Brian Edwards, CBE
University of Sheffield, UK
HOPE (European Hospital and
The EU has recently been exploring the future of medicine and healthcare at a seminar in Brussels entitled ‘European Perspectives in Personalised Medicine’. The basic premise is that at some point in the future, science will enable treatment to be related directly to the characteristics of the individual patient. Evaluating which drugs will work for which patient will herald a new era in medicine. Some think it will be horrendously expensive but others think it will produce massive savings, as medicines would be prescribed only for those who would receive a clear benefit. John Dalli, the Maltese Commissioner, highlighted the potential of personalised medicines to provide solutions better tailored to patient groups, rather than the ‘one size fits all’ medicinal products of today. Adverse reactions could be reduced and become more predictable. Dalli also said that developing and bringing this technology into routine clinical practice represents an enormous challenge, one that needs a long-term and well-structured plan.
Personalised medicine is of course very complicated. Diseases need to be reclassified to reflect up-to-date knowledge on human biology, and many diseases have complex variants, which demand different treatments. Patients will need to be stratified according to their molecular profiles to get the best results, and the rate of discovery and validation of biomarkers will need to increase. Genomic-based diagnostics has already shown its potential in some disease areas. For example, in the USA, a study has been approved that uses genetic tests to establish the correct dosage of warfarin in individual patients.
Regulators will have to respond to the challenge of personalised medicine by creating space for innovation and the rapid uptake of novel approaches. So, who will undertake the tests to inform the prescribing of personalised treatment? Will it be another arm of the hospital laboratory, the pharmacist or a whole new industry that sits astride traditional pharmaceuticals and diagnostics? Will the professional training of pharmacists need to be radically changed? The encouraging news is that the EU is already considering modifications to accelerate progress.
The EU is due to publish an Omics report in 2012 and plans to follow this with a public consultation. Naturally, the general public will want personalised medicine to take effect immediately. But can it be afforded? The answer must be yes; however, the science itself will dictate the time frame for initiation of the process.
Ideally, the development work could be prioritised into areas that offer the greatest clinical benefit, although this seems unlikely, as economics will dominate. Rare, well-researched genetic diseases might be an early priority. The EU could influence the process with economic incentives, although many will be wary of intervention by the EU into a new and emerging science-based industry. Regardless, it seems unlikely that the Commission will get the required budget increase for the next five years, which will inhibit their freedom of manoeuvre. Individual countries might be tempted to intervene through their research and development programmes and currently this looks like the best prospect