Edition 30 November 2017, by Phoebe Potter
In one of her final acts as Dutch Minister for Health, Edith Schippers has reached out to her European counterparts in a bid to equalise access to medicines across all Member States of the European Union. In a letter sent out at then end of October, Schippers urged EU health ministers to push to regulate the marketing of new drugs approved by the central European Medicines Agency (EMA), in her words, “for the sake of all European patients and citizens, and for the industry as well.” Considered one of the most effective EU agencies, the EMA has effectively neutralized political borders for the assessment of new and innovative medicines, a process that now takes place on behalf of all states under this one body. But once this assessment has been completed, market borders remain rigid for the pharmaceutical companies, who then have the freedom to market separately in each country.
As the system currently stands, when new medicinal products gain a positive assessment from the EMA (marking them safe and effective for use), the European Commission grants the pharmaceutical company authorisation to market to the entirety of the EU internal market, reflecting the increasing integration of the pharmaceutical system across the EU in the last fifty years. This authorisation, however, does not oblige the pharmaceutical companies to market these medicines in every EU country at the same time – or, indeed, at all. In practice, this results in significant disparity between EU states in terms of their accessibility to new medicines, with patients in smaller and lower income countries having to wait months or even years to gain any benefits from the innovations. Since the pricing of medicines is up to individual states, the pharmaceutical companies often market to richer states first, in order to maximise their profit margins, as they can – and do – often charge more in these countries. This selective market introduction means pharmaceutical companies have little to gain from marketing in smaller countries, prompting Schippers’ call for the regulation of this practice by the EU to ensure equality across all states. Asking to make this marketing regulation a “political priority,” she roundly dismissed the current system as “in dire need of rethinking and modernization.” These strongly worded comments came alongside the health ministers’ request for support of Amsterdam’s €2 million bid to become the host city of the EMA, after it is forced to relocate from it’s London headquarters, following the Brexit vote.
In her letter to EU health ministers Schippers wrote that her engagement with pharmaceutical reform was because “pharmaceuticals are an essential part of our health systems and because we have to prepare our system for the future in order to maintain resilient and affordable health systems.” With the council deciding on the new host city of the EMA on the 20th November, Schippers’ timely comments mark a commitment to the innovation of the EMA, which she assured ministers would be continued by her successor after she left office at the end of October, due to the change in government. Her comments echo those of the Netherlands special ambassador for the Dutch candidacy of the EMA, Wouter Bos, who cited the pharmaceutical problem as a “major issue in many states,” that he believes “receives too little attention within the Council and European Commission.” Despite having left her post, Schippers made a guarantee to ministers that the initiative had the full support of Dutch Prime Minister Rutte, who remains in his current position. .