India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Nordics inch toward cooperation on drug purchasing, but don't expect early developments
In late March the Danish Institute for Local and Regional Government Research (KORA) published research mapping similarities and differences in pharmaceutical regulation across the Nordic countries of Norway, Sweden, Denmark, Finland, Iceland and Greenland. The document (available in Danish) is based on interviews with regional experts and covers the respective size and capacity of drug regulators in evaluating innovative high-cost drugs, models to prioritize hospital medicine expenditure, as well as variations in cost-effectiveness analysis and therapeutic effect thresholds.
The report was commissioned by the Nordic Council of Ministers, an intergovernmental parliamentary forum that has, among other issues, promoted closer co-operation within the Nordic region on pharmaceutical pricing policies and procurement. In 2015, participating Nordic states agreed to expand collaboration in the area of high-cost hospital medicines. The latest analysis could facilitate future cross-border procurement structures between two or more Nordic countries, although the report offers no concrete proposals in that direction. At the same time, the findings produced by KORA highlight a significant number of legal, economic and practical challenges facing drug regulators in the Nordic territories that could potentially hamper progress in these areas.
To varying degrees Denmark, Finland, Norway and Sweden constitute limited markets for pharmaceutical manufactures. But ongoing regulatory and political discussion among the Nordic states has long seen the prospect of enhanced cooperation and eventually joint procurement as a way to gain greater leverage in pricing and reimbursement negotiations. The KORA report identifies significant similarities in the regulation and use of pharmaceutical products where there are existing therapeutic alternatives. For generic and parallel imported medicines, only relatively small differences were detected between countries. The problem is that there are still substantial and basic differences in approaches to the evaluation of treatment costs under health economic analysis related to the regulation of new high-cost medicines with few or no alternative options available.
The regulatory differences that KORA has astutely identified are not insurmountable. But they could mean that further co-operation in the pricing and procurement arenas for innovative high-cost hospital medicines could be restricted to two or more Nordic states, at least initially. The most likely candidates - in their advances made in implementing prioritisation models based on cost-effectiveness analysis - are Norway, Denmark, and Sweden. Although Sweden's more decentralized purchasing organisation makes it more difficult to carry out joint drug purchases with. Nevertheless, Denmark's regional procurement agency, Amgros, and Norway's drug-procurement agency (Legemiddelinnkjøpssamarbeidet: LIS), have signaled their support for a bilateral pilot programme to jointly purchase select medicines. Work is expected to begin on the proposal in 2017. Progress in this stage was given a boost after Denmark's acting Minister of Health Karen Ellemann reportedly endorsed the possibility of cooperation with Norway through an experimental pilot system.
Moves toward cross-border purchasing in the Nordic region have long been mooted, but progress has been slow and step-wise. There is no suggestion from the KORA report that current framework blockages, which are holding back voluntary public cross-border procurement collaboration and price negotiations, are likely to be overcome quickly or easily. However, there is unlikely to be any let-up in the Nordic drive towards joint procurement models, which will be a long-term concern for the innovative pharmaceutical sector given that the policy effect would likely be to curb prices.
Eóin Ryan is a Senior Life Sciences Analyst at the IHS Markit
Posted 13 April 2017
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