pharmaceutical reimbursement and pricing in spain

The percentage of the population aged 65 years and over may reach 25% in 2033, and the number of persons that are dependent on others will continue increasing up to almost 60% in 2033. Direct price controls do not restrain growth of costs and may not address the need for innovation. In addition to the above, it is relevant to consider that under Spanish rules on public procurement, public contracting bodies are under an obligation to make public the main terms of any contract they enter into with any supplier of any good or service. Third, the pharmacies' payment system has moved from the traditional set margin on the consumer price to a margin that varies according to the consumer price of the product, the generic status of the product, and the volume of sales by pharmacies. For the achievement of these objectives, the Plan proposes specific actions in the following areas: (i) reimbursement; (ii) Pharmacotherapeutic Guide of the NHS; (iii) prescription; (iv) dispensation; and (v) information and training. Accordingly, instead of a convergence to the bottom in EU pharmaceutical prices, the evidence points at ‘convergence to the top’. Additionally, companies are legally obliged to grant a discount on the maximum ex-factory price approved by the authorities. The Spanish Medicines Agency of Medicinal Products and Medical Devices (i.e. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The objectives of this study are to describe experiences in price setting and how pricing has been used to attain better coverage, quality, financial protection, and health outcomes. Using a unique comparative structure, the book allows healthcare professionals, patients, and policymakers alike to know which systems perform well, and why, and which face endemic problems. In some cases, special diplomacy may need to be exerted to ensure that the position of the company is not misinterpreted – it is important to play fair – but in general terms, this is not something to be too concerned about. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Spanish lists were, In recent years, international cooperation processes have become a key mechanism for companies to internationalise their innovative activities, par ticularly in the case of small businesses whose size reduces their possibilities of developing internationalisation strategies autonomously in the same way as larger companies. In this respect, we think that the reason why Spanish law contemplates that reference prices may appear even in the absence of generics or biosimilars is that at the time such reference price would start applying, there should exist in the market at least one product which does not incorporate the research effort done by the reference one, thus opening the door to price competition not conditioned by R&D costs. Third, pharmaceutical expenditure in Spain seems to be responsive to both pricing and volume policies. A reasonable solution to reward real innovation could be to admit a premium price for very innovative drugs according to their estimated cost-effectiveness. The cost of the product is to be determined through the analytical application of the “Complete Cost”, including R&D, manufacturing costs, and allocations corresponding to commercial and administration costs. On the other hand, the Council has issued decisions whereby disclosure requests have been denied. Any person or entity that wishes to manufacture medicinal products or medical devices in Spain, must be previously authorized as manufacturer by the AEMPS, in compliance with the provisions contained in Royal Decree 824/2010 or Royal Decree 1591/2009, as the case may be. It is also important to note that the MOH may also establish restrictions as regards the prescription, dispensing and financing of some medicinal products within the NHS. Biosimilar products are not defined under Spanish law, although there exist provisions under which all biological products are considered non-eligible for substitution without the prior approval of the prescribing doctor. Actual sales of the product being greater than the sales forecast submitted by the company during the price and reimbursement proceeding is one of the reasons that may trigger an ex officio price review. Further, it is worth mentioning that due to a recent modification of the Spanish Law on Medicines and Medical Devices made by Royal Decree-Law 7/2020, the MOH may now establish maximum retail prices for non-reimbursed products sold in Spain (including non-prescription medicinal products) that may be needed for the protection of public health in the context of exceptional health crisis (such as the COVID-19 crisis). This paper argues that the pharmaceutical industry represents an exciting opportunity to carry out academic research. In this respect, we note that on 5 June 2020 the High Court of Justice of Madrid confirmed that the price reduction of a product because of a 15% deviation between the forecasted and actual sales of such product was in accordance with the law.

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