#EAPM – Moving innovation forward, at least in principle…

| December 31, 2018

The idea of innovation in-and-of-itself is all very well, necessary in fact especially in the health-care sector, but many argue that there is not actually enough often-disruptive, specifically focused and cost-effective innovation, and certainly not enough support for it in the EU, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

The European Commission has set about defining innovation in the context of the Horizon Europe research funding programme, taking into account reservations (and even ‘alarm’) from various interested parties, including MEPs in certain cases, who don’t believe that innovation should be a separate part of this programme at all.

A lack of legal clarity has been cited, alongside a lack of clarity of scope, and democratic illegitimacy not least because critics argue that it undermines the so-called precautionary principle found in EU Treaties, which concerns managing any risk to society coming about due to scientific research. The Commission has argued that its proposed innovation principle ‘aims to keep the EU regulatory framework fit for purpose and future proof in a time of very fast developing technological change’.

The EU Executive says that it ensures that innovative solutions will help to better and more efficiently achieve policy objectives (including delivering better solutions for health), which ultimately improve citizen welfare.

It also argues that it complements the precautionary principle, rather than contradicts it. The Commission perhaps gets a little lofty, however, when it says that the principle “will prove to be a strategic asset for Europe as we begin to regulate areas where the future is not waiting for lawmakers – such as big data, artificial intelligence and automated driving”.

It also tries to blow the arguments apart by insisting that the innovation principle is an established concept, and cites the Commission’s recent Single Market Communications, Communication on Artificial Intelligence and a Renewed Agenda for Research and Innovation.

The Commission’s arguments can be persuasive, yet concerns cannot merely be swept under the carpet. Innovation for its own sake may be of considerable value and interest, but for society to get its full benefit it has to be targeted and a useful addition to the marketplace – especially in health where safety concerns are paramount. For example, proponents of personalised medicine have always argued that we don’t need to replace an older treatment with a newer one if the original works perfectly well. If it ain’t broke, don’t fix it, as the saying goes.

The Commission goes on to mention incentives, saying that innovation takes place amid a diverse collection of these. Meanwhile, it unsurprisingly backs its own role in the great scheme of things by saying regulation matters at all stages of the innovation cycle, “from research and development, to diffusion, commercialization, uptake, and beyond”. It points out the general principle that innovation presupposes an element of novelty and experimentation. The pace of change, particularly in the case of disruptive innovation, it says “may at times be at odds with the dynamics of regulatory processes”. This is hardly ground-breaking news as the fore-mentioned proponents of personalised medicine, among others, have often emphasized that much regulation is failing to keep up with fast-moving science and is therefore, in certain cases, unfair for purpose.

That changing this situation is a challenge, no-one can deny, and regulatory bodies often find themselves playing catch-up through no real fault of their own. Unfortunately, sometimes regulation stifles innovations and, in its own words, the Commission admits that regulation “needs to be designed in a way that creates the best possible ecosystem for the flourishing of innovation”. This is not always the case but, in an ideal world, whenever a policy is developed, the impact on innovation should be fully assessed.

Any innovative idea must, as the Commission notes, find its way from theory to practice. As such may also have relevance to processes and organizational change across sectors. But regulators have to be wary pf creating barriers, such as via red tape, which often stymies innovators by chewing up time and resources.   On the other hand, regulatory certainty can provide a strong impetus for innovation and investment. But it has to be the right regulation.

Easy, right? No, it isn’t. But balance is key.  The EU focusses on three main elements under the innovation principle when looking for the right regulatory mix. These are information, flexibility and stringency. Transparent and equal access to information is an important function and target of regulation, says the Commission, adding that flexible regulation provides outcome-oriented targets and empowers the concerned companies to decide how to meet them. Meanwhile, stringency sets challenging targets and acts as a spur to innovation (except for that nasty old red tape thing, of course).  But standards clearly have to be in place and, realistically, it is difficult to impose such standards without regulation which, when it comes to safety concerns in the arena of healthcare have to be robust, to say the least.

The Commission has also taken a look at how to make the innovation principle ‘work’. It says: “It is necessary to account for the different categories of regulation and ensure that synergies between policy areas are created.” General regulation, it states, affects innovative activities by providing the overall framework for business and research activities…(and)…affects in particular the balance of expected risks and benefits associated with entrepreneurial efforts. It is quite clear that what is needed, not least in health care, is an innovation-friendly regulatory network. And that includes incentives.  Innovation and the incentives for it are vital to health and wealth in the current EU-28 and will be even more important after the UK leaves at the end of March.

It also encourages investment from outside of the EU. Innovative modern trial designs are emerging as a patient-centric approach to drug development, and the rise in public-private partnerships and other collaborations is bringing about complex clinical trial designs, which poses significant challenges for health-care systems and regulatory approval. There are now loud calls for a major evolution of policy and processes, particularly regulatory requirements for approval for new therapeutics. Health-care systems are being left flailing in the wake of a huge wave of new discoveries and methodologies. A new, up-to-date paradigm is required, and it is up to all stakeholders, including regulators in the Commission and elsewhere, to deliver it.

Europe has often been shown to be slow in taking account of new technologies, and politicians and specifically those implementing legislation need to ensure that this is no longer the case. The Commission is flying in the face of resistance in some quarters to its innovation principle, but the very acknowledgement of the modern-day need for one is a step in the right direction. At least, we all hope so…

Category: A Frontpage, EU, European Alliance for Personalised Medicine, Health, Personalised medicine