The Netherlands launches initiative for full access to medicines in all EU Member States

When the European Commission grants a central EU marketing authorization for new and innovative medicines, pharmaceutical companies should be obliged to market these medicines in all member states. That is at the core of an initiative launched today by Dutch Minister of Health Edith Schippers. She has send a letter to her colleagues in all EU-member states.

Making an end to selective market introduction

When new medicinal products receive a positive assessment from EMA, the European Commission usually grants the pharmaceutical company involved a central marketing authorization for the entire EU internal market. However, this is no guarantee that patients in all EU member states can benefit from these new medicines. Currently, there is no legal obligation to market medicines in all member states. In many cases, companies choose sophisticated market launch strategies to introduce their products only in some member states or following a certain launching sequence. As a consequence, many patients, especially in smaller or low income member states, are denied access to these medicines or have to wait for months or years. This is an unacceptable situation that needs to be addressed. The Netherlands believes that EU Member States should benefit equally from EU cooperation and the internal market.

Minister Edith Schippers: ‘Strengthening the European cooperation so that patients have timely access to innovative and affordable medicines has been a primary goal during the Netherlands presidency of the European Union in 2016. We take this issue a step further now by specifically promoting ‘union-wide access’ to essential medicines.’

The Netherlands call on the Health Ministers, with the support of the European Commission, to start discussing potential causes and solutions, so that patients in all members states will get equal access to medicines.

During the process towards relocating EMA, The Netherlands special ambassador Mr Wouter Bos has spoken to member states on issues relating the Agency and the role it plays in the EU medicines regulatory system. Bos: ‘The issue of selective market introduction of new medicines was raised in many conversations. It is a major issue in many member states, but receives too little attention within the Council and European Commission. I hope this initiative will change that and that we will be able to work on concrete solutions for this problem that affects many Europeans.’ 

The initiative does not suggest to change the division of competences between the EU level and Member States but aims to create an equal playing field. Member States will still be able to determine the effectiveness and added value of medicinal products and the reimbursement they are prepared to pay.