This is the first of three reports from The Future Delivery of Medicine, a conference held at University College London on 5 and 6 November 5. The second and third reports will be published over the next two weeks.
Chris Brinsmead from the Association of the British Pharmaceutical Industry: cut costs and feed the savings back into innovation.
New health treatments arising from the convergence of once-disparate branches of science, including biopharmaceuticals, diagnostics, medical devices, imaging, sensors and information technology, require new approaches to approval, reimbursement and application.
Policy for the future
The conference provided a showcase for new health treatments and management and delivery systems arising from the convergence of biopharmaceuticals, medical devices, diagnostics, sensors, imaging, bioinformatics and information technology, among others. At a private meeting before the conference a group of experts singled out the strands that must be weighed in formulating future healthcare policy to enable the benefits to be realised.
Read the discussion points here.
According to Brinsmead, four critical factors must be considered in rethinking and reshaping the development and delivery of new treatments: value, access, innovation and trust.
Greater understanding of the value of medicine – not just in a clinical sense – but in terms of the personal and societal value of being healthy, and the savings made elsewhere, should prompt governments to reimburse for all indicated patients.
From this perspective it follows that if a treatment is effective, everyone who needs it should have access. This would, in turn, give companies the returns needed to invest in R&D, thus driving innovation.
And to extract the most value from that innovation there must be greater trust, enabling industry, academics and regulators to work together more productively.
No heroes, no villains
Mike Spyer, Vice Provost of UCL, agreed. “The old ways in which universities and pharma interact are no longer sustainable. There are no heroes and villains: we need to rethink the processes.”
Regulation is another issue that must be tackled. “We need regulation, but not regulation that impedes progress,” Spyer said, adding that much of the problem was caused by a “terrible conservatism” towards risk.
Personalised medicines offer a potent exemplar of why regulators need to rethink their views of risk and reimbursement authorities need to take a different view of value and affordability, Erik Tambuyzer, Senior Vice President of Genzyme Corporation, told the conference. Such personalised, for which read targeted, medicines will work on smaller groups of people. While this will reduce side effects, it will make it harder to satisfy regulators by running large-scale placebo-controlled trials
However, it is fair to expect the benefits will be greater, increasing compliance. “There will be savings on one hand, but higher costs of development,” said Tambuyzer.
Another consequence of the ability to finely tune treatments will be the need to develop diagnostic tools to identify the sub groups that will benefit said Stephan Mumenthaler, Head of Economic Affairs at Novartis. “This has consequences for the industry and the regulatory authorities. You need to bring all aspects together.”
Challenge of convergence
Georgette Lalis, Director in the European Commission’s Directorate General of Enterprises and Industry, agreed. “Convergence of technologies is a big challenge for regulators.” At present Europe has separate regulatory systems for drugs and devices, but more combination products that marry a device with a drug or a human tissue are coming through the pipeline.
“We are conscious of the need to bring the two together, without forgetting that devices and drugs are different,” said Lalis.
One positive consequence of applying new healthcare technologies will be a change in attitudes to patients, who will be enabled to take on more responsibility for their own health, believes Oern Stuge, President for Europe and Central Asia of the diagnostics company Medtronic. It is now possible, for example, for diabetics to monitor their blood sugars in real time, 24 hours per day. “Such technology helps patients to look after themselves,” said Stuge.
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