WHO cross-country study examines regulatory measures' impact on pricing in 16 EU health systems

The World Health Organization's (WHO's) European unit has published a cross-country comparison study examining regulatory measures in 15 European Union (EU) member states. The report examines health systems in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the United Kingdom (including separate health service regions in Scotland and England). The regulatory measures examined include market authorisation, price updates, patient cost-sharing, and generic substitution, and the study provides the resulting price levels. This is designed to enable a comparative assessment of the impact of these different policies on patients' access to effective and affordable medicines. The document is intended to serve as a guide in debates on health policy and pharmaceutical prices in each country surveyed.

The WHO review of the mix of cost-containment and regulatory mechanisms can be accessed here.

The report attempts to assess the quality and efficiency of health system configurations. In a foreword, the WHO concludes that pharmaceutical prices in Europe have "not converged as could be expected, at least for originator drugs". It notes that, while the regulatory systems in all the countries surveyed succeed to some extent in directly controlling pharmaceutical prices, "current pricing policies have real limitations" in some countries.

Data on per-capita expenditure for retail pharmaceutical (i.e. medicines with/without prescription dispensed through community pharmacies or authorised retail outlets) show a significant variation from USD324.6 in Denmark to USD741.1 in Germany in 2014. The majority of countries surveyed display a steady upward trend in retail/outpatient pharmaceutical expenditure, as measured on a per-capita basis. This is notably the case for Austria, Germany, and Poland, while Portugal has followed an ongoing decreasing trend over recent years. Retail pharmaceutical expenditure as a share of current health expenditure also reveals considerable variation among the 16 countries sampled. Overall retail expenditure as a share of health expenditure averaged 14.5%. In Denmark the figure was only 6.7%, in contrast with Greece, where retail expenditure made up 28.4% of overall health spending in 2014. Elsewhere, statistics on public pharmaceutical expenditure as a share of total pharmaceutical expenditure ranked Poland at the bottom with 33.5% and Germany at the top with 83.3%. The Netherlands and France were found to be in the upper tier of countries with over 70%.

Another objective of the report is to investigate pharmaceutical consumption trends for a number of common indications (including diabetes, hypertension, dyslipidaemia, and depression). Unsurprisingly, there is a steady rise in anti-diabetic prescription drugs in almost all countries. In Spain and Portugal, the exceptions, consumption is expected to increase as they re-establish a stable financial footing. On a cross-country comparison basis, Germany, Greece, and the United Kingdom are assessed to have the highest consumption rates for antidiabetic drugs. Austria was found to have substantially lower consumption. Data for the consumption of anti-depressant medications also supports a relatively stable, slowly increasing trend in the majority of countries surveyed. Countries with high consumption patterns include Portugal, Sweden, and the UK, while Italy and Greece have the lowest.

The WHO analysis of time to market for innovative pharmaceutical products reveals no major changes from previous annual reports. The authors conclude that Germany continues to rank first for speed of access (3.5 months). Spain's time to market for 2014 was found to average 15.8 months, while Greece's increased to 21.3 months, almost certainly owing to ongoing efforts to contain public expenditure. Interestingly, the WHO flags concerns regarding the European Medicines Agency (EMA) pilot adaptive pathways programmes, designed to accelerate market access for indications without a therapeutic alternative. The report highlights concerns expressed by regulators and health technology assessment (HTA) agencies over the market authorisation evidence requirements. It also chimes with a recent Dutch report that highlighted that most EU countries lack adequate delisting mechanisms to handle pharmaceuticals that miss their value targets (see Netherlands: 4 November 2016: Netherlands' RIVM assesses challenges in adaptive pathway approvals of new medicines). This could be interpreted as a further setback, particularly after Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) called for a pause and re-evaluation of the adaptive pathway programme (see Germany: 12 August 2016: IQWiG criticism of adaptive pathway programme triggers EMA response).

Outlook and implications

The WHO report offers a valuable survey of the health systems for a broad sample of 15 European countries. Comparative datasets should allow policymakers to track changes in policy levers affecting the pharmaceutical sector and to observe the resulting regulatory and expenditure differences. Nevertheless, there are methodological limitations to the study and another chief shortcoming is that most of the statistical data refer to 2014. The authors also acknowledge that there is no direct evidence of the effects the various cost-containment regulatory mechanisms have on patient outcomes across the 15 EU countries. Given the substantial socio-economic differences between the countries surveyed – in terms of pharmaceutical priorities and expenditure challenges – it is hardly surprising some countries are struggling more than others to provide timely and equitable access to new medicines.