, and innovation requires in a fair amount of cases huge investments. That also means that for life science companies, an effective term of protection from competition is seen as indispensable for the continuation of their business model. To that effect, the life science industry cannot only avail itself of patent protection and patent term extensions, but it has also a rather extensive range of rewards and exclusivities at its disposal (paediatric extension, market exclusivity, data exclusivity, orphan drug designation and related market exclusivity if a marketing authorization is obtained, reduced fees for regulatory processes, variety of systems of tax benefits, etc, to name only the most common ones), more so than any other sector of technology. We see that the importance of some of these incentives, in particular data and market exclusivity, has grown rapidly, and they are today a crucial tool in any product lifecycle strategy. The question is now whether some of these incentives, which are granted with a specific innovation goal in mind, are now in fact leading to the innovation in those areas where it was supposed to be promised, and/or whether the existence of those incentives becomes part of the mix of possibilities to optimize profits. Research has shown that at least for some of these incentives, there is no conclusive evidence that they have led to the expected results. It has at the same been established that some of these incentives have become a useful tool in profit optimization for blockbuster drugs, whilst the intended goal of the incentives has played a less than prominent role. It seems appropriate to develop a more critical approach to the plethora of systems, and preserve and improve what works, and change what does not provide the expected effects