Ireland joins Beneluxa initiative on access to drugs and pricing

In the EU, member states are responsible for setting their own policies on pricing and reimbursement of medicines. In 2015, the Dutch and Belgian health ministers signed a declaration of intent to jointly negotiate with the pharmaceutical sector on the price and reimbursement of some medicines. Since then, the cooperation has been joined by Luxembourg and Austria and now Ireland with several more governments expressing an interest.

The announcement of Ireland's membership was welcomed by life sciences experts at Pinsent Masons, the law firm behind Out-Law.com.

Helen Cline said: "The number of high cost drugs, their complexity and price will continue to grow. This poses a serious threat to the sustainability and survival of national health systems. Current pricing and reimbursement procedures are not always delivering on the objective of providing broad and timely patient access to cost-effective medicines.  Tackling these patient access challenges requires innovative solutions that are a shared responsibility of all players in the healthcare systems, including patients, clinicians, industry and payers."

"Cooperation initiatives such as Beneluxa should not be seen as negative for the pharmaceutical sector. The sector together with patients and payers all have much to gain from streamlining negotiations and economies of scale. It is important however that the primary objective of such cooperation initiatives should be guided by the interests and the needs of patients and like Beneluxa, not limited to using the combined purchasing power of the bloc as a negotiating tool to obtain lower prices - the primary objective of the Beneluxa collaboration is not lower prices per se, but meaningful and affordable innovation for the benefit of all patients ," she said.

Karen Gallagher said Ireland's membership of Beneluxa would be "good news for Irish patients" and that it reflects the Irish government's commitment to improving patient access to drugs in Ireland.

An original priority of the Beneluxa initiative was for joint negotiations to take place between member countries and individual pharmaceutical companies on the pricing of so-called 'orphan drugs' and other medicines of high value or with a high budgetary impact or high cost per patient.

However, under the Beneluxa initiative it is not mandatory for all countries within the collaboration to move together at all times. In addition, the initiative is not solely confined to joint negotiations on drugs pricing - cooperation on other aspects like horizon scanning, shared registers or moving towards harmonized value assessment methods, is also envisaged.

Gallagher said: "The collaboration enables Ireland to share information with other members on new trends, opportunities and technologies in the development of medicines. Ireland will not only benefit from the insights of other members, but will also look to contribute in this area. As the IDA Ireland, the body which promotes inward investment to Ireland notes, Ireland is a centre of excellence for the pharmaceutical sector, a trend which is only set to continue."

"The Irish health minister, Simon Harris, has said that the deal will allow Ireland to secure more medicines, and new and innovative drugs in a more timely manner for patients. This does not necessarily mean that Ireland will spend any less on drugs, but rather that there will be more access to affordable solutions for patients," she said.

"The promise of more 'timely' access to drugs should be welcomed by pharmaceutical companies, who are also keen to see the introduction of a more streamlined medicines approval process in Ireland. The government has started working on this, and is currently undertaking a scoping exercise, before seeking input from stakeholders on how the system might be improved," Gallagher said.

The Beneluxa initiative is not the only such collaboration between EU member states. Bulgaria and Romania signed a similar cooperation agreement, and the Valletta Declaration also provides for enhanced cooperation between and joint negotiations by Croatia, Cyprus, Greece, Ireland, Italy, Malta, Portugal, Romania, Slovenia and Spain on drug pricing.