Europe's Anguish Over New Drugs Isn't Subsiding Anytime Soon

You'd better get used to it. Whether the EU stays together or not after the UK's June referendum on leaving (and if it does go, others will be tempted to follow), all the countries of Europe are going to remain as preoccupied as they are today over how to afford good new medicines. And the navel-gazing over how to set up systems that can sustain drug spending are going to continue for years to come.   It's only a straw in this gale-force wind, but one of Europe's main annual policy meetings – the health forum held each autumn in a mountain resort on the edge of the Austrian Tirol (http://www.ehfg.org/conference.html) – has already programmed a series of reflections on and around this tangled area. In the face of population aging, the rise of multimorbidity, increased societal diversity and migratory pressures, "health systems need to respond" says its preliminary announcement. And to seek responses, it will wheel out national health ministers, senior officials from the World Health Organisation and the European Commission, and leading figures from industry, patients, research, regulators and payers, as well as Nobel prizewinning economist Paul Krugman.   Sessions will explore whether sustainable cancer care is just science-fiction, the role of health technology assessment and prevention in the context of personalized medicine, the balance between medical need and economics in developing advanced therapy medicines, whether successful treatments for Alzheimer's will reduce or increase healthcare costs, and how far integrated care pathways can tackle rising multi-morbidity. And bare-knuckle questioning is promised on the acceptability, the fairness and the justification for expensive medicines, and whether the rules on profit and payment need to be changed.   But longer-term and more ambitious planning is underway in government departments right across the continent. The Netherlands and Belgium are on the brink – they say – of announcing how they will put into effect the plan they have concocted for working together on joint negotiation of drug purchasing with drug firms in the years to come. Luxembourg has already joined the party, and similar joint negotiation or joint procurement schemes are springing up elsewhere – notably in Bulgaria and Romania, and in the framework of an EU-led mechanism that is just coming into use for joint purchasing of medical supplies to counter cross-border health threats.   In a bid to get a handle on evaluating the merit of new medicines, a three-year program of health technology assessment is scheduled to kick off in June that will see national and regional HTA agencies across Europe making a new attempt to find common ground. Their aim is not just to give drug firms a clearer idea of what relative efficacy evidence they will also need to develop while they are running their clinical trials to satisfy authorization authorities. The principal objective is to equip payers with better information for making reimbursement decisions.   Interest is rising everywhere in the idea of wider consultation at the earliest stage of trial design, so that the views of HTA bodies, patients and even payers can be taken in to account alongside the opinion of regulators. A meeting in Brussels of national health officials in late May reviewed such early dialogue initiatives by the European Medicines Agency and the outcome of pilot programs on similar collaboration. It also previewed planned action by the European Commission in “next steps in the EU cooperation on HTA”, and were given a sneak-peek at a “HTA Regulatory and Reimbursement Atlas” that is under preparation. As a new report on the Innovative Medicines Initiative remarks, if payers are not engaged at an early stage, “the danger is that work will be done on the development of medicines that no one is prepared to pay for.”   The challenges and potential of big data and of personalized medicine and adaptive pathways are going to receive thorough scrutiny throughout the year at a series of major European conferences, all taking place against this background of impending crisis, and all urgently seeking to identify the most efficient ways of moving medicines from concept to clinic. And in country after country, the options are under intense study for saving money by shifting to wider generic use, or to mandatory substitution of expensive speciality medicines with biosimilars, or to off-label prescribing of cheaper alternatives to expensive medicines.   Right now, all bets are off on how UK citizens will vote on June 23, and the fall-out for the UK and for the EU is still impossible to accurately forecast. But what is indubitable is that whichever way the EU itself goes at political level, in every country of the continent the needs will persist at human and public health level for more effective medicines, and for more effective ways of paying for them.