I never got to fly Concorde, the world’s first (and so far only) supersonic commercial airplane. One colleague, having experienced the flight, described how, after half an hour in the air, there is a “second take-off” accelerating from 1000 km/h to supersonic speed. I think biopharmaceutical research is about to experience a second take-off.
Professor Bengt Jönsson, adviser to the European Commission on investment in health, recently reminded an audience about the transformative changes in the late 60s and 70s. The new regulatory standards introduced 50 years ago, being celebrated in Brussels today, catalysed a boost in innovation. The requirement to show safety and efficacy for new medicines did not kill innovation, as some people claimed at the time. It did the opposite. Many of today’s basic medicines, which are available as affordable generics, were developed by my member companies in this era: antihistamines against allergy; beta-blockers against high blood pressure; SSRIs against depression; and beta-agonists for asthma – just to mention a few.
Prof Jönsson suggested that we are now in a similarly transformative era. This time it is a combination of scientific progress (genome mapping, epigenetics, use of big population data etc. etc.) and tougher requirements to show added value. To bring a new medicine to patients in Europe these days not only requires a regulatory approval from the European Medicines Agency (or a Member State medicines agency), you also need to show to health systems, including their “payers”, that the medicine is worth the money. We are moving rapidly to a model in which companies will get paid based on the achieved patient outcomes. This requires better tracking of performance and new payment models, such as when the optimal care pathway includes different services (diagnostics, devices, medicines, and supportive care) and a combination of medicines. The evolution towards paying for outcomes will not kill innovation. It will do the opposite. We will have a second take off.0