Article published in 26/01/2010 PHARMACEUTICAL MAIL
health spending needs are independent of the recession because they depend on the pace of adoption of medical and pharmaceutical innovation and the evolution of the population covered and their aging. In this context, the proper design of a generic policy can contribute to more efficient financing of the health system thanks to the effect of competition on the price of drugs whose term has ended allows more space to cover financial innovations with adequate health cost-effectiveness.
Since that 1997 allowed the entry of generic drugs in the English market, generics have become increasingly important due to the reduction of prices for the product brand as well as the growing market share in units (about 22% in 2008). Although the overall share is still comparatively small and is still a very broad sweep upwards taking into account the products whose term ends short term, this market share is significantly higher for drugs subject to reference pricing system (about 55%).
The current design of the so-called reference price system (PR) has served to gradually reduce and remarkable price of drugs for which there are generic and in this regard, it has been a measure to assess very positive. However, this policy has been very positive thanks to the absence of other measures to sensitize patients and prescribers of price differences and the need to prescribe and dispense lower-cost equivalent drugs, ie, was positive only because we have not known any better.
The current system of PR have some important limitations that may even limit the bet in the medium and long term generic. In this sense, the difficulties remain the responsibility of ex-factory prices between laboratories are passed on to retail prices, setting the lower price does not respect the condition to demonstrate ability to meet a certain market share by producers who offer that price, the exclusion of the public financing of products with a higher price point and the elimination of avoidable copayment charged to the user makes generic pay "the price of being a reference", etc..
The report from the General for Competition of the European Commission published in July last year warned of the budgetary consequences of delays in generic entry after the loss of patent exclusivity due to multiple strategic and innovative industry input protected line extensions a new patent that rapidly cannibalize the market for traditional presentation, litigation, advertising campaigns questioning the quality of generics as well as the unacceptable delays due to regulatory process itself (in appearance, Spain has much to improve).
addition, the Commission's report provides evidence that the systems themselves price regulation and public funding can erect barriers to a firm commitment to generics. It was observed that the price regulation policies reduce competition, the price is stagnating at a level higher than you would in the absence of regulation. On the other hand, the study notes that the frequent adjustment of the reference price, the mandatory replacement for the equivalent of a lower price, the maximum reimbursement based on the lowest price and to a lesser extent, the differential co-payments, contributing to a greater reduction price and faster and greater market share of generics.
take decisive action is necessary to promote competition in retail prices in this market, which would be far more useful than continue to base generic policy regulating its retail price of their redemption price and the alleged prohibition of discounts the selling price of lab, except the real volume discounts.
Careful observation and without prejudice to the successful outcome of the experience of the measures taken in recent years in some European countries can provide valuable lessons for the reform of the regulation of generic drugs in Spain: the Norwegian experience with abandonment PR system with the deepening of fixing the maximum reimbursement level referenced as a percentage of PVP from the mark before the expiry of the patent which can reach 85% after one year of the first generic entry, the case of Sweden, which also abolished the PR, and replaced by mandatory substitution and reimbursement of cheaper equivalent product combined with a co-preventable by the patient, and cases of Holland and Germany with the onset of selective employment experiences of competitive auctions to determine preferred laboratory, separating the pharmacy reimbursement price laboratory.
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