Applied Clinical Trials
Officials tackle such areas as early diagnosis and treatment, patient access, and personalized medicine
With Europe’s chief architect of health policy approaching his first anniversary in office, it is a good time for assessing performance and refining the definition of objectives. And that is just what the European health commissioner, Vytenis Andriukaitis, did as the Brussels summer rose to a brief peak in July.
Outlining his “aspirations and hopes” for the four years that he is due to remain in post, the commissioner placed most of his emphasis on prevention in a set-piece speech he delivered to a Brussels think tank. At first glance that may not appear to throw much light on his ambitions for the activities that preoccupy most readers of this publication-clinical trials, research and development, diagnosis and treatment, product authorization, and, arguably, pricing and reimbursement.
Perhaps not so surprising. Because although Andriukaitis is titular head of health policy, his role is circumscribed by the underlying constitution of the EU: its treaty. Healthcare system reform is, he admitted openly, “a responsibility of the member states.”
Maximizing his role
But the commissioner is determined to maximize his role-and that could have a positive impact, too, on those whose job is designing, developing, and delivering care. “I want to see real results at the end of my mandate, not only talk,” he said, citing his tangible achievements as a practicing physician for 27 years, as a member of the Lithuanian parliament, and as his country’s health minister. “I produced practical solutions, and I want to believe that I have an added value at the EU level,” he insisted. So he has committed himself to “striving for health to be included in all policy areas, and ensuring that the European Commission puts the health of European citizens first.”
Andriukaitis’ focus was on “healthy citizens, efficient and equitable health systems, and a thriving health sector.” And he did not shy away from the recognition that this needs expenditure-but he made it clear that he regards health expenditure not as a cost but as an investment. It is time, he said, for “a serious discussion about economic language.”
It is also time, he said, for governments to pay more attention to early access to screening, diagnosis and treatment, and vaccination, he said. He has already launched an expert study assessing health systems performance across the member states, which is developing tools to influence policy-making at national and European levels, with a focus this year on quality of care.
Access to medicines
The commissioner is also responding to what he sees as “an increasing interest among member states to reflect jointly on how to increase patient access to innovative medicines and foster discussion on pricing.” That is almost certainly good news for drug developers dismayed at Europe’s increasingly evident confusion over pricing and reimbursement. And the good news is further embellished by his commitment to “promote cooperation among member states on health technology assessment.” The situation won’t change dramatically tomorrow, but a start to some more coordinated thinking on these most thorny of issues is long overdue. And it cannot do any harm that Andriukaitis is-as he says-“ready to support such reflections.”
There is also some potentially good news in the commissioner’s attachment to creating a series of centers of excellence for highly-specialized healthcare providers-known as European Reference Networks. A major conference in Lisbon in October will spell out just where progress is being made, and an invitation will be issued early next year for organizations to sign up to the scheme. Ultimately, this could provide some top-level treatment centers combining the best of Europe’s often scattered expertise, with a positive impact on drug development and delivery. “Cooperation across national borders will serve to spur innovation in healthcare,” he predicted.
The commissioner’s forthright commitment to tackling antimicrobial resistance also bodes well for drug developers. He promised to review what the EU can do to remedy the deficiencies in antibiotics, and undertook to continue the Commission’s active involvement on the issue “internationally, including through G-7, WHO, and other organizations.”
For the record, he also noted what he had been doing over the past year-notably helping tackle Ebola virus in Africa, confronting the health challenges raised by migration, and exploring the health dimension of the EU’s new strategy to create a digital single market-including e-health, telemedicine, electronic prescriptions, and mobile health applications. And for this, he added, the EU dilemma over data protection “must be addressed without delay.”
But Andriukaitis concluded with a plea-one that the clinical trial community might like to take account of: “I am here to drive the issues at a European level, but the discussions have to make their way through you as well. ... I am here to steer the policy but I cannot do it alone.”
There were some further signals of things to come-although over a shorter time-frame-when the newly-appointed president of the EU council of health ministers (regular readers will recall the bizarre EU custom of rotating the council presidency every six months-it is Luxembourg until December) briefed the European Parliament just days later on plans for the rest of this year. Lydia Mutsch, the Luxembourg health minister, emphasized the importance of innovation, and particularly patient-centred innovation.
She focused on personalized medicine; the presidency already held a conference on this at the start of the month, and Mutsch said the aim is to build on the messages from that meeting to produce formal conclusions at the meeting of health ministers in December. Innovation, she said, should be integrated into clinical practice so everyone can obtain access to advanced personalized medicine. Prospects for this are enhanced by the fact that the Dutch presidency-which will follow the Luxembourgers for the first half of 2016-also plans to focus on innovation in medicines.
The conference was entitled "Making Access to Personalized Medicine a Reality for Patients," and its avowed aim was to assess the obstacles to integrating personalized medicine into Europe’s healthcare systems.
The Luxembourg initiative has won praise and support from the European Alliance for Personalized Medicine, which has already scheduled another conference on the theme for next spring-during the Dutch presidency of the council. Mary Baker, of the European Brain Council and a leading figure in EAPM, underlined the need for collaboration "to help speed a process that currently takes a medicine around 13-and-a-half years to get from bench to bedside.”
Maggie de Block, Belgium's Minister of Public Health, added her support, too. She said that developing personalized medicine is not only a challenge for scientists and innovators, but also a call for creative policymakers to introduce more effective early diagnoses, and safer and better tailored treatments for patients.
As the saying goes, one swallow does not make a summer. But there is some consolation to be derived from the readiness of at least some of the EU's top people on health to look ahead at medicines development.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.