Health Challenges Mount for Europe


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-12-01-2014
Volume 23
Issue 12

In a health policy world where competition for profile is tough, a vacuum at the top is a serious disadvantage.

Top of the news-even for a column that appears with a schedule only tenuously related to a news agenda-has to be the untimely and unfortunate removal of Guido Rasi from his post as executive director of the European Medicines Agency (EMA), as the consequence of an absurd error in the appointment procedure. But at this stage, that news can be little more than a lament. In a health policy world where competition for profile is tough, a vacuum at the top is a serious disadvantage. Until a successor is appointed, the agency is inevitably going to be limited to business as usual-of which there is plenty, but there was plenty more to be done on forward thinking that will now be put on hold. As soon as the situation becomes clearer on who will take over at the head of the EMA, this column will return to exploring options for the new executive director, and for the agency itself.   

The new health commissioner

Meanwhile, to a new appointment that also has major significance for the world of health in general, and clinical trials in particular, and where we do know who is taking on the job. European Commissioner for Health and Food Safety Vytenis Andriukaitis has now been anointed, and will be one of the key influences on health legislation over the next five years. His appointment follows his gaining the backing of the members of the European Parliament (MEPs) who auditioned him for the job in October. In his audition, he offered some clues as to his approach, and articulated them in a number of commitments. Those MEPs are determined to hold him to his word. So much so that they have listed the commitments in a formal document, quoting verbatim Andriukaitis' observations to the parliament.

So we can now look forward to what he may do with public health systems reform. "I plan to continue work to assess the performance of health systems and underpinning advice on healthcare systems reform," he said. And in response to population ageing and the growing burden of chronic diseases, "I will support efforts to make health systems more efficient and innovative; so that they can provide equitable healthcare to all citizens, while remaining financially sustainable." On primary care and e-health, "I will work on universal health coverage, strengthening primary care, improving quality and safety, promoting e-health." In support of prevention and healthy lives, "I intend to put much focus on enhancing prevention." On bridging inequalities in health, "I will seek to ensure that every initiative on health contributes to bridging the wide inequalities in health that persist in Europe."

On his role in enforcing health legislation, he indicated his determination to push forward the follow-up of the recent European Union directive on patients' rights in cross-border healthcare. This is designed to allow a form of health tourism, in which EU citizens can not only go to other EU countries to be treated, but can expect to be reimbursed for their care. This is also the legislative measure which has provided the first legal base for the EU to work on health technology assessment and on e-health.

The Ebola challenge

Andriukaitis said that he would "also work with member states to protect citizens against any cross-border health threat, with an immediate focus on the Ebola outbreak in West Africa." That challenge has grown in significance even since he made the commitment, as the number of deaths in Africa has risen, and as more health workers have returned from the region to be treated for infection. In fact, Andriukaitis' first trip since he took on the job was to Guinea, Sierra Leone, and Liberia, to make an on-the-spot evaluation of the nature of that challenge.

His focus chimes with the EU's broader efforts to boost the developed world response to the Ebola challenge. Already the European Council has appointed the new commissioner for humanitarian aid, Christos Stylianides, as the coordinator of the EU response, and the EU and its member states have made more than $1 billion available for short- and medium-term efforts. New money has been put into developing new vaccines and treatments, including some $300 million for a joint EU-pharmaceutical industry initiative to boost research into Ebola vaccines and protocols for hospital-infection control. At the same time, preparations are now underway to start clinical trials for new treatments for Ebola at three sites in West Africa. The trials, run in partnership with Médécins sans Frontières (MSF), could yield initial results in early 2015.

Meanwhile, the new health commissioner will have to make progress with ensuring that EU legislation on clinical trials and counterfeiting and pharmacovigilance and a host of other matters is satisfactorily put into effect across the EU, as well as advance a series of strategic discussions on how to make health systems in Europe sustainable while fostering innovation.

- Peter O'Donnell

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