#EAPM: Recent innovations in the health-care arena

Imagine a conversation between a healthcare stakeholder (Iain) and a non-medical journalist (Amy). The latter is interested in the subject of innovation in health care, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Amy: OK, let’s start… Can you give me an example of recent innovations in the healthcare arena?

Iain: Certainly, but let me begin by saying that innovation is key to health and wealth in the EU. It’s often been shown that the healthier a country is, then the wealthier it is, because the population tends to work longer and take less time off work. Also, therefore, people spend less time in expensive hospital treatment. Essentially, by working and paying tax, they are topping up the wealth rather than draining it

Viewed historically, there is no doubting the importance of investment in better health, often through innovation, as a way to promote economic growth. Reliable financing is important for entrepreneurial activity and, thus, the innovation to which you refer.

As well as this, length and quality of life improves for everyone. Life expectancy in Europe is going up-and-up, largely as a result of innovation in the healthcare sector, alongside better lifestyles and diets.

As for particular examples, you only have to look at the great leaps in genetic science, imaging techniques and apps that send information back to your doctor, to see how fast science is moving. Meanwhile, the development of new drugs and treatments for cancers is having a significant impact and the emerging field of personalised medicine, which aims to give the right treatment to the right patient at the right time, is quickly gaining ground.

The latter relies heavily on genetic science and also heavily on medical Big Data, which needs to be gathered, stored, shared and used efficiently - albeit under robust ethical and privacy rules.

Amy: OK, so with all this marvellous technology, why are some medicine prices really high, and why does it take so long - up to 15 years - for some medicines to reach the market?

Iain: To a degree you’ve just answered your own question. Because medicines have to be rigorously tested for safety and efficacy, and need to meet very high standards before being approved for the market, there is a significant time lapse. 

Prior to this stage, there are years spent in development and in clinical trials, which also significantly extend the bench-to-bedside timeline.

Amy: So this has an impact on prices, then?

Iain: Yes, of course. Innovation rarely comes without a financial cost. The reason in this case being that pharmaceutical companies spend hundreds of millions of euro developing a drug and there is a high risk that a) it will never get to market and b) even if it does, the company may not get its money back. 

This is especially the case for drugs that treat rare cancers. By definition, the market is small, so the prices are necessarily high as there are currently not enough incentives, or a suitable reimbursement system in place to encourage innovative medicines.

This can, and does, lead to many patients being denied novel drugs and treatments that could extend and improve their lives and, in some cases, actually save it.

Amy: Is cost the only barrier to innovation?

Iain: No, there are several, actually. Among the barriers to integrating innovation are a lack of education and awareness, a need for greater patient empowerment, the recognition of the value of personalised medicine, the collection, storage and sharing of vital research data - Big Data as mentioned - and problems with access to care.

Amy: What can the EU do about this?

Iain: Given that healthcare is a Member State competence, the answer is ‘only so much’. OK, with recent legislation on IVDs, clinical trials and data protection, the EU has had an impact in the healthcare arena.

Fortunately, the EU recognises that innovations in healthcare can contribute to health and well-being of citizens and patients through access to new products, services and treatments that have added value. But, given your question, there is clearly a need for an up-to-date incentives and rewards structure to push forward research.

Also, achieving necessary synergies between individual Member States and the Commission requires improvements to enable applicants from all countries to secure optimal access to EU funding programmes, where they exist.

Amy: Let’s talk more about incentives and investment, where they exist…

Iain: OK. Innovation encourages investment from outside of the EU, which is obviously good for business and jobs. Unfortunately, there is an acute shortage of private sector capital available for research of all types, including SME medical research, for example.

The healthcare sector, and in particular the innovative research, treatments, data streams, new education and unprecedented collaborations that come with personalised medicine, can be a prime driver of the EU’s economy and help to unlock much-needed investment that is currently lacking.

It is absolutely essential to ensure, in terms of healthcare, that revising measures are adopted, including establishing favourable regulatory mechanisms for venture capital funds to invest long term in healthcare research and development.

Amy: Tell me more about incentives…

Iain: Well, let’s start from the fact that the pharmaceutical industry relies on workable incentives - as they invest millions, sometimes billions. But, as I suggested earlier, there is clearly a need for an up-to-date incentives and rewards structure to push forward research.

Again, as I’ve said, industry has a problem with producing new drugs, especially for smaller markets - rare cancer sufferers, for example - as the chances of them getting their money back under current systems are slender without charging high prices. This, in turn, leads to a lack of take-up of the drugs by healthcare systems across the EU.

Despite some incentives, there is a big gap between what drugs are out there and what medicines are authorised. Labyrinthine regulations that govern such products need to be simplified to ensure a swifter take up of such drugs while obviously bearing in mind safety and efficacy in all cases.

Reform is necessary because SMEs and academic institutions are often deterred from entering programmes by the complexity of the submissions process to access EU research budgets, as well as the costs involved in doing so.

In effect, one of the biggest challenges for innovative researchers and companies in the healthcare sector is in finding finance. As you now know, Amy, healthcare innovation is expensive and the risks are similarly high. A close scrutiny of, and changes to, the current system for incentives and reimbursement, right across Europe, is absolutely necessary.

Amy: So how does it look from the perspective of potential investors?

Iain: Well, clearly investors need to feel confident in regulatory frameworks for a start. Then add to the mix a necessary belief in the quality of research, the number of talented innovators and tomorrow’s growing EU economy.

They also need to feel confident that the end product will be used in the best way possible. This means that we need to find ways to keep healthcare professionals up-to-date with the fast-moving developments in healthcare.

To this end, Europe needs to invest in ongoing training programmes and communication skills, as well as find ways of increasing awareness of personalised medicine options among Europe’s patients, therefore helping to empower them. In the end, it should be all about the patient.

Amy: Thank you.

Iain: You’re welcome.

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