The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries─an overview

摘要

Introduction:?To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake.Method:?Data collection on pharmaceutical pricing and reimbursement policies with the staff of competent authorities.Results:?In most European countries the prices of medicines are controlled at the stage of manufacture (ex-factory price) or wholesale. Usually, price control systems target reimbursable medicines, and the prices of reimbursable generics are regulated. Sixteen of the 29 countries surveyed in this study apply a policy of generic price linkage, i.e. setting the price of the generic medicines at a specific percentage lower than that of the originator. Twenty-two of the surveyed countries run a reference price system, i.e. a reimbursement policy based on clusters of identical or similar medicines for which a fixed amount of reimbursement is granted. Most countries cluster medicines with the same active ingredient, and only a few countries have opted for broader reference groups, thus allowing more interchangeability between choice of medicines and higher savings on costs. Demand-side measures such as generics substitution and/or prescribing by the international non-proprietary name are in place in nearly all the countries surveyed. These are usually not mandatory for the stakeholders concerned.Conclusion:?As many pharmaceutical policies tend to address reimbursable medicines, generics fall under the scope of these measures. European countries apply a mix of specific measures to promote generics uptake. There appears to be room for improvement regarding the enforcement of some policies.Submitted: 18 April 2011; Revised manuscript received: 5 March 2012; Accepted: 9 March 2012IntroductionThis article aims to provide an overview about pharmaceutical?pricing and reimbursement policies which European countries,?including all EU Member States, apply to promote the use of?generic medicines.In the EU, Member States are free to develop their national–?and regional–pharmaceutical policies in the field of pricing?and reimbursement. This is permitted so long as they comply?with overall EU provisions, such as the Transparency Directive?[1], e.g. formal procedural aspects such as deadlines or?a transparent publication policy. Despite EU harmonisation?of marketing authorisation [2], EU Member States can freely?design their pharmaceutical pricing and reimbursement framework,?thus opting for more market control and/or promoting?competition with regard to generics and other pharmaceutical?products.All European countries are facing growing pharmaceutical?expenditure, particularly in public expenditure [3] given that?Europe has a comparatively higher coverage of publicly funded?health care compared to the rest of the world [4]. For example,?two thirds of European pharmaceutical expenditure is funded?by a third party payer such as social health insurance, despite?individual countries varying in the share of public funded?medicines [5, 6]. Public pharmaceutical expenditure in the outpatient?sector increased in EU countries by 76% between 2000?and 2009 (median: 53%; lowest value: 21%; highest value:?243%) [5, 7]. Aggravating the situation further, the global financial?crisis has forced several European countries to introduce?short-term rigid cost-containment measures [8].With limited budgets, European countries view generics as a?policy option that enables savings to be made and which can?then be used for funding high-cost medicines. As stated in the?European Commission’s Communication on a Renewed Vision?of the Pharmaceutical Sector: ‘[m]any Member States recognise?that generic medicines play an important role in helping to?limit their healthcare expenditure in their reimbursement and?prescribing practices. Competition with off-patent products?enables sustainable treatment of more patients with less financial?resources. The generated savings creat