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The Dutch Presidency appears to be keeping its cards close to its chest as far as pharmaceuticals and public health are concerned. So far, they seem to have been purposefully ambiguous about their intentions and have not put forward any concrete proposals on the issues they highlight as priorities, namely anti-microbial resistance (AMR), pharmaceuticals, food product improvement, eHealth & innovation, dementia and medical devices.

They have not been forthcoming about the Council conclusions at the end of their Presidency either.

by Yannis Natsis, Policy Coordinator Universal Access and Affordable Medicines

The Dutch Presidency appears to be keeping its cards close to its chest as far as pharmaceuticals and public health are concerned. So far, they seem to have been purposefully ambiguous about their intentions and have not put forward any concrete proposals on the issues they highlight as priorities, namely anti-microbial resistance (AMR), pharmaceuticals, food product improvement, eHealth & innovation, dementia and medical devices.

They have not been forthcoming about the Council conclusions at the end of their Presidency either.

On January 13, the Dutch attaché informed his colleagues at the Working Party on Public Health that in the field of pharmaceuticals, the Presidency will focus on “redefining checks-and-balances in the European pharmaceutical system” and examine “current & future challenges for pharmaceutical policy in Europe”. He stopped short of offering further insight and referred to the expert meeting on pharmaceuticals, market access, HTA bodies and payers scheduled to take place on 1 and 2 March in Amsterdam. He added that the March meeting will determine the next steps.

Nevertheless, Dutch Health Minister Schippers has been more explicit. During her recent presentation before the ENVI Committee of the European Parliament, she echoed a lot of the concerns of the public health community. She identified the issue of affordability of medicines as a key issue, criticized “patent monopolies” and questioned the “necessity” of the patent system. She did not stop there; “the current prices have no clear relationship anymore with the research and development costs or even with the added value of medicines” she noted and surprised many of us with her very straightforward style.

…And here comes the tricky part: it is difficult to believe that the Dutch do not have a clear idea of what they wish to achieve regarding pharmaceuticals during their Presidency. At the ENVI meeting, Minister Schippers explained what in her view could constitute a possible way out of the conundrum of high medicines pricing, of medicines-quality of innovation-patent system and that would be to offer manufacturers faster market access for their products. This complements the ongoing discussions on different levels on the role of Health Technology Assessment (HTA), the cooperation between the Netherlands, Belgium and Luxembourg, the pilot project on adaptive pathways and the Priority Medicines scheme (PRIME) of the European Medicines Agency (EMA), the work undertaken by the STAMP working group of the Commission on reviewing current fast track routes for medicines, to name but a few.

For now, the Presidency lists the problems, but not the solutions it recommends. It is puzzling for instance, that adaptive pathways are endorsed as one of the tools, while numerous worrisome signs point to medicines ending up with even higher price tags. On a similar note, the Minister rightly questions the suitability of the patent system but at the same time, the Presidency considers additional IP incentives for the development of antibiotics.

One thing is certain, the coming months will be far from quiet.

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