10 Apr 2018

Since our EU member states have been active this year in continuing to build their collaborative approaches in appraising and reimbursing medicines. We have witnessed an expansion of the Valletta Group, with the addition of Croatia and Slovenia (January 2018). It is believed that France will be an observer to the Valletta Group, considering their latest participation in the work of the Group’s Technical Committee. Some commentators are suggesting that, as a larger country, France will be offering examples of good practice in medicine appraisal rather than entering into joint negotiations with other countries.


Already part of the Valletta Group, the Irish Government has agreed to issue a Letter of Intent to the Ministers for Health for Belgium, the Netherlands, Luxembourg and Austria, signalling Ireland’s interest in joining the BeNeLuxA Initiative (February 2018). The decision, according to the Minister for Health, Simon Harris, was driven by a desire to secure affordable and sustainable access to new and innovative medicines, in an “increasingly challenging environment of high pricing of medicines by pharmaceutical companies”.


The announcement follows Ireland’s increasing participation at voluntary European forums on the topic of medicines access. Most notably by joining Spain, Italy, Greece, Portugal, Cyprus, Malta and Romania as a signatory to the ‘Valletta Declaration’ to explore possible areas for cooperation.


As for BeNeLuxA, Harris had hoped to advance the agreement between the four countries on bringing Ireland into their initiative during his planned trip to Europe in March 2018. However, the trip was cancelled due to a local healthcare crisis in Ireland. It is unclear if Harris is planning to meet the BeNeLuxA ministers before the next EPSCO meeting scheduled for 22-23 April 2018.


Whilst we are seeing developments in joint collaboration between countries, for the vast majority of medicines currently in the pipeline for reimbursement, companies will have to continue to grapple with the challenges inherent in national pricing and reimbursement systems.


BeNeLuxA is still far from being a cohesive appraisal process. Logistically, cross-country collaboration is exceptionally difficult to achieve due to the differing natures of national health systems and populations – BeNeLuxA’s attempts at a unilateral deal on specific medicines have not achieved everything that was expected, while a handful of pilot projects are currently underway.


There are several obstacles that need to be overcome to secure a successful collaboration between countries and a company on a product. Confidentiality of pricing can present an issue to companies, who may have different pricing strategies for each individual country or should prices genuinely vary due to differing healthcare costs in each country. A country’s own healthcare costs, such as hospital utilisation and primary care capabilities, can create large variances in the cost-effectiveness of a medicine compared to the cost of alternative treatments. Very often a final decision on high-cost medicines is influenced heavily by an individual country’s philosophical stance towards equity of access and the corresponding level of clinical uncertainty they are willing to undertake.


Collaboration on assessment and negotiation is undoubtedly a logical vehicle for providing access to new medicines across Europe, but there are significant barriers to overcome. In the meantime, necessary reform of national pricing and reimbursement processes should not be put on stand-by in expectation that a pan-European solution is forthcoming.


For more information, please contact Emma Eatwell, Director EU Health (eeatwell@hanovercomms.com).